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#Study Description
Brief Summary
The aim of the present study is to assess the impact of the cytochrome P450 2C9 (CYP2C9) genotype (\*2 and \*3 allele versus wild type; \~3-5% poor metabolisers in Caucasian population) on the pharmacokinetics of bosentan and the impact of CYP3A4-induction by St. John's wort (SJW) on steady state bosentan which is a CYP3A4 inducer itself.
Detailed Description
We evaluate the effect of SJW on bosentan pharmacokinetics and its relationship to polymorphisms in the CYP2C9 gene known to reduce CYP2C9 activity. This study will be conducted at bosentan steady-state because concentrations decrease in the first 10 days of treatment due to auto-induction of the metabolism.
#Intervention
- DRUG : St. Johns Wort
- * Administration of bosentan: 1 x 125 mg p.o. on days 1 and 20, 2 x 62.5 mg p.o. on day 2, 2 x 125 mg p.o. on days 3-19.
* Administration of SJW: 3 x 300 mg daily p.o. on days 11-19 and 2 x 300 mg on day 20
- Other Names :
- Jarsin
|
#Eligibility Criteria:
Inclusion Criteria:
* Good state of health (physically and mentally)
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* Voluntarily signed informed consent after full explanation of the study to the participant.
* No clinically relevant findings in any of the investigations of the pre-study examination, especially aminotransferase elevations >= 3 × upper limit of normal(ULN). Minor deviations of other laboratory values from normal range may be acceptable, if judged by the investigator to be of no clinical relevance.
* Known genotype for CYP2C9 polymorphism.
* Agreement to abstain from alcoholic beverages during the time of the study.
* Females must agree to use a reliable contraception (Pearl Index <1%), e.g. double barrier method.
Exclusion Criteria:
* Any regular drug treatment within the last two months, except for oral contraceptives in female volunteers and L-thyroxine.
* Any intake of a substance known to induce or inhibit drug metabolising enzymes or drug transporters within a period of less than 10 times the respective elimination half-life or 2 weeks, whatever is longer
* Any participation in a clinical trial within the last month before inclusion
* Any physical disorder which could interfere with the participant's safety during the clinical trial or with the study objectives
* Any acute or chronic illness, or clinically relevant findings in the pre-study examination, especially: a) any condition, which could modify absorption, distribution, metabolism, or excretion of the drug regimen under investigation b) Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
* Regular smoking
* Blood donation within 6 weeks before first study day
* Excessive alcohol drinking (more than approximately 20 g alcohol per day)
* Inability to communicate well with the investigator due to language problems or poor mental development
* Inability or unwillingness to give written informed consent
* Known or planned pregnancy or breast feeding
* Pre-existing moderate or severe liver impairment
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:
Yes
|
NCT01258504
|
{
"brief_title": "Influence of CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Bosentan",
"conditions": [
"Drug Interactions"
],
"interventions": [
"Drug: St. Johns Wort"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01258504",
"official_title": "Influence of Cytochrome P450 3A4 (CYP3A4)-Induction by St. John's Wort (SJW) on the Steady State Pharmacokinetics of Bosentan",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2012-06",
"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)": "2017-05-31",
"last_updated_that_met_qc_criteria": "2010-12-10",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-12-13",
"first_submitted": "2010-12-10",
"first_submitted_that_met_qc_criteria": "2015-05-29"
}
}
}
|
#Study Description
Brief Summary
The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism.
Detailed Description
While significant progress has been made toward identifying effective interventions for preschool-age children with autism (National Research Council, 2001), few scientifically rigorous studies have compared active ingredients of these interventions or examined outcomes focused on core deficits. To address these areas of need, this collaborative, multi-site project combines the expertise of investigators experienced in randomized controlled clinical trials (RCTs), in the study of core deficits in young children with autism, and in data management and analysis of multi-site clinical trials.
The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism: (1) Discrete trial training (DTT)--an applied behavior analysis approach emphasizing highly structured teaching of school readiness skills (match-to-sample, imitation, functional play, and receptive and expressive language) and (2) Interpersonal developmental approach (IDA): a visually supported, child-focused, flexible engagement, social communicative engagement approach on joint attention, symbolic play, and the use of conventional symbols within socially valid communicative contexts.
Children will be randomly assigned to DTT or IDA. In each condition, children's ongoing early intervention programs will be augmented with two 30-minute sessions daily of the study intervention (DTT or IDA) conducted by supervised therapists for 4 months, with transition to home therapy for 2 months.
Potential moderators (e.g., initial mental age and language age) and mediators (e.g. parent synchronization of joint attention and changes in parental expectancies) on treatment outcome will also be examined.
The assessment measures will include diagnostic and developmental measures. There are three sets of assessments. The first set of assessments is to determine whether the child is eligible for the study. If the child is eligible, we will complete the next set of assessments, which are completed at three points: (1) prior to entry into the treatment (this is a baseline measurement conducted just before the start of the treatment phase); (2) at exit; and (3) at a 6 month follow-up. Several assessments will also be completed after 2 months, 4 months, and 6 months.
#Intervention
- BEHAVIORAL : Discrete Trial Training
- UCLA model, developed by Lovaas and colleagues (Smith, Groen \& Wynn, 2000). Two 30-minute sessions daily (5 hours/week) of 1:1 intervention focusing on imitation, match-to-sample, receptive and expressive language. Using operant conditioning, the therapist works individually with a child in a distraction-free setting and administers approximately 10 trials in a sitting, with breaks between sittings.
During months 5 and 6, we will provide parents with training in an apprenticeship format one day per week for an hour per day. The clinician will demonstrate a DTT instructional program, then the parent will take a turn implementing it. The clinician and parent will give each other feedback on their implementation of the program.
- Other Names :
- DTT
- BEHAVIORAL : Interpersonal Developmental Approach
- Focus on teaching joint attention and symbolic play developmentally via floor play milieu teaching approach. Principles applied include following the child's lead and interest in activities, talking about what the child is doing, repeating back what the child says, expanding on what child says, giving corrective feedback, sitting close to the child and making eye-contact, and making environmental adjustments to engage the child (Kasari et al., 2006).
Parents will be incorporated into the treatment to encourage joint engagement with their child and to focus specifically on joint attention and play skills in their interactions. Each home session will last one hour (once a week) during month 5 and 6 and will involve therapist modeling, and coaching of parent in child-directed activities.
- Other Names :
- IDA
|
#Eligibility Criteria:
Inclusion criteria:
* Diagnosis of an autism spectrum disorder (Autistic Disorder or Pervasive Developmental Disorder Not Otherwise Specified) from a licensed doctoral-level clinician, confirmed by the Autism Diagnostic Observation Schedule and clinical judgment.
* Chronological age between 33 and 54 months
* Must be receiving at least 12.5 hours per week of early intervention or preschool developmental services, some of which must be provided in a school setting.
* Cognitive and language requirements (at least two of the following three criteria must be met:
* >12 months for visual reception (as determined by Mullen Scales of Early Learning) or receptive language (as determined by Mullen or Reynell Developmental Language Scales)
* a score of 1,2 or 3 on the ADOS Module 1
* <30 spontaneous communicative words, as determined by behavior assessments (Mother- Child Interaction, Early Social Communication Scales, and Structured Play Assessment)
Exclusion criteria:
* Major medical conditions other than autism, specifically (a) genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis, (b) sensory disabilities such as blindness or deafness, and (c) motor disabilities such as cerebral palsy
* Nonverbal mental age < 12 months, based on a nonverbal score from the Mullen Scales of Early Learning (Mullen, 1995), as reliability of a diagnosis of autism is questionable at this developmental level.
* Expressive language level that exceeds the First Words level, as evidenced by an age equivalent of 24 months or greater on the Expressive Language Scale of the Reynell
* Exposure to English less than 50% of the time
Sex :
ALL
Ages :
- Minimum Age : 33 Months
- Maximum Age : 54 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01018407
|
{
"brief_title": "Interventions for Communication in Autism Network",
"conditions": [
"Autism"
],
"interventions": [
"Behavioral: Discrete Trial Training",
"Behavioral: Interpersonal Developmental Approach"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01018407",
"official_title": "Multisite Randomized Control Treatment of Early Intervention for Spoken Communication in Autism",
"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)": "2009-12"
},
"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)": "2024-06-14",
"last_updated_that_met_qc_criteria": "2009-11-20",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-23",
"first_submitted": "2009-11-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study, the primary aim will be to estimate the magnitude and variability of strength change over time that may be expected for subjects on the study treatment. This estimate of effect will allow us to develop a rigorous statistical plan in the future randomized study. The specific estimation technique to be applied will use a linear random effects model to estimate average strength change during the 3-month lead-in period and then during the twelve-month treatment period, taking into account the quantitative muscle testing (QMT) measures for each subject. Accounting for the correlation between repeated measures from each subject by using a random effects model will yield an unbiased estimate of variability for the population average change in strength. We will use an analysis of pre- and post-treatment data to inform a best estimate of treatment effect. For example, the difference in QMT trends pre- and post-treatment would provide a straightforward measure of efficacy.
Detailed Description
Duchenne muscular dystrophy (DMD) is a progressive disease of skeletal muscle caused by the absence of dystrophin due to a genetic mutation in the x-linked dystrophin gene. The absence of dystrophin results in a fragile muscle membrane that permits an abnormal permeability to electrolytes, especially Ca ++. The increase in intracellular calcium triggers a pathological cascade of events that ultimately results in muscle necrosis and fibrosis, which impedes normal muscle regeneration. The increased knowledge of the pathophysiology of DMD opens the opportunity for pharmacological treatment, with the purpose of altering the disease process and or reverting the muscle degeneration.
This research study requires having Duchenne muscular dystrophy (DMD) and the subject to be between 4 and 7 years old. We expect 5 children to take part in this study at Children's Hospital and 10 other children to participate at other hospitals worldwide.
There will be two (2) screening visits to help decide whether you will be able to participate in the study. At the second screening visit, there will be a blood test (about 13 tablespoons of blood), and an EKG. Once the study doctors decide eligibility to be in the study, the subject will then come back once a month for three months to have his strength tested. After three months, the subject will begin to take the pentoxifylline and have an MRI (you will have a test called an MRI to look inside the muscles of your legs). This will continue for 12 months.
#Intervention
- DRUG : Pentoxifylline
- Pentoxifylline dosing: 20mg/Kg/day in a 20 mg/mL solution. Maximum dose of 1200mg/day. Dosing split into two equal parts taken morning and night with food.
- Other Names :
- Supplier: Frank's Pharmacy, Ocala, Fl. 34474., Product: Pentoxifylline BP, CAS number: 5/6/6493, Formula weight: 278.35, Chemical formula: C13H18N4O3
|
#Eligibility Criteria:
Inclusion Criteria:
* Male
* Age 4 <= age <= 7
* Ambulant independently. Subjects may use a wheelchair occasionally, but only for long distances
* Diagnosis of DMD confirmed by at least one of the following:
* Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD OR
* Gene deletion test positive (missing one or more exons) in the central rod domain (exons 25 <= age <= 60) of dystrophin, where reading frame can be predicted as 'out-of-frame',
* and clinical picture consistent with typical DMD.
* Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) that can be definitely associated with DMD, with a typical clinical picture of DMD.
* Positive family history of DMD confirmed by one of the criteria listed above in a sibling or maternal uncle, and clinical picture typical of DMD.
* Glucocorticosteroid - naïve (i.e. has not been treated with prednisone or Deflazacort within 1 year before onset of the study)
* Has not participated in other therapeutic research protocol within the last 6 months.
* Evidence of muscle weakness by MRC score or clinical functional evaluation
* Ability to provide reproducible repeat QMT bicep score of either the right or left arm within 15% of first assessment score.
Exclusion Criteria:
* Symptomatic DMD carrier
* Use of any medication, nutritional supplement or herb for treatment of DMD within the last 3 months.
* Symptomatic cardiomyopathy or ventricular arrhythmias
* History of significant concomitant illness, impairment of blood clotting ability (as evidenced by increased PT/PTT or bleeding time over the upper limit of normal (ULN)), recent cerebral or retinal hemorrhage, bleeding diathesis, gastric ulcer, hypotension or significant impairment of renal or hepatic function (defined as serum creatinine and GGT respectively, greater than 1.5 times normal upper limit for age and gender).
Sex :
MALE
Ages :
- Minimum Age : 4 Years
- Maximum Age : 7 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00102453
|
{
"brief_title": "Pentoxifylline in Duchenne Muscular Dystrophy",
"conditions": [
"Muscular Dystrophy, Duchenne"
],
"interventions": [
"Drug: Pentoxifylline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00102453",
"official_title": "An Open-Label Pilot Study of Pentoxifylline in Steroid-naive Duchenne Muscular Dystrophy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-07",
"study_completion_date(actual)": "2007-05",
"study_start_date(actual)": "2002-03"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"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)": "2011-10-27",
"last_updated_that_met_qc_criteria": "2005-01-28",
"last_verified": "2011-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-01-31",
"first_submitted": "2005-01-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Despite recent advances in the treatment of Castrate-Resistant Prostate Cancer (CRPC), there remains an unmet medical need to identify and optimise additional treatment for those patients with early prostate cancer who are at greatest risk of relapse following first-line treatment with curative intent.
This is a phase I study investigating the feasibility and tolerability of a short course of neoadjuvant treatment with olaparib, either as a monotherapy or in combination with degarelix) given in the window-of-opportunity prior to radical prostatectomy in men with early, localised intermediate-/high- risk prostate cancer. Our primary objective is to determine the pharmacodynamic biomarker effects of olaparib (a PARP inhibitor) in this patient population.
Participants will receive either single agent olaparib or olaparib in combination with degarelix (androgen deprivation) for two weeks prior to routine radical prostatectomy. We will use immunohistochemistry to quantify changes in the levels of biomarkers of PARP inhibition, e.g. PAR, gamma H2AX, pH2A(s129) and Rad51 foci, using tumour samples taken at baseline and at the time of radical prostatectomy. An intra-operative prostate biopsy will permit us to examine biomarker variability between the samples.
The incidence and severity of Adverse Events will be documented and we will assess the number of trial participants who undergo surgery on schedule. We will assess preliminary evidence of tumour response, e.g. pathological changes and Prostate Specific Antigen (PSA). We also intend to investigate changes to the ctDNA profile by comparing blood samples collected throughout the study.
#Intervention
- DRUG : Olaparib
- PARP Inhibitor
- Other Names :
- AZD2281, Lynparza
- DRUG : Degarelix
- Gonadotrophin releasing hormone blocker
- Other Names :
- Firmagon
|
#Eligibility Criteria:
Inclusion Criteria:
To be included in the trial the patient must:
* Have given written informed consent to participate*
* Men aged 18 years or over
* Patients suitable for radical prostatectomy
* ECOG performance status of 0 or 1
* Access to archived diagnostic tissue or consent to undergo repeat biopsy, if necessary
* Diagnosis of High risk or Intermediate risk prostate cancer, defined as:
* High risk disease: one or more of stage T2c - 3a, or PSA level >20ng/mL, or Gleason score >= 8
* Intermediate risk disease: two or more of: Stage T2 (any), PSA > 10, Gleason of >= 7
* Adequate bone marrow reserve and organ function (measured within 28 days prior to planned first olaparib administration) as demonstrated by the following values:
* Absolute neutrophil count >= 1.8 x 109/L
* Haemoglobin >= 117g/L
* Platelet count >= 135 x 109/L
* WBC >= 3.6 x 109/L
* Peripheral blood smear with no features of MDS/AML
* Adequate hepatic function:
* Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) <= 1.5 times the upper limit of normal (ULN) AND
* Total bilirubin <= 1.5 times the ULN unless in the presence of Gilbert's syndrome with an elevated indirect fraction
* Adequate renal function:
* Serum creatinine <= 1.5 times the ULN concurrent with creatinine clearance >= 50mL/min (calculated by Cockcroft and Gault equation)
* Willing to use two highly effective forms of contraception (see section 11.8) throughout their participation in the trial and for three months after their last dose of olaparib. Patients must refrain from donating sperm from the start of dosing up until sixteen weeks after discontinuing trial treatment
* Normal chest radiograph (CXR) and oxygen saturations
* Patients who are currently/have recently been involved in non-drug-based research are eligible to participate
* If the patient does not consent to participate in the optional genetic research (ctDNA studies on blood) or to optional additional biopsies there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the trial.
Exclusion Criteria:
The presence of any of the following will preclude patient inclusion:
* Contraindication to olaparib or degarelix
* History of hypersensitivity to active or inactive excipients of olaparib
* Patients with known hypersensitivity to the degarelix active substance or mannitol must not receive degarelix.
* Current refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of olaparib
* As judged by the Investigator, any patient considered a poor medical risk due to a serious uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection including but not limited to:
* Uncontrolled ventricular arrhythmia
* Recent myocardial infarction (within three months)
* Unstable spinal cord compression
* Superior vena cava syndrome
* Extensive bilateral lung disease on High Resolution Computed Tomography (HRCT)
* History of pneumonitis
* Active infection including hepatitis B, hepatitis C and Human Immunodeficiency Virus. Screening for chronic conditions is not required.
* Major surgery within 4 weeks prior to entry into the trial (excluding placement of vascular access). Patients must have recovered from side effects of any major surgery. Minor surgery (not including the diagnostic prostate biopsy) within 2 weeks prior to entry into the trial.
* Patients who have received (within last 3 months of trial entry) an investigational drug within a clinical trial will not be eligible to participate.
* Concomitant use of known potent CYP3A4 inhibitors and inducers. See section 10.4.1.1 for list and consider wash out periods.
* Blood transfusions within 1 month prior to the trial start
* ECG with mean resting QTc of >= 470ms (Fridericia; as per local reading) on two or more time points within a 24 hour period or family history of long QT syndrome
* Concomitant medications known to prolong the QT interval (see Appendix 1) or with factors that increase the risk of QTc prolongation or risk of arrhythmic events (such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age), History of Torsades de pointes.
* Judgement by the Investigator that the patient is unsuitable to participate in the trial and the patient is unlikely to comply with trial procedures, restrictions and requirements
* Patients with MDS or AML, or other previous malignancy except patients that have undergone treatment with curative intent for prior malignancy with no evidence of active prior malignancy are eligible.
* With the exception of alopecia, any unresolved toxicities from prior chemotherapy should be no greater than CTCAE (version 4.03) Grade 1 at the time of starting olaparib treatment.
* Patients with a desire to have children following the trial will not be recruited
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 73 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02324998
|
{
"brief_title": "Study of Olaparib (± Degarelix) Given to Men With Intermediate/High Risk Prostate Cancer Before Prostatectomy",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Drug: Olaparib",
"Drug: Degarelix"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02324998",
"official_title": "A Study Into the Pharmacodynamic Biomarker Effects of Olaparib (a PARP Inhibitor) ± Degarelix (a GnRH Antagonist) Given Prior to Radical Prostatectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05",
"study_completion_date(actual)": "2019-05",
"study_start_date(actual)": "2016-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-29",
"last_updated_that_met_qc_criteria": "2014-12-19",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-24",
"first_submitted": "2014-12-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
40 chronic stroke patients with upper limb spasticity will randomly divided into two groups. First group will receive 3 sessions of radial extracorporeal shock wave therapy (rESWT) with one week apart without cessation of current physical therapy, while the second group will continue to receive conventional rehabilitative program.
Assessment will be done at baseline, 2 weeks after rESWT and 3 months after rESWT using Modified Ashworth Scale, Fugl Meyer Assessment for hand function and wrist control, motricity index for pinch grip and Hmax/ Mmax amplitude ratio of flexor carpi radialis muscle.
#Intervention
- DEVICE : Extracorporeal shock wave therapy
- 3 sessions of radial- extracorporeal shock wave therapy rESWT one week apart, 2000-3000 impulses at 0.25-0.84 millijoule /mm2with a pressure 2.8 bar and 15 Hz frequency.
- OTHER : Conventional rehabilitation
- physical \& occupational therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic stroke with disease duration more than one year will be included in the study with stable modified Ashworth scale for upper limb spasticity ranged from 1+ to 4.
Exclusion Criteria:
* Patients more than 65 years,Patients with double stroke and patients with fixed contractures of wrist & hand ,Patients received anti-spastic measures (botulinum toxins, nerve block) within 6 months,Also patients with contraindication to extra-corporeal shock wave therapy i.e. malignancy at treatment area, coagulopathies, active infection (viral or TB), o bleeding wounds, and patients with pacemakers will be excluded
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04312581
|
{
"brief_title": "Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients",
"conditions": [
"Stroke",
"Spasticity",
"Shock Wave"
],
"interventions": [
"Other: Conventional rehabilitation",
"Device: Extracorporeal shock wave therapy"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04312581",
"official_title": "Effect of Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients :Randomized Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-29",
"study_completion_date(actual)": "2020-07-29",
"study_start_date(actual)": "2020-03-21"
},
"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)": "2020-09-01",
"last_updated_that_met_qc_criteria": "2020-03-16",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-18",
"first_submitted": "2020-03-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Safety and bioequivalence of SPARC_147709
#Intervention
- DRUG : SPARC147709
- SPARC147709 injection
- DRUG : Reference147709
- Reference147709 injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Availability for the entire study period and willingness to adhere to protocol requirements.
* Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome
* 18 years or older
* No evidence of underlying disease (except multiple myeloma)
Exclusion Criteria:
* History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride
* History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
* History of smoking (>= 10 cigarettes/day) or consumption of tobacco products (>= 4 chews/day).
* Positive result to HIV, HCV, RPR and HBsAg.
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
|
NCT00863174
|
{
"brief_title": "A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma",
"conditions": [
"Multiple Myeloma"
],
"interventions": [
"Drug: Reference147709",
"Drug: SPARC147709"
],
"location_countries": null,
"nct_id": "NCT00863174",
"official_title": "A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of SPARC_147709- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-01",
"study_completion_date(actual)": "2011-04",
"study_start_date(actual)": "2010-11"
},
"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)": "2019-05-03",
"last_updated_that_met_qc_criteria": "2009-03-16",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-17",
"first_submitted": "2009-03-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Newborn infants experience pain after surgical procedures,prevention and management of pain in neonates is important due to its deleterious consequences. Fentanyl is a widely used analgesic which promotes rapid analgesia,however, is not free of adverse effects including chest wall rigidity, hypothermia, hypotension, respiratory depression and tolerance.Dexmedetomidine is a selective α 2-adrenergic agonist can cause sedation, anxiolysis, analgesia and minimal respiratory depression.Therefore, the objective of the study is to evaluate the safety and efficacy of dexmedetomidine compared to fentanyl in postoperative mechanically ventilated neonates.
Detailed Description
A prospective, randomized trial, which was conducted upon neonates who needed postoperative mechanical ventilation in Neonatal Intensive Care Unit, Mansoura University Children's Hospital.The patients were randomized to two groups according to the drug they received for postoperative sedation. The first group received dexmedetomidine infusion and the second group received fentanyl infusion.Our primary outcome was the efficacy of postoperative sedation score, and the secondary outcomes were plasma cortisol level, time to extubation, time to reach 100ml/kg enteral feed, need for adjuvant sedative and skeletal muscle relaxant, length of the hospital stay, side effects of sedative drugs and mortality.
#Intervention
- DRUG : Dexmedetomidine
- Infants received dexmedetomidine IV loading dose: 0.5 mcg/kg given over 20 minutes followed by maintenance dose 0.3 µg/kg/hour by infusion over 24 hours.Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.
- DRUG : Fentanyl
- Infants received Fentanyl IV continuous infusion: 1µg/ kg /hour. Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.
|
#Eligibility Criteria:
Inclusion Criteria:
* Neonates need postoperative ventilation.
Exclusion Criteria:
* Major congenital cardiovascular anomalies.
* Chromosomal anomalies.
* Grade IV intraventricular hemorrhage.
* Tracheoesophageal fistula with wide gap (distance between proximal and distal end more than two centimeters).
Sex :
ALL
Ages :
- Minimum Age : 1 Hour
- Maximum Age : 4 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05324891
|
{
"brief_title": "Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates",
"conditions": [
"Postoperative Pain"
],
"interventions": [
"Drug: Dexmedetomidine",
"Drug: Fentanyl"
],
"location_countries": null,
"nct_id": "NCT05324891",
"official_title": "Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-08",
"study_completion_date(actual)": "2017-08-30",
"study_start_date(actual)": "2016-01"
},
"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)": "2022-04-13",
"last_updated_that_met_qc_criteria": "2022-04-05",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-13",
"first_submitted": "2022-04-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.
Detailed Description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Carvedilol Tablets USP 12.5 mg of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Coreg® (Carvedilol Tablets) 12.5 mg Tablets of M/s GlaxoSmithKline, under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.
The study was conducted with 42 healthy adult subjects. In each study period, a single 12.5 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.
#Intervention
- DRUG : Carvedilol Tablets USP 12.5 mg
- 12.5mg tablet once a day
- Other Names :
- Test Product
- DRUG : Carvedilol
- 12.5mg tablet once a day
- Other Names :
- Coreg®
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female human subjects, age in the range of 18 - 45 years.
* Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
* Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
* Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).
* Willingness to follow the protocol requirements as evidenced by written informed consent.
* Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.
* No history of drug abuse in the past one year.
* Non-smokers and non-alcoholics.
* For female subject is child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies,Diaphragm, Intrauterine device and Abstinence.
OR
* is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).
Exclusion Criteria:
* Known history of hypersensitivity to Carvedilol, 4-hydroxyphenyl-carvedilol or related drugs.
* Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
* Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
* History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
* Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.
* History of malignancy or other serious diseases.
* Refusal to abstain from food for at least ten (10) hours prior to study drug administration and for at least four (04) hours post-dose, in each study period.
* Any contraindication to blood sampling or difficulty in accessibility of veins.
* Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.
* Refusal to avoid the use of xanthine-containing food or beverages (chocolates,tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.
* Blood donation within 90 days prior to the commencement of the study.
* Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.
* Found positive in breath alcohol test done before check-in for each study period.
* Found positive in urine test for drugs of abuse done before check-in for each study period.
* Refusal to abstain from consumption of tobacco products 24 hours prior to dosing until the last blood sample collection of last study period.
* History of problem in swallowing Tablets.
* Female subject, demonstrating positive urine pregnancy test at the time of screening.
* Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.
* Female subject, currently breast feeding or lactating.
* Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the 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
|
NCT01577914
|
{
"brief_title": "Bioequivalence Study of Carvedilol Tablets USP 12.5 mg Under Fasting Condition",
"conditions": [
"Fasting State"
],
"interventions": [
"Drug: Carvedilol",
"Drug: Carvedilol Tablets USP 12.5 mg"
],
"location_countries": [
"India"
],
"nct_id": "NCT01577914",
"official_title": "A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Carvedilol Tablets USP 12.5 mg With Coreg® 12.5 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.",
"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)": "2011-07"
},
"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)": "2012-07-09",
"last_updated_that_met_qc_criteria": "2012-04-12",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-04-16",
"first_submitted": "2012-04-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA admitted in a hospital for an acute coronary syndrome.
Overall objective:
To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical evolution of patients with acute coronary syndrome (ACS).
Primary objectives:
1. To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with ACS and co-occurring sleep apnea.
Secondary objectives:
1. Determine the prevalence of OSA in patients who have suffered an episode of ACS.
2. Other secondary objectives will include the effects of CPAP on:
* To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic stroke.
* Components of primary composite endpoints
* Re-vascularization procedures
* To evaluate all-cause death
* To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias
* To evaluate newly diagnosed diabetes mellitus, according to standard definitions
* To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS))
* To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D).
3. To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS.
4. To establish the relationship between CPAP compliance and CV events incidence.
5. To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients.
6. To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.
Detailed Description
Methods:
Study design: multi-centre, open label, parallel, prospective, randomised, controlled trial.
Patients: We will include consecutive patients with an ACS diagnosis evaluated in participating Coronary Care Unit.
Study sites: IRB Lleida (Lleida), Hospital Son Dureta (Palma de Mallorca), Hospital Clínic (Barcelona), Hospital Germans Tries i Pujol (Barcelona), Hospital de Bellvitge (Barcelona), Hospital Sant Pau (Barcelona), Hospital Txagorritxu (Vitoria), Hospital de Cruces (Bilbao), Hospital San Pedro de Alcántara (Cáceres), Hospital Parc Taulí (Barcelona) and Hospital de Guadalajara (Guadalajara), Hospital de Vallecas (Madrid), Hospital de Yagüe (Burgos), Hospital de Requena (Valencia), Hospital San Juan, (Alicante), Hospital Central de Asturias (Oviedo).
Duration of the study: 3 years. Methodology: During a hospital stay we will assess the degree of daytime sleepiness (Epworth Scale) in patients treated at the Coronary Care Unit with a diagnosis of ACS. The results of this evaluation will define the inclusion of the patient in the study.
Patients with and ESS score ≤ 10 will be included in the study and will undergo a cardio-respiratory polygraphy. Patients with an AHI ≥ 15 h-1 will be randomized to CPAP treatment or conservative. Patients with and AHÍ \< 15 h-1 will be followed as standard management according to cardiovascular protocols and will be evaluated as a reference group. Therefore, the study will have three groups, with a total of 1,864 patients, as follows: patients with an AHI ≥ 15 h-1 will be randomized to CPAP treatment (Group 1) (n=632) or conservative treatment (Group 2) (n=632). Patients with an AHI \< 15 h-1 that will be followed as a reference group (Group 3) (n=600).
Patients with an ESS score higher than 10 will be excluded of the study and referred to the sleep unit of each participating center for evaluation.
Patients included in the study will be monitored and followed for a minimum of one year and a maximum of three years. Patients will be examined at the time of inclusion (T0), after one month (T1), three months (T2), six months (T3), 12 months (T4) and every six months thereafter, if applicable, during the follow-up period. Evaluations will include; i)new episodes of ACS, stroke, TIA, heart failure, hospitalization for cardiovascular causes and cardiovascular mortality, ii) biological risk markers involved in cardiovascular complications, iii) an evaluation of the cost-effectiveness of diagnosis and CPAP treatment in patients with ACS who have obstructive sleep apnea.
#Intervention
- OTHER : Standard care
- Patients with conservative treatment: (Group 2). This group will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counselling.
- DEVICE : continuous positive airway pressure
- Patients with CPAP treatment (Group 1): CPAP pressure titration will be performed by automated equipment before discharge. It will follow the methodology described by our group (Mass et al. Alternative Methods of titrating continuous positive airway pressure: a large multicentre study. American Journal of Respiratory and Critical Care Medicine (2004) vol. 170 (11) pp. 1218-1224). This group will also be instructed in hygienic-dietary measures recommended for all patients, standard care of cardiovascular risk factors and sleep hygiene counselling.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women > 18 years.
* Patients admitted for documented symptoms of ACS with or without T segment elevation and have an hospital stay between 24h and 72 h in the moment to perform polygraphy .
* Patients with and Epworth Sleep Scale score <= 10 (patients without excessive daytime sleepiness).
* Written informed consent signed.
Exclusion Criteria:
* Previous CPAP treatment for OSA diagnosis
* Psycho-physical inability to complete questionnaires.
* Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
* Patients with > 50% of central apneas or the presence of Cheyne-Stokes Respiration (CSResp)
* Patients with chronic diseases: neoplasia, renal failure (GFR<30 ml/min), severe chronic obstructive pulmonary disease, chronic depression and other very limiting chronic diseases.
* A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
* Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
* Any process, cardiovascular or otherwise, that limits life expectancy to less than one year.
* Patients in cardiogenic shock who have poor expectations for short-term outcomes.
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
|
NCT01335087
|
{
"brief_title": "Continuous Positive Airway Pressure (CPAP) in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea (OSA)",
"conditions": [
"Acute Coronary Syndrome",
"Obstructive Sleep Apnea"
],
"interventions": [
"Other: Standard care",
"Device: continuous positive airway pressure"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01335087",
"official_title": "Impact of Sleep Apnea Syndrome in the Evolution of Acute Coronary Syndrome. Effect of Intervention With Continuous Positive Airway Pressure (CPAP). A Prospective Randomized Study. ISAACC Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09",
"study_completion_date(actual)": "2018-09",
"study_start_date(actual)": "2011-04"
},
"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)": "2018-10-29",
"last_updated_that_met_qc_criteria": "2011-04-13",
"last_verified": "2018-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-14",
"first_submitted": "2011-04-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Coronary artery disease (CAD) is the leading cause of death worldwide. Patients with severe CAD are often treated with coronary artery bypass grafting (CABG). Novel treatment strategies need to be pursued to respond to the continuous increase in the risk profile of contemporary CABG patients. Surgical myocardial revascularization is commonly performed with the use of cardiopulmonary bypass (CPB). Neurological impairment following CABG may take on the form of a new-onset motor deficit or postoperative cognitive dysfunction. The former is rare, but potentially devastating. Conversely, declines in attention, memory and fine motor skills can frequently be documented.
Ischemic preconditioning is a phenomenon of an endogenous protective response to organ ischemia, which is triggered by brief cycles of nonlethal ischemia and reperfusion in tissues known to be more resistant to ischemic insults. In clinical practice remote ischemic preconditioning (RIPC) is achieved by inflicting short periods of ischemia with intermittent restitution of flow to the upper extremity. This intervention has been shown to be effective in the reduction of myocardial injury in cardiac surgical patients. The hypothesis tested in this research proposal is that RIPC will decrease the extent of postoperative neurological injury following CABG.
In this research project, 70 patients scheduled for an elective CABG will be recruited at a single center. They will be randomly allocated to either undergo RIPC (intervention arm) or a sham procedure (control arm). Inflating a blood pressure cuff to 200 mmHg for 5 min will induce RIPC, thereby inducing a brief period of ischemia. This will be followed by a 5-minute arm reperfusion. In total, three cycles of arm ischemia and reperfusion will be induced in this fashion.
All patients will undergo pre- and post-procedural magnetic resonance imaging (MRI) of the brain, as well as neurocognitive testing. The array of MRI tools that will be used for the quantification of brain injury will include fluid attenuated inversion recovery, diffusion weighted and susceptibility weighted imaging, coupled with resting state functional MRI.
The investigators aim to determine whether RIPC can reduce the adverse impact of CPB on neurological outcome as evaluated by MRI detectable brain ischemia and neurocognition.
Detailed Description
Coronary artery bypass grafting (CABG) is very effective in the management of complex coronary artery disease (CAD). Cardiopulmonary bypass (CPB) is commonly employed to achieve a still and bloodless field, which facilitates the creation of technically impeccable coronary anastomoses. Multiple adverse effects that stem from exposure of blood to a non-endothelial surface contrast the clear benefit of CPB. Neurological damage remains one of the most dreaded complications following CABG. While the incidence of new focal motor deficits is low, postoperative neurocognitive dysfunction (POCD) is seen commonly. The increasing risk profile of contemporary CABG patients makes neuroprotective strategies progressively more important.
Ischemic preconditioning is an endogenous protective response triggered by brief episodes of nonlethal ischemia and reperfusion. In clinical practice remote ischemic preconditioning (RIPC) is achieved by inducing short periods of ischemia of the upper extremity, followed by restitution of flow. This non-pharmacological strategy for inducing ischemic tolerance is cost-free and non-invasive, with potentially wide clinical applicability.
The 'Impact of Remote Ischemic Preconditioning preceding Coronary Artery bypass Grafting on inducing nEuroprotection (RIPCAGE) trial' will recruit 70 patients scheduled for elective CABG at a single academic center. The hypothesis tested in this research proposal is that RIPC will decrease the extent of postoperative neuronal damage and lead to a reduction in POCD among CABG patients. Specifically, the investigators aim to determine whether RIPC can reduce magnetic resonance imaging (MRI) detectable brain damage and attenuate the neurocognitive decline universally seen in patients after CABG.
The primary composite outcome will consist of a composite of new ischemic lesions on brain MRI and POCD.
