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#Study Description
Brief Summary
This study is being conducted in healthy subjects and in subjects with a mild or moderate decrease in GFR (subjects with renal impairment).
Detailed Description
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
#Intervention
- BIOLOGICAL : MGTA-145
- MGTA-145 will be given intravenously
|
#Eligibility Criteria:
Inclusion criteria for all subjects:
* Age from 18 <= age <= 79, inclusive, at the time of signing of the ICF.
* Body weight >=50 kg and BMI 19 to 40 kg/m2, inclusive.
* Systolic blood pressure <=170 mmHg and diastolic blood pressure <=100 mmHg at Screening and Day 1.
* No clinically significant abnormalities on physical examination at Screening.
* Alanine aminotransferase and aspartate aminotransferase up to 1.5 x the upper limit of normal (ULN) as long as total bilirubin and alkaline phosphatase are <= ULN.
* No clinically significant abnormalities on ECG and QTcF <480 msec at Screening.
* Female subjects are not pregnant, non-lactating, and must be of non-childbearing potential being either surgically sterile (eg, documented hysterectomy, bilateral oophorectomy, bilateral salpingo oopherectomy, tubal ligation) or post-menopausal women (> 45 years with 12 months or more amenorrhea verified by follicle stimulating hormone assessment and the absence of other biological or physiological causes).
* Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception (such as condom with spermicide) combined with an acceptable method of contraception for their non-pregnant female partner(s) after informed consent, throughout the study, and for a minimum of 90 days after the last dose, and who do not intend to donate sperm in the period from Screening until 3 months following administration of the study drug.
* Subject using medications known to affect the elimination of serum creatinine (eg, cimetidine, trimethoprim) within the past 30 days.
* Capable of providing informed consent and willing to comply with the requirements of the protocol.
Specific inclusion criteria for subjects with NORMAL renal function:
* Estimated GFR (based on MDRD equation) >=90 mL/min/1.73 m2 (normal) as determined by an average of 2 values obtained at least 48 hours apart within the previous 3 months.
* White blood cell (WBC) count, hemoglobin and platelet count within normal limits. Absolute neutrophil count of >1500/µL for African Americans and >2000/µL for other races.
Specific inclusion criteria for subjects with RENAL IMPAIRMENT:
* Estimated GFR <90 mL/min/1.73 m2 (based on MDRD equation) as determined by an average of 2 values obtained at least 48 hours apart and within the previous 3 months.
* Stable renal function as determined by <20% difference in serum creatinine obtained on 2 occasions at least 48 hours apart and within the previous 3 months.
* Platelet count >=100,000/mm3, hemoglobin count >=10g/dL, WBC count within normal limits. Absolute neutrophil count of >1500/µL for African Americans and >2000/µL for other races.
Exclusion criteria for all subjects:
* Clinically significant abnormal finding on physical examination conducted at Screening. The assessment may be repeated once prior to treatment number assignment. If the repeat value(s) remains outside of protocol-specified ranges, the subject will be excluded from the study. Note: Re assessment is not allowed for subjects who have a positive urine drug screen test at Screening.
* History of chronic alcohol or drug abuse within the previous 12 months. Subject has a positive pre-study drug/alcohol screen (to include at minimum: amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepines, and myelosuppressive drugs). A subject with a positive finding on the drug screen may still be enrolled at the discretion of the Investigator if a plausible clinical explanation exists (eg, prior or concomitant medication use).
* History of kidney transplantation or requiring dialysis or anticipated to initiate dialysis during the study period.
* Donation of more than 500 mL of blood or plasma within 12 weeks prior to dosing.
* Subject smokes more than 10 cigarettes per day (or equivalent) or has done so within 6 months prior to the Screening Visit.
* Acute illness, infection (requiring medical treatment [eg, antibiotics]), or surgery within 30 days of dosing.
* Seropositive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus.
* Subject has received another investigational drug or participated in an investigational device study within 30 days prior to dosing.
* History of anaphylaxis or clinically important reaction to any drug including plerixafor.
Specific exclusion criteria for subjects with NORMAL renal function:
* Any clinically significant laboratory value outside the normal range at Screening. The assessment may be repeated once prior to treatment number assignment. If the repeat value(s) remains outside of protocol-specified ranges, the subject will be excluded from the study. Note: Re assessment is not allowed for subjects who have a positive urine drug screen test at Screening.
* Any clinically significant hematologic, cardiovascular, pulmonary, central nervous system, metabolic, hepatic, or gastrointestinal conditions or history of conditions that, in the opinion of the Investigator may place the subject at an unacceptable risk as a participant in this study or may interfere with the interpretation of the study results.
* Subject has used any prescription drugs within 14 days prior to dosing or any dietary supplements or non prescription drugs within 7 days prior to dosing unless deemed acceptable by the Investigator and Sponsor (Magenta Medical Monitor).
Specific exclusion criteria for subjects with RENAL IMPAIRMENT:
* Presence of acute kidney injury.
* Clinically significant laboratory abnormalities excluding those associated with renal impairment or the underlying cause of renal disease.
* Unstable medical condition or underlying medical condition that has changed within the past 90 days.
* Presence of laboratory abnormalities or clinically significant medical condition that in the opinion of the Investigator may place the subject at an unacceptable risk as a participant in this study or may interfere with the interpretation of the study results.
* Changes in prescription medications within 14 days prior to dosing or anticipated changes during the study period.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04154670
|
{
"brief_title": "Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment",
"conditions": [
"Healthy",
"Renal Insufficiency"
],
"interventions": [
"Biological: MGTA-145"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04154670",
"official_title": "An Open Label, Single Arm, Single Dose Study to Evaluate the Pharmacokinetics and Safety and Tolerability of MGTA 145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-24",
"study_completion_date(actual)": "2020-03-24",
"study_start_date(actual)": "2019-11-07"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-11",
"last_updated_that_met_qc_criteria": "2019-11-05",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-11-06",
"first_submitted": "2019-11-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Septoplasty is one of the most performed surgeries in rhinology as a solo procedure, or in combination with sinus surgery. The procedure for septoplasty and postoperative management has evolved over time based on several studies that have been done. The current standard of care in our centre is to conduct a septoplasty using quilting technique and apply Doyle splints in both nostrils to stabilize the septum for 6 days. However these splints are associated with morbidity in the post-op period. The quilting technique was developed to prevent complications and stabilize the septum. This study examines the efficacy of these splints in stabilizing the septum and preventing complications after septoplasty
Detailed Description
1. Purpose
To compare the success rate of septoplasty in correcting the nasal septal deviation (with regards to nasal obstruction and intranasal access) among patient who used Doyle splints and those who did not. The investigators will also determine if patient's quality of life in the postoperative period is affected by the use of Doyle splints or not.
2. Hypothesis
Is there a significant difference in success rates of septoplasty in patients who used a Doyle nasal splint when compared with patients who did not use the Doyle nasal splint? Null hypothesis There is no significant difference in success rates of septoplasty in patients who used a Doyle nasal splint when compared with patients who did not use the Doyle nasal splint.
3. Justification
Currently in most North American rhinology clinics, nasal splints are used after septoplasty (using the quilting technique) to improve stability of the nasal septum. The quilting technique in addition to reduction of other complications was developed to improve septal stability after septoplasty. No study has been conducted to examine the efficacy of using only the quilting method when compared to the current standard of care which adds extra cost to the surgery. This study aims to evaluate the efficacy of the quilting technique in improving stability of the nasal septum among patients using nasal splints and those not on nasal splints after septoplasty.
A recent study (Objective usefulness of thin silastic septal splints after septal surgery; i Jung, M.D., Kim, M.D. et al Am J Rhinol Allergy 25, 182-185, 2011) has shown Insertion of a silastic septal splint after septal surgery should be accepted as a routine procedure. Our study is aiming to show that quilting suture in x-shaped fashion technique is as effective and safe as using them yet avoids the potential complication of discomfort/pain/toxic shock syndrome etc.
The essence of this study is to show that using the quilting suture technique alone without splints is as good as when used with splints. No other study has been done to investigate this.
4. Objectives
Primary Objective To compare the success rate of septoplasty in correcting the nasal septal deviation (with regards to nasal obstruction and intranasal access) among patient who used Doyle splints and those who did not.
Secondary Objectives To determine if patient's quality of life in the postoperative period is affected by the use of Doyle splints or not.
5. Research Method
This is a Single blind Randomized Control Trial.
Procedure
The study population will be consecutive patients diagnosed with nasal septal deviation and who are undergoing nasal septal surgery. It will be a single blind randomized control trial. Allocation concealment will be ensured by the use of sequentially numbered, opaque, sealed envelopes. An assessor blinded to which patient is using Doyle splints will assess the primary outcome.
Consent will be obtained for this study prior to the surgery.
Blinding The study will be single-blinded study. The patients will be randomized into 2 arms/groups. An assessor blinded to which patient got the Doyle splints will assess the primary outcome.
There will be two possible scenarios resulting from randomization: All patients will undergo septoplasty using quilting technique.
A. The Doyle splint will be places in both nostrils of the patient after septoplasty. The doyle splints will be removed 6 days after surgery as per standard of care. No other procedures will be changed during the surgery.
B. No Doyle splints will be placed in the nostrils of the patient after septoplasty. All standart of care visits will remain the same.
The PI will be the blinded assessor. The choice of which patient gets a Doyle splint will be randomized using the sealed envelope system mentioned above.
The randomization will be balanced to ensure that both arms have patients with extensive surgeries as well as isolated NSRs
6. Statistical Analysis
Sample size calculations Due to lack of data on failure rates of septoplasty in our centre, an a priori sample size calculation was used to determine the number of participants required to adequately compare the use of nasal splints. Given that this clinical trial is designed to investigate equivalency between the use of nasal splints and the lack thereof, an equivalency sample size calculation was performed. An equivalency limit of 5% was considered clinically significant from consultation with our expert rhinologist. A previously conducted study estimating failure and revision rates have estimated that the failure rate was 8%16. If there is truly no difference between the use of splints or lack thereof, then 88 patients (44 patients per group) will be required to be 80% sure that the limits of a two-sided confidence interval will exclude a difference in means of more than 5%. Accounting for dropout rates of 10%, a total of 96 patients (48 patients per group) will be required for this study.
Statistical Comparisons The primary objective of this randomized controlled trial will be to compare the success rates of septoplasty in patents with and without use of nasal splints up to 90 days post-surgery. Count and absolute percentages of rates will be reported. The Chi-Squared test will be used to determine statistical significance between rates. Probability values less than 5% (α=0.05) will be considered significant. Corresponding odds ratios and 95% confidence intervals will be reported.
For the secondary outcome measures (e.g. VAS, NOSE), results will be summated and considered as continuous, numerical variables. Descriptive statistics using mean, median, standard deviation and inter-quartile ranges will be reported. The unpaired two sample student t-tests will be applied to investigate the difference between the means of the various outcome measures. Probability values less than 5% (α =0.05) will also be considered statistically significant.
Baseline demographics and clinical factors will be compared between each treatment group to determine whether randomization yielded comparable groups. Multivariable logistic and linear regression will be used to investigate the relationships in the primary and secondary outcomes.
#Intervention
- DEVICE : Doyle Splint
- Using Doyle splints following septoplasty is the standard of care and may help with stability of the septum in the immediate post op period. owever these splints are associated with morbidity in the post-op period. The quilting technique was developed to prevent complications and stabilize the septum. This study examines the efficacy of these splints in stabilizing the septum and preventing complications after septoplasty
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients 19 years and above diagnosed with deviated nasal septum using the Mladina septal deviation scale who are complaining of nasal obstruction and/or sinus disease
* These patients will also be undergoing a nasal septoplasty either as a standalone case or as part of endoscopic sinus surgery and/or resection of the inferior turbinates. These surgeries could either be a primary or revision case.
Exclusion Criteria:
* Patients with sinonasal tumors
* Cystic fibrosis or syndromic patients (e.g. Wegeners granulomatosis, immunocompromised)
* Patients with autoimmune diseases
* Patients who do not understand English language and to understand the purpose, methods and conduct of this study.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03575689
|
{
"brief_title": "Nasal Splint and Endoscopic Nasal Septal Repair Surgery",
"conditions": [
"Septum Deviated"
],
"interventions": [
"Device: Doyle Splint"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03575689",
"official_title": "The Efficacy of Silastic Sheet Nasal Splints in Endoscopic Nasal Septal Repair Surgery: A Prospective Randomized Control Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-01",
"study_completion_date(actual)": "2019-05-01",
"study_start_date(actual)": "2016-03-24"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-19",
"last_updated_that_met_qc_criteria": "2018-06-28",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-02",
"first_submitted": "2018-06-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress and anxiety. A randomised placebo-controlled clinical trial.
Detailed Description
Ocimum Sanctum or Holy Basil, commonly called Tulsi is a traditional Indian herb. It is believed to bring about a facilitative enhancement of cognitive ability and lower stress levels in individuals. Stress and an inability to perform at a required level of cognition can induce anxiety. This study is looking at the effects of daily consuming Tulsi among a group of individuals who work in an environment that demands memory, attention and executive functioning.
#Intervention
- DRUG : Ocimum Sanctum
- Active capsules containing leaves of organically prepared ocimum sanctum
- DRUG : Placebo
- Placebo capsules of look alike inert substance for control
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects between the ages of 18 and 50 years, providing written informed consent.
Exclusion Criteria:
Subjects who meet the following criteria
* Education level below 8th grade of schooling
* Unable to read or understand English or having no working knowledge of English
* Known history or neurological conditions that can affect cognition
* Known history of drug abuse or potential for drug abuse, a regular consumer of alcohol or unwilling to withhold consumption of alcohol for the duration of the study.
* A chronic smoker or consumer of other tobacco related products or is undergoing a rehabilitation program for alcohol and or tobacco consumption
* Any history or psychiatric disorders - currently on treatment or treated in within the last 12 months
* Any characteristic that makes the investigator uncomfortable to include the subject in the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03184909
|
{
"brief_title": "Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety",
"conditions": [
"Cognitive Change"
],
"interventions": [
"Drug: Placebo",
"Drug: Ocimum Sanctum"
],
"location_countries": [
"India"
],
"nct_id": "NCT03184909",
"official_title": "Consumption of Tulsi and Its Effects on Neurocognition, Stress and Anxiety: A Randomised Controlled Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03-30",
"study_completion_date(actual)": "2018-03-31",
"study_start_date(actual)": "2017-12-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-09-17",
"last_updated_that_met_qc_criteria": "2017-06-11",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-14",
"first_submitted": "2017-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In Vietnam, the prevalence of hepatitis C virus (HCV) infection is estimated between 0.4% and 5%, which is much higher than the prevalence in Europe or in the USA. After HCV diagnosis, HCV viral load quantification is crucial in order to distinguish recovered from active (on-going) HCV infection and hence identify those who need antiviral treatment to cure HCV infection. HCV viral load quantification is also important to assess treatment efficacy.
Currently, anti-HCV antibodies detection is available around the country. However, access to confirmation of HCV viremia remains scarce particularly in decentralized areas. One of the reason is the limited number of laboratories able to perform this complex biological measurement; moreover, these laboratories are situated only in large urban centres.
Blood sampling using DBS could help overcome this difficulty of access to a laboratory, and widen access to HCV viral load monitoring.
The present MOVIDA Hep study aims at validating the use of DBS to measure HCV viral load as compared to plasma (gold standard). A secondary objective is to evaluate the measurement of HCV core antigen on DBS. For this, 315 patients need to be enrolled form outpatient clinics in Hanoi. The laboratory in charge of these measurements would be the virology laboratory of the National Institute of Hygiene and Epidemiology (NIHE) in Hanoi (Vietnam).
Detailed Description
The 'Monitoring Of Viral load In Decentralised Area' (MOVIDA) project aims at giving access to viral load (VL) monitoring to the patients coming from remote areas using Dried Blood Spot as tool of sampling.
In resource-limited settings, many biological exams are not accessible to the entire population due to logistic and financial constraints. Regarding infection with hepatitis B and C viruses (HBV and HCV), serological screening tests are easy to perform and are available nationwide in either laboratory format or rapid diagnosis tests. However, hepatitis B DNA and C RNA assessment is not available in decentralised area as no laboratory is able to perform this complex biological measurement.
WHO, in their latest guidelines, recommends using dried blood spots (DBS) as an alternative to serum or plasma. Blood is easy to collect on DBS, either after veni- or capillary puncture. Capillary blood collection can be of great interest when venipuncture is complex, for example in injecting drug users (IDUs) in whom finding an accessible vein can be difficult. Then it is easily transferred, and at a low cost as it does not require a cold chain, to a laboratory able to perform the HCV VL quantification. As of today, little is known about the performance of standard commercial HCV diagnostic assays when using DBS and none of these studies were performed in routine setting in resource-limited setting.
In Vietnam, HCV seroprevalence in the general population is estimated between 0.4% and 5%, which is much higher than the prevalence in Europe or in the US. Genotype 1 is the more prevalent in Vietnam, genotype 6 that is only found in South East Asia is the second most frequent, but other genotypes are circulating . In Vietnam, HCV prevalence is much higher in the HIV-infected population and in injecting drug users (IDUs). Currently, anti-HCV antibodies detection is available around the country even if some difficulties remain. However, access to HCV HCV viral load measurement in routine remains scarce particularly in decentralized areas because the technique is complex, expensive and need well-trained personnel and high standard of equipment. Thus, HCV viral load measurement remains non accessible to the vast majority of patients diagnosed with HCV.
This study (MOVIDA Hep) aims at evaluating the quality of HCV VL monitoring when using DBS (collection of venous and capillary blood) as compared to plasma (gold standard), in routine condition and using the existing machines. This, to find out if DBS can be used for HCV viremia confirmation in Vietnam, in the virology laboratory of the National Institute of Hygiene and Epidemiology (NIHE) in Hanoi (Vietnam) where these measurements would be performed.
#Intervention
- PROCEDURE : Blood sampling
- Blood sample of 10 mL by venipuncture and 0,4 mL by finger prick
|
#Eligibility Criteria:
Inclusion Criteria:
* >=18 years
* Known HCV infection
* Willing to participate to the study by giving his/her consent.
Exclusion Criteria:
None
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03670251
|
{
"brief_title": "Evaluation of Hepatitis C Viral Load Quantification on DBS in Vietnam",
"conditions": [
"Hepatitis C",
"Dried Blood Spot"
],
"interventions": [
"Procedure: Blood sampling"
],
"location_countries": [
"Vietnam"
],
"nct_id": "NCT03670251",
"official_title": "Improving Access to Viral Load Monitoring in HIV-infected Patients on ART in Decentralised Area Using Dried Blood Spot : Evaluation of Hepatitis C Viral Load Quantification on DBS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07-11",
"study_completion_date(actual)": "2019-07-11",
"study_start_date(actual)": "2019-05-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-01",
"last_updated_that_met_qc_criteria": "2018-09-11",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-13",
"first_submitted": "2018-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in obese subjects over a 24-week treatment period.
#Intervention
- DRUG : THR-4109
- THR-4109 maximum dose in study is 115 mg via oral capsule daily in a.m. and 115 mg via oral capsule daily in p.m. for 24 weeks
- DRUG : Placebo
- Oral capsules daily in a.m. and in p.m. for 24 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* 30 <= age <= 60 of age
* Body mass index between 30 and 40 kg/m2
* Women of child bearing potential with a negative pregnancy test prior to entry and who agree to use an acceptable method of contraception throughout the study
* Able and willing to give written informed consent
Exclusion Criteria:
* Weight loss of more than 3 kg in the previous 3 months
* Current or previous use (within 3 months) of medications that influence weight
* Known endocrine origin for obesity, such as hypothyroidism and Cushing's syndrome
* Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse
* Current serious/unstable medical condition
* Current pharmacologically treated diabetes or fasting plasma glucose >= 126 mg/dL
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00485017
|
{
"brief_title": "Efficacy and Safety of THR-4109 in Obese Subjects",
"conditions": [
"Obesity"
],
"interventions": [
"Drug: Placebo",
"Drug: THR-4109"
],
"location_countries": [
"Russian Federation",
"Sweden"
],
"nct_id": "NCT00485017",
"official_title": "A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of THR-4109 in Obese Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-06",
"study_completion_date(actual)": "2008-06",
"study_start_date(actual)": "2007-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-30",
"last_updated_that_met_qc_criteria": "2007-06-08",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-06-12",
"first_submitted": "2007-06-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine whether circulating molecular and cellular biomarkers are predictive of imatinib effect on pulmonary artery hypertension.
Detailed Description
We hypothesize that bone marrow progenitor cells are mobilized into the circulation in PAH, home to the lungs and differentiate into mast cells, which promote vascular remodeling and vasoconstriction through release of renin and chymase. As a corollary to this, we hypothesize that anti cKit tyrosine kinase inhibitor (TKI), imatinib, provides clinical benefit to patients through inhibition of mast cell progenitor proliferation, mobilization and differentiation. To test this, we will determine if mast cell progenitors and mast cell biomarkers are related to imatinib clinical response. This will be an ancillary study, part of a placebo-controlled, double-blind multi center clinical trial of imatinib in pulmonary arterial hypertension.
|
#Eligibility Criteria:
Inclusion Criteria:
from Imatinib Trial
* Male or Female >= 18 years
* A current diagnosis or Pulmonary Arterial Hypertension according to the Dana Point 2008 Meeting: WHO Diagnostic Group I, idiopathic or heritable (familial or sporadic) PAH, PAH associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH following one year repair of congenital heart defect (ASD, VSD, or PDA), or PAH associated with diet therapies or other drugs
* A PVR>1000dynes.sec.cm-5(as assess by RHC at screening or in the 2 months preceding the screening visit despite treatment with two or more specific PAH therapies, including endothelin receptor antagonists (ERA), phosphodiesterase 5 inhibitors (PDE5), or inhaled, intravenous or oral prostacyclin analogues for >=3 months. On stable background therapy doses for >= 30 days except for warfarin (>=30 days but doses can vary even within the mouth before enrollment)
* WHO Functional Class II-IV. For WHO Functional Class IV, one of the 2 or more specific PAH therapies must be an inhaled, intravenous or oral prostacyclin analogue, unless the subject has been shown to be intolerant of prostacyclin analogues.
* 6MWD>=150meters and >=450meters at screening. Distances of two consecutive 6MWTs should be within 15% of one another.
* Ability to provide written informed consent
Exclusion Criteria: from Imatinib Trial
* Women of childbearing potential who are not practicing birth control methods.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of positive hCG laboratory test (> 5 mIU/MI)
* Have previously received treatment with imatinib
* In treatment with chronic nitric oxide therapy
* Pre-existing lung disease including parasitic diseases affecting lungs, congenital abnormalities of the lungs, thorax or diaphragm or bronchial asthma associated with chronic hypoxia that may contribute to severity of PAH
* With a pulmonary capillary wedge pressure >15 mm Hg to rule out PAH secondary to left ventricular dysfunction
* With a diagnosis of pulmonary artery or vein stenosis
* With other diagnosis of PAH in WHO Diagnostic Group 1 re excluded including congenital systemic to pulmonary shunts (large, small that not surgically repaired, portal hypertension, HIV infection, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopthaies, myeloproliferative disorders)
* With a diagnosis of PAH associated with: venous hypertension (WHO Diagnostic Group II), hypoxia (WHO Diagnostic Group III), chronic pulmonary thromboembolic disease (WHO Diagnostic Group IV) or other miscellaneous causes (WHO Diagnostic Class V, which includes sarcoidosis, histiocytosis X, lympangiomatosis, compression of pulmonary vessels).
* With deficient thrombocyte function, thrombocytopenia >50x109/L(50x103/µL)
* With a history of acute heart failure or chronic left sided heart failure
* With uncontrolled systemic arterial hypertension, systolic >160mmHg or diastolic >90mmHg
* With hemoglobin <100g/L (10 g/dl)
* With deficiencies of blood coagulation, inherited or acquired blood disorders, factor XII, factor XIII; decreased generation of coagulation factors due to acute or chronic liver diseases, efficient coagulation due to auto-antibodies against coagulation factors such as in lupus anticoagulant
* With disseminated intravascular coagulation (DIC)
* With evidence of major bleeding or intracranial hemorrhage
* With a history of latent bleeding risk such as diabetic retinopathy, gastrointestinal bleeding due to gastric or duodenal ulcers, or colitis ulcerosa
* With a history of moderate or greater hepatic insufficiency transaminase levels >4times the upper limit or normal or a bilirubin >2times the upper limit of normal
* With a history of renal insufficiency (serum creatinine >200µmol/1or 2.6mg/dl)
* Previous therapeutic radiation of lungs mediastinum
* With a history of sickle cell anemia
* With a QTcF>450msec for males and >470 msec for females at screening
* With a history of ventricular tachycardia, ventricular fibrillation or ventricular flutter
* Having syncope in the 3 months prior to the screening visit
* With a history of Torsades de Pointes
* With a history of long QT syndrome
* Having undergone atrial septostomy in the 3 months prior to screening visit
* Having undergone radiofrequency catheter ablation for atrial or sinus arrhythmias in the 3 months prior to screening visit
* With an advanced, sever, or unstable disease of any type that may interfere with the primary and secondary endpoint evaluations
* With a history of immunodeficiency diseases, including HIV
* With a known hypersensitivity to QTI571 or drugs similar to the study drug
* With a disability that may prevent the patient from competing all study requirements and in particular, interfere with the 6MWT assessment
* With a life expectancy of 6months or less
* Having used other investigational drugs at the time of enrollment, within 30 days or 5 half-lives of enrollment, whichever is longer
* With a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* With a diagnosis of Hepatitis B or C
* With a history of alcohol abuse within 6 months of screening
* With a history of illicit drug abuse within 6 months of screening
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01092897
|
{
"brief_title": "Pulmonary Hypertension and Imatinib",
"conditions": [
"PAH"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01092897",
"official_title": "Biomarkers in Pulmonary Arterial Hypertension Treated With Imatinib",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-02-04",
"last_updated_that_met_qc_criteria": "2010-03-24",
"last_verified": "2014-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-25",
"first_submitted": "2010-03-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Single-injection transversus abdominis plane (TAP) blocks have been used to treat postoperative pain, and are become very popular within the United States because of their high analgesic potency and relative ease of placement. Unfortunately, the longest local anesthetic available lasts only 8-12 hours. Continuous TAP blocks-also termed 'perineural infusion'-involve bathing the multiple nerves of the abdominal wall in local anesthetic using a percutaneously-inserted perineural catheter inserted just anterior (ventral) and cephalad to the anterior superior iliac spine. For most catheter locations, an infusion is preferred to a single-injection nerve block because the duration of analgesia may be extended to better match the duration of surgical pain. But, unlike brachial plexus, femoral, and sciatic nerve perineural infusion, a continuous basal infusion of local anesthetic does not provide adequate analgesia for TAP catheters. This may be due to the fact that the TAP is a relatively tight space, so it might require a bolus of fluid to adequately spread the perineural local anesthetic to the multiple required nerves (as evidence of this, single-injection TAP blocks are very effective, although with a limited duration). The result is that while single-injection TAP blocks are widely used, TAP catheters have not been adopted. This scenario leaves surgical pain untreated following the resolution of the single-injection TAP block. The recent development of an infusion pump that can automatically deliver repeated bolus doses may allow the spread of local anesthetic to the multiple sensory nerves necessary to provide adequate analgesia, with a duration that better matches postoperative requirements. The investigators therefore propose a randomized, double-masked, controlled trial to determine if delivering local anesthetic as a repeated bolus dose results in improved local anesthetic spread/effects compared with a continuous basal infusion for TAP catheters.
Detailed Description
This investigation will be a randomized, observer-masked, controlled, split-body, human-subjects clinical trial. Of note, the investigators will be using standard-of-care local anesthetics under their FDA approved purpose and do not plan to research a possible change of indication or use of these drugs as part of this research project.
Volunteers will be solicited using the CTRI Research Match and an existing database of volunteers (IRB approved). If a volunteer meets inclusion/exclusion criteria (see Eligibility Criteria) and desires study participation, written, informed consent will be obtained using a UCSD IRB-approved/stamped ICF. A urine pregnancy test will be administered to all women of childbearing age following written informed consent but before any study interventions. This urine test will be administered by CTRI nursing staff using standard, FDA-approved urine pregnancy testing devices.
Perineural catheter insertion: Following written, informed consent, subjects will be admitted to the UCSD CTRI Center for Clinical Research Services (CCR) and have demographic/morphometric data recorded (e.g., age, weight, height). An intravenous line will be placed in an upper extremity, followed by external monitors (pulse oximeter, blood pressure, and EKG), and oxygen by nasal cannula. Sedation will be provided with intravenous fentanyl (50 μg) and/or midazolam (1 mg). Bilateral TAP perineural catheters (FlexBlock, Teleflex Medical, Reading, PA, USA) will be inserted using ultrasound guidance using a technique previously described. To check the perineural catheter placement accuracy, 5 mL of normal saline will be administered via the catheters under ultrasound guidance with the definition of a successful catheter insertion an increase in fluid volume within the TAP (the plane between the transversus abdominis muscle and internal oblique muscle). Inaccurately inserted catheters will be replaced.
Treatment Group Assignment: Subjects will act as their own controls: the right side will be randomized to one of two treatment groups: ropivacaine 0.2% administration as either a basal infusion (8 mL/h) or bolus doses (24 mL administered every 3 hours). The left side will receive the other possible treatment. Randomization will be based on computer-generated codes. Randomization will be in blocks of four. An infusion pump with study infusate will be attached to each of the perineural catheters and initiated at Hour 0. Which side of the participant's body will receive the basal rate and which side will receive bolus volume will depend upon the treatment group assignment but the total dose of local anesthetic is the same for each side.
The tubing from the pumps to the subjects will be gently wound at least 5 rotations and covered with opaque tape, masking which perineural catheter is receiving which treatment (ropivacaine is clear, so the flow through the clear tubing from the tape to the perineural catheters will not be visually distinguishable).
Local Anesthetic Administration: The infusion pump administering the basal infusion will be initiated at Hour 0. The infusion pump administering bolus doses will administer a 24 mL bolus dose every 3 hours beginning at Hour 0. Perineural catheters will be removed after 6 hours (a total of 2 bolus doses).
Food and Drink: Both food and accompanying beverages/water will be provided by the hospital and served by the nursing staff immediately following catheter insertion. Meals will be provided without charge to the study subjects. There is no restriction on oral intake following catheter insertion. Subjects will remain within the CTRI-CCR until catheter withdrawal.
Outcome measurements: At all time points, the right side will be measured first, followed by the left side (subjects in the supine position).
Measurements will be performed at baseline (prior to local anesthetic administration), after 6 hours of administration, and at each hour in between for a total of 7 time points:
* Hour 0 (baseline) just prior to local anesthetic administration
* Hours 1 and 2
* Hour 3, just prior to the scheduled bolus dose at Hour 3
* Hours 4 and 5
* Hour 6
The sensory deficit will be measured using two methods:
* von Frey filaments (mechanical detection threshold)
* Cold roller (cold deficit)
The sensory deficit will be measured along two separate anatomical lines at each time point:
* The mid-axillary 'vertical' line (measuring cephalad-caudad effects)
* A transverse 'horizontal' line passing through the anterior superior iliac spine (measuring anterior-posterior effects)
Statistical analysis: The investigators' calculations are focused on the primary hypothesis that when using transversus abdominis plane (TAP) block perineural catheters, providing local anesthetic in repeated bolus doses increases the cephalad-caudad local anesthetic effects compared with a basal-only infusion of the same volume and dose of local anesthetic. To measure cephalad-caudad local anesthetic effects, we will measure the cephalad-caudad sensory deficit to cold temperature in centimeters along the mid-axillary line. The primary end point will be this measurement after 6 hours of local anesthetic administration (6 hours of a continuous basal infusion or 2 bolus doses at 3-hour increments, the last being 3 hours prior to the measurement of the primary endpoint). Each subject will act as their own control with each side receiving a different treatment. Normality of distribution will be determined using the Shapiro-Wilk normality test (Prism 6, GraphPad, San Diego, California). For normally distributed data, comparisons for parametric and nonparametric data will be tested using the t-test or Mann-Whitney test and presented as mean (SD) or median \[interquartile\], respectively. Nominal data will be analyzed using the Pearson Chi square test. P\<0.05 will be considered significant.
Sample size estimation: With 21 evaluable subjects we will have 80% power at the 0.05 significance level to detect the superiority of the administration of local anesthetic as repeated bolus doses as compared with a continuous basal infusion at Hour 6 (primary outcome). Using an expected standard deviation of 7 cm for the primary endpoint, and given a 2-sided Type I error protection of 0.05 and power=0.80, approximately 21 subjects in each treatment arm will be required to detect a difference between treatment group means of 6 cm. Since this is a split-body study design and each subject will have one of each treatments on opposite sides of the body, 21 subjects total will produce 21 subjects in each treatment arm. The investigators chose 6 cm as a detectable treatment difference because a 3 cm distance is approximately equivalent to the width of one dermatome, and the vast majority of anesthesiologists would consider a 2-dermatome difference clinically significant. To allow for a larger-than-anticipated standard deviations, smaller-than-anticipated difference between treatment means, drop out subjects, or failed catheters, the investigators will enroll a total of 24 subjects.
#Intervention
- DRUG : Bolus
- A transversus abdominis catheter was inserted and ropivacaine 0.2% administered as two separate bolus doses of 24 mL each: one at time point zero and one 3 hours later.
- Other Names :
- automatic intermittent bolus doses
- DRUG : Basal
- A transversus abdominis catheter was inserted and ropivacaine 0.2% administered as a continuous basal infusion (8 mL/h) from time point zero for the following 6 hours.
- Other Names :
- continuous basal infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy volunteers weighing more than 45 kg;
* must be willing to have bilateral transverses abdominis plane nerve block catheters be placed with subsequent ropivacaine administration and sensory testing for 6 hours
Exclusion Criteria:
* BMI greater than 40 (BMI=weight in kg/ [height in meters];
* regular opioid use within the previous 2 months;
* previous participation within the same study;
* allergy to study medications;
* known renal insufficiency (creatinine > 1.5 mg/dL);
* pregnancy;
* incarceration; and
* any known neuro-muscular deficit of either abdominal wall.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02662023
|
{
"brief_title": "Continuous TAP Blocks: Relative Effects of a Basal Infusion vs. Repeated Bolus Doses",
"conditions": [
"Postoperative Pain"
],
"interventions": [
"Drug: Basal",
"Drug: Bolus"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02662023",
"official_title": "Continuous Transversus Abdominis Plane Nerve Blocks: Relative Effects of a Basal Infusion vs. Repeated Bolus Doses (A Randomized, Double-Masked, Active-Control, Split-Body, Crossover Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2016-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-03-18",
"last_updated_that_met_qc_criteria": "2016-01-22",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-25",
"first_submitted": "2016-01-20",
"first_submitted_that_met_qc_criteria": "2021-02-24"
}
}
}
|
#Study Description
Brief Summary
Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.
Detailed Description
Prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.
#Intervention
- DEVICE : Exoseal closure device
- Closure device for femoral artery access closure
- DEVICE : Angioseal closure device
- Closure device for femoral artery access closure
|
#Eligibility Criteria:
Inclusion Criteria:
* Should be able to provide valid informed signed consent
* PCI procedure including treatment by balloon and/or stent
* PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)
Exclusion Criteria:
* Only coronary angiography
* Multiple punctures
* Active infection
* Groin haematoma before the closure procedure
* Sheath size > 7 French
* Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin
* Prior arterial surgery in abdomen and/or lower extremities
* Cardiogenic shock
* Life expectancy less than one year
* The patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating
* Simultaneous or planned subsequent femoral vein access
* Allergy to any of the components in the closure material left in the groin
* Puncture on same site < 30 days
* Peripheral artery disease patients can be included at operator´s discretion except if heavy calcification is present at the access site which at the operator's discretion precludes insertion of the VCD
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02234830
|
{
"brief_title": "Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial",
"conditions": [
"Coronary Disease"
],
"interventions": [
"Device: Angioseal closure device",
"Device: Exoseal closure device"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT02234830",
"official_title": "Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05-14",
"study_completion_date(actual)": "2017-05-14",
"study_start_date(actual)": "2012-12-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-01",
"last_updated_that_met_qc_criteria": "2014-09-04",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-09",
"first_submitted": "2014-06-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
12 elderly (65-70 years of age) male subjects will be included and complete a double blinded cross-over study. They will be habituated for 21 days to either low or high protein intake (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will switch to the alternate group. At the end of each habituation period, the investigators will measure the appearance of labelled amino acids from milk proteins.
#Intervention
- DIETARY_SUPPLEMENT : Meal serving at high dietary protein
- Participants are habituated to a high level of dietary protein intake for 21 days.
- DIETARY_SUPPLEMENT : Meal serving at low dietary protein
- Participants are habituated to a low level of dietary protein intake for 21 days.
- DIETARY_SUPPLEMENT : Meal serving
- To investigate impact of habituated protein level
|
#Eligibility Criteria:
Exclusion Criteria:
* Hyperlipidemia
* Hypertension
Inclusion Criteria:
* Males age 65 <= age <= 70
* Independently dwelling
* Without any major health issues (blood pressure, cholesterol and lipid profile will be measured and evaluated by a physician)
* Non-diabetic
* No organ disease
* No back pain
* Not regularly take any prescription drugs or dietary supplements, which can influence muscle protein synthesis
* Alcohol intake below 21 units pr. week
* No known arthrosclerosis
Sex :
MALE
Ages :
- Minimum Age : 65 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02587156
|
{
"brief_title": "Fate of Nutrient-Derived Amino Acids, FONDAA",
"conditions": [
"Protein Utilization",
"Dietary Protein"
],
"interventions": [
"Dietary Supplement: Meal serving at low dietary protein",
"Dietary Supplement: Meal serving at high dietary protein",
"Dietary Supplement: Meal serving"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT02587156",
"official_title": "Fate of Nutrient-Derived Amino Acids: Influence of Habituated Levels of Daily Dietary Protein Intake on Protein Utilization",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02-08",
"study_completion_date(actual)": "2018-02-08",
"study_start_date(actual)": "2015-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-03-05",
"last_updated_that_met_qc_criteria": "2015-10-26",
"last_verified": "2018-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-27",
"first_submitted": "2015-10-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every day for 6 weeks at a time. Temozolomide given by this extended schedule is experimental, although we have found that it is safe and can shrink melanoma in some patients.
One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it can be given daily over a long period of time rather than off and on like DTIC. We think that TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients. When extended dosing TMZ was given with either thalidomide or long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves.
In this study, we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage.
We also want to learn more about which tumors are more likely to shrink from TMZ treatment. We will test samples of your tumor for whether or not a gene called MGMT has been turned on,
#Intervention
- DRUG : Temozolomide (TMZ)
- One group treatment study
|
#Eligibility Criteria:
Inclusion Criteria:
* Stage III (unresectable) or Stage IV melanoma from a cutaneous or an unknown primary.
* Histologic proof of melanoma reviewed and confirmed at MSKCC
* Measurable disease (RECIST criteria)
* No prior chemotherapy for melanoma. Prior interferon, interleukin-2 or vaccine therapy are allowed.
* No other concurrent chemotherapy, immunotherapy, or radiotherapy
* Karnofsky performance status >= 60
* Adequate organ function defined as follows: ANC > 1500, Platelets > 100,000, creatinine < 2, Alkaline Phosphatase, AST and total bilirubin < 1.5x upper limit of normal. For patients with suspected Gilbert's syndrome bilirubin will not be a requirement.
* Tumor tissue for MGMT promoter methylation analysis and/or IHC must be available. In most cases, this will be unstained slides from previously-obtained paraffin-embedded tumor material. If this is not available, patients must have an easily-accessable tumor for biopsy (e.g. skin or lymph node).
Exclusion Criteria:
* History of CNS metastases unless brain metastases have been resected and the patient has been free from CNS recurrence for 6 months.
* Uveal or mucosal melanoma primary
* Frequent vomiting or medical conditions that could interfere with oral medication intake
* Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
* History of HIV infection even if on HAART
* Immunosuppressive drugs
* High dose vitamins and herbs
* Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00591370
|
{
"brief_title": "Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma",
"conditions": [
"Melanoma"
],
"interventions": [
"Drug: Temozolomide (TMZ)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00591370",
"official_title": "Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-06",
"study_completion_date(actual)": "2008-06",
"study_start_date(actual)": "2005-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-25",
"last_updated_that_met_qc_criteria": "2008-01-10",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-11",
"first_submitted": "2007-12-26",
"first_submitted_that_met_qc_criteria": "2015-01-20"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare capillary (the smallest of a body's blood vessels) and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single oral, immediate-release dose to healthy participants.
Detailed Description
This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of patients will be treated at the same time), single-center study. Participants will be randomly assigned to 1 of 5 cohorts (groups) defined by the antipsychotic drug (aripiprazole, quetiapine, olanzapine, risperidone or paliperidone). Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Participants will enter the investigational site in the morning of Day -1 and stay until the morning of Day 2. Participants will return to the study site for subsequent assessments as per study's schedule. The total study length for a participant is approximately 26 days, except for participants receiving aripiprazole for whom the total study length is approximately 39 days.
#Intervention
- DRUG : Aripiprazole
- Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg aripiprazole tablet will be administered after an overnight fast.
- DRUG : Quetiapine
- Type= exact number, unit= mg, number= 100, form= tablet, route= oral administration. A single oral dose of two 50-mg quetiapine tablets will be administered after an overnight fast.
- DRUG : Olanzapine
- Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg olanzapine tablet will be administered after an overnight fast.
- DRUG : Risperidone
- Type= exact number, unit= mg, number= 1, form= tablet, route= oral administration. A single oral dose of a 1-mg risperidone tablet will be administered after an overnight fast.
- DRUG : Paliperidone
- Type= exact number, unit= mg, number= 3, form= tablet, route= oral administration. A single oral dose of a 3-mg paliperidone tablet will be administered after an overnight fast.
|
#Eligibility Criteria:
Inclusion Criteria:
* Body mass index (weight [kg]/height2 [m]2) between 17 and 35 kg/m2 (inclusive), and body weight not less than 50 kg
* If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
* If a woman, must have negative pregnancy test at screening
* If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug
* Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
Exclusion Criteria:
* History of or current clinically significant medical illness or condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for laboratorial tests
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen), oral contraceptives and hormonal replacement therapy, within 14 days before the study drug administration is scheduled
* Positive test for alcohol or drugs of abuse at screening
* Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01607762
|
{
"brief_title": "A Study to Compare Capillary and Venous Whole Blood and Plasma Concentrations of Five Antipsychotics",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Risperidone",
"Drug: Olanzapine",
"Drug: Paliperidone",
"Drug: Quetiapine",
"Drug: Aripiprazole"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT01607762",
"official_title": "Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-04",
"study_completion_date(actual)": "2012-10",
"study_start_date(actual)": "2012-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-04-09",
"last_updated_that_met_qc_criteria": "2012-05-25",
"last_verified": "2013-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-30",
"first_submitted": "2012-05-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
• Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness
Detailed Description
The main objective of this study is to correlate a glycoprotein panel with prostate biopsy outcome, i.e. distinguishing PCa from benign prostatic conditions as well as high-grade cancer. The quantities of the two protein analytes cathepsin D (CTSD) and thrombospondin 1 (THBS1) are measured in human serum samples. In combination with percent free PSA (%fPSA), the results are correlated with prostate biopsy outcome. The potential future benefit of using this glycoprotein panel is to validate positive tPSA tests in men with negative digital rectal examination (DRE) and enlarged prostates to reduce the need for undergoing a biopsy, thereby reducing unnecessary biopsies and potentially predicting high-grade disease.
#Intervention
- DIAGNOSTIC_TEST : Blood sample collection
- During a routine blood draw an additional tube of blood will be taken for the study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male patient between 45 and 80 years.
* tPSA between 2 and 10 ng/ml
* Prostate volume >=35 ml
* Non-suspicious DRE for prostate cancer
* Scheduled for prostate biopsy
* Patient must give written informed consent
Exclusion Criteria:
* Patient not undergoing biopsy of the prostate
* Prior prostate biopsy within the last 12 months
* Transurethral resection of the prostate (TURP) in the last 5 years
* Patients with known acute or chronic prostatitis/cystitis or other known prostate abnormalities
* Patient taking 5-alpha-reductase inhibitor
* Any other prior treatment of the prostate (cryoablation, hifu, ire, radiation therapy, alcohol instillation, etc.)
Sex :
MALE
Ages :
- Minimum Age : 45 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03565289
|
{
"brief_title": "PRospective Prostate biOmarker Study",
"conditions": [
"Indication for Prostate Biopsy Due to Suspected Prostate Cancer"
],
"interventions": [
"Diagnostic Test: Blood sample collection"
],
"location_countries": [
"Austria",
"Germany",
"Denmark"
],
"nct_id": "NCT03565289",
"official_title": "PRospective Prostate biOmarker Study (PROPOSe)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-31",
"study_completion_date(actual)": "2020-01-31",
"study_start_date(actual)": "2018-08-14"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-12-16",
"last_updated_that_met_qc_criteria": "2018-06-20",
"last_verified": "2020-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-21",
"first_submitted": "2018-06-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.
#Intervention
- DRUG : APD791
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adult men and women, ages 19 <= age <= 45
* Non smokers
Exclusion Criteria:
* History of a bleeding disorder
* Recently donated blood or had significant blood loss
* Current use of a prescription medication
* Pregnant females
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00529646
|
{
"brief_title": "Single-Dose Safety Study of APD791 in Healthy Volunteers",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00529646",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability, Pharmacokinetics, and Pharmacodynamics of APD791 Administered to Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "2007-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": null,
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-12-30",
"last_updated_that_met_qc_criteria": "2007-09-13",
"last_verified": "2008-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-09-14",
"first_submitted": "2007-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study consists of two phases: The first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase 2 study to define the efficacy and safety profile of single agent SB1518 at the recommended dose in subjects with CIMF.
#Intervention
- DRUG : SB1518
- SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
|
#Eligibility Criteria:
Inclusion Criteria
* Subjects with CIMF (including post ET/PV MF) requiring therapy, including:
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2
* Men of reproductive potential who can agree to practice effective contraception during the entire study period and for one month after the last study treatment
* Women of child-bearing potential who have a negative pregnancy test within 14 days prior to the first dose of study drug and can agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists
* Subjects who are able to understand and willing to sign the informed consent form
Exclusion Criteria
* Subjects with uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study unless the antibiotic is a CYP3A4 inducer/inhibitor
* Subjects known to be HIV-positive
* Subjects with known active hepatitis A, B, or C, or latent hepatitis B
* Women who are pregnant or lactating
* Subjects with prior radiation therapy to more than 20% of the hematopoietic marrow (prior radiation to spleen is allowed)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00745550
|
{
"brief_title": "A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis",
"conditions": [
"Myelofibrosis",
"Myeloproliferative Disorders",
"Polycythemia Vera",
"Essential Thrombocythemia"
],
"interventions": null,
"location_countries": [
"Australia",
"United States"
],
"nct_id": "NCT00745550",
"official_title": "A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-01",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2008-08"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-04-20",
"last_updated_that_met_qc_criteria": "2008-09-02",
"last_verified": "2012-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-03",
"first_submitted": "2008-09-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to validate a possible diagnostic test for bile acid diarrhoea prospectively compared to the SeHCAT scintigraphy. Fasting participants are given a standard meal and 1,250 mg chenodeoxycholic acid. The investigators measure fasting FGF19, bile acids species including 7-alpha-CHO and serial blood samples after the stimulation.
#Intervention
- DRUG : Oral chenodeoxycholic acid stimulation
- oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor
- Other Names :
- Chenodeoxycolic acid
|
#Eligibility Criteria:
Inclusion Criteria:
* Consecutive patients referred for SeHCAT
Exclusion Criteria:
* Treatment with sequestrants within one week before the SeHCAT.
* Treatment with any constipants/laxatives one day before the SeHCAT, with the exception of opioids, if the dosis has been stable in the prior 2 weeks.
* Pregnancy, screening by pregnancy test before inclusion.
* Breastfeeding women.
* Small bowel resection, including right sided hemicolectomy.
* Any ongoing treatment for inflammatory bowel disease with systemic steroids (i.e. budesonide or prednisone) or treatment in the prior 4 weeks.
* Allergies to constituents of Xenbilox: (chenodeoxycholic acid, cornflour, magnesium stearate, highly dispersed silica, gelatine, sodium dodecylsulphate, titanium dioxide (E171), quinolone yellow (E104), erythrosine (E127)
* Chronic or acute cholecystitis.
* Liver cirrhosis,
* Obstructed bile flow causing jaundice or elevated p-bilirubin (> 1,5 UNL).
* Known disability in gall bladder contractility.
* Bile duct atresia.
* Frequent gallstone attacks (>2/month).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03059537
|
{
"brief_title": "Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea",
"conditions": [
"Bile Acid Malabsorption"
],
"interventions": [
"Drug: Oral chenodeoxycholic acid stimulation"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03059537",
"official_title": "Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-27",
"study_completion_date(actual)": "2017-11-27",
"study_start_date(actual)": "2017-03-13"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-12",
"last_updated_that_met_qc_criteria": "2017-02-20",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-23",
"first_submitted": "2017-02-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this prospective randomized controlled study was to investigate the effects of chewing gum on interdialytic weight gain, thirst, dry mouth and intradialytic symptoms in hemodialysis patients.
Detailed Description
The prevalence of xerostomia varies high in patients with chronic hemodialysis (HD), and the decreased saliva flow rate due to various mechanisms is the main factor in its development. The significant decrease in saliva flow due to the atrophy and fibrosis of the salivary glands in HD patients is further affected by the restriction in fluid intake. The use of drugs such as antidepressants, antipsychotics, antihistamines, antihypertensives, aspirin, benzodiazepines, opioids and proton pump inhibitors also leads to hyposalivation and xerostomia. Thirst is common in chronic HD patients due to both volumetric and osmometric causes but the primary mechanism is osmometric. The osmolarity of the extracellular fluid increases with the dietary salt and the hypothalamus is stimulated by the shrinkage of the osmoreceptor cells, leading to the desire to ingest liquids. Volumetric thirst develops secondary to water and salt loss and the resultant stimulation of cardiac baroreceptors, with the cardiac return volume decreasing gradually towards the end of the HD session. Increased interdialytic weight in HD patients causes increased risk of death due to cerebrovascular events and cardiovascular diseases and leads to an increase in morbidity and mortality together with a deterioration of the patient's quality of life. Interdialytic weight gain (IWG) causes incompliance with fluid control as a result of the secondary excessive consumption of liquid and food and is an important condition.
#Intervention
- DIETARY_SUPPLEMENT : Chewing Gum
- The patients will chew one piece of regular chewing gum six times in a day and feeling of thirst for ten minutes for three months.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* On maintenance hemodialysis three times per week for four hours per session
* Receiving hemodialysis therapy for a least six moths at the time of the study
* Able to communicate in Turkish
* Willing to participate to the study
Exclusion Criteria:
* 18 years younger
* Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis.
* The patient who took chemotherapy and radiotherapy
* Have salivary gland infection and dementia
* Oral and / or dental diseases to prevent chewing gum
* Unwilling to to participate to the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04142216
|
{
"brief_title": "Effect of Chewing Gum in Hemodialysis Patients",
"conditions": [
"Chewing Gum",
"Hemodialysis"
],
"interventions": [
"Dietary Supplement: Chewing Gum"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT04142216",
"official_title": "Effect of Chewing Gum on Interdialytic Weight Gain, Thirst, Dry Mouth and Intradialytic Symptoms in Hemodialysis Patients: A Prospective Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-10",
"study_completion_date(actual)": "2020-01-30",
"study_start_date(actual)": "2019-10-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-21",
"last_updated_that_met_qc_criteria": "2019-10-25",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-29",
"first_submitted": "2019-10-24",
"first_submitted_that_met_qc_criteria": "2020-05-12"
}
}
}
|
#Study Description
Brief Summary
A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal infection.
#Intervention
- DRUG : Piperacillin/Tazobactam
|
#Eligibility Criteria:
Inclusion Criteria
* Written informed consent will be obtained prior to enrollment into the study. If any patient is unable to give consent, it may be obtained from next of-kin or a legal representative if in accordance with local laws and regulations
* Hospitalized, >=18 years
* Male or non-pregnant, non-lactating female who is post-menopausal, surgically sterilized or is using birth control pills, contraceptive implant or injection (ex: NORPLANT®; DEPO-PROVERA®), intra-uterine device, barrier methods with spermicide, or abstinence. (Effective contraception should have been in place for at least two months prior to study entry and must continue for at least 30 days after treatment discontinuation)
Exclusion Criteria
* Patients with underlying immunodeficiency disease or patients requiring chronic treatment with known immunosuppressant medications including >5mg/day prednisone
* Active or treated leukemia, or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the past year or which is anticipated to begin prior to the Test-of-Cure visit; or any known or suspected malignancy to the abdomen
* Concurrent hemodialysis, peritoneal dialysis or patients with indwelling peritoneal catheters or shunts, plasmapheresis or hemoperfusion
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00044928
|
{
"brief_title": "Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection",
"conditions": [
"Bacterial Infections"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00044928",
"official_title": "Randomized, Open-label, Comparative Study of Zosyn (Pip/Tazo [12g/1.5g]) Administered by Daily 24hr Continuous Infusion vs Zosyn (Pip/Tazo) [3g/0.375g]) q6h for the Treatment of Hospitalized Patients With Complicated Intra-abdominal Infection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-02",
"study_completion_date(actual)": "2004-02",
"study_start_date(actual)": "2002-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-02-08",
"last_updated_that_met_qc_criteria": "2002-09-09",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-09-10",
"first_submitted": "2002-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research has two main specific aims. First, a commercially-available stimulator will be utilized to assess the effect of low-level electromagnetic field (EMF) stimulation on atrial fibrillation (AF) inducibility in patients with paroxysmal AF presenting for catheter ablation as compared to sham stimulation. We hypothesize a reduction in AF inducibility in patients treated with EMF stimulation. Second, we aim to assess for the effect of low-level EMF on level of systemic inflammatory mediators. We hypothesize a reduction in the level of the inflammatory mediator tissue necrosis factor (TNF)-α in patients treated with EMF stimulation as compared to sham stimulation. The long-term objective of this research is to develop low-level EMF as a therapeutic alternative for patients with AF, and this research will help to determine the efficacy of low-level pulsed EMF in this regard.
Detailed Description
This is a prospective, randomized, sham-controlled trial. Patients will be enrolled upon presentation to our electrophysiology (EP) lab for ablation of paroxysmal AF. After informed consent is obtained, the patient will be randomized to one of two protocols that have been pre-programmed into the magnetic field stimulator. As described below, one of the protocols will be an active stimulation protocol, and one will be sham (i.e. no stimulation delivered). These will be named 'Stim 1' and 'Stim 2' in the computer. Because the specifics of the protocol are programmed into the stimulator by the device manufacturer, investigators will not know which of these two protocols is active vs. sham. The patient will then be brought to the EP lab for the procedure and will be placed on the lab table with their head positioned in the magnetic coil. Vascular access will then be obtained and diagnostic catheters placed as is standard practice for AF ablation.
Because the study is limited to patients with paroxysmal AF, patients will begin the study in normal sinus rhythm (NSR). Before the experimental protocol is begun, baseline electrophysiologic intervals will be recorded as is standard practice for all patients presenting for EP study. This will include measurement of the atrio-ventricular nodal effective refractory period (AVNERP) using programmed stimulation from the right atrial (RA) appendage, atrio-his (AH) interval, and his-ventricular (HV) interval per standard practice. Burst atrial pacing will then be utilized to induce AF. Measurements of the number of burst pacing attempts required to induce AF, as well as the AF cycle length, and duration of pacing-induced AF will be recorded. Attempts at AF induction will occur for 15 minutes. Prior to induction of AF, 5ml of venous blood will be drawn from the central venous sheaths to measure baseline levels of the inflammatory mediator (TNF)-α. These samples will be stored for analysis.
After baseline measurements are obtained, the coil will be turned on and whichever protocol the patient has been assigned to will be run. The system to be used contains a signal-generator coupled to a Helmholtz coil capable of producing a magnetic field in response to an electric current. The Helmholtz coil itself is has 9 inches of separation in between the two coils that allows for placement of the coil around the participant's head and upper neck. The choice of the head and neck as the site of stimulation is intended to target the vagus nerve as it exits the jugular foramen to course caudally in the carotid sheath. The system is designed to create a homogenous, isotropic magnetic field with a field strength from 1 to 99 pico-Tesla (pT) with a frequency range of 0.01 Hz to 50 Hz.
Active Stimulation will involve application of a pulsed-EMF with the parameters 0.032 micro-gauss (µG) at 0.89 Hz for 60 minutes. In participants randomized to sham stimulation, the coil will be positioned around the neck as previously described, but no current will be applied to the stimulator.
During the 60 minute stimulation time, trans-septal puncture and mapping of the left atrium will be performed as is standard practice for this procedure, but no ablation will be performed. After the 60 minute protocol is complete, venous blood samples will again be drawn (within 5 minutes of protocol completion), stored, and analyzed as previously described. If the patient remains in AF after the end of the 60 minute session, they will be electrically cardioverted to sinus rhythm. The same stimulation protocol as described previously will again be employed, again noting number of attempts required to induce AF, duration of pacing-induced AF, AF cycle length, and measurements of AVNERP, AH, HV intervals and levels of TNF-α.
#Intervention
- DEVICE : Low-level Pulsed EMF
- Low-level pulsed electromagnetic field stimulator delivered through a Helmholtz coil positioned around the participant's head and neck. Stimulation parameters are 0.032 µG at 0.89 Hz for 60 minutes.
- DEVICE : Sham Stimulation
- The stimulator will be placed around the participant's head and neck, but no EMF will be delivered.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged 21 <= age <= 85 presenting for ablation of paroxysmal atrial fibrillation (episodes of atrial fibrillation lasting < 7 days with or without prior cardioversion)
Exclusion Criteria:
* Left ventricular ejection fraction (LVEF) < 40%
* Stroke or myocardial infarction within the past 6 months
* Greater than moderate valvular stenosis or regurgitation as assessed by pre-procedure transthoracic echocardiogram (TTE)
* Presence of a prosthetic heart valve.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03593486
|
{
"brief_title": "Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation",
"conditions": [
"Atrial Fibrillation",
"Catheter Ablation",
"Autonomic Imbalance"
],
"interventions": [
"Device: Sham Stimulation",
"Device: Low-level Pulsed EMF"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03593486",
"official_title": "Effect of Low-Level Electromagnetic Field Stimulation on Patients With Paroxysmal Atrial Fibrillation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-26",
"study_completion_date(actual)": "2019-11-26",
"study_start_date(actual)": "2018-09-27"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-12-20",
"last_updated_that_met_qc_criteria": "2018-07-09",
"last_verified": "2019-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-20",
"first_submitted": "2018-06-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The hypotheses are: 1) the intestinal stem cell marker, DCLK1, which is increased in both the epithelium and stroma in colon cancer is also increased in BE (Barrett's esophagus) with HGD (high grade dysplasia) and in EAC (esophageal adenocarcinoma), 2) this expression correlates with disease progression towards EAC and 3) eradication of cells expressing stem cell markers occurs after therapy of EMR (endoscopic mucosal resection) or RFA (radiofrequency ablation) to eradicate BE with HGD and intramucosal adenocarcinoma and esophagectomy for EAC. We will test our hypotheses with the following aims: 1) To characterize the cell specific expression patterns of intestinal stem cell biomarkers in BE patients and correlate them with serum expression and disease progression, 2) To examine prospectively the effects of EMR, RFA or esophagectomy on the expression of stem cell biomarkers and the progression to EAC.
Detailed Description
Barrett's esophagus (BE) is a metaplasia of normal squamous epithelium. BE can progressively develop more abnormal features like low-grade intraepithelial dysplasia (LGID), high-grade intraepithelial dysplasia (HGID) before ultimately developing esophageal adenocarcinoma (EAC), with a low 5-year survival rate of 20 % or less. Recent evidence for the existence of cancer stem cells (CSCs) has advanced our understanding of cancer and has opened doors to new therapeutic strategies in cancer treatment. The fundamental goals of this project are to determine the effectiveness of endoscopic mucosal resection (EMR) and radiofrequency ablation (RFA) on eradication of putative intestinal stem cell markers that are overexpressed in BE with HGID and EAC. A better understanding of the cellular mechanisms that regulate the progression from normal squamous mucosa to EAC has enormous implications in the diagnosis and treatment of esophageal cancer. The presence of a CSC in esophageal cancer has been reported in both dysplastic BE/ EAC as well as in mouse models of the disease. The central hypotheses of the current proposal are: elimination of cells expressing stem cell markers occurs after ablative therapies (EMR/RFA) to eradicate BE with HGID/ EAC, and monitoring of stem cell marker expression during follow-up will correlate with disease recurrence or appropriate clinical response. Recently, we have reported that DCLK1, although minimally expressed in normal distal esophageal squamous mucosa, is markedly expressed in BE epithelium and EAC. We will test our central hypotheses with the following specific aims: 1. To prospectively characterize the cell specific expression patterns of putative intestinal stem cell biomarkers in BE patients and correlate them with serum/plasma protein expression and disease progression, 2. to examine prospectively the effects of EMR/RFA on the expression of putative stem cell biomarkers and correlate them with serum/plasma protein expression and disease progression and/or recurrence, and 3. to examine prospectively the effects on EMR/ RFA on esophageal-related quality of life and dysphagia during the endoscopic intervention period as well as following completion. The studies proposed have the potential to offer new insights for both the early diagnosis and monitoring of therapeutic response of future therapies for EAC. Moreover, these studies may identify novel biomarkers that can aid in the confirmation of HGID and potentially predict disease onset, progression and/or recurrence. Finally, these studies have the potential to provide preliminary data that will serve as the rationale for large scale multicenter trials to compare the effectiveness of EMR and RFA in BE with respect to clinical outcome, molecular features and effect on putative tumor stem cells. The recent identification of DCLK1 as a marker that distinguishes between normal and tumor stem cells in a rodent model of intestinal tumorigenesis lends support for our rationale for examining DCLK1 as a potential mediator of the neoplastic response in BE.
#Intervention
- OTHER : EMR and RFA effect on stem cell marker expression in BE/EAC
- Observation of EMR and RFA on the expression of putative stem cell biomarkers and correlate them with serum/plasma protein expression and disease progression and/or recurrence (Barrett's esophagus/ esophageal adenocarcinoma)
|
#Eligibility Criteria:
Inclusion Criteria:
* BE length of 12 cm or less
* presence of non-dysplastic BE on 2 sequential endoscopies or low-grade intraepithelial dysplasia (LGIN), high-grade intraepithelial dysplasia (HGIN) or EAC in BE segment on 2 endoscopies in the previous 6 months
* no signs of metastasis on endoscopic ultrasonography or computerized tomography scan.
Exclusion Criteria:
* pre-RFA EMR with cancer at the resection margin
* greater than T1sm1 invasion
* poor differentiation or worse
* angiolymphatic invasion
* esophageal stenosis preventing passage of an 11.3 mm endoscope
* persistent visible lesions after EMR before RFA and invasive cancer on biopsies after EMR pre-RFA.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03526328
|
{
"brief_title": "DCLK1 as a Marker/Indicator of Stem Cell Response in Barrett's Esophagus/Esophageal Adenocarcinoma",
"conditions": [
"Barrett's Esophagus",
"Esophageal Adenocarcinoma"
],
"interventions": [
"Other: EMR and RFA effect on stem cell marker expression in BE/EAC"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03526328",
"official_title": "Doublecortin Like Kinase-1 as a Marker and Indicator of Treatment Response for Intestinal Stem Cells in Barrett's Esophagus and Progression to Esophageal Adenocarcinoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-13",
"study_completion_date(actual)": "2019-08-13",
"study_start_date(actual)": "2013-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-06",
"last_updated_that_met_qc_criteria": "2018-05-03",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-16",
"first_submitted": "2013-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In head and neck squamous cell carcinoma (HNSCC), the presence of lymph node metastases in addition to free resection margins following surgical resection of the primary tumor is an important prognostic factor, and may impact planning of surgery as well as of radiotherapy. Until now, imaging modalities including PET/CT and MRI did not allow to exclude especially small lymph node metastases.
Compared to standard whole-body PET/CT acquisition techniques, high-resolution (HR) head and neck PET/CT acquisitions promise improved detection of lymph node metastases in head and neck squamous cell carcinoma (HNSCC). This prospective study aims to determine the sensitivity and specificity of lymph node staging with HR FDG-PET/CT in HNSCC by correlating PET/CT with histopathology after neck dissection. HR PET/CT may have a relevant impact on the therapeutic concept, and the planning and dose prescription of radiotherapy.
Detailed Description
In head and neck squamous cell carcinoma (HNSCC), the presence of lymph node metastases in addition to free resection margins following surgical resection of the primary tumor is an important prognostic factor, and may impact planning of surgery as well as of radiotherapy. Neck dissection and histopathology are regarded as diagnostic standard procedures to define the lymph node status in patients with HNSCC. Occult lymph node metastases after imaging have been described in up to 46% of patients, e.g. in patients with cancer of the tongue.
Although neck dissection generally has a low rate of intra- and postoperative complications, a small but statistically significant group of patients suffers from surgery-related side effects such as lymphedema, chronic pain syndromes and injury of cranial nerves with paralysis (shoulder lift and mouth angle). Therefore it would be desirable to spare diagnostic neck dissection in patients without macroscopic lymph node metastasis. However, the sensitivity and/or specificity of the non-invasive imaging techniques available up to now, including positron emission tomography (PET) and magnetic resonance imaging (MRI), did not allow to exclude lymph node metastases, which is especially true for small metastases. Therefore, imaging is not able to replace the histological examination of the cervical lymph nodes and have limited impact on the therapeutic concept, the surgical planning and the planning and dose prescription of radiotherapy.
Acquisition techniques and image quality of PET (with the glucose analog F-18-fluorodeoxyglucose (FDG)) and the combined examination with computed tomography (PET/CT) were considerably improved with last generation PET/CT machines. New generation PET/CT machines provide significantly improved image quality and image resolution image, and probably higher sensitivity to detect smaller lesions. However, in the face of an expected increase of detected metabolically active cervical lymph nodes by high-resolution (HR) PET/CT, a diagnostic problem in terms of a potentially increased number of false-positive lymph nodes arises, e. g. due to an inflammatory lymphadenopathy.
Until now there are no evidence-based criteria to classify small metabolically active lymph nodes detected by HR PET/CT. Hence, a correlation of PET/CT findings and histopathology of cervical lymph metastases and inflammatory lymph nodes in patients with HNSCC is required to develop diagnostic criteria for HR PET/CT and to exploit the diagnostic potential of HR PET/CT.
Modern concepts of radiotherapy planning for neck lymph node metastases increasingly take into consideration the metabolic and morphological information of PET/CT for target volume definition. Detailed information on the diagnostic performance of HR PET / CT are of importance for the dose prescription of intensity-modulated radiotherapy (IMRT). In radiotherapy side effects depend significantly on the dose and the irradiation volume. Modern radiation techniques, especially IMRT, allow for highly-conformal radiation therapy with steep dose gradients to protect organs such as the salivary glands, and to reduce side effects of radiotherapy. On the other hand modern radiotherapy concepts carry the risk to fail due to non-inclusion of subclinical lymph node metastases in the target volume. HR PET/CT may allow to minimize out-of-field recurrences caused by incorrect target volume contouring or dose prescription. Evidence-based data on the diagnostic accuracy of HR PET/CT with special regard to small lymph node metastases are needed to clarify the potential role of HR PET/CT for radiation treatment planning.
Objective:
* To determine the sensitivity, specificity, accuracy, PPV and NPV of lymph node staging with HR PET/CT in patients with HNSCC
* To determine the sensitivity, specificity, accuracy, PPV and NPV of HR PET/CT for lymph node metastases of different size in patients with HNSCC
* To determine the detection rate of distant metastases by PET/CT in patients with HNSCC
* To develop diagnostic criteria for the multi-modal lymph node staging with HR PET/CT in patients with HNSCC
* To evaluate the potential impact of HR PET/CT on radiation treatment planning
Methods:
Patients with HNSCC are managed according to clinical recommendations of the interdisciplinary tumor board. Elective patients receive selective, modified radical or radical neck dissection of the relevant lymph node region according to clinical routine standards at the Inselspital Bern. The neck dissection must be carried out within a maximum of 6 weeks after the PET / CT examination.
As part of the neck dissection the lymph nodes will be sent to the Institute of Pathology separated by level and side by topographic markers (cranial / caudal, medial / lateral). The histological examination of the removed lymph nodes serves as reference standard for the analysis of PET/CT image data, and calculation of the diagnostic accuracy of HR PET/CT.
Theoretical radiation treatment plans are generated based on conventional imaging, whole-body PET/CT and HR PET/CT protocols to determine the impact of PET/CT.
|
#Eligibility Criteria:
Inclusion Criteria:
* Head and neck squamous cell carcinoma (HNSCC), fulfilling one or more of the following criteria:
* Advanced primary tumor stage (cT3 or cT4)
* Clinical suspicion of neck lymph node metastases
* Cervical lymph node metastases of unknown primary tumor (CUP)
* Tumor recurrence
* Mature adult
* Written informed consent
Exclusion Criteria:
* Inoperability
* Histologically verified cervical lymph node metastases of other tumors
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02372890
|
{
"brief_title": "Validation of High-resolution PET/CT for the Pretherapeutic Lymphnode Staging of Head/Neck Cancer",
"conditions": [
"Otorhinolaryngeal Neoplasms",
"Cancer of Head and Neck"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT02372890",
"official_title": "Validation of High-resolution PET/CT for the Pretherapeutic Lymphnode Staging of Head/Neck Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-31",
"study_completion_date(actual)": "2017-12-31",
"study_start_date(actual)": "2012-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-27",
"last_updated_that_met_qc_criteria": "2015-02-20",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-26",
"first_submitted": "2015-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of study was to compare insertion ease by modified I-gel jaw thrust insertion technique and standard I-gel insertion technique on the basis of I-gel insertion attempts and I-gel insertion time duration. The secondary objective of study was to analyse the impact of prior information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques. And, tertiary objective of study was to analyse the trainee's preference insertion technique at the basis of learning method and practical adaptability.
Hypothesis:
The modified I-gel jaw thrust insertion technique is easy to understand and practice than the standard I-gel insertion technique at the beginning of airway management training among the novice anesthesiologists.
Detailed Description
* I-gel insertion attempts are the number of I-gel insertion attempts with each study's insertion technique. The 10 insertion attempts allowed to performed with each insertion technique by trainees.
* I-gel insertion time duration was the time taken to complete I-gel insertion; from the holding of device till the confirmation of chest movement (artificial lung inflation in manikin).
* The correlation of previous information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques were assessed by asking from participant's questionnaire based at the start of study.
* The trainees were asked at the end of study for preferred insertion method at novice level on the basis of learning method and practical conduct (user friendly).
#Intervention
- DEVICE : I-gel with standard insertion technique
- Standard I-gel insertion technique (grasping I-gel from integral bite block site and cuff facing towards chin and pressing down the manikin chin. I-gel introduced in patient's mouth in a direction towards hard palate. Then I-gel slided downwards and backwards along hard palate with a continuous but gentle push until a definitive resistance is felt)
Modified jaw thrust technique (grasping I-gel from integral bite block site and cuff facing towards chin and pressing down manikin chin. I-gel introduced in patient's mouth in a direction towards hard palate with gently advancing into oropharynx. Then after, I-gel left in oral cavity and both hands used to thrust jaw by lifting angle of mandible with little fingers and other fingers to stabilise jaw. And, at this point, both hand's thumbs used to apply balance force from I-gel stem head towards final placement position by looking at integral bite block mark at incisor teeth level)
- Other Names :
- Modified jaw thrust I-gel insertion technique
|
#Eligibility Criteria:
Inclusion Criteria:
* First year anaesthesia residents
* Using adult mannequin
Exclusion Criteria:
* Pediatric mannequin
* Participant's refusal
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05545163
|
{
"brief_title": "Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists",
"conditions": [
"Training Group, Sensitivity",
"Igel"
],
"interventions": [
"Device: I-gel with standard insertion technique"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05545163",
"official_title": "Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists: A Randomised Control Crossover Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-02",
"study_completion_date(actual)": "2021-10-02",
"study_start_date(actual)": "2021-10-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-19",
"last_updated_that_met_qc_criteria": "2022-09-14",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-19",
"first_submitted": "2022-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background: environmental influences in the first years of life have a great impact on adulthood. Adequate environmental stimulation in the first years of life positively influence cognitive, emotional and neurological development. Studies show that high quality education for 3 to 6 years old children are cost-effective for diverse outcomes, such as socioemotional and cognitive development, as well as school performance. However, it is not clear why specific types of interventions are most effective on school readiness, an important precursor of literacy status and later life outcomes. Objectives: adapt to the Brazilian context two well-known intervention programs: (1) executive functions training developed by Diamond, and (2) oral language skills based on the Nuffield Programme developed by Snowling and colleagues. Methods: a randomized controlled trial involving 720 children (4 to 5 years old) allocated to three groups: (1) adapted school curriculum focusing on executive functions training, (2) adapted school curriculum focusing on oral language skills training, and (3) regular school curriculum.
#Intervention
- BEHAVIORAL : Executive functions training
- Daily training of executive functions via activities to develop auto-regulation, attention and memory.
- BEHAVIORAL : Language skills training
- Daily training of language skills via activities to develop phonological awareness and vocabulary.
- OTHER : Regular school curriculum
- Ministry of Education national school curriculum.
|
#Eligibility Criteria:
Inclusion Criteria:
* Schools interested in the intervention program
* Preschool children (4 <= age <= 6 old)
Exclusion Criteria:
* Presence of any sensory impairment
* Intellectual disability
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02807831
|
{
"brief_title": "A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children",
"conditions": [
"Executive Function",
"Language",
"Preschool Child"
],
"interventions": [
"Behavioral: Executive functions training",
"Other: Regular school curriculum",
"Behavioral: Language skills training"
],
"location_countries": null,
"nct_id": "NCT02807831",
"official_title": "A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-06-21",
"last_updated_that_met_qc_criteria": "2016-06-16",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-21",
"first_submitted": "2016-06-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine the effectiveness of beta-alanine supplementation. The physical working capacity test has been used to show significant increases in physical working capacities following supplementation. The physical working capacity tests were originally developed by Moritani et al. 1981 and Devries et al. 1982 to measure the point of onset of muscular fatigue. It is hypothesized that beta-alanine will increase physical working capacity at heart rate threshold, thereby signifying a delay in fatigue.
Detailed Description
An equal number of men and women will be recruited \[Men, n=20 (10 placebo \[PL\]; 10 beta-alanine (Active)\]; \[Women,n=20 (10 PL; 10 Active)\]. Men and women will be randomly assigned to respective groups to allow for equal numbers in supplement and placebo groups.
#Intervention
- DIETARY_SUPPLEMENT : Placebo
- DIETARY_SUPPLEMENT : Beta-alanine
|
#Eligibility Criteria:
Inclusion Criteria:
* Between the ages of 18 <= age <= 35 years
* Be recreationally active (defined as accumulating 1 <= age <= 5 hours of moderate intensity
Exclusion Criteria
* Any health risks or indicators that would prevent them from participating in physical activity, as determined by a health history questionnaire
* Must not have taken performance enhancing supplements containing beta-alanine or creatine during the last 3 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01745016
|
{
"brief_title": "Effect of Beta-Alanine on Heart Rate Response",
"conditions": [
"Exercise",
"Fatigue"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: Beta-alanine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01745016",
"official_title": "The Effect of 28 Days of Beta-alanine Supplementation on the Physical Working Capacity at Heart Rate Threshold (PWCHRT)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-04",
"study_completion_date(actual)": "2013-04",
"study_start_date(actual)": "2013-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-04-30",
"last_updated_that_met_qc_criteria": "2012-12-05",
"last_verified": "2013-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-07",
"first_submitted": "2012-12-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
Detailed Description
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
The study population is comprised of Rutherford 5 and 6 CLTI subjects who have hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and:
1. 2 revascularizations in the last 6 months that failed to resolve symptoms, OR
2. have inadequate popliteal, tibial, or pedal revascularization target
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject must be >=18 years
* Subject is Rutherford 5 or 6 classification with hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and: a) 2 revascularizations in the last 6 months that failed to resolve symptoms, OR b) An inadequate popliteal, tibial, or pedal revascularization target
* Subject is willing and able to sign the informed consent form and willing to participate in the phone follow-ups.
Exclusion Criteria:
* Any significant concurrent psychological or social condition (e.g., no support person/network), which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
* Subject is participating in the PROMISE II Clinical Trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04304105
|
{
"brief_title": "Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study",
"conditions": [
"Critical Limb Ischemia",
"Peripheral Artery Disease"
],
"interventions": null,
"location_countries": [
"Puerto Rico",
"United States"
],
"nct_id": "NCT04304105",
"official_title": "Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-12",
"study_completion_date(actual)": "2022-09-12",
"study_start_date(actual)": "2020-02-24"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-20",
"last_updated_that_met_qc_criteria": "2020-03-09",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-11",
"first_submitted": "2020-03-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test an intervention focused towards promoting mindfulness among VA physicians and nurses. Mindfulness is a tool that can help people focus. It helps clear the mind of distractions and biases. Some physicians and nurses will be randomized to receive the study intervention, while others will not. The study intervention will include the following: 1) education about mindfulness; 2) group discussions about mindfulness; and 3) an optional mobile app to promote mindfulness. Participants randomized to the intervention will be encouraged to use the act of cleansing their hands as a prompt for practicing mindfulness. The study will test if this intervention will increase physician and nurse mindfulness. It will also test if it leads to improved well-being and use of proper hand hygiene.
Detailed Description
Physician and nurse well-being is important for providing high quality patient care. Many physicians and nurses suffer from stress, fatigue, psychological distress, depression, and burnout. This can lead to poor patient care. In this study, the investigators will use a repeat-measures randomized controlled mixed-methods trial to evaluate an intervention designed to improve healthcare provider well-being. The intervention will help physicians and nurses practice moments of mindfulness. Mindfulness is paying attention to the present moment. It can help people feel more aware instead of feeling like they are running on automatic pilot. The investigators will test if practicing mindfulness while cleaning hands before and after seeing patients will lead to improved well-being and hand hygiene.
This is a multi-center, repeat-measures randomized controlled mixed-methods trial that will last 3 years. The primary objective of this phase 1/2 clinical trial is to implement and evaluate an intervention to improve physician \& nurse well-being through promoting mindfulness. Secondary objectives include monitoring physician and nurse hand hygiene adherence and duration and conducting a qualitative assessment to evaluate the intervention. The study will enroll approximately 334 physicians and nurses from 2 VA Medical Centers (LTC Charles S. Kettles VA Medical Center, Ann Arbor, MI; and Michael E. DeBakey VA Medical Center, Houston, TX).
The proposed study will focus on Internal Medicine physicians who are part of inpatient care teams and nurses providing care on medical and medical/surgical units at LTC Charles S. Kettles VAMC in Ann Arbor, MI and MEDVAMC in Houston, TX. Medical students, surgical physicians, and physicians on sub-specialty teams will not be included. At both participating facilities the inpatient care teams are predominately composed of 1 attending, 1 senior resident, 2 interns, and up to 3 medical or physician assistant students. Interns and senior residents are usually assigned to a team for 4-week blocks (occasionally 2 weeks), while attendings rotate approximately every 2 weeks. The Ann Arbor VAMC has 3 medical or medical/surgical inpatient units, while MEDVAMC has 5 units. At both facilities each nursing unit employs between 20-30 nurses. The investigators will aim to recruit approximately 30 attendings, 72 residents and 40 nurses at Ann Arbor VAMC. As MEDVAMC is larger, with a greater number of inpatient care teams and nursing units than the Ann Arbor VAMC, the investigators will aim to recruit approximately 40 attendings, 72 residents and 80 nurses. The target study sample size is a total of 334 physicians and nurses (167 intervention/167 control). For Aim 3, the investigators plan to interview approximately 8 physician team members and 4-6 nurses from the intervention arm at each site.
Randomization: At each study site the participating physician teams and nursing units will be randomly assigned into one of two study arms (intervention/control). For physician teams, this will occur on a rolling basis for 12 months with 2 physician teams randomly selected at each site each month for participation (1 intervention, 1 control). Once randomized, an email will be sent to the initial attending of the team introducing the study and seeking approval for their team to participate in the randomized controlled trial. If the attending physician from a team refuses participation, the next team identified from the randomized list will be approached to participate. If a new attending joins the team mid-month, they will be approached to participate in the study, but will be automatically assigned to the same randomization group as the rest of their team.
Similarly, a total of 2 medical/surgical units from the Ann Arbor VA (1 intervention, 1 control) and 4 medical/surgical units from Houston VA (2 intervention, 2 control) will be randomly selected to participate in the nurse portion of the project. The nurse manager for each selected unit will then be approached to obtain approval for the unit to participate. If a nurse manager declines, the next unit on the list will be selected.
An independent statistician will allocate the physician teams and nursing units at both study sites in a concealed fashion, using a computer-generated randomization schema. The physicians and nurses from the intervention groups will receive both independent and group-facilitated mindfulness education, will be encouraged to use a mindfulness mobile app as a practice reminder and additional resource, and instructed to integrate moments of mindfulness with repeated episodes of hand hygiene during the course of caring for patients. The control groups will receive no such education or intervention and will continue providing care as usual.
Recruitment and Control Arm: Potential subjects will be recruited via email or in-person communications. Everyone who consents to participate (regardless of study arm) will be asked to complete baseline surveys containing validated scales measuring dispositional mindfulness, well-being, and hand hygiene perceptions. The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. Additionally, participants will be asked to complete the Well-Being Index (WBI). The 9-question WBI assesses distress across a variety of dimensions including fatigue, depression, burnout, stress, and quality of life, and has been validated for use in physicians, residents, and nurses. Participants will also be asked to complete 8 questions on healthcare-associated infections and hand hygiene perceptions selected from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization. Similar to other studies on hand hygiene perceptions guided by the constructs based on the Theory of Planned Behavior, the selected PSHW questions cover behavioral, normative, and control beliefs, as well as self-reported hand hygiene adherence. Participants will also be asked whether they meditate or perform any form of internal reflection prior to the study, as this may influence performance during the intervention. Completing the full survey questionnaire will take approximately 10 minutes.
Habituation Period: To collect baseline data on hand hygiene adherence and duration for both study arms and to habituate providers to the presence of observers, 1 month of covert, unit-based hand hygiene observations will be conducted. Observation of hand hygiene adherence will include hand hygiene prior to patient room entry and after exiting the patient room. Hand hygiene observers will not enter patient rooms or interfere in patient care. Observation of hand hygiene duration will be done when providers exit patient rooms, as observing hand hygiene duration upon room entry will not be feasible since observers will not enter patient rooms and providers may practice hand hygiene while entering the patient room.
Intervention Activities: Participants in the intervention will be asked to complete 3 self-directed online education modules on mindful practice developed by the Ohio State University Mind-Body Skills Training for Resilience, Effectiveness, and Mindfulness (STREAM) program (http://mind-bodyhealth.osu.edu). Subjects will receive compensation for completion of each online training module completed outside of their working hours. Participants will also be asked to participate in group-facilitated discussions with their site mindfulness champion where they will discuss using mindfulness during their work day. During these discussions, participants will be instructed to use the act of hand hygiene as a moment to pause and reflect - a mindful moment. The guided discussions will be recorded, transcribed, and used in the qualitative evaluation of the intervention. Intervention participants will also be given the option of using a self-directed mobile application to enhance their mindfulness education and practice. The study will use the Mindfulness Coach mobile app, which was developed by researchers at the National Center for Posttraumatic Stress Disorder, Dissemination \& Training Division at the VA Palo Alto Health Care System.
Post-Intervention Activities: The same measures that were collected during the pre-intervention period will again be collected during the post-intervention period. Subjects will be asked to complete the same survey once the 1-month intervention has ended. They will also be asked to complete the survey again 6-months post-intervention to assess sustainability. The research assistants will again conduct covert direct observations of hand hygiene moments during the intervention phase and 3-12 months post-intervention. Select subjects will also be asked to participate in qualitative interviews after the intervention is complete to provide: views on the intervention; overall perceptions of and experiences with mindfulness; barriers encountered while trying to implement the intervention during clinical practice; personal sense of well-being and whether or not the intervention had any effect on well-being; perceptions on whether or not practicing mindfulness during hand hygiene had any impact on hand hygiene adherence; and the potential benefits of using mindfulness in the clinical setting.
Data Analysis: Differences in hand hygiene adherence and duration between intervention and control groups will be assessed using Fisher's exact test and t-test, as appropriate. Risk differences in adherence to duration of hand hygiene will be calculated for both intervention and control groups. Because the primary outcomes for Aim 1 (i.e., hand hygiene adherence and duration) are expected to occur frequently, the investigators will use generalized linear models to evaluate differences in hand hygiene adherence and duration for the intervention versus control group, with the Poisson distribution (log link) and robust error variance. Models will account for provider type and level, and will incorporate clustering by physician team (and separately for nursing unit). Statistical significance will be calculated for the intervention (intervention vs. control) coefficient.
As a secondary outcome for Aim 1, the investigators will assess changes and differences in hand hygiene perception based on responses to select questions from the PSHW. For Aim 2, mindfulness will be based on responses to the FFMQ and well-being will be based on responses to the WBI. Survey scales will be scored according to the published algorithms. Descriptive statistics will be used to summarize participant scores from pre- and post-intervention, as well as 6-month post-intervention follow-up assessments. Within-group paired-samples t-tests will be used to test for improvement in participant scores across the baseline, post-intervention (\~14 days for physicians and 1-month for nurses), and 6-month post-intervention follow-up periods, for the intervention and control groups separately. Analyses will use list-wise deletion for missing data. Participants not completing all surveys will still be included in any analysis for which they provide data. For all analyses, p-values less than 0.05 will be considered significant and all tests will be two-tailed. Analysis of covariance (ANCOVA) models will then be used to assess relative changes in mindfulness, well-being, and hand hygiene perceptions across groups, the most direct test of discriminant validity. In these models, post-test scores will be predicted by group status controlling for pre-test scores.
#Intervention
- BEHAVIORAL : Mindful Hand Hygiene
- Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.
|
#Eligibility Criteria:
Inclusion Criteria:
* Nurses on participating unit
* Physician on an inpatient medical team, including attending, senior resident, and intern physicians
Exclusion Criteria:
* Medical students
* Surgical attendings
* Physicians on sub-specialty teams
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05261282
|
{
"brief_title": "Mindful Hand Hygiene for Healthcare Workers",
"conditions": [
"Burnout",
"Mental Health"
],
"interventions": [
"Behavioral: Mindful Hand Hygiene"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05261282",
"official_title": "Mindful Hand Hygiene to Reduce Infections Among Veterans While Enhancing Provider Well-Being",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-08",
"study_completion_date(actual)": "2024-12-08",
"study_start_date(actual)": "2022-11-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-14",
"last_updated_that_met_qc_criteria": "2022-02-24",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-02",
"first_submitted": "2022-02-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Bloodstream infections are common in Intensive Care Units (ICUs). The need of a central venous line increases the risk of bacteremia and central venous catheter (CVC) related infections. The use of catheters coated and/or impregnated with different antimicrobial agents has been proposed to reduce the risk of such infections. However, results obtained so far did not reach enough clinical relevance to consider these medicated catheters as a valid alternative to the conventional ones.
The aim of this comparative randomized study is to assess the ability of recently developed silver ion-releasing central venous catheters in preventing associated infections in comparison with the conventional ones.
Experimental groups are defined as follows:
* Group A: patients treated with standard, triple lumen, non medicated catheters
* Group B: patients treated with triple lumen catheters impregnated with silver nanoparticles
Detailed Description
RATIONALE
Central venous catheter (CVC) infections are one of the major causes of infections acquired in intensive care unit (ICU) patients. About 25% of bloodstream infections recorded in ICUs are secondary to proven catheter-related infections and up to 80% of the so-called primary bacteraemia may be caused by catheters. Pittet et al. have estimated that nosocomial bloodstream infection, irrespective of its source, was associated with an overall 35% attributable mortality and a prolonged hospital stay of 32 days, including 8 days in the ICU. Prevention of catheter-related infections is a priority for infection control programs. Clear preventive measures include strict barrier precautions during insertion and careful aseptic techniques during subsequent manipulations of catheters. Other preventive measures, including the use of catheters specifically designed to inhibit microbial colonisation, such as antimicrobial-coated catheters, are not universally accepted or recommended for routine use, also due to their high cost. Previous trials have demonstrated a 50% risk reduction of infection rates when using antiseptic-coated catheters; however, their efficacy in reducing catheter related bloodstream infections is still unclear. A new generation of silver nanoparticle impregnated CVCs (Logicath AgTive®, Medex Medical INC., UK), has become recently available, but no clinical trial documenting their activity in preventing microbial colonization of catheters has been carried out so far. In this study, we want to assess the ability of this new generation catheters to prevent short-term (\< 28 days) catheter-related infections in critically ill patients, in comparison with conventional untreated catheters.
STUDY POPULATION
All consecutively admitted critically ill patients needing central venous catheterization for more than 5 days.
TRIAL OBJECTIVE AND PURPOSE
The objective of this study is to test the ability of these new medicated catheters, to reduce the risk of Central Venous Catheter Related Infections (CVCRI) in ICU patients. CVCRI is defined as a positive culture from the catheter when hemoculture is concurrently positive for the same microbial strain for at least two consecutive times.
TRIAL DESIGN
Study Design
This is a randomized, open, controlled, parallel multicenter study involving 5 Italian ICUs and the supporting clinical microbiology laboratories under the supervision of Prof. Massimo Antonelli, for the clinical issues and Prof Gianfranco Donelli, for the microbiology issues. Statistical evaluation of the data will be under the responsibility of Dott. Andrea De Gaetano, belonging to the Biomatematic Laboratory of the Italian National Research Council (CNR-IASI).
Endpoints
The primary end-point is the difference in raw percentage occurrence of CVCRI (on a patient basis) between groups A and B.
The secondary end-point are the infection-free time and the probability of CVCRI as a function of multiple predictors.
METHODS
Randomization and blinding
An Internet-based randomization scheme, stratified by center, age and gender will be employed, indicating the allocated treatment at the moment of enrollment. The randomization procedure will require that when guide wire exchange is performed, a catheter from the same allocation group (medicated or not medicated) is used. The treatment will be open to the physician performing the procedure, and data collection will indicate group membership as A and B in random order. While the data manager will hold the key to the group/treatment associations, both the adjudication committee members (deciding on database record freezing) and the statisticians performing the analyses will be blinded to treatment allocation.