The secondary endpoints will be the following:
1. Brain connectivity profiles on resting-state functional MRI (rs-fMRI).
2. Pooled ischemic volumes of new diffusion-weighted imaging (DWI) hyperintensity.
3. Percent declines of components in individual neurocognitive tests.
Patients will be randomly allocated in a 1:1 ratio to either receive RIPC or no intervention (control group). In the intervention arm, transient upper extremity ischemia will be induced after induction of anesthesia by inflating a blood pressure cuff to 200 mmHg for 5 min, followed by a 5 min cuff deflation. This sequence will be repeated 3 times. Patients in the control group will also have a blood pressure cuff placed, but it will not be inflated. All patients will undergo preoperative neurocognitive testing coupled with baseline brain MRI. The neurocognitive evaluation will consist of the Montreal Cognitive Assessment (MoCA) test and the Trail Making Test (TMT). Decreased cognitive function for each test will be defined as an individual decrease of at least 1 standard deviation of the group baseline mean for that test. POCD will be defined as a decrease in two or more tests. The patients will have a repeat neurocognitive evaluation prior to discharge from hospital.
Standard MRI sequences will be performed in all patients. DWI will be utilized for volumetric analysis of brain tissue exhibiting stigmata of ischemic injury. The timing of apparent diffusion coefficient quantification will be standardized to postoperative day 7, as it normalizes over time. Additional MRI sequences will include susceptibility weighted imaging (SWI) and diffusion tensor imaging (DTI). Resting state functional MRI will be performed in order to investigate the coordination of activity across brain networks. Pre- and postprocedural rs-fMRI data will be subsequently compared with each other. Disruption in the connectivity of neural circuits induced by the operation will be thereby be objectivized.
Patients will be followed for a total of 3 months, during which time all adverse events will be recorded and adjudicated by an independent clinical events committee.
#Intervention
- PROCEDURE : Remote ischemic preconditioning
- A blood pressure cuff will be placed on the left arm and three cycles of 5 min ischemia followed by 5 min reperfusion will be applied.
- PROCEDURE : Control
- The cuff will be placed around the arm but not inflated.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients with multi-vessel coronary artery disease undergoing primary, elective on-pump CABG
* Written informed consent
Exclusion Criteria:
* Prior stroke, transient ischemic attack or reversible ischemic neurologic deficit
* Stenosis of the internal carotid artery (>50%)
* Significant peripheral arterial disease affecting the upper limbs
* Acute coronary syndrome within 30 days prior to surgery
* Inability to provide consent
* Postoperative exclusion criteria will be limited to contraindications to follow-up MRI (such as pacemaker dependence)
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
|
NCT02177981
|
{
"brief_title": "Impact of Remote Ischemic Preconditioning Preceding Coronary Artery Bypass Grafting on Inducing nEuroprotection",
"conditions": [
"Brain Ischemia",
"Postoperative Confusion"
],
"interventions": [
"Procedure: Control",
"Procedure: Remote ischemic preconditioning"
],
"location_countries": [
"Croatia"
],
"nct_id": "NCT02177981",
"official_title": "A Randomized, Double-Blind, Controlled Clinical Trial: Impact of Remote Ischemic Preconditioning Preceding Coronary Artery Bypass Grafting on Inducing Neuroprotection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10",
"study_completion_date(actual)": "2016-03",
"study_start_date(actual)": "2014-03"
},
"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)": "2018-04-25",
"last_updated_that_met_qc_criteria": "2014-06-26",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-30",
"first_submitted": "2014-04-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Intra-articular hip injections are commonly used for diagnostic and therapeutic purposes but are often associated with patient anxiety and fear. The disparity between anticipated and experienced pain during this injections and the role of pre-injection local anesthesia in pain modulation remains unclear.
This study investigate the difference between anticipated and experienced pain during Intra-articular hip injections. In addition the study investigate the impact of pre-injection local anesthesia in 60 prospectively recruited patients, with or without pre-injection local anesthesia. These study findings offer value in understanding experienced pain during Intra-articular hip injections which can be applied to improve patient experiences and treatment compliance.
Detailed Description
1. Identification of patients, in the outpatient clinic, and completion of the questionnaires will be carried out by the principal investigator/sub-investigators in the clinic.
2. Data processing will be conducted by physicians holding an MD certification.
3. The type of study is prospective.
4. Data collection will be done from the medical records of Tel Aviv Medical Center Hospital only, between the years 2021 and 2022.
5. Demographic data will be collected - gender, year of birth, age, diagnosis, indication for injection, previous treatments Clinical data - underlying diseases, side of injection, complications, indications, follow-up time.
#Intervention
- PROCEDURE : Intra-articular corticosteroid injection
- Intra-articular hip injections with and without local anastesia and questionnaire about pain and anxiety related to the procedure was administered before and after the injection to the study and control groups.
- Other Names :
- Local anasthesia
|
#Eligibility Criteria:
Inclusion Criteria: patients undergoing first-time intra-articular hip injection as indicated by an orthopedic surgeon either for diagnostic (e.g. lidocaine test, arthrography) and/or therapeutic (steroid injection for osteoarthritis) purposes. Participants were 18 years or older, had no previous hip joint injections, and could fill in the survey questionnaire.
*
Exclusion Criteria: patients under 18 years, patients with a known history of hypersensitivity or allergy to the injectant material (e.g. local anesthetics, steroids), and patients lacking the ability to sign informed consent or to complete a survey questionnaire. Patients with previous hip joint injections were also excluded, due to the possibility that these patients could recall the prior pain experienced.
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06760559
|
{
"brief_title": "Does Pre-injection Local Anesthesia Affect Experienced Pain During Intra-articular Hip Injections.",
"conditions": [
"Pain",
"Pain Intensity Assessment",
"Injection",
"Injection Pain Prevention"
],
"interventions": [
"Procedure: Intra-articular corticosteroid injection"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT06760559",
"official_title": "Pain Scores Following Intrarticular Injections",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-02",
"study_completion_date(actual)": "2022-01-02",
"study_start_date(actual)": "2021-01-03"
},
"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)": "2025-01-07",
"last_updated_that_met_qc_criteria": "2024-12-31",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2025-01-07",
"first_submitted": "2024-12-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to the bones) outpatient or emergency setting.
Detailed Description
This is an open-label (all people know the identity of the intervention), non-randomized, multi-center (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) study of tramadol hydrochloride-paracetamol tablets. Participants will receive 1 to 2 tablets of tramadol hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \[mg\] and paracetamol 325mg). Participants may be given the additional dose according to the clinical requirement. The total treatment duration will be 6 hours. The total study duration will be 4 months. Efficacy will be evaluated primarily by pain intensity and pain relief. Participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours respectively after the first dose; and the drug efficacy and overall satisfaction level at the end of 6 hours after the first dose. Participants' safety will be monitored throughout the study.
#Intervention
- DRUG : Tramadol HCl-Paracetamol
- Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \[mg\] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement.
|
#Eligibility Criteria:
Inclusion Criteria:
* Intermittent or persistent pain for less than 3 months, required analgesic therapy, orthopedic surgery and emergency call participants suffering with severe neck, shoulder, low back pain or chronic neck, shoulder, lower back pain, acute (a quick and severe form of illness in its early stage) exacerbation pain
* Pain intensity to be assessed using Numerical Rating Scale (NRS), NRS score more than or equal to 4 (from 0 to 10, 0 = no pain, 10 = extreme pain)
* During normal pain and stable feeling, can study pain assessment methods and can fill in pain control diary
* Be willing to participate in the study and must give written informed consent
Exclusion Criteria:
* Have used strong opium kind of medication 7 days prior to the enrolment
* Have severe mental disease or using antipsychotic (agent that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect) medication for medical treatment
* Drug abuse/dependence, or chronic alcohol abuse/depend on history
* Pregnant or lactating women
* Unable to tolerate tramadol or any failed treatment in past by using tramadol
* Comparatively more severe pain in other parts of the body than that of the pain mentioned in the research
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
|
NCT01843660
|
{
"brief_title": "An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain",
"conditions": [
"Low Back Pain",
"Shoulder Pain",
"Neck Pain"
],
"interventions": [
"Drug: Tramadol HCl-Paracetamol"
],
"location_countries": null,
"nct_id": "NCT01843660",
"official_title": "The Clinical Efficacy and Safety Study of Tramadol Hydrochloride - Paracetamol Tablets in the Treatment of Moderate to Severe Acute Neck-shoulder Pain and Low Back Pain in Orthopaedics Outpatient or Emergency Setting",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-05",
"study_completion_date(actual)": "2008-05",
"study_start_date(actual)": "2007-09"
},
"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)": "2013-08-26",
"last_updated_that_met_qc_criteria": "2013-04-26",
"last_verified": "2013-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-04-30",
"first_submitted": "2013-04-26",
"first_submitted_that_met_qc_criteria": "2013-06-18"
}
}
}
|
#Study Description
Brief Summary
Adolescence is the period in which a person grows and develops the fastest, covering the transition from childhood to maturity. Compared to sedentary adolescents who regularly exercise, there were significant differences in levels of functional capacity, cognitive function, and quality of life. The balance that shows significant development in the adult period, if not sufficiently developed, results in a lack of proper balance during movements, making individuals exposed to injuries.
A strong 'core' area is needed to ensure the stabilization of the whole body and increase functional capacity. In the studies carried out, the 'core' exercise programs resulted in increased lumbopelvic stability, improved small and large muscle strength, and increased body control and balance.
Motor imagery is defined as the resurrection of movement in the mind before movement occurs. For individuals with health or health-related problems, it has been found that the implementation of imaging tasks is beneficial, either alone or in addition to physical practice and that similar brain regions are activated during the performance of the movement and imaging the movement.
56 healthy girls will be included in our study. The participants will be randomly divided into 2 groups, including 28 control groups and 28 training groups. The core performance will be assessed with the Modified Push-Up Test and Sit-Up Test. The Flamingo test will be used to assess static balance and the Y test will be used to assess dynamic balance. Quality of life will be assessed with the Pediatric Quality of Life Questionnaire (PedsQL) for adolescents aged 13-18 years. Functional capacity will be assessed with the 6-Minute Walk Test. Exercise Readiness Questionnaire will be used to measure exercise readiness. The Movement Imagery Questionnaire-Revised (MIQ-R) form will be used for motor imagery; the Vividness of Motor Imagery Questionnaire (VMIQ) will be used for clarity and vividness of motor imagery. During the motor imagery training, heart rate will be measured to determine whether the participant performs the imagery correctly. In addition to all of these assessments, the values of Heart Rate, Blood Pressure, Saturation, Dyspnea, and Fatigue Levels (Modified Borg Dyspnea and fatigue scales) will be recorded. The control group will be subject to Jeffreys' core (body) stabilization training protocol. The training group will receive engine simulation training in addition to Jeffreys' core (body) stabilization training protocol. The control group and the training group will implement training programs with a physiotherapist 3 times a week for 8 weeks. All assessments will be repeated before and after the 8-week training program.
The aim of the present study is to investigate the effect of motor imagery training given in addition to core stabilization training on core performance, balance, functional capacity, and quality of life in healthy adolescent girls.
#Intervention
- OTHER : Motor Imagery Training
- The motor imagery training will be given with an audio recording containing 15 minutes of motor imagery training. The protocol will be administered by a physiotherapist 3 times a week for 8 weeks.
- OTHER : Core Stabilization Exercises
- Jeffreys' Core (body) Stabilization Exercises will be implemented. The protocol consists of exercises that progress gradually from the first level to the third level. The first level consists of static contraction training on a stable surface; the second level is dynamic training on stable surfaces; and the third level is dynamic and resistant training on an unstable surface. Each session is scheduled to last 45 minutes, with 5 minutes of heating and 5 minutes of cooling exercises. The protocol will be administered by a physiotherapist 3 times a week for 8 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Being between 10 and 19 years
* Having no barriers to exercise according to Activity Readiness Questionare for Everyone (PAR-Q+)
* To get a valid score from Vividness of Imagery Questionnaire (VMIQ)
* To volunteer to participate in the study
Exclusion Criteria:
* Having had any neurological and orthopedic injury in the last 1 year
* Having a history of any vestibular-visual disease that may affect balance
* Having a history of any disease that may cause disability or systemic problems during exercise
Sex :
FEMALE
Ages :
- Minimum Age : 10 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05986175
|
{
"brief_title": "The Effect of Motor Imagery Training in Addition to Core Stabilization Exercises on Core Performance, Balance, Functional Capacity, and Quality of Life in Healthy Adolescents Girls",
"conditions": [
"Adolescent"
],
"interventions": [
"Other: Motor Imagery Training",
"Other: Core Stabilization Exercises"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05986175",
"official_title": "The Effect of Motor Imagery Training in Addition to Core Stabilization Exercises on Core Performance, Balance, Functional Capacity, and Quality of Life in Healthy Adolescents Girls",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-30",
"study_completion_date(actual)": "2023-12-30",
"study_start_date(actual)": "2023-06-01"
},
"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)": "2024-05-16",
"last_updated_that_met_qc_criteria": "2023-08-03",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-14",
"first_submitted": "2023-07-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The satiety effects of the combination of protein and fiber within egg and whole grain breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating than low protein, low fiber.
Detailed Description
Subjects will consume 3 different breakfast meals. Satiety will be measured by visual analogue scales; food intake will be recorded at subsequent meal as well as 24 hour food log; blood glucose response will be assessed following test meals. Subjects will consume an ad libitum lunch meal 3.5 hours after breakfast meal and food intake will be measured.
#Intervention
- OTHER : Egg refined grain
- OTHER : Egg Whole Grain
- OTHER : Cereal Refined grain
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy,
* non-smoking,
* BMI of 18 <= age <= 27,
* non-dieting,
* typically consumes breakfast/lunch
Exclusion Criteria:
* distaste for eggs,
* vegetarian,
* current smoker,
* restrained eating habits,
* recent weight change,
* history of significant disease of past medical history,
* pregnant,
* lactating irregular menstrual cycle
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02272153
|
{
"brief_title": "Satiety Effects of the Combination of Egg and Whole Grains",
"conditions": [
"Food Selection"
],
"interventions": [
"Other: Egg Whole Grain",
"Other: Cereal Refined grain",
"Other: Egg refined grain"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02272153",
"official_title": "The Effects of the Combination of Egg and Whole Grains on Appetite, Blood Glucose Response and Food Intake",
"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": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-01-15",
"last_updated_that_met_qc_criteria": "2014-10-21",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-22",
"first_submitted": "2014-10-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Urban air pollution is a major contributor to greenhouse gases and has been shown to increase cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel marketing and research, with biodiesel emerging as one of the strongest contenders within international markets. The pursuit of alternative renewable fuels is incredibly complex and has powered research in agriculture, biotechnology, production, transportation, feedstocks, ecology and biomass manufacturing. In spite of this, health effects have been an almost completely overlooked aspect. The purpose of this study is to investigate whether 100% biodiesel exhaust exposure in healthy volunteers leads to cardiovascular and inflammatory responses. Further investigations into the chemical composition of biodiesel exhaust will also be performed.
#Intervention
- OTHER : Forearm venous occlusion plethysmography study
- Measurement of forearm blood flow during unilateral intrabrachial infusion of four vasodilator drugs in incremental doses separated with 20-min washout periods. Bradykinin (endothelial-dependent vasodilator that releases t-PA) was infused at 100, 300 and 1000 pmol/min; acetylcholine (endothelial independent vasodilator that does not release t-PA) was infused at 5, 10 and 20 mcg/min; sodium nitroprusside (endothelial independent vasodilator that does not release t-PA) was infused at 2, 4 and 8 mcg/min and verapamil (endothelial independent and NO independent vasodilator that does not release t-PA) was infused at 10, 30 and 100 mcg/min. Bradykinin, acetylcholine and sodium nitroprusside were given in random order and verapamil was administered last due to its long acting effects.
|
#Eligibility Criteria:
Inclusion Criteria:
Non-smoking, healthy male subjects. All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function.
Exclusion Criteria:
* Diabetes Mellitus
* Cardiovascular disease
* Asthma
* Respiratory infection within 2 weeks of the study
* Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
* Smokers or regular snus usage
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01883466
|
{
"brief_title": "Health Effects of Biodiesel Exhaust Exposure",
"conditions": [
"Vascular Endothelium"
],
"interventions": [
"Other: Forearm venous occlusion plethysmography study"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT01883466",
"official_title": "Cardiovascular Effects of Exposure to 100% Biodiesel Exhaust in Man",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-04",
"study_start_date(actual)": "2012-09"
},
"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)": "2013-06-21",
"last_updated_that_met_qc_criteria": "2013-06-18",
"last_verified": "2013-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-21",
"first_submitted": "2013-04-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.
Detailed Description
Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.
#Intervention
- DRUG : Doxorubicin hydrochloride (liposomal)
|
#Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy provided these doses have been stable for at least 1 month.
* Maintenance therapy for tuberculosis, fungal, and herpes infections.
* Therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
* Foscarnet or ganciclovir for CMV infection.
* Colony stimulating factors and erythropoietin.
Patients must have:
* Moderate to severe AIDS-related Kaposi's sarcoma.
* Documented anti-HIV antibody.
* No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
NOTE:
* Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Clinically significant cardiac disease.
* Confusion or disorientation.
Concurrent Medication:
Excluded:
* Other cytotoxic cancer chemotherapy.
Patients with the following prior conditions are excluded:
* Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function.
* History of idiosyncratic or allergic reaction to anthracyclines.
* History of major psychiatric illness.
Prior Medication:
Excluded within the past 4 weeks:
* Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol).
* Interferon treatment.
Prior Treatment:
Excluded within the past 3 weeks:
* Radiation or electron beam therapy.
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
|
NCT00002319
|
{
"brief_title": "A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma",
"conditions": [
"Sarcoma, Kaposi",
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00002319",
"official_title": "Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma",
"recruitment_information": null,
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2005-06-24",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "1996-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "1999-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Down syndrome is a congenital condition which includes physical mental, and functional abnormalities. It arises from defect involving chromosome 21, usually an extra copy (trisomy 21). Purpose of this study will determine the relationship between BMI, physical fitness and motor skills in youth with down syndrome
Detailed Description
This will be a cross-sectional study. The sample size is 169. The inclusion criteria will be Diagnosed with trisomy 21, Aged 6-11 years, Abel to follow a minimum of two-step instructions, The minimum motor ability of participants with DS is independent locomotion where as the exclusion criteria will be medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems, orthopedic instability, including those associated with DS (e.g., Atlanto-axial instability), behavioral issues that hindered instruction. The BMI will be assessed using a person's height and weight. The formula is BMI = kg/m 2 where kg is a person's weight in kilograms and m 2 is their height in meters squared. Physical Fitness by using SAMU Disability Fitness Battery (SAMU-DISFIT). the Timed Up and Go test (TUG), the Deep Trunk Flexibility test (DTF), the Hand Grip test (HG), the Timed Stand Test (TST), the 30-s Sit-Up (SUP), the 6-Min Walk Test (6MWT) and Motor Skills using Test of Gross Motor Development (TUG-2) Data will be analyzed using SPSS 22.0. Frequency tables and bar charts will be used for descriptive statistics Chi-Square will be used to find the Association
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with trisomy 21.
* Aged 5 <= age <= 15 years.
* Abel to follow a minimum of two-step instructions.
* The minimum motor ability of participants with DS is independent locomotion.
Exclusion Criteria:
* Medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems.
* Orthopedic instability, including those associated with DS (e.g., Atlanto-axial instability).
* Behavioral issues that hindered instruction
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05904821
|
{
"brief_title": "Relationship Between BMI, Physical Fitness and Motor Skills in Children With Down's Syndrome",
"conditions": [
"Down Syndrome"
],
"interventions": null,
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05904821",
"official_title": "Relationship Between BMI, Physical Fitness and Motor Skills in Children With Down's Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-31",
"study_completion_date(actual)": "2023-09-15",
"study_start_date(actual)": "2023-05-23"
},
"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)": "2023-11-13",
"last_updated_that_met_qc_criteria": "2023-06-06",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-06-15",
"first_submitted": "2023-06-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A single centre, open label, study to assess the safety, tolerability and biodegradation of PA5108 ocular implant in adults who have Open Angle Glaucoma (Primary or Secondary).
Detailed Description
Participants who are currently managing their Open Angle Glaucoma with combination drop therapy will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.
#Intervention
- DRUG : PA5108
- single ocular implant, administered on day 1
|
#Eligibility Criteria:
Inclusion Criteria:
* Grade 3 or 4 open angle glaucoma (Shaffer-Etienne scale)
* Visual acuity in non-study eye same or better than study eye
* Currently taking topical ocular hypotensive medication including a prostaglandin analogue
Exclusion Criteria:
* Aphakic eyes
* Only one eye
* History of, or current uveitis, Cystoid Macular Edema (CME) or cornea edema
* Intraocular surgery or cornea/refractive surgery in study eye in past 6 months or anticipate need for eye surgery (including laser) in study eye during study period
* Current retinal detachment
* Uncontrolled infection in the eye
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
|
NCT03604328
|
{
"brief_title": "Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma",
"conditions": [
"Open-angle Glaucoma"
],
"interventions": [
"Drug: PA5108"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT03604328",
"official_title": "An Open-label Phase I Study to Evaluate the Safety, Tolerability and Biodegradation Period of PolyActiva PA5108 Ocular Implant When Administered Intracamerally to the Anterior Chamber of the Eye",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-15",
"study_completion_date(actual)": "2020-06-15",
"study_start_date(actual)": "2018-07-24"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-16",
"last_updated_that_met_qc_criteria": "2018-07-26",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-27",
"first_submitted": "2018-07-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Suaahara's primary aim is to reduce the prevalence of stunting, wasting, and underweight among children under 5 years of age and to reduce the prevalence of anemia among women of reproductive age and children 6-59 months of age. For this, the program uses a multi-sectoral approach to achieve four key intermediate results: 1) improved household nutrition, sanitation, and health behaviors; 2) increased use of quality nutrition and health services by women and children; 3) improved access to diverse and nutrient-rich foods by women and children; and 4) accelerated roll-out of the Multi-Sectoral Nutrition Plan (MSNP) through strengthened local governance
Detailed Description
The Government of Nepal and development partners have prioritized multi-sectoral (integrated) nutrition as a key development agenda. The Suaahara program funded by the United States Agency for International Development is one of the programs that support the Government of Nepal's multi-sectoral nutrition plan. It aims to reduce maternal and child under-nutrition over a period of ten years, spanning two phases: Suaahara I (2011-2016) and Suaahara II (2016-2021). Initially launched in 20 of 75 districts, the program has scaled-up to 42 of 77 districts that span across Nepal's three agroecological zones of mountains, hills, and terai.
Suaahara I was led by Save the Children International in partnership with Helen Keller International, Johns Hopkins University Center for Communications Programs, Jhpiego, Nepal Water for Health (NEWAH), the National Promotion and Consultancy Service, and the Nepali Technical Assistance Group (NTAG). Suaahara II was led by Helen Keller International in partnership with Cooperative for Assistance and Relief Everywhere, Inc., Family Health International 360), he Nepali Technical Assistance Group, Digital Broadcast Initiative Equal Access, Environmental and Public Health Organization, and Vijaya Development Resource Center.
Suaahara's primary aim is to reduce the prevalence of stunting, wasting, and underweight among children under 5 years of age and to reduce the prevalence of anemia among women of reproductive age and children 6-59 months of age. For this, the program uses a multi-sectoral approach to achieve four key intermediate results (IRs): 1) improved household nutrition, sanitation, and health behaviors; 2) increased use of quality nutrition and health services by women and children; 3) improved access to diverse and nutrient-rich foods by women and children; and 4) accelerated roll-out of the MSNP through strengthened local governance. Suaahara interventions span health and family planning (FP), nutrition, agriculture/homestead food production (HFP), and water, sanitation and hygiene (WASH). Diverse social and behavior change communication interventions are used, primarily to generate demand for access to improved services and to motivate households to adopt optimal health, nutrition, and WASH practices. All Suaahara interventions are supported by a crosscutting theme of gender equality and social inclusion (GESI), in part by targeting women and disadvantaged groups and conducting activities that address GESI-related barriers to optimal health, nutrition, and WASH behaviors. Suaahara's conceptual framework illustrates the paths by which the program activities linked to desired outcomes achieve Suaahara II objectives.
#Intervention
- BEHAVIORAL : Health and family planning
- Promotion of health and family planning behaviors
- BEHAVIORAL : Nutrition
- Promotion of maternal, infant, and young child feeding behaviors and nutrition
- BEHAVIORAL : Agriculture and homestead food production
- Promotion of knowledge and practices about homestead food production
- BEHAVIORAL : Water, sanitation, and hygiene
- Promotion of behaviors to improve water, sanitation, and hygiene
|
#Eligibility Criteria:
Inclusion Criteria:
* At the household level, the primary respondents are mothers of children under 5 years from the selected households.
* Other survey respondents include a primary male (or female, if male unavailable) household decision-maker, and a grandmother of children under 5 years residing in the household.
* The Female Community Health Volunteer and health workers are also Suaahara beneficiaries, as the program explicitly aims to improve their knowledge and skills.
Exclusion Criteria:
* None.
Sex :
ALL
Ages :
- Minimum Age : 0 Months
- Maximum Age : 60 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05448287
|
{
"brief_title": "Suaahara Impact Evaluation: End-line Survey",
"conditions": [
"Nutritional Stunting",
"Feeding Behavior"
],
"interventions": [
"Behavioral: Water, sanitation, and hygiene",
"Behavioral: Nutrition",
"Behavioral: Health and family planning",
"Behavioral: Agriculture and homestead food production"
],
"location_countries": [
"Nepal"
],
"nct_id": "NCT05448287",
"official_title": "Suaahara Impact Evaluation: End-line Survey",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-30",
"study_completion_date(actual)": "2022-09-30",
"study_start_date(actual)": "2022-06-17"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-06",
"last_updated_that_met_qc_criteria": "2022-07-02",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-07",
"first_submitted": "2022-06-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of Stress Urinary Incontinence (SUI) that she ranks as a greater disruption to her quality of life than her original vaginal bulge. While retropubic (RP) slings are considered to be the 'gold-standard' referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.
Detailed Description
Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. Efficacy and risk always compete for equilibrium. Level I evidence has demonstrated a positive efficacy benefit of a concomitant synthetic mid-urethral sling in women with, and without, pre-operative symptoms of SUI who are undergoing POP repair. Concomitant sling placement has been shown to reduce the risk of de novo or persistent SUI from 50% to 23%. The combination of surgical treatment of POP and SUI at the same time, however, increases the risk of incomplete bladder emptying. While retropubic (RP) slings are considered to be the 'gold-standard' referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. As the combination of POP and sling surgery increases the risk of voiding dysfunction, and rates of incomplete bladder emptying appear significantly lower for SIS than RP slings, the study team hypothesizes that the use of the Single-incision Mid-Urethral Sling SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding symptoms/voiding dysfunction at one year after combined surgery.
#Intervention
- DEVICE : RP sling placement
- A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.
- DEVICE : SIS placement
- The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
|
#Eligibility Criteria:
Inclusion Criteria:
* At least 21 years
* Women being considered for a native tissue vaginal repair in any vaginal compartment or colpocleisis
* POP >= stage II of any vaginal compartment, according to the pelvic organ prolapse quantification (POP-Q) system
* Vaginal bulge symptoms
* Positive standardized cough stress test on clinical examination, or on urodynamic testing
* Surgical plan that includes a native tissue vaginal repair including colpocleisis for symptomatic POP in any compartment
* Understanding and acceptance of the need to return for all scheduled follow-up visits
* English speaking and able to give informed consent
* Willing and able to complete all study questionnaires
Exclusion Criteria:
* Prior surgery for stress urinary incontinence
* Status post reconstructive pelvic surgery with transvaginal mesh kits or sacrocolpopexy with synthetic mesh for prolapse
* Any serious disease, or chronic condition, that could interfere with the study compliance
* Unwilling to have a synthetic sling
* Inability to give informed consent
* Pregnancy or planning pregnancy in the first postoperative year
* Untreated urinary tract infection (may be included after resolution)
* Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)
* Prior pelvic radiation
* Incarcerated
* Neurogenic bladder/ pre-operative self-catheterization
* Elevated post-void residual (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
* Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) prolapse repair
* Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy.
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03520114
|
{
"brief_title": "Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence",
"conditions": [
"Stress Urinary Incontinence",
"Pelvic Floor Disorders"
],
"interventions": [
"Device: RP sling placement",
"Device: SIS placement"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03520114",
"official_title": "Randomized Trial of Retropubic Versus Single-incision Mid-Urethral Sling (Altis ) for Concomitant Management of Stress Urinary Incontinence During Native Tissue Vaginal Repair",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-02",
"study_completion_date(actual)": "2024-01-02",
"study_start_date(actual)": "2018-12-12"
},
"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)": "2025-01-16",
"last_updated_that_met_qc_criteria": "2018-04-26",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-09",
"first_submitted": "2018-04-26",
"first_submitted_that_met_qc_criteria": "2025-01-14"
}
}
}
|
#Study Description
Brief Summary
The investigators hypothesize that the combination of the FOLFIRINOX regimen (a combination of 5-fluorouracil, irinotecan and oxaliplatin chemotherapy) to provide maximal systemic disease control and FDR-gemcitabine chemotherapy with concurrent IMRT (Radiation therapy) to address local disease, will achieve a significant improvement R0 resection (Radiation oncology repeat surgeries) rate in borderline resectable (surgical) pancreatic cancer and enhance disease free and overall survival in this patient population.
Detailed Description
Gemcitabine has been the cornerstone of systemic therapy for pancreas cancer over this past decade. Recently, a combination of 5-fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) was reported to have significant efficacy in advanced pancreatic cancer. Preclinical data suggests synergy between irinotecan and 5FU as well as between oxaliplatin and 5FU. Results of a phase II trial in advanced disease were reported in 2005 demonstrating a 26% confirmed response rate and median overall survival of 10.2 months. A follow-up phase III trial comparing FOLFIRINOX with gemcitabine for patients \<75 years of age with advanced pancreatic cancer was presented at ASCO 2010 revealing improvement in PFS (6.4 vs 3.3 months, p=\<.0001) and improved disease control rate (CR+PR+SD) (70.2% vs 50.9%, p=.0003). The most notable result was an impressive improvement in median overall survival with FOLFIRINOX compared to gemcitabine (11.1vs 6.8 months, p-value = \<.0001, HR=.57). The main toxicity was grade 3/4 neutropenia (45.7% vs 18.7%, p=.0001) and increased risk of febrile neutropenia (5.4% vs 0.6%, p=.009)31.
#Intervention
- DRUG : FOLFIRINOX
- Starting dose levels as following:
Oxaliplatin 85mg/m2 intravenously over 120 minutes on day 1. Irinotecan 180mg/m2 intravenously over 90 minutes on day 1. NOTE: patients homozygous for the UGT1A1 (TA)7 promoter allele will be treated at an initial lower dose 140mg/m2 (please see Section 6.3.a) Leucovorin 400mg/m2 intravenously over 90 minutes on day 1. 5FU 400mg/m2 as bolus intravenous injection following leucovorin on day 1. 5FU 2,400mg/m2 infused intravenously as a continuous infusion over 46 hours following the bolus 5FU, beginning on day 1.
- RADIATION : Intensity-modulated radiotherapy (IMRT)
- 50.0Gy in 2.0Gy per fraction
- PROCEDURE : Surgical Exploration
- Patients without metastatic disease will be offered surgical exploration.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
* Patients must be deemed to have borderline resectable disease with no radiologic evidence of distant metastatic disease prior to registration.
* Specifically, patients must have at least one designation of borderline resectable and no designation of unresectable disease.
* Patients must have a life expectancy of at least 12 weeks, a Zubrod performance status of < 1 and be willing and medically able to undergo surgical resection.
* Patients must have adequate organ function defined as follows: absolute neutrophil count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin < 2.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
* Patients must be free of other active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
* Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial due to the unacceptable teratogenic toxicity of abdominal radiation and cytotoxic chemotherapy.
* Patients must be aware of the investigational nature of the therapy and provide written informed consent.
Exclusion Criteria:
* Patients with neuroendocrine tumors are excluded.
* Active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
* Patients with preexisting peripheral neuropathy > grade 2 are ineligible
* Pregnant or nursing women are ineligible.
* Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
* Patients may not have used any investigational agent within 4 weeks prior to enrollment into 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
|
NCT01661088
|
{
"brief_title": "A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients",
"conditions": [
"Pancreatic Cancer"
],
"interventions": [
"Drug: FOLFIRINOX",
"Procedure: Surgical Exploration",
"Radiation: Intensity-modulated radiotherapy (IMRT)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01661088",
"official_title": "A Phase II Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients With Borderline Resectable Pancreatic Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-08-10",
"study_completion_date(actual)": "2019-08-30",
"study_start_date(actual)": "2011-06"
},
"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)": "2019-11-13",
"last_updated_that_met_qc_criteria": "2012-08-08",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-08-09",
"first_submitted": "2012-07-24",
"first_submitted_that_met_qc_criteria": "2018-08-06"
}
}
}
|
#Study Description
Brief Summary
BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used.
OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture.
Detailed Description
A retrospective study design of adult patients (\> 15 years) with suspected pulmonary M. tuberculosis infection was conducted from January 2023 until October 2023, at Khon Kaen Hospital. Sample size was 101 cases. Sensitivity, specificity, accuracy, negative predictive value (NPV), and positive predictive value (PPV) of Allplex™ MTB/MDRe Detection, each with its respective 95% confidence interval (95% CI) were analysed with compared to MTB culture as the gold standard.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical suspected pulmonary M. tuberculosis infection
* Aged 15 years and older
Exclusion Criteria:
* Children under 15 years
* Non-tuberculous mycobacteria (NTM) detection
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06284187
|
{
"brief_title": "Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis",
"conditions": [
"Tuberculosis",
"Pulmonary"
],
"interventions": null,
"location_countries": [
"Thailand"
],
"nct_id": "NCT06284187",
"official_title": "Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-31",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2023-01-01"
},
"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)": "2024-02-28",
"last_updated_that_met_qc_criteria": "2024-02-27",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-02-28",
"first_submitted": "2024-02-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Several studies have shown that tumour hypoxia may have a negative impact on the outcome of anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of treatment may serve as a predictive marker to determine treatment efficacy at an early stage. Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive imaging with positron emission tomography (PET) using the 2-nitroimidazole nucleoside analogue, 3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol (18F-HX4), was tested as a new marker of tumor hypoxia. Before hypoxia-measurements can be clinically implemented for response prediction, the reproducibility of the technique should be assessed for each specific tumor type. Knowledge of reproducibility is needed to determine what change in parameters between two examinations can be considered relevant in an individual patient. Assessment of reproducibility becomes even more important in early response monitoring since the changes in the tumor induced by the treatment may be smaller during the treatment compared to response monitoring after completion of treatment. Also, as image quality of 18F-HX4-PET increases with increasing time intervals after injection, determination of the optimal time point for measurement of hypoxia is warranted.
Detailed Description
Background of the study:
Several studies have shown that tumour hypoxia may have a negative impact on the outcome of anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of treatment may serve as a predictive marker to determine treatment efficacy at an early stage. Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive imaging with positron emission tomography (PET) using the 2-nitroimidazole nucleoside analogue, 3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol (18F-HX4), was tested as a new marker of tumor hypoxia. Before hypoxia-measurements can be clinically implemented for response prediction, the reproducibility of the technique should be assessed for each specific tumor type. Knowledge of reproducibility is needed to determine what change in parameters between two examinations can be considered relevant in an individual patient. Assessment of reproducibility becomes even more important in early response monitoring since the changes in the tumor induced by the treatment may be smaller during the treatment compared to response monitoring after completion of treatment. Also, as image quality of 18F-HX4-PET increases with increasing time intervals after injection, determination of the optimal time point for measurement of hypoxia is warranted.