Insertion and maintenance of catheters
Recommendations will be provided to study centers to comply with maximal barrier precautions during insertion and repositioning of catheters, if indicated. A transparent, semipermeable dressing, will be provided to all the participating ICUs to be used after insertion, to allow daily inspection of the insertion site. Subsequent dressings will be carried out as clinically indicated, at 2 to 5 days intervals. Line tubing and three-way stopcocks will be changed on the basis of each unit's protocol at 1 to 3 days intervals, although changing these after each blood product transfusion and following the administration of lipid solutions will be required.
The catheter will be kept in place as long as required in the absence of complications. Catheters will be removed when no longer required, or because of malfunction, when suspicion of infection or otherwise unexplained bloodstream infection occurs; and in the presence of gross inflammation or pus at the catheter insertion site. In situ treatment of catheter infection will not be allowed.
Data recorded
The following information will be recorded upon inclusion: age, sex, date of hospital admission and to the intensive care unit; underlying disease and severity (McCabe class); admission category (medical, surgical, whether or not scheduled, or trauma), diagnosis and primary organ failure on ICU admission. The severity score SAPS II, organ dysfunction and SOFA score will also be recorded, as well as the presence of an active infection focus, ongoing antibiotic therapy, and presence of other intravascular devices. Patients will be followed up to 48 hours after catheter removal. Data recorded will include: a) Mechanical complication occurring during insertion (number of venipunctures, arterial puncture, hematoma, pneumothorax); b) presence of local signs suggesting infection (erythema at the catheter skin entry site, scored as 0: absence; 1+: \<5mm; 2+: 5-10mm; 3+: \>10mm; presence of induration or purulence); c) presence of a systemic inflammatory response syndrome or of symptoms characterizing severe sepsis; d) Presence of other documented infection ; e) other intravascular devices in place or inserted each day; f) dressing changes; g) Results of blood and catheter-tip cultures, and of other clinically significant microbiological samplings; h) antibiotics administered.
Microbiological data
Blood cultures will be obtained when temperature is \> 38°2 or \< 36°5C. Diagnostic samples of any other suspected infection foci will be taken as clinically indicated. Upon catheter removal, the intravascular catheter tip will be cultured using the semi quantitative culture described by Maki et al. (Maki DG, Weise CE, Sarafin HW. A semiquantitative culture method for identifying intravenous-catheter-related infection. N Engl J Med 1977;296:1305-1309). This technique involves rolling of the catheter distal tip on Agar plate and reading the high-density colonization on a semiquantitative culture (more than 15 colonies on each plate).
Inclusion Criteria
Patients will be eligible when insertion of a central venous catheter (CVC) at a new site (subclavian or internal jugular) has to be planned for therapy or monitoring of at least 3-day duration.
Exclusion Criteria Age below 18 years and all patients with a history of failed catheterization attempts or the need for catheterization at a site of previous surgery, skeletal deformity, or scarring.
Data analysis
A Clinical Evaluation (Adjudication) Committee composed of the two coordinating investigators (Prof. Massimo Antonelli and Prof. Gianfranco Donelli) and the statistician (Dr. Andrea De Gaetano) will assess, blindly with respect to the randomization group, the evaluability of catheters and the classification of all episodes of bloodstream infection and of catheters having a positive culture, according to the above definitions. Catheters will be excluded from the analysis when insertion fails. Catheters that have not been adequately followed-up until the time of removal (transfer to another unit or hospital) will be censored on the last day of follow-up in the ICU and classified by the Committee as infected or uninfected, using the data available up to the last day of follow-up and any bacteriological data subsequently received.
ASSESSMENT OF SAFETY
Adverse Events
Complications of the procedure will be classified according to a Complications Diagnosis Dictionary. Text comments will be added to the recordings as appropriate. Descriptive analysis of the complications as well as comparison of complication rates (overall and by family of most frequent complications) will be obtained.
STATISTICS
Sample Size and Power Computation
The catheter-related infection rate was estimated at 10% in the conventional catheter group. Assuming a 50% relative reduction (to 5%) in the silver impregnated CVC treated group, the number of patients needed (or equivalently the number of patients enrolled, assuming an attrition rate of 10%) for each treatment group in order to reach the desired statistical power is reported below, assuming a Type I error level of 0.05 and depending on the significance level and the number of tails of the statistical test.
Two-tailed tests will be considered throughout. A power of 80% will be considered sufficient. Therefore, 472 patients per group should be enrolled.
#Intervention
- PROCEDURE : CVC impregnated with silver nanoparticles (AgTive®)
- insertion of medicated silver nanoparticles CVC
- PROCEDURE : CVC cannulation
- placement of conventional trilumen CVCs
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients will be eligible when insertion of a central venous catheter (CVC) at a new site (subclavian or internal jugular) has to be planned for therapy or monitoring of at least 3-day duration.
Exclusion Criteria:
* Age below 18 years and all patients with a history of failed catheterization attempts or the need for catheterization at a site of previous surgery, skeletal deformity, or scarring.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00337714
|
{
"brief_title": "Comparison of Central Venous Catheters With Silver Nanoparticles Versus Conventional Catheters",
"conditions": [
"Central Venous Catheter Related Infections"
],
"interventions": [
"Procedure: CVC impregnated with silver nanoparticles (AgTive®)",
"Procedure: CVC cannulation"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT00337714",
"official_title": "A Parallel, Randomized Multicenter Comparison of Triple Lumen Central Venous Catheters Impregnated With Silver Nanoparticles (AgTive®) Versus Conventional Catheters in Intensive Care Unit Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2008-09",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-05-16",
"last_updated_that_met_qc_criteria": "2006-06-14",
"last_verified": "2008-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-06-16",
"first_submitted": "2006-06-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
#Intervention
- DRUG : rituximab [Mabthera/Rituxan]
- Intravenous repeating dose
|
#Eligibility Criteria:
Inclusion Criteria:
* adult patients 60 <= age <= 75 years;
* B-cell follicular NHL;
* no previous treatment;
* active disease, with rapid progression.
Exclusion Criteria:
* other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
* long-term use (>1 month) of systemic corticosteroids;
* central nervous system involvement;
* history of significant cardiovascular disease;
* positive test result for HIV, or hepatitis B or C.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01144364
|
{
"brief_title": "A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)",
"conditions": [
"Non-Hodgkin's Lymphoma"
],
"interventions": [
"Drug: rituximab [Mabthera/Rituxan]"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT01144364",
"official_title": "A Randomized, Open-label Study of MabThera Maintenance Therapy Compared With no Further Therapy After a Brief Induction With Chemotherapy Plus MabThera on Failure-free Survival in Treatment-naïve Elderly Patients With Advanced Follicular Lymphoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-07-21",
"study_completion_date(actual)": "2011-07-21",
"study_start_date(actual)": "2004-01-19"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-15",
"last_updated_that_met_qc_criteria": "2010-06-14",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-15",
"first_submitted": "2010-06-11",
"first_submitted_that_met_qc_criteria": "2014-12-03"
}
}
}
|
#Study Description
Brief Summary
Correlation between hernias reparation in patients who have received a kidney transplant. The investigators will analyze the data of patients who have been treated for reparation of incisional hernia after kidney transplantation with or without the placement of a prosthesis.
Detailed Description
In the scientific literature, the percentage of post incisional hernia in kidney transplanted patients is very variable, and not too well-argued, especially in the context of prevention and individuation of risk factors.
The increase of surgical management of hernias reparation in renal transplant patients justifies the start of a mon-centric type study. The investigators will look for risk factors with a retrospective, observational study, by analyzing the type of surgical repair of their post-surgical wall defect.
The analysis of costs/benefits on postoperative, intraoperative, or preoperative prevention will be taken into account.
|
#Eligibility Criteria:
Inclusion criteria:
* hernia post renal transplantation
Exclusion criteria:
* underage
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04730492
|
{
"brief_title": "HErnias REparation After Kidney Transplantation Study",
"conditions": [
"Prosthesis User",
"Renal Transplantation"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT04730492",
"official_title": "A Retrospective Observational Study of Hernias Reparation in Patients Who Have Received a Kidney Transplant",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-30",
"study_completion_date(actual)": "2021-02-28",
"study_start_date(actual)": "2020-11-30"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-05-06",
"last_updated_that_met_qc_criteria": "2021-01-25",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-29",
"first_submitted": "2021-01-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study to obtain pilot data on Nocturnal Hypertension and Nocturia. In Dr. Victor's current NIH grant (Cut Your Pressure Too: The LA Barbershop Blood Pressure Study) the results show that uncontrolled systolic hypertension is independent determinantal of nocturia in African American men.
We now went to pursue this correlation by designing a new NIH grant Proposal to determine whether replacing short acting with long acting drugs and dosing them at bed time rather than in the morning will:
A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to nocturia in some patients.
Detailed Description
AIMS AND SIGNIFICANCE OF PILOT DATA
Determine:
1. The feasibility of Southern California registry as an effective measure to recruit African American men to participate in a new research program.
2. If men will comply with the study procedures including Actigraphy and ambulatory blood pressure monitors.
3. The within subject coefficient of variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure monitoring, vertical activity at night by Actigraphy monitors.
4. Whether the ambulatory Blood pressure itself affects the sleep pattern on Actigraphy.
5. Nocturnal systolic blood pressure and nocturnal vertical activity are higher in men with self-reported nocturia ≥2 at night than in men with no reported nocturia.
Purpose:
Obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.
|
#Eligibility Criteria:
Inclusion Criteria:
* African American Men
* Age 35 to 79 year-old
* Able to give informed consent
* Pass the home sleep study
* Willing to wear the wrist Actigraphy monitor for 9 days continuously.
* Willing to wear ambulatory blood pressure monitoring (ABPM) for 48 hours twice during the 9 days of the study period.
Exclusion Criteria:
* Diabetes Mellitus
* Taking Prostate medication
* Symptoms of prostate disease or urinary urgency
* Sleep apnea
1. A neck circumference greater than 17 inches
2. Using Continuous Positive Airway Pressure (CPAP)
3. History of a diagnosis of Sleep Apnea
4. Apnea Hypopnea Index (AHI) > 15 per hour
Sex :
MALE
Ages :
- Minimum Age : 35 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03048734
|
{
"brief_title": "Nocturnal Hypertension and Nocturia in African American Men",
"conditions": [
"Hypertension"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT03048734",
"official_title": "A Pilot Study : Nocturnal Hypertension and Nocturia in African American Men",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06",
"study_completion_date(actual)": "2017-10",
"study_start_date(actual)": "2017-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-14",
"last_updated_that_met_qc_criteria": "2017-02-07",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-09",
"first_submitted": "2016-12-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.
Detailed Description
This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months.
In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals.
The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months.
Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.
#Intervention
- DRUG : Interferon-beta-1a
- dosage and frequency as per label
- Other Names :
- Avonex
- DRUG : methylprednisolone
- dosage and frequency as per Biogen Idec protocol
|
#Eligibility Criteria:
Inclusion Criteria:
* Relapsing remitting Multiple Sclerosis according to Poser criteria (CDMS or LDMS) or Multiple Sclerosis according to McDonald criteria
* Disability equivalent to EDSS of 6.0 or less
* Clinical activity defined as at least one relapse rate within the last 12 months
* NAb titre >20 (measured at least 48 hours after last interferon-beta injection
* has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (Rebif) for at least 24 hours before enrollment
Exclusion Criteria:
* Any condition that might give rise to similar symptoms as MS
* Immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
* Treatment with glucocorticoids or ACTH less than one month prior to inclusion into the trial
* History of major depression
* Alcohol or drug dependency
* Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
* hypertension (BP > 180/110 mmHg)
* Renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
* Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
* Gastro-intestinal ulcers, gastritis, or dyspepsia
* Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00492466
|
{
"brief_title": "Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies",
"conditions": [
"Relapsing-Remitting Multiple Sclerosis"
],
"interventions": [
"Drug: Interferon-beta-1a",
"Drug: methylprednisolone"
],
"location_countries": [
"Finland"
],
"nct_id": "NCT00492466",
"official_title": "A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-08",
"study_completion_date(actual)": "2006-08",
"study_start_date(actual)": "2003-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-01-30",
"last_updated_that_met_qc_criteria": "2007-06-26",
"last_verified": "2008-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-06-27",
"first_submitted": "2007-06-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cleaning the mouth is difficult in critically ill patients who require support from a breathing machine (ventilator). This is because the plastic (endotracheal) tube which is a necessary interface between patient and ventilator impedes cleaning. New evidence suggests that poor oral health may be linked to ventilator associated pneumonia. Throughout the world both toothbrushes and foam swabs are used to clean the teeth and remove dental plaque, however it is unknown if one method is more effective than the other. The purpose of this study is to establish which (if any) method is most effective at removing plaque in this population of patients.
Detailed Description
Study Objective: The principle aim of this work is to determine whether foam swabs or toothbrushes offer the most effective method of removing dental plaque in orally intubated mechanically ventilated patients.
The secondary objective is to profile the microbiological flora in dental plaque, endotracheal tube and lung. In addition, collection of both plaque samples, used endotracheal tubes (ETTs) and non-directed bronchoalveolar lavage (NBL) will allow us to determine whether oral microorganisms contribute to biofilm formation within the ETT and potentially promote VAP. The findings of this study will not only enhance our knowledge on the organisms involved in promoting biofilms on ETT, but may also highlight potential management strategies to reduce their formation.
Study Population: Critically ill adult patients admitted to the intensive care unit at the University Hospital of Wales, Cardiff in whom mechanical ventilation has been initiated.
Recruitment: All patients satisfying inclusion and exclusion criteria, admitted to the adult ICU at the University Hospital of Wales from the start date of the study will be considered eligible for recruitment. Patients identified by the duty consultant will be notified to the research team. Consent will be obtained and in total 50 patients will be recruited.
Interventions: This is a split mouth design study whereby the intervention (cleaning with a foam swab or toothbrush) is performed on one side of the mouth. For example foam swab left side of mouth and toothbrush right side of mouth. Cleaning will be performed daily for a minimum of 24-hours or until extubation or up to seven days after recruitment, whichever is the shorter.
Non-directed bronchoalveolar lavages (NBLs) will be taken on a Monday and Thursday and when clinically indicated (for example a suspected VAP). This involves the insertion of a sterile suction catheter into the lung, 10-20ml of sterile saline is instilled and drawn back, and placed in a sterile universal. The sample will be split into two when there is a suspected infection, one half going to the UHW microbiology laboratory as usual, the other half will be profiled as part of the study. If there is no suspected infection all of the sample will be profiled as part of the study.
Methods: Following recruitment, patients will have their teeth cleaned twice a day with sterile water for 2 minutes using a 'baby toothbrush' and foam swab, the side to which the cleaning method is allocated will be randomised. One minute of cleaning assigned to each side of the mouth.
A modified Silness and Loe plaque score (Scannapieco et al 1992) and gingival index (Loe and Silness 1963) will be recorded prior to cleaning and then each morning following cleaning throughout the duration of the study. The plaque index will be recorded on the upper and lower first molars, first bicuspid and central incisors on each side of the mouth from the buccal surface. The plaque index score will be an average of the six teeth on each side. For patients with missing index teeth, the remaining teeth in closest proximity will be scored. The gingival index will be scored on the same teeth.
Following recording of the plaque and gingival index plaque samples will be collected on the same teeth as used for the plaque score. Samples of supragingival plaque will then be collected from the gingival third portion of the targeted teeth using a sterile curette prior to initiation of oral care and then once a day before cleaning. Plaque will immediately be inoculated into 1ml of microbiological transport medium. The transport medium will be diluted in a serial decimal manner in phosphate buffered saline prior to inoculation of agar plates using a spiral plating system (Don Whitley Scientific). The following agars will be used to culture the microorganisms: Blood Agar (aerobic bacteria), Fastidious Anaerobe Agar (anaerobic bacteria) and CHROMagar Candida (Candida and yeast species). Differential counts of lactose fermenting enteric bacteria will be through the use of MacConkey Agar, whilst Staphylococcus species (coagulase positive and coagulase negative) will be detected using Mannitol Salt Agar (MSA). The inoculated media will be incubated under appropriate gaseous environments at 37°C for 48 h (aerobes) or 7 d (anaerobes). A total aerobic microbial count from each side will be obtained from the blood agars and expressed as total colony forming units (CFUs).
Identification of each distinct colony morphotype will be through extensive phenotypic investigation. Tests will involve Gram staining, oxidase and catalase activity and biochemical profiling through a range of test systems. The biochemical test systems will include the APICoryne system (Gram-positive bacilli), APIStrep system (catalase-negative Gram-positive cocci), APIStaph and ID32Staph (catalase-positive Gram-positive cocci). Oxidase-negative, Gram-negative bacilli will be profiled using the API20E test whilst, oxidase-positive Gram-negative bacilli will be profiled using the API NE. Fungal organisms (Candida and yeast species) will be identified based on colony colour and appearance on the differential medium, CHROMagar and by biochemical profiling with the Auxocolour 2 system (biorad).
NBLs collected as outlined in the section on interventions above. Identification of the organisms present within the NBL samples will be done using the cultural methods outlined above.
If patients are extubated during the study then the endotracheal tube will be collected and transferred to the laboratory. Processing of ETT will involve dividing each tube into sections for either quantitative identification of organisms by microbial culture, molecular analysis or microscopical imaging.
Sections of each ETT will initially be placed in 2 ml of phosphate buffered saline and vortex mixed for 30 s with sterilised glass beads to disrupt biofilm aggregates. The PBS solution will then be removed and diluted serial decimally, 106-fold.
Identification of the organisms present within the biofilms will be done using the cultural methods outlined above, together with supplemental molecular analysis (outlined below).
16S ribosomal RNA gene-defined bacterial contamination of endotracheal tubes Sections from each region of recovered endotracheal tubes will be analysed using molecular procedures. The method will involve the extraction of total DNA from 500 µl of the specimens using a Puregeneâ bacterial DNA isolation kit (Gentra Systems). Universal bacterial primer pairs, d88 and e94 (Paster et al, 2001) and primers specific for target organisms (Porphyromonas gingivalis, Streptococcus mutans, Pseudomonas aeruginosa and Staphylococcus aureus) will then be used to amplify the 16S rRNA gene targets within the extracted samples using standard PCR and reaction conditions. Negative controls will include a reagent control (sterile water as PCR template) and a sample preparation control (sterile water used in place of the original sample and exposed to the entire extraction protocol). Positive controls of template DNA from known species of P. gingivalis, S. aureus and mutans will also be included.
Confocal laser scanning microscopy Sections of the used ETT will also be analysed using fluorescent in situ hybridization using organism specific Peptide Nucleic Acid (PNA) probes. Each specific probe will be conjugated with a distinct fluorescent label to allow for spatial location and distribution of target organisms (S. aureus, P. aeruginosa, Candida albicans, S. mutans) within the ETT biofilm.
Collection of other data: Baseline demographics of patients will be recorded, including age, sex, APACHE II score, co-morbidities, days from hospital admission, and recent antibiotic administration.
A Zsigmondy and DMFT (decayed, missing, filled teeth) score will be recorded by a dental hygienist during the study to assess the baseline dental status of patients enrolled.
Outcome measures: Primary outcome: Daily plaque and gingival scores following mechanical cleaning, with identification and quantification of bacteria within plaque. Quantitative comparisons will be ascertained from the total log transformed CFU counts and plaque and gingival scores from the two cleaning methods.
#Intervention
- PROCEDURE : Cleaning of teeth with a toothbrush
- This is a split mouth study where patients will have one side of their mouth randomised for teeth cleaning with a toothbrush. Cleaning will be twice daily from recruitment until day seven.
- PROCEDURE : Cleaning of teeth with a foam swab
- This is a split mouth study where patients will have one side of their mouth randomised for teeth cleaning with a foam swab. Cleaning will be twice daily from recruitment until day seven.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients aged >18 years
* Patients mechanically ventilated with an oral endotracheal tube ->20 teeth with symmetric distribution
Exclusion Criteria:
* Absence of an oral endotracheal tube
* Age <18 years
* <20 teeth or asymmetric distribution
* Expected to be intubated less than 24-hours from recruitment
* Thrombocytopaenia (platelet count <30)
* Uncontrolled coagulopathy
* Suffering from facial or oral trauma
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01154257
|
{
"brief_title": "Comparison of Swabs and Toothbrushes in Cleaning the Teeth of Mechanically Ventilated Patients",
"conditions": [
"Dental Plaque",
"Gingivitis"
],
"interventions": [
"Procedure: Cleaning of teeth with a foam swab",
"Procedure: Cleaning of teeth with a toothbrush"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01154257",
"official_title": "Comparison of Foam Swabs Versus Toothbrushes in Removing Dental Plaque From Orally Intubated Mechanically Ventilated Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2010-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-31",
"last_updated_that_met_qc_criteria": "2010-06-29",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-30",
"first_submitted": "2010-06-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of therapeutic results, the benefit of ART increases as adherence improves. Consequences of suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous co-occurring conditions and therefore take many medications making adherence to multiple drug regimens more difficult. A mobile application capable of improving medication adherence among HIV-infected persons would be highly useful.
The investigators propose an intervention study designed to address these potential mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app). The current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart phone application titled 'Care4Today v2.0' versus standard of care to improve medication adherence to ART over a 4-week period with 60 HIV-infected participants.
The pilot RCT consists of 60 HIV-infected persons who are at risk for ART medication nonadherence. Using random assignment, 30 HIV-infected participants will be assigned to medication adherence improvement via 'Care4Today' app as compared to 30 HIV-infected participants assigned standard of care.
The investigators will assess the effectiveness and acceptability of the app in improving objectively measured ART adherence (i.e., via medication event monitoring system caps) over a 4-week period via a pilot RCT with 30 HIV-infected persons assigned to the Care4Today intervention and 30 HIV-infected persons assigned to standard of care.
#Intervention
- BEHAVIORAL : Care4Today v2.0 mobile application + electronic monitoring of adherence
- Care4Today mobile application will send automated medication alert messages to HIV-infected persons. The alert messages are customizable and automated, and real-time results are viewable within the application. The Care4Today intervention is designed to improve adherence to ART medications among HIV-infected persons who experience adherence difficulties over standard of care.
|
#Eligibility Criteria:
Inclusion Criteria:
* Ability to provide informed consent
* >= 18 years at the time of enrollment
* HIV-infected
* Taking at least one medication to treat HIV illness
* Indication of medication nonadherence, or having a condition (e.g., active substance use, depression) that puts the individual at risk for medication non adherence
* Willingness to use electronic monitoring caps to track ART medication
* Willingness to respond to application alert messages
Exclusion Criteria:
* Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features
* Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke)
* Unwillingness or inability to use electronic medication monitoring technology
* Unwillingness or inability to use daily alert messages
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02001064
|
{
"brief_title": "Care4Today v2.0 Application for Improving Adherence to HIV Medications",
"conditions": [
"HIV",
"AIDS"
],
"interventions": [
"Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02001064",
"official_title": "Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-10",
"study_completion_date(actual)": "2014-10",
"study_start_date(actual)": "2013-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-29",
"last_updated_that_met_qc_criteria": "2013-11-27",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-04",
"first_submitted": "2013-11-27",
"first_submitted_that_met_qc_criteria": "2021-07-08"
}
}
}
|
#Study Description
Brief Summary
This randomized clinical trial compares virtual reality exposure therapy to exposure group therapy to a waiting list control group.
Detailed Description
Virtual reality exposure therapy (VRE) for the treatment of anxiety disorders has received considerable attention. During VRE, a person encounters a feared stimulus in a computer-generated environment, often through the use of a head mounted display and motion tracker that allows for multisensory input and natural movement. Several advantages of VRE have been noted - both clinical, such as treatment acceptability, and methodological, such as the ability to conduct exposure in a tightly controlled environment. Empirical support for VRE varies across anxiety disorders. Specifically, randomized controlled trials support the efficacy of VRE with fear of flying and acrophobia and show that it is equally effective as in vivo exposure. These phobias lend themselves well to VRE; the feared stimulus is circumscribed and contains powerful physical cues that can be produced within a virtual environment. There is less controlled research on the use of VRE for other anxiety disorders. The current study examines VRE for social anxiety disorder, which is characterized by fear of negative evaluation, and thus may be more difficult to evoke and treat using a virtual environment. Further, no research to date has compared VRE and the gold standard treatment for social anxiety disorder - cognitive behavioral therapy in a group format.
The purpose of the current study is to compare VRE and Exposure Group Therapy to wait list in a sample of adults meeting criteria for social anxiety disorder with a primary fear of public speaking. It is hypothesized that, relative to wait list, those receiving treatment will improve on standardized measures of public speaking fears and fears of negative evaluation, as well as a behavioral avoidance task. Participants also are expected to maintain treatment gains at 3 and 12-month follow-up. Comparisons between the two active treatments also will be made.
Procedure
Following consent, study candidates completed a phone interview to screen for obvious exclusion criteria (e.g., current treatment for social anxiety disorder) and then an in-person, pretreatment assessment consisting of the Structured Clinical Interview for the DSM-IV (SCID), speech task, and the battery of self-report measures. Eligible participants were randomly assigned to virtual reality exposure therapy, exposure group therapy, or wait list by simple randomization using a computerized random number generator. Concealment procedures were used to prevent foreknowledge of treatment assignment from influencing enrollment. Each potential participant had a participant number, which was only known by the study coordinator. The first author kept a hard copy of a list linking participant number to condition assignment in a locked file drawer. Once a participant was enrolled, the study coordinator asked for the treatment condition for a particular participant number. The first author had no knowledge of which participant was linked with a participant number, and the study coordinator had no knowledge of which participant number was linked with treatment condition. Participants assigned to wait list were re-randomized to virtual reality exposure therapy or exposure group therapy following the waiting period (Figure 1). Participants completed all assessment and treatment sessions at a psychology clinic within at an urban research university that is accessible by public transportation.
Assessments
Participants completed assessments at pretreatment, posttreatment, and follow-up. Self-report outcome measures were completed at each assessment point. Participants were asked to complete the behavioral avoidance task at pretreatment and posttreatment. The anxiety, mood, and substance use modules of the SCID were administered at pretreatment, and the anxiety module was administered at the 3-month follow-up.
All assessments were conducted by doctoral students who were blind to the type of treatment to be received. All pretreatment and follow-up diagnostic assessments were videotaped, and a randomly selected subset (N=10) were reviewed by a licensed psychologist to calculate the inter-rater reliability of pretreatment assessment (100% agreement for primary diagnosis, with one disagreement on severity). Compensation was provided to participants who completed the self-report battery of measures administered at posttreatment, 3- and 12-month follow-up.
Treatment
Prior to administering therapy, study therapists attended two day training workshops for each treatment, led by the developers of the respective treatments. Each study therapist also received weekly supervision by the first author. There were 5 study therapists: 2 licensed clinical psychologists with experience in manualized treatment, and 3 doctoral students with no experience with manualized treatments. All therapists administered both treatments.
Both treatments were administered according to a manualized protocol for 8 sessions. The VRE and EGT treatment groups were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. Both treatments began with a treatment rationale and psychoeducation about social anxiety disorder. During sessions 2- 8, both treatments addressed specific aspects of social anxiety disorder identified in psychopathology literature, including self-focused attention, perceptions of self and others, perceptions of emotional control, rumination, realistic goal setting for social situations through the use of such techniques as cognitive preparation, and challenging of cost and probability biases. Session 8 also included relapse prevention. Homework was assigned for both treatments, including a daily mirror task, daily record of social situations, and identification of cognitive biases.
Virtual Reality Exposure (VRE)
Virtual environments included a virtual conference room (\~5 audience members), a virtual classroom (\~35 audience members), and a virtual auditorium (100+ audience members). Therapists could manipulate audience reactions in a number of ways including making them appear interested, bored, supportive, hostile, distracted (i.e., cell phone ringing). Virtual audience members could also pose questions, either standardized (e.g., 'I don't understand, could you explain again') or tailored to the client using therapist voice-over. Virtual environments were manipulated according to the participants fear hierarchy. Participants were exposed to each item on their hierarchy until their fear decreased.
Exposure Group Therapy (EGT)
EGT was co-led by a licensed clinical psychologist and an advanced doctoral student. Groups consisted of up to five participants. During exposure, participants gave a videotaped speech in front of the group. Group members were also asked to provide each other with positive feedback when the videotaped speeches were reviewed.
Every effort was made to equate time in exposure across treatment group. Participants receiving VRE completed 4 trials of exposure. Because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials lasted no longer than 30 minutes, for a total of up to 120 minutes. Participants receiving EGT received 6 trials of exposure. The amount of time spent on each group member varied according to the number of participants in the group. On average, for a group with 4 participants, participants completed 6 trials of exposure for 20 minutes for a total of 120 minutes.
Wait List
After 8 weeks, wait list participants completed the self-report battery. Wait list participants were re-randomized to either virtual reality exposure or exposure group therapy following the waiting period and received the same 8-week treatment protocol described above.
#Intervention
- BEHAVIORAL : Virtual Reality Exposure Therapy
- During virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment.
- BEHAVIORAL : Exposure Group Therapy
- Exposure Group Therapy a behavioral treatment for social phobia. Participants face their fears by giving speeches to other group members.
|
#Eligibility Criteria:
Inclusion Criteria:
* Speakers of English meeting DSM-IV (APA, 2000) criteria for a primary diagnosis of social anxiety disorder
* Self-identifying public speaking as their primary social fear
* Participants were required to be stabilized on psychoactive medication(s) and dosage(s) for 3 months.
Exclusion Criteria:
* history of mania, schizophrenia, or psychosis
* current suicidal ideation, alcohol, or substance dependence
* inability to tolerate the virtual reality helmet/environment
* history of seizures
* concurrent psychotherapy for social anxiety disorder
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02379949
|
{
"brief_title": "Virtual Reality Exposure Therapy for the Treatment of Social Phobia",
"conditions": [
"Social Anxiety Disorder"
],
"interventions": [
"Behavioral: Exposure Group Therapy",
"Behavioral: Virtual Reality Exposure Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02379949",
"official_title": "Virtual Reality Exposure Therapy for the Treatment of Social Phobia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-08",
"study_completion_date(actual)": "2007-08",
"study_start_date(actual)": "2004-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-05",
"last_updated_that_met_qc_criteria": "2015-03-04",
"last_verified": "2015-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-05",
"first_submitted": "2015-01-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache
Detailed Description
Patients planned for randomization: 91 patients in the eptinezumab 100 mg group and 91 patients in the placebo group.
The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Open-Label Period (12 weeks) and a Safety Follow-up Period (8 weeks). Patient will receive investigational medicinal product (IMP) at the Baseline Visit with either eptinezumab or placebo by IV infusion and at week 12 visit.
#Intervention
- DRUG : Placebo
- Placebo - solution for infusion
- DRUG : Eptinezumab
- Eptinezumab - 100 mg, solution for infusion
- Other Names :
- Lu AG09221
|
#Eligibility Criteria:
Inclusion Criteria:
* The patient has a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 guidelines confirmed at the Screening Visit with a history of migraine onset of at least 12 months prior to the Screening Visit.
* The patient has >=8 migraine days per month for each month on average within the past 3 months prior to the Screening Visit.
* The patient has a diagnosis of medication overuse headache (MOH) as defined by IHS ICHD-3 guidelines.
* The patient has headache on >=15 days/month for each month within the past 3 months prior to the Screening Visit.
* The patient has regular overuse of one or more drugs that can be taken for acute and/or symptomatic treatment of headache, for >3 months.
* The patient has >=15 to <=26 headache days, of which >=8 days were assessed as migraine days during the Screening Period, based on prospectively collected information in the eDiary.
* The patient overuses drugs that can be taken for acute and/or symptomatic treatment of headache during the Screening Period, based on prospectively collected information in the eDiary.
* The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days of the Screening Period.
* The patient has had an onset of migraine at <50 years
Exclusion Criteria:
* The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
* The patient has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
* The patient has a diagnosis of acute or active temporomandibular disorder.
* The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
* Patients with a lifetime history of psychosis, bipolar mania, or dementia are excluded. Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded.
* The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
Other in- and exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04772742
|
{
"brief_title": "Eptinezumab in Adults With Migraine and Medication Overuse Headache",
"conditions": [
"Migraine",
"Medication Overuse Headache"
],
"interventions": [
"Drug: Placebo",
"Drug: Eptinezumab"
],
"location_countries": [
"Georgia",
"China",
"Taiwan",
"Spain",
"Korea, Republic of"
],
"nct_id": "NCT04772742",
"official_title": "Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine in Patients With a Dual Diagnosis of Migraine and Medication Overuse Headache",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-23",
"study_completion_date(actual)": "2022-09-30",
"study_start_date(actual)": "2021-02-17"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-31",
"last_updated_that_met_qc_criteria": "2021-02-23",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-26",
"first_submitted": "2021-02-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.
Secondary Objectives:
- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone on:
* Percentage of patients reaching HbA1c \< 7%
* Percentage of patients reaching HbA1c \< 6.5%
* Fasting Plasma Glucose (FPG)
* Safety and tolerability
Detailed Description
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.
#Intervention
- DRUG : GLIMEPIRIDE
- Pharmaceutical form: oral
Route of administration: oral
- Other Names :
- HOE490
- DRUG : METFORMIN
- Pharmaceutical form: oral
Route of administration: oral
|
#Eligibility Criteria:
Inclusion criteria
* Patients with type 2 diabetes mellitus, as defined by the World Health Organization (WHO), diagnosed within one year prior to the screening visit
* Signed informed consent, obtained prior to any study procedure
Exclusion criteria
* Age < 18 and => 78 years
* HbA1c < 7.6% or > 9%
* BMI > 35 kg/m2
* Diabetes other than type 2 diabetes (e.g.: type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...)
* Subjects currently receiving or who have received any hypoglycemic agent within 3 months before screening visit
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 78 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01459809
|
{
"brief_title": "Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: GLIMEPIRIDE",
"Drug: METFORMIN"
],
"location_countries": [
"India",
"Ukraine",
"Colombia",
"Guatemala",
"Mexico",
"United Arab Emirates",
"South Africa",
"Iran, Islamic Republic of",
"Russian Federation",
"Egypt",
"Tunisia",
"Turkey",
"Lebanon",
"Algeria"
],
"nct_id": "NCT01459809",
"official_title": "A Multinational, Open Label, Randomized, Active-controlled, 3-arm Parallel Group, 24-week Study Comparing the Combination of Glimepiride and Metformin Versus Glimepiride and Metformin Alone in Patients With Type 2 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-01",
"study_completion_date(actual)": "2014-01",
"study_start_date(actual)": "2012-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-01-21",
"last_updated_that_met_qc_criteria": "2011-10-24",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-10-26",
"first_submitted": "2011-10-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the effects of transcutaneous vagus nerve stimulation (t-VNS) on Long Covid symptoms in females and to identify factors influencing susceptibility and recovery-particularly in the cognitive domain, as over 80% of long-haulers experience 'brain fog'.
Detailed Description
Long COVID is a post-viral illness estimated to affect 10-30% of COVID-19 patients. Post-COVID symptoms can last for months and affect multiple organs. Major risk factors of long COVID include the female sex and pre-existing anxiety/depression. Because women already have higher rates of anxiety/depression, the combined risks could exacerbate their susceptibility.
Based on the rationale that long COVID symptoms significantly overlap with functions of the vagus nerve, which serves as a conduit between the brain and body, the investigators propose to use non-invasive transcutaneous vagus nerve stimulation (t-VNS) as a novel treatment for long COVID in 20 female participants.
This pilot study will utilize a holistic approach by integrating neuromodulation, neuroimaging, genetics, blood biomarkers, behavioral assessments, and wearable technology to examine the effects of VNS therapy on post COVID-19 symptoms and to identify factors that influence susceptibility and recovery, particularly in the cognitive domain, as over 80% of long-haulers report experiencing 'brain fog' (i.e., cognitive disruptions).
#Intervention
- DEVICE : Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)
- Electrode clip will be placed on the left ear.
|
#Eligibility Criteria:
Inclusion Criteria:
* Biologically female at birth and at time of enrollment
* At least 18 years or older
* Experiencing persistent symptoms of brain fog/cognitive impairment beyond 3 months of COVID-19 infection that are not explained by an alternative diagnosis
Exclusion Criteria:
* Not t-VNS compatible (e.g. pacemaker implants)
* Not MRI compatible (e.g. metal implants, claustrophobia)
* Currently pregnant
* Long COVID without cognitive impairment
* History of neurological conditions prior to COVID-19 infection
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05225220
|
{
"brief_title": "Multimodal Investigation of Post COVID-19 in Females",
"conditions": [
"Post COVID-19",
"Cognitive Dysfunction"
],
"interventions": [
"Device: Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05225220",
"official_title": "Multimodal Investigation of Post COVID-19 in Females: A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-06",
"study_completion_date(actual)": "2023-01-06",
"study_start_date(actual)": "2022-03-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-07",
"last_updated_that_met_qc_criteria": "2022-02-02",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-04",
"first_submitted": "2022-02-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. The efficacy of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.
Detailed Description
Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. However, since a great extent of pain is a subjective phenomenon, it has frequently defied objective, quantitative measurement. Traditionally, physicians have had to assess a patient's pain by relying on the patient's own description. Self-description is not only subjective by definition; it is often inaccurate, in part because it is difficult for subjects to precisely articulate their pain while in the midst of a pain experience. Moreover, the report might be impossible when the subject cannot communicate
Presently, in order to quantify pain, the care provider asks the patient to rate his/her pain intensity using one-dimensional scale usually scored from 0 to 10. This scale is known as Numeric Pain Scale. This and other measures are used by the care providers to estimate the correct treatment dose and or to track a treatment progress. Due to its impact on care provider decision to prescribe painkiller mediation, some patients also intentionally misrepresent the existence or extent of their pain. Yet, without any reliable basis for denying such prescriptions, physicians generally must assume that the claims are truthful, even when they may suspect a lack of sincerity. Otherwise, the care provider may be accused of inhumane treatment. Conversely, other patients may underreport their pain, again for a variety of reasons.
The presented clinical trial is intended to implement, validate performances and evaluate efficacy of the pain monitoring device for automated assessment of patient's pain level. During the trial, up to 100 healthy young adults will be voluntarily inflicted by pain stimuli. The pain stimuli will be thermal heat pain stimulus and cold water pain stimulus applied with different intensities. Plurality of Non-Invasive Physiological Measurements will be recorded from volunteers and their Numeric Pain Scale reports will be monitored before, during and after the pain induction. Additional information such as age, gender, ethnicity, etc. will be collected as well. The collected database will be used to implement the algorithm that applies modern signal processing and machine learning methods in order to differentiate between different pain levels. The algorithm will be later integrated into pain monitoring device. The efficacy of the algorithm of the pain monitor will be tested by comparing its results to the patient pain reports towards a given pain stimuli.
#Intervention
- DEVICE : Scanlaf Circulator and water bath
- Cold Pressor Test
- Other Names :
- Open Cold Water Bath
- DEVICE : Medoc TSA 2000
- Thermal stimuli pain
- Other Names :
- Medoc Advanced Medical Systems TSA-II System
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy participant that response to pain stimuli
* Blood Pressure < (90,140), Heart Rate < 100pps
* Patient informed consent must be obtained
Exclusion Criteria:
* Not responding to pain stimuli (Hypoalgesia)
* Over responding to pain stimuli (Hyperalgesia)
* Classifying non pain stimuli as painful event (Allodynia)
* Medication/drugs were taken in the last week
* Usage of chronic medication in the last 3 months (not including contraceptive pills)
* Alcohol usage during the last 48 hours
* Caffeine in the last 3 hours
* Pregnant women
* Inability to comply with the study protocol.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00914173
|
{
"brief_title": "Pain Monitoring Using Plurality of Non-invasive Physiological Measurement",
"conditions": [
"Pain"
],
"interventions": [
"Device: Medoc TSA 2000",
"Device: Scanlaf Circulator and water bath"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT00914173",
"official_title": "A Single-blind Randomized Clinical Trial to Assess the Efficacy of the Medasense's Non-Invasive Pain Monitor in Estimating the Pain Level Comparing to the Pain Stimuli and the Reported Pain Level on Healthy Subjects.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10",
"study_completion_date(actual)": "2009-10",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-01-28",
"last_updated_that_met_qc_criteria": "2009-06-03",
"last_verified": "2010-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-06-04",
"first_submitted": "2009-06-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this exploratory randomized, placebo controlled study is to evaluate the efficacy of Circadin® 2mg in patients with mild to moderate Alzheimer Disease (AD) treated with the acetylcholinesterase (AChE) inhibitor. The effects of add-on Circadin® 2mg vs. placebo on the decline in cognitive skills and global functioning, as well as on daytime somnolence and will be assessed.
#Intervention
- DRUG : Circadin
- Prolonged Release melatonin (Circadin) 2mg tablets
- DRUG : Placebo
- Matched placebo tablets, with identical features to the Circadin tablets
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent as dictated by local legal circumstances.
* Age range: adult patients between 50 <= age <= 85 years.
* Gender: men and women. Women of child bearing potential or within two years of the menopause must have a negative urine pregnancy test at the Screening Visit.
* A documented history of confirmed Alzheimer's disease
* Dementia severity: MMSE score > 15,
* Stable AChE inhibitor dose for 2 months prior to Screening visit.
* Stable medications for non-excluded concurrent medical conditions for four weeks prior to the screening visit.
* Stable doses of B12 and/or Folic acid supplements for at least 3 months prior to enrollment and throughout the study.
* Cranial image: no evidence of focal disease to account for dementia (established by CT, PET or MRI). If there is no such available scan (CT, PET or MRI), one must be performed prior to enrollment.
* Health: Physically acceptable for the study with no pathology likely to occur during or immediately after the study, as confirmed by medical history and exam and ECG.
* Clinical laboratory values must be within normal limits, or judged not clinically significant by the investigator.
* Residence: Stable home situation with no planned move during the 28-week investigational period.
* A family member or a regular caregiver that will be available for visits and will ensure compliance. The caregiver must speak fluent Hebrew, Russian or English.
* Ability to ingest oral medication and participate in all scheduled evaluations.
* Ability to spend 2 daily hours outdoors exposed to sunlight.
Exclusion Criteria:
* Severe agitation.
* Unstable medical condition, mental retardation.
* moderate to severe depression as defined by DSM-IV
* Use of benzodiazepines or other hypnotics during the study and the preceding four weeks.
* Use of Circadin® during the two weeks prior to study enrollment.
* Pharmacological immunosuppression.
* Participation in a clinical trial with any investigational agent within two months prior to study enrollment.
* Alcoholism.
* Known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists.
* Patients with rare hereditary problems of galactose intolerance, the LAPP lactose deficiency or glucose mal absorption.
* Renal Failure with creatinine >150 micromol/l.
* Hepatic Failure with ASAT; ALAT; GGT levels above three times the upper normal limit.
* Clinically significant abnormal laboratory findings which have not been approved by the Safety Officer (sponsor)
* Other serious diseases that could interfere with patient assessment.
* Caregivers who are unwilling or unable to give informed consent or otherwise fulfill requirements of the study.
* Untreated B12 and/or Folic acid deficiency.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00940589
|
{
"brief_title": "Efficacy of Circadin® 2 mg in Patients With Mild to Moderate Alzheimer Disease Treated With AChE Inhibitor",
"conditions": [
"Alzheimer's Disease",
"Sleep Disorder"
],
"interventions": [
"Drug: Circadin",
"Drug: Placebo"
],
"location_countries": [
"Israel",
"United Kingdom",
"United States"
],
"nct_id": "NCT00940589",
"official_title": "A Double-blind, Parallel Group, Randomized, Placebo Controlled Study of the Efficacy of Circadin® 2mg in Patients With Mild to Moderate Alzheimer Disease (AD) Treated With Acetylcholinesterase (AChE) Inhibitor",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-02",
"study_completion_date(actual)": "2013-05",
"study_start_date(actual)": "2009-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-01",
"last_updated_that_met_qc_criteria": "2009-07-15",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-16",
"first_submitted": "2009-07-15",
"first_submitted_that_met_qc_criteria": "2018-05-29"
}
}
}
|
#Study Description
Brief Summary
This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and tadalafil) in healthy male volunteers.
Detailed Description
This study is conducted to evaluate the pharmacokinetics of DKF-313 (dutasteride and tadalafil) comparing with the concomitant administration of AVODART and CIALIS in healthy male volunteers.
#Intervention
- DRUG : DKF-313
- Combination of dutasteride 0.5 mg and tadalafil 5 mg
- DRUG : AVODART
- Dutasteride 0.5 mg
- Other Names :
- Dutasteride
- DRUG : CIALIS
- Tadalafil 5 mg
- Other Names :
- Tadalafil
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 19 <= age <= 29
* BMI 17.5 to 30.5 kg/m2 and body weight 55 kg or more
* No congenital or chronic diseases within 3 years, no disease symptoms or findings
* Eligible according to the laboratory results of hematology, blood chemistry and urinalysis and ECG
* Voluntarily signed the informed consent form 6. Willing to participate in the study
Exclusion Criteria:
* Clinically significant disorders of blood, kidney, endocrine, respiratory system, gastrointestinal system, urology, cardiovascular system, liver, psychiatry, neurology or allergy
* Gastrointestinal diseases or surgery which may affect absorption of the investigational products
* ALT or AST > 2xULN
* Excessive alcohol consumption (> 210 g/week) within 6 months
* Participated and administered the investigational products in other clinical trial within 2 months
* SBP <= 100 mmHg or >= 150 mmHg or DBP <= 60 mmHg or >= 100 mmHg
* History or positive result of serious alcohol or drug abuse within 1 year
* Drugs which induce or inhibit drug metabolism within 1 month
* Smoked more than 10 cigarettes a day
* Prescribed drugs or over-the counter drugs within 10 days
* Donated whole blood within 2 months or apheresis within 1 month
* Severe acute/chronic medical and mental conditions or lab abnormalities which may increase the risk or interfere in the interpretation of study results
* Hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-α reductase inhibitor, or other drugs including aspirin, antibiotics, etc.
* Galactose intolerance, fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* CYP3A4 inhibitors or CYP3A4 inducers within 2 weeks
* Myocardial infarction within 90 days
* Unstable angina or angina during sexual intercourse
* Heart failure (New York Heart Association Class 2 or higher) within 6 months
* Uncontrolled arrhythmias
* Stroke within 6 months
* Inherited retinal degeneration including retinitis pigmentosa
* Vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION)
* Plans to donate blood for at least 6 months after final dose of the investigational products
* Unwilling to comply with the lifestyle guidelines in the protocol
* Not eligible due to other reasons at the investigator's discretion
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 29 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02352311
|
{
"brief_title": "Safety and Pharmacokinetic Characteristics of DKF-313",
"conditions": [
"Benign Prostate Hyperplasia",
"Healthy"
],
"interventions": [
"Drug: AVODART",
"Drug: DKF-313",
"Drug: CIALIS"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02352311",
"official_title": "A Randomized, Open-label, Single-dose, 2-treatment, 2-way, 2-period Crossover Study to Evaluate the Safety and the Pharmacokinetic Characteristics of DKF-313 in Healthy Male Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2015-06",
"study_start_date(actual)": "2015-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-06",
"last_updated_that_met_qc_criteria": "2015-01-30",
"last_verified": "2015-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-02",
"first_submitted": "2015-01-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In order to develop effective personalized healthcare service program for breast cancer rehabilitation, we designed this study using mobile phone and clinical intervention(feedback coaching).
#Intervention
- BEHAVIORAL : Personalized health care service
- Physical activity coaching, other functional outcome observation
|
#Eligibility Criteria:
Inclusion Criteria:
* Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user
Exclusion Criteria:
* Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who can not participate rehabilitation exercise program
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03194399
|
{
"brief_title": "Development of Personalized Health Care Service in Patients With Breast Cancer",
"conditions": [
"Breast Cancer",
"Lymphedema",
"Cancer-related Problem/Condition"
],
"interventions": [
"Behavioral: Personalized health care service"
],
"location_countries": null,
"nct_id": "NCT03194399",
"official_title": "Development of Personalized Health Care Service in Patients With Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02-15",
"study_completion_date(actual)": "2016-02-22",
"study_start_date(actual)": "2015-11-27"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-21",
"last_updated_that_met_qc_criteria": "2017-06-20",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-21",
"first_submitted": "2017-06-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants.
Detailed Description
Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several strategies to reduce the burden of this complication have been proposed in the last decade. A definite answer about what is the best technique to approach a high-risk pancreatic stump is still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains have been proposed in this setting, but often studies do not provide a reliable risk stratification and result are extremely variable.
The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk stratification will be provided through the Fistula Risk Score, a clinical risk score that has been extensively validated.
#Intervention
- PROCEDURE : Pancreaticogastrostomy with external drain
- Pancreatico-enteric anastomosis is provided according to the 'Bassi technique', pancreatic remnant is pushed into the gastric cavity through a posterior gastrotomy. An externalized drain is placed into the main pancreatic duct.
- PROCEDURE : Pancreaticojejunostomy with transanastomotic drain
- Pancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain.
|
#Eligibility Criteria:
Inclusion Criteria:
* All the patients undergoing pancreaticoduodenectomy (only Whipple or Traverso) for all kind of pancreatic disease (benign, malignant or premalignant).
* Patients able to give their informed consent
Exclusion criteria
* Informed consent withdrawal
* Impossibility to undergo surgery for any reason
* Use of glues or biological matrices to protect the anastomosis
* Fistula Risk Score < 7
* Post-operative octreotide analogues administration (only prophylactic use, therapeutic use allowed)
* Wrong randomization
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03212196
|
{
"brief_title": "Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant",
"conditions": [
"Pancreatic Fistula"
],
"interventions": [
"Procedure: Pancreaticogastrostomy with external drain",
"Procedure: Pancreaticojejunostomy with transanastomotic drain"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT03212196",
"official_title": "Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-10",
"study_completion_date(actual)": "2019-07-10",
"study_start_date(actual)": "2017-06-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-13",
"last_updated_that_met_qc_criteria": "2017-07-06",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-07-11",
"first_submitted": "2016-11-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study (TOTXVI) is to compare the clinical benefit, the pharmacokinetics, and the pharmacodynamics of polyethylene glycol-conjugated (PEG) asparaginase given in higher dose (HD PEG) versus those of PEG-asparaginase given in conventional dose (CD PEG) during the continuation phase.
This study has several secondary objectives:
Therapeutic Objectives:
To estimate the event-free survival and overall survival of children with ALL who are treated with risk-directed therapy.
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD \> 5%, will result in improved leukemia cytoreduction in this subgroup compared to TOTXV.
To assess whether intensification of central nervous system (CNS)-directed intrathecal and systemic chemotherapy will improve outcome in patients at high risk of CNS relapse.
Exploratory Pharmacologic Objectives:
To identify pharmacogenetic, pharmacokinetic and pharmacodynamic predictors for treatment-related outcomes in the context of the systemic therapy used in the protocol.
To compare the pharmacokinetics and pharmacodynamics of PEG-asparaginase given in higher dose (3,500 or 3,000 units/m2) versus those of PEG-asparaginase given in conventional dose (2,500 units/m2) in the continuation phase.
Exploratory Biologic Objectives:
To determine the prognostic value of levels of minimal residual disease in peripheral blood at day 8 of remission induction.
To validate new markers and methods for MRD detection. To genotype natural killer (NK) cell receptors and measure their expressions at diagnosis and before reinduction, and to associate these features with treatment outcome.
To identify new prognostic factors by applying new technologies to study patient material (e.g., stored plasma, serum, cerebrospinal fluid, and normal and leukemic cells).
Exploratory Neuroimaging Objectives:
To use quantitative MR measures (Diffusion Tensor Imaging and high resolution volumetric imaging) to assess differences in myelin and cortical thickness development in patients treated for ALL relative to healthy controls matched for age and gender.
To assess the impact of folate pathway genetic polymorphisms on myelin and cortical thickness development and neurocognitive performance.
To assess the impact of frontal-parietal lobe myelin and cortical thickness development on neurocognitive performance in attention, working memory, fluency, visual-spatial reasoning and processing speed.
Detailed Description
Details of the Treatment Plan:
Treatment will consist of three main phases: Remission Induction, Consolidation, and Continuation.
1. Remission Induction
* Intrathecal Treatment during Induction
Frequency and total number of triple intrathecal treatments for Remission Induction is based on the patient's risk of CNS relapse.All patients will receive triple intrathecal treatment on days 1 and 15. Patients with high risk features may receive additional triple intrathecal treatment on days 4, 8, 11, and 22.\[t(1;19)/E2A-PBX1.
Induction treatment will begin with prednisone, vincristine, daunorubicin, PEG-asparaginase and triple intrathecal treatment, followed by cyclophosphamide plus cytarabine plus thioguanine.
Remission Induction Chemotherapy (6-7 weeks) Prednisone 40 mg/m2/day PO (divided t.i.d.) Days 1 - 28 Dexamethasone will be substituted for prednisone in patients with early T-cell precursor (ETP) immunophenotype.
Mercaptopurine will be substituted for thiopurine in TPMT HET/deficient patients Dexamethasone (for ETP immunophenotype only) 10 mg/m2/day PO (divided t.i.d.)Days 1-21; 4 mg/m2/day PO (divided t.i.d) Days 22-24; 2 mg/m2/day PO(divided t.i.d) Days 25-28 Vincristine 1.5 mg/m2 IV (max 2 mg) Days 1, 8, 15, 22 Daunorubicin 25 mg/m2 IV Days 1 and 8 PEG-asparaginase 3,000 Units/m2 IV Day 3
- Participants with Day 15 MRD greater than or equal to 1%: PEG-asparaginase 3,000 Units/m2 IV Day 15
- Participants with Day 15 MRD less than 5% (excluding MLL positive infants): Cyclophosphamide 1000 mg/m2 IV Day 22 Cytarabine 75 mg/m2/dose IV Days 23-26, 30-33 Thioguanine \[Mercaptopurine (TPMT HET/deficient patients only)\]60 mg/m2/dose PO Days 22-35 Dasatinib (Ph+ participants only) 40 mg/m2 b.i.d starting Day 22 of induction to continue until end of treatment
Day 15 MRD \> or equal to 5% (excluding MLL+ infants) Cyclophosphamide† 300 mg/m2 IV/ q12 hrs on Days 22-23 Cytarabine 75 mg/m2/dose IV Days 23-26, 30-33 Thioguanine \[Mercaptopurine (TPMT HET/deficient patients only) 60 mg/m2/dose PO Days 22-35 Dasatinib‡ (Ph+ participants only) 40 mg/m2 b.i.d Daily Starting Day 22 of induction to continue until end of treatment
- Infants with MLL positive rearrangement: Clofarabine 40 mg/m2/dose IV Days 22-26 Etoposide 100 mg/m2/dose IV Days 22-26 Cyclophosphamide 300 mg/m2/dose IV Days 22-26
2. Consolidation Treatment (8 weeks) High Dose Methotrexate (HDMTX) 2.5 gm/ (low risk), or targeted 65 μM (std/high-risk) days 1, 15, 29 and 43. Mercaptopurine 50 mg/m2/day Days 1 to 56. All patients will receive triple intrathecal therapy every other week for four doses on Days 1, 15, 29, and 43. Dose is age dependent.
- Reintensification
Patients with high-risk leukemia may receive reintensification therapy and then will be offered the option of transplant. This treatment will attempt to maximize leukemic cell kill before allogeneic hematopoietic stem cell transplantation.
Dexamethasone 20 mg/m2/day PO or IV Days 1-6.Cytarabine 2 grams/m2, 3-hour IV infusion every 12 hours Days 1-2. Etoposide 100 mg/m2, 1-hour IV infusion every 12 hours Days 3-5. Intrathecal methotrexate+hydrocortisone+cytarabine (ITMHA) Day 5; PEG-asparaginase 3,000 units/m2 IV Day 6
Patients with suboptimal response to reintensification may receive one to two cycles of clofarabine/cyclophosphamide/etoposide/dexamethasone:
Clofarabine 40 mg/m2/day, 2-hour IV infusion Days 1-5 Etoposide 100 mg/m2/day, 2-hour IV infusion Days 1-5 Cyclophosphamide 300 mg/m2/day, 30-60 minute IV infusion Days 1-5 Dexamethasone 8 mg/m2/day (divided t.i.d) Days 1-5
3. Continuation Treatment (120 weeks)
Abbreviations used below: DEX=dexamethasone; DOX=doxorubicin; VCR=vincristine; MP=mercaptopurine; PEG-ASP=polyethylene glycol-conjugated asparaginase; MTX=methotrexate; 6MP=mercaptopurine
Weeks 1 through 20 - treatment depends on risk assignment standard-high versus low-risk
Week Standard-/High-Risk Low-Risk
1. DEX+DOX+VCR+MP + PEG-ASP/MP + DEX + VCR
2. MP MP + MTX
3. MP + PEG-ASP/MP + MTX
4. DEX + DOX + VCR + MP/MP + DEX + VCR
5. MP + PEG-ASP MP + MTX
6. MP MP + MTX
7. Reinduction I
8. Reinduction I
9. Reinduction I
10. MP/MP + MTX
11. DOX + VCR +MP + PEG-ASP/MP + MTX
12. MP/MP + MTX
13. MP + PEG-ASP/MP + MTX
14. DEX + DOX + VCR +6MP/MP + DEX + VCR
15. MP + PEG-ASP/MP + MTX
16. MP/MP + MTX
17. Reinduction II
18. Reinduction II
19. Reinduction II
20. No chemotherapy/MP + MTX
Drug Dosages, Schedules and Routes for Continuation Therapy Weeks 1 to 6 and 10 to 16:
Dexamethasone 12 mg/m2 (std/high risk) or 8 mg/m2 (low risk) PO daily (divided t.i.d.) for 5 days, Days 1-5. Doxorubicin 30 mg/m2 IV, Day 1. Vincristine 2 mg/m2 IV push (max. 2 mg), Day 1 (0.05 mg/kg for patients \< 1 year of age or \< 10kg in weight). MP (mercaptopurine) 50 mg/m2 PO daily for 7 days (std/high risk), Days 1-7, 75 mg/m2 PO daily for 7 days (low risk), Days 1-7. PEG-ASP (PEG-asparaginase) 2,500 vs. 3,500 units/m2 IV randomization, Day 1. Methotrexate 40 mg/m2 IV Day 1.
Dexamethasone, vincristine, and asparaginase will be given regardless of blood counts, provided that the patient is clinically well. Doxorubicin, mercaptopurine and methotrexate will be held if white blood count (WBC) \<1000/mm3 or absolute neutrophil count (ANC) \<300/mm3. Doxorubicin, mercaptopurine and methotrexate will be reduced for WBC \< 1500/mm3, or if WBC and ANC not increase by at least 2 folds a week after the start date of dexamethasone pulse.
Reinduction Treatment - This phase of treatment is part of continuation and will be started at weeks 7 and 17 after bone marrow examination confirms complete remission. Doxorubicin and HD-cytarabine will be held if ANC \< or equal to 300/mm3 or WBC \< 1000/mm3.It is preferable to start HD-cytarabine when WBC \> or equal to 1800/mm3 and ANC \> 300/mm3 Reinduction treatment will be given twice: weeks 7 to 9 and weeks 17 to 19 for all patients. Intrathecal treatment will be followed by leucovorin rescue (5 mg/m2/dose PO, max 5 mg) at 24 and 30 hours only in patients with prior CNS toxicities or in patients with WBC \< 1500/mm3, or ANC \< 500/mm3.
- Reinduction I for Standard/High Risk ALL excluding MLL infants: Dexamethasone 8 mg/m2/day PO (divided t.i.d.) Days 1-8, 15-21. Vincristine 1.5 mg/m2/week IV Days 1, 8, 15 Doxorubicin 30 mg/m2 IV Days 1, 8. PEG-asparaginase 2,500 or 3,500 units/m2 IV Days 1, 15.
Intrathecal chemotherapy, Methotrexate + hydrocortisone + Ara-C dose age dependent, Day 1.
- Reinduction II for Standard/High Risk ALL including MLL infants: Dexamethasone 8 mg/m2/day PO (t.i.d.) Days 1-8, 15-21. Vincristine 1.5 mg/m2/week IV Days 1, 8, 15. PEG-asparaginase 2,500 or 3,500 units/m2 IV Days 1, 15. High-dose cytarabine 2 gm/m2 IV q 12 hr Days 15, 16. Intrathecal chemotherapy, dose age dependent, Day 1.
- Reinduction I for Low-Risk ALL: Dexamethasone 8 mg/m2/day PO (divided t.i.d.) Days 1-8, 15-21. Vincristine 1.5 mg/m2/week IV Days 1, 8, 15. PEG-asparaginase 2,500 or 3,500 units/m2 IV Days 1, 15. Doxorubicin 30 mg/m2/IV Day 1. Intrathecal chemotherapy, dose age dependent, Day 1.
- Reinduction II for Low-Risk ALL: Dexamethasone 8 mg/m2/day PO (divided t.i.d.) Days 1-8, 15-21. Vincristine 1.5 mg/m2/week IV Days 1, 8, 15. PEG-asparaginase 2,500 or 3,500 units/m2 IV Days 1, 15. Intrathecal chemotherapy, dose age dependent, Day 1.
- Reinduction I for MLL Infants: Dexamethasone 8 mg/m2/day PO (divided t.i.d.) Days 1-8 and 15-21. Clofarabine 40 mg/m2/day, -hour IV Days 1-5. Etoposide 100 mg/m2/day, 2-hour IV Days 1-5. cyclophosphamide 300 mg/m2/day, 1-hour IV Days 1-5. PEG-asparaginase 2,500 or 3,500 units/m2 IV Days 1, 15. Intrathecal chemotherapy, dose age dependent, on Day 1.
- Intrathecal Chemotherapy:
* Triple intrathecal treatment will be given to low-risk cases with CNS-1 status (no identifiable blasts in CSF) on weeks 7, 12, 17, 25, 33, 41, and 49.
* Triple intrathecal treatment will be given to low-risk cases with CNS-2, traumatic CSF with blasts status, or WBC \> 100 x 109/L on weeks 3, 7, 12, 17, 25, 29, 33, 37, 41, 45 and 49.
* Triple intrathecal treatment will be given to standard/high-risk cases on weeks 7, 12, 17, 25, 29, 33, 37, 41, 45 and 49.
* Triple intrathecal treatment will be given to other standard/high-risk cases with WBC \> or equal to 100 x 109/L, T-cell ALL, t (1;19)/E2A-PBX1, presence of Philadelphia chromosome, MLL rearrangement, hypodiploidy \<44, CNS-2 or CNS-3 status, or traumatic lumbar puncture with blasts on weeks 3, 7, 12, 17, 25, 29, 33, 37, 41, 45, 49, 57, 65, 73, 81, 89 and 97
Treatment (weeks 21 to 29)
Week Standard/High Risk Low Risk
21. MP + PEG-ASP+Dasatinib MP + MTX
22. MP +Dasatinib MP + MTX
23. MP + PEG-ASP + Dasatinib MP + MTX
24. Cyclo + Ara-C + Dasatinib MP + MTX
25. DEX + VCR + PEG-ASP + Dasatinib MP + DEX + VCR
26. MP + Dasatinib MP + MTX
27. MP + PEG-ASP+Dasatinib MP + MTX
28. Cyclo + Ara-C + Dasatinib MP + MTX
29. DEX + VCR +PEG-ASP + Dasatinib MP + DEX + VCR Dasatinib in Ph+ only
Treatment (weeks 30 to end of therapy)
Week Standard/High Risk Low Risk
30. MP + MTX + Dasatinib MP + MTX
31. MP + MTX + Dasatinib MP + MTX
32. Cyclo + Ara-C+Dasatinib MP + MTX
33. DEX + VCR + Dasatinib MP + DEX + VCR
34. MP + MTX + Dasatinib MP + MTX
35. MP + MTX + Dasatinib MP + MTX
36. Cyclo + Ara-C + Dasatinib/MP + MTX
37. DEX + VCR + Dasatinib /MP + DEX + VCR Dasatinib in Ph positive patients only
Drug Dosages, Schedules and Routes for Continuation Therapy from Week 21 to End of Therapy:
Mercaptopurine 75 mg/m2 PO daily for 7 days, Days 1-7. Methotrexate 40 mg/m2 IV or intramuscularly (IM) Day 1. Cyclophosphamide 300 mg/m2 IV, Day 1. Cytarabine 300 mg/m2 IV, Day 1. Dexamethasone 12 mg/m2 (std/high risk) or 8 mg/m2 (low risk) PO daily (divided t.i.d.) for 5 days, Day 1-5 (between week 21 and week 68).Decrease dexamethasone to 6 mg/m2 PO daily (divided t.i.d.) x 5 days,Day 1-5 between week 69 and week 101 for all risk groups.
Vincristine2 mg/m2 IV push (max 2 mg), Day 1 (0.05mg/kg for patients \< 1 year or \< 10 kg).
PEG-ASP 2,500 vs 3,500 units/m2 IV randomization (until week 30)
Dexamethasone, vincristine, and asparaginase will be given regardless of blood counts, provided that the patient is clinically well. Cyclophosphamide, cytarabine, mercaptopurine and methotrexate will be held if WBC \<1000/mm3 or ANC \<300/mm3. Mercaptopurine and methotrexate will be reduced for WBC \< 1500/mm3, or if WBC and ANC do not increase by at least 2 folds a week after the start date of dexamethasone pulse. Doses of cyclophosphamide and cytarabine may need to be reduced if patient misses 25% of chemotherapy and if the low counts deem to be related to this combination.
The same treatment (weeks 30-37) will be repeated for a total of 5 times, until week 69 (see Section 5.5.3 for intrathecal therapy). After week 69, all patients will receive daily mercaptopurine and weekly methotrexate interrupted with pulses of dexamethasone, vincristine, and mercaptopurine every 4 weeks. The dose of dexamethasone will be decreased to 6 mg/m2 between week 69 and week 101, after which only mercaptopurine and methotrexate will be given. Intrathecal treatment will be given every 8 weeks only to patients at risk of CNS relapse after week 49 and will be discontinued after week 97. Continuation therapy will be discontinued after 120 weeks.
Hematopoietic Stem Cell Transplantation (for patients who meet the criteria of high-risk ALL are candidates for allogeneic hematopoietic stem cell transplantation). However, if the option is declined by the patients or guardians, or the procedure is deemed unsuitable by the attending physician and the principal investigator, the patient will remain on study and continue to receive chemotherapy.
#Intervention
- DRUG : Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine
- See Detailed Description section for details of treatment interventions.
- Other Names :
- Prednisone: prednisolone, Vincristine: Oncovin(R), Daunorubicin: daunomycin, Cerubidine(R), PEG-L-asparaginase: pegaspargase, Oncaspar(R), Erwinia L-Asparaginase: Erwinase(R), Doxorubicin: Adriamycin(R), Cyclophosphamide: Cytoxan(R), Cytarabine: Ara-C, Cytosar-U(R), Thioguanine: 6-TG
- DRUG : Clofarabine, Methotrexate, Mercaptopurine, Dexamethasone, Etoposide, Dasatinib
- See Detailed Description section for details of treatment interventions.
- Other Names :
- Clofarabine: clofarex, Clolar(TM), Methotrexate: MTX, Mercaptopurine: 6-MP, Purinethol(R), Dexamethasone: Decadron(R), Etoposide: VP-16, Vepesid(R), Dasatinib: Sprycel(R)
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant has a confirmed diagnosis of precursor B-cell or precursor T-cell acute lymphocytic leukemia (ALL) by immunophenotyping
* Participant is less than or equal to 18 years
* Limited prior therapy, including systemic glucocorticoids for one week or less, one dose of vincristine, emergency radiation therapy to the mediastinum and one dose of intrathecal chemotherapy. Other circumstances must be cleared by principal investigator (PI) or co-PI.
* Written, informed consent and assent following Institutional Review Board, NCI, FDA, and Office for Human Research Protections (OHRP) Guidelines.
Exclusion Criteria:
* Participants with prior therapy, other than that listed above
* Pregnant or lactating
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Sex :
ALL
Ages :
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00549848
|
{
"brief_title": "Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia",
"conditions": [
"Acute Lymphoblastic Leukemia"
],
"interventions": [
"Drug: Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine",
"Drug: Clofarabine, Methotrexate, Mercaptopurine, Dexamethasone, Etoposide, Dasatinib"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00549848",
"official_title": "Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-26",
"study_completion_date(actual)": "2022-03-26",
"study_start_date(actual)": "2007-10-29"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-08-23",
"last_updated_that_met_qc_criteria": "2007-10-25",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-26",
"first_submitted": "2007-10-25",
"first_submitted_that_met_qc_criteria": "2022-01-14"
}
}
}
|
#Study Description
Brief Summary
A test-retest study on the stability and repeatability of healthy skin features on OCT
#Intervention
- DIAGNOSTIC_TEST : Optical coherence tomography
- Optical coherence tomography is a non-invasive scanner which generates real-time in-vivo images of the skin and its adnexal structures. Images are generated by light-interferometry.
|
#Eligibility Criteria:
Inclusion Criteria:
* At least18 years
Exclusion Criteria:
* Unable to sign informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05517889
|
{
"brief_title": "Repeatability and Stability of Healthy Skin Features on OCT",
"conditions": [
"Optical Coherence Tomography",
"Artificial Intelligence",
"Radiomics"
],
"interventions": null,
"location_countries": [
"Netherlands"
],
"nct_id": "NCT05517889",
"official_title": "Assessing the Stability and Repeatability of OCT Features in Healthy Skin: a Test-retest Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-31",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2022-09-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-16",
"last_updated_that_met_qc_criteria": "2022-08-24",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-26",
"first_submitted": "2022-08-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective was to investigate whether multiple-dose administration of ESL 800 mg once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.
Detailed Description
This was a single centre, two-way crossover, randomised, open-label study in 24 healthy volunteers. The volunteers will receive an oral single-dose of simvastatin 80 mg on two occasions - once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days -, separated by a washout period of 3 weeks or more
#Intervention
- DRUG : Eslicarbazepine acetate
- Other Names :
- Zebinix
- DRUG : Simvastatin
- Other Names :
- Zocor
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects aged 18 <= age <= 45, inclusive
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive
* Healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG; negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening; clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
* Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period
* Non-smokers or ex-smokers
* Able and willing to give written informed consent;
* If female, not of childbearing potential by reason of surgery or, if of childbearing potential, she uses one of the following methods of contraception: double barrier method: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);
* If female, has a negative urine pregnancy test at screening and admission to each treatment period.
Exclusion Criteria:
* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders
* Clinically relevant surgical history;
* History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives, simvastatin or other statins or any of its excipients
* History of fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain
* Second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator
* History of alcoholism or drug abuse
* Consume more than 14 units of alcohol a week
* Significant infection or known inflammatory process on screening or admission to each treatment period
* Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period
* Use of medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion
* Have donated or received any blood or blood products within the 3 months prior to screening
* Vegetarians, vegans or have other medical dietary restrictions
* Cannot communicate reliably with the investigator
* Unlikely to co-operate with the requirements of the study
* Unwilling or unable to give written informed consent
* If female, is pregnant or breast-feeding
* If female, is of childbearing potential and does not use an approved effective contraceptive method (double-barrier method: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intra-uterine device) or uses hormonal contraceptives
* Have received an investigational drug within 3 months of screening or is currently participating in another study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00987558
|
{
"brief_title": "Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects",
"conditions": [
"Epilepsy"
],
"interventions": [
"Drug: Simvastatin",
"Drug: Eslicarbazepine acetate"
],
"location_countries": [
"France"
],
"nct_id": "NCT00987558",
"official_title": "Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-08",
"study_completion_date(actual)": "2009-08",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-01-13",
"last_updated_that_met_qc_criteria": "2009-09-30",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-01",
"first_submitted": "2009-09-30",
"first_submitted_that_met_qc_criteria": "2015-01-12"
}
}
}
|
#Study Description
Brief Summary
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
#Intervention
- DRUG : Telavancin
- Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
- Other Names :
- VIBATIV, TD-6424
- DRUG : Vancomycin or antistaphylococcal penicillin
- Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism as the major cause of the infection:
* major abscess requiring surgical incision and drainage
* infected burn (see exclusion criteria for important qualifications)
* deep/extensive cellulitis
* infected ulcer (see exclusion criteria for important qualifications)
* wound infections
* Patients must be expected to require at least 4 days of intravenous antibiotic treatment
Exclusion Criteria:
* Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study medication unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days).
* Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00061633
|
{
"brief_title": "Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)",
"conditions": [
"Infections, Gram-Positive Bacterial",
"Abscess",
"Burns",
"Cellulitis",
"Ulcer",
"Wound Infections"
],
"interventions": [
"Drug: Vancomycin or antistaphylococcal penicillin",
"Drug: Telavancin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00061633",
"official_title": "A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-01",
"study_completion_date(actual)": "2004-01",
"study_start_date(actual)": "2003-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-16",
"last_updated_that_met_qc_criteria": "2003-05-30",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2003-06-02",
"first_submitted": "2003-05-30",
"first_submitted_that_met_qc_criteria": "2009-12-02"
}
}
}
|
#Study Description
Brief Summary
Non-invasive neuromodulation has been applied in several forms of primary headaches, and its usefulness has been suggested for both episodic and chronic migraine (CM). Transcranial direct current stimulation (tDCS) represents a non-invasive electrical stimulation technique that modulates neural brain activity by means of low amplitude direct current trough surface electrodes.
Very little evidence is available on the potential effect of tDCS in medication overuse and in the management of medication overuse headache (MOH), a condition frequently associated to CM.
CM associated to MOH still represents a challenge for physicians and patients due to the high prevalence in the general population, the associated severe disability, and the high costs imposed by the treatment.
The aim of the study was to investigate the possible application of tDCS in the management of CM associated to MOH. The primary objective of this pilot study was therefore to investigate the efficacy of anodal tDCS delivered on the primary motor cortex (M1) as add-on therapy to an in-hospital detoxification protocol in subjects affected by CM and MOH. The secondary objective was to evaluate the possible changes induced by tDCS on conventional EEG in order to obtain further clues about the effects of tDCS on brain activity.
Detailed Description
The study was a randomized, double-blind, controlled trial aimed at assessing the efficacy of five daily sessions of anodal t-DCS in add-on to a standardized in-hospital detoxification protocol in patients suffering from CM+MOH.
Twenty patients were enrolled among those consecutively attending the outpatient clinic of the IRCCS Mondino Foundation. All subjects underwent a screening visit with a physician of the Headache Science Centre of Mondino Institute. During the screening visit, a complete neurological and general examination was performed , and the inclusion/exclusion criteria were revised. Patients fulfilling criteria were enrolled in the baseline observation period for a month after an adequate training to monitor and record migraine and headache days, type and amount of acute medications and days of acute drug intake in an ad hoc diary. At the end of the baseline observation period, if inclusion/exclusion criteria were still satisfied, patients were randomized to the double-blind phase of the study (T0). To this end, patients were hospitalized on Mondays at the IRCCS Mondino Foundation for a 7-day detoxification protocol, that included: acute withdrawal of the overused drug and e.v. treatment with isotonic 0.9% NaCl saline 500 ml + cyanocobalamin 2500 mcg + folic acid 0.70 mg + nicotinamide 12 mg + ascorbic acid 150 mg + sodic glutathione 600 mg + delorazepam 0.5 mg administered b.i.d.
The day of hospital admission (T0), before the first infusion, patients were tested with a complete set of clinical scales and they completed the baseline EEG recording. After these procedures, the patients were randomized (1:1) to two different treatment groups: 'tDCS group' or 'sham group' and received 1 daily session of tDCS/sham stimulation for 5 consequent days (see below).
On day 5 (T1) patients underwent a follow-up EEG recording, administration of clinic scales for sleepiness, and attentional functions, evaluation of adverse events.
On day 7 patients were discharged from the hospital with or without the prescription of preventive medication (based on the physician judgement) and returned for a follow-up visit after 1 month (T2) and 6 months (T3). An addition EEG recording was obtained at T2.
Patients continued to record headache characteristic on the headache diary for the entire study observation period.
The study protocol was approved by the local Ethic Committee and all participants provided a written informed consent.
Transcranial direct current stimulation (tDCS) was delivered by a technician that was not otherwise involved in the management of patients. The managing physician were instead blind to the type of stimulation.
The technician used a specific battery-driven direct current stimulator (Newronika HDCstim, Newronika s.r.l.). The current was transferred by an approved saline-soaked pair of surface sponge electrodes (anode of 3x3 cm and cathode of 6x4 cm).
All the participants received daily stimulation sessions for 5 consecutive days (Monday to Friday). For the stimulation, the anode was placed over the primary motor cortex (M1), identified using the International 10-20 system for C3 (left M1) or C4 (right M1), and the cathode positioned over the contralateral supraorbital region (immediately below the Fp position of the 10-20 system). According to data from literature, in patients with a strict or prevalent (\>70% of attacks) unilateral headache the contralateral hemisphere was stimulated, instead in patients with bilateral or shifting headache the dominant hemisphere was conventionally stimulated.
Patients randomized to the tDCS group were treated with the following parameters: duration of stimulation of 20 minutes per session with a 2 mA intensity of anodal stimulation.
In the sham group, the stimulation setting was exactly the same but the stimulation intensity was set according to a ramping up/ramping down method and delivered only in the first and last 30 seconds of each session. This stimulation paradigm is insufficient to produce a meaningful therapeutic effect, but it is necessary to guarantee to blind condition as it mimics the possible initial tingling sensation associated with active stimulation. All participants were informed about possible feelings related to tDCS treatment, such as a tingly sensation under the electrodes at the beginning of the stimulation. These procedures adequately blind participants to their group allocation. At the end of the 5 days stimulation period a blind check was performed.
An EEG recording was performed at baseline (T0), at the end of the tDCS/sham treatment (T1), and after 1 month from hospital discharge (T2).
The EEG was recorded with 19 Ag/AgCl electrodes which were placed according to the 10-20 EEG International System.
The EEG registration was performed in the morning (between 9:00 a.m. and 11 a.m.), in a dedicated sound-attenuated room by a technician blinded to the study procedures. The subjects were instructed to remain awake with their eyes closed. The EEG was recorded for 10 min with a sampling rate of 1024 Hz and it was filtered between 0.4 and 70 Hz. A Notch filter was also applied to avoid 50 Hz interferences.
For the EEG signal analysis, the investigators used a spectral analysis through a fast Fourier transformation. The investigators evaluated the power spectral density in these frequency ranges: Delta (1-4 Hz), Theta (4-8 Hz), Alpha (8-12 Hz), Beta (12-30 Hz). The absolute band power values (µV2) for each frequency were computed for each active electrode (Fp1, Fp2, F3, F4, F7, F8, Fz, C3, C4, Cz, P3, P4, Pz, T3, T4, T5, T6, O1, O2), using Cz as ground reference.
For statistical purpose, the band power values were expressed as the percentage variation respect to baseline (normalized as 100%). Moreover, in patients with tDCS/sham stimulation of the right hemisphere the investigators performed an offline virtual right to left inversion all the electrodes of the right hemisphere. In this setting, unless differently specified, all the odd electrodes were ipsilateral to the side of stimulation, while all the even electrodes were contralateral to the side of stimulation.
At T0 and T2 time points all patients completed a set of questionnaires to assess migraine-related disability, quality of life, sleep disturbances, and psychological aspects. The set included:
* the Migraine Disability Assessment (MIDAS) test;
* the Headache Impact Test-6 (HIT-6);
* Visual Analogue Scale (VAS);
* the Migraine-Specific Quality-of-Life Questionnaire (MSQ);
* Short Form Health Survey (SF-36);
* Sleep Condition Indicator (SCI);
* Pittsburgh Sleep Quality Index (PSQI);
* Zung scale for anxiety;
* Zung scale for depression.
Moreover, before every EEG recording (T0, T1, and T2), patients were tested for their level of sleepiness, and attentional functions with:
* Stanford Sleepiness Scale: 1-item questionnaire, with a score that range from 1 (optimal alertness) to 7 (high level of sleepiness);
* Symbol Digit Modalities Test (SDMT): the SDMT was administered to test attentive functions. Patients were trained to match numbers and abstract symbols, according to a coded key. The total score (0-110) is represented by the number of correct substitutions in 90 seconds, with higher values representative of better attention.
#Intervention
- DEVICE : Transcranial direct current stimulation (tDCS) group
- Patients randomized to the tDCS group were treated with the following parameters: duration of stimulation of 20 minutes per session with a 2 mA intensity of anodal stimulation.
- DEVICE : Sham group
- In the sham group, the stimulation setting was exactly the same but the stimulation intensity was set according to a ramping up/ramping down method and delivered only in the first and last 30 seconds of each session.
|
#Eligibility Criteria:
Inclusion Criteria:
* age 18 <= age <= 65;
* chronic migraine according to the criteria of the InternationaI Classification of Headache Disorders (code 1.3 ICHD-III) and Medication Overuse Headache (code 8.2 ICHD-III) present for at least 6 months at inclusion;
* previous failure of at least three prophylactic treatments.
Exclusion Criteria:
* other neurologic or neuropsychiatric diseases;
* other chronic painful syndromes;
* other types of primary or secondary headaches;
* use of a preventive medication at baseline;
* use of central nervous system modulating drugs;
* epilepsy;
* metallic head implants or use of a cardiac pacemaker;
* pregnancy or lactation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04336267
|
{
"brief_title": "Anodal tDCS in Chronic Migraine With Medication Overuse",
"conditions": [
"Chronic Migraine",
"Medication Overuse Headache"
],
"interventions": [
"Device: Sham group",
"Device: Transcranial direct current stimulation (tDCS) group"
],
"location_countries": null,
"nct_id": "NCT04336267",
"official_title": "Anodal Transcranial Direct Current Stimulation in Chronic Migraine With and Medication Overuse Headache: a Pilot Randomized Sham-controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-15",
"study_completion_date(actual)": "2018-01-15",
"study_start_date(actual)": "2015-01-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-07",
"last_updated_that_met_qc_criteria": "2020-04-02",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-07",
"first_submitted": "2020-03-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in accordance with SmPCs approved in Croatia. Data collection for each patient will take place at a single visit. The investigator will complete a Case Report Form with the patient's demographics, the presence of the factors for high cardiovascular risk, current treatment, cholesterol values as well as with further treatment decision.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients who have been treated with one HMG-CoA reductase inhibitor for at least 6 months without changing the dose for the last 4 weeks at least.
* All patients must sign Informed consent form.
Exclusion Criteria:
* Patients who have not signed the Informed consent form.
* Patients with contraindication for the treatment with HMG-CoA reductase inhibitors as per SmPC approved in Croatia.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01257971
|
{
"brief_title": "Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors",
"conditions": [
"Hypercholesterolaemia"
],
"interventions": null,
"location_countries": [
"Croatia"
],
"nct_id": "NCT01257971",
"official_title": "Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) Reductase Inhibitors in Croatia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-10",
"study_completion_date(actual)": "2011-10",
"study_start_date(actual)": "2011-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-03-20",
"last_updated_that_met_qc_criteria": "2010-12-09",
"last_verified": "2012-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-12-10",
"first_submitted": "2010-12-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Adhesive restorative materials are routinely used in operative dentistry to improve tooth tissues with minimal preparation, achieve more esthetic and long term restorations. Despite these efficacy to dentistry these materials still present some drawbacks like polymerization shrinkage. Postoperative sensitivity, marginal discoloration and possibly secondary caries are often associated with loss of marginal integrity in composite restorations occurred as a result of polymerization shrinkage. To achieve optimal long term performance, the requirements will be first to manage polymerization stress buildup following restoration.Low-shrinking composites with new formulas have been successful in brilliantly further developing the leader product els extra low shrinkage.
The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material ELS versus ELS Extra resin composite for Class I and Class II cavities that needs to be restored in permanent teeth.
Detailed Description
The detrimental impact of resin composite polymerization shrinkage on restoration interface quality and stability has been recognized since the early use of this material is still one of the major drawbacks in adhesive dentistry, as it frequently leads to loss of marginal integrity or enamel fracture. According to clinical studies, drawbacks such as postoperative sensitivity, marginal discoloration and possibly secondary caries are often associated with loss of marginal integrity in composite restorations occurred as a result of polymerization shrinkage. Various technological solutions were investigated, including improved filler technology; improved, novel matrix structure with reduced shrinkage; use of stress-decreasing compounds within the resin matrix; changes in light-initiation technology to increase curing depth; and use of sonic vibrations and energy to favor flow and adaptation of highly filled resin composite. To achieve optimal long term performance, the requirements will be first to manage polymerization stress buildup following restoration. Low-shrinking composites should help to avoid clinical problems that are commonly associated with composite restorations, such as post-operative sensitivity, enamel cracks, rapid discoloration and deterioration of restoration margins, early development of caries recurrence, with a new formula and improved sculptability SAREMCO has been successful in brilliantly further developing the leader product els extra low shrinkage. When using new simplified restorative systems featuring distinctive physicochemical characteristics, the potential impact of different parameters such as fatigue behavior and/or elastic modulus on restoration quality and behavior is unknown and justifies additional investigations. Instead of in vitro evaluations, consideration of a rather well-established clinical trials suggesting medium to long term observation periods to discriminately appraise the clinical performance of various operative protocols.
The project includes 30 patients. Most of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. After giving their consent to take part in the study Class I \& II restorations of both upper and lower molars and premolars are performed.The treatment procedure is: The patients are offered local anesthetic before treatment start. The cavity is excavated and filled according to the guidelines for composite restorations.
The control procedure is:
The restoration is evaluated according to marginal adaptation, cavo surface marginal discoloration, approximal contact, fractures, caries associated with restorations and postoperative hypersensitivity. The controls will take place after two weeks, one year, two years and three years.
#Intervention
- DEVICE : ELS Extra composite
- One of the teeth will be restored using ELS composite. Procedures will be done under local anesthesia if necessary. The preparation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.
- DEVICE : ELS composite
- the other teeth will be restored with a ELS resin composite with ordinary restorative techniques.
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary caries removal
* Class I & II restoration replacement
* No obvious untreated caries, dental health problems (regularly checked by a dentist)
* Good or moderate oral hygiene (plaque score of less than 30% in anterior region be-fore treatment)
* No untreated periodontal disease (only DPSI 1, 2)
* Subjects had to present no active carious lesions
* Subjects had to be over the age of 18, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
* Subjects had to agree to keep the scheduled recall appointments for data collection and maintenance and plan to stay in the area for at least 3 years.
Exclusion Criteria:
* Caries extends cemento-enamel junction in Class II.
* Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3
* Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
* Endodontic treatment with extensive loss of tooth tissue
* Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago
* Excluding the teeth, with opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
* Subjects who presented with severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism
* Subjects who were restored with a removable partial dental prosthesis (RPDP), unless the RPDP replaced the tooth that was planned to be restored in the study
* Subjects who were pregnant pregnant during the duration of the study
* Subjects who are known to be allergic to the ingredients of resin materials
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03306576
|
{
"brief_title": "Clinical Evaluation of ELS Versus ELS Extra Resin Composite",
"conditions": [
"Caries, Dental"
],
"interventions": [
"Device: ELS composite",
"Device: ELS Extra composite"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT03306576",
"official_title": "Clinical Evaluation of Restorations Made of ELS Versus ELS Extra Resin Composite: A Prospective Randomized Controlled Clinical Trial up to 3 Years",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-15",
"study_completion_date(actual)": "2020-12-30",
"study_start_date(actual)": "2017-12-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-01",
"last_updated_that_met_qc_criteria": "2017-10-05",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-11",
"first_submitted": "2017-10-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To analyze the effects of a resistance training program based on the blood flow restriction modality on muscle strengthening and functionality in people over 45 years of age with multiple sclerosis (MS).
Detailed Description
This research corresponds to an experimental study, a double-blind randomized controlled clinical trial, where a total of blood flow (n = X) 12 weeks; and the control group (n= X) that will only receive general recommendations about the benefits of physical exercise. The variables will be measured for both groups with the same validated tools and the same researcher to avoid information bias and differential misclassification. The evaluations will be carried out at the beginning of the intervention and immediately after the end of this period, and the results will be noted in a data record that will later be unified in an Excel database, registering a code for each participant to maintain condition. of privacy, but at the same time allow the required comparability.
For the independent variables, sociodemographic characteristics, clinical history and the socio-familial assessment scale will be addressed; For their part, the result variables are divided by areas: those focused on the health status of patients with MS will measure the level of disability through the Expanded Disability Status Scale (EDSS), the impact of MS through the Multiple Sclerosis Impact Scale 29 (MSIS-29) and health-related quality of life (HRQoL) with the Short Form-36 (SF-36). For the physical condition variables, the Maximal Voluntary Isometric Contraction (MVIC) will be used with a dynamometer to measure general muscle strength and grip strength, as well as the Sit to Stand-5 repetitions (STS-5) and the Sit to Stand-5 repetitions (STS-5). 30 seconds (STS-30) to evaluate lower limb strength. For the functional variables, the impact on walking is evaluated using the Timed 25-Foot Walking Test (T25FWT); gait speed with the 10-Meters Walk Test (10-MWT) and Timed Up and Go (TUG); while walking endurance will be measured with the 6-Minute Walk Test (6-MWT). For its part, postural stability and balance from the Berg Balance Scale (BBS). To evaluate the level of physical activity, Godin Leisure-Time Exercise Questionnaire scores (GLTEQ) will be used. The questionnaire to determine fatigue will be the Fatigue Severity Scale (FSS) and the one in charge of measuring cognitive function will be the Symbol Digit Modalities Test (SDMT). On the other hand, in the psychological variables, the Hospital Anxiety and Depression Scale (HADS) will be applied for anxiety and depression and the Perceived Stress Scale (PSS) for the stress level. Finally, to measure sleep quality, the Pittsburgh Sleep Quality Index (PSQI) will be used. All variables will have pre and post intervention measurements. As a result, a training program with blood flow restriction is expected to improve the health status, muscle strength, functionality and psychological domains of middle-aged patients (\> 45 years) with MS, thus contributing to the comprehensive approach of this population. Once the intervention is completed, the final evaluation will be carried out and, based on the comparative process, define whether there are significant differences with respect to the results initially obtained.
#Intervention
- OTHER : Blood Flow Restriction training with Oclussion Cuff.
- A strength training program with blood flow restriction will be performed for 12 weeks, with 30-45 minute sessions on Mondays, Wednesdays and Fridays. Each session includes a warm-up, the main part with specific exercises and a cool-down with stretching.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female users > 45 years, who voluntarily agree to participate in the study, who are able to understand the instructions and exercise protocols of this project.
Exclusion Criteria:
* People with contraindications for performing physical tests or exercise. Users with a diagnosis of pathologies such as cancer, pulmonary hypertension and kidney failure, population with a diagnosis of heart disease or heart failure, population with a diagnosis and/or under psychiatric management, with neurological or cognitive alterations will be excluded. Population diagnosed with Human Immunodeficiency Virus infection or disease (HIV/AIDS). Population that does not agree to participate in the study or who, at the time of entering the program, have denied the endorsement of the use of their data for research in the informed consent.