Objective of the study:
In this study, we first intend to investigate the optimal time point for measurement of hypoxia in esophageal, pancreatic and rectal cancer using 18F-HX4-PET and then assess reproducibility of hypoxia measurements in these tumor types.
Study design:
In this study two steps will be taken. 1) First, as 18F-HX4-PET image quality may improve when allowing for relatively longer time intervals after injection, in three patients with esophageal, pancreatic or rectal cancer 18F-HX4-PET scans will be performed 90, 180 and 240 minutes after injection of 18F-HX4. The time-point with the best image quality (in terms of tumor-to-background-ratio) will be chosen for the reproducibility study. 2) In the second step, patients with proven esophageal, pancreatic or rectal cancer will undergo an 18F-HX4-PET twice within one week before start of treatment. 18F-HX4-PET will be performed at 90, 180 or 240 minutes after injection of 18F-HX4, depending on the results of the first part of the study. Reproducibility of hypoxia measured by 18F-HX4-PET will be assessed. In those patients for whom tumor tissue is available which has not been treated with radiation or chemotherapy, levels of hypoxia measured by 18F-HX4-PET will be compared with endogenous hypoxia markers (HIF1-alfa, CA9, GLUT1, PAI-1, VEGF) using immunohistochemistry. In those patients that underwent 18F-HX4-PET before start of neoadjuvant treatment, levels of hypoxia measured by 18F-HX4-PET will be compared to pathological response after neoadjuvant treatment.
#Intervention
- DRUG : [F-18]HX4
- 400 MBq \[F-18\]HX4, is administered in a single intravenous bolus injection, followed by a saline flush.
- Other Names :
- [18 F]-3-Fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-, 1H-1,2,3-triazol-1-yl)propan-1-ol
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with biopsy proven invasive carcinoma of the esophagus, pancreas or rectum. In pancreatic cancer cytological proof or a high suspicion on CT imaging is allowed, too.
* Tumor size >= 1cm
* WHO-performance score 0 <= age <= 2
* Written informed consent
Exclusion Criteria:
* Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
* Surgery, radiation and/or chemotherapy foreseen within the timeframe needed for two PET scans.
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
|
NCT01995084
|
{
"brief_title": "In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study",
"conditions": [
"Pancreatic Cancer",
"Esophageal Cancer",
"Rectal Cancer"
],
"interventions": [
"Drug: [F-18]HX4"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT01995084",
"official_title": "In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-06",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2012-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-01-14",
"last_updated_that_met_qc_criteria": "2013-11-21",
"last_verified": "2015-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-26",
"first_submitted": "2013-11-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to examine how adults can improve their physical activity levels and eating habits using an interactive web-based weight control program and regular contact with a dietician.
Detailed Description
* All study participants must have regular access to the Internet, however, the study will not provide this access. Participants will be randomly placed in one of two study groups (Group 1 or Group 2).
* Group 1 participants will be asked to make 3 in-person visits, each lasting 75-90 minutes. The following information will be collected: name, mailing address, telephone number, and email address. During the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns.
* Group 1 participants will also receive counseling around diet and physical activity from a registered dietician and be asked to use a specialized website that will allow them to track eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants.
* Group 1 will also receive 5 telephone counseling calls with a health counselor. During the telephone calls, we will teach the participant new skills such as tracking diet and physical activity, goal-setting and staying motivated.
* Group 2 participants will be asked to make 2 in-person visits, each lasting 75-90 minutes in length. The following information will be collected: your name, mailing address, and telephone number. During the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns.
#Intervention
- BEHAVIORAL : Counseling Sessions
- Counseling Sessions at each study visit around diet and physical activity from a registered dietician
- BEHAVIORAL : Specialized Website
- Specialized website that allows participants to track their eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants
- BEHAVIORAL : Telephone Counseling Calls
- 5 telephone calls with a health counselor, lasting 15-20 minutes each.
|
#Eligibility Criteria:
Inclusion Criteria:
* 25 <= age <= 65 of age
* Body mass index between 30 <= age <= 40 kg/m2
* Non-smoker (quit within previous 6 months)
* Comfort reading and speaking English
* Stage 1 hypertension
* Not currently pregnant
* Regular web access from home
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00644202
|
{
"brief_title": "A Pilot Weight Control Intervention at HPHC",
"conditions": [
"Obesity"
],
"interventions": [
"Behavioral: Counseling Sessions",
"Behavioral: Specialized Website",
"Behavioral: Telephone Counseling Calls"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00644202",
"official_title": "A Pilot Weight Control Intervention at Harvard Pilgrim Health Care (HPHC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-02",
"study_completion_date(actual)": "2007-02",
"study_start_date(actual)": "2006-05"
},
"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)": "2008-03-26",
"last_updated_that_met_qc_criteria": "2008-03-20",
"last_verified": "2008-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-03-26",
"first_submitted": "2008-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris
#Intervention
- DEVICE : Sebacia Microparticles
- Topical microparticle suspension
- DEVICE : Nd:Yag Laser
- Laser delivering 1064 nm wavelength light
|
#Eligibility Criteria:
Inclusion Criteria:
* Mild to moderate acne vulgaris
* At least 15 inflammatory acne lesions
* Skin phototype I - III
* Able to understand and comply with study requirements
Exclusion Criteria:
* Severe acne vulgaris
* Nodulocystic acne
* Ongoing use of medications and/or treatments for acne
* New hormone regimen (used for less than 12 weeks)
* Significant medical or mental health condition
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03303170
|
{
"brief_title": "Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris",
"conditions": [
"Acne Vulgaris"
],
"interventions": [
"Device: Sebacia Microparticles",
"Device: Nd:Yag Laser"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03303170",
"official_title": "A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-10",
"study_completion_date(actual)": "2018-04-10",
"study_start_date(actual)": "2017-09-25"
},
"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)": "2019-10-14",
"last_updated_that_met_qc_criteria": "2017-10-02",
"last_verified": "2019-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-05",
"first_submitted": "2017-10-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The use of high-flow nasal cannula (HFNC) has increased. Diaphragmatic ultrasonography is a tool that, as a noninvasive complement to esophageal pressure (Pes) measurement, allows the evaluation of diaphragm function and reflects, through the diaphragm thickening fraction (DTf), the magnitude of diaphragmatic fiber recruitment. The objective of this study was to evaluate the impact of HFNC therapy on the DTf in healthy subjects. Second, this study aimed to assess the behavior of the respiratory rate (RR) and the work of breathing in these subjects.
#Intervention
- DEVICE : High flow nasal canula
- Measurement of diaphragm thickening fraction, respiratory rate and esophageal pressure swing with calculation of diaphragmatic pressure-time product without the use of HFNC and with the use of HFNC at 20 and 40 Liters per minute
- Other Names :
- diaphragm thickening fraction, esophageal pressure swing, Respiratory rate
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy subjects > 18 years
Exclusion Criteria:
* contraindication for esophageal balloon placement
* diagnosis of lung disease
* smokers
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
|
NCT06086769
|
{
"brief_title": "High Flow Oxygen Therapy Effect on Healthy Subjects",
"conditions": [
"Healthy Volunteers",
"Diaphragm",
"Respiratory Rate"
],
"interventions": null,
"location_countries": [
"Argentina"
],
"nct_id": "NCT06086769",
"official_title": "Impact of High Flow Oxygen Therapy on Diaphragm Thickening Fraction in Healthy Subjects. A Prospective Cohort Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-30",
"study_completion_date(actual)": "2022-06-30",
"study_start_date(actual)": "2022-03-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-17",
"last_updated_that_met_qc_criteria": "2023-10-11",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-17",
"first_submitted": "2023-09-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to compare the modulation of pergolide, a D1/D2 receptor agonist, to placebo in non-acute schizophrenic subjects under concomitant therapy with atypical antipsychotics on specific PFC functions. Further aims are to assess the influence of pergolide on psychopathology and extrapyramidal symptoms in comparison to placebo.
Detailed Description
Additionally to the desired treatment of positive symptoms, the administration of typical neuroleptics can lead to undesired side effects such as increase of negative symptomatic and cognitive deficits. The influence of atypical neuroleptics on cognition is still not very well studied. Furthermore there is evidence that some cognitive symptoms seen in schizophrenia are related to a disturbance in the prefrontal cortex PFC and involve specific subtypes of dopamine receptors, namely D1 subtypes, which predominates in this area. It is assumed that patients with this spectrum of cognitive deficits have the worse course and prognosis. Furthermore these deficits are more therapy resistant to the conventional current therapy approaches. There is however some evidence pointing to a positive influence of dopamine agonists on these deficits, but the selective effect of dopamine sub-receptors is still not well investigated. The aim of the study is to examine whether cognitive deficits in higher cognitive functions of the PFC such as working memory, semantic association and executive control improves under dopamine agonistic therapy in schizophrenia and whether this is related to selective D1 modulation.
We predict that the modulation of D1 subtype receptors improve performance in each of these tasks. Because there is no D1 agonist available for human research we decided to use a design comparing a dopamine agonist with mixed D1 and D2 agonistic properties (pergolide) to placebo under a stable D2 antagonistic continuous-therapy with atypical antipsychotics. With this design the D2-component of pergolide can be antagonized by the atypical antipsychotics and a D1 agonistic effect can be suggested, as well as protecting patients against a psychotic re-exacerbation. With this study we aim to bring more insight in the therapy of PFC cognitive deficits of schizophrenia by helping to elucidate the role of selective agonists on cognition in schizophrenic patients. I
#Intervention
- DRUG : Pergolide
- 0,3 mg pergolide (the first two days begin with 0,05mg, then increase of dose of 0,1mg every 3 days for a maximum of 0,3mg/d, taken orally 3x 0,1mg/day). Then stable dose of 0,3mg for one week.. Subsequently slow (for 8 days) reduction of dosage of 0,1mg every 3 days for 6 days then 0,05mg every day for the last two days.
Placebo group is identical in appearance and number of placebo capsules, in the same starting and maintenance scheme as for the pergolide group.
- Other Names :
- Parkotil, Pergolid
|
#Eligibility Criteria:
Inclusion Criteria:
* Non-acute in- and outpatients, with predominantly negative symptoms, and remitted from positive symptoms like hallucinations and delusions for 1 week, with the diagnosis of schizophrenia (ICD 10: F20) at the Psychiatry Hospital of the Universities of Heidelberg, Hamburg-Eppendorf, Zentralinstitut für Seelische Gesundheit Mannheim, SRH Klinikum Karlsbad - Langensteinbach (Clinical interview to establish diagnosis with DSM-IV (M.I.N.I International Neuropsychiatric Interview _ German Version 5.0.0)
* Verbal IQ higher than 80, as measured by the Mehrfachwahl-Wortschatz-Intelligenztest
* Visual acuity must be normal or corrected.
* Color sight intact
* Positive neuroleptics drug monitoring level
* Females must be under adequate contraception (oral hormonal contraceptive, IntraUterineDevice)
Exclusion Criteria:
* Concomitant neurologic and internistic diseases (especially cardiovascular diseases and others like untreated thyroid hyper-/hypofunction, liver or kidney dysfunction, seizures or history of traumatic brain injury)
* Known allergy reaction under ergoline-therapy
* Actual history of drug abuse/addiction, concomitant other psychiatric disorder (screened by SCID) and suicide attempt in the medical history
* Other long term pharmacological treatment which can interact with dopamine agonists and antagonists (e.g. anticoagulants, digitoxin)
* Pregnancy and breastfeeding (anamneses and pregnancy test in urine)
* Participation in other clinical trial for the last 3 months
* History of malignant neuroleptic syndrome
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
|
NCT01066403
|
{
"brief_title": "Adjuvant Therapy With Pergolide in Treating Cognitive Deficits in Schizophrenia",
"conditions": [
"Schizophrenia"
],
"interventions": [
"Drug: Pergolide"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01066403",
"official_title": "Dopaminergic Modulation of Prefrontal Functions in Schizophrenic Patients: Adjuvant Therapy With Pergolide",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-03",
"study_completion_date(actual)": "2008-03",
"study_start_date(actual)": "2003-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-02-10",
"last_updated_that_met_qc_criteria": "2010-02-09",
"last_verified": "2008-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-10",
"first_submitted": "2010-02-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia.
Detailed Description
Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming (via an exothermic reaction) ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia. Near body core temperature is measured by a sublingual sensor as the 'gold standard' of body core temperature measurement - the pulmonary artery catheter - is too invasive and not suited for this collective of patients in the emergency room setting. Blanket use will be randomized. Temperature will be taken at emergency room admission, after 15, 30 and 45 minutes of treatment as well as right before handing the patient over to the next caring unit (ICU, IMC, operating theatre etc.). If treatment time is shorter than expected measurement will stop at the latest possible point. Blankets will be applied to the patient once admission in the emergency room is complete and will only be lifted for interventions.
#Intervention
- DEVICE : ReadyHeat® blanket
- Using ReadyHeat® blanket for patient warming
- DEVICE : Cotton wool blanket
- Using cotton wool blanket for patient warming
|
#Eligibility Criteria:
Inclusion Criteria:
* Trauma patients >= 18 years of all severity stages including poly traumatized patients admissioned through the emergency room
Exclusion Criteria:
* Patients < 18 years
* Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission
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
|
NCT02353793
|
{
"brief_title": "Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket",
"conditions": [
"Hypothermia",
"Trauma"
],
"interventions": [
"Device: ReadyHeat® blanket",
"Device: Cotton wool blanket"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02353793",
"official_title": "Trauma Patients and Hypothermia in the Emergency Room: a Trial Between Self-warming ReadyHeat® Blanket and Traditional Cotton Wool Blanket",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-09",
"study_completion_date(actual)": "2016-09",
"study_start_date(actual)": "2015-04"
},
"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)": "2016-11-29",
"last_updated_that_met_qc_criteria": "2015-02-02",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-03",
"first_submitted": "2014-12-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this retrospective study is to assess the treatment benefits of probiotic Streptococcus salivarius K12 for the prevention of recurrent bacterial and viral infections of the pharynx, tonsils and ears in children under 3 years of age.
Detailed Description
Recurrent bacterial and viral infections of the pharynx, tonsils and ears are a problem that can affect children of all ages. The persistence of these infections can lead to an overuse of drugs such as antibiotics, antipyretics and anti-inflammatories, with the possible consequent presence of side effects and above all an increase in antibiotic resistance, a global public health issue.
In search at reducing the use of antibiotics and antivirals, there is currently a great scientific interest in probiotic therapies for the oral cavity infection.
The aim of this retrospective, controlled, multicenter, non-profit study is to evaluate the efficacy and safety of the administration of Streptococcus salivarius K12 in pediatric patients attending the 1st or 2nd year of nursery school (\< 3 years of age ), in the prophylaxis of the most common bacterial or viral respiratory infections, assessing the consequent reduction in the use of antibiotics, antivirals or other therapies compared to children.
#Intervention
- DIETARY_SUPPLEMENT : Probiotic Streptococcus salivarius K12
- Oral 1 billion CFU of Probiotic Streptococcus salivarius K12
- OTHER : No probiotic supplementation
- Children who did not receive any probiotic supplementation
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy children attending the 1st or 2nd year of nursery (under aged 3 years)
* Treated with probiotic Streptococcus salivarius K12 (1 billion CFU) for 90 continuous days
* Children not treated with probiotic Streptococcus salivarius K12
Exclusion Criteria:
* Children with underlying health condition
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05840926
|
{
"brief_title": "Probiotic S. Salivarius K12 for the Prevention of Upper Respiratory Tract Infection in Nursery-age Children",
"conditions": [
"Upper Respiratory Tract Infection"
],
"interventions": [
"Dietary Supplement: Probiotic Streptococcus salivarius K12",
"Other: No probiotic supplementation"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05840926",
"official_title": "Possible Prophylactic Role of the S. Salivarius K12 Probiotic Strain for the Upper Respiratory Tract Infection and Nursery-age Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-20",
"study_completion_date(actual)": "2023-03-31",
"study_start_date(actual)": "2022-01-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-03",
"last_updated_that_met_qc_criteria": "2023-04-21",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-03",
"first_submitted": "2023-04-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer.
The current 'gold standard' treatment for lichen sclerosus is ultra-potent topical corticosteroids. When properly administered, topical ultra-potent corticosteroids help to resolve the symptoms of itching and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying inflammation of LS, and preliminary data shows that the risk of cancer also declines. While effective, topical corticosteroids have serious local and systemic side effects that include thinning of the skin, superimposed fungal infections, and suppression of the adrenal gland.
Elidel 1% cream is a new type of medication that has been approved by the FDA for the treatment of eczema. In theory, Elidel should also treat LS without the serious side effects that accompany corticosteroids. Therefore, this study is designed to compare the effectiveness and safety of a topical corticosteroid (clobetasol) versus Elidel 1% cream for the treatment of LS.
Detailed Description
Lichen sclerosus (LS) is a chronic cutaneous disorder affecting approximately one in seventy women. Presenting symptoms may include intense pruritis, pain, burning, and severe dyspareunia. The typical lesions of LS are white plaques and papules, often with areas of echymosis, excoriation, and ulceration. Often, LS causes destruction of the vulva architecture. In addition, 4-6% percent of women with LS will develop vulvar carcinoma. The histopathologic changes of LS are distinctive and make biopsy a very useful diagnostic tool. While there is no known cure for LS, the current gold standard treatment is ultra-potent corticosteroids. When properly administered, topical ultra-potent corticosteroids help to resolve the symptoms of pruritis and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying histopathologic changes of LS, and preliminary data shows that the risk of malignant transformation also declines. Although treatment with topical corticosteroids is effective, topical corticosteroids have serious local and systemic side effects, including dermal thinning, skin atrophy, superimposed fungal infections, rebound dermatitis, and adrenal insufficiency.
Pimecrolimus cream 1% (Elidel®, Novartis Pharmaceutical) is a topical calcineurin inhibitor that binds to macrophilin-12 and inhibits cytokine synthesis by T lymphocytes. Elidel has been approved by the FDA for the treatment of mild to moderate atopic dermatitis. In theory, as Elidel inhibits T lymphocytes, it should effectively treat lichen sclerosus. In addition, as Elidel does not inhibit keratinocytes, or affect collagen synthesis, it does not cause dermal atrophy. Therefore, Elidel may be an effective and safer alternative treatment for LS. This study is designed to compare the effectiveness and safety of Elidel 1% cream versus an ultra-potent corticosteroid (clobetasol 0.05% cream) for the treatment for vulvar LS.
#Intervention
- DRUG : pimecrolimus and clobetasol
- DRUG : clobetasol 0.05% cream
- twice daily for three months
|
#Eligibility Criteria:
Inclusion Criteria:
* Female, >= 18 years.
* With a diagnosis of biopsy proven active vulvar lichen sclerosus.
* Signed written informed consent.
* Willingness and ability to comply with the study requirements.
* Negative urine pregnancy tests must be documented for all females of childbearing potential prior to enrollment.
* Two forms of birth control will be required for women with childbearing potential.
* IGA at baseline >=1
* Subjects must have >= 4 or greater (on a 0 to 10 point scale) on at least one of the two visual analog scales (pruritus or pain/burning).
Exclusion Criteria:
* Who have received systemic immunosuppressants (e.g. corticosteroids) within 4 weeks prior to participation in the study.
* Who have been treated with topical therapy (e.g., topical corticosteroids, pimecrolimus, and tacrolimus) at the affected area within two weeks prior to participation in the study.
* Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
* Who have a history of lymphoma
* Who have lympadenopathy
* Who have active vulvar herpes, molluscum, or condyloma
* Who suffer from systemic or generalized infections (bacterial, viral or fungal).
* Who have been diagnosed with lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva.
* Who have been diagnosed with diabetes mellitus or Netherton's syndrome.
* Menstruating females of childbearing potential who are not using two medically accepted methods of contraception during the study. Medically approved contraception may, at the discretion of the investigator, include abstinence.
* Women who are breastfeeding.
* Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
* Who are hypersensitive to pimecrolimus or clobetasol or any of the components of the creams.
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
* Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
* Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00393263
|
{
"brief_title": "Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus",
"conditions": [
"Lichen Sclerosus"
],
"interventions": [
"Drug: pimecrolimus and clobetasol",
"Drug: clobetasol 0.05% cream"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00393263",
"official_title": "A Double-Blind, Parallel-group Trial of Topical Pimecrolimus Cream 1% (Elidel®) Versus Clobetasol 0.05% Cream for the Treatment of Vulvar Lichen Sclerosus",
"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)": "2006-10"
},
"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)": "2014-05-12",
"last_updated_that_met_qc_criteria": "2006-10-26",
"last_verified": "2014-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-27",
"first_submitted": "2006-10-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
Detailed Description
AD is a disease mainly characterized by pruritic eczema, and those with the disease experience repeated exacerbations and remissions. Therapeutic guidelines for the disease, currently being developed in many countries, all recognize AD as chronic eczema that is accompanied by the physiological dysfunction of the skin and in which inflammation is caused by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations of OPA 15406 ointment compared to vehicle, when administered topically twice daily in participants with mild to moderate AD.
#Intervention
- DRUG : OPA-15406
- OPA-15406 topical ointment
- DRUG : Vehicle ointment
- OPA-15406 1%-matching placebo topical ointment
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants 10 <= age <= 70 years
* Diagnosis of AD
* History of AD for at least 3 years
* AD affecting greater than or equal to 5% and less than or equal to 40% of total body surface area (BSA) at Baseline
* Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s)
Exclusion Criteria:
* Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.
* Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment area(s) that may have an impact on the study assessments.
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02068352
|
{
"brief_title": "A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis",
"conditions": [
"Atopic Dermatitis"
],
"interventions": [
"Drug: OPA-15406",
"Drug: Vehicle ointment"
],
"location_countries": [
"Poland",
"Australia",
"United States"
],
"nct_id": "NCT02068352",
"official_title": "A Phase 2 Multi-center, Randomized, Double-blind, Vehicle-controlled, Three-arm, Parallel Group Study to Assess the Safety, Tolerability, and Efficacy of Topical OPA-15406 Ointment, in Subjects With Mild/Moderate Atopic Dermatitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01-28",
"study_completion_date(actual)": "2015-02-03",
"study_start_date(actual)": "2014-06-20"
},
"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)": "2021-11-23",
"last_updated_that_met_qc_criteria": "2014-02-20",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-21",
"first_submitted": "2014-02-19",
"first_submitted_that_met_qc_criteria": "2021-10-25"
}
}
}
|
#Study Description
Brief Summary
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.
Detailed Description
This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.
#Intervention
- PROCEDURE : Peroral Endoscopic Myotomy (POEM)
- Endoscopy myotomy for treatment of achalasia
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Achalasia
* Age 16 <= age <= 80
* ASA Class 1 <= age <= 3
Exclusion Criteria:
* Pregnancy
* Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.
After eight subjects have been treated as part of this study, this exclusion criteria no longer applies
* Patients who are taking immunosuppressive medications or are immunocompromised
* Patients on anticoagulant medications or abnormal coagulation tests
* Patients with severe medical comorbidities, in the judgment of the treating surgeon
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
|
NCT02073578
|
{
"brief_title": "Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia",
"conditions": [
"Achalasia"
],
"interventions": [
"Procedure: Peroral Endoscopic Myotomy (POEM)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02073578",
"official_title": "Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-09",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2012-08"
},
"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)": "2021-09-27",
"last_updated_that_met_qc_criteria": "2014-02-25",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-27",
"first_submitted": "2014-02-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an observational study aiming at describing COVID-19 vaccination outcomes among HIV-positive and HIV-negative individuals, using electronic health records to observe their usual clinical care. This study will describe levels of COVID-19 vaccine response (i.e., Ig spike antibody measurements). Rates of antibody level decay after vaccination will be assessed. The efficacy of using antibody levels to help guide the timing of booster doses among HIV-negative and HIV-positive patients will be evaluated.
Detailed Description
The aim of this study is to assess levels of COVID-19 vaccine response through measuring surrogate Ig spike antibody measurements, to determine the rates of antibody level decay after vaccination, and to measure the efficacy of utilizing these antibody measurements to help guide the timing of booster doses among HIV-negative and HIV-positive patients.
The study population will include adults who were fully vaccinated against SARS-CoV-2 virus (i.e., two doses of Pfizer or Moderna vaccines or one dose of the J\&J vaccine), and have received a Roche SARS-CoV-2 Semi-Quant Spike Ig Ab test at least 3 weeks after full vaccination as part of their usual clinical care at AHF Midtown Manhattan Healthcare Center.
Incidence rates of COVID vaccine response levels (i.e., adequate, low, non-response) will be estimated using univariate Poisson regression, overall and by vaccine type. Among individuals with at least two antibody measurements, rates of antibody levels decay will be estimated using univariate linear regression, overall and stratified by HIV status, vaccine type and baseline CD4 cell count. In the sub-population of individuals who received a COVID vaccine booster, vaccination and antibody response will be characterized at least 3 weeks after the booster is received. Univariate linear regression will be used to estimate rates of antibody levels decay, among individuals with at least two antibody measurements, including one after the booster dose. Rates of response decay will be produced overall, and stratified by HIV status, booster type and baseline CD4 cell count.
#Intervention
- OTHER : Observational
- HIV-positive versus HIV-negative patients, individuals with at least 2 measurements of antibody levels, and boosted individuals are the subgroups of interest.
|
#Eligibility Criteria:
Inclusion Criteria:
* Cared for at AHF Midtown Manhattan Healthcare Center and followed in the OPERA observational database
* Active in care in the last 24 months
* Fully vaccinated against SARS-CoV-2 virus, implemented as 21 days after the second Pfizer or Moderna injections, 21 days after the one J&J injection
* Received a Roche SARS-CoV-2 Semi-Quant Spike Ig AB test after full vaccination as usual clinical care
Exclusion Criteria:
* Unvaccinated or partially vaccinated against SARS-CoV-2 virus
* Never tested with a SARS-CoV-2 Semi-Quant Total AB test after full vaccination
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
|
NCT05104359
|
{
"brief_title": "COVID-19 Quantitative Antibody Titers & Booster Vaccinations",
"conditions": [
"COVID-19",
"COVID-19 Vaccines",
"Immunogenicity, Vaccine"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT05104359",
"official_title": "Should COVID-19 Quantitative Antibody Titers be Implemented to Guide COVID-19 Booster Vaccinations Regardless of HIV Status, Immunosuppression, or Age?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-30",
"study_completion_date(actual)": "2022-04-30",
"study_start_date(actual)": "2020-12-11"
},
"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)": "2022-07-27",
"last_updated_that_met_qc_criteria": "2021-11-01",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-03",
"first_submitted": "2021-11-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate clinical safety and pharmacokinetics of Maxmarvil® in healthy postmenopausal women
Detailed Description
Pharmacokinetics of a single Oral Dose of Maxmarvil® in healthy postmenopausal women without a previous history of fractures
1. evaluation of Pharmacokinetics
* Urine collection : Pre-dose(pre 1hour), post-dose 0\~6 hour, 6\~12 hour, 12\~24 hour
* Evaluation Variables : Aet
2. Evaluation of safety, pharmacodynamics
* Adverse Event : check it every and frequently
* Physical exam : screening, just before injection, post-dose 24 hour and post-study visit
* Vital sign : screening, just before injection, post-dose 1 hour, 24 hour and post-study visit
* Laboratory test : screening, post-dose 24hour
#Intervention
- DRUG : Maxmarvil®
- Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
- Other Names :
- Alendronate 5mg + calcitriol 0.5 μg
|
#Eligibility Criteria:
Inclusion Criteria:
* Screening test in healthy postmenopausal women without a previous history of fracture
* Normal range in laboratory test arranged by principal investigator because of the character of medicine
* over 50kg, body weight is in ± 20% of ideal body weight Written concent by himself and following the protocol after understanding of the explained clinical trial
Exclusion Criteria:
* Subject who have taken something to induce and inhibit the drug metabolizing enzyme within 1 month like Barbiturate.
* Subject who have a history of drug abuse and got a positive in urine test for drug abuse.
* Subject who have taken a prescription only medicine or an oriental medicine within 2 weeks after first administration the clinical drug trial , taken a OTC within 1 week after first administration the clinical drug trial like some OTC including calcium, an antacids, multiple vitamin, mineral.
* Subject who have been chronic drinking(over 21 units/week) or can not stop drinking during the clinical trial.
* Subject who have smoked over 10 unit/day for 3months.
* Subject who have light or clear hypersensitivity reaction about OTC(aspirin, antibiotic medication) or bisphosphonates(alendronate)
* Subject who have got a disease about liver, kidney, neurology, respiratory, endocrine, hematooncology, cardiovascular, musculoskeletal, psychological or history of fracture within 12months or a tooth extraction within 6month
* Subject who have a history of gastrointestinal disease or stomach surgery without appendectomy, herniotomy having an effort the absorb of clinical drug trial.
* Subject who have a esophageal disease like esophagitis, esophageal ulcer, esophagus erosion, esophagorrhaphy, esophagostenosis, dysphagia.
* Subject who can not keep the sitting position for 30minutes
* Subject who is out of normal range of calcium concentration in blood (8.8 ~ 10.5 mg/dl)
* Subject who is hypotension(systolic blood pressure <= 90mmHg or diastolic blood pressure <= 50 mmHg ) or hypertension(systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100 mmHg ) in sitting position after rest 3 minutes
* join the other clinical trial within 2months after administration of the clinical drug trial.
* Subject who have donated whole blood within 2 months or plasma within 1 month.
* Subject who have a grapefruit and something including caffeine in close season(from 3 days before administration to discharge from the hospital )
* For the result of laboratory and the other reason subject is considered unsuitable by principal's decision
Sex :
FEMALE
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01526278
|
{
"brief_title": "Pharmacokinetics of Maxmarvil® in Healthy Postmenopausal Women",
"conditions": [
"Osteoporosis"
],
"interventions": [
"Drug: Maxmarvil®"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01526278",
"official_title": "Pharmacokinetics of a Single Oral Dose of Maxmarvil® in Healthy Postmenopausal Women Without a Previous History of Fractures",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-07",
"study_completion_date(actual)": "2012-09",
"study_start_date(actual)": "2011-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-25",
"last_updated_that_met_qc_criteria": "2012-02-01",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-03",
"first_submitted": "2012-02-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To investigate the relative bioavailability of the proposed formulation of PERSANTIN® compared to the present commercial formulation.
#Intervention
- DRUG : Persantin® new formulation
- DRUG : Persantin® commercial formulation
|
#Eligibility Criteria:
Inclusion Criteria:
* All participants in the study should be healthy males, range from 21 <= age <= 50 of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2
* All participants must give their written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the study
Exclusion Criteria:
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (<= two months prior to administration or during the trial)
* Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (> 60 g/day)
* Drug abuse
* Blood donation (>= 100 ml within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial
Following exclusion criteria are of special interest for this study:
* History of haemorrhagic diathesis
* History of gastro-intestinal ulcer, perforation or bleeding
* Glucose-6-phosphate-dehydrogenase (G-6-PD) deficiency
Sex :
MALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02259998
|
{
"brief_title": "Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Persantin® commercial formulation",
"Drug: Persantin® new formulation"
],
"location_countries": null,
"nct_id": "NCT02259998",
"official_title": "An Open-labelled, Randomised, 2-way Crossover Study to Compare the Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets 75 mg p.o. (Present and Proposed Formulation in France) q.i.d. for Three Days in Healthy Male Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2001-12",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2001-10"
},
"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)": "2014-10-09",
"last_updated_that_met_qc_criteria": "2014-10-07",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-09",
"first_submitted": "2014-10-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a study of HDL function in healthy individuals classified in three groups according to their HDL-cholesterol levels (Low HDL-C, Intermediate HDl-C and High HDL-C), with the purpose of investigating which characteristics of the HDL particle might be associated to atherosclerotic burden, characterized by carotid intima-media thickness above 1mm.
Detailed Description
Selection: Study participants are initially selected trough the evaluation of consecutive lipid profiles from individuals who spontaneously seek governmental primary care centers of the city of Campinas, Sao Paulo, Brazil. Telephone-based screening interviews are performed, followed by in-person clinical evaluation and blood exams.
Biochemical analyses: Glucose, triglycerides, HDL-C and c-reactive protein (CRP) are measured in an automated Modular® Analytics Evo (Roche Diagnostics, Burgess Hill, West Sussex, UK), using Roche Diagnostics® reagents (Mannheim, Germany). LDL-cholesterol is calculated by the Friedewald formula. Serum insulin levels are measured using ELISA (Millipore, Massachusetts, USA). The Homeostasis Model Assessment (HOMA) Calculator version 2.2 (University of Oxford, UK) is used to estimate insulin sensitivity. Apolipoproteins A-I and B-100 and lipoprotein (a) are determined by nephelometry in an automated system and reagents from Dade-Behring® (Marburg, Germany).
Carotid artery ultrasound: Carotid artery atherosclerosis is estimated by using high-resolution B-mode ultrasound, at the posterior wall of the common carotid artery.
Lipoprotein isolation: HDL from each study participant is isolated from plasma, through ultracentrifugation (Beckman Coulter Inc., Palo Alto, USA).
HDL chemical composition: Using commercially available enzymatic kits, HDL content of total proteins, total cholesterol, free cholesterol, phospholipids, triglycerides and apolipoprotein A-I are measured. Cholesteryl ester (CE) is calculated as the difference between total cholesterol and free cholesterol times 1.67. HDL molar concentration is estimated based on particle total mass and molecular weight.
HDL physical-chemical characterization: HDL particle size is determined using dynamic light scattering, and zeta potential using laser Doppler micro-electrophoresis.
Determination of proteins involved in HDL metabolism: Cholesteryl ester transfer protein, phospholipids transfer protein, lipoprotein lipase, hepatic lipase and lecithin:cholesterol acyl transferase activities are determined trough radiometric exogenous assays.
HDL functions: Cholesterol efflux capacity, antioxidant activity, susceptibility to oxidation, anti-inflammatory activity and platelet aggregation inhibition are measured using straightforward and consolidated methodologies.
Statistical Analyses: Differences between groups are evaluated using ANOVA or Kruskal-Wallis, with Bonferroni's post-hoc multiple comparison analysis, according to variable distribution. Chi-Square is used to compare categorical data. Analysis of covariance (ANCOVA) adjusted for confounding variables is also used, after checking variables with histograms, normality plots, and residual scatter plots that tested for linearity, normality, and variance. Pearson's correlation test is used to assess the relationships between variables. A two-sided p-value of 0.05 is considered significant.
|
#Eligibility Criteria:
Inclusion Criteria:
* glucose <100 mg/dL
* Urea <71 mg/dL
* Creatinine < 1.20 mg/dL
* Uric acid <7.0 mg/dL
* Alanine aminotransferase <50 U/L
* Aspartate aminotransferase < 33 U/L
* Gamma-glutamyl transferase <71 U/L
* Alkaline phosphatase <129 U/L
* Thyroid stimulating hormone between 0.41 and 4.50 μUI/mL
* Free thyroxin between 0.9 and 1.8 ng/dL
Exclusion Criteria:
* Symptomatic cardiovascular disease
* LDL-cholesterol >=130 mg/dL
* Triglycerides >=150 mg/dL
* Metabolic syndrome
* BMI >= 30 kg/m2
* Smoking habit
* Daily intake of alcohol >14g
* Regular use of medical treatments
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02106013
|
{
"brief_title": "Association Between HDL Functions and Atherosclerotic Burden in Healthy Individuals",
"conditions": [
"Low HDL Cholesterol"
],
"interventions": null,
"location_countries": [
"Brazil"
],
"nct_id": "NCT02106013",
"official_title": "Association Between HDL Functions and Atherosclerotic Burden in Healthy Individuals",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-11",
"study_completion_date(actual)": "2014-03",
"study_start_date(actual)": "2008-04"
},
"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)": "2014-04-07",
"last_updated_that_met_qc_criteria": "2014-04-02",
"last_verified": "2014-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-07",
"first_submitted": "2014-03-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to \<13 years of age.