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06061939
|
{
"brief_title": "Effects of Blood Flow Restriction Training on Middle-aged People With Multiple Sclerosis.",
"conditions": [
"Sclerosis, Multiple"
],
"interventions": [
"Other: Blood Flow Restriction training with Oclussion Cuff."
],
"location_countries": [
"Spain"
],
"nct_id": "NCT06061939",
"official_title": "Effects of a Resistance Training Program Based on Blood Flow Restriction Training for People Over 45 Years of Age With Multiple Sclerosis on Muscle Strength and Functionality.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-12",
"study_completion_date(actual)": "2024-05-13",
"study_start_date(actual)": "2024-01-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-13",
"last_updated_that_met_qc_criteria": "2023-09-25",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-09-29",
"first_submitted": "2023-09-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Treatment of recurrent bladder cancer with dendritic cells
#Intervention
- BIOLOGICAL : Dendritic cells
- Autologous dendritic cells primed with muc-1/wt-1 peptides
- OTHER : Standard treatment according to the Clinical protocols
- Standard treatment of bladder cancer according to the Clinical protocols
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of pTa bladder cancer;
* Patient who require repetitive transurethral resection;
* Expression of muc-1/wt-1 by the tumor;
* EGOC 0 <= age <= 3;
Exclusion Criteria:
* any medical condition which can be associated with the high risk for the patient;
* pregnancy/lactation;
* chronic infections, including hepatitis B/C, tuberculosis, HIV
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04184232
|
{
"brief_title": "Treatment of Recurrent Bladder Cancer With Dendritic Cells",
"conditions": [
"Bladder Cancer"
],
"interventions": [
"Biological: Dendritic cells",
"Other: Standard treatment according to the Clinical protocols"
],
"location_countries": [
"Belarus"
],
"nct_id": "NCT04184232",
"official_title": "Treatment of Recurrent Bladder Cancer With Autologous Monocyte-derived Dendritic Cells",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-31",
"study_completion_date(actual)": "2020-12-31",
"study_start_date(actual)": "2019-07-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-01-22",
"last_updated_that_met_qc_criteria": "2019-12-01",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-12-03",
"first_submitted": "2019-12-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study estimates the treatment goal achievement rate, depicts the implementation of the Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and transitioning, and assesses patient adherence and persistence with adalimumab therapy in the routine clinical practice in Greece.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of plaque psoriasis for at least 6 months, and moderate to severe disease course at the time of adalimumab treatment onset, defined as Body Surface Area (BSA) >10 or PASI >10 and DLQI >10
* Patients for whom the decision to prescribe therapy with adalimumab (Humira®) according to the locally approved summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study
* Patients with an available Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores at the start of adalimumab treatment
* Patients able and willing to provide written informed consent and to comply with the requirements of this study protocol
* Patients with a signed informed consent document
Exclusion Criteria:
* Patients should not have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular)
* Patients for whom treatment with adalimumab has been initiated more than 2 weeks prior to their enrolment into the study
* Patients that meet any of the contraindications to the administration of the study drug according to the latest version of the locally approved SmPC
* Patients who have previously been exposed to adalimumab unless a period of at least 6 months from the last dose has elapsed
* Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with adalimumab.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02713295
|
{
"brief_title": "A Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece",
"conditions": [
"Moderate to Severe Plaque Psoriasis"
],
"interventions": null,
"location_countries": [
"Greece"
],
"nct_id": "NCT02713295",
"official_title": "A Non-interventional Prospective Cohort Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-19",
"study_completion_date(actual)": "2019-04-19",
"study_start_date(actual)": "2016-06-16"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-15",
"last_updated_that_met_qc_criteria": "2016-03-15",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-03-18",
"first_submitted": "2016-03-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in multiple myeloma patients.
Detailed Description
Autologous hematopoietic stem cell transplantation (autoHSCT) is a standard treatment of eligible patients suffering from multiple myeloma (MM). Tandem autoHSCT allows to further improve results of the therapy. Nowadays, 99% of the procedures are performed using peripheral blood as a source of stem cells. Hence, the crucial point is to harvest adequate number of stem cells allowing hematopoietic recovery. The number of 5 × 10\^6 CD34+ cells/kg is considered the optimal level, as far as double autoHSCT is concerned. There are two main mobilization strategies being used: based on G-CSF alone or in combination with chemotherapy (cyclophosphamide (CY) at dose range 1.5-7 g/m2 is mainly used in MM setting). However, a proportion of patients (5-40%) fail to collect the minimum number of cells required. Novel agents, like plerixafor, CXCR4 inhibitor, may enable effective CD34+ cell harvest in 'poor mobilizers'. Nevertheless, the optimal first-line and cost-effective protocol for mobilization of hematopoietic stem cells has not been determined so far.
Randomized trials comparing chemomobilization with use of CY + G-CSF to G-CSF alone, which had been conducted so far, did not demonstrate clear advantage of addition of CY to growth factor. Intermediate-dose cytosine arabinoside (AraC), 1.6 g/m2 plus filgrastim, has been shown to produce very high efficacy as a first or second-line mobilization regimen in patients with lymphoid malignancies, including MM. In a retrospective comparison, this strategy was significantly more effective than CY + filgrastim. This suggest that the type of chemotherapy agent added to G-CSF may play role in mobilization efficacy and that the combination of AraC and G-CSF may be more effective than G-CSF used alone. The goal of current study is to verify this hypothesis in randomized controlled trial.
#Intervention
- DRUG : G-CSF (filgrastim)
- DRUG : Cytosine arabinoside + G-CSF (filgrastim)
|
#Eligibility Criteria:
Inclusion Criteria:
* Multiple myeloma patients considered eligible for tandem autologous stm cell transplantation procedure.
* Must have received at least one line of therapy including six or more cycles containing components like thalidomide, bortezomib, lenalidomide or melphalan.
* Must have achieved a partial remission (PR) or better response as assessed by International Myeloma Working Group guidelines.
* Must be 18 <= age <= 65 years.
* Must have World Health Organization performance status 0 <= age <= 1.
* Time form discontinuation of administration of any chemotherapy agent must be at least four weeks and immunomodulatory drug at least seven days.
* Hemoglobin level > 8 g/dl, Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count >100 x 109/L.
* Serum creatinine < 1.5 x upper limit of normal (ULN), serum bilirubin < 1.5 ULN, serum aspartate transaminase (AST/SGOT) < 2.5 x ULN, serum alanine transaminase (ALT/SGPT) < 2.5 x ULN.
* Negative human immunodeficiency virus (HIV) infection test.
* Negative pregnancy test.
* Must understand and voluntarily sign informed consent form.
Exclusion Criteria:
* Failure of prior, first-line mobilization regimen.
* Bone marrow plasma cell infiltration of above 20%.
* Administration of growth-factor other than G-CSF within 4 weeks before starting study treatment.
* Administration of G-CSF within 14 days before starting study treatment.
* Ongoing or active infection.
* Coexisting neoplasm, other than multiple myeloma.
* Pregnant or lactating females.
* Patients treated with use of autologous or allogenic stem cell transplantation in the past.
* Positive human immunodeficiency virus (HIV) infection test.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01908621
|
{
"brief_title": "Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Multiple Myeloma Patients.",
"conditions": [
"Multiple Myeloma"
],
"interventions": [
"Drug: G-CSF (filgrastim)",
"Drug: Cytosine arabinoside + G-CSF (filgrastim)"
],
"location_countries": [
"Poland"
],
"nct_id": "NCT01908621",
"official_title": "Safety and Efficacy of Stem Cell Mobilization Using G-CSF (Filgrastim) Alone Compared to Intermediate-dose Cytosine Arabinoside Plus G-CSF in Multiple Myeloma Patients.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03-18",
"study_completion_date(actual)": "2017-10-27",
"study_start_date(actual)": "2013-03-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-28",
"last_updated_that_met_qc_criteria": "2013-07-23",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-07-25",
"first_submitted": "2013-07-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Benefits from cardiac rehabilitation (CR) programs are evidence based and widely recognized. Less than 50% of people who participate in hospital-based CR programs maintain an exercise regimen for as long as six months after completion. Despite the benefits associated with regular exercise training (ET), adherence with supervised exercise-based CR remains low.
Current exercise guidelines for CR focus on moderate intensity steady state exercises, with walking and cycling being the most recommended types of ET. The repetitive nature of this type of activity can become monotonous for the patient, affecting exercise adherence, compliance and training outcomes. Exercise periodization is a method typically used in sports training, but the impact of periodized exercise to yield optimal beneficial effects in cardiac patients is still unclear.
In healthy or trained populations, periodization aims to optimize ET adaptations as compared with non periodized training, to prevent overtraining and to avoid plateauing of training adaptations. Periodized methods are considered to be superior to non periodized methods in trained populations and appears to be superior in inactive adults. In most of the CR programs there are no periodization or exercise progression during medium to long term interventions. Further randomized controlled trials (RCT) are necessary to evaluate long-term periodization outcomes.
The purpose of this research project is twofold:
1. To conduct a 12-month randomized control trial to evaluate the effects of a periodized ET regime versus a non periodized ET regime (guidelines) on VO2 peak, maximal strength, body composition, functionality and quality of life in cardiovascular disease patients.
2. to differentiate the effects of a 12-month periodized ET regime versus a non periodized ET regime on the different components of the oxygen kinetics response and oxidative adaptations in cardiovascular disease patients.
These patients will be randomized in 2 ET groups: 1) periodization; 2) non periodization. This experimental design will occur during 48 weeks 3 times per week with 4 assessment time points: M0) before starting the ET program (baseline); M1) 3 months after starting the ET; M2) 6 months after starting the ET program and M3) 12 months at the end of the community-based ET program.
Detailed Description
Cardiac Rehabilitation (CR) of patients with Cardiovascular Disease (CVD) has been practiced in Europe to varying degrees since the early 1970s. CR is a comprehensive, long-term program involving medical evaluation, prescribed Exercise Training (ET), cardiac risk factor modification, education and counselling. These programs are designed to limit the physiologic and psychological effects of cardiac illness, reduce the risk for sudden death or re-infarction, control cardiac symptoms, stabilize or reverse the atherosclerotic process, and enhance the psychosocial and vocational status of selected patients. Furthermore, it is a safe, useful and an effective treatment for patients with coronary artery disease (CAD), particularly after myocardial infarction, but also for patients with cardiac interventions and chronic stable heart failure.
Exercise adherence after a hospital-based CR program is reported to be poor with only 30% to 60% of those who complete a phase II CR program are still exercising 6 months later and after 12 months, up to 50 to 80% of participants failing to adhere to exercise. Despite the benefits associated with regular ET, adherence with supervised exercise-based CR remains low.
A brief review of meta-analysis studies that assess the impact of different types of exercise in short term outcomes for participants of CR will now be presented. The findings of a meta-analysis in 2015 indicated that high intensity interval training (HIIT) is more effective than moderate continuous training (MCT) for the improvement of both VO2 peak and the anaerobic threshold in patients with stable CAD. The greater improvement in VO2 peak following HIIT compared to MCT (4.6 ± 3.1 versus 2.8 ± 2.4 ml/kg/min) is important in the context of a 10-25% survival advantage with every 3.5 ml/kg/min improvement in VO2 peak.
Another meta-analysis in 2016, compared HIIT and MCT in their ability to improve patients aerobic exercise capacity and various cardiovascular risk factors. Ten studies with 472 patients were included for analyses (218 HIIT, 254 MCT) and the main conclusions were that HIIT improves the mean VO2 peak in patients with CAD more than MCT, although MCT was associated with a more pronounced numerical decline in patients resting heart rate and body weight.
Current CR guidelines recommend the inclusion of a standardized resistance training (RT) program. A recent meta-analysis of ET programs in patients with CAD revealed that the addition of RT training to MCT led to superior improvements in body composition, muscle strength, peak work capacity, and a trend for greater increases in VO2 peak. Similar to HIIT, RT has not been shown to compromise patient safety or program adherence.
Less is known about central and peripheral adaptations during long term effects on HIIT, MCT or even aerobic combined training with RT. In 2016, a systematic review and meta-analysis with a total of 63 studies with 14,486 participants with CAD median follow-up of 12 months were included. It was concluded that exercise-based CR reduces cardiovascular mortality and provides important data showing reductions in hospital admissions and improvements in quality of life. Madssen et al, showed that a 12-month maintenance exercise program consisting of infrequent supervised exercise sessions did not result in improved adherence to exercise or increased VO2 peak in CAD patients compared to usual care. One monthly session during a year of HIIT was not enough to improve or maintain exercise capacity. In the literature there is a lack of evidence on the effects in exercise capacity, muscle strength and body composition in long term weekly supervised exercise sessions on a maintenance exercise program in CVD patients.
Current exercise guidelines for CR focus on moderate intensity steady state exercises, with walking and cycling being the most recommended types of ET. Multiple training variables can be manipulated during exercise prescription, including repetitions, interval length, rest period length and intensity of resistance. In this regard, much insight could be gained from approaches used in sport conditioning, where exercise prescription is designed to be physiologically and psychologically sustainable using periodization.
Periodization is defined as an organized cyclic program that uses planned variations in intensity, volume, and specificity to minimize fatigue and maximize performance outcomes. In healthy or trained populations, periodization aims to optimize ET adaptations as compared with non periodized training, to prevent overtraining and to avoid plateauing of training adaptations. Periodized methods are considered to be superior to non periodized methods in trained populations and appears to be superior in inactive adults. Interestingly, a recent study investigated the effect of 22 weeks of 2 different types of periodization and non periodization resistance training protocols on a comprehensive range of physical function and health outcomes in apparently healthy untrained older adults. Contrary of what was hypothesised, all three training models were equally effective for promoting significant improvements in various physical function and physiological health outcomes through resistance training in this population.
In most of the CR programs there are no periodization or exercise progression during medium to long term interventions. Evaluate long-term periodization outcomes and assess the length of change observed in supervised CR programs might be of interest and necessary.
This study will hopefully contribute to generate evidence-based exercise prescription approaches to prolong the ET after the end of hospital-based CR programs.
The purpose of this research project is twofold:
1. To conduct a 12-month randomized control trial to evaluate the effects of a periodized ET regime versus a non periodized ET regime (guidelines) on VO2 peak, maximal strength, body composition, functionality and quality of life in CVD.
2. to differentiate the effects of a 12-month periodized ET regime versus a non periodized ET regime on the different components of the oxygen kinetics response and oxidative adaptations in CVD patients.
The hypothesis for this study are: 1) considering that this type of periodization exerts higher stress on the cardiovascular and neuromuscular systems, so that there could be greater adaptations leading to higher increases in VO2max, muscle strength, body composition and functionality compared to non periodized ET regime; 2) there will be a better improvement microvascular O2 delivery in the exercise transient in response to periodized ET regime that will be associated with a faster adjustment of pulmonary VO2 kinetics than in non periodized group. Improvements in microvascular O2 delivery will be indicated by a better matching between the rate of adjustment of muscle deoxygenation relative to phase II pulmonary VO2, which represents a decreased reliance on O2 extraction for a given pulmonary VO2.
STUDY DESIGN:
A longitudinal RCT research design performed in the Cardiovascular Rehabilitation Center of the University of Lisbon (CRECUL) at the Lisbon University Stadium (EUL) using two distinct ET prescriptions (periodization vs non periodization) will be applied in cardiovascular disease patients. Briefly, following the informed consent process, patients will be randomized and stratified (by gender and age) to periodization or non periodization groups. The randomization code will be developed with a computer random-number generator to select random permuted blocks. Participants will exercise for a period of 12 months. All the same assessments, except the echocardiogram that will be done in M0 and M3 (for risk stratification), are going to be taken in 4 different time points during a year: M0 - baseline, M1 - 3 months after starting the ET, M2 - 6 months after starting the ET and M3 - 12 months after starting the ET. The patients will be randomized into either one of the two ET group.
Sample size was calculated (G-Power, Version 3.1.3) assuming a difference in peak oxygen uptake (VO2 peak) between groups of 3 ml/kg/min to be a clinical important difference with a standard deviation of 3.5 ml/kg/min, α=0.05, 1-β=0.80 and an expected dropout rate of 50%. The calculations yielded a total minimum sample size of 56 participants (28 in each group).
The following assessments on the 4 time points will be performed at the Pulido Valente Hospital, Faculty of Human Kinetics - University of Lisbon (FMH-UL) and Academia de Fitness at EUL: Echocardiogram (Echo) (MyLab Alpha, ESAOTE); cardiopulmonary exercise test (CPET) (Ergostik, Geratherm Respiratory GmbH, Bad Kissingen); skeletal muscle deoxygenation dynamics (NIMO, Nirox srl); body composition - dual energy radiographic absorptiometry (DXA, Hologic Explorer-W); objective measured physical activity - accelerometer (ActiGraph GT3X+); functional physical fitness - Fullerton Functional Fitness Test; isometric strength - portable hand dynamometer JAMAR plus digital (Sammons Preston); maximal strength - 1RM and Quality of Life questionnaire (Short Form-36 Health Survey).
All assessment moments will be done in 1 to 2 weeks:
Day 1 - Echo and CPET will be performed at the Hospital; Day 2 and 3 - during the day and time of the ET session at the EUL, the patient will perform: functional physical fitness tests; maximal strength; isometric strength and Quality of Life questionnaire; Day 4 - In FMH-UL, the dual energy radiographic absorptiometry (DXA) exam and the activation of the accelerometer to measure the objective measured physical activity will be done.
Day 5 - Submaximal CPET with the skeletal muscle deoxygenation dynamics at the Hospital.
In order to assure the confidentiality of the participants an ID code will be attributed to each participant in the database and all the equipment's and sheets used. A single researcher will perform the database management.
DATA ANALYSIS:
Data will be analyzed in M0, M1, M2 and M3. It will be tested the data for normality and homogeneity of variance with the Shapiro Wilk and Levene's tests, respectively. Data analysis will be described according to the established purposes for this project (descriptive values: mean, standard deviation, range, % change) and comparisons of means will be used for all purposed outcomes intra and inter groups. Baseline characteristics between groups will be evaluated with oneway ANOVA. Mixed between within subjects ANOVA will be conducted in a 2 (pre vs post ET) design to assess efficiency of the program. When a significant interaction is observed, t tests, or Wilcoxon signed-rank tests will be used to determine where the interaction occurred.
M0 versus M1, M0 versus M2, M0 versus M3, M1 versus M2, M2 versus M3 and M1 versus M3 will be compared to evaluate the changes in patients and trace the necessary timespan for such changes using General Linear Mixed Model Analysis for repeated measures with Tukey's post hoc procedure for the mean comparisons. Pearson product moment correlation coefficient or Spearman's rank correlation coefficient will be used to study the relationship between different variables by group and correlation coefficients will be compared between groups. Statistical significance will be set at an alpha level of 0.05. Other statistical procedures can be done.
Statistical analyses will be conducted using Statistical Package for the Social Sciences (SPSS) 22.0 (IBM SPSS Statistics, Chicago, IL, USA).
#Intervention
- OTHER : Periodized Exercise Training Regime
- MCT 1st: 20 min on an ergometer; at Anaerobic Threshold (AT) 1 or, if the AT could not be adequately determined, 50-60% of the Heart Rate Reserve (HRR), Borg Rating of Perceived Exertion (RPE) equivalent 9-11. MCT 2nd: 20 minutes; 60-70%HRR, RPE 12-13. HIIT 1st: 4 interval training periods of 2 minutes (AT2 intensity or 80-90%HRR, RPE 15-17) and 4 active pauses of 2 minutes (below AT 1 or 40-50%HRR, RPE 6-9) between interval training periods. HIIT 2nd: same intervals as in 1st HIIT different intensities: high intensity interval above AT2 intensity or \> 90%HRR, RPE 17-19 and active pauses at AT 1 or 50-60%HRR, RPE 9-11. Resistance training adaptation: 2 sets of 15-20 repetitions 50% 1RM; Hypertrophy: 2 sets 8-12 repetitions at 60% 1RM; Maximal Strength: 2 sets of 6-8 repetitions at 80% 1RM.
- OTHER : Non Periodized Exercise Training Regime
- To ensure that total training loads were similar in both groups despite differences in intensity, it will be used the training impulses (TRIMP) method from Edwards for the aerobic component and the volume load method for the RT component. All sessions will include 10 minutes of warm up and cool down standardized for both groups. By design, the non periodized group involves an identical total training volume and time commitment but differed regarding metabolic stress induced by the linear periodized group. All patients will be monitored with a HR monitor during the execution of the exercise session in order to achieve the HR training. Blood pressure will be assessed before and after completing each session. If necessary, the blood pressure will be measured during the ET session.
|
#Eligibility Criteria:
Inclusion Criteria:
* angiographically documented coronary artery disease in at least one major epicardial vessel
* myocardial infarction,
* coronary revascularization (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, or coronary artery stent),
Exclusion Criteria:
* heart failure
* unstable angina pectoris
* heart transplants with either cardiac resynchronization therapy or implantable defibrillators
* inability to comply with guidelines for participation in exercise testing and training
* significant limiting and/or unstable comorbidities that would prevent full participation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03335319
|
{
"brief_title": "The Effect Of An Expanded Long Term Periodization Exercise Training In Patients With Cardiovascular Disease",
"conditions": [
"Cardiovascular Diseases",
"Coronary Artery Disease"
],
"interventions": [
"Other: Non Periodized Exercise Training Regime",
"Other: Periodized Exercise Training Regime"
],
"location_countries": [
"Portugal"
],
"nct_id": "NCT03335319",
"official_title": "The Effect Of An Expanded Long Term Periodization Exercise Training In Patients With Cardiovascular Disease: Central And Peripheral Adaptations",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-20",
"study_completion_date(actual)": "2019-12-20",
"study_start_date(actual)": "2017-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-25",
"last_updated_that_met_qc_criteria": "2017-11-02",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-07",
"first_submitted": "2017-10-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The project is a 15-year follow-up of 240 young adults whose families participated in an experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for divorced families. The NBP was provided in late childhood; the follow-up occurred in young adulthood. Families were randomly assigned to one of three conditions: mother program (MP), dual-component mother and child program (MPCP), or literature-control (LC) condition. Programs were designed to change several putative mediators of children's post-divorce mental health problems using empirically-supported change strategies. The investigators expected that the NBP would have either main or risk by program interactive effects on mental health and substance use problems and disorders, developmental tasks, parent-young adult relationships, physical health problems, and competencies, such that YAs who participated in NBP will have better functioning than YAs in the control condition. The investigators expected that the NBP will have either main or risk by program interactive effects on mothers' mental health; those in the NBP are expected to have fewer mental health problems than those in the control condition.
#Intervention
- BEHAVIORAL : New Beginnings Program
- A preventive intervention for divorced families.
|
#Eligibility Criteria:
Inclusion Criteria:
* Divorced in past two years
* Female residential parent
* At least one 9 <= age <= 12 year-old child resided (at least 50%) with the mother
* Neither mother nor any child was currently in treatment for mental health problems
* Mother had not remarried nor planned to remarry during the program, and did not have a live-in boyfriend
* Custody was expected to remain stable
* Family resided within an hour drive of program site
* Mother and child could complete assessments in English
* Child was not learning disabled nor in special education
* If diagnosed with attention deficit disorder, child was taking medication
Exclusion Criteria:
* Child scored above 17 on the Children's Depression Inventory (CDI, endorsed an item indicating that s/he wanted to kill her/himself, or scored above the 97th percentile on the Externalizing Subscale (Child Behavior Checklist [CBCL])
Sex :
ALL
Ages :
- Minimum Age : 9 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01407120
|
{
"brief_title": "15 Year Follow-up of New Beginnings Program for Divorced Families",
"conditions": [
"Mental Disorder",
"Substance Use"
],
"interventions": [
"Behavioral: New Beginnings Program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01407120",
"official_title": "Effects of NBP for Children of Divorce 15 Years Later",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-09",
"study_completion_date(actual)": "2009-09",
"study_start_date(actual)": "2006-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-08-02",
"last_updated_that_met_qc_criteria": "2011-08-01",
"last_verified": "2011-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-08-02",
"first_submitted": "2011-07-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Oropharyngeal bacteria play an important role in the pathogenesis of nosocomial pneumonia in critically ill patients. Oral cleansing with chlorhexidine has been shown to decrease incidence of pneumonia in patients undergoing open heart surgery. Its role in critically ill general ICU patients is not yet proven. The present study proposes to study the effectiveness of twice-daily oral cleansing with 0.2% chlorhexidine solution on the incidence of nosocomial pneumonia in ICU patients admitted to a single intensive care unit of an Indian public hospital
Detailed Description
Nosocomial pneumonia is common in intensive care units (ICU) patients and is associated with increase in mortality rates by 24% to 76% in various studies. Interventions that effectively prevent nosocomial pneumonia are strategically important in order to reduce morbidity, mortality and healthcare costs. Colonization of the pharynx has been implicated as the reservoirs for pathogens causing nosocomial pneumonia and interventions like selective digestive decontamination have been tried to control this source of infection. Recently, colonization of the dental plaque by aerobic organisms with subsequent aspiration into the lower respiratory tract has received attention. Previous smaller studies using antiseptic agents to sterilize dental plaques in patients at risk of pneumonia have shown conflicting results. The present study aims to determine whether twice daily oral cleansing with 0.2% chlorhexidine reduces the incidence of nosocomial pneumonia in patients staying in the ICU for \>48 hours.
After obtaining informed consent, subjects would be randomized to treatment with either 0.2% chlorhexidine gluconate (CHG) solution or 0.01% potassium permanganate solution (PP) (Control Group), as per the protocol approved by the Institutional Ethics Committee. At baseline, the parameters which would be noted are: age, sex, surgical or non-surgical status, immunosuppression, chronic ailments, smoking and alcohol consumption, Glasgow coma scale score (GCS), laboratory parameters and blood gas analysis. All subjects would be followed up daily and the GCS, presence of nasogastric tube (feeds), endotracheal tube, tracheostomy, ventilator, central venous and urinary catheterization, anti-stress ulcer prophylaxis and prior antibiotic use will be noted. Presence or absence of nosocomial pneumonia would also be noted daily. Lower respiratory secretions would be obtained by the protected non-bronchoscopic mini-BAL technique in order to identify the causative organisms. All the subjects will be followed up daily until discharge from the ICU or death.
Primary outcome variable was the development of nosocomial pneumonia during the ICU stay. Secondary outcome variables were hospital mortality, length of ICU stay.
A total of 506 patients will have to be studied (approximately 253 patients in each treatment group). This study will have a statistical power of 75% to detect a 50% reduction in the incidence of nosocomial pneumonia in the intervention group with a 95% level of confidence assuming that incidence of pneumonia in the control group is 16%.
#Intervention
- DRUG : Chlorhexidine gluconate
- Twice-daily oropharyngeal cleansing with 0.2% Chlorhexidine gluconate
- DRUG : Potassium permanganate
- Twice-daily oropharyngeal cleansing with 0.01% Potassium permanganate
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients admitted to the medical intensive care unit and are expected to stay in ICU for > 48 hours
Exclusion Criteria:
* Pregnant women
* Patients with nosocomial pneumonia at time of ICU admission
* Patients with community-acquired pneumonia at time of ICU admission
* Patients in whom oropharyngeal cleansing is contra-indicated
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00610324
|
{
"brief_title": "Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients",
"conditions": [
"Nosocomial Pneumonia",
"Healthcare-Associated Pneumonia",
"Aspiration Pneumonia",
"Ventilator-Associated Pneumonia"
],
"interventions": [
"Drug: Potassium permanganate",
"Drug: Chlorhexidine gluconate"
],
"location_countries": [
"India"
],
"nct_id": "NCT00610324",
"official_title": "Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients: an Open-Labelled Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-10",
"study_completion_date(actual)": "2007-12",
"study_start_date(actual)": "2004-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-02-07",
"last_updated_that_met_qc_criteria": "2008-01-24",
"last_verified": "2008-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-07",
"first_submitted": "2008-01-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the changes in energy expenditure, fat oxidation, reaction time, and perceptual indicators of energy and focus after acute ingestion of a caffeine-based energy drink. Approximately 60 healthy adults aged 18-50 will be recruited for a randomized, double-blind, placebo-controlled study. They will undergo baseline measurements for energy expenditure, fat and carbohydrate oxidation, reaction time, cognition, and perceptual indicators of energy, focus, and concentration. After 28 days, these measurements will be taken again, comparing the effects of a caffeine-based energy drink versus a placebo.
Detailed Description
The study will be conducted using a randomized, double-blind, placebo-controlled, parallel study design. Approximately 60 healthy men and women between the ages of 18 - 55 years of age will be recruited to participate in this study. Prior to beginning the study, all participants will sign an IRB-approved informed consent document and complete a health history questionnaire to determine study eligibility. All participants will report to the laboratory for all study visits between 0600 - 1000 hours. Prior to each study visit, participants will be asked to abstain from exercise, tobacco, nicotine, and alcohol for 12 hours and observe an overnight (8 - 10 hours) fast including caffeine. Study visit 1 will be a screening visit where participants will first sign an IRB-approved informed consent document. To determine eligibility, participants will then complete a health and medical history form and have their height and weight assessed along with their resting heart rate and blood pressure. If determined eligible, study participants will then have their body composition assessed and then be asked to record their past 24-hour intake of food and fluid. This form will be copied and all participants will be instructed to replicate this diet prior to each visit.
Study visits 2 and 3 will be identical and separated by approximately 28 days whereby each study participant will have ingested a single dose of their assigned beverage each day between visits 2 and 3. Prior to these visits, participants will not be allowed to exercise within 24 hours of each subsequent study visit and may only partake in a light workout two days prior to their study visit. Participants will be instructed to follow an overnight fast whereby no food or fluid with calories will be consumed for the 8 to 10-hour period prior to each study visit. Water intake will be encouraged during this time for appropriate hydration status. Upon arrival for study visits 2 and 3, body mass will be assessed before having their body temperature, resting heart rate, and blood pressure assessed. From there, participants will be instructed to complete simple and choice reaction time and cognition assessments using a DynaVision board. After cognition assessments are completed, visual analog scales will be completed to assess perceived levels of energy, focus, and concentration. Finally, participants will then complete a resting metabolic assessment to evaluate rates of calorie burning (energy expenditure), rate of fat oxidation, and amount of fat oxidized. After completion of all assessments, participants will ingest their assigned dose of beverage. Each participant will be given 15 minutes to ingest their assigned beverage. As soon as the entire beverage is consumed, the study protocol timer will be activated and all subsequent assessments will occur as outlined. During visit 2 (dose 1) and visit 3 (dose 28), participants will have energy expenditure and fat oxidation assessments completed 0, 30, 60, 90, and 120 minutes after ingestion while cognition, hemodynamics, and VAS will be evaluated 0, 60, and 120 minutes.
Participants will be assigned to each group in a randomized, double-blind, placebo-controlled fashion with parallel groups that are matched according to BMI and gender. This will ensure each study condition has similar numbers of males and females that are of similar body mass index levels. After completion of study visit 2, participants will be provided with a 14-day supply of their assigned beverage. After 14 days, participants must return to the laboratory to pick up their remaining assigned beverage and communicate with research staff about compliance, adverse events, etc. After 28 days of supplementation, participants will return to the laboratory for study visit 3, which will complete their participation in the study.
#Intervention
- DIETARY_SUPPLEMENT : Caffeine-Based Energy Drink
- Caffeine-based energy drink containing 200 mg caffeine
- DIETARY_SUPPLEMENT : Placebo
- Placebo void of all active ingredients
|
#Eligibility Criteria:
Inclusion Criteria
* Male or female participants between 18 - 50 years
* Signed informed consent
* Healthy, is defined as currently not being treated for an active cardiac, pulmonary, metabolic, immunological, neurological, respiratory, orthopedic, musculoskeletal, psychiatric, or reproductive disease or disorder. With the research team and principal investigator's discretion, some ongoing treatments will be permitted if a determination is made that the treatment will not increase the risk of study participation and the treatment will not confound with desired study outcomes
* Physically active is defined as performing aerobic or resistance-based physical exercise between 2 and 5 times per week
* Moderate caffeine users (~300 mg/day)
* Body mass index values will range from >24.0 to < 31.9 kg/m2. The average body mass index for the entire study cohort will be less than 31.99 kg/m2. As such an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 31.99 kg/m2
* Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures
Exclusion Criteria
* Body mass index > 31.9 kg/m2
* Positive medical history and/or is currently being treated for some form of heart or cardiovascular, neurological impairment, disease or condition, immune disorder or disease, thyroid disease, kidney disease, renal failure, regular dialysis, liver disease, or other diagnosed hepatic impairment
* Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
* Diagnosed with a major affective disorder or other psychiatric disorder that required hospitalization in the prior year
* History of cancer (except localized skin cancer without metastases or in situ 6. cervical cancer within 5 years prior to screening visit).
* Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea) 7. Currently prescribed statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha-blockers, 8. Vasodilators, etc.) or any other medication at the discretion of the principal investigator 9. Current smoker (>10 cigarettes per day) 10. Participants who are lactating, pregnant, or planning to become pregnant History of alcohol or substance abuse in the 6 months prior to screening 11. Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol 12. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data 13. Extensive travel (>1 month) that will disrupt the original outline of the study protocol
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05998096
|
{
"brief_title": "A Randomized Study to Examine the Ability of a Caffeine-Based Energy Drink to Impact Energy Expenditure, Fat Oxidation, Reaction Time, and Other Perceptual Indicators",
"conditions": [
"Energy Expenditure",
"Cognition",
"Reaction Time"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: Caffeine-Based Energy Drink"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05998096",
"official_title": "A Randomized Study to Examine the Ability of a Caffeine-Based Energy Drink to Impact Energy Expenditure, Fat Oxidation, Reaction Time, and Other Perceptual Indicators",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-23",
"study_completion_date(actual)": "2024-04-23",
"study_start_date(actual)": "2023-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-11",
"last_updated_that_met_qc_criteria": "2023-08-10",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-18",
"first_submitted": "2023-08-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is aimed to assess the correct real-world use of an autoinjector for the repeat self-administration of mepolizumab SC, so to improve subject / physician convenience and to enable repeat dose self injection themselves or via caregivers. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in autoinjector (100 milligrams \[mg\]) administered subcutaneously (SC) every 4 weeks (3 doses) in subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab SC as a single injection that is self-administered in the thigh, abdomen or administered in the upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks including pre-screening visit, a screening visit and a 12-week treatment period which concludes with end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab. Approximately 158 subjects will be enrolled in the study.
#Intervention
- DRUG : Mepolizumab
- It is a clear to opalescent, colorless to pale yellow sterile solution for SC injection, supplied in a single-use, prefilled syringe containing 100 mg/mL mepolizumab with sodium phosphate, citric acid, sucrose EDTA and polysorbate 80 within an autoinjector.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: At least 12 years inclusive, at the time of signing the informed consent. For those countries where local regulations permit enrolment of adults only, subject recruitment will be restricted to those who are >=18 years.
* Asthma: A physician diagnosis of asthma for >=2 years that meets the National Heart, Lung and Blood Institute guidelines or Global Initiative for Asthma guidelines.
* Mepolizumab treatment:
a. Not receiving mepolizumab treatment at Visit 1. These subjects must also meet following inclusion criteria related to eosinophilic asthma, inhaled corticosteroid, controller medication and exacerbation history):
* Eosinophilic asthma: A high likelihood of eosinophilic asthma as per the required 'Continuation to Treatment'-criterion,
* Inhaled corticosteroid: A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS), for subjects >=18 years, ICS dose must be >=880 micrograms (mcg)/day fluticasone propionate (FP) (ex-actuator) or equivalent daily, For ICS/long-acting-beta-2-agonist (LABA) combination preparations, the highest approved maintenance dose in the local country will meet this ICS criterion, for subjects >=12 to <=17 years, ICS dose must be >=440 mcg/day FP (ex-actuator) or equivalent daily, for ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion. (Subjects will be permitted to be enrolled without continuous high dose ICS providing the subject was receiving continuous ICS and the Investigator attest that the subject should have been treated with high dose ICS to mitigate the risk of exacerbations, or the subject has financial or tolerance issues that prevent the use of high-dose ICS. Such subjects should be discussed with GSK Medical Monitor prior to enrolment)
* Controller medication: Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication (e.g., LABA, leukotriene receptor antagonist [LTRA], or theophylline) for at least 3 successive months.
* Exacerbation history: Previously confirmed history of one or more exacerbations requiring treatment with systemic corticosteroid (CS) [intramuscular (IM), intravenous, or oral] in the 12 months prior to Visit 1, despite the use of high-dose ICS. For subjects receiving maintenance CS, the CS treatment for an exacerbation must have been a two-fold dose increase or greater.
or, b. Receiving 100 mg SC mepolizumab administered for the treatment of severe eosinophilic asthma every 4 weeks for at least 12 weeks prior to Visit 1.
* Body weight: A minimum body weight >=40 kilograms (kg) at Visit 1
* Gender: Male or female. A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG)]test), planning to become pregnant during the time of study participation (and up to 16 weeks after the last dose), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: pre-menopausal females with documented tubal ligation or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion or hysterectomy or documented bilateral oophorectomy, postmenopausal female, reproductive potential and agrees to follow highly effective methods for avoiding pregnancy in females of reproductive potential from 30 days prior to the first dose of study medication and until 16 weeks after the last dose of study medication and completion of the end of study/early withdrawal visit. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
* Informed consent: Capable of giving signed informed consent.
Exclusion Criteria:
* Concurrent respiratory disease: Presence of a known pre-existing, clinically important lung condition other than asthma. This includes current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
* Eosinophilic diseases: Subjects with other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, including churg-strauss syndrome, or eosinophilic esophagitis. Subjects with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 will also be excluded.
* Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening. Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded.
* Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus [HIV]), other than that explained by the use of corticosteroids taken as therapy for asthma.
* Other concurrent medical conditions: Subjects who have known, pre-existing, clinically significant cardiovascular, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
* Liver disease: Known, pre-existing, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* ECG assessment: QT interval corrected for heart rate by either Fridericia's or Bazett's formula (QTc[F] or QTc[B]) >=450 milliseconds (msec) or QTc(F) or QTc(B) >=480 msec for subjects with bundle branch block at Visit 1.
* Xolair: Subjects who have received omalizumab within 130 days of Visit 1.
* Other monoclonal antibodies not including mepolizumab: Subjects who have received any monoclonal antibody to treat inflammatory disease within 5 half-lives of Visit 1.
* Investigational medications: Subjects who have received treatment with an investigational drug, other than mepolizumab within the past 30 days or five terminal phase half-lives of the drug whichever is longer, prior to visit 1 (this also includes investigational formulations of marketed products) or experimental anti-inflammatory drugs (non biologicals) in the past 3 months.
* Chemotherapy: Subjects who have received chemotherapy within 12 months prior to Visit 1.
* Alcohol/substance abuse: A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
* Hypersensitivity: Subjects with hypersensitivity to mepolizumab or to any of the excipients (sodium phosphate, citric acid, sucrose, ethylenediaminetetraacetic acid [EDTA], polysorbate 80).
* Adherence: Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03099096
|
{
"brief_title": "Study of Mepolizumab Autoinjector in Asthmatics",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: Mepolizumab"
],
"location_countries": [
"Sweden",
"United States",
"Germany",
"Canada",
"Russian Federation",
"Australia",
"United Kingdom"
],
"nct_id": "NCT03099096",
"official_title": "An Open-label, Single Arm, Repeat Dose, Multi-centre Study to Evaluate the Use of an Autoinjector for the Subcutaneous Administration of Mepolizumab in Subjects With Severe Eosinophilic Asthma (Study 204959)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-30",
"study_completion_date(actual)": "2017-11-30",
"study_start_date(actual)": "2017-05-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-28",
"last_updated_that_met_qc_criteria": "2017-03-29",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-04",
"first_submitted": "2017-03-29",
"first_submitted_that_met_qc_criteria": "2018-05-31"
}
}
}
|
#Study Description
Brief Summary
Primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out Phase-II, III and IV. It also aimed at to see the level of difference of glucose tolerance and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic to evaluate the potential benefit for treatment of insulin resistance and sensitivity. To see the for prevention of Diabetes Mellitus (DM) and stopping / delaying the onset of DM.
Detailed Description
This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in the study by observing the Helsinki Declaration for clinical trials.
volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2.
On screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into A and B.
Biochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation.
Collected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done. One year followup of participants was conducted.
#Intervention
- DIETARY_SUPPLEMENT : Polyherbal formulation
- Test candidate will be administered per oral before / with meal in two divided doses
|
#Eligibility Criteria:
Inclusion Criteria:
* Age: 18 <= age <= 59
* Impaired Fasting Glucose (100 <= age <= 125mg/dl)
* Impaired Glucose Tolerance (140 <= age <= 199mg/dl) 2h-75gm OGTT
* History of Diabetes in first degree relation with one condition
* At high risk with BMI > 35%
* Early onset diabetic / accidental on screening (glucose >200mg/dl)
Exclusion Criteria:
* on renal dialysis;
* an acute or terminal illness or serious mental illness;
* history of recent coronary event within the last 12 months;
* a recent history of acute medical problem or admission to hospital;
* any other severe medical conditions that need intervention / treatment
* has poor short-term prognosis (expected death in <2 years);
* is planning to travel for longer than 6 weeks during the 6-week intervention period; or
* is with compromised liver / kidney / cardiac function
* older patients of DM taking any form of medication / intervention
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 59 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03884920
|
{
"brief_title": "Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation",
"conditions": [
"Diabetes Mellitus",
"Pre Diabetes"
],
"interventions": [
"Dietary Supplement: Polyherbal formulation"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT03884920",
"official_title": "Impaired Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation of Eastern Medicine",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-05",
"study_completion_date(actual)": "2021-12-30",
"study_start_date(actual)": "2019-03-20"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-22",
"last_updated_that_met_qc_criteria": "2019-03-19",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-21",
"first_submitted": "2019-03-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.
Detailed Description
The purpose of this study is to see what effects CNTO 328 has on relapsed or refractory multiple myeloma. The study drug, CNTO 328, is a chimeric (part mouse) antibody (small protein that is important for fighting infection).CNTO 328 blocks a small protein called Interleukin 6 (IL-6). IL-6 is made naturally by your body, and at normal levels is important for inflammatory response. High levels of IL-6 can help cancer cells grow and interfere with chemotherapy drugs killing cancer cells. Cancer-related sickness such as cachexia (weight loss), bone resorption (weakening of your bones), and depression have been linked to high levels of IL-6. CNTO 328 has been shown to slow down tumor growth or shrink tumors when tested in animals. In other clinical trials, over 100 patients have received CNTO 328. There are studies ongoing in participants with kidney cancer, hematologic malignancies (blood cancers such as multiple myeloma), and prostate cancer, to see if CNTO 328 is safe and to see what effects it has on these types of cancer. At this time, it is unknown what effect CNTO 328 has had on the participants' cancer. Bortezomib is a type of drug known as a 'proteasome inhibitor.' A proteasome is a substance that is found in every cell and it is there to help to break down other substances ('proteins') and has a role in the way cells divide. If the proteasome is inhibited, it cannot perform its function in the cell, and if a cell cannot divide it dies. Over 8000 patients with multiple myeloma and other types of cancer have been treated with bortezomib. Bortezomib has been extensively studied in patients with previously treated multiple myeloma. Based on its established activity in pretreated multiple myeloma, bortezomib is registered in the United States and in Europe for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Bortezomib is currently also being studied in several other cancer types.This study consists of two parts. The purpose of Part 1 is to determine the safety of CNTO 328 and bortezomib when given together as a treatment. The purpose of Part 2 is to compare the safety and effects (good and bad) of the combination of CNTO 328 and bortezomib to the safety and effects of bortezomib alone. About 20 patients will take part in the first part of the study. About 270 patients will take part in the second part of the study at approximately 70 sites in the US, Canada, and Europe. Patients will be in the study for about 12 months, with a follow-up period of around 9 months. The study is divided into four different phases: Screening phase-which lasts up to 4 weeks. During this phase the study doctor will perform tests to see if the patient can participate in the study.Treatment phase-which may last up to 4 cycles of 42 days each during which the patient will be treated with CNTO 328 and bortezomib. Maintenance phase-If the patient benefits from the therapy in the treatment phase, the patient will continue to receive CNTO 328 and bortezomib, but now in cycles of 35 days each. Follow up phase, this includes an end of treatment visit 4 weeks after the patient's last infusion and follow up visits every three months until the patient starts a new anti-cancer treatment. CNTO 328 6mg/kg ( 6 milligrams per kilogram of body weight) will be given intravenously (into the vein) over 2 hours once every 2 weeks. Patients who respond with stable disease or better may receive additional doses. Bortezomib will be given IV (into the vein) at 1.3 mg/m2 over 3-5 seconds twice a week for 2 weeks followed by 1 week of rest.
#Intervention
- BIOLOGICAL : Siltuximab
- Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during cycle 1 in Part 1. Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during 42-day Treatment Phase and 35-day Maintenance Phase in Part 2.
- Other Names :
- CNTO 328
- DRUG : Bortezomib
- Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus once every 2 weeks during cycle 1 in Part 1. Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10-day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period during 42-day treatment phase in Part 2. Bortezomib 1.3 mg/m2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) during 35-day Maintenance Phase in Part 2.
- Other Names :
- VELCADE
- DRUG : Placebo
- Matching placebo will be administered as intravenous infusion once every 2 weeks during 42-day treatment phase and 35-day maintenance phase in Part 2.
- DRUG : Dexamethasone
- Dexamethasone tablet will be administered in this study at the first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles in treatment phase and maintenance phase of Part 2.
|
#Eligibility Criteria:
Inclusion Criteria:
* Measurable secretory disease defined as either serum monoclonal paraprotein, (M-protein) greater than or equal to (>=)1 gram per deciliter (g/dL) or urine monoclonal (light chain) protein (> 200 mg/24 hours)
* Documented disease progression after at least 1 prior line of therapy but no more than 3 or have had no response to previous treatment (primary refractory disease)
* ECOG performance status score of less than or equal to (<=) 2
* Adequate bone marrow, liver, and renal function
Exclusion Criteria:
* No prior treatment with bortezomib
* Not Refractory to high-dose dexamethasone
* Not >= Grade 2 peripheral neuropathy
* Have not received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
* No prior or concomitant malignancy (other than multiple myeloma) except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for <= 3 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00401843
|
{
"brief_title": "A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma",
"conditions": [
"Multiple Myeloma"
],
"interventions": [
"Biological: Siltuximab",
"Drug: Placebo",
"Drug: Dexamethasone",
"Drug: Bortezomib"
],
"location_countries": [
"France",
"Slovakia",
"Netherlands",
"United States",
"Poland",
"Germany",
"Portugal",
"United Kingdom",
"Romania",
"Canada",
"Russian Federation",
"Spain",
"Bulgaria",
"Brazil",
"Hungary",
"Belgium",
"Czechia",
"Greece"
],
"nct_id": "NCT00401843",
"official_title": "A Phase 2, Randomized, Double-blind, Placebo-controlled Study Comparing the Combination of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and Velcade Versus Velcade Alone in Subjects With Relapsed or Refractory Multiple Myeloma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-08-16",
"study_completion_date(actual)": "2019-09-24",
"study_start_date(actual)": "2006-11-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-19",
"last_updated_that_met_qc_criteria": "2006-11-17",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-11-22",
"first_submitted": "2006-11-17",
"first_submitted_that_met_qc_criteria": "2015-07-07"
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to elucidate if CYP-phenotypes, variations in CYP-genotypes and dose of chlordiazepoxide is correlated to chlordiazepoxide plasma concentrations in patients admitted to Intensive Care or High Dependency Units due to either respiratory insufficiency and/or agitation while treated for alcohol withdrawal symptoms.
Detailed Description
Pharmacological treatment caries a risk of overdosing and adverse events. Chlordiazepoxide, among other sedative drugs, has been associated with an increased risk of death. Chlordiazepoxide treatment for alcohol withdrawal symptoms will render some patients in need of ventilatory support and ICU admission. Other patients will not obtain the desired effect from the treatment and will be in a state of agitation despite having received high doses of chlordiazepoxide. This individual variation in effect is not predictable and may be explained by variations in the capacity of drug metabolism.
Chlordiazepoxide is extensively metabolized in the liver by hepatic microsomal enzymes and exhibits capacity limited, protein binding sensitive, hepatic clearance. Metabolism is primarily by cytochrome P450 (CYP), especially CYP3A4 and CYP2C19 systems. Evaluation of CYP phenotypes by drug probe phenotyping is extensively used. Midazolam possesses several characteristics that makes it useable as a pharmacological probe for CYP3A activity despite having already received other benzodiazepines. It is metabolized to a primary metabolite exclusively by CYP3A4/3A5.Omeprazole can likewise be used as a pharmacological probe for CYP2C19.
The drug of investigation is chlordiazepoxide, which has been given before study inclusion. After inclusion and during the study period (12 hours), it is not allowed to administer chlordiazepoxide to the patient. In case of abstinence, the recommended therapy is diazepam or propofol.
Blood samples will be collected and plasma concentrations of chlordiazepoxide and metabolites will be analyzed and compared with the amount of chlordiazepoxide administered at inclusion and 12 hours after inclusion.
Independent variables:
* Variations in genotypes of CYP3A4/3A5 and CYP2C19.
* Phenotypes of CYP3A4/3A5 and CYP2C19, analyzed as above /below the median value of enzyme activity.
Variations in genotypes of CYP3A4/3A5 and CYP2C19 will be analyzed from blood samples.
Phenotyping of CYP3A4/3A5 and CYP2C19 will be performed with midazolam and omeprazole as pharmacological probes respectively. 2 mg of midazolam and 10 mg of omeprazole will be administered intravenously as bolus within 12 hours after inclusion. Blood samples 2 h after dosing (t=2 h dosing) will be collected and analyzed for plasma concentrations of omeprazole, hydroxyomeprazole, midazolam and 1-hydroxymidazolam. The ratio between omeprazole and hydroxyomeprazole will be used to classify the CYP2C19 phenotype as the ratio between midazolam and 1-hydroxymidazolam will be used in the classification of CYP3A4/3A5
By measuring concentration of chlordiazepoxide and the ability to metabolize chlordiazepoxide in ICU- or HDU-patients with respiratory insufficiency, impaired consciousness or agitation after treatment for alcohol withdrawal symptoms, we will investigate if there is a correlation between the patient's phenotypes of the CYP3A4/3A5 and CYP2C19 systems (independent variable) and the concentration of chlordiazepoxide (primary outcome).
#Intervention
- DIAGNOSTIC_TEST : Blood samples
- p-chlordiazepoxide and metabolites, p-omeprazole and metabolites, p-midazolam and metabolites, CYP3A4 and CYP2C19 genotyping
- Other Names :
- Midazolam and omeprazole as pharmacological probes
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >=18 years
* Treatment with minimum 200 mg chlordiazepoxide for alcohol withdrawal symptoms during hospital admission
* Acute admittance to ICU or HDU due to respiratory insufficiency, impaired consciousness or agitation.
* Inclusion possible within 12 h of ICU/HDU admission.
Exclusion Criteria:
* Allergies to omeprazole/esomeprazole and midazolam
* Treatment with chlordiazepoxide within the first 12 h after inclusion (from blood samples at inclusion until blood samples 12 h after inclusion)
* Treatment with omeprazole/esomeprazole within 1 day prior to ICU/HDU admission and within the first 12 h after inclusion.
* Treatment with midazolam within 1 day prior to ICU/HDU admission
* Cardiac arrest prior to admission
* Pregnancy (a negative hcg (from urine or blood sample) has to be present before inclusion of women aged <50 years)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05563350
|
{
"brief_title": "Metabolism of Chlordiazepoxide in the Treatment of Alcohol Withdrawal Symptoms",
"conditions": [
"Alcohol Withdrawal"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT05563350",
"official_title": "Association Between Variations in CYP Pheno- and Genotypes and Plasma Concentration of Chlordiazepoxide in the Treatment of Alcohol Withdrawal Symptoms",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-11",
"study_completion_date(actual)": "2023-07-01",
"study_start_date(actual)": "2022-01-29"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-07",
"last_updated_that_met_qc_criteria": "2022-09-28",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-03",
"first_submitted": "2022-09-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.
Detailed Description
The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The EBV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.
The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.
It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.
Based on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve System was approved by the FDA for the treatment of severe emphysema in June 2018. Following this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5 years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under the auspices of the 'LIBERATE Extension Study'. This is an administrative change with absolutely no change to the design or conduct of the study and, therefore has no material impact to the study participants or the study sites. All annual follow-up visits and evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the LIBERATE Extension Study.
#Intervention
- DEVICE : EBV
- This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
- OTHER : Optimal Medical Management
- This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical and radiological evidence of emphysema
* Nonsmoking for 4 months prior to screening interview
* BMI less than 35 kg/m2
* Stable on current medication regimen
* Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
* Residual Volume less than 175% predicted (determined by body plethysmography)
* Little or no collateral ventilation (CV-) as determined using the Chartis System
Exclusion Criteria:
* Had two or more hospitalizations over the last year for a COPD exacerbation
* Had two or more hospitalizations over the last year for pneumonia
* Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
* Had a heart attack or congestive heart failure within the last 6 months
* Have heart arrhythmia
* Is alpha-1 antitrypsin deficient
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01796392
|
{
"brief_title": "Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)",
"conditions": [
"Emphysema"
],
"interventions": [
"Device: EBV",
"Other: Optimal Medical Management"
],
"location_countries": [
"Brazil",
"United Kingdom",
"Netherlands",
"United States"
],
"nct_id": "NCT01796392",
"official_title": "Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09",
"study_completion_date(actual)": "2023-04",
"study_start_date(actual)": "2013-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-15",
"last_updated_that_met_qc_criteria": "2013-02-20",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-21",
"first_submitted": "2013-02-20",
"first_submitted_that_met_qc_criteria": "2019-02-08"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.
Detailed Description
Phase 1 clinical trial
#Intervention
- DRUG : PF-04427429
- Single 0.2mg dose of intravenous infusion
- DRUG : PF-04427429
- Single 1mg dose of intravenous infusion
- DRUG : PF-04427429
- Single 3 mg dose of intravenous infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects between the ages of 18 and 50 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Willing and able to comply with the requirement for using the recommended highly effective contraceptive methods throughout the study.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* History of febrile illness within 5 days prior to the first dose.
* A positive urine drug screen
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01011296
|
{
"brief_title": "First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: PF-04427429"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01011296",
"official_title": "A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group, First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-05",
"study_completion_date(actual)": "2010-05",
"study_start_date(actual)": "2009-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-04",
"last_updated_that_met_qc_criteria": "2009-11-10",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-11",
"first_submitted": "2009-11-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To study whether oxygen therapy titrated to maintain oxygenation (SpO2) \> 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.
Detailed Description
Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.
#Intervention
- OTHER : Oxygen Therapy
- Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent as documented by signature
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance >=3 wood units, pulmonary arterial wedge pressure <=15 mmHg during baseline measures at the diagnostic right-heart catheterization
Exclusion Criteria:
* resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude >1000 m for >=3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05112172
|
{
"brief_title": "Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m",
"conditions": [
"High Altitude Pulmonary Hypertension",
"Oxygen Therapy"
],
"interventions": [
"Other: Oxygen Therapy"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT05112172",
"official_title": "The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-15",
"study_completion_date(actual)": "2022-04-15",
"study_start_date(actual)": "2021-10-18"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-11",
"last_updated_that_met_qc_criteria": "2021-10-27",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-08",
"first_submitted": "2021-10-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare the infection rate in patients receiving/not receiving their own blood, collected during surgery, during and after orthopedic surgery.
The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative infection.
Detailed Description
Postoperative infections (both systemic and wound infections) are complications that should be avoided both due to the discomfort and the risk to the patients and for the corresponding increment of hospital costs.
There are some studies indicating that transfusion of autologous salvaged blood may reduce postoperative infections. This may be due to immunostimulating cytokines released in these products. However, as these cytokines also may cause adverse events as febrile transfusion reactions and activation of the complement and the coagulation cascades, the overall impact may be different.
There are two publications from an Austrian group indicating that allogeneic blood transfusion in orthopedic patients cause increased postoperative infection rate irrespectively of the leukocyte content of the red cell concentrates.
The Austrian studies were not randomized. Therefore, it would be useful to perform a randomized, prospective study where the patients receive transfusion of salvaged blood versus allogeneic red cell concentrate as their primary replacement product, respectively.
The purpose of the pilot study is to evaluate if transfusion of autologous salvaged blood reduces the infection rate in orthopedic patients compared with patients receiving allogeneic blood transfusion. The study is limited to one source of autologous blood; blood collected by the Sangvia Blood Collection System, and the study is partially sponsored by the manufacturer.
#Intervention
- PROCEDURE : Autologous blood transfusion
- Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.
- PROCEDURE : Allogeneic blood transfusion
- Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a risk of needing red cell transfusion after surgery estimated to be above 75%, judged by preoperative hemoglobin concentration and known risk of preoperative bleeding
* Patients > 16 years
* Patients who have consented to participate
Exclusion Criteria:
* Patients with a known hemolytic anemia (congenital or acquired)
* Patients for whom informed consent has not been obtained
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01725724
|
{
"brief_title": "Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients",
"conditions": [
"Coxarthrosis"
],
"interventions": [
"Procedure: Autologous blood transfusion",
"Procedure: Allogeneic blood transfusion"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT01725724",
"official_title": "Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2012-12",
"study_start_date(actual)": "2009-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-30",
"last_updated_that_met_qc_criteria": "2012-11-08",
"last_verified": "2013-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-11-14",
"first_submitted": "2012-04-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Appropriate pain and anxiety management of critically-ill patients during bedside procedures remains a big challenge. Clinical Practice Guidelines recommend preemptive analgesia or non-pharmacological interventions, such as relaxation techniques or distraction, to prevent and treat pain during nursing procedures. One of the most painful procedures in the Intensive Care Unit (ICU) is the removal of chest drains in post-cardiac surgical patients.
Virtual reality (VR) is a computer-generated simulation of a 360º immersive world in which the patient can receive visual and auditory stimuli that distract them from the real environment. Current research has demonstrated that VR reduced pain and anxiety in intravenous catheter insertions or wound care.
The primary objective of the study is to evaluate the effectiveness of VR on pain and anxiety during the removal of chest drains, in post-cardiac surgical patients. The hypothesis is that VR reduces both pain and anxiety, in critically-ill patients, during the removal of chest drains in post-cardiac surgical patients.
Detailed Description
This is a prospective, randomized, open-label, prospective study of two parallel groups of patients during the removal of chest drains:
Group 1: removal of chest drains according to the usual management protocol.
Group 2: removal of chest drains according to the usual management protocol supplemented by the use of virtual reality glasses (VR glasses)
#Intervention
- DEVICE : VR glasses
- Patients will watch a virtual world in VR glasses during the painful procedure. They will be able to choose between 3 VR content based on their preferences.
- OTHER : Control group
- Patients will not receive distraction during chest drain removal
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >= 18 years
* Patients with Richmond Agitation-Sedation Scale (RASS) between -1 to RASS +1
* Patients undergoing cardiac surgery
* Patients with chest drains
* Patients who voluntarily agree to participate (informed consent form)
Exclusion Criteria:
* Patients with a language barrier
* Patients with cognitive impairments
* Patients with neuromuscular blockers
* Patients with a previous history of documented anxiety
* Patients with epilepsy
* Hemodynamically unstable patients
* Face or ocular infections, with could contaminate VR glasses
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05332119
|
{
"brief_title": "Virtual Reality During the Removal of Chest Drains in Critically-ill Patients",
"conditions": [
"Pain",
"Anxiety"
],
"interventions": [
"Device: VR glasses",
"Other: Control group"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT05332119",
"official_title": "Effectiveness of Virtual Reality on Pain and Anxiety During the Removal of Chest Drains in Critically-ill Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-15",
"study_completion_date(actual)": "2023-03-15",
"study_start_date(actual)": "2021-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-28",
"last_updated_that_met_qc_criteria": "2022-04-12",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-18",
"first_submitted": "2022-04-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1 beta pathways will be associated with preserved insulin secretory capacity.
Detailed Description
Type 1 diabetes mellitus (T1D) is caused by autoimmune and autoinflammatory destruction of the insulin-producing beta cells in the pancreatic islets of Langerhans. Historically, treatment for this condition has consisted of insulin replacement therapy and dietary modification. Recent studies have demonstrated the potential benefits of immunomodulatory therapy in patients with newly diagnosed T1D to prevent further immune-mediated damage. Thus far, there has been a paucity of completed research using agents that target pro-inflammatory cytokines dysregulated in T1D.
IL1B, the gene encoding the proinflammatory cytokine interleukin-1β (IL-1β) is significantly overexpressed in peripheral blood mononuclear cells (PBMC) in patients with newly diagnosed T1D compared to healthy controls. There is ample precedent to support the involvement of IL-1β in the pathogenesis of diabetes. In particular, incubation of human or animal islets or insulinoma cell lines with IL-1β inhibits insulin secretion and leads to apoptosis of beta cells.
Additionally, the IL-1 receptor antagonist protein, anakinra, improves glycemic control and insulin secretory capacity in patients with type 2 diabetes.However, no data have been published regarding efficacy of agents targeting IL-1β in modifying the course of the disease in patients with T1D. Anti-Interleukin-1 in Diabetes Action (AIDA) is a randomized, placebo controlled clinical trial of anakinra in 160 adults with newly diagnosed type 1 diabetes. This trial is currently recruiting subjects. Review of clinicaltrials.gov demonstrates two other planned trials of IL-1 agents in newly diagnosed T1D, one using canakinumab, a monoclonal antibody directed at IL-1β, and another using rilonacept, a cytokine trap targeting IL-1β. To assess the effectiveness of these drugs in future studies and in clinical practice, it will be valuable to identify biomarkers that allow us to monitor their therapeutic effects. However, to the best of our knowledge, the pattern of changes in gene expression induced by IL-1β in normal PBMC has not been systematically studied, making it difficult to identify candidate biomarkers for validation studies.
In this exploratory study, we aimed to determine which of the characteristic changes in gene expression from patients with newly diagnosed T1D are IL-1β-mediated, using both in vitro and in vivo approaches. We also determined the effect size of a short course of anakinra therapy on glycemic control, insulin dosing, and C-peptide area under the curve during mixed-meal tolerance testing (MMTT). Finally, we evaluated the tolerability of anakinra in children and adolescents with newly diagnosed T1D.
Methods In vitro studies To determine the effects of IL-1β on gene expression in peripheral blood mononuclear cells (PBMC), blood samples were collected from 7 healthy adult volunteers under an IRB-approved protocol.
Isolating serum. Blood was collected in EDTA tubes (BD, Franklin Lakes, NJ) and centrifuged at 2500 rpm for 15 minutes. The plasma layer was treated with topical thrombin (5000 U/ml, King Pharmaceuticals, Bristol, TN) equaling 5% total volume and incubated at 38° for 20 minutes. The resulting clot was removed from the serum and discarded.
Cell culture. PBMC were isolated from the cellular fraction by centrifugation using Lymphocyte Separation Medium (Mediatech, Manassas, VA) and washed with PBS (Mediatech, Manassas, VA). Cells were plated at 3 x 106 per well in 6 well plates in RPMI 1640 (Mediatech) supplemented with 10% fetal bovine serum (Atlanta Biologicals, Lawrenceville, GA), 10% autologous human serum, 5.5 mM glucose, 100 U penicillin, 100 µg/ml streptomycin, 50 µmol/l 2-mercaptoethanol and 5% HEPES. IL-1β (15 ng/ml final concentration, Abcam, Cambridge, MA), or 9.3 µg/ml S100b (Sigma, St. Louis, MO) were added to some wells, All experimental conditions were plated in triplicate. Cells were collected after 24 hours of incubation at 37°C in a 5% CO2 atmosphere.
Validation by RT-PCR. Total RNA was isolated using RNA-Stat 60 (Tel-Test, Friendswood, TX). The High Capacity cDNA Reverse Transcription Kit (Applied Biosystems, Carlsbad, CA) was used with 750 ng RNA to create cDNA. Real time PCR was performed on the Roche LightCycler 480 system using 5 ul of the cDNA sample, the Roche LightCycler Probes Master kit and human IL1B primers (Applied Biosystems). RNA was quantitated by delta Ct values using GADPH as the internal control (Applied Biosystems).
Microarray analysis. Triplicate samples for each experimental condition were pooled for further analysis. From 2-5 µg of total RNA, double-stranded cDNA containing the T7-dT(24) promoter sequence were generated using GeneChip® One-Cycle cDNA Synthesis Kits (Invitrogen, Santa Clara, CA). Synthesis of cRNA used 200ng of cDNA for in vitro transcription, amplification and labeling steps according to the manufacturer's instructions using the Illumina RNA amplification kit (Ambion Inc, Austin, TX). 1.5 µg of amplified biotin-labeled cRNA was subsequently hybridized to Illumina Human HT-12 v3.0 Beadchip microarrays according to standard protocols. at the Baylor Institute for Immunology Research, Dallas, TX.
Slides were scanned on an Illumina Beadstation 500 and data processed with Beadstudio software. For each chip, raw intensity data were normalized to the mean intensity of all measurements on that chip. Data were imported into Genespring GX11 (Agilent) for further analysis. Probe sets were selected if 'Present' or 'Marginal' in at least 50% of samples in any group. Principal component analysis was performed to detect outliers. Class comparisons were performed using t-tests after log transformation with the Type 1 error rate controlled using Benjamini-Hochberg false discovery rates (FDR).
In vivo studies Subjects. The study was approved by the Institutional Review Board of the University of Texas Southwestern Medical Center. Written informed consent was obtained from parents or legal guardians, and assent for participation was obtained from subjects aged 10 years and older. Patients at Children's Medical Center Dallas between ages 6 and 18 years with Type 1 diabetes within one week of diagnosis were eligible. Exclusion criteria included treatment with systemic or inhaled corticosteroids or any other immunomodulatory drug, active infection, history of mycobacterial disease, pregnancy or lactation, use of a live vaccine within 90 days of study enrollment, and severe comorbidities (such as chronic kidney disease, heart failure, or uncontrolled hypertension). Patients were excluded if it was unclear whether they had Type 1 or Type 2 diabetes.
Data collected from the medical charts included age, gender, race/ethnicity, weight, height, hemoglobin A1c (HbA1c) and beta-hydroxybutyrate at diagnosis. A blood sample was obtained at study entry; a portion was analyzed for screening labs including alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), creatinine, complete blood count (CBC) with differential, and serum pregnancy test for all menstruating females and any female over age 10 years. Additionally, 20 mL was processed for microarray analysis.
Diabetes care At diagnosis, all subjects were placed on a basal-bolus insulin regimen with glargine and either lispro or aspart. For the duration of the study, insulin doses were adjusted per standard clinic protocol with target glucose of 80-140 mg/dL fasting and 80-180 mg/dL before meals. At each study visit, we recorded the subject's current insulin doses and weight to allow calculation of the total daily dose (units/kg/day).
Anakinra After study enrollment, all subjects started anakinra (Kineret; Amgen, Thousand Oaks, CA) as a subcutaneous daily injection. Subjects weighing more than 25 kg at the time of enrollment received 100 mg daily whereas those weighing 25 kg or less received 50 mg daily. Anakinra was continued for a total of 28 days with no dose adjustment.
Diabetes autoantibodies Per standard protocol, all patients were tested for antibodies to insulin, protein tyrosine phosphatase receptor type N (insulinoma-associated antigen (IA-2)), and glutamic acid decarboxylase (ARUP Laboratories, Salt Lake City, UT). The results of these studies were typically not available at the time of study enrollment and therefore were not used as criteria for study entry. However, we excluded patients with negative results for all three antibodies from further analysis.
Surveillance laboratory tests Upon completion of anakinra therapy (4-5 weeks after diagnosis), a blood sample was collected and sent for ALT, AST, BUN, creatinine, and CBC with differential. Per standard protocol, all subjects had point-of-care hemoglobin A1c (DCA Vantage Analyzer, Siemens Healthcare Diagnostics, Deerfield, IL) and capillary glucose tested at clinic visits 4-5 weeks after diagnosis, 4 months after diagnosis, and 7 months after diagnosis.
Adverse event monitoring During the 28 days of anakinra therapy, study personnel called subjects weekly to document frequency of hypoglycemia and presence of rash, injection site reactions (swelling, erythema, and pain at the site of anakinra administration), headaches, fevers, and any other adverse events. After the completion of anakinra therapy, patients were assessed for adverse events at each subsequent study visit.
Mixed meal tolerance tests (MMTTs) MMTTs were conducted at the University of Texas Southwestern Medical Center Clinical Translational Research Center (CTRC). Subjects underwent MMTTs essentially as described (8) at 3-4 weeks after diagnosis and again at 7 months after diagnosis. C-peptide analyses were performed in the laboratory of Dr. Philip Raskin (UT Southwestern Medical Center, Dallas, TX).
Microarray blood sample processing Microarray blood samples were collected in EDTA tubes (BD Vacutainer) at study enrollment, 3-4 weeks after diagnosis, and upon completion of anakinra therapy. PBMC were isolated and stored at -80°C within 4 hours of the blood draw. Cells were lysed in RLT lysis buffer containing β-mercaptoethanol (Qiagen, Valencia, CA). Total RNA was extracted using the RNeasy® Mini Kit according to the manufacturer-recommended protocol (Qiagen, Valencia, CA) and analyzed as described above.
Control groups Because subjects in the anakinra study were not randomized, we used two different pre-existing control groups. Subjects in control group A were previously enrolled at our institution under a separate, IRB-approved protocol in a randomized, controlled trial examining the effect of the initial choice of longer-acting insulin on the rate of loss of beta cell function. Subjects were enrolled during their hospitalization for diabetes diagnosis and randomized to receive either NPH or basal insulin (glargine or detemir). Diabetes care and routine clinic visits, schedule and procedures for mixed meal tolerance testing and microarray analysis were the same as for our anakinra-treated subjects.. Control group A includes all patients in that study randomized to receive basal insulin, except those with negative autoantibody results.
Subjects in control group B were identified in a chart review of all new diabetes diagnoses from April 2008 through November 2009 in patients aged 9-18 years (to match date range of recruitment and age of anakinra-treated subjects). Subjects were included in this control group if they had at least one positive autoantibody and were not enrolled in the anakinra study. We collected age, gender, race/ethnicity, weight, height, and beta-hydroxybutyrate at diagnosis. We also collected HbA1c and total daily insulin dose (expressed as units/kg/day) at diagnosis and for clinic visits at 1 month, 4 months, and 7 months after diagnosis.
A subset of 10 of these subjects consented to enroll in an IRB-approved study in which blood was drawn for microarray analysis at diagnosis and again 1 month after diagnosis. Microarray procedures were the same as described above for the anakinra-treated subjects.
Statistical analysis Descriptive statistics were compiled and all comparative analyses performed using SAS version 9.2 (Cary, NC). C-peptide area under the curve (AUC) was calculated for each MMTT using the trapezoidal method.. Insulin-dose adjusted A1c (IDAA1c) was calculated as outlined by Mortensen, et. al. (9), IDAA1c = hemoglobin A1C (percent) + \[4 × insulin dose (units per kilogram per 24 h)\]. Hemoglobin A1c and IDAA1c between groups were compared using Wilcoxon rank-sum tests. Since total daily insulin dose was normally distributed, between groups comparisons were performed by standard t-test.
#Intervention
- DRUG : Anakinra
- Patients will receive daily anakinra therapy for 28 days
- Other Names :
- Kineret
|
#Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed type 1 diabetes (by ADA criteria) within 1 week of diagnosis.
* Age 6 <= age <= 18 years.
* Males and females will be recruited.
* Subjects and families must be English and/or Spanish-speaking.
Exclusion Criteria:
* Patients with other autoimmune conditions or any other condition (including asthma) necessitating treatment with systemic or inhaled corticosteroids or chronic NSAIDs. Patients cannot have received such therapy in the three months prior to enrollment. Hashimoto's thyroiditis is not an exclusion criterion.
* Patients with active bacterial infections must be cured prior to entry into the study protocol.
* Serum creatinine > 1.5 mg/dL or greater than 1.5x the upper limit of normal for age
* Serum ALT or AST > 3 times the upper limit of normal for the lab
* Platelet count < 100,000/mm3
* WBC count < 3,000 cells/mm3
* Hemoglobin, Hematocrit or Red blood cell count outside 30% of the upper or lower limits of normal for the lab
* Any medication that, in the opinion of the investigator, is being administered for immunomodulatory purposes, including but not limited to systemic or inhaled corticosteroids and chronic NSAIDs
* Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit
* Treatment in the past with anakinra
* Patients with known hypersensitivity to E. coli-derived proteins, anakinra, or any components of anakinra.
* Must not have received immunosuppressive agents (including systemic or inhaled corticosteroids and scheduled/chronic NSAIDs) for at least three months prior to enrollment
* Known HIV-positive status or known history of any other immunodeficiency state.
* Any mycobacterial disease
* Active severe infections within 4 weeks before screening visit, or between the screening and baseline visits.
* Severe comorbidities (congestive heart failure of any severity, myocardial infarction, cerebrovascular accident or transient ischemic attack within 3 months of screening visit, unstable angina pectoris, uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer])
* History of tuberculosis or tuberculosis exposure, chronic hepatitis B or hepatitis C, or systemic lupus erythematosus.
* Pregnant or lactating females
* Use of a live vaccine 90 days prior to, or during this study
* Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient
* History of non-compliance with other therapies
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00645840
|
{
"brief_title": "Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes",
"conditions": [
"Type 1 Diabetes Mellitus"
],
"interventions": [
"Drug: Anakinra"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00645840",
"official_title": "An Exploratory, Open Label Study of Anti-inflammatory Therapy With Anakinra in Children With Newly Diagnosed Type 1 Diabetes Mellitus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-09",
"study_completion_date(actual)": "2009-09",
"study_start_date(actual)": "2008-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-14",
"last_updated_that_met_qc_criteria": "2008-03-27",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-28",
"first_submitted": "2008-03-25",
"first_submitted_that_met_qc_criteria": "2019-10-24"
}
}
}
|
#Study Description
Brief Summary
This is a Phase I, randomized, double blind, IV, single dose, 4-arm parallel study to compare the PK, and to evaluate the safety, tolerability and immunogenicity of HLX04, US Avastin®, EU Avastin®, and CN Avastin® in healthy male subjects.
Detailed Description
A total of 188 evaluable male subjects are required. Taking into account a dropout rate of approximately 10%, a total of 208 healthy male subjects who meet the required entry criteria will be randomly assigned to one of four treatment groups in a 1:1:1:1 ratio to receive a single IV infusion of HLX04, EU Avastin® or US Avastin®. The first 8 subjects (with at least 2 subjects receiving HLX04) will be dosed as a maximum of 1 subject per day. Prior to administration of study drug to the next subject, the safety findings of the preceding subject must be reviewed by the Principal Investigator. Each subject will be required to remain in the study center for 96 hours after dosing (overnight) for safety evaluation. After the first 8 subjects are evaluated and the experimental drug deemed safe, the Principal Investigator will decide the continuous enrollment in the four parallels according to the Phase I clinical trial unit capability.
The duration of participation for each subject is expected to be approximately120 days starting with a 21 day screening period, followed by administration of study drug and a 99 day follow up period.
After the follow up visit on Day 99, subjects who are confirmed positive for anti drug antibody (ADA) will be followed for 12 months after study drug administration or until 2 consecutive samples are tested negative for ADA.
The start of study is considered the date of the first subject providing informed consent and the end of study will be the last subject's last scheduled visit (Day 99 or early termination). Additional follow up visits for subjects who are positive for ADAs or have ongoing/resolving adverse events (AEs) will be conducted and recorded separately.
Subjects who meet all eligibility criteria and have signed the informed consent form (ICF) will be admitted to the Phase I clinical trial unit the day prior to dosing (Day 1) and will be discharged 96 hours postdose on Day 5. Then after, subjects will be followed up and continue participation in the study on an outpatient basis for further safety assessments, for blood sampling for PK and to test for ADA and neutralizing ADA (NADA) at selected visits.
#Intervention
- DRUG : HLX04
- HLX04: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
- DRUG : US-Avastin®
- US Avastin®: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
- DRUG : EU-Avastin®
- EU-Avastin®: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
- DRUG : CN-Avastin®
- CN-Avastin®: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who are willing to comply with the contraception restrictions for this study (see Section 4.3.3).
* Subjects who are able and willing to give written informed consent.
* Subjects who are willing to comply with the study restrictions from screening until end of study.
* Adult males aged 18 <= age <= 50 inclusive and between 19 and 26 kg/m2 body mass index and body weight >= 50 kg and <= 80 kg.
* Subjects who are non smokers or have not used tobacco or nicotine containing products for at least 3 months preceding screening and have less than 5 cigarettes per day smoking history. Subjects must agree to refrain from smoking during days of confinement at the study center.
* Subjects negative for Hepatitis B surface antigen, Hepatitis C virus antibody, Treponema pallidum antibody, and human immunodeficiency virus antibody tests.
* Subjects negative for urine drug screen and alcohol tests.
* Subjects determined healthy by medical history, physical examination, laboratory tests, 12 lead electrocardiogram (ECG), and chest X ray, without any clinically significant abnormality judged by the Investigator.
Exclusion Criteria:
* History of gastrointestinal, endocrine, pulmonary, hepatic, renal, psychiatric, neurological, cardiovascular, hematological, and metabolic (including known diabetes mellitus) disease or disorder considered as significant by the Investigator.
* History of any cancer, lymphoma, or leukemia, except basal cell carcinoma of skin after localized cancer is removed.
* History or current clinically significant atopic allergy, hypersensitivity or allergic reactions including known or suspected clinically relevant drug hypersensitivity to any component of the study drug formulations or comparable drugs.
* Any disorder that, in the Investigator's opinion, may interfere with the safety of the subject and the study procedures and evaluations.
* Blood loss or blood donation (including blood components donation) >= 400 mL or blood transfusion within 3 months before screening; blood loss or blood donation (including blood components donation) >= 200 mL within 1 months before screening.
* Surgery within the past 8 weeks or surgery planned during the study duration.
* Poor oral hygiene that may require surgical intervention during the study or any planned dental interventions during the study duration.
* Live virus vaccination within 4 weeks prior to screening or intention to receive live virus vaccination during the study until the final follow up visit.
* History of prior exposure to bevacizumab or any anti VEGF or anti VEGF receptor (VEGFR) monoclonal antibodies or proteins (e.g., aflibercept, ramucirumab, lapatinib, and sunitinib).
* Prior exposure to any other investigational monoclonal antibody within 12 months of study drug administration.
* Use of any investigational drug in any clinical study within the 3 months prior to first dose administration in this study; or remains on follow up of any clinical study.
* Any intake of a non steroidal anti inflammatory drug (NSAID) including any dose of aspirin in the last 14 days. NSAIDs are not allowed for the duration of the study. Paracetamol is allowed for pain control if required.
* Intake of prescribed or over the counter drugs within 28 days of study drug administration or herbal drugs or dietary supplements within 28 days prior to study drug administration.
* Any persons who are:
* An employee of the Principal Investigators, study centers, contract research organization (CRO) or the Sponsor.
* A relative of an employee of the study centers, the Investigators, CRO or the Sponsor.
* Abnormal ECG with clinical significance judged by the Investigator.
* Abnormal serum Immunoglobulin G with clinical significance judged by the Investigator.
* Confirmed positive ADA at screening.
* Occurrence of acute disease during screening or predose, e.g., acute hepatitis, acute diarrhea.
* Intake of any product containing alcohol within 24 hours of study drug administration.
* Subjects with relevant family history of hypertension or abnormal blood pressure at screening or admission to the study center (Day 1):
* Systolic blood pressure > 140 mmHg
* Diastolic blood pressure > 90 mmHg.
* Any inherited predisposition to bleeding or to thrombosis or history of non traumatic hemorrhage (i.e., requiring medical intervention), thromboembolic event or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia (platelet count < 100000/µL) or an international normalized ratio (INR) higher than 1.5.
* Any clinically significant infection ongoing at screening or admission to the Phase I clinical trial unit.
* Total cholesterol > 1.5×upper limit of normal or fasting glucose abnormality with clinical significance at screening or admission.
* History of alcohol abuse or a positive alcohol breath test, history of drug abuse or positive urine drug screen.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03483649
|
{
"brief_title": "Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX04 Versus Avastin® in Healthy Male Subjects",
"conditions": [
"Healthy Male Subjects"
],
"interventions": [
"Drug: HLX04",
"Drug: CN-Avastin®",
"Drug: EU-Avastin®",
"Drug: US-Avastin®"
],
"location_countries": [
"China"
],
"nct_id": "NCT03483649",
"official_title": "Randomized, Double Blind, Intravenous, Single Dose, Parallel, 4-arm Comparative Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX04 Versus US-sourced Avastin®, EU-sourced Avastin®, and CN-sourced Avastin® in Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10-29",
"study_completion_date(actual)": "2017-10-29",
"study_start_date(actual)": "2017-04-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-11",
"last_updated_that_met_qc_criteria": "2018-03-28",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-30",
"first_submitted": "2017-11-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created by different insufflation flows are very limited in the literature. In a current literature review, there was no study found comparing the effects of hemodynamic changes created by low and high insufflation flows and pneumoperitoneum pressure on cerebral oxygenation. The purpose of the study was to contribute to the literature by investigating the effects of pneumoperitoneum pressures created by different flows on brain oxygenation.
Detailed Description
After the approval of the Ethics Committee, a total of 69 (sixty-nine) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients low insufflation flow (10 lt/min) and 35 (thirty-five) patients and high insufflation flow (40 lt/min) with pneumoperitoneum pressure.
The study will be conducted as a single-center observational study in Trabzon KTU Faculty of Medicine General Surgery Operating Room. Anesthesia always be performed by the same anesthesia team, and no intervention will be made regarding the choice of the method. The data obtained will be recorded by the anesthetists other than the team who constitute the study group, and the data obtained at the end of the surgery will be interpreted by the study team. The decision for laparoscopic cholecystectomy of the patients who will be included in the study will be made by the General Surgery doctor, and the patients who are scheduled to be operated on electively will be included in the study.
The patients will be taken to the operating room after their written consents are obtained and preoperative evaluations are made, and routine premedication will be applied to the patients who arrive at the operating room. The patients who will be included in the study will be monitored routinely in the general surgery room (i.e. electrocardiography (ECG), non-invasive blood pressure measurement, peripheral oxygen saturation, Bispectral Index (BIS), and additionally NIRS monitoring. No interference will be made regarding the groups in which patients who will undergo general anesthesia will be in the pneumoperitoneum group formed with low insufflation flow or high insufflation flow, only non-invasive cerebral oxygenation measurements will be made with NIRS monitor (INVOS™ 5100C Cerebral/Somatic Oximeter, SOMANETICS, COVIDIEN, Mansfield/ USA)
#Intervention
- PROCEDURE : pneumoperitoneum insufflation (flow) rate
- Patiens who initiate with low insufflation flow (10 lt/min)
Patiens who initiate with high insufflation flow (40 lt/min)
|
#Eligibility Criteria:
Inclusion Criteria:
* elective laparoscopic cholecystectomy were planned,
* ASA I-III,
* 18 <= age <= 65 years
Exclusion Criteria:
* Cerebrovascular diseases and/or intracranial pathologies and/or related neurological events,
* Uncontrolled diabetes
* Uncontrolled hypertension
* Coagulopathy,
* Cirrhosis and/or peritonitis,
* Asthma and/or respiratory diseases e.g. COPD,
* Morbid obesity,
* Patients with severe organ failure,
* Emergency cases,
* Cases converted to laparotomic cholecystectomy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05992636
|
{
"brief_title": "Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy",
"conditions": [
"Pneumoperitoneum"
],
"interventions": [
"Procedure: pneumoperitoneum insufflation (flow) rate"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05992636",
"official_title": "The Effects of Hemodynamic Changes on Cerebral Oxygenation Caused by Pneumoperitoneum With Different Insufflation Flows in Laparoscopic Cholecystectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-23",
"study_completion_date(actual)": "2022-06-20",
"study_start_date(actual)": "2021-05-19"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-15",
"last_updated_that_met_qc_criteria": "2023-08-07",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-15",
"first_submitted": "2021-11-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Narrative reformulation (NR) is an active ingredient of cognitive analytic therapy (CAT) which is assumed to increase engagement and improve outcomes. This trial sought to test these claims. A randomized and controlled dismantling trial method has been designed to investigate treatments outcomes for depressed patients receiving CAT in an Improving Access to Psychological Therapies service. Participants will be randomized to either treatment as usual (full-CAT) or CAT minus narrative reformulation (CAT-NR). The primary outcome measure is the Patient Health Questionnaire (PHQ-9), with secondary outcome measures of anxiety, functioning, helpfulness and the alliance. Outcomes will be assessed at screening, every treatment session and at 8-weeks follow-up. The trial will enable as assessment of the utility of NR during CAT. and whether CAT appears suitable for treating depression in Primary Care.
Detailed Description
Rationale Despite extensive outcome research validating psychotherapy in general as an effective treatment, the outcome literature has been slower to identify the effective, active ingredients of individual therapies. It has been proposed that different active ingredients within therapy relate to outcomes; and definitive technical features are hypothesised to gain importance as psychopathology increases. Therefore research is necessary which compares components of overall treatments to assess their contribution to outcome.
Cognitive analytic therapy (CAT) is a brief therapy (16 or 24 session intervention) drawing upon components of cognitive, and psychodynamic psychotherapies. CAT proposes the use of specific interventions at identified time points within therapy, such as the reformulation letter after a period of assessment. This narrative account reformulates distress, explicitly linking problematic repetitive behavioural patterns with their developmental origins. The client's current life situation is then described alongside target problems and their underlying maladaptive procedures. The reformulation letter is considered a 'crucial therapeutic task' and 'powerful agent of change', but its ability to act in such a manner is largely assumed as the evidence base for these claims has been poorly researched.
Reformulation Despite numerous claims regarding the benefits of cognitive case formulation, there is a paucity of methodologically sound research. This is magnified when looking specifically at the CAT reformulation process. Existing research focuses on accuracy, and whilst some research does exist regarding the impact of reformulation, these are narrative case studies and cannot be generalised. Research utilising the single case experimental design methodology has identified evidence of sudden gains at the point of reformulation.
Depression The introduction of the Increasing Access to Psychological Therapies (IAPT) initiative has focussed on the use of brief, evidence based therapies for this client group and particularly CBT at step 3 of a stepped care model. However, CAT is increasingly used in primary care settings where a naturalistic evidence base is growing regarding its effectiveness for treating depression. The contract can be shortened where 'the threshold to consultation is low' and patients symptomology suggests mild disturbance. Working with predetermined time limits acts to heighten the therapeutic process whilst protecting against over-dependence; hence time-limited interventions can be as clinically effective as lengthy therapy for most people. Brief CAT interventions may therefore be of use for mild to moderate depression.
Aims
The proposed study aims to:
1. Investigate the impact of reformulation letters with mild-moderately depressed clients in terms of the therapeutic alliance and the helpfulness of therapy
2. Compare the outcomes (symptom amelioration) for depressed clients receiving a reformulation letter as part of therapy and those who don't receive the reformulation letter over time including follow-up.
3. Provide initial practice-based evidence of the effectiveness of 8-session CAT in Primary Care with depressed clients.
Hypotheses
Clients receiving a reformulation letter will:
1. Display enhanced therapeutic alliances in comparison to clients receiving CAT without the letter.
2. Perceive therapy as more helpful in comparison to clients receiving CAT without the letter.
3. Achieve better outcomes (greater symptom amelioration) in comparison to clients receiving CAT without the letter.
Theoretical and Clinical Implications The proposed study will add to the nascent evidence base for CAT, with regard to the impact of the reformulation letter on therapeutic processes, outcome and effectiveness. Comparing the impact of receiving a reformulation letter versus excluding this specific event allows its effects to be isolated. This contributes to theoretical understandings of the active ingredients of CAT, and more particularly the role of this specific tool. In addition this may inform the debate surrounding the role of specific versus non-specific contributions in therapy. Identifying tools that augment treatment effectiveness offers the potential to improve therapeutic outcomes.
Improved understanding of how specific tools augment therapeutic processes and affect outcomes has clinical utility. Producing and negotiating reformulation letters takes valuable therapist, and in-session time. Their use, impact and perceived helpfulness are therefore important to investigate thoroughly. This is perhaps of greater importance in brief therapies, where time is a valuable resource. Furthermore, exploring the potential utility of a brief 8-session CAT for primary care mental health problems provides a test of whether CAT could be further adapted and shortened to match the service demands of Primary Care.
Design Utilising a randomised deconstruction methodology, participants will be randomly allocated into one of two active study arms (e.g. 'reformulation letter CAT' or 'no reformulation letter CAT'). Outcome measures will be matched and taken on a session-by-session basis, prior to, during, and following CAT treatment in both arms to enable the comparison of relative efficacy.
Method Participants Participants will be recruited via Barnsley PCT's 's Improving Access to Psychological Therapies (IAPT) service. They will be working age adults (18-65), referred to primary care mental health services with mild to moderate depression.
The study aims to recruit 24 participants in total.
For supervisory purposes, fidelity to the CAT model will be assessed using:
A measure of CAT competence (CCAT; Bennett \& Parry, 2004). The CCAT measures therapist competence over ten domains related to practice and model characteristics. Validity, reliability and internal consistency have been established as sufficient (Bennett \& Parry, 2004).
Procedure A Consultant Cognitive Behavioural Psychotherapist will identify clients meeting the inclusion criteria for the study. Suitable participants will be provided with an information sheet explaining the research and inviting them to participate. Clients agreeing to participate will be asked to sign a consent form. The consent form clarifies that participants have read the information sheet and had opportunities to ask questions. The voluntary nature of participation, confidentiality, and right to withdraw at any time is stated. Consent will be sought to audiotape therapy sessions for supervision purposes. Once consent to participate has been established the identified clients details will be passed to the research team for randomisation.
Participants will be randomly allocated into one of two arms ('letter' or 'no letter') using the GraphPad (2005) computer randomisation software package. Randomised participants will be offered an 8-session course of CAT. The CAT will be delivered by one of three trainee clinical psychologists in their final year of training, one of which is the researcher. All of the trainees have completed a two-day introductory CAT workshop, in addition to standard clinical psychology training to date. To minimise therapist effects participants in each arm will be equally distributed among the team.