Detailed Description
The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to \<13 years of age.
#Intervention
- OTHER : iPad®
- Binocular therapy using a Dig Rush application on an iPad®
- OTHER : Spectacle correction
- Spectacle correction for all waking hours, 7 days per week
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 4 to <13 years
* Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
1. Criteria for strabismic amblyopia: At least one of the following must be met:
* Presence of a heterotropia on examination at distance or near fixation (with or without optical correction, must be no more than 5pd by SPCT at near fixation (see #6 below)
* Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
2. Criteria for anisometropia: At least one of the following criteria must be met:
* >=1.00 D difference between eyes in spherical equivalent
* >=1.50 D difference in astigmatism between corresponding meridians in the two eyes
3. Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
* Criteria for strabismus are met (see above)
* >=1.00 D difference between eyes in spherical equivalent OR >=1.50 D difference in astigmatism between corresponding meridians in the two eyes
* No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment)
* Requirements for required refractive error correction (based on a cycloplegic refraction completed within the last 7 months):
* Hypermetropia of 2.50 D or more by spherical equivalent (SE)
* Myopia of amblyopic eye of 0.50D or more SE
* Astigmatism of 1.00D or more
* Anisometropia of more than 0.50D SE
NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.
1. Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:
* SE must be within 0.50D of fully correcting the anisometropia.
* SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes.
* Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
* Axis must be within +/- 10 degrees if cylinder power is <=1.00D, and within +/- 5 degrees if cylinder power is >1.00D.
* Myopia must not be undercorrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
2. Spectacle correction meeting the above criteria must be worn:
* For at least 16 weeks OR until VA stability is documented (defined as <0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
* For determining VA stability (non-improvement):
* The first of two measurements may be made 1) in current spectacles, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
* The second measurement must be made without cycloplegia in the correct spectacles that have been worn for at least 8 weeks.
* Note: since this determination is a pre-study procedure, the method of measuring VA is not mandated.
* VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the ATS-HOTV VA protocol for children < 7 years and the E-ETDRS VA protocol for children >= 7 years on a study-approved device displaying single surrounded optotypes, as follows:
1. VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters (E-ETDRS)
2. VA in the fellow eye 20/25 or better (ATS-HOTV) or >= 78 letters (E-ETDRS)
3. Interocular difference >= 3 logMAR lines (ATS-HOTV) or >= 15 letters (E-ETDRS)
* Heterotropia with a near deviation of <= 5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation >5∆ are not allowed because large magnitudes of the deviation would compromise successful playing of the game.)
* Subject is able to play the Dig Rush game (at least level 3) on the study iPad under binocular conditions (with red-green glasses). Subject must be able to see both the red 'diggers' and blue 'gold carts' when contrast for the non-amblyopic eye is at 20%.
* Investigator is willing to prescribe computer game play, or continued spectacle wear per protocol.
* Parent understands the protocol and is willing to accept randomization.
* Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
* Relocation outside of area of an active PEDIG site for this study within the next 8 weeks is not anticipated.
Exclusion Criteria:
* Prism in the spectacle correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
* Myopia greater than -6.00D spherical equivalent in either eye.
* Previous intraocular or refractive surgery.
* Any treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy or previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks prior to enrollment.
* Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above VA criteria are met).
* No Down syndrome or cerebral palsy
* No severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
* Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02983552
|
{
"brief_title": "Binocular Dig Rush Game Treatment for Amblyopia",
"conditions": [
"Amblyopia"
],
"interventions": [
"Other: iPad®",
"Other: Spectacle correction"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT02983552",
"official_title": "Binocular Dig Rush Game Treatment for Amblyopia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-20",
"study_completion_date(actual)": "2020-07-10",
"study_start_date(actual)": "2017-03-02"
},
"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)": "2021-06-11",
"last_updated_that_met_qc_criteria": "2016-12-05",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-06",
"first_submitted": "2016-11-16",
"first_submitted_that_met_qc_criteria": "2021-06-10"
}
}
}
|
#Study Description
Brief Summary
The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and immunogenicity data on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of patients with drug-related adverse events (AEs) during the treatment phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI 695501 by evaluation of:
* the change from Baseline in DAS28 (ESR) at Week 48
* the proportion of patients meeting American College of Rheumatology 20% (ACR20) response criteria at Week 48
* the proportion of patients who meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition of remission at Week 48
* the proportion of patients with EULAR response (good response, moderate response, or no response) at Week 48.
#Intervention
- DRUG : BI 695501
|
#Eligibility Criteria:
Inclusion criteria:
* All patients must sign and date an Informed Consent Form consistent withInternational Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local legislation prior to participation in the trial (i.e., prior to any trial procedures, which include medication washout and restrictions) and be willing to follow the protocol.
* Adult patients with moderately to severely active RA who have completed Trial 1297.2, and who wish to participate in this extension trial and in the investigator´s assessment can benefit from receiving BI 695501.
* Patients willing and able to self-administer BI 695501 pre-filled syringe.
* Willing to use a reliable means of contraception throughout trial participation (females) and willing to use an acceptable method of contraception for 6 months following completion or discontinuation from the trial medication males and females).
Exclusion criteria:
* Investigator-reported drug-related Serious Adverse Events (SAEs) in Trial 1297.2
* ACR functional Class IV or wheelchair/bed bound
* Primary or secondary immunodeficiency (history of, or currently active)
* Positive QuantiFERON test
* Known clinically significant coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (NYHA Classes III / IV), or interstitial lung disease
* Anaphylactic reaction or hypersensitivity to adalimumab in Trial 1297.2
* History / recent evidence of cancer incl. solid tumours, hematologic malignancies, and carcinoma in situ (certain exceptions permitted)
* Positive serology for Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
* Planned live virus or bacterial vaccinations during the trial, or up to 3 months after the last dose of trial drug
* Receipt or treatment (including biologic therapies) that may place the patient at unacceptable risk during the trial
* Significant disease (disease which may (i) put the patient at risk because of participation or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial) other than RA and/or a significant uncontrolled disease
* Women: premenopausal (last menstruation 1 year prior to screening), sexually active, pregnant or nursing, or of child-bearing potential and not practicing an acceptable method of birth control, or not planning to use an acceptable method of birth control throughout the trial
* Current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, etc.) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, pulmonary fibrosis, etc.). Secondary Sjögren´s syndrome or secondary limited cutaneous vasculitis with RA is permitted
* Any planned surgical procedure, including bone/joint surgery/synovectomy for the duration of the trial
* Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with iv. anti-infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit
* Serious infection or opportunistic infection during the 1297.2 trial
* Any acquired neurological, vascular, systemic or demyelinating disorder that might affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinson´s disease, cerebral palsy, diabetic neuropathy) that occurred during the 1297.2 trial.
* Currently active alcohol or drug abuse
* Treatment with iv. Gamma Globulin or the Prosorba® Column during the 1297.2 trial
* Planned treatment with iv. intramuscular, intra-articular and parenteral corticosteroids
* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >1.5 times upper limit of normal (ULN)
* Hemoglobin <8.0 g/dL
* Platelets <100,000/µL
* Leukocyte count <4000/µL
* Creatine clearance <60 mL/min
* Current participation in another clinical trial
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
|
NCT02640612
|
{
"brief_title": "Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis",
"conditions": [
"Arthritis, Rheumatoid"
],
"interventions": [
"Drug: BI 695501"
],
"location_countries": [
"Ukraine",
"United States",
"Chile",
"Germany",
"Poland",
"Thailand",
"Malaysia",
"Serbia",
"Russian Federation",
"Spain",
"Estonia",
"Bulgaria",
"Hungary",
"Korea, Republic of"
],
"nct_id": "NCT02640612",
"official_title": "Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-01",
"study_completion_date(actual)": "2017-11-01",
"study_start_date(actual)": "2016-01-22"
},
"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)": "2018-12-05",
"last_updated_that_met_qc_criteria": "2015-12-23",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-29",
"first_submitted": "2015-12-18",
"first_submitted_that_met_qc_criteria": "2018-12-03"
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of treatment in participants with hypercholesterolemia.
Secondary Objective:
* To evaluate the effect of two treatment regimens of alirocumab on other lipid parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non HDL-C), total cholesterol (TC), lipoprotein (a) (Lp\[a\]), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1).
* To evaluate the safety and tolerability of alirocumab administration.
* To evaluate the development of anti-alirocumab antibodies.
* To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab administration.
* To evaluate the long-term safety in participants receiving open-label alirocumab administration.
Detailed Description
The duration of study per participant was approximately 71 weeks consisting of a run-in period (4 weeks), a screening period (3 weeks), a double-blind treatment period (12 weeks), and an open-label treatment period (52 weeks).
#Intervention
- DRUG : Alirocumab
- Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
- Other Names :
- SAR236553, REGN727
- DRUG : Placebo
- Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
- DRUG : Atorvastatin
- Atorvastatin 5 mg tablet orally.
- DRUG : Non-statin Lipid-Modifying Therapy
- Ezetimibe, Bezafibrate or Fenofibrate at stable dose as background therapy.
- OTHER : Diet Alone
- Stable cholesterol-lowering diet as background therapy.
|
#Eligibility Criteria:
Inclusion criteria :
Participants with hypercholesterolemia (heFH or non-FH) receiving non statin LMTs or the lowest strength of statin.
Exclusion criteria:
* LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit (Week -3) in participants with heFH or in participants with non-FH who have a history of documented coronary heart disease.
* LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit (Week -3) in participants with non-FH participants who had a history of documented diseases or other risk factors classified as primary prevention category III as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
* Not on a stable dose of LMT (including diet therapy alone) in the run-in period or the screening period.
* Fasting serum TGs >400 mg/dL (>4.52 mmol/L) at the screening period.
* Systolic blood pressure (BP) >160 mmHg or diastolic BP >100 mmHg at the run-in visit (Week -7) or the screening visit (Week -3) or the randomization visit (Week 0).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02584504
|
{
"brief_title": "Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin",
"conditions": [
"Hypercholesterolemia"
],
"interventions": [
"Drug: Non-statin Lipid-Modifying Therapy",
"Drug: Alirocumab",
"Drug: Atorvastatin",
"Other: Diet Alone",
"Drug: Placebo"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT02584504",
"official_title": "A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-05",
"study_completion_date(actual)": "2018-01-09",
"study_start_date(actual)": "2015-11-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-23",
"last_updated_that_met_qc_criteria": "2015-10-21",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-22",
"first_submitted": "2015-10-21",
"first_submitted_that_met_qc_criteria": "2018-05-03"
}
}
}
|
#Study Description
Brief Summary
Upper-limb disorders in patients with Parkinson's disease include decreased speed and amplitude of movements, difficulty in sequential tasks, and disrupted execution of fine manipulative hand activities.The aim of the study was to evaluate the effects of home-based goal-oriented upper limb intervention in patients with Parkinson's disease.
Detailed Description
Parkinson's disease is a neurodegenerative neurological disorders involving progressive impairment in motor, mood and cognitive functions. Movement disorders have a negative impact on individual's ability to perform well-learned motor skills. These include akinesia, bradykinesia, rigidity and tremor at rest.
A goal-planning process should be useful to ensure that patients agree on the goals of rehabilitation. Thus, the purpose of the study was to evaluate the effects of home-based goal-oriented upper limb intervention in patients with Parkinson's disease.
#Intervention
- OTHER : Goal-oriented upper-limb intervention
- The Goal-oriented upper-limb intervention evaluated patients' expectations and the environmental factors influencing the performance of the specific task were identified for each of the three tasks. Patients were asked to perform the activity at home. After this, the observable target behavior corresponding to the target activity was determined. Then, an occupational and a physical therapist worked together with the patient to identify the assistance required to perform this activity such as human assistance, technical aids, assistive devices or verbal guidance.
- OTHER : Standard upper limb intervention
- The standard upper limb intervention involved active upper limb range of motion, manual dexterity involving grasp and manipulation of small pieces such as marbles and stretching upper limb exercises.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of Parkinson's Disease.
* Stage II-III of disease progression as defined by the Hoehn and Yahr scale.
* Upper limbs impairment
Exclusion Criteria:
* Clinical signs of dementia or psychiatric disturbance.
* Comprehension deficits that prevented them from following verbal commands.
* Visual or acoustic limitations.
* A neurologic condition other than Parkinson's Disease.
* Musculoskeletal disorders and/or if they had previous trauma or fracture of upper extremity.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02938819
|
{
"brief_title": "Goal-oriented Intervention in Parkinson's Disease",
"conditions": [
"Parkinson's Disease"
],
"interventions": [
"Other: Standard upper limb intervention",
"Other: Goal-oriented upper-limb intervention"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT02938819",
"official_title": "Effects of a Goal-oriented Upper-limb Intervention in Patients With Parkinson's Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2016-08"
},
"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)": "2016-12-14",
"last_updated_that_met_qc_criteria": "2016-10-17",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-19",
"first_submitted": "2016-10-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is being done to test the effects of Lingual Muscle Therapy (LMT) in patients with Late-Onset Pompe Disease (LOPD) who have tongue weakness. The results of this study will help design future research studies about LMT in LOPD.
#Intervention
- OTHER : Lingual Muscle Training
- Lingual Muscle Training using the Iowa Oral Performance Instrument (OIPI) device
|
#Eligibility Criteria:
Inclusion criteria:
* Age >= 12 years
* Lingual weakness as measured by quantitative muscle testing (<= 5% lower limit of normal for stratified age)
* Confirmed diagnosis of LOPD
* On enzyme replacement therapy for >= 26 weeks at pretest
* Able to follow directions for study participation
* Able to complete a home-based LMT regimen
* Access to reliable internet connection
* Access to use of electronic device that allows for FaceTime, Jabber, or WebEx use
Exclusion Criteria:
* Neurodegenerative conditions (e.g. stroke, dementia) or other serious neurologic condition that would prevent meaningful study participation as determined at the discretion of the principle investigator
* Any current or past history of seizures.
* Head and neck cancer or radiation treatment to head/neck
* Inability to tolerate IOPI device tongue bulb
* Inability to give legally effective consent
* Inability to read and understand English
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
|
NCT03255213
|
{
"brief_title": "Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)",
"conditions": [
"Glycogen Storage Disease"
],
"interventions": [
"Other: Lingual Muscle Training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03255213",
"official_title": "Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-23",
"study_completion_date(actual)": "2020-04-23",
"study_start_date(actual)": "2018-03-21"
},
"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)": "2021-07-28",
"last_updated_that_met_qc_criteria": "2017-08-17",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-21",
"first_submitted": "2017-08-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods: intervention (I) and control (C) in different order (I/C or C/I). Both periods were separated by a 4 weeks wash-out interval during which subjects returned to their usual diet:
During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.
During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
Functional meat (FM) products (Functional cooked Ham (FH) and Functional cooked Turkey breast (FT)), were manufactured mixing the meats with the patented formula® (P200402755.2004). The amount of supercritical rosemary extract, deodorized salmon oil and vitamin E used was respectively, 0.02% w/w, 0.6% w/w, and 0.001% w/w.
Control meat (CM) products (Control cooked Ham (CH) and Control cooked Turkey (CT), were prepared without addition of the functional ingredients.
Detailed Description
The total duration of the study was 28 weeks: first experimental period 0-12 weeks, washout period 12-16 weeks second experimental period 16-28 weeks:
#Intervention
- OTHER : Functional Meet
- During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.
- Other Names :
- Functional food
- OTHER : Control Meat
- During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
- Other Names :
- Control Food
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women aged > 18 years
* At least 2 lipid profile parameters altered (TAG >=150 mg /dl and/or total cholesterol >=200 mg / dl and/or LDL >=130 mg / dl and/or HDL >=40mg/dl men or >= 50mg/dl women).
* Signed informed consent
Exclusion Criteria:
* Individuals with body mass index (BMI) >= 35 kg/m2
* Individuals with Diabetes Mellitus insulin dependent
* Individuals with disorders associated with eating behaviour
* Individuals with consumption of omega 3 functional foods, fish oil or antioxidant supplements
* Individuals inability to consume the test foods (ej. Vegetarians)
* Individuals with special diet due to disease as celiac disease, chronic renal failure, etc.
* Individuals with mental disease or low cognitive function.
* Individuals with consumption of drugs to weight lost.
* Individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory).
* Individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.).
* Pregnant women or lactating.
* Individuals with regular consumption of anti-inflammatory or glucocorticoids.
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
|
NCT01999088
|
{
"brief_title": "Health Benefits of Functional Meat (With n-3 Fatty Acids and Rosemary Extract) on Low Risk for Cardiovascular Disease People",
"conditions": [
"Low Risk for Cardiovascular Disease"
],
"interventions": [
"Other: Control Meat",
"Other: Functional Meet"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT01999088",
"official_title": "Randomized, Double-blind, Cross-over Placebo-controlled Study to Assess the Functional Meat Products With n-3 and Rosemary Extract Fluid in Biochemical Markers of Cardiovascular Disease Related Risk in Subjects at Low Risk for Cardiovascular Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-06",
"study_start_date(actual)": "2009-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-12-03",
"last_updated_that_met_qc_criteria": "2013-11-25",
"last_verified": "2013-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-03",
"first_submitted": "2013-11-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to validate and provide applicable norms for the United States (US) Spanish versions of the IntelliSpace Cognition (ISC) neuropsychological tests.
Detailed Description
The study will collect test scores from the Spanish speaking Hispanic US population for Spanish translations/adaptations of the ISC tests with the aim to assess how the Spanish language version of ISC tests compare to the English language version of ISC tests, and to create norms for the Spanish language version of the tests.
#Intervention
- DEVICE : observation
- no intervention
|
#Eligibility Criteria:
Inclusion Criteria:
* Self-reported:
* Participant is >= 18 years.
* Participant considers herself or himself to be Hispanic/Latino.
* Participant has Spanish as their primary and dominant language, or reports speaking Spanish as equally as good as she or he speaks English.
* Participant is able to see well (naturally or corrected by means of eyeglasses or lenses).
* Participant is able to hear well (naturally or corrected by means of a hearing aid).
* Participant is able to use their fingers, hands and arms to write symbols.
* Participant has valid health insurance.
Investigator observed:
* Participant is able to give informed consent.
* Participant is able to understand test instructions and participate fully in testing.
* Participant has normal fine and gross motor ability.
Exclusion Criteria:
* Self-reported:
* Participant has participated in previous studies where IntelliSpace Cognition was used (PJ-011726: 'Study to establish the psychometric properties of the digital cognitive tests on the Philips IntelliSpace Cognition Platform' conducted during 2019 or ICBE-S-000233: 'Norms Expansion and Validation for IntelliSpace Cognition' conducted during 2021).
* Participant is currently admitted to a hospital, assisted living, nursing home or a psychiatric facility.
* Participant is diagnosed with a neurological disorder or disease that may affect cognitive functioning (e.g., Parkinson's, brain tumor, stroke, Traumatic Brain Injury (TBI), epilepsy, encephalitis, dementia).
Admissible: Epilepsy with no more than 2 seizures and not currently receiving epilepsy treatment and not currently seeking medical attention related to seizures.
* Participant is diagnosed with a language disorder or aphasia (expressive or mixed receptive/expressive).
Admissible: Articulation disorder.
* Participant is diagnosed with a learning disorder.
* Participant is diagnosed with an autoimmune disorder that may affect cognitive functioning (e.g., LUPUS, Multiple Sclerosis).
* Participant is or was diagnosed with a current or past psychotic disorder (e.g., schizophrenia).
* Participant is diagnosed with a severe mood disorder. Admissible: Major Depressive Disorder in remission / Major Depressive Disorder with no current episode / Dysthymic Disorder / Adjustment Disorder
* Participant is diagnosed with a severe anxiety disorder. Admissible: Phobia / Anxiety disorders with symptoms not significant enough to interfere with test performance.
* Participant is or was diagnosed with current or past Autism Spectrum Disorder or Intellectual Disability.
* Participant is diagnosed with a current substance abuse or dependence. Admissible: In remission for at least 1 year.
* Participant has carried a substance abuse or dependence diagnosis for more than 10 years at any point in their life.
* Participant has an average alcohol consumption of 4 or more units per day.
* Participant uses medical marijuana.
* Participant uses recreational marijuana more than once a week.
* Participant uses recreational drugs other than alcohol and marijuana in the last 6 months (e.g., cocaine, ecstasy, LSD).
* Participant has been unconscious related to traumatic brain injury or 'medical condition' for more than 20 minutes.
Admissible: Medication-induced or due to heat stroke.
* Participant has stayed in a hospital overnight due to a head injury.
* Participant has had a medical event requiring resuscitation in which they were non-responsive for more than 15 minutes.
* Participant has received chemotherapy treatment in the past 2 months.
* Participant has received electroconvulsive therapy (ECT).
* Participant has received radiation to the central nervous system.
* Participant experiences a physical condition or illness that interferes with normal cognitive functioning at work, school, Instrumental Activities of Daily Living (IADLs) etc.
Admissible: Diabetes, hypothyroidism, hypertension if controlled.
* Participant is currently taking anti-convulsants (e.g. Depakote, Lamictal or Lyrica, Gabapentin, Keppra, Topamax, Divalproex Sodium, Valproate Sodium, Levetiracetam, Lamotrigine, Pregabalin, Topiramate).
* Participant is currently taking anti-psychotics (e.g. Abilify, Rexulti, Zyprexa, Clozaril, Clozapine, Latuda, Seroquel, Risperdal, Risperidone, Aripipazle, Bexipiprazole, Olanzapine, Lurasidone HCL, Quetiapine).
* Participant is currently taking benzodiazepines (e.g. Diazepams, Valium, Klonopin, Ativan, Xanax, Lorazepam, Alprazolam, Clonazepam).
* Participant is currently taking psychostimulants (e.g. Amphetamines, Adderall, Ritalin, Methamphetamines, Dextroamphetamine, Methylphenidate HCL).
Admissible: Coffee.
* Participant is currently taking opioids (e.g. Oxycontin, Tramadol, Codeine, Dilaudid, Suboxone, Oxycodone, Percocet, Buprenorhine, Naloxone).
* Participant is currently taking antidepressants (e.g. Amitriptyline, Elavil, Pamelor, Tofranil, Vivactil, Imipramine, Protriptyline HCL).
Admissible: Antidepressants that are not tricyclic.
* Participant is currently taking oxybutynin (Ditropan).
* Participant is currently seeking medical diagnostic procedures for cognitive difficulties from a medical professional.
* Participant has received neuropsychological testing before. Admissible: Previous MMSE (-2) or MoCA testing more than 6 months prior.
Investigator observed:
* Participant shows evidence of current cognitive impairment.
* Participant displays disruptive behavior or insufficient compliance with testing to ensure a valid assessment.
* Participant is primarily nonverbal or uncommunicative.
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
|
NCT05210777
|
{
"brief_title": "Norms and Validation for IntelliSpace Cognition Spanish Version",
"conditions": [
"Cognitive Functioning of Healthy Individuals",
"Hispanic"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT05210777",
"official_title": "Norms and Validation for IntelliSpace Cognition Spanish Version",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-15",
"study_completion_date(actual)": "2022-05-19",
"study_start_date(actual)": "2022-01-31"
},
"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)": "2022-07-18",
"last_updated_that_met_qc_criteria": "2022-01-14",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-27",
"first_submitted": "2022-01-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Use of low-voltage, direct current pulsed electromagnetic fields (PEMF) in treating Post Traumatic Stress Disorder (PTSD), complex PTSD (cPTSD) and trauma-related injuries manifesting in physical and/or mental symptoms.
Detailed Description
The PEMF devices used are the Scientific Consciousness Interface Operations (SCIO) device; it is CE-marked, ISO certified and FDA classified as a Type II medical device. The device measures frequencies emitted by the patient as a Biofeedback tool, and then emits frequencies in square (50% duty cycle), sinus or sawtooth wave form.
Wave forms, frequencies (herz and kiloherz respectively), ampers and voltage are adjusted automatically using the in-built Artificial Intelligence of the software employed to control the SCIO machine. The maximum is 5 Direct Current volts.
Electrodes to both read and emit signals are placed on the forehead, wrists and ankles. Irregular frequencies are corrected by use of entrainment. Efficacy of entrainment is displayed in the software as a percentage between 0-100. A rectification level or entrainment result of 85-100% is considered successful treatment, that is, entrainment was as effective as possible for that one session.
PEMF therapy has already been shown to be effective in trauma, PTSD, anxiety and depression treatment. The University of Denmark have recently conducted a similar clinical trial, which investigated Transcranial Direct Current Electro-Magnetic Therapy for patients who were treatment-resistant to depression medication. This study was also a one-arm test. This test was conducted over the space of 8 weeks and involved 52 participants of mixed gender. All the results indicated a reduction in depression-related symptoms in different ways, using the Hamilton Depression Scale as a reference point. The baseline of the Hamilton Depression Scale dropped from 20.6 to 12.6, whilst 49 participants experienced a reduction of over 50% on the Hamilton Depression Scale. Their study concluded that Transcranial Electro-Magnetic Therapy was a beneficial treatment for treatment-resistant depression, and further studies should be conducted to highlight the potential benefits of similar treatments.
This pilot study does not make use of a placebo, no double-blind, and no control group. The aim of this pilot study is two-fold: Firstly to determine whether a lower total amount of sessions would be effective (namely twice weekly rather than five days a week over the course of three weeks); secondly, whether the setup and process of this pilot study can function at scale (multiple locations and relatively little training time required by therapists due to the artificial intelligence built into the software guiding the machine).
#Intervention
- DEVICE : S.C.I.O.
- The devices read, emit and entrain Electromagnetic waves of the body.
- Other Names :
- Scientific Consciousness Interface Operations Biofeedback Device, Nucleus Device, Eductor Device, Eductor1 Device
|
#Eligibility Criteria:
Inclusion Criteria:
* Human adults above or equal to 19 years
* All sexes and genders
* It is okay if they are currently seeking or undergoing complementary therapies and treatments for their PTSD such as cognitive behavioural therapy or anti-depressant pharmaceutical medications
* Diagnosed with PTSD and/or trauma
* Experiencing symptoms of PTSD and/or trauma, listed below:
* Re-imagining or 3D flash backs
* Sudden bouts of anger or irritability
* Self-sabotage
* Reliance upon coping mechanisms such as drugs or alcohol
* Insomnia
* Hyper-sensitivity
* Anxiety
* Able to travel to one of 3 treatment locations in London, Bristol or Bournemouth at the participant's own expense
* Able to attend all 6 treatments consisting of twice-weekly therapy sessions each 90 minutes in duration for three consecutive weeks
Exclusion Criteria:
* Any person on medication for severe psychotic episodes and/or suicidal thoughts / attempts
* Anyone under the age of 18.
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
|
NCT05033600
|
{
"brief_title": "Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Post-Traumatic Stress Disorder (PTSD) & Trauma",
"conditions": [
"Unspecified Trauma- and Stressor-Related Disorder"
],
"interventions": [
"Device: S.C.I.O."
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05033600",
"official_title": "Low-Voltage, Direct Current Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Patients With Post-Traumatic Stress Disorder (PTSD and cPTSD) and Trauma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-04",
"study_completion_date(actual)": "2021-10-04",
"study_start_date(actual)": "2021-09-20"
},
"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)": "2021-10-20",
"last_updated_that_met_qc_criteria": "2021-09-02",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-09-05",
"first_submitted": "2021-07-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations.
#Intervention
- BIOLOGICAL : IMVAMUNE (MVA-BN)
|
#Eligibility Criteria:
Inclusion Criteria:
* Male subjects between 18 and 49 years or female subjects between 18 and 55 years who provided informed consent.
* Women with negative pregnancy test.
* Women of childbearing potential must use an acceptable method of contraception.
* Cardiac enzymes within ULN.
* White blood cells >= 2500/mm3 and < 11,000/ mm3.
* Absolute neutrophil count >= 1000/mm3.
* Adequate renal function.
* Adequate hepatic function.
* Negative hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
* Negative antibody test to hepatitis C virus (HCV).
* Negative urine glucose by dipstick or urinalysis.
* Normal 12-lead electrocardiogram.
* Availability for follow-up during the study.
Groups 1 and 3 (All vaccinia-naïve subjects) additionally:
* No history of known or suspected previous smallpox vaccination.
* No detectable vaccinia scar.
* No military service prior to 1989 or after January 2003.
Groups 2 and 4 (All previously vaccinated subjects) additionally:
* History of at least one previous smallpox vaccination
* Time since most current smallpox vaccination > 10 years.
Groups 1 and 2 (All HIV Infected subjects) additionally:
* Documented HIV-1 infection
* Plasma HIV-1 RNA level < 400 copies/mL at screening.
* CD4 cells >= 350/µL
* Haemoglobin >= 9.0 g/dL.
* Platelets >= 100,000/mm3.
* AST (SGOT), ALT (SGPT) and alkaline phosphatase <= 3 x ULN
Groups 3 and 4 (All Healthy subjects) additionally:
* Negative ELISA for HIV.
* Haemoglobin >11 g/dL.
* Platelets >= 140,000/mm3.
* AST (SGOT), ALT (SGPT) and alkaline phosphatase without clinically significant findings
Exclusion Criteria:
* Pregnant or breast-feeding women.
* Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
* History of any serious medical condition (other than HIV infection).
* History of or active autoimmune disease.
* Known or suspected impairment of immunologic function (other than HIV infection).
* History of malignancy.
* History or clinical manifestation of clinically significant and severe haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
* Clinically significant mental disorder not adequately controlled by medical treatment.
* Any condition which might interfere with study objectives.
* History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
* History of an immediate family member with onset of ischemic heart disease before age 50.
* Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool.
* History of chronic alcohol abuse and/or intravenous drug abuse.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Known previous allergic reaction to immunoglobulins.
* Known allergies to cidofovir or probenecid.
* History of anaphylaxis or severe allergic reaction.
* Acute disease (illness with or without a fever) at the time of enrollment.
* Temperature >100.4°F at the time of enrollment.
* Subjects undergoing treatment for tuberculosis infection or disease.
* Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after study vaccination.
* Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior or after study vaccination.
* Chronic administration of immuno-suppressant or immune-modifying drugs.
* Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
* Administration or planned administration of immunoglobulins and/or any blood products.
* Use of any investigational or non-registered drug or vaccine.
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
|
NCT00189904
|
{
"brief_title": "Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected Patients",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00189904",
"official_title": "A Multicenter, Open-label Phase I/II Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in HIV Infected Subjects (CD4 Counts >350 / µl) and Healthy Subjects With and Without Previous Smallpox Vaccination",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "2005-07"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-09-28",
"last_updated_that_met_qc_criteria": "2005-09-11",
"last_verified": "2007-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-19",
"first_submitted": "2005-09-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study if to determine the specific contributions of energy intake and energy expenditure to changes in body weight and fat.
Detailed Description
1. Changes in body weight and fat will be positively associated with increases in total energy intake.
2. Changes in body weight and fat will be positively associated with decreases in total energy expenditure.
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI: 20 <= age <= 35 *Note : For participants that come to Orientation, we are allowing participants with a variance of 0.1 either way in the BMI range: 19.9 - 35.1
* 21 <= age <= 35 years
* Men and women
* Email address
* Access to a phone
Exclusion Criteria:
* Currently on medications to lose weight
* >90th percentile on the Brief Symptom Inventory (BSI)
* Planning to move from the Greater Columbia area in the next 15 months
* Other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
* Changed birth control status in past 3 months
* Currently taking birth control but plan to stop taking it within the next 12 months or are planning to start taking birth control in the next 12 months
* Planning to have weight loss surgery
* Started or stopped smoking in the past 6 months
* Blood pressure >= 150/90
* Blood glucose >= 145 mg/dL @ orientation
* Blood glucose >= 126 mg/dL @ B3
* Total cholesterol >= 240 mg/dl with LDL-C >= 190 mg/dl or Triglyceride levels >= 300 mg/dL
* Currently diagnosed with or taking medications for a major chronic health condition
* Presence of an eating disorder
* Currently participating in another study
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01746186
|
{
"brief_title": "The Energy Balance Study",
"conditions": [
"Total Energy Expenditure,Total Energy Intake"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01746186",
"official_title": null,
"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)": "2010-10"
},
"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)": "2023-02-13",
"last_updated_that_met_qc_criteria": "2012-12-06",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-10",
"first_submitted": "2012-11-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in preventing cancer in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an orange juice suspension, in healthy male participants.
II. Determine a safe dose range of this drug in these participants. III. Determine a recommended phase II dose of this drug in these participants.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of this drug in these participants.
OUTLINE: This is a randomized, placebo-controlled, double-blind, dose-escalation study.
Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension, on day 1.
After completion of study treatment, participants are followed periodically for 4 weeks.
#Intervention
- OTHER : placebo
- Given orally
- Other Names :
- PLCB
- DRUG : Bowman-Birk inhibitor concentrate
- Given orally
- Other Names :
- BBIC
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteer
* Male
* Performance status - ECOG 0 <= age <= 2
* RBC normal
* WBC >= 3,000/mm^3
* Platelet count normal
* Hemoglobin normal
* Hematocrit normal
* ALT and AST normal
* Bilirubin normal
* Creatinine normal
* No history of heart disease
* EKG normal
* No history of pancreatitis or obstruction of pancreatic ducts
* No history of pancreatic cancer or pancreatic adenoma
* Amylase normal
* Lipase normal
* Cholesterol normal
* Triglycerides normal
* Serum glucose ± 10% of normal
* Within 15% of ideal body weight
* No history of chronic medical condition
* No history of excessive alcohol consumption (i.e., > 2 alcoholic beverages per day on average)
* No history of amyloidosis
* Non-smoker
* Former smokers are eligible provided they have not smoked within the past 3 months
* No history of medical condition that would influence gastrointestinal uptake of the study drug
* No history of diabetes mellitus
* No allergy or prior adverse reaction to soybeans
* Not a vegetarian
* No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
* No evidence of other life-threatening disease
* No evidence of psychiatric problems
* More than 12 months since prior chemotherapy
* More than 1 month since prior experimental drugs
* More than 3 days since prior consumption of alcoholic beverages
* More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of nonsteroidal anti-inflammatory drugs
* More than 2 weeks since prior multivitamin tablets (or other vitamin supplements) of > 2 per day
* No more than 2 multivitamin tablets (or other vitamin supplements) per day during study participation
* No more than 1 serving of tofu, soy milk, or other primarily soy-based food per day
Sex :
MALE
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:
Yes
|
NCT00287833
|
{
"brief_title": "Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men",
"conditions": [
"Unspecified Adult Solid Tumor, Protocol Specific"
],
"interventions": [
"Drug: Bowman-Birk inhibitor concentrate",
"Other: placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00287833",
"official_title": "Phase I Single Dose Safety and Pharmacokinetic Study of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-04",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2006-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-05-03",
"last_updated_that_met_qc_criteria": "2006-02-06",
"last_verified": "2013-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-02-07",
"first_submitted": "2006-02-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to examine whether non-alcoholic fatty liver disease (NAFLD) is associated with hepatic glucagon resistance and hyperglucagonemia.
Detailed Description
Hyperglucagonemia is a common condition in obesity, prediabetes and type 2 diabetes. It increases the hepatic glucose production, thus contributing to type 2-diabetic hyperglycemia. In the current study we wish to examine whether non-alcoholic fatty disease (NAFLD) results in hepatic glucagon resistance. This could result in hyperglucagonemia through a feedback mechanism acting on the level of pancreatic alpha cells. Cirrhosis and type 1 diabetes, respectively, has previously been shown to be associated with hepatic glucagon resistance but it has not been examined in relation to NAFLD in humans so far.