All participants will receive eight sessions of CAT with a follow-up appointment eight weeks post-therapy. Assessment will take place over the initial two sessions followed by reformulation at session three. At the reformulation stage 12 patients ('letter' arm) will receive a reformulation letter and provisional sequential diagrammatic reformulation in line with standard CAT practice. 12 patients ('no letter' arm) will receive the SDR without a reformulation letter at session 3. The remaining intervention and termination procedures will follow standard CAT procedures. Patients in both arms will receive, and be invited to produce, a goodbye letter at termination. All participants will be invited to attend a follow-up session eight weeks post-therapy.
To ensure model adherence all therapy sessions will be taped for supervision purposes and reviewed by the CAT qualified, and supervisor-trained supervisor. A minimum of one full taped session from each therapist will be assessed for model adherence by the supervisor using CCAT. In addition, taped excerpts from sessions will be routinely reviewed in supervision; therapists will be invited to employ CCAT as a self-reflective tool in preparation for this. Issues of non-adherence will be considered a training implication, representative of areas for improvement and addressed via standard supervisory procedures. Non-adherence will not preclude data inclusion for the purposes of this research; rather it will be addressed as a limitation of the study related to therapist experience.
Data Analysis To allow comparisons between the two active study arms the primary outcome variables relevant to each hypothesis will be subject to analysis using ANOVA. Trend analyses will be additionally conducted on session-by-session data to highlight and compare patterns of change within the study arms over time. On the pre-post data assessments of clinical and reliable change in each arm will be calculated and compared using the Reliable Change Index (RCI; Jacobson \& Truax, 1991). Outcome data from the PHQ9 will be used to calculate the reliable change index (RCI; Jacobson \& Truax, 1991). This identifies reliable and clinically significant changes at small (z \> 1.96, p\<.05), medium (z \> 2.58; p\<.01), and large (z \> 3.29, p\<.001) effect sizes. Power analysis suggests sufficient power for a Between x Within Subjects ANOVA, paying particular attention to the Groups x Time-Points interaction effect. Assuming a 'medium' effect size of f = .25, a significance level of alpha = .05, and 2 groups of participants providing data at four time points (pre, reformulation, post, and follow up) the proposed total sample size of 24 gives 80% power. Power analysis also suggests sufficient power to conduct a trend analysis form of ANOVA to investigate patterns of change over time (session-by-session data). Assuming a 'medium' effect size of f = .25, a significance level of alpha = .05, and 2 groups of participants providing data at eight time points (session-by-session data excluding follow up) the proposed sample size of 24 will give 95% power.
Hypotheses
Clients receiving a reformulation letter will:
1. Display enhanced therapeutic alliances in comparison to clients receiving CAT without the letter.
2. Perceive therapy as more helpful in comparison to clients receiving CAT without the letter.
3. Achieve better outcomes (greater symptom amelioration) in comparison to clients receiving CAT without the letter.
#Intervention
- BEHAVIORAL : Cognitive Analytic Therapy (CAT)
- Cognitive Analytic Therapy (CAT) is a relational, integrative and time-limited psychotherapy. This is a study with two active arms. Therefore in the full CAT arm the participants receive the full therapy, but in the CAT-NR arm participants get CAT with the narrative reformulation aspect removed.
|
#Eligibility Criteria:
Inclusion criteria were:
* clinical diagnosis of depression (conducted using DSM-IV criteria)
* participants needed to reach caseness (i.e. score 10 <= age <= 21) on the PHQ-9
Exclusion criteria were:
* a PHQ-9 score <10
* not meeting DSM criteria for depression
* significant risk issues
* co-morbid anxiety disorder
* previous in-patient admission
* significant amount of previous contact with mental health services
* visual impairment
* non-English speaking
* history of overdoses/self-injury
* currently abusing substances
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02961738
|
{
"brief_title": "Is Narrative Reformulation During Cognitive Analytic Therapy Helpful?",
"conditions": [
"Depression"
],
"interventions": [
"Behavioral: Cognitive Analytic Therapy (CAT)"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02961738",
"official_title": "Efficacy of Narrative Reformulation During Cognitive Analytic Therapy: A Randomized Dismantling Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-01",
"study_completion_date(actual)": "2015-01",
"study_start_date(actual)": "2011-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-11",
"last_updated_that_met_qc_criteria": "2016-11-10",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-11",
"first_submitted": "2016-10-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of our study was to investigate whether different methods of dressing could lower catheter-associated bloodstream infections.
Detailed Description
The study method was experimental in design and recruited 331 medical intensive care unit patients with placement of central catheters in one regional hospital in northern Taiwan. The investigators used block randomization to assign patients to the study group or control group. In study group which included 163 participants, the investigators used aseptic coverings during dressing and in the control group which included 168 participants the process of dressing was as routine. Study period started from the first day of catheter insertion and ends with either the removal of catheter or discharge from intensive care unit. The investigators defined the infection outcome according to culture results, and the guidelines by Infectious Diseases Society of America and Centers for Disease Control and Prevention, USA. Analysis was done by SPSS version 23. The investigators used percentage and average to study characteristics of participants. The investigators used Chi-Square or Fisher's exact test and Poisson distribution to analyze the incidence rate of bloodstream infections and the infection density. The investigators used Kaplan-Meier curve to demonstrate the catheter infection-free days and the catheter redness symptoms days of the two groups. The investigators used logistic regression model to analyze factors associated with development of bloodstream infections.
#Intervention
- OTHER : full aseptic dressing
- Replacement of the central venous catheters in the dressing process
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults older than 20 years
* Patients with central venous catheters
* Agree to participate in this study, and fill out the study consent
Exclusion Criteria:
* PICC patients placed
* Patients with bloodstream infection
* Patients with immunocompromised patients (such as HIV, AIDS, pregnant, or cancer patients who are receiving chemotherapy or radiotherapy)
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03692559
|
{
"brief_title": "The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections",
"conditions": [
"Central Line-associated Bloodstream Infection (CLABSI)"
],
"interventions": [
"Other: full aseptic dressing"
],
"location_countries": null,
"nct_id": "NCT03692559",
"official_title": "The Effects of Different Ways of Dressing Central Line Associated Bloodstream Infections",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-02-03",
"study_completion_date(actual)": "2017-02-03",
"study_start_date(actual)": "2015-08-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-10-02",
"last_updated_that_met_qc_criteria": "2018-09-30",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-02",
"first_submitted": "2017-10-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is intended to validate the use of neck auscultation with an electronic stethoscope during intubation to confirm tracheal tube placement.
It is hypothesized that the ability to confirm correct tube placement with this technique will be similar to that of the end-tidal CO2 monitor, the current gold-standard device for confirming tracheal intubation.
Detailed Description
Unrecognized esophageal intubation results in disastrous consequences. Fortunately, a variety of techniques have been cited to confirm placement of the endotracheal tube. However, even end-tidal CO2 monitoring, considered to be the gold standard, has been associated with false positive and false negative results. In addition, use of this monitor requires ventilation through the tube, resulting in gastric distention if the esophagus has been intubated.
When the lateral neck is auscultated during insertion of an endotracheal tube, there is a distinct difference between the sounds generated by a tube placed in the esophagus compared to a tube inserted into the trachea. Stethoscopes are readily available in any OR setting, and ventilation and release of cricoid pressure need not occur prior to confirmation of tube placement. However, this technique has yet to be validated.
A series of sounds heard at the lateral neck during both tracheal and esophageal intubation will be recorded using an electronic stethoscope. These sound files will be played to a group including both experienced and inexperienced intubators, who will be asked to identify which sounds represent tracheal and esophageal intubation. Overall accuracy will be determined for the group of listeners.
#Intervention
- PROCEDURE : Neck Auscultation
|
#Eligibility Criteria:
Inclusion Criteria:
* Elective surgery requiring general anesthesia with endotracheal intubation
Exclusion Criteria:
* Anticipated difficult intubation
* Contraindication to esophageal intubation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00378651
|
{
"brief_title": "Use of the Stethoscope to Confirm Breathing Tube Placement",
"conditions": [
"Intubation, Endotracheal"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT00378651",
"official_title": "Differentiation Between Esophageal and Tracheal Intubation Utilizing Neck Auscultation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-01",
"study_start_date(actual)": "2006-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-12-19",
"last_updated_that_met_qc_criteria": "2006-09-19",
"last_verified": "2007-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-09-20",
"first_submitted": "2006-09-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of visceral leishmaniasis.
#Intervention
- BIOLOGICAL : LEISH-F3 + SLA-SE
- BIOLOGICAL : LEISH-F3 + GLA-SE
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females 18 <= age <= 49 of age.
* Must be in good general health as confirmed by a medical history and physical exam.
* Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study vaccination, must not be breast-feeding, and are required to use one of the following methods of contraception during the first 3 months of the study: hormonal (e.g., oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); abstinence; or bilateral tubal ligation (if no conception post-procedure). These precautions are necessary due to unknown effects that LEISH-F3 + SLA-SE or LEISH-F3 + GLA-SE might cause in a fetus or newborn infant.
* The following screening laboratory values must be within the normal ranges or not clinically significant as determined by the PI and Medical Monitor (MM): sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobin, and platelet count.
* The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
* Negative urine test for recreational drugs and alcohol per Clinical Research Unit standards.
* Urinalysis not clinically significant as determined by the study clinician.
* Must be capable of completing a study memory aid in English.
* Must give informed consent, be able and willing to make all evaluation visits, be reachable by telephone or personal contact by the study site personnel, and have a permanent address.
Exclusion Criteria:
* History of possible infection with Leishmania or previous exposure to Leishmania vaccines or experimental products containing SLA or GLA.
* Veterans who served in the military in the Middle East (Iran, Iraq), Afghanistan, or any other areas endemic to Leishmania.
* Travelers to, or immigrants from, areas endemic to Leishmania.
* Participation in another experimental protocol or receipt of any investigational products within the past 3 months.
* Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) within the past 6 months.
* Received a blood transfusion within the past 3 months.
* Donated blood products (platelets, whole blood, plasma, etc.) within past one month.
* Received any vaccine within past 1 month and no planned immunizations while on study with the exception of seasonal influenza vaccine which should not be given between Day 0 <= age <= 84 or Day 138 <= age <= 168 due to 30-day washout period prior to immunology blood draws.
* History of autoimmune disease or other causes of immunosuppressive states.
* History or evidence of any acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic, or renal disorders, controlled hypertension), or use of medication that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
* Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
* BMI, that in the opinion of the Investigator, poses a health risk.
* Hypertension (systolic >150 or diastolic >95).
* History of significant psychiatric illness with current use of medication.
* Known or suspected alcohol or drug abuse within the past 6 months.
* Chronic smoker (> 20 pack years).
* Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines, eggs, or unknown allergens.
* Subjects who are unlikely to cooperate with the requirements of the study protocol.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02071758
|
{
"brief_title": "Phase 1 LEISH-F3 + SLA-SE Vaccine Trial in Healthy Adult Volunteers",
"conditions": [
"Visceral Leishmaniasis"
],
"interventions": [
"Biological: LEISH-F3 + SLA-SE",
"Biological: LEISH-F3 + GLA-SE"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02071758",
"official_title": "A Phase 1, Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F3 + SLA-SE Vaccine Compared to LEISH-F3 + GLA-SE Vaccine in Healthy Adult Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2014-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-23",
"last_updated_that_met_qc_criteria": "2014-02-24",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-26",
"first_submitted": "2014-02-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.
Detailed Description
Univariate comparisons of the baseline/pre-intervention outcomes to the post-intervention outcomes will be performed on outcomes in order to determine how the intervention affects each. For continuous outcomes data the univariate comparisons of the pre-treatment and post-intervention outcomes will be performed using related samples t-test comparisons. For categorical outcomes data, comparisons of pre-intervention to post-intervention time frames will be performed using McNemar tests.
#Intervention
- BEHAVIORAL : Health Management; Blood Pressure
- Pharmacists will work with the patient/study subject, referred to as the participant hereafter, and the participant's other health care providers to manage their blood pressure, making recommendations for medication and lifestyle adjustments as needed.
|
#Eligibility Criteria:
Inclusion Criteria:
* All health plan beneficiaries 18 years-of-age and older
* Have filled at least one blood pressure medication in the last three months,
* Have a known hypertension diagnosis or have an uncontrolled blood pressure
Exclusion Criteria:
* Not an adult
* Not a health plan beneficiary of the self-insured employer
* Not ambulatory and able to work or participate in care visits
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04275934
|
{
"brief_title": "Blood Pressure First Medication Therapy Management",
"conditions": [
"Hypertension",
"Blood Pressure",
"Cardiovascular Diseases"
],
"interventions": [
"Behavioral: Health Management; Blood Pressure"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04275934",
"official_title": "Evaluation of the Impact of Self-insured Employer Implementation of an Innovative Care Model Utilizing Pharmacist-delivered MTM Services for Health Plan Beneficiaries With High Blood Pressure",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-31",
"study_completion_date(actual)": "2020-12-31",
"study_start_date(actual)": "2020-02-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-21",
"last_updated_that_met_qc_criteria": "2020-02-17",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-19",
"first_submitted": "2020-02-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. The purpose is to evaluate the coronary arteries and direct and indirect findings of coronary artery disease/complications with 3 tesla magnetic resonance imaging.
Detailed Description
This study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. The patients were operated with two different methods of re-implantation of the coronary arteries ('trap-door'/non-'trap-door', see description below).
#Intervention
- OTHER : 3 tesla magnetic resonance imaging findings; coronary artery status
- OTHER : 3 tesla magnetic resonance imaging findings; ventricular function and morphology
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of transposition of the great arteries with or without ventricular septum defect
* Surgically corrected during neonatal period with arterial switch procedure
Partial or total Exclusion Criteria:
* Heart arrhythmias
* Known allergic reaction to gadolinium based contrast media
* Reduced renal function (below 60 ml/min/1,73m2)
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01916499
|
{
"brief_title": "MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries",
"conditions": [
"Transposition of Great Vessels",
"Surgery"
],
"interventions": [
"Other: 3 tesla magnetic resonance imaging findings; coronary artery status",
"Other: 3 tesla magnetic resonance imaging findings; ventricular function and morphology"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT01916499",
"official_title": "MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2017-01",
"study_start_date(actual)": "2012-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-25",
"last_updated_that_met_qc_criteria": "2013-08-02",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-08-05",
"first_submitted": "2013-08-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
We put forward that probiotics have an effect on infectious episodes evolution in subjects aged 60 years or over. The main objective of this research is to observe the effect of consumption of the probiotic on the average number of days with infectious episodes.
#Intervention
- DIETARY_SUPPLEMENT : Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033
- 1 pill per day for 12 weeks
- DIETARY_SUPPLEMENT : Starch of potato
- 1 pill per day for 12 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who accept not to alter their food habits
Exclusion Criteria:
* Food allergy
* Regular consumption of probiotics
* Diabetes
* Respiratory deficiency
* Cardiac deficiency
* Cancer or chronicle disease not stabilized
* Splenectomy, sickle-cell anemia
* Immuno depression or immunodeficiency acquired or congenital
* Immuno depressor or corticoid treatments
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00796393
|
{
"brief_title": "Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.",
"conditions": [
"Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)"
],
"interventions": [
"Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033",
"Dietary Supplement: Starch of potato"
],
"location_countries": [
"France"
],
"nct_id": "NCT00796393",
"official_title": "Effects of Daily Consumption of a Probiotic on the Evolution of Infectious Episodes (ENT, Gastro-intestinal and Pulmonary), in Subject Aged 60 Years or Over, During Winter.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-04",
"study_completion_date(actual)": "2010-04",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-06-23",
"last_updated_that_met_qc_criteria": "2008-11-21",
"last_verified": "2011-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-11-24",
"first_submitted": "2008-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This controlled study is undertaken to investigate the effects of a long term outpatient training program on physical fitness and quality of life in elderly asthmatics.
Detailed Description
Physical training is well known to support a healthy lifestyle. Patients with asthma are often unnecessarily restricted of physical activities or avoid exercise due to the unpleasant experience of exercise-induced dyspnea. As a consequence both children and adults with asthma are less fit than their peers. Like in healthy individuals, regular training supports health in asthmatics. In short-term training programs improvements of physical capabilities have been achieved in children and young adults with asthma. Programs of longer durations than 3 months have not been published in controlled trials. Effects of exercise training on quality of life in adult asthmatics are lacking.
#Intervention
- PROCEDURE : Exercise training
- Exercise training in outpatient sport groups once weekly with a duration of 60 min each
|
#Eligibility Criteria:
Inclusion Criteria:
* physician diagnosed asthma
* non-smoker
* stable condition
* informed consent
Exclusion Criteria:
* participation in pulmonary rehabilitation in the past 12 months prior to study inclusion
* unability to attend training sessions on a regular basis for one year
* symptomatic coronary heart disease
* uncontrolled heart failure
* hemodynamically relevant cardiac rhythm disorders
* hemodynamically relevant cardiac valvular disorders
* uncontrolled arterial hypertension
* hypercapnic respiratory failure
* severe hypoxemia (i.e. PaO2 <50 mm Hg resp. SaO2 <80% at rest)
* history of decompensated right heart failure
* pulmonary arterial hypertension (PA mean pressure at rest >20 mm Hg)
* severe osteoporosis
* severe airway obstruction (FEV1 <50% predicted, FEV1 <60% predicted following bronchodilatation)
* maximum work rate of less than 50 watt during ergometer testing
* uncontrolled asthma
* COPD exacerbation
* severe adipositas (BMI >35 kg/m2)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01097473
|
{
"brief_title": "Long Term Physical Training in Asthma",
"conditions": [
"Asthma"
],
"interventions": [
"Procedure: Exercise training"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01097473",
"official_title": "Effects of Long Term Physical Training Once a Week on Fitness and Quality of Life in Elderly Asthmatics",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "1998-01",
"study_completion_date(actual)": "1998-03",
"study_start_date(actual)": "1996-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-04-01",
"last_updated_that_met_qc_criteria": "2010-03-31",
"last_verified": "2010-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-01",
"first_submitted": "2010-03-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic (PK) and safety of an age-appropriate tofacitinib Modified Release (MR) formulation with varying level of enteric coating. The effect of food on the PK of age-appropriate tofacitinib MR formulation with the lowest and higher levels of enteric coating will also be assessed.
#Intervention
- DRUG : tofacitinib modified release (MR)
- Single oral 10 mg multi particulate dose of dose of tofacitinib MR with different levels of enteric coating (MR E1, MR E2, and MR E3) in the fasted state. Additionally, the lowest and highest enteric coating levels will also be evaluated in the fed state.
Treatment F: a 10 mg oral dose of tofacitinib IR solution
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
1. . Achieved postmenopausal status, defined as: cessation of regular menses for at lease 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
2. . have undergone a documented hysterectomy and/or bilateral oophorectomy;
3. . have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight ˃50 kg (110 lbs) for males and ˃45 kg (99 lbs) for females
* No evidence of active or latent or inadequately treated infection with Mycobaceterium tuberculosis (TB)
Exclusion Criteria:
* Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, season allergies at the time of dosing.
* Clinically significant infections within the past 3 months (for example, those requiring hospitalization or parenteral antibiotics, or as judged by the investigator), evidence of any infection within the past 7 days, history of disseminated herpes simplex infection or recurrent (˃1 episode) herpes zoster or disseminated herpes zoster.
* Absolute lymphocyte count at Screening or Baseline (Day -1 of Period 1) less than the lower limit of the reference range for the local laboratory (lymphocyte count ˂0.8* 10˄3).
* Evidence of hematopoietic disorder or hemoglobin ˂12.5 g/dL for females and ˂13 g/dL for males at Screening or Baseline ((Day -1 of Period 1).
* Evidence or history of cyclic neutropenia.
* Personal or family history of hereditary immunodeficiency (eg, severe combined immunodeficiency disorder [SCID], Wiskott-Aldrich syndrome, X-linked agammaglobulinemia).
* Vaccination with live or attenuated vaccines within 6 weeks of dosing, or is to be vaccinated with these vaccines at any time during study treatment or within 6 weeks following discontinuation of dosing.
* Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection, etc.).
* History of, or current positive results for any of the following serological tests: human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatits B surface antigen (HepBsAg), Hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
* Malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
* Positive urine drug test.
* History of regular alcohol consumption.
* Use of tobacco-or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of the investigational product (whichever is longer).
* Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval ˃450 msec or a QRS interval ˃120 msec.
* Nursing females or females of childbering potential. Male subjects who are unwilling or unable to use a condom plus a highly effective method of contraception as outline in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. Herbal supplements and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of investigational product.
* Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg, phenytoin, carbamazepine, rifampin) within 14 days or 5 half-lives (whichever is longer) prior to dosing.
* Consumption of grapefruit or grapefruit-related citrus fruits (eg, Seville oranges, pomelos) or juices within 7 days prior to dosing.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
* History of sensitivity to heparin or heparing-induced thrombocytopenia.
* History of hypersensitivity to tofacitinib or any of the components of the formulation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04338711
|
{
"brief_title": "A Study In Adult Healthy Volunteers To Asses Once Daily (QD) Dosing With The Selected Age-Appropriate Modified Release (MR) Formulations",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: tofacitinib modified release (MR)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04338711",
"official_title": "A PHASE 1, RANDOMIZED, OPEN LABEL, PARTIAL CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF THREE AGE-APPROPRIATE MODIFIED RELEASE FORMULATIONS AND THE IMMEDIATE RELEASE SOLUTION OF TOFACITINIB IN HEALTHY ADULT VOLUNTEERS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-15",
"study_completion_date(actual)": "2020-09-15",
"study_start_date(actual)": "2020-06-17"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-10-29",
"last_updated_that_met_qc_criteria": "2020-04-06",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-08",
"first_submitted": "2020-03-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.
#Intervention
- DRUG : pregabalin
- 75mg bid titrating to 150mg bid on day 4
- DRUG : pregabalin/PF-00489791
- Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
- DRUG : Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female of non-childbearing potential
* Pain present for more than 3 months after healing of herpes zoster skin rash
* VAS score of >=40mm at screening and baseline visits
Exclusion Criteria:
* Patients with pain conditions which might impair the assessment of postherpetic neuralgia
* Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
* History or diagnosis of DSM IV major depressive disorder
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00599638
|
{
"brief_title": "A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia",
"conditions": [
"Postherpetic Neuralgia"
],
"interventions": [
"Drug: Placebo",
"Drug: pregabalin",
"Drug: pregabalin/PF-00489791"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00599638",
"official_title": "A TWO WEEK DOUBLE-BLIND PLACEBO-CONTROLLED CROSSOVER STUDY TO COMPARE THE EFFICACY AND SAFETY OF A PREGABALIN/PF-00489791 COMBINATION VERSUS PREGABALIN ALONE IN PATIENTS WITH POST-HERPETIC NEURALGIA",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-12-16",
"study_completion_date(actual)": "2008-12-23",
"study_start_date(actual)": "2008-04-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-05",
"last_updated_that_met_qc_criteria": "2008-01-11",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-24",
"first_submitted": "2008-01-04",
"first_submitted_that_met_qc_criteria": "2021-08-04"
}
}
}
|
#Study Description
Brief Summary
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC 28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy, adult, human, male subjects under fed conditions.
Detailed Description
Test for drugs of abuse (opiates and cannabinoids) in urine and breath test for alcohol were carried out prior to admission in each period of the study. Following an overnight fast of at least 10 hour, a high-fat high-calorie breakfast was served to the study subjects.
Thirty minutes after start of this breakfast, a single oral dose of minocycline hydrochloride extended release tablet 135 mg of either test or reference investigational product was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel.
During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study.
#Intervention
- DRUG : Minocycline hydrochloride
- extended release tablets 135 mg
|
#Eligibility Criteria:
Inclusion Criteria:
Volunteers who met the following criteria were included in the study
* Were in the age range of 18 <= age <= 45 years
* Were neither overweight nor underweight for their height as per the Life Insurance Corporation of India height/weight chart for non-medical cases
* Had voluntarily given written informed consent to participate in this study
* Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study
* Male subjects and:
* Whose female partner(s) was/were not pregnant or was/were not planning to become pregnant
* Whose female partner(s) was/were using at least one highly effective and one acceptable method of birth control (at the same time) for the duration of the study and for 2 weeks after completion of the study, such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence. Dual method of contraception must be used during the study and for 2 weeks after its discontinuation
* Whose female partner was surgically sterile (bilateral tubal ligation, bilateral oophorectomy, hysterectomy)
* Those using condoms even if vasectomy has been done; during the study and for 2 weeks after completion of the study
* Had a non-vegetarian diet habit
Exclusion Criteria:
* Hypersensitivity to minocycline or related group of drugs or to any other drug
* History of diarrhoea in last one week or antibiotic induced diarrhoea
* Frequent episodes of light headedness, vertigo and dizziness preceding one week
* History of photosensitivity
* Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
* History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma
* History of any psychiatric illness, which may impair the ability to provide written informed consent
* Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection
* Presence of values which are out of acceptable limits for total white blood cells count, differential WBC count or platelet count
* Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
* Presence of values which are out of acceptable limits for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol
* Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
* Clinically abnormal ECG or Chest X-ray
* Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period
* History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period
* Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study
* Participation in any clinical trial within 12 weeks preceding Day 1 of this study
* Subjects who, through completion of this study, would have donated and /or lost more than 350 ml of blood in the past 3 months other than study participation
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02312609
|
{
"brief_title": "Bioequivalence Study of Minocycline HCl 135 mg ER Tablet Sunder Fed Conditions",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Minocycline hydrochloride"
],
"location_countries": null,
"nct_id": "NCT02312609",
"official_title": "An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover, Bioequivalence Study Comparing Minocycline Hydrochloride 135 mg Extended Release Tablets (Containing Minocycline Hydrochloride 135 mg) of OHM Laboratories, USA. (A Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With SolodynTM Extended Release Tablets (Containing Minocycline Hydrochloride 135 mg) of AAI Pharma, Inc. in Healthy, Adult, Male, Human Subjects Under Fed Condition",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-09",
"study_completion_date(actual)": "2008-12",
"study_start_date(actual)": "2008-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-12-09",
"last_updated_that_met_qc_criteria": "2014-12-08",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-09",
"first_submitted": "2014-12-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main purpose of this study is to determine whether implantation of a paclitaxel-eluting stent (Taxus™) in saphenous vein graft lesions will reduce the incidence of in-stent restenosis after 12 months when compared to a similar bare metal stent.
Detailed Description
Introduction: The prevalence of coronary artery bypass graft (CABG) surgery is high in the veteran population. Saphenous veins are used as conduits in the majority of CABG operations. Compared to arterial conduits, saphenous vein grafts (SVGs) have a high rate of failure, requiring percutaneous coronary intervention (PCI) or repeat CABG. Bare metal stents are currently used in the majority of PCI in SVGs because they increase the procedural success rate and decrease restenosis. However, even with the use of bare metal stents, restenosis still occurs in 37-53% of the SVGs, often requiring repeat target vein graft revascularization.
Drug-eluting stents (DES) have been a major breakthrough in percutaneous coronary intervention because they significantly reduce the incidence of in-stent restenosis in de novo lesions of native coronary arteries. Even though, no randomized controlled trials have compared DES with bare stents in SVG interventions, DES are increasingly being used off label in this setting, based on registry data. DES are expensive and may not provide benefit in SVGs since the atherosclerotic process is different in SVGs and in native coronary arteries. We propose to compare the 12-month angiographic restenosis rates after implantation of a polymer-based paclitaxel-eluting stent or the Express-2 bare metal stent (which is identical to the paclitaxel-eluting stent but has no drug coating) in saphenous vein graft lesions.
Hypothesis: Compared to implantation of a bare metal stent, implantation of a similar paclitaxel-eluting stent (Taxus™, Boston Scientific, Nattick, Massachusetts) in saphenous vein graft lesion will reduce the incidence of angiographic in-stent restenosis after 12 months.
Specific objectives: We propose to randomize patients undergoing stenting of a saphenous vein graft lesion to a bare metal stent or an identical paclitaxel-eluting stent (Taxus™) in order to determine:
1. whether the paclitaxel-eluting stent will reduce the incidence of binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography (primary study endpoint), and
2. whether the paclitaxel-eluting stent will reduce the 24-month incidence of ischemia-driven target vessel revascularization, target vessel failure, overall major adverse cardiac and cerebrovascular events, and intra-stent intimal hyperplasia accumulation, as measured by intravascular ultrasound (secondary endpoints).
#Intervention
- DEVICE : Taxus polymer-based paclitaxel-eluting stent
- Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
- Other Names :
- Taxus drug-eluting stents
- DEVICE : Express 2 bare metal stent
- Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
|
#Eligibility Criteria:
Inclusion Criteria:
* at least one 50 <= age <= 99% de-novo or restenotic lesion in a saphenous vein graft that is between 2.5 and 4.0 mm in diameter, requiring percutaneous coronary intervention according to the opinion of the attending cardiologist
* willing to return for repeat coronary angiography after 12 months
* able to give informed consent
Exclusion Criteria:
* previous or planned use of intravascular brachytherapy in the target vessel
* a left ventricular ejection fraction of less than 25 percent
* hemorrhagic diatheses
* contraindications or allergy to aspirin, thienopyridines, paclitaxel, or stainless steel
* a history of anaphylaxis in response to iodinated contrast medium
* use of paclitaxel within 12 months before study entry or current use of colchicine
* a serum creatinine level of more than 2.0 mg per deciliter (177 µmol per liter)
* a leukocyte count of less than 3500 per cubic millimeter, or a platelet count of less than 100,000 per cubic millimeter
* a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy
* coexisting conditions that limit life expectancy to less than 24 months or that could affect a patient's compliance with the protocol
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00247208
|
{
"brief_title": "The SOS (Stenting Of Saphenous Vein Grafts) Trial",
"conditions": [
"Coronary Artery Bypass",
"Arteriosclerosis"
],
"interventions": [
"Device: Express 2 bare metal stent",
"Device: Taxus polymer-based paclitaxel-eluting stent"
],
"location_countries": [
"Greece",
"United States"
],
"nct_id": "NCT00247208",
"official_title": "The SOS (Stenting Of Saphenous Vein Grafts) Randomized-controlled Trial of a Paclitaxel-eluting Stent vs. a Bare Metal Stent in Saphenous Vein Graft Lesions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-10",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2005-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-04-26",
"last_updated_that_met_qc_criteria": "2005-10-31",
"last_verified": "2012-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-11-01",
"first_submitted": "2005-10-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting.
Detailed Description
Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention. Approximately 72 subjects at 8 sites in Japan will be enrolled. Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.
#Intervention
- DEVICE : Lithotripsy
- Deliver Lithotripsy to the target vessel prior to placing a coronary stent
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is >=18 years
* Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
* For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn both must be normal)
* For patients with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.
1. If drawn prior to the procedure, biomarkers (troponin or CK- MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the index procedure (note: if both labs are drawn, both must be normal)
2. If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment.
* Left ventricular ejection fraction > 25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criteria; may be assessed at time of index procedure)
* Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
* Lesions in non-target vessels requiring PCI may be treated either:
1. >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
2. >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation
>normal; or
3. >30 days after the study procedure
Angiographic Inclusion Criteria
* The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
* Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:
1. Stenosis of >=70% and <100% or
2. Stenosis >=50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value <=0.80, or iFR <0.90 or IVUS or OCT minimum lumen area <=4.0 mm²
* The target vessel reference diameter must be >=2.5 mm and <=4.0 mm
* The lesion length must not exceed 40 mm
* The target vessel must have TIMI flow 3 at baseline (visually assessed, may be assessed after pre-dilatation)
* Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of >=270 degrees of calcium on at least 1 cross section
* Ability to pass a 0.014' guide wire across the lesion
Exclusion Criteria:
* Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
* Subject is a member of a vulnerable population including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
* Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
* Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
* Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months
* Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
* Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK- MB greater than 1 times the local laboratory's upper limit of normal
* New York Heart Association (NYHA) class III or IV heart failure
* Renal failure with serum creatinine >2.5 mg/dL, or chronic dialysis
* History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
* Active peptic ulcer or upper gastrointestinal (GI) b>=leeding within 6 months
* Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
* Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
* Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
* Uncontrolled diabetes defined as a HbA1c >=10%
* Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
* Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
* Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
* Subjects with a life expectancy of less than 1 year
* Non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure
* Planned non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days after the index procedure
* Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
* Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
* Unprotected left main diameter stenosis >30%
* Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
* Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
* Evidence of aneurysm in target vessel within 10 mm of the target lesion
* Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
* Target lesion is a bifurcation with ostial diameter stenosis >=30%
* Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
* Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
* Previous stent within the target vessel implanted within the last year
* Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
* Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04151628
|
{
"brief_title": "Disrupt CAD IV With the Shockwave Coronary IVL System",
"conditions": [
"Coronary Artery Disease",
"Myocardial Infarction"
],
"interventions": [
"Device: Lithotripsy"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT04151628",
"official_title": "Prospective, Multicenter, Single-Arm Study of the SWM-1234 in Calcified Coronary Arteries (Disrupt CAD IV Study - Japan)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-08",
"study_completion_date(actual)": "2022-03-25",
"study_start_date(actual)": "2019-11-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-22",
"last_updated_that_met_qc_criteria": "2019-11-01",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-11-05",
"first_submitted": "2019-11-01",
"first_submitted_that_met_qc_criteria": "2021-06-03"
}
}
}
|
#Study Description
Brief Summary
To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.
#Intervention
- DEVICE : Pro Kinetic Energy bare metal stent
- PCI
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient signed informed consent for data release
* Patient eligible for percutaneous coronary intervention (PCI)
* De novo and re-stenosed coronary artery lesions
* Patient is geographically stable and willing to participate at all follow up assessments
* Patient is > 18 years
Exclusion Criteria:
* Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel
* Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI
* Patient presents with ISR (in-stent restenosis)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01056120
|
{
"brief_title": "Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice",
"conditions": [
"De Novo and Re-stenosed Coronary Artery Lesions"
],
"interventions": [
"Device: Pro Kinetic Energy bare metal stent"
],
"location_countries": [
"France",
"Israel",
"Netherlands",
"Germany",
"Austria",
"Spain",
"Ireland",
"Switzerland",
"Belgium",
"Latvia"
],
"nct_id": "NCT01056120",
"official_title": "Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-02",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-01",
"last_updated_that_met_qc_criteria": "2010-01-25",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-26",
"first_submitted": "2010-01-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S. Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among their top priorities. PTSD-related anger and aggression are associated with profound functional impairments, yet to date there are no empirically-supported treatments for Veterans with PTSD and aggression. Effective group treatment programs could improve functioning and facilitate community reintegration for these Veterans. Given that anger impedes progress in treatment of PTSD symptoms, group anger treatment could also improve Veterans' capacity to benefit from individually-administered empirically-supported therapy for PTSD such as prolonged exposure or cognitive processing therapy.
Detailed Description
Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression (Olatunji, Ciesielski, \& Tolin, 2010), and U.S. Iraq/Afghanistan-era Veterans report that controlling anger and aggressive urges are primary readjustment concerns (Sayer et al, 2010). Trauma-related anger and aggression are associated with functional impairments that significantly limit community reintegration (Rodriguez, Holowka, \& Marx, 2012) and that may persist for decades (Koenen et al, 2003). As more troops return from multiple deployments to Iraq and Afghanistan, there is an urgent and growing need for the development and testing of psychosocial treatment for anger and aggression in combat Veterans with PTSD. VA clinicians are doing their best to be responsive to Veteran's needs by offering anger management treatment to Veterans: A survey of clinical practices within the VA found that 35-65% of VA PTSD specialists report providing anger management to their patients (Rosen et al., 2004). Yet to date only one randomized clinical trial (RCT), published in 1997, has investigated the efficacy of treatment of anger and aggression in Veterans with PTSD (Chemtob et al., 1997).
A recent review noted that most researchers who have examined the effects of anger management interventions have not done so as part of a systematic program of research (DiGiuseppe and Tafrate, 2003). The proposed CDA-2 application outlines Training and Mentoring Plans that will provide the applicant with the foundation to establish a career systematically developing, testing, and refining treatments for PTSD-related anger and aggression in Veterans. The following specific Training Goals have been formulated: 1) To acquire the advanced skills in the development and evaluation of clinical interventions necessary to begin an independent research career within the VA; 2) To develop greater expertise in delivery of behavioral interventions to improve functional outcomes and community reintegration in Veterans with PTSD, anger problems, and aggression; 3) To acquire expertise in the development and evaluation of treatment innovations to help Veterans generalize treatment gains beyond the therapy setting; 4) To increase understanding of rehabilitation theory and methods in treatment practices and research; and 5) To achieve critical professional development milestones, including submission of a Merit Review proposal based on the pilot data generated from the CDA-2 project.
The Research Plan proposes a pilot feasibility trial for an RCT of Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A). CBT-A is a 12-week manualized group treatment protocol that has been designed to address the specific needs of combat Veterans whose PTSD-related anger and aggression interfere with effective community reintegration. The group was implemented with 4 male Vietnam Veterans with severe combat-related PTSD who were referred for anger management treatment, and preliminary data were promising. The active comparison treatment for the pilot RCT will be group Present-Centered Therapy (PCT), a manualized treatment for PTSD that controls for treatment time, social support, and instillation of hope. The proposed research project will address the following Specific Aims: Aim 1: Characterize the differential effects of group CBT-A and group PCT on anger, aggression, and anger/aggression-related limitations to psychosocial functioning and community reintegration in combat Veterans with PTSD; and Aim 2: Evaluate study feasibility and treatment delivery procedures of an RCT comparing CBT-A to a PCT comparison condition. The results generated will guide the design of a full RCT to be funded by the end of the CDA-2 funding period. The research, training, and mentoring plans outlined here will provide the foundation for the PI's independent research career developing a systematic program of research in the treatment of anger and aggression among combat Veterans with PTSD. The availability of empirically-supported anger treatment would benefit the many Veterans with PTSD who return from combat reporting problems with anger and aggression.
#Intervention
- BEHAVIORAL : Cognitive Behavioral Therapy
- Cognitive Behavioral Therapy provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning.
- BEHAVIORAL : Present Centered Therapy
- Present Centered Therapy utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the 'here-and-now' to support patients in their efforts to improve functioning.
|
#Eligibility Criteria:
Inclusion Criteria:
A Veteran will meet criteria for inclusion if he/she meets all of the following criteria:
* Current PTSD based on the CAPS;
* served in combat (regardless of era or country of combat service);
* can speak and write fluent conversational English;
* at least 18 years;
* report problems with irritability, anger, or aggression within the past month. Problems with anger and aggression will be defined via the 'rule of 4': Inclusion in the study will require a CAPS-V score > 2 on item 15 (E1), 'irritable or angry and showed it in your behavior' item within the past month.
Exclusion Criteria:
A Veteran will be excluded from participation if he/she:
* is expected to be unstable on his/her medication regimen during the study;
* currently meets criteria for Bipolar I Disorder or a primary psychotic disorder as determined by the Structured Clinical Interview for the DSM (most current version available) (SCID);
* is receiving (or plan to) other anger-management psychotherapy during the course of the study;
* will be undergoing empirically supported psychotherapy for PTSD during the treatment component of the study;
* meets criteria for substance dependence (other than nicotine) within the past month as determined by the SCID; or
* is determined to have moderate or severe impairment related to traumatic brain injury as measured by the Brief Traumatic Brain Injury Screen and consultation with the Veteran's provider.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02233517
|
{
"brief_title": "Group CBT for Aggression in Veterans",
"conditions": [
"Aggression",
"Anger",
"Posttraumatic Stress Disorder"
],
"interventions": [
"Behavioral: Cognitive Behavioral Therapy",
"Behavioral: Present Centered Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02233517",
"official_title": "Group Cognitive Behavioral Therapy for Anger and Aggression in Veterans With PTSD",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-05",
"study_completion_date(actual)": "2017-07-05",
"study_start_date(actual)": "2015-02-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-31",
"last_updated_that_met_qc_criteria": "2014-09-03",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-08",
"first_submitted": "2014-08-18",
"first_submitted_that_met_qc_criteria": "2019-05-30"
}
}
}
|
#Study Description
Brief Summary
Volunteers were divided randomly in five experimental groups. VAS (Visual Analogic scale) to measure DOMS (Delayed Onset Muscle Soreness) and blood samples was taken before any procedure. Then, volunteers performed stretching and warm-up followed by MVC test (isometric test in isokinetic dynamometer to measure muscle function). After, volunteers performed the exercise protocol (75 eccentric contractions) to lead to muscle fatigue. Immediately after exercise protocol (1 minute) and 1 hour, 24, 48, 72 and 96 hours after, blood sample, VAS measure and MVC test were repeated. The treatments according to randomisation were performed three minutes after exercise protocol and it were performed again in 24, 48, 72h after eccentric exercise.
The variables regarding to muscle function (MVC, DOMS) and the indirect marker of muscle damage (CK activity) were monitored in all time points mentioned above (baseline, 1 minute, 1 hour, 24, 48, 72 and 96 hours after exercise protocol).
Detailed Description
A randomized, double-blind, placebo-controlled clinical trial was performed at the Laboratory of Phototherapy in Sport and Exercise at Nove de Julho University in the city of São Paulo, Brazil.
Fifty healthy untrained male subjects were recruited from university staff and students to participate in the study. All participants voluntarily must agree to participate and they signed the informed consent statement. The intention-to-treat analysis was followed.
The volunteers were randomly allocated to five experimental groups (n=10 per group) according to the applied comparator. Randomisation was carried out by a simple drawing of lots (A, B, C, D or E). Blood samples (10 ml) was taken by a qualified nurse to analyse CK activity posteriorly. This blood collection was repeated 1 minute, 1 hour, 24, 48, 72 and 96 hours after eccentric protocol.
A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher. DOMS assessments were performed at baseline, immediately after eccentric exercise protocol (1 minute), and it was repeated at 1, 24, 48, 72 and 96 hours after the exercise protocol. Before exercise protocol, volunteers will perform a stretching and warm-up of the non-dominant lower limb and then they will perform Maximum voluntary contraction (MVC) to evaluate muscle function. MVC measurements were repeated at the same time intervals as the CK measures.
The exercise protocol consists in 75 eccentric isokinetic contractions of the knee extensor musculature in the non-dominant leg (5 sets of 15 repetitions, 30-second rest interval between sets) at a velocity of 60°.seg-1 in both the eccentric and concentric movements with a 60° range of motion (between 90° and 30° of knee flexion).
Regarding to treatment, all volunteers received the treatment according to randomisation three minutes after eccentric exercise protocol. Comparators were repeated at 24, 48, and 72 hours following the collection of additional blood samples for CK analyses and MVC and DOMS assessments.
The five groups was divided in: PBMT (photobiomodulation therapy)+cryotherapy; cryotherapy+PBMT; active PBMT; placebo PBMT and only cryotherapy.
PBMT was applied employing a cordless, portable GameDay™ Super Pulsed Laser (manufactured by Multi Radiance Medical, USA) to 6 sites of quadriceps femoris in direct contact with the skin (2 centrally - rectus femoral and vastus intermedius; 2 laterally - vastus lateralis; and 2 medially - vastus medialis) and cryotherapy was done with two flexible ice packs filled with ice cubes and water (with a volume of 1.15 liters each) that will cover the entire quadriceps for 20 minutes.
#Intervention
- OTHER : PBMT
- Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.
- Other Names :
- photobiomodulation therapy
- OTHER : Cryotherapy
- Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects were included in the study if they performed less than 2 exercise session per week
Exclusion Criteria:
* Subjects were excluded if occurred any musculoskeletal injury to hips or knees within the previous two months,
* if they were currently using pharmacological agents or nutritional supplements regularly,
* if a musculoskeletal injury during the study occurred or if they reported use of either alcohol or tobacco.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02622971
|
{
"brief_title": "Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery",
"conditions": [
"Post-exercise Muscle Recovery"
],
"interventions": [
"Other: PBMT",
"Other: Cryotherapy"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT02622971",
"official_title": "Isolated and Combined Effects of Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2014-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-03",
"last_updated_that_met_qc_criteria": "2015-12-04",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-07",
"first_submitted": "2015-11-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This will be a randomized, double-blind, placebo-controlled study. The study will use a three-period, six-sequence, complete-block, cross-over study design to characterize two doses of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to an allergen. Each of the three periods will be 14 days, followed by a washout period before the next period.
#Intervention
- DRUG : TD-8236
- The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.
- DRUG : Placebo
- The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 <= age <= 65 of age
* Willing and able to give informed consent and comply with study requirements
* Documented physician-diagnosed asthma for >= 4 months prior to Screening
* Body mass index (BMI) >= 18.0 and <= 35.0 kg/m2 at Screening and weighs >= 50 kg at Screening.
* Women of child bearing potential must have a negative pregnancy test
* Males and females must use a highly efficient birth control method
* Pre-bronchodilator FEV1 >= 70% predicted
* Documented allergy to at least one common allergen
* Dual responder to inhaled bronchial challenges
* Additional inclusion criteria apply
Exclusion Criteria:
* Positive for hepatitis A, B or C, HIV or tuberculosis
* Clinically significant abnormalities of laboratory evaluations
* Have abnormal ECG measurements
* Any sign of respiratory tract infection within 6 weeks of screening
* Have a current bacterial, parasitic, fungal or viral infection
* History of life-threatening asthma
* Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
* Additional exclusion criteria apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04150341
|
{
"brief_title": "Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: Placebo",
"Drug: TD-8236"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04150341",
"official_title": "A Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study to Evaluate the Effects of Repeated Doses of Inhaled TD-8236 and Impact on Airway Responses Following Allergen Challenge in Patients With Asthma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-28",
"study_completion_date(actual)": "2020-09-03",
"study_start_date(actual)": "2019-11-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-18",
"last_updated_that_met_qc_criteria": "2019-11-01",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-11-04",
"first_submitted": "2019-10-15",
"first_submitted_that_met_qc_criteria": "2022-02-17"
}
}
}
|
#Study Description
Brief Summary
This is a pivotal study. The study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for pain, function and stiffness in the knees of osteoarthritic subjects.
Detailed Description
Osteoarthritis is the main form of arthritis and affects over 20 million people in the United States. In the knee it can cause severe pain, reduced functionality and increased stiffness thus, a treatment that would reduce pain, increase function and reduce stiffness would be of benefit to many people.
This study will collect and disassociate adipose tissue and inject the stromal vascular fraction into the knee of the same patient. The study is controlled, randomized and double-blinded with 2 SVF treatments (high and low dose) and a placebo control.
#Intervention
- DEVICE : GID SVF-2
- The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain associated with joint osteoarthritis.
- OTHER : Placebo
- Placebo Control
|
#Eligibility Criteria:
Inclusion Criteria:
* Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI.
* Study Subjects must have failed a minimum of at least two conservative therapies, spanning a period of at least 3 months.
* Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
* Subjects will be in good health (ASA Class I-II) with a BMI < 35.
* Subjects must have continued pain in the knee despite conservative therapies for at least 3 months.
* Subjects with unilateral disease must present with symptomatic knee pain using the WOMAC subscale for pain.
* Subjects must speak, read and understand English.
* Subjects must be reasonably able to return for multiple follow-up visits.
Exclusion Criteria:
* Subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans.
* Subjects who have had surgery of either knee within 6 months prior to the screening visit.
* Subjects who have had a major injury to the targeted knee within 12 months prior to enrolling in the study.
* Subjects who have had an injection in either knee in the prior 3 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP).
* Subjects who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication.
* Subjects who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee.
* Subjects that are unwilling to stop taking prescription or over the counter pain medication for 7 days prior to any visit
* Subjects that are allergic to lidocaine, epinephrine or valium
* Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as prior to injection.
* Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis.
* Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
* Subjects that use any form of tobacco
* Women that are pregnant or planning to become pregnant during the study.
* Subjects on long term use of oral steroids
* History of any chemotherapy or radiation therapy of the targeted/treatment leg or adipose harvest site.
* Subjects currently on worker's compensation
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02726945
|
{
"brief_title": "Adipose-derived SVF for the Treatment of Knee OA",
"conditions": [
"Osteoarthritis (OA)"
],
"interventions": [
"Device: GID SVF-2",
"Other: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02726945",
"official_title": "Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Controlled, Randomized, Double-Blinded Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-01",
"study_completion_date(actual)": "2019-10-01",
"study_start_date(actual)": "2016-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-02",
"last_updated_that_met_qc_criteria": "2016-04-01",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-04",
"first_submitted": "2016-03-24",
"first_submitted_that_met_qc_criteria": "2019-08-08"
}
}
}
|
#Study Description
Brief Summary
This is a Phase I, prospective, randomized, placebo-controlled, double-blinded study designed to test the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) for the treatment of subjects with clinically diagnosed Alzheimer's disease.
Detailed Description
This is a randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) or placebo in subjects with Alzheimer's Disease. Following a successful Safety Run-In Phase, a total of twenty-five (25) subjects will be randomized to (2:2:1) to receive low-dose LMSCs, high-dose LMSCs or placebo. After randomization, baseline imaging, and study product infusion, subjects will be followed up at 2,4,13, 26, 39 and 52 week post study product infusion. Intention-to-treat study population will be used for the purpose of the endpoint analysis and safety evaluations.
#Intervention
- BIOLOGICAL : Longeveron Mesenchymal Stem Cells
- via peripheral intravenous infusion
- BIOLOGICAL : Placebo
- via peripheral intravenous infusion
|
#Eligibility Criteria:
Inclusion Criteria: All subjects enrolled in this trial must:
* provide written informed consent;
* be 50 - 80 years at the time of signing the Informed Consent form;
* have a body mass of 45 - 150 kg;
* at the time of enrollment, be diagnosed with AD in accordance with the NINCDS-AA criteria;
* score between 18 and 24 on the Mini Mental State Examination (MMSE);
* has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for >=2 hours/day >=3 days/week; and agrees to accompany the subject to each study visit;
* blood oxygen saturation >=93% determined via pulse oximetry;
* have a brain MRI consistent with AD;
* have a PET scan using an FDA-approved tracer (e.g., AMYViD, Vizamyl, or Neuraceq), and which indicates the presence of beta-amyloid plaques in the cerebral cortex, within 5 years of enrollment;
* have normal levels of thyroid hormone (free T4) and thyroid-stimulating hormone (TSH);
* have normal levels of B12 and folate;
* have a designated study partner who will accompany the subject to all clinic visits and participate in the subject's clinical assessments; or
* be living in the community, including in an assisted living facility, but excluding long-term care nursing facilities.
Exclusion Criteria: All subjects enrolled in this trial must not:
* be unable to perform any of the assessments required for endpoint analysis;
* show signs of dementia other than AD, such as from AIDS (Acquired Immunodeficiency Syndrome), CJD (Creutzfeldt-Jakob disease), LBD (Lewy Bodies dementia), CVD (Cerebrovascular dementia), PSP (Progressive Supranuclear Palsy), MCI (multiple cerebral infarctions) or NPH (normal pressure hydrocephalus);
* have any other neurodegenerative disease;
* have a history of a seizure disorder;
* have clinically important abnormal screening laboratory values beyond AD;
* have any conditions that would contraindicate an MRI, such as the presence metallic objects in the eyes, skin, or heart;
* have any conditions that would contraindicate a PET scan;
* have > 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as 'possible' or 'definite'), a single area of superficial siderosis, or evidence of a prior macrohemorrhage as assessed by MRI;
* be currently using corticosteroids or similar powerful steroidal anti-inflammatory medication (e.g., Prednisone) on a regular basis (exceptions allowed include regular use of steroidal nasal sprays, topical steroids, and estrogen-replacement therapy);
* be active listed (or expected to be listed) for transplant of any organ;
* be an organ transplant recipient;
* have a known hypersensitivity to dimethyl sulfoxide (DMSO).
* have a condition that is projected to limited life expectancy to < 1 year.
* have a sitting or resting systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg at Screening;
* have a history of alcohol or drug abuse within the past 5 years.
* have been diagnosed with malignancy within the past 5 years, with the exception of curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma;
* be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraception (female subjects must undergo a urine pregnancy test at screening and on the infusion day prior to infusion);
* have any serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study;
* have any serious illness or any other condition that, in the opinion of the investigator, may compromise the validity of the study (e.g., signs of stroke, traumatic brain injury (TBI), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and Parkinsonism;
* have participated in any investigational therapeutic or device trial within the past 5 years that the investigator feels would influence or affect the outcome of the study;
* be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial;
* be positive for HIV, Syphilis and Hepatitis C; or
* be positive for Hepatitis B. If the subject tests positive for anti-HBc or anti-HBs, subject must be currently receiving treatment for hHepatitis B prior to infusion and remain on treatment throughout the study.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02600130
|
{
"brief_title": "Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease",
"conditions": [
"Alzheimer's Disease"
],
"interventions": [
"Biological: Placebo",
"Biological: Longeveron Mesenchymal Stem Cells"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02600130",
"official_title": "A Phase, I Prospective, Randomized, Double-Blinded, Placebo-controlled, Trial to Evaluate the Safety and Potential Efficacy of Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09",
"study_completion_date(actual)": "2021-09",
"study_start_date(actual)": "2016-10-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-12-14",
"last_updated_that_met_qc_criteria": "2015-11-06",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-09",
"first_submitted": "2015-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare the efficacy and safety of laparoscopically inserted transversus abdominis plane block (LTAP) in comparison to local wound analgesia in laparoscopic surgery due to suspected or diagnosed peritoneal endometriosis.
Detailed Description
The LTAP-trial is a prospective randomized controlled double-blinded study comparing the efficacy and safety of LTAP with local wound analgesia in laparoscopic endometriosis surgery. Patients are randomized to receive LTAP with levobupivacain and wound infiltration with placebo or wound infiltration with levobupivacain and LTAP with placebo. The primary outcome is postoperative opioid consumption measured by Patient Controlled Analgesia -pump (PCA). Secondly, subjective postoperative pain up to 24 h postoperatively will be measured by Numeric Rating Scale (NRS). Additional outcome measures are factors related to recovery and length of stay in the hospital as well as a 6 month follow-up survey regarding pain and general wellbeing after surgery. A total of 46 patients will be randomized in a proportion of 1:1.
#Intervention
- PROCEDURE : Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine
- Postoperative pain management
|
#Eligibility Criteria:
Inclusion Criteria:
* Surgery indicated because of pain caused by diagnosed or suspected peritoneal endometriosis
* ASA class 1 <= age <= 3
* Patient is capable of giving informed consent
Exclusion Criteria:
* Obstructive sleep apnea
* ASA class >4
* Other significant risks associated with opioid use
* Contraindications for local anesthetics or NSAIDs
* Regular opioid consumption before operation
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04735770
|
{
"brief_title": "LTAP Block in Endometriosis Surgery - a Randomised Controlled Double-blind Trial",
"conditions": [
"Endometriosis; Peritoneum",
"Postoperative Pain"
],
"interventions": [
"Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine"
],
"location_countries": [
"Finland"
],
"nct_id": "NCT04735770",
"official_title": "Laparoscopically Inserted Transversus Abdominis Plane Block Versus Wound Local Anesthesia in Laparoscopic Endometriosis Surgery: a Prospective Randomized Controlled Double-blinded LTAP-trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-22",
"study_completion_date(actual)": "2023-12-22",
"study_start_date(actual)": "2021-05-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-11",
"last_updated_that_met_qc_criteria": "2021-02-02",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-03",
"first_submitted": "2021-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
OTf is a monomeric glycoprotein of 686 amino acid residues and, as a member of the transferrin family, folds into two homologous globular lobes, each containing a single reversible Fe3 + binding site located within the interdomain cleft of each lobe. A comparison of apo (metal-free) and holostructures shows that iron binding or release in OTf occurs via a mechanism that involves opening or closing domains. human lactoferrin, transferrin, and OTf share the same reversible iron binding mechanism. Lactoferrin (Lf) is a 77 kDa glycosylated protein highly concentrated in human and bovine milk and can exist in an apo (metal free) state or can bind two ferric ions with very high affinity (k = 1022 M-1) forming holo-Lf . It has been recently reported that the addition of apo-Lf to a test meal containing FeSO4 significantly increased (+56%) iron absorption in young infants \[19\]. Despite these positive results in infants, to our knowledge, the ability of Lf to improve iron absorption from FeSO4 has not yet been assessed in adult women.
OTf and Lf will be tested as iron absorption enhancers by comparing the fractional iron absorption with that of FeSO4, the most widely used iron supplement. This study will provide information on how to improve iron absorption.In a randomized single-blind crossover study, the iron bioavailability is determined by means of stable iron isotope technology via the incorporation of stable isotopes from intrinsically labeled compounds into the erythrocytes 14 days after the study product.
Detailed Description
Iron deficiency remains a major public health problem in both developed and developing countries. At present, iron deficiency is mostly combated with iron supplements in the form of iron salts, especially iron sulfate. Iron salts are absorbed via the nonhemic iron route via the DMT-1 receptor, the rate of absorption being 20% of the total iron content. The dietary supplement industry tries to counteract this problem and to supply the required amount of iron by increasing the iron concentration in the dietary supplements in order to compensate for the low absorption rate. However, the high dosage of iron leads to side effects. It would be more effective to maximize iron absorption rather than a high dose of iron. Chicken protein ovotransferrin (OTf) is recognized as an iron-binding protein and a member of the transferrin family. OTf has amino acid sequences that are identical to chicken serum transferrin and shows approximately 50% homology with mammalian transferrin and lactoferrin. Despite its iron binding properties and safety for human consumption, no studies have evaluated OTf as an enhancer of iron absorption in humans.
OTf is a monomeric glycoprotein of 686 amino acid residues and, as a member of the transferrin family, folds into two homologous globular lobes, each containing a single reversible Fe3 + binding site located within the interdomain cleft of each lobe. A comparison of apo (metal-free) and holostructures shows that iron binding or release in OTf occurs via a mechanism that involves opening or closing domains. human lactoferrin, transferrin, and OTf share the same reversible iron binding mechanism.
Lactoferrin (Lf) is a 77 kDa glycosylated protein highly concentrated in human and bovine milk and can exist in an apo (metal free) state or can bind two ferric ions with very high affinity (k = 1022 M-1) forming holo-Lf . There are various studies that show the iron bioavailability of intrinsically labeled holo-Lf and apo- Lf and FeSO4. Lf appears to be a good source of bioavailable iron in both infants and in adults. Whether this is due to iron absorption through the Lf receptor and/or due to iron released from Lf joining the common non-heme iron pool and being subsequently absorbed, remains uncertain. The high affinity of OTf for iron (∼1030 M-1) at pH 7.5 implies that in presence of apo-OTf, iron will be sequestered. Lf also possesses the ability to bind iron (binding constants of ∼1022-1024 M-1) and retain it at lower pH. This difference in iron binding capacity, however, is not sufficient to establish conclusive statements regarding the activity of OTf in iron absorption.
It has been recently reported that the addition of apo-Lf to a test meal containing FeSO4 significantly increased (+56%) iron absorption in young infants. Despite these positive results in infants, to our knowledge, the ability of Lf to improve iron absorption from FeSO4 has not yet been assessed in adult women. Furthermore, despite its iron-binding properties and safety for human consumption, to the best of our knowledge, no studies have assessed OTf as an enhancer of iron absorption in humans. Therefore the use of OTf and Lf as iron absorption enhancers by comparing fractional iron absorption with that of FeSO4, the most commonly used iron supplement is investigated. This study will provide information regarding iron absorption enhancement, as well the behavior of OTf and Lf in adult women.
OTf and Lf will be tested as iron absorption enhancers by comparing the fractional iron absorption with that of FeSO4, the most widely used iron supplement. This study will provide information on how to improve iron absorption.In a randomized single-blind crossover study, the iron bioavailability is determined by means of stable iron isotope technology via the incorporation of stable isotopes from intrinsically labeled compounds into the erythrocytes 14 days after the study product.
Participants are given OTf, Lf and iron sulfate solutions. To quantify this, stable iron isotopes are used as marker substances. Stable isotopes exist in nature and in our body and there are no risks associated with their ingestion. No changes in the iron status of the subjects are expected during the study.35 women of childbearing age are being recruited for the study.
#Intervention
- DIETARY_SUPPLEMENT : FeSO4 + OTf
- OTf (apo ovotransferrin) + FeSO4
- DIETARY_SUPPLEMENT : FeSO4 + Lf
- Lf (lactoferrin) + FeSO4
- DIETARY_SUPPLEMENT : FeSO4
- Ferrous sulfate
|
#Eligibility Criteria:
Inclusion Criteria:
* female aged between 18 <= age <= 45 years;
* SF <25 µg / L;
* BMI 18.5 <= age <= 24.9 kg / m2;
* weight <70 kg;
* signed informed consent;
* Able to communicate and comprehend English language.
Exclusion Criteria:
* Anemic (Hb <12 g / dL);
* inflammation (CRP> 5 mg / L);
* chronic digestive, renal and / or metabolic disease;
* chronic medications (except for oral contraceptives);
* use of vitamin, mineral and pre- and / or probiotic supplements in the previous 2 weeks and during the course of the study;
* blood transfusion, blood donation or significant blood loss over the past 4 months;
* difficulties with blood sampling;
* antibiotic treatment in the previous 4 weeks before the start of the study and during the course of the study;
* known hypersensitivity to egg;
* pregnancy (tested in serum at screening) or intention to become pregnant during the course of the study;
* lactation up to 6 weeks before study initiation;
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05233709
|
{
"brief_title": "The Effect of Ovotransferrin and Lactoferrin on Iron Absorption From Ferrous Sulfate in Adult Women",
"conditions": [
"Iron-deficiency"
],
"interventions": [
"Dietary Supplement: FeSO4",
"Dietary Supplement: FeSO4 + Lf",
"Dietary Supplement: FeSO4 + OTf"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT05233709",
"official_title": "The Effect of Ovotransferrin and Lactoferrin on Iron Absorption From Ferrous Sulfate in Adult Women With Non-anemic Iron Deficiency: Stable Isotope Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-20",
"study_completion_date(actual)": "2022-05-20",
"study_start_date(actual)": "2022-04-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-06-10",
"last_updated_that_met_qc_criteria": "2022-02-09",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-10",
"first_submitted": "2021-10-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In recent years there has been increasing focus on the earlier detection of deterioration in the clinical condition of hospital patients with the aim of instigating earlier treatment to reverse this deterioration and prevent adverse outcomes. This is especially important in the ED, a dynamic environment with large volumes of undifferentiated patients, which carries inherent patient risk. SNAP40 is an innovative medical-grade device that can be worn on the upper arm that continuously monitors patients' vital signs including relative changes in systolic blood pressure, respiratory rate, heart rate, movement, blood oxygen saturation and temperature. It uses automated risk analysis to potentially allow clinical staff to easily and quickly identify high-risk patients. The aim of this study is to investigate whether the SNAP40 device is able to identify deterioration in the vital sign physiology of an ED patient earlier than current standard monitoring and observation charting techniques.
Detailed Description
As well as the potential of the SNAP40 device to improve patient safety, we believe that the SNAP40 device will increase ED efficiency, improve and increase use of resources and enable improved patient flow through the ED. Currently the only option for continuous monitoring or regular observations in the ED is to connect the patient to a standard monitor. Whilst these monitors can be portable they are not lightweight enough to allow the patient to be ambulatory within the ED and therefore require the patient to have a bed and a bed space or cubicle. This leads to lack of space within the ED, less cubicles (which allow privacy) free for performing history taking, examination and procedures, difficulty accessing patients and difficulty transporting them to areas where specialist tests can be performed (i.e. radiology and ECG). SNAP40 may remove the need for patients to be confined to beds and bed spaces (unless clinically required) freeing up space within the ED and allowing the ED care processes to occur much more freely increasing efficiency and speed of patient processing. This will undoubtedly lead to improved patient experiences around their ED and hospital journey.
The SNAP40 device also has the potential to free up resources, which can be used to improve patient care and experience in the ED. SNAP40 may reduce clinical staff time taken to record observations enabling them to provide patients with other aspects of care (i.e. analgesia and treatments) more regularly and in a timelier manner. Clinical staff may be able to spend more time with patients allowing better quality communication with them and their relatives. There will potentially be more time for traditional nursing care and personal care.
Whilst there are some other similar medical devices on the market (i.e. www.biovotion.com, www.sensium-healthcare.com, www.vitalconnect.com, http://www.caretakermedical.net) using wristbands, patches or finger cuff technology, currently none are being used in ED clinical practice.
This study will examine the SNAP40 device by comparing its performance to detect physiological deterioration against standard observations taken by clinical staff (nurses, doctors and clinical support workers) within the ED. The study will assess whether the device is able to detect physiological derangement sooner that standard monitoring devices.
#Intervention
- DEVICE : SNAP40
- SNAP40 ambulatory monitoring device
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant aged 16 years or over AND
* Participant triaged to Majors (High Dependency or Immediate Care) OR Participants who are stepped down from Resuscitation room care to High Dependency or Immediate Care
Exclusion Criteria:
* Participants under 16 years
* Previous participation in the study
* Participant in custody
* Participants deemed high risk for absconding by clinical staff
* Participants unable to communicate in English
* Participants who are triaged to immediate resuscitation. These participants may be considered for inclusion once immediate assessment and treatment have been initiated and they are stepped down to High Dependency (HD)/Immediate Care (IC) areas
* Patients with implantable defibrillators, pacemakers or neurostimulators will be excluded
* Patients who cannot have blood pressure measured in both arms e.g. patients with renal fistula, a Peripherally Inserted Central Catheter (PICC) line or who have had a lymph node clearance
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03179267
|
{
"brief_title": "Detection of Deterioration by SNAP40 Versus Standard Monitoring in the ED",
"conditions": [
"Vital Signs"
],
"interventions": [
"Device: SNAP40"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03179267",
"official_title": "Detection of Physiological Deterioration by the SNAP40 Wearable Device Compared to Standard Monitoring Devices in the Emergency Department",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-22",
"study_completion_date(actual)": "2017-12-22",
"study_start_date(actual)": "2017-09-25"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-04-12",
"last_updated_that_met_qc_criteria": "2017-06-06",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-07",
"first_submitted": "2017-06-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.
Detailed Description
Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.
#Intervention
- DEVICE : Intermittent Oral-esophageal Tube Feeding
- During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on the health condition.The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support (developed by the Dysphagia Institute of Zhengzhou University, CN201821314797.2), which is made of silicone material, 40 cm long, with an inner diameter of 0.54 cm.
- DEVICE : nasogastric tube feeding
- During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on the health condition.The control group is provided with nutritional support as nasogastric tube feeding, performed 6-10 times per day according to relevant guidelines, with an interval of more than 2 hours between every two feedings, and a feeding volume not exceeding 200 ml per time.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65 years.
* With the history of Nasopharyngeal Carcinoma and radiation therapy.
* With dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support.
* Conscious and with stable vital signs;
* Willing to participate and sign the written informed consent form either personally or by a family member.
Exclusion Criteria:
* Presence of other diseases that might cause dysphagia.
* With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies.
* Concurrent participation in other treatments that could interfere with the trial.
* Inability to cooperate with treatment due to aphasia, mental health issues, etc.
* Received tube feeding for enteral nutrition support within the past three years.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06301763
|
{
"brief_title": "Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma",
"conditions": [
"Dysphagia"
],
"interventions": [
"Device: Intermittent Oral-esophageal Tube Feeding",
"Device: nasogastric tube feeding"
],
"location_countries": [
"China"
],
"nct_id": "NCT06301763",
"official_title": "Oral Enteral Nutrition in Delayed Onset Radiotherapy-related Swallowing Disorder in Nasopharyngeal Carcinoma: A Randomly Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-11",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2023-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-14",
"last_updated_that_met_qc_criteria": "2024-03-04",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-03-08",
"first_submitted": "2024-03-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if two formulations of diphenhydramine hydrochloride are bioequivalent.
Detailed Description
Subjects were required to observe a ten-hour fast and a one-hour fluid restriction prior to each dosing period.
Subjects were randomized into one of two active treatment groups, received supervised dosing of their treatment with approximately eight ounces of water, and were required to maintain fluid restriction for one hour after treatment. Following the one-hour post-dose fluid restriction, subjects could drink water, but consumer no other food or fluids for four hours post-dose.
Following a seven-day washout period, the comparison treatment was administered according to the same procedure as above.
#Intervention
- DRUG : Diphenhydramine hydrochloride
- After a ten-hour fast and a one-hour fluid restriction prior to each dosing period, subjects received supervised dosing of their first 25 mg treatment with approximately eight ounces of water. Following a seven-day washout, the comparison treatment was administered according to thye same procedure.
- Other Names :
- Benadryl Allergy, 25 mg KAPSEALS capsule, 25 mg ULTRATAB tablets
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
* approximately 18 to 30 kg/m2 BMI
* total body weight at least 55 kg (121 lbs)
* able to understand and sign the written Informed Consent Form
* willing to follow the protocol requirements and comply with protocol restrictions
Exclusion Criteria:
* pregnant or lactating women
* women of childbearing potential not using acceptable form of contraception 3 months prior to the first dose until completion of follow-up procedures
* history of allergy, sensitivity, and/or idiosyncratic reaction to Benadryl, diphenhydramine hydrochloride, or diphenhydramine citrate
* evidence of clinical, dietary or psychiatric deviation from normal that could increase the risk to the subject or research staff or interfere with the interpretation of study results
* use of licit or illicit drugs
* participated in any other trials within a specified number of days prior to the first dose of the trial treatment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00662337
|
{
"brief_title": "Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride",
"conditions": [
"Nasal Congestion"
],
"interventions": [
"Drug: Diphenhydramine hydrochloride"
],
"location_countries": null,
"nct_id": "NCT00662337",
"official_title": "A Randomized, Two-Way Crossover Evaluation of the Bioequivalence Between Two Oral Formulations of Diphenhydramine: ULTRATAB Tablet Versus KAPSEALS Capsule",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-11",
"study_completion_date(actual)": "2006-11",
"study_start_date(actual)": "2006-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-09-08",
"last_updated_that_met_qc_criteria": "2008-04-18",
"last_verified": "2011-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-21",
"first_submitted": "2008-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether participants with Stage IIIC and Stage IV Melanoma experience benefit when treated with Denileukin diftitox in two different dosing schedules.
Detailed Description
This is a multicenter, open-label, dose/schedule and clinical efficacy study in participants with Stage IIIC and Stage IV melanoma.
Dose-Schedules: This is a schedule, dose, and pharmacodynamic study of Denileukin diftitox in participants with Stage IIIC and Stage IV melanoma. Two arms of 40 participants each were originally planned (see below) for a total of 80 participants. Participants were randomly assigned to 1 of 2 arms: 1. 12 mcg/kg/day on Days 1 through 4 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks); 2. 12 mcg/kg/day on Days 1, 8, and 15 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks). Participants will be evaluated for (clinical response, safety and tolerability, and pharmacodynamic measures of ONTAK activity. An optional substudy will be conducted that will involve collection of serial tumor biopsies at study entry and Day 84 in order to assess tissue pharmacodynamic markers of ONTAK activity (Treg depletion in tumor, appearance of melanoma antigen-specific CD8+lymphocytes, and other markers of mucosal immunity and inflammatory response).
Following an amendment, participants will be enrolled in Arm 1 only (expanded to a total of 55 participants) and Arm 2 was closed. According to the original design, if two responses or less were observed among 22 participants on either arm, that arm would be discontinued.
Participants experiencing clinical benefit (immune-related stable disease \[irSD\], immune-related partial response \[irPR\], or immune-related complete response \[irCR\] per irRC) after 4 cycles of treatment, may continue their denileukin diftitox treatment for up to 8 cycles.
#Intervention
- DRUG : Denileukin diftitox
- Denileukin diftitox intravenous infusion over 30-60 minutes.
|
#Eligibility Criteria:
Inclusion Criteria Participants may be entered in the study only if they meet all of the following criteria.
* Male or female participants greater than or equal to18 years;
* Participants with histologically confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
* Naive to prior systemic chemotherapy, targeted therapy (eg, BRAF), or immunotherapy (eg, interleukin-2 [IL-2] or interferon) for the treatment of melanoma, including any cytotoxic agents or IL-2 used for adjuvant therapy (adjuvant interferon is allowed). Prior granulocyte macrophage colony-stimulating factor (GM-CSF) is allowed;
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;
* Life expectancy greater than or equal to 3 months;
* At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);
* Serum albumin greater than or equal to 3 g/dL;
* Adequate hematologic, renal, and liver function as defined by laboratory values performed within 21 days prior to initiation of dosing:
* Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L;
* Platelet count greater than or equal to 100 x 10^9/L;
* Hemoglobin greater than or equal to 9 g/dL;
* Serum creatinine less than or equal 1.5 x upper limit of normal (ULN) or creatinine clearance greater than or equal to 50 mL/min;
* Total serum bilirubin less than or equal to 1.5 x ULN;
* Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) less than or equal to 2.5 x ULN, and less than or equal to 5 x ULN if liver metastases are present.
* Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
* Pre-menopausal females and females less than 2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for greater than or equal to 1 year; Before study entry, written informed consent must be obtained from the participants prior to performing any study-related procedures.
Exclusion Criteria
Participants will not be entered in the study for any of the following:
* Known central nervous system (CNS) lesions, except for asymptomatic non-progressing, treated brain metastases.
Treated brain metastases are defined as having no evidence of progression or hemorrhage for 2 months, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computerized tomography [CT]) during the Screening period (using the pretreatment brain image as Baseline). Treatment for brain metastases must have been completed at least 2 months prior to Day 1 of the first treatment cycle and may include whole brain radiotherapy, radiosurgery (Gamma Knife, LINAC, or equivalent), or a combination as deemed appropriate by the treating physician. Dexamethasone must be discontinued at least 4 weeks prior to Day 1. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 2 months prior to Day 1 will be excluded;
* Carcinomatous meningitis;
* Prior treatment with denileukin diftitox;
* Known hypersensitivity to denileukin diftitox or any of its components: diphtheria toxin, IL-2, or excipients;
* Prior surgery for melanoma less than 4 weeks before enrollment;
* Other malignancy within 3 years of randomization, with the exception of adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer, with no subsequent evidence of recurrence and/or malignancies diagnosed at a stage where definitive therapy results in near certain cures. The Medical Monitor must be consulted in such cases;
* Currently receiving any other anticancer treatment for melanoma (including palliative radiotherapy);
* Received treatment in another clinical study within the 4 weeks prior to commencing study treatment or participants who have not recovered from side effects of an investigational drug to Common Terminology Criteria for Adverse Events (CTCAE) Grade less than or equal to 1, except for alopecia;
* Received radiotherapy for non-CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade less than or equal to 1, except for alopecia;
* Significant cardiovascular impairment (history of congestive heart failure New York Heart Association [NYHA] Grade greater than 2 [see Appendix 5], unstable angina, or myocardial infarction within the past 6 months, or serious cardiac arrhythmia);
* Use of chronic systemic steroids (>5 days) within 2 weeks of Day 1 of the first treatment cycle (replacement therapy for adrenal insufficiency is allowed);
* Participants with an allograft requiring immunosuppression;
* Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive;
* Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures; Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01127451
|
{
"brief_title": "Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma",
"conditions": [
"Stage IIIC Melanoma",
"Stage IV Melanoma"
],
"interventions": [
"Drug: Denileukin diftitox"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01127451",
"official_title": "A Phase II Open-Label, Multicenter Study of Denileukin Diftitox in Patients With Stage IIIC and Stage IV Melanoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04-07",
"study_completion_date(actual)": "2015-04-07",
"study_start_date(actual)": "2010-06-22"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-13",
"last_updated_that_met_qc_criteria": "2010-05-19",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-20",
"first_submitted": "2010-05-19",
"first_submitted_that_met_qc_criteria": "2022-03-18"
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).
#Intervention
- DRUG : Vildagliptin
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion criteria
* Confirmed diagnosis of T2DM by standard criteria.
* Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (>= 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
* Age: >=18 to <= 80 years
* HbA1c of >= 7.5 and <= 11.0%
* Body Mass Index (BMI) >=22 to <=45 kg/m2
Exclusion criteria:
* FPG >= 270 mg/dL (>= 15.0 mmol/L)
* Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
* Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01233622
|
{
"brief_title": "Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride",
"conditions": [
"Type 2 Diabetes Mellitus"
],
"interventions": [
"Drug: Placebo",
"Drug: Vildagliptin"
],
"location_countries": [
"Mexico",
"Germany",
"Taiwan",
"Romania",
"Australia",
"Hungary",
"Italy",
"Philippines",
"Korea, Republic of"
],
"nct_id": "NCT01233622",
"official_title": "A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-11",
"study_completion_date(actual)": "2011-11",
"study_start_date(actual)": "2010-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-23",
"last_updated_that_met_qc_criteria": "2010-11-02",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-03",
"first_submitted": "2010-11-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The last decade has seen progressive advances in RT delivery, such as intensity modulated radiation therapy (IMRT)and image-guided radiation therapy (IGRT), which now allow highly precise radiation dose delivery. Together, IMRT and IGRT offer the potential of more selective treatment of the primary tumour and surrounding neck nodes by reducing the dose inflicted on critical organs at risk without compromising tumour dose and. IMRT has been shown to significantly decrease radiation-induced toxicity, and is now considered standard treatment for H\&N tumors. With these advances in delivery technology, the accurate definition of the target is emerging as the weakest link in the radiotherapeutic treatment chain. Accurate target definition is the primary link on which all subsequent treatment planning and delivery depend and is therefore critical for successful RT. Incorrect target definition can result in poorer outcomes through either less tumour control, more normal tissue toxicity, or both. Computed x-ray tomography (CT) is the standard volumetric imaging modality for RT because of its high resolution, accurate definition of anatomy and its intrinsic measure of electron density necessary for accurate dose calculation. However, its ability to distinguish between tumour and normal tissue is limited due to a lack of contrast for structures of similar electron density and image artifacts for objects of high density. This additional noise can result in large inter-observation variability. Disease visible on endoscopy can be contoured and registered to the planning CT, allowing inclusion of superficial disease invisible on the volumetric CT image dataset into the treatment plan.
#Intervention
- OTHER : Spatially registered endoscopy
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Histologic diagnosis of squamous cell carcinoma
* Primary cancer of the H&N
* Intention to treat using external beam radiation therapy as part of standard radiotherapy.
* Ability to provide written informed consent to participate in the study
Exclusion Criteria:
* Prior complete or partial radiation therapy to H&N
* Prior complete or partial surgery of the tumour
* Contraindications to full dose radiation therapy including pregnancy, lactation, connective tissue disorders, serious co-morbid illness
* Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning
* Psychiatric or addictive disorders that preclude informed consent or adherence to protocol
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02704169
|
{
"brief_title": "Quantitative Endoscopy of H&N",
"conditions": [
"Head and Neck Cancer"
],
"interventions": [
"Other: Spatially registered endoscopy"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02704169",
"official_title": "Comparing GTV Delineation With and Without Spatially Registered Endoscopy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-12",
"study_completion_date(actual)": "2019-08-12",
"study_start_date(actual)": "2013-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-19",
"last_updated_that_met_qc_criteria": "2016-03-08",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-03-09",
"first_submitted": "2013-06-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research project aims to test if sulforaphane, administered as broccoli sprout extract (BSE) can ameliorate glucose control in adult patients with chronic kidney disease (CKD) and DM 2 with GFR \> 15 \< 45 ml/min/1.73 m2. The glucose control will be evaluated by the oral glucose tolerance test. Moreover, as a secondary aim, we will investigate the role of sulforaphane in improving other signs of metabolic derangements present in this group of patients, including oxidate stress, proteinuria, inflammation and a decrease in the production of uremic toxins from the gut microbiota. This a multicentre randomized double-blinded controlled trial including 100 adult patients with CKD and glomerular filtration rate (GFR) between 15 and 29 ml/min/1.73m2, DM type 2, age \> 18 years old. Patients will be randomized into BSE group or Placebo group. Both groups will be followed for 20 weeks: The first 12 weeks patients will receive the BSE or Placebo and, the next 8 weeks, both groups will be followed with no intervention to observe the changes in the primary and secondary outcomes. Patients randomized to BSE Group will receive 50 µmmol/day of sulforaphane administered as BSE (Lantmännen®) from week 0 to week 4. If no side-effects are reported, the sulforaphane dose will increase to 100 µmmol/day from week 5 to week 8 and in the absence of side-effects, the dose will increase to 150 µmmol/day from week 9 to week 12. Blood and urine samples and OGTT (in non-insulin dependent patients) will be performed at week 0, 12 and 20. On week 4 and 8 blood drawn for partial exam will be performed. The BSE and the placebo (maltodextrin sprayed with copper-chlorophyllin) will be administered as powder provided in a double-blind manner as dry mixtures in sealed portion size bags of similar shape and size. Randomization will be done using a computer-based block randomization algorithm. Comparisons between the primary and secondary studied variables will be done with two-way analysis of variance (ANOVA) with repeated measures for normally distributed variables. Variables that can interfere with the glycemic control, such as changes in the dosage of hypoglicemiants agents and insulin during the intervention will be controlled in the analysis. Those non-normally distributed will be log transformed aiming to normalize the distribution. All test will consider a P\<0.05 for statistical significance. The software Stata will be used for the statistical analysis.
#Intervention
- OTHER : Sulforaphane, administered as Broccoli sprout extract
- Patients will randomized to BSE or Control Group. The group BSE will receive the sulforaphane, administered as broccoli sprout extract for 12 weeks. The dose will increase every four weeks if no side-effects are reported (50 µmmol/day; 100 µmmol/day and 150 µmmol/day, respectivelly). The Control group will receive a placebo (maltodextrin sprayed with copper-chlorophyllin) for the same period (12 weeks). The BSE/placebo will be administered as powder provided in 10 ml of water in the morning in a double-blind manner as dry mixtures in sealed portion size bags of similar shape and size.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a GFR 15 <= age <= 45 ml/min/1.73 m2, DM type 2, age >18 years, able to read and understand Swedish.
Exclusion Criteria:
* Use of metformin, use of warfarin, levels of ASAT, ALAT more than three times the upper limit at screening or at any subsequent visit, kidney transplantation, inflammatory bowel disease, celiac disease, malignant diseases (except skin basalioma) in the previous 3 years, and any other condition that the treating doctor believes is contraindicated; allergy to broccoli; participation in another clinical trial which may affect the outcome of the present study; not to understand the study information.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04858854
|
{
"brief_title": "Effect of Broccoli Sprout Extract in Patients With Chronic Kidney Disease With Diabetes Type 2",
"conditions": [
"Chronic Kidney Disease Stage 3B",
"Chronic Kidney Disease stage4",
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Other: Sulforaphane, administered as Broccoli sprout extract"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT04858854",
"official_title": "Effect of Broccoli Sprout Extract in Patients With Chronic Kidney Disease With Diabetes Type 2",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-30",
"study_completion_date(actual)": "2023-05-18",
"study_start_date(actual)": "2021-10-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-04",
"last_updated_that_met_qc_criteria": "2021-04-23",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-26",
"first_submitted": "2021-04-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \\and hardware complications.
#Intervention
- DEVICE : Flower Cube
- single use, sterile disposable fixation construct
|
#Eligibility Criteria:
Inclusion Criteria:
* Painful Hallux Limitus or Rigidus
* Painful Geriatric Hallux Valgus
* Failed prior 1st MTP joint arthroplasty (hemi-total)
* Arthritis of any etiology other than degenerative causes
Exclusion Criteria:
* Age less than 18 years
* Pregnant Females
* Active or prior infection at the target joint
* Immunocompromised patients
* Patients unwilling to sign informed consent
* Patient's unwilling to participate the in study protocol
* Subject with known sensitivity to titanium implants
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03290586
|
{
"brief_title": "Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis",
"conditions": [
"First Metatarsophalangeal Joint Arthritis"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03290586",
"official_title": "Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis; the Evaluation of a Novel, Single Use Sterile, Disposable Delivery System",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-03",
"study_completion_date(actual)": "2018-04-03",
"study_start_date(actual)": "2017-02-16"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-08",
"last_updated_that_met_qc_criteria": "2017-09-20",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-09-25",
"first_submitted": "2017-09-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 \[1,25(OH)2D3\], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.
#Intervention
- DRUG : 1,25-dihydroxy-vitamin D3 (calcitriol)
- DRUG : placebo
- pill without agent
|
#Eligibility Criteria:
Inclusion Criteria:
* New onset Typ 1 diabetes (< 6 weeks insulin therapy)
* Age 18 <= age <= 39 years
* GADA and/or IA-2A positive
Exclusion Criteria:
* Kidney disease
* Pregnancy
* Lactating
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 39 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00960635
|
{
"brief_title": "Immunointervention With Calcitriol in New-Onset Type 1 Diabetes",
"conditions": [
"Type 1 Diabetes"
],
"interventions": [
"Drug: placebo",
"Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00960635",
"official_title": "Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-08",
"study_completion_date(actual)": "2008-08",
"study_start_date(actual)": "2001-06"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-08-18",
"last_updated_that_met_qc_criteria": "2009-08-17",
"last_verified": "2009-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-08-18",
"first_submitted": "2009-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
"Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised training cognitive therapy which addresses the difficulties in flexibility and holistic processing that have been incriminated in AN. CRT has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered.
The aim of the present study is to determine if CRT in AN adolescents and young adults has a favourable impact on cognitive functioning and clinical status. We will also explore whether the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There will also be an Historical Control Group of patients, sixty, who received traditional medical interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN study)."
Detailed Description
"Several studies have documented that patients with Anorexia Nervosa (AN) display a trait of cognitive inflexibility (e;g., poor set-shifting performances on the Trail Making Task B), i.e. an inability to move flexibly back and forth between tasks, operations, or mental sets which allows for the adaptation of behaviour in response to changing demands within the environment. This cognitive inflexibility can be observed both during the acute phase of the illness and after weight restoration, and has been found to predict negative treatment outcomes. 'Weak central coherence' is another skill which is particularly problematic in AN. It refers to a cognitive style in which information remains fragmented as opposed to integrated, with processing occurring at the level of 'detail' as opposed to 'whole'. AN patients exhibit this detail focussed information-processing style (e.g., as measured by the Embedded Figures Test). To treat these difficulties, clinicians from the Institute of Psychiatry (London, UK) have specifically tailored a treatment for AN. Cognitive remediation therapy (CRT) is an intensive training cognitive therapy that encourages people to reflect on and try to modify the way they think, with a particular focus on improving cognitive flexibility. It is a manualised therapist-led intervention consisting of multiple versions of a variety of tasks and mental exercises that address the difficulties in flexibility and holistic processing. CRT is a 10-sessions long program that has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered.
To address these issues, we designed a multicenter randomized clinical trial on the effectiveness of CRT in AN adolescents and young adults.
Main hypothesis: AN patients treated with CRT present a better clinical status than those treated by a control therapy.
Recruitment and Procedure: 120 female adolescents or young adults \[15-40 years old\] AN (60 Anorexic Restrictive; 60 Anorexic Binge-Purging) will be recruited among the patients of specialized ED care units of three hospitals: PAUL BROUSSE, INSTITUT MUTUALISTE MONTSOURIS, COCHIN-MAISON DE SOLENN. In each group of AN subtype, the patients will be randomly allocated to one of the two treatment arms: CRT or Sham Therapy (ST). Each therapy is manualised and includes 10 sessions over a period of 5 weeks (2 sessions/week). All the patients will be assessed just prior the beginning and after the end of the CRT/ST, at 6 months and 1 year of follow-up."
#Intervention
- BEHAVIORAL : Cognitive Remediation Therapy
- Cognitive remediation therapy (CRT) is an intensive training cognitive therapy that encourages people to reflect on and try to modify the way they think, with a particular focus on improving cognitive flexibility. It is a manualised therapist-led intervention consisting of multiple versions of a variety of tasks and mental exercises that address the difficulties in flexibility and holistic processing. CRT is an individual 10-sessions long program (2 sessions per week).
- Other Names :
- CRT
- BEHAVIORAL : Sham Therapy
- The Sham therapy (ST) has been designed to match the CRT format: an individual manualised therapist-led 10-sessions long program (2 sessions per week). ST sessions have been designed so as to avoid set-shifting and central coherence training. Rather, ST is a manualised sham intervention consisting of multiple exercises on 3 domains: soft physical activity, emotional expression recognition and interpersonal functioning.
- Other Names :
- ST
|
#Eligibility Criteria:
Inclusion Criteria:
* female;
* 15 <= age <= 40 years;
* hospitalised for a diagnosis of Anorexia Nervosa (DSM-IV Revised criteria) in one of the three departments participating in this research ;
* fluent in French;
* who provide their informed consent (or as far as possible their parents for those under 18).
Exclusion Criteria:
* previous history of neurological disorders;
* actual substance use disorder;
* schizophrenia;
* presenting a related somatic illness (diabetes, Crohn's disease, metabolic illness) or a life-threatening condition.
Sex :
FEMALE
Ages :
- Minimum Age : 15 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01772394
|
{
"brief_title": "Cognitive Remediation Therapy in Anorexia Nervosa",
"conditions": [
"Teenager",
"Young Adult",
"Hospitalized",
"Anorexia Nervosa (DSM-IV Revised Criteria)"
],
"interventions": [
"Behavioral: Cognitive Remediation Therapy",
"Behavioral: Sham Therapy"
],
"location_countries": [
"France"
],
"nct_id": "NCT01772394",
"official_title": "Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2017-01",
"study_start_date(actual)": "2012-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-16",
"last_updated_that_met_qc_criteria": "2013-01-17",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-21",
"first_submitted": "2013-01-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The present work aims to develop a randomized clinical trial with a sample of 150 patients diagnosed with at least one of the following emotional disorder: somatoform disorder, panic disorder, generalized anxiety disorder and depression disorder. Participants are tested by several self-reports related to the emocional disorders mentioned in a repeated measures design, pre and post treatment. The investigators think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life.
Detailed Description
Nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. So-called 'emotional disorders' and their mostly pharmacological treatment are, in no small part, responsible for this situation. However, research indicates that psychological treatment should be the first step when caring for these types of problems. The investigators expect that the results show that brief psychological therapies are more effective than pharmacological interventions. Moreover, it is expected that brief individual psychotherpay approach delivered in secondary care is more effective than brief group psychotherapy delivered in primary care.
#Intervention
- BEHAVIORAL : Brief transdiagnostic cognitive-behavioral therapy
- Time-limited transdiagnostic evidence-based psychological treatment
- DRUG : Pharmacological treatment
- Treatment as usual in PC
|
#Eligibility Criteria:
Inclusion Criteria:
* Emotional Disorder
Exclusion Criteria:
* Severe mental disorder
* Substance use disorder
* Severe depression
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04343391
|
{
"brief_title": "Brief Psychotherapies for Emotional Disorders in Primary and Secondary Care",
"conditions": [
"Emotional Disorder"
],
"interventions": [
"Behavioral: Brief transdiagnostic cognitive-behavioral therapy",
"Drug: Pharmacological treatment"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT04343391",
"official_title": "Brief Psychotherapies for Emotional Disorders in Primary and Secondary Care: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-15",
"study_completion_date(actual)": "2020-10-15",
"study_start_date(actual)": "2020-01-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-04",
"last_updated_that_met_qc_criteria": "2020-04-10",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-13",
"first_submitted": "2020-04-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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