#Intervention
- PROCEDURE : Liver biopsy
- One ultrasound guided liver biopsy
- OTHER : Pancreatic clamp
- I.v. infusions of somatostatin and insulin (basal rate) for will be adminstered for 3 hours. Glucagon will administered for 3 hours in total with infusion rates at a basal and a high physiological rate for 1.5 hours each.
|
#Eligibility Criteria:
Inclusion Criteria:
* Normal fasting plasma glucose and HbA1c < 6.0%
* Between 18.5 and 25 kg/m2 or between 30 and 40 kg/m2
* Normal haemoglobin
* Normal coagulation factor II, VII and X, INR and thrombocytes
* Age above 25 years
* Informed consent
Exclusion Criteria:
* Diabetes
* Prediabetes (impaired glucose tolerance and/or impaired fasting plasma glucose)
* First-degree relatives with diabetes
* Nephropathy (eGFR < 60ml/min and/or albuminuria)
* Liver disease (ALAT and/or serum ASAT >2x normal values)
* Use of anticoagulative medicine like Clopidogrel og Warfarin
* Pregnancy and/or breastfeeding
* Age above 80 years
* Any condition that the investigator feels would interfere with trial participation
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02337660
|
{
"brief_title": "Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia",
"conditions": [
"Non-alcoholic Fatty Liver Disease"
],
"interventions": [
"Other: Pancreatic clamp",
"Procedure: Liver biopsy"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT02337660",
"official_title": "Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2015-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-11-16",
"last_updated_that_met_qc_criteria": "2015-01-12",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-01-13",
"first_submitted": "2015-01-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare.
Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept.
Detailed Description
Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe GPA. Patients who enter the trial will be maintained on a stable dose of their maintenance immunosuppressive agent which may include methotrexate (MTX), azathioprine (AZA), or mycophenolate (MA) and will undergo a blinded randomization to receive abatacept or placebo. Patients will additionally receive prednisone 30 mg daily that will then be tapered to zero using a standardized tapering schedule.
If an enrolled patient experiences a non-severe relapse or non-severe disease worsening though common closing, or if they have not achieved remission by month 6, they will have the option of entering an open-label trial period whereby they would receive abatacept in conjunction with their maintenance immunosuppressive and a standardized glucocorticoid taper. Patients with a severe disease relapse or severe disease worsening will have met criteria for early termination criteria and be removed from active study treatment. Patients will remain on study until reaching criteria for early termination or until common closing, 12 months after randomization of the final patient. After common closing or early termination, patients will be treated with best medical judgment and will undergo a post-treatment safety visit 3 months after coming off of study treatment.
#Intervention
- DRUG : Abatacept
- Those randomized to abatacept will receive abatacept 125 mg administered by subcutaneous injection once a week Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept. .
- Other Names :
- CTLA4-Ig, Orencia
- DRUG : placebo
- Those randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must be considered as being best characterized as GPA and not microscopic polyangiitis (MPA) or eosinophilic granulomatosis with polyangiitis (EGPA) and must have met at least 2 of the 5 modified ACR classification criteria for GPA. These do not need to be present at the time of study entry. The modified ACR criteria are:
1. Nasal or oral inflammation, defined as the development of painful or painless oral ulcers or purulent or bloody nasal discharge
2. Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates, or cavities
3. Active urinary sediment, defined as microscopic hematuria (>5 red blood cells per high power field) or red blood cell casts
4. Granulomatous inflammation on biopsy, defined as histologic changes showing granulomatous inflammation within the wall of an artery or in the perivascular or extravascular area (artery or arteriole)
5. Positive anti-neutrophil cytoplasmic antibody (ANCA) test specific for proteinase-3 or myeloperoxidase measured by enzyme-linked immunoassay
* Relapse of GPA within the 28 days prior to screening where the active disease features meet the following definition of non-severe disease:
1. No disease manifestations that would be scored as a major element in the BVAS/WG
2. Absence of any disease feature that poses an immediate threat to either a critical individual organ or the patient's life
* Age 15 and older
* Willing and able to comply with treatment and follow-up procedures
* Both women and men must be willing to use an effective means of birth control while receiving treatment through this study. Women should continue the use of an effective means of birth control for a minimum of 14 weeks after the last dose of study drug. Effective contraception methods include abstinence, oral contraceptives (birth control pills), IUD, diaphragm, Norplant, approved hormone injections, condoms, or medical sterilization. If applicable, participating sites will defer to their local authorities if they require stricter guidelines on the types of allowable contraception methods.
* Willing and able to provide written informed consent (and written assent of minor participants if applicable.)
Exclusion Criteria:
* Presence of involvement that does not meet the criteria for non-severe disease
* Treatment with CYC within 3 months prior to screening
* Treatment with methylprednisolone 1000 mg within 28 days prior to enrollment
* Treatment with prednisone or prednisolone> 30 mg/day for > 28 days immediately prior to study entry
* Initiation or dose increase of the maintenance immunosuppressive agent (MTX, AZA, MA) within 3 months prior to screening
* Evidence of active infection (includes chronic infection)
* Patients who are pregnant or who are nursing
* Known infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen
* Inability to comply with study guidelines
* Cytopenia: platelet count < 100,000/mm3, white blood cell count (WBC) < 3,000/mm3 (3 x 109/L), absolute neutrophil count < 1500/mm3, hemoglobin (Hgb) < 8.5 g/dL
* Chronic renal insufficiency defined by a creatinine clearance of less than or equal to 20 ml/min
* AST or ALT > 3 times above the upper limit of the normal laboratory range
* Known current use of illegal drugs
* Other uncontrolled disease (co-morbidity) that could prevent a patient from fulfilling the study requirements or that would substantially increase the risk of study procedures
* History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure
* Receipt of an investigational agent or device within 30 days prior to enrollment or 5 half lives of the investigational drug (whichever is longer)
* A live vaccination fewer than 3 months before enrollment
* Current clinical, radiographic, or laboratory evidence of active tuberculosis
* A history of active tuberculosis within the past 3 years even if treated
* A history of active tuberculosis greater than 3 years ago unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
* Latent tuberculosis unless there is documentation of prior anti-tuberculosis treatment of appropriate duration and type
* Latent tuberculosis currently being treated with isoniazid (INH) or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., Center for Disease Control (CDC)) who have received such therapy for 4 weeks or less prior to randomization (Day 1). Subjects with a positive tuberculosis screening test indicative of latent tuberculosis will be eligible for the study if they have no evidence of current tuberculosis on chest xray at screening and they are actively being treated for tuberculosis with INH or other therapy for latent tuberculosis given according to local health authority guidelines (e.g., CDC) that has been given for at least 4 weeks prior to randomization (Day 1). These subjects must complete treatment according to local health authority guidelines.
* History of herpes zoster that resolved less than 2 months prior to enrollment
* Treatment with rituximab or any other biologic B cell depleting agent within the past 6 months
* Treatment with alemtuzumab or anti-thymocyte globulin within the last 12 months
* Treatment with intravenous immunoglobulin given at an immunomodulatory dosage or plasma exchange within the past 3 months. Patients can be enrolled if they are otherwise eligible and receiving immunoglobulin replacement for hypogammaglobulinemia.
* Treatment with infliximab, etanercept, adalimumab, tocilizumab, or any other biologic agent within the past 3 months or 5 half lives of the agent (whichever is longer)
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02108860
|
{
"brief_title": "Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)",
"conditions": [
"Granulomatosis With Polyangiitis (Wegener's)",
"Granulomatosis With Polyangiitis",
"Wegener's Granulomatosis",
"ANCA-Associated Vasculitis"
],
"interventions": [
"Drug: placebo",
"Drug: Abatacept"
],
"location_countries": [
"United States",
"Germany",
"Canada",
"Ireland",
"United Kingdom"
],
"nct_id": "NCT02108860",
"official_title": "Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-25",
"study_completion_date(actual)": "2023-12-20",
"study_start_date(actual)": "2015-04-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-07-29",
"last_updated_that_met_qc_criteria": "2014-04-04",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-09",
"first_submitted": "2014-03-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test the safety and tolerability of an investigational inhaled flu medication, CS-8958. Study participants will include 38 elderly males and females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups (Groups A, B, C and D) to receive the study drug or placebo (substance containing no medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be reviewed prior to administering a higher dose of treatment. Study procedures will include blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay. Participants will be involved in study related procedures for up to 6 weeks.
Detailed Description
Influenza is an acute febrile illness caused by influenza A and B virus affecting all age groups. Influenza occurs annually and each year it is estimated that influenza epidemics cause 36,000 deaths and 114,000 hospitalizations in the US alone. Influenza infections are generally self-limiting; however significant morbidity and mortality can occur, predominantly in high risk groups such as the elderly and those suffering from chronic conditions. This study is a Phase I, double-blind, placebo-controlled, ascending single inhaled dose, safety, tolerability and pharmacokinetic study in elderly subjects with stable health status. The primary objective of this study is to evaluate the safety and tolerability of CS-8958 (5, 10 20 and 40 mg) in elderly subjects after a single dose administered via inhalation. Primary outcome measures of safety and tolerability will be addressed in terms of occurrences of treatment-emergent adverse events (AEs), changes in vital signs including blood pressure and pulse rate, functional oxygen saturation of arterial hemoglobin, oral body temperature, electrocardiogram, spirometry \[Forced Vital Capacity (FVC)\], Forced Expiratory Volume in 1 second (FEV1), Forced Expiry Volume percentage in 1 second (FEV1.0%), Forced Expiratory Flow Rate (FEF) 25%-75%), Peak Expiratory Flow Rate (PEFR, also called PEF), physical examinations, psychological assessments, and laboratory parameters. The secondary objectives of this study are to assess the systemic exposure of CS-8958 and its active metabolite R-125489 after single inhaled doses of CS-8958 in elderly subjects. The secondary outcome measures of pharmacokinetic parameters will be calculated for CS-8958 and R-125489 (active metabolite) concentrations in plasma and urine using a non-compartmental approach. These measurements will be used to assess the systemic exposure of CS-8958 and its active metabolite in elderly subjects after a single inhaled dose of CS-8958 (5, 10, 20 and 40 mg). This data will help to determine safety margins for dosing of elderly subjects in future studies. Thirty-eight healthy adults (male and female), aged 65 years and older, with stable health status, will be recruited for this UK based study. Subjects will be studied in 4 groups (Groups A to D) with each group consisting of at least 8 subjects. Within each group, subjects will be randomly allocated to Arm 1 or Arm 2. Arm 1 will receive the investigational drug with lactose to 25 mg (placebo) and Arm 2 will receive placebo only. Treatment will begin with a low dose of 5 mg (Group A) and subsequent higher doses of 10, 20 and 40 mg (Group B, C and D, respectively) It is planned that doses will be administered in an escalating manner. The Safety Monitoring Committee will review the safety, tolerability and pharmacokinetic data from each group prior to administration of the next dose. Following these reviews, the dose increment for subsequent groups may be increased, or the doses administered may be reduced, and may be lower than the starting dose. The maximum dose level to be studied will be 40 mg. The duration of the study for each subject will be a maximum of 6 weeks from initial screen to the follow-up visit. The screening period will be at most 4 weeks followed by 7 days in the clinic and a follow up visit 5-7 days after leaving the clinic.
#Intervention
- DRUG : CS-8958 formulated as dry powder
- CS-8958, formulated as a dry-powder and will be administered from capsules containing 5 mg CS-8958 and lactose to 25 mg (placebo) inserted into a FlowCaps inhaler device.
- OTHER : Placebo
- placebo capsules containing 25 mg lactose
|
#Eligibility Criteria:
Inclusion Criteria:
* Ambulatory male and female adults aged 65 years and older.
* Elderly adults in good health, as determined by vital signs (heart rate less than 100 bpm, blood pressure [systolic less than or equal to 160 mm Hg and diastolic less than or equal to 90 mm Hg], oral temperature less than or equal to 37.7 degrees C and SpO2 of at least 95%), stable medical condition and a full physical examination. A stable medical condition is defined as no change in medication, dose, or frequency of medication in the last 1 month; health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months; and no unplanned hospitalizations within the last 3 months (hospitalizations for minor elective procedures may be considered for inclusion on a case by case basis following discussion between the Investigator and the DMID Medical Monitor).
* Female subjects must be surgically sterile or post-menopausal (defined by a measurement of follicle stimulating hormone [FSH] greater than 18 mlU/mL and serum oestradiol less than 110 pmol/L (or 30 pg/mL), or by 24 consecutive months of amenorrhoea for which there is no other obvious pathological cause) and have a negative serum pregnancy test.
* No clinically significant abnormality in the ECG. QTc must be less than 450 ms and PR 120 <= age <= 209 ms. Any ECGs considered abnormal will be reviewed and approved by an independent cardiologist, (normal variants such as sinus arrhythmia and sinus bradycardia do no need to be independently reviewed).
* Negative results in Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen (HBsAg) and Hepatitis C antibody tests.
* Negative results in urine drug screen and alcohol breath test.
* Able to understand and comply with all planned study procedures including ability to perform respiratory testing and use the inhaler device after training.
* Provide informed consent prior to any study procedures and is available for all study visits.
Exclusion Criteria:
* A Grade 2 biochemistry, hematology or urinalysis abnormal finding as defined in the Appendix to the protocol. Subjects with a Grade 1 biochemistry, hematology or urinalysis abnormality will be considered for inclusion on a case by case basis following discussion between the Investigator and the DMID Medical Monitor.
* Has any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
* A history or clinical evidence of hepatic disease, including abnormal laboratory values for AST, ALT or total bilirubin or abnormal laboratory values for potassium.
* A history or clinical evidence of hematological abnormalities; specifically abnormal laboratory values for hemoglobin, platelets, WBC or neutrophils.
* A history or clinical evidence of renal disease; specifically abnormal laboratory values for serum creatinine.
* A history or clinical evidence of ventricular arrhythmias, or any subject with an implantable defibrillator.
* A history or clinical evidence of significant respiratory disease (including asthma, hyper-reactive lung disease, COPD [on oral steroids or with chronic bronchitis], cystic fibrosis and/or recurrent lower respiratory tract infection, pneumonectomy or pulmonary insufficiency requiring home O2) and/or upper respiratory tract infection within the last 3 weeks or lower respiratory tract infection within the last 3 months.
* Any diagnosis of dementia (such as Alzheimer's disease) or current treatment for dementia (e.g. Aricept), or a mini mental state score of less than or equal to 25 at Screening.
* A Geriatric Depression Scale-Short Form (GDS-SF) score of greater than or equal to 6 (out of a total possible score of 15) at Screening, or a history or clinical evidence of endogenous depression, or a history or clinical evidence or treatment of exogenous depression within 1 year prior to enrollment in this study.
* A score of less than or equal to 16 out of 20 in the Clock Drawing Test (CDT) on Day 0.
* Has an acute or chronic medical condition that in the opinion of the Investigator would interfere with the evaluation of response.
* Is using parenteral or oral steroids, inhaled medications, anticoagulants, immune modulators (oral or topical) or other immunosuppressive or cytotoxic drugs within 2 weeks prior to enrolment in this study.
* Has received any other neuraminidase inhibitor within 2 weeks prior to enrollment in this study.
* A history or clinical evidence of dizziness with unknown cause.
* History of severe adverse reaction or hypersensitivity to lactose or neuraminidase inhibitors.
* Intake of any investigational drug product within 4 months prior to the intake of investigational product (Day 1).
* Receipt of blood or blood products or loss of 450 mL or more of blood during the last 3 months before screening.
* Has a clinically significant history of alcohol abuse or drug abuse.
* Body Mass Index (BMI) less than 18.5 kg/m2 or greater than 32.0 kg/m2.
* FEV1 less than or equal to 85%, FEV1.0% less than or equal to 70%, and/or FVC less than or equal to 80% of the predicted value, as calculated from standard age and height formula. If the first assessment is borderline then 2 further assessments may be made, both of which must have values above these criteria for the subject to be eligible.
* Subjects who smoke or have been non-smokers for less than 6 months prior to Screening.
* Subjects who were previously enrolled in this study.
* Poor veins or fear of venipuncture or sight of blood.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00657111
|
{
"brief_title": "CS-8958 Single Inhaled Dose in Elderly",
"conditions": [
"Influenza"
],
"interventions": [
"Drug: CS-8958 formulated as dry powder",
"Other: Placebo"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00657111",
"official_title": "CS-8958 - A Phase I, Double-Blind, Placebo Controlled, Ascending Single Inhaled Dose, Safety, Tolerability and Pharmacokinetic Study in Elderly 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)": "2008-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-09-17",
"last_updated_that_met_qc_criteria": "2008-04-10",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-14",
"first_submitted": "2008-04-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An open label, 2-period, sequential study to determine the impact of multiple doses of ketoconazole on single-dose pharmacokinetics of HCV-796
#Intervention
- DRUG : Ketoconazole
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
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
|
NCT00384917
|
{
"brief_title": "Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796",
"conditions": [
"Healthy"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00384917",
"official_title": "An Open Label, 2-Period, Sequential Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-09",
"study_start_date(actual)": "2006-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-07-10",
"last_updated_that_met_qc_criteria": "2006-10-05",
"last_verified": "2009-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-06",
"first_submitted": "2006-10-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a health services demonstration project that evaluates three methods of health care delivery for the management of individuals with symptoms of asthma. This study will evaluate the impact of a telephonic asthma disease management process, with and without a home intervention program, on preventing asthma-related morbidity through patient/family asthma education.
The investigators' central thesis is that comprehensive clinical disease management protocols for the management of asthma will improve clinical outcomes; reduce fiscal resource consumption; and improve both patient satisfaction and patient quality of life. Additionally, individualized, in-home patient education and environmental assessment, when added to the telephonic protocol, will further improve these measures. However, incremental improvement will vary according to the population's access to care.
Detailed Description
This trial addresses the real-world concerns of asthma management through a disease management approach that will assist both the patient and the primary care physician by providing education, additional outpatient resources and additional access to health care personnel. This approach will stress empowering the patient to participate in his or her own health care at a higher level, which, in the case of asthma, is critical to wellness.
In a cooperative network of San Antonio medical centers, civilian and military, with a collective mission to care for military beneficiaries and the underserved patients of South Texas, this trial will evaluate the clinical benefits, as well as the cost savings, of a chronic disease management intervention in asthma. This study will fill a conspicuous gap in the medical literature by addressing the effectiveness of disease management through a large, decentralized, randomized, controlled trial.
DISEASE MANAGEMENT INTERVENTION
The project will use asthma disease management protocols and educational materials developed by the National Jewish Medical and Research Center. The program will be fully available in both English and Spanish, allowing a direct test of its impact on the State's vulnerable Hispanic population. Based on the principles of comprehensive disease management, National Jewish Medical and Research Center has developed a disease management program for asthma (DMP: Asthma) which addresses continuity of care by integrating traditional treatment methods with a program that focuses on creating a stronger partnership between the patient and the healthcare team, as well as greater patient empowerment. The primary program goal is empowering patients with the tools and resources they need for better self management of their prescribed treatment regimens and control of their environment. The program incorporates practice guidelines outlined by the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH).
HOME VISIT INTERVENTION
In addition, the demonstration will evaluate the addition of a home-based disease management protocol focusing on patient education, to test for incremental improvement. Patients will be taught about their disease (symptoms, treatment, appropriate action plans), as well as about the healthcare system (how and when to access it). Based on the principles of comprehensive disease management and the unique needs of South Texas residents, the South Texas Asthma Management Program (STAMP) is designed for a diverse, mobile, underserved patient population. The protocol delivers up-front home-based education and environmental assessment, with follow-up visits focused on reinforcement of the earlier messages. The program ensures access to a primary care provider for patients who lack this critical member of the healthcare team. It also provides multiple resources for social services and guidance in appropriately accessing the healthcare system. The goal of the program is to equip patients, who have barriers to access due to a number of factors (lack of phone, language, remote location, etc), to navigate the healthcare system and effectively receive the care they need.
#Intervention
- BEHAVIORAL : Disease Management
- BEHAVIORAL : Disease Management + Educational Home Visits
|
#Eligibility Criteria:
Inclusion Criteria:
* Physician diagnosis of asthma
* One or more of the following:
* Acute visit with the primary diagnosis of asthma within the previous 6 months. (Includes visits to physician's office, emergency department, or any other health care facility.); OR
* Three or more refills for inhaler medicine in the past 6 months, based on review of pharmaceutical records; OR
* Diagnosis of asthma based on asthma symptoms and pulmonary function testing.
Exclusion Criteria:
* Other lung disease(s) with a possible reactive component (i.e. chronic obstructive pulmonary disease [COPD])
* Any diagnosis requiring chronic systemic steroids
* Enrollment in any other asthma disease management program
* Pregnancy
* Plan to reside at current residence for less than 12 months.
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00124085
|
{
"brief_title": "Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough?",
"conditions": [
"Asthma"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00124085",
"official_title": "Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough? A Randomized, Controlled Trial Comparing Traditional Care to Two Systems of Disease Management for a Decentralized Population of Patients in South Texas",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-03",
"study_completion_date(actual)": "2006-03",
"study_start_date(actual)": "2003-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-08-09",
"last_updated_that_met_qc_criteria": "2005-07-22",
"last_verified": "2012-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-07-26",
"first_submitted": "2005-07-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Episodes of inactivity due to hospitalisation, as short as 5 days, are associated with rapid muscle and strength loss in the elderly. The observed muscle loss with inactivity is likely due to muscle anabolic resistance and increased breakdown rates of muscle tissue. This is of great concern as the average hospital stay in the elderly is 5-6 days. Moreover, minor illnesses not requiring hospitalisation generally require short-term periods of inactive home-based recovery. The accumulation of repeated disuse events in older individuals manifests in a chronic muscle anabolic resistance (i.e. the inability of muscle to respond to anabolic stimuli such as exercise and nutrition) that may underpin the slow but devastating process of age-related muscle loss.
It is our belief that strategies to promote muscle health in ageing and reduce healthcare expenditure, should focus on alleviating muscle deterioration and anabolic resistance during short-term disuse.
In this regard, we propose that resistance exercise (i.e. weight lifting) performed prior to a disuse event (termed 'prehabilitation') may be sufficient to offset muscle loss in older individuals. Thus, we suggest the potent effect of resistance exercise in older muscles may prevent muscle loss during short-term disuse.
Detailed Description
Participants will be assigned to either single-bout (SINGLE; n=10) or multiple-bouts (MULTI; n=10) of resistance exercise prehabilitation prior to 5 consecutive days of bed rest. Groups will be matched for age, anthropometric characteristics and activity levels. Only males will be studied due to potential gender differences in muscle protein turnover. A single-leg resistance exercise prehabilitation model will allow for a direct within-subject comparison against the non-exercised control leg.
Preliminary Assessments
Following an induction meeting and obtainment of informed consent, participants will report to The National Institute of Health/Wellcome Trust Clinical Research Facility (CRF) at University Hospital Birmingham (UHB) at 0800h having fasted from 2100h the previous night. After measuring height and weight, the following parameters will be determined in the order outlined:
1. Muscle biopsy, blood and saliva sampling: a muscle biopsy sample will be obtained from a specific thigh muscle under local anaesthetic. A blood sample will then be obtained from a forearm vein. Participants will also provide a saliva sample. This will be obtained prior to the following measurements.
2. Lower-limb function: The short physical performance battery (SPPB) test will be used.
3. Body composition: bioelectrical impedance analysis will be used to determine fat/fat-free mass on a whole-body and anatomical regional basis (CRF nurse).
4. Muscle size/architecture: The thickness of the thigh muscles will be determined via non-invasive ultrasound imaging.
5. Leg strength and muscle activation: Estimated maximal leg strength will be measured firstly on a standard knee extension exercise machine.
6. Stable isotope procedure: Immediately following muscle biopsy, blood and saliva sampling, participants will orally consume a small bolus of 'heavy water' tracer to label the body water pool with a small amount of this isotope. Participants will provide a daily saliva sample to monitor body water tracer enrichment. This technique will allow us to quantify muscle protein synthesis over the course of prehabilitation and bed-rest.
7. Participants will be fitted with an accelerometer and pedometer to asses daily activity levels.
8. Participants are given a food diary to record daily nutritional intake over a 3-day period.
Exercise Prehabilitation (Days 0-7) Participants will be randomly assigned to undergo 4 resistance exercise bouts the week before (Day 1, 2, 5 and 7), or 1 resistance exercise bout on the evening prior to bed rest (i.e. Day 7). Exercise bouts will consist of 8 sets of single-leg knee extension exercise and 8 sets of single-leg leg curls. The non-exercised control leg will remain passive throughout training. Resistance exercise will be performed at 70% of previously determined maximal strength (10-15 repetitions).
Intervention - 5-days of bed-rest (Days 8-13) Participants will report to the CRF at 0700h the morning immediately after exercise prehabilitation phase. At 0800h, muscle biopsies will be obtained from both legs to assess changes in muscle metabolism over the 7 days of prehabilitation. Participants will then be transported for dual energy x-ray absorptiometry (DXA), Magnetic Resonance Imaging (MRI) and ultrasound assessment of body/muscle composition, after which the 5 consecutive days of strict bed rest will begin. The bed rest model will mimic a traditional inpatient hospital stay and reflect the level of muscle unloading that occurs in older individuals following acute illness. Participants will spend the majority of time in bed and will be allowed to adjust the hospital bed head height for reading, eating and watching television, but will otherwise be instructed to lie flat in bed. Bathing/hygiene will be performed in a wheelchair at a sink. The bathroom accessed using a wheelchair. Adherence to bed rest will be monitored by nursing staff and through daily analysis of accelerometry data.
Post Intervention Assessments (Day 13) On the morning after completion of the 5-day bed rest phase (i.e. Day 13) participants will awake at 0700h in the CRF and remain in bed for assessment of muscle protein synthesis in trained and untrained control legs. A cannula will be inserted into a vein of both forearms for frequent blood sampling and a stable isotope tracer infusion. During the tracer infusion, muscle biopsies will be obtained from both trained and untrained legs before and after consumption of a milk protein drink, to assess muscle metabolism. Participants will then be transported by wheelchair for repeat bioelectrical impedance analysis, MRI and ultrasound scans to assess body/muscle composition. Leg strength will be reassessed in trained and untrained legs. A physiotherapist will perform a functional assessment of participants before they are discharged.
Rehabilitation Training Participants will be given the opportunity to complete a 6-week rehabilitation programme, consisting of a progressive 3 x weekly leg resistance training with protein supplementation, designed to fully restore any loss in muscle mass and strength from short-term bed rest. Resistance training rehabilitation will not form a specific study objective, but muscle size and strength will be assessed to ensure restoration of any muscle decline from bed rest.
#Intervention
- OTHER : Resistance exercise
- Single-legged resistance exercise
|
#Eligibility Criteria:
Inclusion Criteria:
* Males aged between 65 <= age <= 80 years
* No history of structured resistance training within 10 years prior to study participation.
* Generally good health as indicated by a thorough health questionnaire.
* A score of >=9 points on the Short Physical Performance Battery to assess lower extremity function.
* Body Mass Index <30kg/m2
Exclusion Criteria:
* Coagulation disorders
* Myocardial infarction
* Artery/vein disease
* Hormone replacement therapy
* Other chronic/systemic illnesses (i.e. renal failure, chronic obstructive pulmonary disease, cancer).
* Undergone 2 or more muscle biopsies from each leg previously.
* Received a stable isotope infusion in the last 3 years prior to study enrollment.
Sex :
MALE
Ages :
- Minimum Age : 65 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04422665
|
{
"brief_title": "Preventing Bed-rest Induced Muscle Loss in the Elderly",
"conditions": [
"Muscle Loss",
"Disuse Atrophy",
"Protein Metabolism",
"Prehabilitation",
"Sarcopenia"
],
"interventions": [
"Other: Resistance exercise"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04422665",
"official_title": "Exercise 'Prehabilitation': A Novel Intervention to Protect Against Disuse-induced Muscle Atrophy and Sarcopenia in the Old",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-01",
"study_completion_date(actual)": "2020-01-01",
"study_start_date(actual)": "2017-09-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-09",
"last_updated_that_met_qc_criteria": "2020-06-04",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-09",
"first_submitted": "2020-06-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or drinking) conditions in healthy male participants.
Detailed Description
This is a Phase 1, randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single-center, single-dose and 3-way Crossover (the same medications provided to all participants but in different sequence) pivotal study to determine the bioequivalence of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated tablet formulation. Approximately 102 healthy male participants will participate in this study. Participants will be randomly assigned to 1 of 6 treatment sequences. The study will consist of 3 parts: Screening Phase (within 21 days before the first study drug administration of the first period), an open-label treatment Phase consisting of 3 single-dose treatment periods (45 days) and follow-up Phase (5 to 7 days after the last study procedure). The total study duration for each participant will be from 45 days to a maximum of 61 days. Participants will receive a single oral 1000 milligram (mg) dose of abiraterone acetate under fasted conditions either as Treatment A (current commercial formulation, uncoated), Treatment B (current commercial formulation, coated) or Treatment C (new composition, coated). Bioequivalence will be primarily evaluated by pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
#Intervention
- DRUG : Abiraterone acetate (Treatment A)
- Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
- Other Names :
- JNJ-212082
- DRUG : Abiraterone acetate (Treatment B)
- Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment B (current commercial formulation, 4\*250 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
- Other Names :
- JNJ-212082
- DRUG : Abiraterone acetate (Treatment B)
- Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment C (new composition, 2\*500 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
- Other Names :
- JNJ-212082
|
#Eligibility Criteria:
Inclusion Criteria:
* If sexually active, participants must always use a condom during the study and for 1 week after last intake of study drug. If sexually active with a pregnant woman or woman of child-bearing potential, participants must agree to abstain from intercourse during the study and for 1 week after last intake of study drug. Participants should not donate sperm during the study and for 1 week after receiving the last dose of study drug
* Body mass index (BMI; weight [kilogram(kg)]/height^2 [meter square (m^2)]) between 18.5 and 30.0 kg/m^2, (inclusive), and body weight not less than 50 kg
* Blood pressure (after the participants is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at Screening
* A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at Screening as specified in the protocol
* Non-smoker, no history of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report
Exclusion Criteria:
* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participants or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology or clinical chemistry at Screening
* Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled through study completion
* History of, or a reason to believe a participants has a history of drug or alcohol abuse within the past 5 years
Sex :
MALE
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
|
NCT02230046
|
{
"brief_title": "Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Abiraterone acetate (Treatment B)",
"Drug: Abiraterone acetate (Treatment A)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02230046",
"official_title": "A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Abiraterone Acetate Coated Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Uncoated Tablet Formulation Under Fasted Conditions in Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-11",
"study_completion_date(actual)": "2014-11",
"study_start_date(actual)": "2014-10"
},
"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)": "2016-01-20",
"last_updated_that_met_qc_criteria": "2014-09-02",
"last_verified": "2016-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-03",
"first_submitted": "2014-08-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride).
The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.
#Intervention
- DRUG : pembrolizumab
- IV infusion
- Other Names :
- KEYTRUDA®, MK-3475
- DRUG : lenvatinib
- oral capsule
- Other Names :
- MK-7902, E7080
- DRUG : regorafenib
- oral tablet
- Other Names :
- STIVARGA®, REGONIX®
- DRUG : TAS-102 (trifluridine and tipiracil)
- oral tablet
- Other Names :
- LONSURF®
|
#Eligibility Criteria:
Inclusion Criteria:
* Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma (Stage IV A, B and C as defined by American Joint Committee on Cancer [AJCC] 8th edition). Note: Tumor must be determined to be NOT microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) by local testing
* Has been previously treated for their disease and has shown disease progression as defined by RECIST 1.1 on or after or could not tolerate standard treatment, which must include ALL of the following agents if approved and locally available in the country where the participant is randomized:
1. fluoropyrimidine, irinotecan and oxaliplatin
2. with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab)
3. with anti- epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) for RAS (KRAS/NRAS) wild-type (WT) participants
4. BRAF inhibitor (in combination with cetuximab +/- binimetinib) for BRAF V600E mutated metastatic colon cancer (mCRC)
* Has measurable disease per RECIST 1.1 assessed by the investigator
* Has provided to a designated central laboratory an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion which has not been previously irradiated
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days prior to randomization
* Has a life expectancy of at least 3 months, based on the investigator assessment
* Has the ability to swallow capsules or ingest a suspension orally or by a feeding tube
* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP <=150/90 millimeter of mercury (mmHg) with no change in antihypertensive medications within 1 week prior to randomization
* Male participants must agree to the following during the treatment period and for at least 90 days after the last dose of regorafenib or TAS-102 and at least 7 days after the last dose of lenvatinib: refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle or use contraception. The male contraception period should continue for at least 7 days after discontinuation of lenvatinib
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a highly-effective contraceptive method during the treatment period and for at least 30 days after the last dose of lenvatinib, 120 days after the last dose of pembrolizumab, and 180 days after the last dose of regorafenib or TAS-102 (whichever is last) AND agrees not to donate eggs (ova, oocytes)
* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study treatment
Exclusion Criteria:
* Has a tumor that is microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) per local testing
* Has presence of gastrointestinal condition, eg, malabsorption, that might affect the absorption of study drug.
* Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
* Has radiographic evidence of encasement or invasion of a major blood vessel invasion or of intratumoral cavitation. In the chest, major blood vessels include the main pulmonary artery, the left and right pulmonary arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the aorta
* Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
Participants with cardiac failure NYHA Class II, III and IV are not allowed to be assigned to the regorafenib in Arm B
* Has a history of arterial thromboembolism within 12 months of start of study drug
* Has urine protein >=1 gram/24 hour
* Has prolongation of QT interval corrected with Fridericia's formula (QTcF interval) to >480 milliseconds
* Has left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with certain exceptions
* Has serious nonhealing wound, ulcer or bone fracture
* Has had major surgery within 3 weeks prior to first dose of study treatment
* Has received biologic response modifiers (eg, granulocyte colony-stimulating factor) within 4 weeks before study entry
* Has preexisting >=Grade 3 gastrointestinal or nongastrointestinal fistula
* Has received prior treatment with a combination of an anti-PD-1, anti-PD-L1, or anti PD-L2 agent with anti-VEGF monoclonal antibodies or vascular endothelial growth factor receptor (VEGFR) inhibitors
* Has previously received regorafenib or TAS-102
* Has received prior systemic anti-cancer therapy including investigational agents within 28 days prior to randomization
* Has received prior radiotherapy within 2 weeks of start of study treatment
* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment
* Has known intolerance to lenvatinib, regorafenib, or TAS-102 and/or any of their excipients
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first dose of study treatment
* Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Has a known history of Human Immunodeficiency Virus (HIV) infection
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Has had an allogenic tissue/solid organ transplant
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
|
NCT04776148
|
{
"brief_title": "Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)",
"conditions": [
"Colorectal Neoplasms"
],
"interventions": [
"Drug: lenvatinib",
"Drug: TAS-102 (trifluridine and tipiracil)",
"Drug: pembrolizumab",
"Drug: regorafenib"
],
"location_countries": [
"Japan",
"Israel",
"China",
"United States",
"Germany",
"Taiwan",
"United Kingdom",
"Canada",
"Russian Federation",
"Korea, Republic of",
"Spain",
"Australia",
"Argentina",
"Turkey",
"Denmark"
],
"nct_id": "NCT04776148",
"official_title": "A Phase 3 Randomized Study of Lenvatinib in Combination With Pembrolizumab Versus Standard of Care in Participants With Metastatic Colorectal Cancer Who Have Received and Progressed On or After or Became Intolerant to Prior Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-02-20",
"study_completion_date(actual)": "2024-09-27",
"study_start_date(actual)": "2021-03-29"
},
"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)": "2024-10-29",
"last_updated_that_met_qc_criteria": "2021-02-26",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-01",
"first_submitted": "2021-02-26",
"first_submitted_that_met_qc_criteria": "2024-03-11"
}
}
}
|
#Study Description
Brief Summary
This study will quantify the intraocular pressure elevation in the immediate time period following intravitreous injection. With more widespread use of intravitreous injections in patients that may require several injections per year, it is important to document the sudden increase in intraocular pressure, including the maximum intraocular pressure and the time required for the intraocular pressure to return to baseline. This data may be useful in stimulating additional studies to evaluate the long term ocular effects of repeated intravitreous injections.
We hypothesize that the intraocular pressure increases significantly following intravitreous injection and then returns to baseline during the initial thirty minutes following ranibizumab injection.
Detailed Description
We will assess the trend of intraocular pressure immediately following intravitreal injection of ranibizumab 0.5 mg (0.05 mL) by taking serial intraocular pressure readings every five minutes for thirty minutes after injection. This study is a prospective descriptive data collection consisting of measuring intraocular pressure immediately following intraocular injection, and at 5, 10, 15, 20, 25, and 30 minutes following injection of ranibizumab 0.5 mg.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or Female Patients >18 years
* Patients will have documented choroidal neovascular membranes on fluorescein angiogram and/or optical coherence tomography
* Requiring treatment or maintenance therapy for choroidal neovascular membrane
* Able and willing to provide written informed consent
Exclusion Criteria:
* History of arterial occlusive disease of the eye.
* History of advanced glaucoma.
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
|
NCT00417703
|
{
"brief_title": "Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab",
"conditions": [
"Choroidal Neovascularization"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00417703",
"official_title": "A Prospective Investigation of the Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-01",
"study_completion_date(actual)": "2008-01",
"study_start_date(actual)": "2007-01"
},
"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)": "2008-01-24",
"last_updated_that_met_qc_criteria": "2007-01-03",
"last_verified": "2008-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-04",
"first_submitted": "2007-01-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a Phase I, open-label, multicenter, pharmacokinetic study of MDX-010 in up to 90 evaluable subjects with surgically unresectable malignant melanoma.
Detailed Description
Group A: Six to 12 subjects will be treated with transfectoma-derived MDX-010 at 2.8 or 5 mg/kg/dose, or with hybridoma-derived MDX-010 at 3 mg/kg/dose administered on Days 1, 57, and 85. The 2.8, 3, and 5 mg/kg dosage cohorts may be initiated concurrently. Additionally, 6 subjects per cohort will receive single doses of transfectoma-derived MDX-010 at 7.5, 10, 15, and 20 mg/kg.
Dose escalation from the 5 mg/kg cohort to the 7.5 mg/kg cohort will depend on the safety profile following a single dose of 5 mg/kg. Once all subjects are enrolled in the 5 mg/kg cohort and 4 weeks have elapsed since the sixth subject in the cohort has received the first infusion, dose escalation to the 7.5 mg/kg cohort may occur if ≤1 DLT has occurred in the 5 mg/kg cohort. Dose escalation to the 10 mg/kg cohort may occur 4 weeks after the sixth subject in the 7.5 mg/kg/dose cohort has received the first infusion (with ≤1 DLT). Dose escalation to the 15 and 20 mg/kg cohorts may occur 4 weeks after the sixth subject in the previous cohort has received the first infusion (with ≤1 DLT). Up to six additional subjects may be enrolled in the MTD dose cohort or in the 20 mg/kg dose cohort if MTD is not attained.
Group B: If single-dose administration of MDX-010 at 10 mg/kg is well tolerated (≤1 DLT in the cohort in Group A), then an additional 12 to 20 subjects will be enrolled and treated with MDX-010 at 10 mg/kg/dose administered on Days 1, 22, 43, and 64.
Subjects who respond to therapy will be followed until disease progression or a maximum of approximately 1 year. Subjects with a response of SD ≥ 3 months, PR, or CR to their initial treatment cycle who subsequently relapse may be eligible for retreatment with the same regimen or an alternate regimen considered to be more effective at the time of retreatment.
#Intervention
- BIOLOGICAL : MDX-010
- Subjects will be treated with transfectoma-derived MDX-010 at 2.8 or 5 mg/kg/dose, or with hybridoma-derived MDX-010 at 3 mg/kg/dose administered on Days 1, 57, and 85. The 2.8, 3, and 5 mg/kg dosage cohorts may be initiated concurrently. Additionally, 6 subjects per cohort will receive single doses of transfectoma-derived MDX-010 at 7.5, 10, 15, and 20 mg/kg.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject must have read, understood, and provided written informed consent and authorization in compliance with the Health Insurance Portability and Accountability Act (HIPAA) afer the nature of the study has been fully explained.
* Subject must be at least 18 years with a histologic diagnosis of unresectable Stage III or IV malignant melanoma (may include mucosal melanoma). Subjects with either stable or progressive malignancy will be permitted in the study. Classification of stable or progressive disease, to be recorded for all subjects, will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST), as detailed in Appendix 3 and determined since last melanoma treatment. Subjects must have at least 1 site of measurable disease.
* At least 4 weeks since treatment (surgery, chemotherapy, radiation, or immuno- therapy) for melanoma and recovered from any serious toxicity experienced during treatment.
* Life expectancy of at least 18 weeks.
* Karnofsky Performance Status of at least 70%
* Screening laboratory values must meet the following criteria:
* WBC >=2500/μL
* ANC >=1500/μL
* Platelets >=100 x 10'/μL
* Hematocrit >=30%
* Hemoglobin >=10 g/dL
* Creatinine <=2 mg/dL
* AST <=2 x ULN*
* Bilirubin <=1.0 x ULN*, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
* HIV negative
* HBsAg negative
* anti-HCV nonreactive. If reactive, subject must have a negative HCV RNA qualitative PCR.
* Unless definitely attributable to disease.
Exclusion Criteria:
* Any prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer from which the subject has been disease-free for at least 5 years
* History of autoimmune disease (including uveitis and autoimmune inflammatory eye disease) prior to entrance into the study.
* Active infection requiring therapy, chronic active HBV or HCV, or confirmed reactivity with HIV tests.
* Tetanus booster immunization within 2 months of initial screening procedures, or a history of anaphylaxis or severe local reaction to the tetanus vaccine.
* Pregnant or nursing: it is not known what effect MDX-010 could have on the developing immune system of the fetus or infant, therefore, exposure in utero or via breast milk will not be allowed.
* Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events.
* Any concurrent medical condition requiring the use of systemic or topical corticosteroids or the use of immunosuppressive agents (e.g. cyclosporine and its analog, or chemotherapy agents). All corticosteroid use must have been discontinued at least 4 weeks prior to trial entry.
* Prior treatment with MDX-010 or any other anti-CTLA-4 monoclonal antibody.
* Evidence or history of significant cardiac, pulmonary, hepatic, renal, psychiatric or gastrointestinal disease that would make the administration of MDX-010 unsafe.
* Concurrent treatment with chemotherapy or other immunotherapy regimens (must be completed at least 4 weeks before 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
|
NCT00729950
|
{
"brief_title": "Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma",
"conditions": [
"Malignant Melanoma"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00729950",
"official_title": "An Open-Label Pharmacokinetic and Safety Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-10",
"study_completion_date(actual)": "2007-06",
"study_start_date(actual)": "2003-07"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-04-26",
"last_updated_that_met_qc_criteria": "2008-08-07",
"last_verified": "2010-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-08",
"first_submitted": "2008-08-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.
#Intervention
- DRUG : biphasic insulin aspart 30
- One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
- DRUG : biphasic human insulin 30
- One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
|
#Eligibility Criteria:
Inclusion Criteria:
* Non-smokers
* BMI (body mass index) maximum 27 kg/m^2
* HbA1c (glycosylated haemoglobin A1c): 3.4 <= age <= 6.1%
* FBG (fasting blood glucose) maximum 6.0 mmol/L
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
|
NCT01707160
|
{
"brief_title": "Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers",
"conditions": [
"Diabetes",
"Healthy"
],
"interventions": [
"Drug: biphasic insulin aspart 30",
"Drug: biphasic human insulin 30"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01707160",
"official_title": "A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "1995-12",
"study_completion_date(actual)": "1995-12",
"study_start_date(actual)": "1995-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-04",
"last_updated_that_met_qc_criteria": "2012-10-15",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-10-16",
"first_submitted": "2012-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This Phase I dose escalation study will evaluate Procaspase Activating Compound-1 (PAC-1), a small molecule that activates procaspase -3 to caspase-3, resulting in apoptosis of cancer cells, in patients with advanced malignancies. As of March 1, 2019, only patients with neuroendocrine tumors will be enrolled in Component 1 of this study. PAC-1 is taken orally on days 1-21 of a 28-day cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined using a modified-Fibonacci dose-escalation 3+3 design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.
#Intervention
- DRUG : PAC-1
- PAC-1 is taken orally on days 1-21 of a 28-day cycle.
- Other Names :
- Procaspase Activating Compound-1
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female >= 18 years
* Diagnosis of advanced solid tumor or hematologic malignancy (limited to lymphoma) that has failed or become intolerant to standard therapy
* Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1, or lymphoma that fulfills the Deauville PET Criteria
* Has an ECOG PS of 0, 1, or 2
* Has total bilirubin < 1.5 mg/dL, serum albumin > 3.0 gm/dL, AST and ALT < 1.5 ULN or < 3 x ULN for subjects with known hepatic metastases
* Has serum creatinine < 1.5 × ULN
* Has hemoglobin >= 10 g/dL, ANC >= 1.5 × 109/L, and platelet count >= 100 × 109/L
* Must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after capsule(s) administration
* Must be willing and able to comply with study
* Has read, understood, and signed the ICF
* Women of childbearing potential must not be pregnant or breast-feeding. In addition, a medically acceptable method of birth control must be used or total abstinence. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP
* Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms at least one month after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative
* Prior systemic treatments for metastatic disease are permitted but may not be ongoing, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy
* Willingness to donate blood for biomarker studies related to the type of therapies used in this trial and the tumor types being treated
Exclusion Criteria:
* Had surgery within 4 weeks prior to study treatment except for minor procedures (hepatic biliary stent placement is allowed)
* Gliomas are excluded, as well as any history of brain metastases, seizures or underlying brain injury
* May not have received cytotoxic chemotherapy, targeted therapies, biologic response modifiers, chemotherapy, and hormonal therapy within the last 3 weeks, or nitrosureas within the last 6 weeks prior to study treatment.
* Has a history of blood clots, pulmonary embolism, or DVT unless controlled by anticoagulant treatment
* Has a history of an arterial thromboembolic event within the prior six months including CVA, TIA, MI, or unstable angina
* Has uncontrolled HIV or hepatitis B or C
* Has any clinically significant infection
* Has any other severe, uncontrolled medical condition, including uncontrolled DM or unstable CHF
* Radiation therapy to more than 25% of the bone marrow
* Prior allogeneic bone marrow or organ transplantation
* > Grade 1 peripheral neuropathy within 14 days before enrollment.
* Patient has received other investigational drugs with 14 days before enrollment
* Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation
* Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant (such as acute ischemia, left bundle branch block, ventricular arrhythmias) or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > 480 milliseconds)
* Presence of any non-healing wound, fracture, or ulcer
* Has any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance
* Has any mental or medical condition that prevents the patient from giving informed consent
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
|
NCT02355535
|
{
"brief_title": "Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1",
"conditions": [
"Solid Tumor",
"Pancreatic Neuroendocrine Tumor",
"Neuroendocrine Tumors"
],
"interventions": [
"Drug: PAC-1"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02355535",
"official_title": "(STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-05-18",
"study_completion_date(actual)": "2020-05-18",
"study_start_date(actual)": "2015-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-24",
"last_updated_that_met_qc_criteria": "2015-02-03",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-04",
"first_submitted": "2015-01-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Proximal femoral fracture is associated with severe morbidity and mortality and high socioeconomic costs. The main mechanical complication of internal fixation in trochanteric fracture is lag-screw cut-out through the femoral head. Several factors are involved, but remain controversial. The aim of the present study was to determine risk factors for cut-out in internal fixation of extracapsular proximal femoral fracture.
#Intervention
- OTHER : Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.
- Identification of factors for mechanical failure of internal fixation of extracapsular proximal femoral fracture in over 75 year olds
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients > 75 years
* Operated on for extracapsular proximal femoral fracture
* After bodyheight fall
Exclusion Criteria:
* Intra-capsular fractures
* trochantero-diaphyseal fractures
* subtrochanteric fractures
* fractures involving pathological bone
Sex :
ALL
Ages :
- Minimum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03975868
|
{
"brief_title": "Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.",
"conditions": [
"Proximal Femoral Fracture"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT03975868",
"official_title": "Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-03-31",
"study_completion_date(actual)": "2015-03-31",
"study_start_date(actual)": "2009-07"
},
"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)": "2019-06-05",
"last_updated_that_met_qc_criteria": "2019-06-04",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-05",
"first_submitted": "2019-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An analysis of Low-Dose Cat Scan(LDCT) Screenings for Lung Cancer completed within the St. Elizabeth system from January 2015 until December 2019. The study investigator, or designee(s), will retrospectively review patient encounters, collecting data related to LDCT referrals and completions. Data analysis will focus on the subsequent imaging, procedures, reviews at The Nodule Review Board and Lung Cancers diagnosed as a result of the LDCT.
Detailed Description
This study is a single center, minimal risk, physician initiated retrospective chart review. Potential subjects will be identified using records provided by the St. Elizabeth Healthcare Thoracic Oncology and Radiology Department. Potential subjects will be screened for eligibility. Study investigator and designees will review patient electronic medical records, extracting data related to the ordering/completion of a LDCT and interventions that occurs thereafter. Collected data will focus on dates of encounters, diagnostic imaging/procedures, and treatments. Please see Appendix A for a complete list of data points. All of the data that will be collected for study purposes will be kept confidential. This will be attained by the following: First, each enrolled subject will be assigned a study specific serial number for the database. All study documents and data collection tools will be maintained with the investigative site file in a locked cabinet in a secure location maintained by the investigator. The database will not include the patient's name or hospital medical record number. No one will have access to the database but the study principal investigator and study staff designated by the principal investigator. However, study data may be reviewed by the Institutional Review Board of record, an appointed study monitor, an internal auditor for St. Elizabeth Healthcare, and necessary regulatory authorities. The security of the database will be maintained under the direction of the principal investigator. Fourth, when the study is completed, the manuscript is published, and IRB storage document requirements have been met, the file will be permanently deleted and destroyed
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients within St Elizabeth Healthcare who are referred for and/or have completed a LDCT from January 2015-February 2018
* >=18 years
Exclusion Criteria:
* Patient undergoes subsequent imaging, procedures and/or treatment at a facility outside of St. Elizabeth where records are not available through EPIC
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
|
NCT03560791
|
{
"brief_title": "A Review of Low-Dose CT Lung Cancer Screenings in a Community-Based Healthcare System With High Incidence",
"conditions": [
"Non-small Cell Lung Cancer"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT03560791",
"official_title": "A Review of Low-Dose CT Lung Cancer Screenings in a Community-Based Healthcare System With High Incidence",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-31",
"study_completion_date(actual)": "2023-03-06",
"study_start_date(actual)": "2018-04-06"
},
"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)": "2024-07-12",
"last_updated_that_met_qc_criteria": "2018-06-06",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-18",
"first_submitted": "2018-05-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The novel humanized monoclonal antibody CaCP29 was developed to control the inflammatory response to various stimuli in humans and espacially during sepsis. Purpose of this phase I clinical trial in healthy human males is to investigate various parameters concerning safety and tolerability of CaCP29 and assess pharmacokinetic and pharmacodynamic parameters.
Detailed Description
The acute inflammatory innate host response, as being present during the development of sepsis and various other acute inflammatory diseases, represents a powerful mechanisms which can lead to destruction of host tissue and severe organ dysfunction. CaCP29 was developed to lower the complement mediated acute inflammatory response and thereby control the extend of a strongly activated often times self-destructive inflammatory response by controlling activation of a key inflammatory mechanism.
#Intervention
- BIOLOGICAL : CaCP29, a humanized monoclonal antibody
- CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males
|
#Eligibility Criteria:
Inclusion Criteria:
* Male, Caucasian subjects aged between 18 <= age <= 40 years (inclusive)
* Healthy subjects as determined by medical history, physical examination
* Body weight between 70 - 100 kg and BMI between 19 and 29 kg/m2, extremes incl
* ECG recording based on a 12-lead ECG which is normal (PR < 210 ms, QRS <110 ms, QTC 380 -430 ms) or contains only slight deviations
* Normal vital signs (after 5 minutes resting), blood pressure values (systolic > or equal to 100 and < or equal to 140 mmHg, diastolic > or equal to 50 and < or equal to 90 mmHg), heart rate between 45 and 90 beats per minute (bpm), body temperature < 37.5°C
* Subjects who are able and willing to give written informed consent
* Normal white blood cell count, CRP and IL-6 at screening and Day -1
* Subjects must be using two acceptable methods for contraception (e.g. spermicide and condom) during the study and refrain from fathering a child in the 3 months following dosing
Exclusion Criteria:
* In the opinion of the investigator subjects with clinically significant history or presence of cardiovascular, respiratory, renal, hepatic, metabolic, endocrinological, gastrointestinal, hematological, neurological, dermatological, psychiatric diseases, cancer or other major diseases;
* Infection or known inflammatory process;
* Known autoimmune diseases or immunodeficiency or known family history of autoimmune diseases or immunodeficiency;
* Clinical significant allergic disease;
* Known serum hepatitis or who are carriers of the Hepatitis B surface antigen or Hepatitis C antibodies or with a positive result to the test for HIV 1/2 antibodies;
* Subjects who have received an investigational drug and/or a vaccination within 3 months prior to start of the treatment in study and those who anticipate receipt of a vaccine within 2 months after the last dose of study drug;
* Subjects, who have received prior treatment within 1 year with monoclonal antibodies or other biologic agents;
* The use of any concomitant prescription or non-prescription medication within 14 days prior to the first administration of study medication until follow-up; or treatment with medication that may affect immune function (e.g. immunoglobulins, corticosteroids) within 6 months before dosing;
* Donation of blood (>400 ml) or blood products within the last 3 months prior to admission to the clinical unit or plasmapheresis within 4 weeks prior to study start;
* Definite or suspected personal history of adverse reactions or hypersensitivity to drugs especially to the ingredients of the trial compound or to compounds with a similar structure;
* Use of more than 5 cups or glasses of coffee, tea and / or cola per day;
* Presence or history of drug and/or alcohol abuse or an average daily intake of more than 20 g alcohol per day;
* Positive test for alcohol or drugs at screening and/or on Day -1;
* Smokers of > 5 cigarettes/day or equivalent;
* Subjects who are unlikely to be compliant and attend scheduled clinic visits as required;
* Participation in this study on a previous dose level
Sex :
MALE
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
|
NCT01319903
|
{
"brief_title": "Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29",
"conditions": [
"Drug Safety"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT01319903",
"official_title": "A Single Ascending, Placebo-controlled, Double-blind Study in Healthy Male Subjects to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the New Humanized Monoclonal Antibody CaCP29",
"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)": "2011-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-01-13",
"last_updated_that_met_qc_criteria": "2011-03-21",
"last_verified": "2012-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-22",
"first_submitted": "2011-03-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.
Detailed Description
This study will use mixed-methods to investigate the feasibility of skills-based virtual reality (VR) for acute orthopedic injury in an open pilot with individual exit interviews (target N=10). Participants will be patients with acute orthopedic musculoskeletal injuries who are at risk for chronic pain and disability (PCS ≥ 20 and PASS-20 ≥ 40) and meet inclusionary/exclusionary criteria. Participants will be recruited through the MGH Orthopedics Department, flyers, and the Rally research platform. Participants will self-administer a skills-based virtual reality (VR) program at home over an 8-week period. Participants will attend two in-person study assessments to complete study assessments (surveys and an fNIRS imaging session). The primary outcome for the pilot will be a-priori Go/No-Go feasibility markers (feasibility, acceptability, fidelity, credibility, expectancy, satisfaction) of the VR program and data collection procedures to increase the success of subsequent trials. Exploratory measures include: multi-modal assessment of pain intensity, pain-specific coping (catastrophizing, self-efficacy, acceptance), disability, physical function, and emotional function (depression, anxiety, stress). The VR headset will collect usage data and daily smartphone surveys will track changes in pain during the 8-week intervention. Completers will have the opportunity to attend 30 min individual exit interviews to understand patients' perception of the VR and their experience with the study procedures to increase the success of larger trials.
#Intervention
- DEVICE : RelieveVRx
- Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education.
|
#Eligibility Criteria:
Inclusion Criteria:
* Outpatient adults in the Level 1 Trauma Center
* Age >= 18 years
* Able to meaningfully participate meaningfully (English fluency and literacy) and stable living situation
* Acute musculoskeletal injury (e.g., fracture, dislocation, rupture) 1 <= age <= 2 months earlier (acute phase).
* Pain Catastrophizing Scale >=20 or Pain Anxiety Symptom Scale-20 >=40
* Has access to internet (Wi-Fi or wireless)
* Willing to participate and comply with the requirements of the study protocol, including virtual reality program and questionnaire completion No psychotropics or stable for >6 weeks
* Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic medication for a minimum of 6 weeks and willing to maintain a stable dose (i.e., no psychotropics or stable for >6 weeks)
* Cleared by orthopedic surgeon for study participation
Exclusion Criteria:
* Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological diseases that are contraindicated for VR
* Medical condition predisposing to nausea or dizziness.
* Hypersensitivity to flashing light or motion.
* Vision or severe hearing impairment.
* Injury to eyes, face, or neck that impedes comfortable use of virtual reality
* Diagnosed with a medical illness expected to worsen in the next 3 months (e.g., malignancy)
* Other serious injuries that occurred with the orthopedic injury or surgical complications (e.g., infection, need for repeat surgery)
* Current or prior untreated mental illness, substance use disorder, or suicidal ideation
* Self-reported pregnancy
* Currently in litigation or under Workman's Comp
* Practice of cognitive-behavioral therapy, yoga/meditation, or other mind body techniques once per week for 45 minutes or more within the last 3 months
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
|
NCT05552430
|
{
"brief_title": "Virtual Reality for Pain in Acute Orthopedic Injuries",
"conditions": [
"Injuries",
"Injury Arm",
"Injury;Sports",
"Injury, Knee",
"Injury Wrist",
"Injury, Ankle",
"Injury Foot",
"Injury, Hand",
"Injury Finger",
"Injury Leg"
],
"interventions": [
"Device: RelieveVRx"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05552430",
"official_title": "Physical and Psychological Measures of Pain in Acute Orthopedic Injuries: Use of At-home Virtual Reality",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-12",
"study_completion_date(actual)": "2023-10-12",
"study_start_date(actual)": "2022-10-17"
},
"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)": "2024-08-22",
"last_updated_that_met_qc_criteria": "2022-09-20",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-23",
"first_submitted": "2022-09-20",
"first_submitted_that_met_qc_criteria": "2024-08-20"
}
}
}
|
#Study Description
Brief Summary
This study will assess the effects of the medication doxazosin on sleep in men and women with PTSD. Sleep will be measured objectively at home using a portable sleep recorder and wrist actigraphy.
Detailed Description
This pilot study will assess the effects of doxazosin on objective measures of sleep in PTSD subjects using home ambulatory polysomnography. Twenty (20) men and women with chronic PTSD will be enrolled at the San Francisco Veterans Affairs Medical Center. After initial screening, subjects will complete 1 week of baseline assessments including 2 nights of home ambulatory polysomnography. They will then participate in a 2-week flexible-dose titration of doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose treatment ending with 2 nights of home polysomnography. Subjective and rater-based assessments will be conducted at baseline and at set intervals during and at the end of treatment. Wrist actigraphy measurements will also be made at baseline and at end of treatment as an economical, fairly valid and unobtrusive measure of sleep duration. We hypothesize that doxazosin will be associated with an increase in total sleep time (TST) and a decrease in wake time after sleep onset (WASO). We hypothesize that doxazosin will also be associated with clinical gains with respect to nightmares, subjective sleep quality, non-sleep PTSD symptoms, depression symptoms, and quality of life.
#Intervention
- DRUG : Doxazosin XL
- Subjects will participate in a 2 week flexible-dose titration of doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose treatment.
- Other Names :
- Cardura XL
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 69
* Current full or partial syndromal PTSD of at least 3 months duration as indexed by the CAPS (Clinician-administered PTSD scale) score >30
* CAPS recurrent distressing dreams item of >= 5
Exclusion Criteria:
* alcohol and or drug abuse/dependence in the last 3 months
* lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, obsessive-compulsive disorder
* exposure to trauma within the last 3 months
* prominent suicidal or homicidal ideation
* sleep apnea diagnosis or positive screen for sleep apnea by Type III device.
* neurologic disorder or systemic illness affecting CNS function
* history of brain trauma or head injury with loss of consciousness greater than 10 minutes
* chronic or unstable medical illness including unstable angina, myocardial infarction within the past 6 months, congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, and pancreatitis
* pregnancy, breastfeeding and/or refusal to use effective birth control
* previous serious adverse reaction to an alpha-1-antagonist (such as priapism, hepatitis, angioedema, or intraoperative floppy iris syndrome)
* current use of trazodone, hypnotics/benzodiazepines, mirtazapine, atypical antipsychotics, beta-adrenergic blockers, alpha-2-agonists, and current prazosin or other alpha-1-antagonists
* previous non-response to prazosin for treatment of PTSD related sleep disturbance
Participants taking SSRIs, bupropion, venlafaxine and duloxetine may be included if they have been on a stable dose for 2 months. Participants may be included if they have been stable in psychotherapy treatment for 2 months and/or if they begin no new psychotherapy while in the trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 69 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01959022
|
{
"brief_title": "A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD",
"conditions": [
"Stress Disorders, Post-Traumatic"
],
"interventions": [
"Drug: Doxazosin XL"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01959022",
"official_title": "A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD",
"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)": "2013-10"
},
"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)": "2016-10-20",
"last_updated_that_met_qc_criteria": "2013-10-07",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-09",
"first_submitted": "2013-10-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this randomized controlled trial is to test the effect of screening patients in Penn Medicine Emergency Departments for eligibility of public benefits programs and using text messages post-discharge to connect patients to benefits enrollment specialists at Benefits Data Trust (BDT). Eligible patients will be randomly selected to receive text messages for two weeks after Emergency Department discharge with the phone number to speak with a benefits enrollment specialist at BDT. The number of calls to the BDT phone line and the number of submitted applications to public benefits programs will be compared between patients receiving a summary flyer with the phone number for BDT and the text message intervention to connect with BDT in comparison to an active control group who receives only a summary flyer with the phone number for BDT.
Detailed Description
Every year, Philadelphians fail to claim approximately $450 million dollars in federal and state benefits1. Across the United States, unclaimed benefits are estimated at approximately $60 billion1. These benefits include support for food, housing, healthcare, economic support, and others that can make a significant impact on well-being, upward mobility, and financial stability. The reasons that benefits are unclaimed are numerous, including lack of awareness about benefit programs and eligibility criteria, lack of agency and self-efficacy in completing expansive application requirements and organizing the necessary paperwork, and navigating the psychological costs of stigma associated with seeking public benefits2. In accordance with incentive structures developed as a result of the Affordable Care Act, health care systems have demonstrated value in screening for patients' social needs and creating partnerships with public service agencies to connect patients to social services to improve individual and population health and reduce health care disparities3-5. Patients presenting to emergency departments are more likely to possess unmet social needs6-8. Thus, it is critical for health care providers in emergency departments to effectively identify patients' social needs and connect patients to social services agencies that can provide both immediate and long-term assistance through the connection to public benefits programs.
Benefits Data Trust (BDT), a benefits support organization based in Philadelphia, has a long track record of success in consistently securing benefits for individuals with unmet social needs. BDT assists individuals with the completion and submission of applications for 19 public benefits programs (e.g., Supplemental Nutrition Assistance Program, the Low-Income Home Energy Assistance Program, and the Pharmaceutical Contract for the Elderly) via different channels, including web, phone, text, and in-person support services. Trained outreach specialists are knowledgeable about the intricacies of benefits applications and eligibility requirements, and support is available in multiple languages. Building trust with clients and serving vulnerable underserved communities is a central focus for outreach specialists. For services that they do not provide assistance for, BDT is also staffed to provide warm handoffs to help connect individuals to relevant organizations.
The focus of this proposal is to test whether patients identified in Penn Medicine Emergency Departments (ED) randomized to receive a warm handoff text messaging intervention are more likely to connect to study-specific BDT phone line and submit more applications for public benefits programs in comparison to patients who only receive a summary flyer with the BDT study-specific phone line upon discharge from the Emergency Department.
We will first conduct a pilot study with 30 participants to assess the design efficacy and implementation success of the text messaging intervention. After which, we will concurrently launch a two-arm prospective intervention randomized controlled trial that is expected to occur over 6 months in Penn Medicine Emergency Departments. The study will use Way To Health, a research information technology platform at the University of Pennsylvania used previously in digital health engagement clinical trials.
We propose to first survey patients to determine their eligibility for public benefits programs. Second, patients who are eligible for at least 1 of the 21 benefits programs to which BDT either provides direct application support or provides referrals to agency websites to complete applications will be randomly selected to either receive a flyer with the study-specific BDT phone number to apply for public benefits programs (active control) or receive a text messaging intervention for two weeks after leaving the ED with instructions to connect to the BDT study-specific phone line in addition to the flyer. Patients randomized to the intervention arm will receive an initial text message one-day post-discharge from the ED with instructions for connecting with BDT and will receive subsequent reminders to connect with BDT on Days 3, 7, and 14 post-discharge. Patients who indicate that they have successfully connected with BDT on Day 3 will not receive intervention messages on Days 7 and 14. All patients, both those randomized to the control and intervention groups, will receive an end-of-study survey on Day 14 post-discharge from the ED to ask patients if they connected with BDT, assess the patient's experience in the research study, and provide a reminder about the number to connect with BDT.
Insights from this randomized controlled trial will inform future work evaluating benefits enrollment outcomes, the relationship between benefits enrollment and health care outcomes, and variations in health services use among patients connected to BDT in the ED.
#Intervention
- BEHAVIORAL : Text Messaging Intervention
- A text messaging intervention will be conducted that includes prompts to call trained BenePhilly enrollment specialists to submit applications for benefits programs. Text message prompts will be sent on days 2, 4, 7, 14, and 21 post-discharge from a Penn Medicine emergency department.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients will be included in the study based on the following criteria:
* Adults at least 18 years
* Patients must legally reside in Philadelphia
* Patients receiving care from Penn Medicine Emergency Departments at the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Centerwho are deemed unlikely to require inpatient hospitalization or observation at the time of enrollment
* Patients must have one of the following insurance plans: Medicaid and/or Medicare (managed and traditional).
* Patient must be able to read/write in English.
* Patients must be eligible for at least 1 of the benefits programs for which BDT can provide either direct application assistance or provide a referral to the social services agency website to submit applications.
* Patients have a stable mobile phone number for the next 3 weeks.
Exclusion Criteria:
Patients will be excluded from participating in the study based on the following criteria:
* Individuals < 18 years
* Patients deemed by ED physicians to be in critical or unstable condition
* Does not speak/read English
* Patient is in severe distress, e.g., respiratory, physical, or emotional distress
* Patient is intoxicated, unconscious, or unable to appropriately respond to questions
* Patients under police custody
* Patients with a positive COVID-19 test
* Patients with private health insurance benefits or without health insurance
* Patients without a stable mobile phone number for the next 21 days
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
|
NCT05654220
|
{
"brief_title": "Linking Emergency Department Patients to Assistance Programs Study",
"conditions": [
"Social Determinants of Health"
],
"interventions": [
"Behavioral: Text Messaging Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05654220",
"official_title": "A Randomized Controlled Trial to Link Emergency Department Patients to Navigation Services for Enrollment in Public Benefits",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-15",
"study_completion_date(actual)": "2024-06-30",
"study_start_date(actual)": "2023-07-19"
},
"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)": "2024-07-31",
"last_updated_that_met_qc_criteria": "2022-12-08",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-12-16",
"first_submitted": "2022-12-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure to an adverse developmental environment, including environmental toxins, are linked to increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Although the mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong evidence suggests that alterations in the epigenome play a critical role in this process. The central hypothesis of this proposal is that intrauterine exposure to benzo\[a\]pyrene leads to epigenetic changes which will have functional consequences and may be a marker for, or may contribute to, increased susceptibility to adverse outcomes in childhood including increased adiposity and the subsequent development of obesity, metabolic syndrome or diabetes. The goals of this proposal are to: 1) determine benzo\[a\]pyrene levels in umbilical cord blood of newborns, 2) determine whether benzo\[a\]pyrene exposure during pregnancy correlates with early onset of obesity and metabolic disease by examining the children at 12 and 24 months of age, 3) determine whether in utero benzo\[a\]pyrene exposure programs metabolic disease through alterations in DNA methylation and gene expression, and 4) determine the plasticity of the DNA methylation patterns in the same offspring at 12 months of age. The long-term goal of this project is to define biomarkers that identify neonates at 'high-risk' for diminished attainment of full health potential, who can then be targeted for preventative measures.
|
#Eligibility Criteria:
Inclusion Criteria:
* Infants whose mothers were followed by the Obstetric Department at MMC, and
* Deliver a single healthy live term infant
Exclusion Criteria:
* Multiple gestation,
* Maternal depression,
* History of maternal smoking in the 3rd trimester of pregnancy,
* Infants in extremis,
* Apgar score <7 at 5 min and umbilical artery pH <=7.25,
* Chromosomal/congenital abnormalities,
* Congenital infections, and
* Inborn errors of metabolism
Sex :
ALL
Ages :
- Minimum Age : 1 Hour
- Maximum Age : 72 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01815385
|
{
"brief_title": "Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants",
"conditions": [
"Full Term Infants",
"Environmental Exposures",
"Adiposity"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01815385",
"official_title": "Early Life Exposure to Polycyclic Aromatic Hydrocarbons: Metabolic Perturbations and Epigenetic Biomarkers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12",
"study_completion_date(actual)": "2020-03-28",
"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)": "2021-02-11",
"last_updated_that_met_qc_criteria": "2013-03-20",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-21",
"first_submitted": "2013-03-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.
Detailed Description
Pancreatic ductal adenocarcinoma (PDAC) incidence has increased with a high rate during the past few years (+4.7% per year between 2005 and 2012, source InfoCancer 2013). No cure is currently available for this deadly disease, with an overall survival \<5%. Survival can reach 20% when surgery is possible, giving the best chance to the patients. If patients present locally advance disease, it is crucial to quickly establish resectability to avoid unneeded and even deleterious surgery in patients with metastatic stages. It is also important to increase the rate of true R0 resection with effective preoperative therapy. However, when the cancer is suspected, neoadjuvant chemotherapies are often delayed because the mandatory histologic proof is difficult to make with non-informative biopsies. It is necessary to find new markers to help for rapid diagnosis that could allow neoadjuvant therapies and surgery when anatomo-pathologic proof is not available. New developments in the field of liquid biopsy hold great promise in providing valuable information for diagnosis assistance. The project will be run in two steps. First, several methods will be compared for tumor cell recovery after cell spiking in blood of non-cancer patients and pancreatic cell line onco-exosomes will characterized by flow cytometry. Second the best method will be used to detect and enumerate CTCs in 20 PDAC patients and 20 non-cancer patients. In parallel GPC1+ exosomes from patients' plasmas will be quantified. Diagnosis accuracy will be established and compared. Correlations between circulating tumor elements presence and clinical and biological parameters will be evaluated at the time of the diagnosis. Patient clinical outcome will be assessed according to initial circulating element quantification.
#Intervention
- PROCEDURE : Blood samples
- Blood samples for both group
- PROCEDURE : Portal vein blood sample
- Portal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient with informed consent
* Patient with health care coverage
* Group of PDAC patients: Patient with resectable lesion with suspicion or recent diagnosis of PDAC recruited in the surgery department
* Group of non-cancer patients: Patients in the surgery department without cancer lesion, Patients with intestine inflammatory disease, Patients with gastric bypass or sleeve gastrectomy procedure
Exclusion Criteria:
* Patients <18 or under tutelage
* Patient with recent chemotherapy or radiotherapy
* Pregnant or lactating woman
* Patient with negative or non-informative biopsy
* Patient with technically unserectable disease
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
|
NCT03032913
|
{
"brief_title": "Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC",
"conditions": [
"Pancreatic Ductal Adenocarcinoma (PDAC)"
],
"interventions": [
"Procedure: Blood samples",
"Procedure: Portal vein blood sample"
],
"location_countries": [
"France"
],
"nct_id": "NCT03032913",
"official_title": "Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-11-13",
"study_completion_date(actual)": "2017-11-13",
"study_start_date(actual)": "2017-02-15"
},
"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)": "2018-04-10",
"last_updated_that_met_qc_criteria": "2017-01-24",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-26",
"first_submitted": "2016-12-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to investigate the pharmacokinetics, lipid lowering effect and lipidomic profiles of 8-weeks rosuvastatin treatment by OATP1B1 genotype in hyperlipidemia patients.
Detailed Description
Within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. Study drugs will be administered at about 9 A.M. in the morning of the first drug administration day, after blood collection for evaluation of pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomic and genetic analyses.
Subjects should take the investigational product by themselves every morning for 8 weeks. On the days of 2nd, 4th, 6 and 8th week, blood collection for evaluation of pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomics will be conducted by visiting the clinical trials center. On the days of 2nd, 4th and 6th week, the study drug will be taken after blood and urine collection.
#Intervention
- DRUG : Rosuvastatin
- Oral administration of rosuvastatin 20 mg once daily for 21 days.
- Other Names :
- Crestor Tablet 20 mg manufactured by Astrazeneca
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults aged 35 <= age <= 55 at the time of screening
* Serum LDL cholesterol (LDL-C) level <=130 mg/dL
* Must be reliable and willing to make themselves available during the study period
* Must be willing to give blood sample for genotyping
Exclusion Criteria:
* A subject with present clinical manifestation or past medical history of hepatic, renal, respiratory, neurologic, hematologic, oncologic, psychiatric, cardiovascular or endocrine disease, except hyperlipidemia and mild hypertension (SBP < 160 mmg, DBP <100 mmHg).
* Administration of lipid lowering agent within 2 weeks before the first study drug administration.
* A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which could influence the absorption of the study drug.
* A subject with a history of drug abuse, or a positive urine drug screening test
* A subject who takes or should take any medication that can influence lipid lowering effects or metabolic profiles of the study drug during the study period. (Investigators judge the wash-out period of the previously used medication before the administration of the study drug.)
* A subject who has participated in any other clinical trial within 3 months before the study drug administration.
* A subject who is judged to be ineligible to participate in the study due to abnormal clinical laboratory results or other reasons by investigators.
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01466608
|
{
"brief_title": "Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients",
"conditions": [
"Hypercholesterolemia"
],
"interventions": [
"Drug: Rosuvastatin"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01466608",
"official_title": "Lipid Lowering Effect, and Lipidomic Profiles by Genotype of OATP1B1 and BCRP After Administration of Rosuvastatin in Patients With Hyperlipidemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-08",
"study_start_date(actual)": "2011-11"
},
"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)": "2014-05-16",
"last_updated_that_met_qc_criteria": "2011-11-03",
"last_verified": "2014-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-08",
"first_submitted": "2011-10-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The SARS-CoV-2 pandemic has consisted of multiple surges of infection because of continuous viral mutations. The WHO and CDC have defined the main SARS-CoV-2 variants based on international and national data for the circulation of SARS-CoV-2 into at least 4 waves. Studies from different parts of the world have demonstrated significant variations in the clinical manifestations of viral infection in relation to different SARS-CoV-2 variants. They also indicated that the current high levels of population immunity, due to prior infection and/or vaccination, have been associated with a vastly decreased overall risk of severe disease. Anosmia (with or without ageusia) was identified as a hallmark of COVID-19 early in the pandemic (ancestral Wuhan strain, alpha and delta variants), with a prevalence of \~60%. Prolonged olfactory disorders, lasting ≥6 months to years, has been reported in \~35-40% of infected individuals. However, studies reported that olfactory and gustatory disorders were less frequent with Omicron variants compared to pre-omicron variants. It has been indicated that SARS-CoV-2 can cause destruction, disorganization and molecular changes in the nasal olfactory neuroepithelium resulting in loss and distortion of the sense of smell. There are several trials to treat these persistent disorders but none has shown significant positive results except ours (Hamed et al., Expert Review of Clinical Pharmacology 2023;16(12):1261-1276 DOI: 10.1080/17512433.2023.2282715). Hamed et al. reported that cerebrolycin, a commercially available multimodal neurotropic factor, has the ability to cure at least 60% (100% complete and persistent recovery) of post-covid-19 persistent olfactory and gustatory dysfunctions. This drug is available in the market of at least 75 countries since 1996 and easily dispensed from local pharmacies after doctors prescriptions. It is used for treatment of many disorders of the central and peripheral nervous systems. This could be due to its ability to promote neurogenesis and remodeling of olfactory and gustatory neurons.
Detailed Description
The diminished senses of smell (or hyposmia/anosmia) and taste (or hypogeusia/ageusia) have been commonly reported after infection by ancestral Wuhan, alpha and delta strains of the SARS-CoV-2 virus in ≥ 60% of patients. Persisted dysfunctions (deficits and distortions), lasting for months to years, were also reported in \~40%.
The SARS-CoV-2 pandemic has different waves of infection because of the dynamic viral mutations. The first wave (ancestral Wuhan strain) has been defined as the period from approximately the last week of February 2020 to the first Week of February 2021; the second wave (Alpha variant) started from approximately week 7 of February 2021 to July 2021; the third wave (Delta variant) was the period from approximately August 2021 to December 2021; and the fourth wave (Omicron and its subvariants) was the period from approximately January 2022 to December 2023 and after. These Viral strains were also categorized according to the main variants and their subvariants based on the viral pathogenicity and transmissibility, the clinical manifestations, immunity and response to vaccination. Studies from different parts of the world reported less severe viral manifestations in the periods of omicron strain and its subvariants compared to the pre-omicron years of the pandemic. They also reported less frequent involvement of olfactory and gustatory systems with omicron and its subvariants compared to previous viral variants (alpha and delta).
Experimental studies strongly indicated that post-covid olfactory and gustatory disorders are due to peripheral damage of the sensory neuroepithelia (olfactory and gustatory) and their disorganization by severe viral infection and its immune mediated pathology.
In general, the characterization of the prevalence and clinical manifestations and risk variables of olfactory and gustatory complications of different SARS-CoV-2 variants is unclear. furthermore, the treatment of these prolonged complications is still aworldwide challenge. Detailed search in clinical trials' websites, for example: WHO International Clinical Trials Registry Platform (ICTRP Search Portal-WHO; https://trialsearch.who.int/), Cochrane ENT Trials Register (https://ent.cochrane.org), Ovid Embase (https://tools.ovid.com), ClinicalTrials.gov, Medfind (https:// medfind.in), Web of Science, PubMed and Scopus, demonstrated that there is only a completed and published trial which showed promising positive and maintained results (Hamed et al., 2023). In this trial, the authors concluded that cerebrolysin, a commercially available multimodal neurotropic factor, had fast, promising, and constant effect, with cure rate of \>/+ 60%. This could be due to its ability to initiate and enhance neuronal regeneration, reorganization and remodeling of sensory neuroepithelia.
#Intervention
- DRUG : Cerebrolysin
- Cerebrolysin Dose:5 ml ampoule (1ml contains 215.2 mg cerebrolysin) once daily through intramuscular injection five times per week, for a total of 20 treatments (for 4 weeks), after which the cycle was repeated again for at least 6 weeks till a maximum of 24 weeks.
- Other Names :
- Active arm
- OTHER : olfactory and gustatory trainings
- olfactory and gustatory trainings using oils of strong odors for the same time frame as for the drug intervention
- Other Names :
- controls
|
#Eligibility Criteria:
Inclusion Criteria:
* Children and adults with sudden hyposmia/anosmia and/or hypoageusia/ageusia during COVID-19 pandemics (2020 <= age <= 2024).
* Persisting symptoms were defined as disorders lasting >=6 months.
* Cooperation during objective evaluation
* compliance to drug treatment or olfactory and gustatory trainings for at least 8 weeks.
Exclusion Criteria:
* Prior neurological, medical or psychiatric disease which are known as a cause of progressive olfactory or gustatory dysfunction
* Nasal congestion
* Nasal polyps
* Surgery or head trauma or radiation for head and neck cancers as may result in injury to the nerves that control smell
* Exposure to toxic chemicals (such as pesticides and solvents) Cocaine or other drug abuse
* Lack of compliance to drug treatment or olfactory and gustatory trainings for at least 8 weeks.
* Lack of cooperation to complete the objective testings.
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06208540
|
{
"brief_title": "Clinical Characteristics and Treatment of Anosmia and Ageusia Due to SARS-CoV2 Variants",
"conditions": [
"Post-covid-19 Persistent Smell and Taste Disorders"
],
"interventions": [
"Drug: Cerebrolysin",
"Other: olfactory and gustatory trainings"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT06208540",
"official_title": "Persistent Olfactory and Gustatory Dysfunctions Due to Different SARS-CoV-2 Variants: Clinical Characteristics and Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-30",
"study_completion_date(actual)": "2024-05-30",
"study_start_date(actual)": "2021-08-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-05",
"last_updated_that_met_qc_criteria": "2024-01-11",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-17",
"first_submitted": "2024-01-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
6,000 patients with HT and/or DM will be recruited to participate a 12-week EIM exercise intervention, which also involve consistent feedback and reminders using information technology (IT). The primary outcome will be improvement of blood pressure at 1-year. Other clinical outcomes will be obtained on recruitment (baseline), 12-week (immediately after EIM classes) and 1-year after recruitment
#Intervention
- BEHAVIORAL : exercise is medicine
- a 12-week exercise classes program combined with other motivational skills, including feedback and information technology support. The whole program lasts for 1 year for each participant
|
#Eligibility Criteria:
Inclusion Criteria:
* have a clinical diagnosis of primary HT and/or type II DM from clinical medical record
* having less than 150 minutes of moderate intensity exercise per week OR having less than 75 minutes of intensive intensity exercise per week (this is set according to latest World Health Organization guideline)
* who have used any mobile apps on their phone (because the intervention involve use of apps to monitor and remind regular exercise)
Exclusion Criteria:
* patients with diagnosed chronic obstructive lung disease and recent stroke (within last 12 months)
* Patients on 3 or more anti-hypertensive medications (on maximum or maximal tolerable doses) are excluded because these patients have resistant HT and may represent another spectrum of disease.
* Patients with spinal cord compression, radiculopathy with active pain, or osteoarthritis of hips and knees that are on the waiting list for joint replacement surgery are excluded for safety reasons.
* acute myocardial infarction in last 6 months
* ongoing angina
* uncontrolled cardiac arrhythmia
* acute diseases including known active endocarditis/acute pulmonary embolism, pulmonary infarction, deep vein thrombosis, acute aortic dissection, acute myocarditis
* known aortic stenosis
* known heart failure
* known obstructive left main coronary artery stenosis
* uncontrolled ventricular rates
* complete heart block
* known hypertrophic obstructive cardiomyopathy
* mental impairment that limit co-operation
* resting blood pressure with systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg
* known anaemia with haemoglobin level less than 11gm/dL
* known uncorrected electrolyte imbalance
* known uncontrolled hyperthyroidism.
* For DM patients, patients with proliferative diabetic retinopathy and recent retinal bleeding (in last 12 months)
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
|
NCT04249557
|
{
"brief_title": "Exercise is Medicine: a Cohort Study",
"conditions": [
"Hypertension"
],
"interventions": [
"Behavioral: exercise is medicine"
],
"location_countries": [
"Hong Kong"
],
"nct_id": "NCT04249557",
"official_title": "Exercise is Medicine: a Cohort Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-30",
"study_completion_date(actual)": "2024-06-30",
"study_start_date(actual)": "2020-07-01"
},
"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)": "2024-07-16",
"last_updated_that_met_qc_criteria": "2020-01-29",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-31",
"first_submitted": "2020-01-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. For cutting balloon angioplasty in venous stenosis, the primary patency after 12 months is 55-60% (9,16) and in recurrent stenoses up to 48%(10).
We hypothesise that DEB angioplasty after cutting balloon angioplasty leads to improved primary patency at 12 months.
#Intervention
- DEVICE : Cutting balloon followed by paclitaxel coated balloon
- Cutting balloon followed by paclitaxel coated balloon
|
#Eligibility Criteria:
Inclusion Criteria:
* Recurrent stenoses (within 1 year after angioplasty) in the venous outflow of AVFs for dialysis access (> 0.5cm from AV anastomosis up to cephalic arch)
* Successful guidewire crossing of target lesion
* >= 21 years
* Informed and valid consent given.
* Patient willing and able to return for follow up .
Exclusion Criteria:
* Thrombosed AVFs or occlusions in the access circuit
* Significant cephalic arch (central perpendicular portion of the cephalic vein) or central vein stenoses.
* > 3 stenosed segments (lesions are considered separate if they are separated by at least 2 cm normal vessel.)
* Only potential target lesion located in cephalic arch, central veins or anastomotic lesions.
* Only de novo stenoses identifiable as target lesion.
* Target lesion resistant to cutting balloon angioplasty (>30% residual stenosis with incomplete effacement of the lesion during cutting balloon angioplasty)
* Target lesion not treatable with the available sizes of cutting balloon (4 <= age <= 7mm) and drug eluting balloon (up to 8mm) so native reference vessel <3 mm or need for DEB balloon >8mm.
* Lesion in excess of 8 cm
* Unable to take dual antiplatelet therapy for 1 month and/or aspirin for 6 months
* Coagulopathy (PT or PTT >1.5 times the median of normal range) or thrombocytopenia (platelet count <50,000 /μL) that cannot be managed adequately with periprocedural transfusion.
* Patient on Warfarin.
* Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication.
* Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel.
* Acute infection over proposed puncture site.
* Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
* Participant with medical conditions, which in the opinion of the investigator may cause non-compliance with protocol.
* Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05018962
|
{
"brief_title": "Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study",
"conditions": [
"Dialysis Access Malfunction"
],
"interventions": [
"Device: Cutting balloon followed by paclitaxel coated balloon"
],
"location_countries": [
"Singapore"
],
"nct_id": "NCT05018962",
"official_title": "Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-15",
"study_completion_date(actual)": "2020-03-18",
"study_start_date(actual)": "2017-09-08"
},
"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)": "2021-08-24",
"last_updated_that_met_qc_criteria": "2021-08-22",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-24",
"first_submitted": "2021-08-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In the present study, midazolam and palonosetron in combination were more effective than palonosetron alone in lowering the incidence and severity of postoperative nausea and vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical complications were not different in both groups.
#Intervention
- DRUG : midazolam and palonosetron group
- intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting
- DRUG : palonosetron group
- intravenous palonosetron administraion as prevention of postoperative nausea and vomiting
|
#Eligibility Criteria:
Inclusion Criteria:
* The patients (aged 20 <= age <= 65) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2
Exclusion Criteria:
* The patients with a history of allergy to any other drugs used in this study, gastrointestinal disorder, previous PONV, pregnant woman, breastfeeding woman, use of antiemetics within 24 hours or body mass index > 30 kg/m2
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03933605
|
{
"brief_title": "Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy",
"conditions": [
"Postoperative Nausea",
"Postoperative Vomiting"
],
"interventions": [
"Drug: palonosetron group",
"Drug: midazolam and palonosetron group"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03933605",
"official_title": "Comparison of Palonosetron With Combined Palonosetron and Midazolam for Preventing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02-01",
"study_completion_date(actual)": "2019-02-08",
"study_start_date(actual)": "2017-07-10"
},
"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)": "2019-05-01",
"last_updated_that_met_qc_criteria": "2019-04-28",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-01",
"first_submitted": "2019-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Aims and objectives: This study was performed to examine the effects of Non-nutritive sucking, breast milk odor, and Facilitated tucking on preterm infant pain before, during, and after heel-stick procedures.
Design: A randomized clinical trial in a single center.
Methods:
The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital in Iran. Neonates were randomly assigned to four groups: 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Pain score, heart rate, oxygen saturation, and respiratory rate of the babies in all groups before, during, and after the procedure were evaluated by two nurses independently.
Detailed Description
Aim: Due to the necessity of various painful procedures and their side effects on infants, pharmacological and non-pharmacological methods are adopted to reduce the pain. Since pharmacological methods can be associated with several side effects, it is better to use non-pharmacological methods for pain control in newborns. Therefore, the purposes of this study were to compare the effects of three different methods (including Non-nutritive sucking, breast milk odor, and Facilitated tucking) on preterm infant pain before, during, and after heel-stick procedures.
Method: The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital, Iran. Initially, neonates are divided into two groups according to gestational age (including neonates between 31-33 weeks and 34-36 weeks) to moderate the confounding effect of the age, and then the allocation of neonates to four groups was performed.
Using the stratification block randomization method, 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Two researchers viewed the recorded videos independently and evaluate the heart rate, oxygen saturation, respiratory rate, and neonatal pain at 1st,2nd,3rd minute before the procedure, during, and at 1st,2nd,3rd minutes after the procedure according to the Premature Infant Pain Profile (PIPP).
#Intervention
- PROCEDURE : Breast milk odor group
- The researcher applied the breast milk that dripped on the pad for 3 minutes before the heel stick for 36 premature newborns in the breast milk odor group. About three cc breast milk dripped onto a sterile pad and placed at a distance of 10 cm from the nose of the newborn. It continued until 3 minutes after the invasive procedure. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
- Other Names :
- Breast milk odor
- PROCEDURE : Facilitated tucking group
- The Facilitated tucking position was given to 36 premature newborns in the Facilitated tucking group, from 3 minutes before to 3 minutes after the heel stick procedure. Premature newborns were kept in the facilitated tucking position by the investigator using the incubator windows without opening the incubator cover to prevent heat loss of the newborn. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
- PROCEDURE : Non-nutritive sucking group
- 36 premature newborns who were in the non-nutritive sucking group were given a silicone pacifier suitable for the week of the baby's mouth from 3 minutes before to 3 minutes after the heel stick. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
- Other Names :
- pacifire
- PROCEDURE : Control group
- The control group will consist of 36 premature newborns who are routinely applied in the clinic. In the clinic where the research was conducted, no attempt is made to reduce pain during heel stick. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study.
Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
|
#Eligibility Criteria:
Inclusion Criteria:
* Week of gestation is between 31 and 36 weeks
* Not being exposed to a painful procedure at least 1 hour before the interventions
* At least 1 hour has passed since feeding
* Not taking analgesics and/or sedatives in the last 4 hours
* Body weight of 1000 grams or more
* Having mother's milk
* Not exceeding the 10th day of postnatal age
Exclusion Criteria:
* Having ventilator support
* Having a congenital anomaly
* Using analgesic / narcotic analgesic drugs
* Continuous sedative treatment
* Having a congenital malformation that may cause asphyxia and affect respiration
* Having intracranial bleeding
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 10 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05281367
|
{
"brief_title": "Non-pharmacological Methods in Pain Managment During Heel Stick in Preterm Infants",
"conditions": [
"Pain, Acute",
"Neonatal Intensive Care Unit"
],
"interventions": [
"Procedure: Facilitated tucking group",
"Procedure: Breast milk odor group",
"Procedure: Non-nutritive sucking group",
"Procedure: Control group"
],
"location_countries": [
"Iran, Islamic Republic of"
],
"nct_id": "NCT05281367",
"official_title": "The Effect of Facilitated Tucking, Maternal Breast Milk Odor and Non Nutritive Sucking During Heel Stick on Procedural Pain in Premature Neonates",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-25",
"study_completion_date(actual)": "2022-01-02",
"study_start_date(actual)": "2021-12-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-16",
"last_updated_that_met_qc_criteria": "2022-03-15",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-16",
"first_submitted": "2022-01-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the RITURNS II study is to evaluate the efficacy and safety of Repeat courses of Rituximab to that of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 24 months among Children with Steroid Dependent Nephrotic Syndrome (SDNS).
Detailed Description
The vast majority of children with idiopathic nephrotic syndrome respond well to corticosteroid treatment. However, as many as 70% experience at least one relapse, and 30% develop a more complicated course with frequent relapses (FRNS) with or without steroid dependency (SDNS). Extended steroid exposure in these children often results in long-term complications. The management of patients with SDNS is challenging and expensive. Relapses may lead to serious complications, e.g. related to anasarca, hypertension, life threatening infections (peritonitis, pneumonia, meningitis), thrombosis and malnutrition. Repeated courses or even continuous steroid treatment lead to considerable medication related toxicity and morbidity.
The goal of treatment is to reduce the rate of relapses, the cumulative dose of corticosteroids, and the incidence of serious complications. Various prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population. Single rituximab infusion have been shown to be efficacious for 6 to 12 months and the side effect profile observed to date is very benign but after 6-8 months there was relapse due to regeneration of B-lymphocytes, hence for maintenance of remission MMF has been considered. In spite of good initial response, rituximab responders always remain prone to further relapse with regeneration of B lymphocytes, necessitating either repeat course of rituximab or addition of another steroid-sparing immunosuppressant. Reports suggest efficacy of rituximab may vary depending on disease pathology, clinical course, and simultaneous use of other immunosuppressants.
The aim of the RITURNS II study is to evaluate the efficacy and safety of Repeat courses of Rituximab to that of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 24 months among Children with Steroid Dependent Nephrotic Syndrome (SDNS).
#Intervention
- DRUG : Rituximab
- First course Course Rituximab at Randomization.
- DRUG : Mycophenolate Mofetil
- Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards
|
#Eligibility Criteria:
Inclusion Criteria
* Children between 3 and 16 years with SDNS.
* Minimal Change disease/ FSGS/MesPGN as per Kidney Biopsy report.
* Estimated glomerular filtration rate (eGFR) >80 ml/min per 1.73 m2 at study entry.
* Remission at study entry (Urine albumin nil or trace (or proteinuria <4 mg/m2/h) for 3 consecutive early morning specimens).
* Not received any steroid sparing agent previously.
* Parents willing to give informed written and audiovisual consent.
* Ability to swallow tablet.
Exclusion Criteria
* Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS).
* Patients with severe leukopenia (leukocytes <3.0× 1000 cells/mm3), severe anemia (haemoglobin <8.9 g/dl), thrombocytopenia (platelet <100.0 × 1000 cells/mm3) or deranged liver function tests (AST or ALT to >50 IU/L ) at enrolment.
* Known active chronic infection (tuberculosis, HIV, hepatitis B or C).
* Live vaccination within one month prior to screening.
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03899103
|
{
"brief_title": "Compare Efficacy and Safety of Repeated Courses of Rituximab to That of Maintenance Mycophenolate Mofetil Following Single Course of Rituximab Among Children With Steroid Dependent Nephrotic Syndrome",
"conditions": [
"Steroid-Dependent Nephrotic Syndrome"
],
"interventions": [
"Drug: Mycophenolate Mofetil",
"Drug: Rituximab"
],
"location_countries": [
"India"
],
"nct_id": "NCT03899103",
"official_title": "Randomized Clinical Trial to Compare Efficacy and Safety of Repeated Courses of Rituximab to That of Maintenance Mycophenolate Mofetil Following Single Course of Rituximab in Maintaining Remission Over 24 Months Among Children With Steroid Dependent Nephrotic Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-05",
"study_completion_date(actual)": "2023-12-24",
"study_start_date(actual)": "2019-05-15"
},
"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)": "2024-12-17",
"last_updated_that_met_qc_criteria": "2019-04-01",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-04-02",
"first_submitted": "2019-04-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.
#Intervention
- DRUG : Pandel Cream 0.1%
- A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area
* Good health with the exception of psoriasis or atopic dermatitis
Exclusion Criteria:
* Any disease affecting the HPA-axis
* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
Sex :
ALL
Ages :
- Minimum Age : 3 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01137032
|
{
"brief_title": "Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population",
"conditions": [
"Psoriasis",
"Atopic Dermatitis"
],
"interventions": [
"Drug: Pandel Cream 0.1%"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01137032",
"official_title": "An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-08",
"study_completion_date(actual)": "2005-08",
"study_start_date(actual)": "2004-06"
},
"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)": "2016-05-04",
"last_updated_that_met_qc_criteria": "2010-06-03",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-06-04",
"first_submitted": "2010-06-02",
"first_submitted_that_met_qc_criteria": "2016-02-26"
}
}
}
|
#Study Description
Brief Summary
This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.
#Intervention
- DRUG : Product 1 - AquaCelle Fish Oil Triglyceride
- 1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle.
- DRUG : Product 2 - AquaCelle Fish Oil Ethyl Ester
- 1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle
- DRUG : Product 3 - Standard Fish Oil Triglyceride
- 1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)).
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and females > 19 years and otherwise healthy
* Healthy BMI >18.0 and <30.0
* Able to provide informed consent
* Agree to arrive fasted on the day of the trial
* Agree to participate in all arms of the study
Exclusion Criteria:
* Unstable or serious illness [e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy]*
* Any treatment that included radiation or chemotherapy within the previous 2 years
* Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy.
* Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) #
* Active smokers, nicotine, alcohol, drug abuse
* Chronic past and/or current alcohol use (>14 alcoholic drinks week)
* Allergic to any of the ingredients (i.e., fish oil)
* Pregnant or lactating women
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
* Regular use or consumption is considered if participants are consuming omega containing supplements or foods on 3 or more days per week.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05491759
|
{
"brief_title": "A Study to Determine Optimal Absorption of Single Dose Omega-3",
"conditions": [
"Optimal Gastrointestinal Absorption of Omega-3"
],
"interventions": [
"Drug: Product 3 - Standard Fish Oil Triglyceride",
"Drug: Product 1 - AquaCelle Fish Oil Triglyceride",
"Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT05491759",
"official_title": "A Randomised Three-way Cross Over Study to Determine the Optimal Absorption of an Omega-3 Supplement Administered as a Single Oral Dose to Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-28",
"study_completion_date(actual)": "2022-09-28",
"study_start_date(actual)": "2022-08-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-24",
"last_updated_that_met_qc_criteria": "2022-08-04",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-08",
"first_submitted": "2022-08-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
1. In order to obtain further insight as to how NVP affects HDL metabolism, the in vivo kinetics of the HDL apolipoprotein, Apo A-1, before and 6 weeks after initiation of NVP containing treatment were evaluated. In addition, the activity of the key enzymes related to HDL metabolism were assessed.
\[ Designated as safety issue: No \]
2. In order to determine the relevance of the HDL increase in decreasing cardiovascular risk in HIV-positive subjects we evaluated endothelial function (FMD) as a surrogate marker for cardiovascular disease in patients.
\[ Designated as safety issue: No \]
#Intervention
- DRUG : nevirapine
|
#Eligibility Criteria:
Inclusion Criteria:
Patients will be included when they meet the following criteria:
* 18 years or older.
* Ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
* Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening.
* Patients with plasma HIV-1-RNA <=50 copies/mL documented on at least two occasions within 6 months prior to enrollment.
* Documentation of plasma HIV-1 RNA of <=50 copies/mL for >=6 months while on Trizivir without other antiretroviral agent. Documentation will include dates and results of all viral load testing from the previous six months.
* Ability and willingness to complete the study.
Exclusion Criteria:
Patients will not be included when they meet one or more of the following criteria:
* Previous exposure to NNRTI drugs.
* Documented diabetes mellitus.
* Documented hypertension (systolic >155 mmHg and/or diastolic >95 mmHg).
* Fasting hypertriglyceridemia (>5.6 mmol/L or 500 mg/dl).
* Use of lipid-lowering medication during the 90 days prior to study enrollment.
* Chronic active hepatitis B and/or C infection by history.
* Anemia (Hb <7.0 mmol/l or 11 g/dl hematocrit <32%).
* Active opportunistic infection or neoplasm within 3 months prior to screening visit with the exception of cutaneous Kaposi's sarcoma without evidence of progressive disease.
* Any history of cardiovascular disease (infarction, heart failure, peripheral vascular disease, cerebrovascular disease).
* Hepatic, renal or thyroid abnormalities, as determined significant by the Principal Investigator.
* Pregnancy or lactation.
* Active anticoagulation therapy (coumarin derivates, heparin).
* History of HIV-2 infection.
* Female patients with CD4 counts >250 cells/mm3.
* Male patients with CD4 counts >400 cells/mm3. Others which can not be listed here.
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
|
NCT00144261
|
{
"brief_title": "An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects",
"conditions": [
"HIV Infections",
"Metabolism, Lipids"
],
"interventions": null,
"location_countries": [
"Netherlands",
"United Kingdom"
],
"nct_id": "NCT00144261",
"official_title": "An Open-label, Non-randomized, Single-arm Study, to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma High Density Lipoproteins Concentration in HIV+ Subjects Treated With VIRAMUNE® Tablets",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-12",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2003-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-28",
"last_updated_that_met_qc_criteria": "2005-09-02",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-05",
"first_submitted": "2005-09-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.
Detailed Description
Despite a potential link between the pathogenetic mechanisms involved in Chronic Obstructive Pulmonary Disease (COPD) and atherosclerotic cardiovascular disease, there are no currently approved therapies for patients with COPD that have clearly shown an additional beneficial effect in patients with cardiovascular comorbidities. The TOwards a Revolution in COPD Health (TORCH) study assessed the impact of the inhaled corticosteroid (ICS) fluticasone propionate (FP) in combination with the long-acting beta agonist (LABA), salmeterol (SAL), in reducing all-cause mortality. TORCH demonstrated a 17.5% reduction on all-cause mortality with salmeterol-fluticasone propionate combination (SFC) compared with placebo (HR=0.825, 95% CI (0.681, 1.002), p=0.052) in the entire COPD population with disease severity form moderate to very severe. A post hoc analysis of the data restricted to those subjects with an forced expiratory volume in 1 second (FEV1) \>=50% predicted with an apparent history of cardiovascular co-morbidities (defined as use at baseline of beta-blockers, angiotensin converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB), HMG CoA reductase inhibitors (i.e. statins) or a prior MI recorded at baseline) demonstrated a 49% reduction in the risk of dying within 96 weeks for the comparison of SFC with placebo. These post hoc data suggest the possibility of an ICS/LABA combination product to be of substantial benefit in COPD subjects with less severe airflow obstruction yet with increased cardiovascular risk.
The mechanism by which SFC appears to be associated with a greater reduction in mortality in these less severe COPD subjects with concomitant cardiovascular comorbidities is speculative at present, but could potentially in part be related to a lessening of the degree of inflammation in the systemic circulation, potential plaque stabilization and/or amelioration of arterial stiffness.
ICS/LABA combinations that are currently available require twice daily administration. A once daily ICS/LABA combination has the potential to improve patient compliance and as a result, overall disease management.
The purpose of this study is to prospectively evaluate the effect of the once daily ICS/LABA combination Fluticasone Furoate (FF)/Vilanterol (VI) on survival in subjects with moderate COPD (\>=50 and =\<70 % predicted FEV1 ) and a history of, or at increased risk for cardiovascular disease.
#Intervention
- DRUG : fluticasone furoate/vilanterol
- 100/25mcg given once daily via novel dry powder inhaler
- DRUG : fluticasone furoate
- 100mcg given once daily via novel dry powder inhaler
- DRUG : vilanterol
- 25mcg given once daily via novel dry powder inhaler
- OTHER : Placebo
- placebo comparator once daily via novel dry powder inhaler
|
#Eligibility Criteria:
Inclusion Criteria:
* Type of subject: outpatient.
* Informed consent: Subjects must give their signed and dated written informed consent to participate.
* Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
* Age: >=40 and <=80 years at Screening (Visit 1).
* Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
* Airflow Obstruction:
Subjects with a measured post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio of <=0.70 at Screening (Visit 1).
Subjects with a measured post-albuterol/salbutamol FEV1 >=50 and <=70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1).
Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.
* Symptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1)
* Cardiovascular disease:
For patients >= 40 years: any one of the following:
Established (i.e. by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e. by clinical signs or imaging studies) peripheral vascular disease (PVD) Previous stroke Previous MI Diabetes mellitus with target organ disease OR
For patients >=60 years: any 2 of the following:
Being treated for hypercholesterolemia Being treated for hypertension Being treated for diabetes mellitus Being treated for peripheral vascular disease
Exclusion Criteria:
* Pregnancy: Women who are pregnant or lactating.
* Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD).
* alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD.
* Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
* Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant.
* A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
* Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD).
* Other diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study.
* End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal).
* Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
* Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
* Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary.
* Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study or the potential compliance to study procedures.
* Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
* Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified):
Medication No use within the following time intervals prior to Screening or thereafter at any time during the study (unless otherwise specified) Inhaled Long acting beta-agonists (LABA) 48 hours ICS/LABA combination products 48 hours Inhaled corticosteroids 48 hours Tiotropium 1 week Systemic, Oral, parenteral, intra-articular corticosteroids 30 days (oral and systemic corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, and Nefazodone 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/ 8 ounces) or one grapefruit per day Any other investigational drug 30 days or 5 half lives whichever is longer.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01313676
|
{
"brief_title": "Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease",
"conditions": [
"Pulmonary Disease, Chronic Obstructive"
],
"interventions": [
"Other: Placebo",
"Drug: fluticasone furoate",
"Drug: fluticasone furoate/vilanterol",
"Drug: vilanterol"
],
"location_countries": [
"Colombia",
"United States",
"China",
"Germany",
"Netherlands",
"Poland",
"Romania",
"Serbia",
"Austria",
"Bosnia and Herzegovina",
"Macedonia, The Former Yugoslav Republic of",
"Belarus",
"Czechia",
"United Kingdom",
"France",
"Japan",
"Israel",
"Taiwan",
"South Africa",
"Thailand",
"Russian Federation",
"Australia",
"Hungary",
"Argentina",
"Indonesia",
"Italy",
"Croatia",
"Philippines",
"Turkey",
"Slovakia",
"Georgia",
"Mexico",
"Korea, Republic of",
"Latvia",
"India",
"Ukraine",
"Chile",
"Canada",
"Malaysia",
"Vietnam",
"Spain",
"Bulgaria",
"Belgium",
"Greece"
],
"nct_id": "NCT01313676",
"official_title": "A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07-15",
"study_completion_date(actual)": "2015-07-15",
"study_start_date(actual)": "2011-01-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-06",
"last_updated_that_met_qc_criteria": "2011-03-10",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-03-14",
"first_submitted": "2011-02-03",
"first_submitted_that_met_qc_criteria": "2016-06-29"
}
}
}
|
#Study Description
Brief Summary
The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.
Detailed Description
The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.
#Intervention
- DIETARY_SUPPLEMENT : Infant formula
- OTHER : Breastfeeding
- Breastfeeding
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy newborn infant
* Full term infant (>= 37 weeks gestation; <= 42 weeks gestation)
* Age of infant is between 14 days at the time of enrollment
* Birth weight between 2500g and 4500g
* For the Formula fed groups: The infant's mother has elected, before the 14th day of their child's life, not to continue breastfeeding (no breastfeeding after the 14th day of the child's life) For the Breastfed group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
* Having obtained his/her legal representative's informed consent
Exclusion Criteria:
* Congenital illness or malformation that may affect normal growth
* Significant pre-natal and/or post-natal disease
* Re-hospitalization for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
* Newborn who have received antibiotics during the first 14 days of life
* Receiving infant formula containing pro and/or prebiotics at the time of enrolment
* Newborn whose parents / caregivers cannot be expected to comply with treatment
* Newborn currently participating in another clinical trial
Sex :
ALL
Ages :
- Maximum Age : 4 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01983072
|
{
"brief_title": "Symbiotic & Colonization",
"conditions": [
"Healthy"
],
"interventions": [
"Dietary Supplement: Infant formula",
"Other: Breastfeeding"
],
"location_countries": [
"France",
"Poland"
],
"nct_id": "NCT01983072",
"official_title": "Effect of Starter Formula With Symbiotic on Microbiota Balance",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-08",
"study_completion_date(actual)": "2011-08",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-11-13",
"last_updated_that_met_qc_criteria": "2013-11-12",
"last_verified": "2013-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-13",
"first_submitted": "2013-10-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase Ia clinical study. It is aimed to evaluate the safety, tolerability, PK and PD characteristics of HDM1005 injection in healthy adult subjects.
Detailed Description
In this study, 7 dose cohorts will be set up, with 10 subjects in each cohort, and subjects in each cohort will be randomized in a 4:1 ratio to receive HDM1005 injection or placebo via subcutaneous injection. Proposed dose cohorts include: Cohort 1 (0.1 mg), Cohort 2 (0.25 mg), Cohort 3 (0.5 mg), Cohort 4 (1 mg), Cohort 5 (2.5 mg), Cohort 6 (5 mg), and Cohort 7 (10 mg). Scientific review committee (SRC) will be established to review the data in a blinded manner to confirm whether to proceed with the next cohort and determine the dose for the next cohort according to both protocol and data obtained from previous cohorts. Administration of higher dose cohorts will only be allowed when the safety and tolerability of the lower dose cohorts have been established and are acceptable. SRC composes representatives from the Sponsor (including but not limited to medical responsible, statistician, clinical pharmacologist) and investigator(s). External consultant may be invited as SRC member per specific scientific question.
#Intervention
- DRUG : HDM1005 injection or placebo
- HDM1005 injection or placebo isubcutaneous injection once
|
#Eligibility Criteria:
Inclusion Criteria:
* Chinese subjects aged 18 to 55 (including 18 and 55 years), male or female subjects
* BMI at the time of screening was between 19.0 and 32.0 kg/m2 (including 19.0 and 32.0 kg/m2), and the weight of female subjects was >=45 kg and that of male subjects was >=50 kg
* Normal or abnormal vital signs, physical examination, laboratory examination, 12-lead ECG and chest imaging during the screening period have no clinical significance
* Fertile female subjects, from 14 days before signing the ICF to 2 months after the administration of the drug, have taken and agreed to continue to take effective contraceptive measures, and have no family planning or egg donation plan; Male subjects had no plans to have children, no plans to donate sperm, and agreed to use highly effective contraceptive methods from signing ICF to 4 months after dosing
* Be able to understand the procedures and methods of this study, voluntarily sign ICF, and be willing to strictly follow the requirements of clinical trial protocol to complete relevant procedures
Exclusion Criteria:
* Previous diagnosis of type 1, type 2, or other types of diabetes
* History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2
* As determined by the investigator, the subject has a co-existing disease or condition that affects gastric emptying or gastrointestinal nutrient absorption. Or a history of acute pancreatitis or acute gallbladder disease within 3 months prior to signing the ICF
* Had any malignancy within 5 years prior to signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured)
* Cardiovascular and cerebrovascular diseases, gastrointestinal diseases, diabetes mellitus, medullary thyroid cancer, thyroid C cell hyperplasia, multiple endocrine adenomatosis type 2, chronic pancreatitis, and malignant tumors with obvious clinical significance were present; And any respiratory, neurological, urogenital, hematological, or endocrine disorders that may affect the safety of the subject or the findings of the study
* Patients who have undergone major surgery within 3 months before signing the ICF, or who plan to undergo surgery during the study period
* Known allergy to any component of the investigational drug or prior history of severe drug allergy
* Drugs (including prescription drugs, over-the-counter drugs, Chinese herbs, health products, etc.) that have been used within 3 months before signing the ICF and have been determined by researchers to significantly affect body weight and blood sugar.
* Participated in any clinical trial within 30 days prior to randomization or within 5 half-lives (whichever is older) after the last administration of the investigational drug in the clinical trial (except those who signed ICF and did not receive drug or device intervention)
* Any of the auxiliary test indicators during the screening period meet the following criteria:
1. Alanine aminotransferase >1.5x upper limit of normal (ULN), or ASpartate aminotransferase >1.5x ULN, alkaline phosphatase >1.5x ULN, or total bilirubin >1.5x ULN (subjects with Gilbert's syndrome can participate in this study if direct bilirubin <=ULN);
2. calcitonin >=50 ng/L;
3. Blood amylase or lipase >ULN;
4. Thyroid stimulating hormone >6.0 mIU/L or <0.4 mIU/L;
5. Hemoglobin a1C (HbA1c) >=6.0%; Fasting blood glucose >=6.1 mmol/L or < 3.9 mmol/L; Or OGTT 2 h blood glucose >=7.8 mmol/L;
6. eGFR < 60 mL/min/1.73m2;
7. Male QTcF>450 ms, female QTcF>470 ms
* People tested positive for infectious diseases 12 Habitual smokers, alcoholics and drug abusers;
* Pregnant or lactating women 14. Blood donors within 3 months prior to randomization 15. In the Investigator's opinion, the subject is not suitable to participate in any other circumstances of the trial
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
|
NCT06640647
|
{
"brief_title": "Phase Ia Clinical Study of HDM1005 Injection",
"conditions": [
"Obesity and Overweight"
],
"interventions": [
"Drug: HDM1005 injection or placebo"
],
"location_countries": [
"China"
],
"nct_id": "NCT06640647",
"official_title": "A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HDM1005 After a Single Subcutaneous Dose in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-06",
"study_completion_date(actual)": "2024-09-26",
"study_start_date(actual)": "2024-03-19"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-15",
"last_updated_that_met_qc_criteria": "2024-10-11",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-10-15",
"first_submitted": "2024-05-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital arthritis)
Detailed Description
To investigate in patients having rheumatoid arthritis (RA), or axial spondyloarthritis (AS) or digital osteoarthritis (DA) practices and beliefs about influence of food and diet on their rheumatic disease.
200 patients of each disease will be included in this cross-sectional non interventional study Factors associated with specific practices or specific beliefs will be determined.
Only questionnaires are used in this study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Over 18 years
* Rheumatoid arthritis (RA) according to ACR/EULAR criteria or axial spondyloarthritis (AS) according to ASAS 2009 criteria or digital osteoarthritis (DA) according to ACR criteria.
Exclusion Criteria:
* Severe upper functional or psychiatric disorders
* Patients under guardianship or trusteeship
* Patients unable to answer the questionnaire in French
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03770884
|
{
"brief_title": "Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)",
"conditions": [
"Rheumatoid Arthritis",
"Axial Spondyloarthritis",
"Hand Osteoarthritis"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT03770884",
"official_title": "Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-18",
"study_completion_date(actual)": "2019-04-18",
"study_start_date(actual)": "2019-01-08"
},
"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)": "2021-08-03",
"last_updated_that_met_qc_criteria": "2018-12-06",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-10",
"first_submitted": "2018-07-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile.
Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing.
Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
#Intervention
- DRUG : Intranasal Ketorolac Tromethamine
- Intranasal at 30mg
- DRUG : Intranasal Placebo
- Intranasal Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Men or women age 18 through 64 years
* Major abdominal surgery
* Body weight >= 100 and <= 300 pounds
* Negative serum pregnancy test
* Pain intensity score at least 40 (moderate pain) on 100 mm visual analog scale
* Minimum 48 hour hospital stay and 5 day maximum stay
* Able to provide written informed consent
* Willing and able to comply with all testing requirements of the protocol
Exclusion Criteria:
* Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
* Allergy or significant reaction to opioids
* Allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (NSAIDs)
* Current upper respiratory tract infection or other respiratory tract condition that could interfere with absorption of the nasal spray or adverse event assessment
* Use of any intranasal product in past 24 hours
* Clinically significant abnormality on screening lab tests
* History of cocaine use
* Active peptic ulcer disease or significant history of peptic ulcer disease or gastrointestinal bleeding
* Advanced renal impairment or risk for renal failure
* History of other medical problems that could interfere with the study participation
* Pregnancy or breastfeeding
* Participation in another investigational study within past 30 days
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00266786
|
{
"brief_title": "Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery",
"conditions": [
"Postoperative Pain"
],
"interventions": [
"Drug: Intranasal Placebo",
"Drug: Intranasal Ketorolac Tromethamine"
],
"location_countries": [
"New Zealand",
"United States"
],
"nct_id": "NCT00266786",
"official_title": "A Phase 3, Double-Blind, Randomized Study of the Safety, Tolerability, and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain Following Major Abdominal Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-02",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2005-12"
},
"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)": "2017-02-08",
"last_updated_that_met_qc_criteria": "2005-12-16",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-12-19",
"first_submitted": "2005-12-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Although soldiers must be ready to respond to occupational and war theatre demands at a moment's notice, there is an epidemic of overweight and obesity and a need for improved fitness and health in the military. Using a cluster randomized clinical trial we propose to test the effectiveness of a High-Intensity Functional Training (HIFT) exercise intervention to improve the body composition and fitness of active duty military personnel. The effectiveness of the HIFT intervention will be compared to usual Army Physical Readiness Training. Main outcomes will include changes in body composition and traditional fitness measures, a test of combat-preparation, and measures of cardiovascular health risk for both groups.
Detailed Description
We will examine the effectiveness of a high-intensity functional training (HIFT) exercise intervention compared to Army Physical Readiness Training (APRT) and their related dietary instructions in improving body composition (percent body fat \[%BF\], fat mass, lean body mass, weight) and domains of Total Force Fitness (TFF; Army Physical Fitness Test \[APFT\], aerobic capacity, power, strength, and combat preparation and readiness) in a 6-month cluster-randomized clinical trial (CRCT) with 2 (+/- 1) month follow-up. We also will examine the effects of both exercise programs on cardiovascular disease (CVD) health risk (resting heart rate, blood pressure). We will conduct assessments at baseline, 6-months, and 2-month follow-up (+/- 1 month). We also will assess training time/volume, injuries, adverse events, adherence, and participant satisfaction and account for demographic and psychosocial variables.
In our CRCT, we aim to recruit and randomize approximately 150 soldiers (n=15 clusters-staff groups/platoons-per condition with at least 5 soldiers nested within each cluster) comparing the effectiveness of HIFT versus usual care (APRT) on:
Specific Aim 1 - changes in body composition including: percent body fat (%BF), fat mass, fat free mass, and body weight.
We hypothesize that soldiers in the HIFT condition will be significantly more likely to decrease a. %BF and b. fat mass, and to increase c. fat free mass than those in the APRT condition; we expect both groups to d. maintain body weight.
Specific Aim 2 - changes in fitness (e.g., APFT, power, strength), while accounting for actual physical training time in each condition.
We hypothesize that soldiers in the HIFT condition will have significantly greater improvement in their performance on fitness tests when compared to those in APRT, despite significantly less total training time. These outcomes will help determine if functional-oriented training can result in better fitness and combat preparedness for Army personnel.
#Intervention
- BEHAVIORAL : High-Intensity Functional Training
- Constantly varied functional movements performed at a high intensity and incorporating monostructural (aerobic), gymnastics (body weight) and/or weightlifting movements. CrossFit is a good model of HIFT for the military because of its emphasis on general physical preparedness and functional movements and because it is open source and programming is available at no cost (see www.crossfit.com). Sixty-minute HIFT sessions will include a warm-up, workout and cool down. Workouts will average 15 minutes in duration (range = 5-45 minutes) for a total of 50-100 minutes per week.
- Other Names :
- CrossFit
- BEHAVIORAL : Army Physical Readiness Training
- Usual physical training program for Army personnel from directive FM 7-22, using the Reset phase. Exercises will address strength, endurance, and mobility training. APRT is designed to be completed in 60-90 minute sessions, 5 days/week for a total dose of 300-450 minutes per week.
- Other Names :
- Army PT
|
#Eligibility Criteria:
Inclusion Criteria:
* physical activity clearance to participate in the study via the Physical Activity Readiness Questionnaire;
* willingness to adhere to study protocol and complete all study assessments; and
* high likelihood of assignment to the military post over the 8 (+/-) 1-month course of the study.
Exclusion Criteria:
* being on permanent or temporary medical profile or having any medical condition or injury which would prevent participation in the exercise protocols;
* having a pacemaker or other implanted/internal electrical device;
* currently on administrative leave or assigned to exclusively administrative duties; and
* (if female) pregnant or lactating, or planning to become pregnant in the next 9-months.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02407093
|
{
"brief_title": "Army Training at High Intensity Study",
"conditions": [
"Obesity"
],
"interventions": [
"Behavioral: Army Physical Readiness Training",
"Behavioral: High-Intensity Functional Training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02407093",
"official_title": "HIFT for Obesity Prevention, Fitness and Health Promotion in Military Personnel",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-28",
"study_completion_date(actual)": "2020-06-28",
"study_start_date(actual)": "2015-10-28"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-13",
"last_updated_that_met_qc_criteria": "2015-03-30",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-04-02",
"first_submitted": "2015-03-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Computerized physician order entry with clinical decision support system CPOE+CDSS)completely eliminated errors in filling in the resuscitation medications order forms and significantly reduced time to completing the forms in a pediatric critical care department (PCCD).
Detailed Description
Introduction: Computerized physician order entry with clinical decision support system (CPOE+CDSS) is an important tool in attempting to reduce medication errors. The objective of this study was to evaluate the impact of a CPOE+CDSS on (1) the frequency of errors in ordering resuscitation (CPR) medications and (2) the time for printing out the order form, in a pediatric critical care department (PCCD).
Methods: Setting: An 18-bed PCCD in a tertiary-care children's hospital. Design: Prospective cohort study. Measures: Compilation and comparison of number of errors and time to fill in forms before and after implementation of CPOE+CDSS. Errors were identified by reviewing orders and classified as potential adverse drug events (ADEs), medication prescribing errors (MPEs), and rule violations (RVs). They were compared during the year preceding and following implementation of CPOE CDSS. Simulated forms were also used to further test error occurrence. Time to fill in conventional, simulated and CPOE forms was measured and compared.
Results: There were 3 reported incidents of errors among 13,124 CPR medications orders during the year preceding implementation of CPOE+CDSS. These represent errors that escaped the triple check by three independent staff members (two nurses and one physician). There was an average of 11.6 errors/100 orders in the simulated CPR form and potential ADEs occurred at a rate of 11.3/100 orders and MPEs at a rate of 0.3/100 orders. There were no errors after CPOE+CDSS was implemented (100% error reduction). Time to completion of drug forms dropped from 14 min 42 sec to 2 min 14 sec (p\<0.001).
Conclusions: CPOE+CDSS completely eliminated errors in filling in the forms and significantly reduced time to completing the form.
|
#Eligibility Criteria:
Inclusion Criteria:
* all admissions to PICU January 2002 - August 2006
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 3 Days
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00297609
|
{
"brief_title": "Prevention of Errors in Resuscitation Medications Orders by Means of a Computerized Physician Order Entry",
"conditions": [
"Critical Care",
"Pediatrics"
],
"interventions": null,
"location_countries": [
"Israel"
],
"nct_id": "NCT00297609",
"official_title": "Prevention of Potential Errors in Resuscitation Medications Orders by Means of a Computerized Physician Order Entry With Clinical Decision Support System in Pediatric Critical Care - a Prospective Cohort Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "2002-01"
},
"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)": "2006-02-28",
"last_updated_that_met_qc_criteria": "2006-02-27",
"last_verified": "2006-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-02-28",
"first_submitted": "2006-02-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine.
Detailed Description
This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw and urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender will be requested at or soon after delivery. The accuracy of the test and the optimal time to perform the test during pregnancy will be assessed by comparing the test results from maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal sex results obtained at birth.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 <= age <= 45 years inclusive
* Subject is female
* Subject is pregnant
* Gestational age can be determined via IVF or IUI
* Subject is 36 <= age <= 42 days pregnant as determined by IVF transfer or IUI
* Subject agrees to provide 3 separate blood and urine samples
Exclusion Criteria:
* None
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:
No
|
NCT01021085
|
{
"brief_title": "Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies",
"conditions": [
"Fetal Sex Determination"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01021085",
"official_title": "Evaluation Of A Fetal Sex Determination Test At 36-56 Days Gestation In Assisted Reproductive Technology (ART) Achieved Pregnancies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-08",
"study_completion_date(actual)": "2011-09",
"study_start_date(actual)": "2009-04"
},
"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)": "2011-09-05",
"last_updated_that_met_qc_criteria": "2009-11-25",
"last_verified": "2011-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-26",
"first_submitted": "2009-10-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Intra-articular joint injuries are the most common and prognostically unfavorable in case of untimely or erroneous diagnosis, which leads to a significant violation of the quality of life and activity of patients. For example, untimely diagnosis and determination of the degree of damage to the subchondral bone can lead to progression, namely, an increase in the edema zone with transformation into an irreversible process - avascular necrosis of the bone. Mistakes in diagnosing subsynovial injuries of the ligamentous apparatus and assessing its functional viability can lead to the development of chronic joint instability, chronic synovitis, and progression of intraarticular destruction.
Methods of early and accurate diagnosis allow timely and personalized treatment, they are aimed at preventing the development of complications and the need for repeated expensive and often disabling operations. The issue of developing the method of intraoperative navigation with the use of quantitative assessment methods in operations on the musculoskeletal system is also relevant.
In this regard, the methods of optical spectroscopy and optoacoustics proposed in the project, which can solve the above problems, are of particular relevance.
Thus, the scientific problem to be solved by the proposed project is the development of optical and optoacoustic spectroscopy methods for biomedical diagnostics. The development of new methods and tools capable of detecting and characterizing both early and hidden predictors of the possible progression of osteoarthritis will prevent or reduce the risks of possible complications and irreversible intra-articular changes.
Detailed Description
The objectives of this work is to create new optical methods for in vivo analysis of the state of cartilage tissue.
Methods: A prospective study will develop an instrument that implements two optical methods for assessing the condition of cartilage tissue: diffuse reflectance spectroscopy (DRS) and near-infrared fluorescence spectroscopy. Explants (knee joint) will be used as experimental material. To assess the diagnostic capabilities of optical spectroscopy methods, studies of the mechanical characteristics of cartilage will be carried out simultaneously with the optical characteristics. Cartilage mechanical parameters will be measured using a Mach-1 v500c indenter (Biomomentum, Laval, QC, Canada) equipped with a three-axis dynamometer. The direction of the normal to the sample will be measured with a spherical indenter; a needle puncture will be performed to assess the thickness of the explant tissue. Measurements will determine the Young's modulus, the direction of the normal and the thickness of the cartilage. This work is supported by the Russian Science Foundation (grant no. 21-79-10325).
An indentation will be performed to determine the mechanical parameters of the cartilage at different points and to obtain DCR spectra of the cartilage in the wavelength range of 850-1050 nm.Analysis of changes in the properties of water in the cartilaginous tissue of the knee joint in normal and pathological conditions will be supplemented by a study of its own IR fluorescence. In preliminary experiments, it was found that different parts of the cartilage of different explants have different levels of red fluorescence at different stages of degeneration, however, in order to draw conclusions, it is necessary to expand the number of measured samples to assess the reliability of the results of the observed differences.
In the course of the work, a mobile unit will be developed that implements the methods of fluorescence spectroscopy in the near infrared range and DLS, and the mechanical properties of explants will also be studied. In the future, it is planned to use the developed technique for assessing the state of the cartilage intraoperatively.
Before conducting the experimental work, it is planned to write a systematic review on the research topic.
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent of the patient to participate in the study.
* The age of the patient is from 18 <= age <= 85.
* Gender male and female.
* The patient has intra-articular injuries of the knee joint.
Exclusion Criteria:
* Refusal to participate in the study and to sign informed consent.
* The age of the patient is less than 18 and more than 85 years.
* Pregnancy, lactation.
* The presence of severe concomitant somatic pathology (diseases of the cardiovascular system, lungs, liver and kidneys), decompensated diabetes mellitus.
* Oncological diseases.
* Mental illness.
* Alcohol abuse or drug use.
* Chronic viral and bacterial infections in the acute stage.
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:
Yes
|
NCT05454605
|
{
"brief_title": "Оptical Spectroscopy in the Diagnosis of Intra-articular Injuries",
"conditions": [
"Cartilage Destruction"
],
"interventions": null,
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT05454605",
"official_title": "Оptical Spectroscopy in the Diagnosis of Intra-articular Injuries of the Knee Joint",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-20",
"study_completion_date(actual)": "2023-11-20",
"study_start_date(actual)": "2022-01-24"
},
"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)": "2024-01-18",
"last_updated_that_met_qc_criteria": "2022-07-07",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-12",
"first_submitted": "2022-05-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to assess the pharmacodynamic effect of single, oral doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) and prednisolone as measured by levels of ex vivo LPS-induced TNF-alpha production in whole blood of healthy adult subjects.
The secondary purposes of this study are to assess the pharmacodynamic effects of single, oral doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) and prednisolone (30mg) as measured by levels of IL-6, IL-8 and IL-1beta in whole blood of healthy adult subjects. In addition, plasma pharmacokinetics, safety and tolerability of SRT2104 following the administration of single, oral doses of SRT2104 (250 mg, 500 mg, 1000 mg, 2000 mg) in healthy adult subjects will also be assessed. As exploratory endpoints, transcriptomic profiles, biomarker exploration, and relationships between plasma SRT2104 levels and ex vivo LPS-induced TNF-alpha production may also be examined.
Detailed Description
This is a prospective, single center, non-therapeutic clinical study of SRT2104 administered orally as 250 mg capsules. Randomized, double-blind study to evaluate and compare the sensitivity of systemic biomarkers, such as ex-vivo LPS-induced TNF-alpha, IL-6, IL-8, and IL-1beta, to treatment with four-single oral doses of SRT2104 (250 mg, 500 mg, 1000 mg, and 2000 mg), prednisolone (30 mg), and placebo in healthy adult volunteers. Twenty (20) subjects (males and females of non-childbearing potential) aged 18-60, who fulfill the inclusion/exclusion criteria, will be enrolled in this study to achieve a minimum of 15 evaluable subjects. Each subject will participate in 6 treatment periods. For each treatment period subjects will fast for at least 10 hours overnight. After pre-dosing procedures, subjects will consume a standard, non-high-fat (approximately 650 kcal with approximately 30% of calories derived from fat) meal 15-30 minutes prior to receiving test material. During the first five treatment periods, subjects will receive a single dose of SRT2104 or matched placebo; during the last treatment period, subjects will receive 30 mg open-label prednisolone. Assessments will be performed until 24 hours post dose in each treatment period.
Subjects will be asked to sign the informed consent form(s) at the screening visit. If eligible and willing to participate, subjects will enter into the study. Subjects will be required to attend the research unit in a fasted state (at least 10 hours without food) on six separate occasions (treatment visits) during the study. There will be at least a 7-day washout period between treatment visits.
During the first five treatment visits, subjects will receive one of the following five treatments:
A. 250 mg SRT2104 administered as eight oral capsules (one active SRT2104 250 mg capsule + seven placebo capsules) B. 500 mg SRT2104 administered as eight oral capsules (two active SRT2104 250 mg capsules + six placebo capsules) C. 1000 mg SRT2104 administered as eight oral capsules (four active SRT2104 250 mg capsules + four placebo capsules) D. 2000 mg SRT2104 administered as eight oral capsules (eight active SRT2104 250 mg capsules + zero placebo capsules) E. Eight placebo capsules
During the last treatment visit, subjects will receive 30 mg of open-label prednisolone tablets.
Subjects will be required to return to the research unit 24 hours after dosing in each treatment period in order to gather the required PK and PD samples. Subjects will be asked to return to the study center for an End of Study safety assessment 7 to 10 days after the last treatment visit.
#Intervention
- DRUG : Placebo
- Matching placebo is supplied containing microcrystalline cellulose (Avicel PH 105). Placebo will be administered as eight matched capsules.
- DRUG : 0.25g SRT2104
- SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 0.25g SRT2104 treatment visit will be administered as one SRT2104 capsule with 7 placebo capsules. Dosing will take place during one of the 6 treatment visits.
- DRUG : Prednisolone
- During the last treatment period, subjects will receive 30 mg open-label prednisolone.
- DRUG : 0.5g SRT2104
- SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 0.5g SRT2104 treatment visit will be administered as two SRT2104 capsules with 6 placebo capsules. Dosing will take place during one of the 6 treatment visits.
- DRUG : 1g SRT2104
- SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 1g SRT2104 treatment visit will be administered as four SRT2104 capsules with four placebo capsules. Dosing will take place during one of the 6 treatment visits.
- DRUG : 2g SRT2104
- SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. The 2g SRT2104 treatment visit will be administered as eight SRT2104 capsules. Dosing will take place during one of the 6 treatment visits.
|
#Eligibility Criteria:
Inclusion Criteria:
* The study is open to healthy male and female volunteers, 18 <= age <= 60 of age, with hematology, clinical chemistry, electrolytes, serology, and urinalysis tests within normal, allowable limits using normal laboratory values (if out-of-range values result, they must be considered clinically significant by the Investigator to be exclusionary) and performed within 21 days to 1 day of receiving the first dose of test material.
* All male subjects and their female partners must be willing and able to use an acceptable form of double-barrier birth control (hormonal or double barrier method of birth control [condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream, or suppository]; true abstinence) for at least 12 weeks after the last treatment dose.
* All female subjects must be of non-childbearing potential. For the purposes of this study, non-childbearing potential is defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use adequate contraception (hormonal or double barrier method of birth control [condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream, or suppository]; true abstinence) for the duration of the study dosing and for at least 12 weeks after the last treatment dose, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 <= age <= 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method].
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00920660
|
{
"brief_title": "Clinical Study to Assess the Effects of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers",
"conditions": [
"Pulmonary Disease, Chronic Obstructive"
],
"interventions": [
"Drug: 0.5g SRT2104",
"Drug: 2g SRT2104",
"Drug: Prednisolone",
"Drug: 0.25g SRT2104",
"Drug: 1g SRT2104",
"Drug: Placebo"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00920660",
"official_title": "A Randomised, Double-blind, Placebo-controlled, Multi-way Crossover Study to Assess the Effects of Single Oral Doses of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06-12",
"study_completion_date(actual)": "2009-06-12",
"study_start_date(actual)": "2009-04-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-07-07",
"last_updated_that_met_qc_criteria": "2009-06-12",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-06-15",
"first_submitted": "2009-06-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the effectiveness of a health management and supported rehabilitation intervention in treating serious mental illnesses in older people.
Detailed Description
This randomized, controlled study will evaluate the effectiveness of a health management (HM) and supported rehabilitation (SR) intervention for 180 older persons (age 50+) with serious mental illness. We will address the following specific aims and hypotheses:
Specific Aim 1- To compare the effectiveness of SR/HM to UC in improving independent living skills and health management. We hypothesize that compared to older individuals with SMI receiving UC, individuals receiving SR/HM will have better independent living skills and health management, evidenced by:
1. Better community living skills and better social skills based on performance-based measures and self-reports of functioning, and
2. Better medication management skills based on performance-based and self-report measures and greater use of preventive and routine primary health care (including annual check-ups with a primary care provider and participation in preventive health care).
Specific Aim 2- To compare the effectiveness of SR/HM to UC in decreasing the use of high-cost acute and long-term institution-based services. We hypothesize that compared to older individuals with SMI receiving UC, individuals receiving SR/HM will use fewer high cost services, including emergency room visits, acute hospitalizations, and nursing home care. In addition, the reduced use of high cost institution-based services will be associated with better independent living skills and health management practices resulting from the SR/HM intervention.
We will also evaluate the following secondary, exploratory hypotheses:
1. The SR/HM intervention will be associated with better general health status.
2. The effectiveness of SR/HM in improving living skills and community functioning will be greatest for individuals with low levels of cognitive impairment.
In addition, we will describe outpatient service utilization for SR/HM and UC models within each study site in order to present a more comprehensive account of services used by study participants.
Little is known about how to provide effective rehabilitation and health management services to older persons with serious mental illness (SMI) to decrease the use of high-cost institution-based services. To address this need, we developed a supported rehabilitation and health management (SR/HM) intervention for older persons with SMI that addresses functioning in two areas essential for preventing hospitalizations and long-term institutional care: (1) enhanced independent living skills and (2) improved health management. The supported rehabilitation (SR) component consists of skills training aimed at improving competence in everyday functioning, including community living skills and social skills. The health management (HM) component consists of training in health management skills and health case management by nurses who monitor and facilitate routine preventive and acute health care. Results from a pilot study indicate that SR/HM is effective in improving independent living skills and health management for older persons with SMI.
The aims of this study are to test the effectiveness of the SR/HM intervention in improving the functioning and health care of older persons with SMI and in reducing the use of high cost, acute and long-term institution-based care. The proposed research will compare the SR/HM intervention to usual care (UC) in a randomized, controlled study of 180 individuals age 60 and older with SMI living in the community.
#Intervention
- BEHAVIORAL : Health Care Management and Supported Rehabilitation
|
#Eligibility Criteria:
Inclusion Criteria:
* age 50+ with schizophrenia,schizoaffective disorder,bipolar disorder, major depression with functional impairment
Exclusion Criteria:
* dementia, life threatening acute medical condition.
Sex :
FEMALE
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00169052
|
{
"brief_title": "Health Care Management and Rehabilitation Skills Training for Treating Serious Mental Illness in Older People",
"conditions": [
"Schizophrenia",
"Schizoaffective Disorder",
"Bipolar Disorder",
"Major Depression"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00169052",
"official_title": "Rehabilitation and Health Care for Elderly With SMI",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-08",
"study_start_date(actual)": "2001-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-10",
"last_updated_that_met_qc_criteria": "2005-09-11",
"last_verified": "2001-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-15",
"first_submitted": "2005-09-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to investigate if occupational therapy may delay or prevent the need for surgery in patients with carpometacarpal(CMC) osteoarthritis (OA) who are scheduled for surgery in the CMC-joint.
Our study hypothesis is that compared to participants in the intervention group, significantly more participants in the control group have received CMC-surgery after two years.
Detailed Description
Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population, and approximately 68% of people between the ages of 71 and 80 years have radiographic OA in the carpometacarpal (CMC) joint.
Currently, there is no cure for hand OA. However, several studies have demonstrated that hand exercises and CMC-orthoses may reduce pain and improve grip strength, and in a recent study, assistive devices improved activity performance and satisfaction with performance in people with hand-OA. Still, most people do not receive any such treatment, but those with severe CMC-OA are often referred for surgery in this joint. The effect of occupational therapy to prevent or delay need for surgery CMC-OA has been investigated in a small study with 33 participants, but randomised controlled trails (RCT) of good quality are needed.
#Intervention
- OTHER : Care as usual
- OTHER : Occupational therapy
- Occupational therapy in the waiting period before surgery. Occupational therapy comprises orthoses for the CMC-joint, hand exercises, and use of alternative working methods and assistive devices. The participants are encouraged to perform hand exercises three times a week for the first 12 weeks, and to use orthosis as much as possible, both during daytime (day orthosis) and night time (night orthosis).
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with CMC-OA who are referred for review for the need for surgery in the CMC joint.
Exclusion Criteria:
* Persons with cognitive dysfunction
* Persons who do not understand the Norwegian language
* Persons with other diseases or injuries that may negatively impact hand function
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01794754
|
{
"brief_title": "Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis",
"conditions": [
"Osteoarthritis in the Carpometacarpal (CMC) Joint"
],
"interventions": [
"Other: Occupational therapy",
"Other: Care as usual"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT01794754",
"official_title": "May Occupational Therapy Delay the Need for Surgery in Carpometacarpal Osteoarthritis: A Randomised Controlled Trial.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-06",
"study_completion_date(actual)": "2018-08",
"study_start_date(actual)": "2013-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-31",
"last_updated_that_met_qc_criteria": "2013-02-19",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-20",
"first_submitted": "2013-02-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The overarching objective of this study is to develop an innovative strategy to address the problems of obesity and diabetes by promoting exercise adoption. An automated telephone intervention will be developed that can be used to enhance exercise adoption over a twelve month period in a population of overweight or obese veterans with Type 2 diabetes.
Detailed Description
Approximately two thirds of American adults are overweight (body mass index - BMI \> 25), and nearly one third of American adults are obese (BMI \> 30) with veterans exhibiting even higher rates of being overweight and obese than those in the general population. Obesity is a significant risk factor for a number of serious medical conditions, including diabetes, and is associated with high rates of morbidity, and mortality. Greater than 80% of individuals with diabetes are overweight or obese. Sixteen million Americans have been diagnosed with diabetes, and it has been speculated that this number will increase to 23 million by the year 2010. Furthermore, there is a substantially higher prevalence of diabetes in the veteran population as compared to the general population, with nearly 16 percent of veterans being affected. This alarming increase has been associated with the increasing prevalence of obesity and sedentary lifestyles. In a conference conducted by the National Institute of Diabetes and Digestive and Kidney Diseases in 1999, it was concluded that a major research initiative was needed to address the growing problem with physical inactivity and obesity because of the major impact these behaviors have on the development and treatment of diabetes.
The benefits associated with exercise in the diabetic population are extensive, and even though regular exercise is typically prescribed as a significant component of the diabetic treatment plan, compliance tends to be very poor. The overarching objective of this study is to adapt a low cost telephone intervention to be used to enhance exercise adoption in a population of overweight or obese veterans with type 2 diabetes. The primary aim of this study is to implement and evaluate the effectiveness of this telehealth intervention over a six month period. The secondary aim is to evaluate the impact this telehealth intervention has on weight and other diabetes relevant physical health parameters, quality of life and psychological distress. If the telehealth intervention is found to be efficacious, the tertiary aim will be to evaluate the cost effectiveness of the intervention. Over a 4-year period, 140 overweight or obese veterans with type 2 diabetes will be recruited from the VA Boston Healthcare System. All participants will be evaluated and provided with an exercise prescription for a home based walking program. Participants will be randomized to either the Exercise Prescription condition alone, or Exercise Prescription plus TLC-PED (Telephone Linked Care - Promoting Exercise for Diabetes), an automated telehealth intervention. TLC-PED will use interactive voice response and recognition telephone technology to provide individualized phone messages for participants with diabetes. It will be developed to incorporate theoretical principles that are known to enhance exercise adoption. Specifically, the intervention will use motivating principles based on the transtheoretical model of change. Those in the TLC-PED condition will receive weekly automated telephone calls for a six month period. It is hypothesized that overweight veterans with diabetes who receive the TLC-PED intervention (versus those who do not) during their six month participation in a home based walking program will be more likely to engage in regular physical activity and obtain improvements in self-reported physical activity, and maintain these changes over a twelve month period.
#Intervention
- BEHAVIORAL : TLC-PED
- Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 2 diabetes mellitus
* Receive a medical clearance from physician
* Be sedentary
* Be interested in exercising
* Have a BMI > 25 kg/m2
* Have an HbA1c between 7 & 10%
* Be on medication for diabetes
Exclusion Criteria:
* Significant peripheral neuropathy
* Active psychosis
* Psych admission or substance abuse in the last 6 months
* Severe brain dysfunction
* Abnormal ECG
* Orthopedic related limitations
* Unable to understand English
* No direct access to telephone
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
|
NCT00334113
|
{
"brief_title": "Telerehabilitation Intervention to Promote Exercise for Diabetes",
"conditions": [
"Diabetes Mellitus, Type 2",
"Obesity"
],
"interventions": [
"Behavioral: TLC-PED"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00334113",
"official_title": "Telerehabilitation Intervention to Promote Exercise for Diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-04",
"study_completion_date(actual)": "2012-04",
"study_start_date(actual)": "2009-01"
},
"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)": "2015-01-06",
"last_updated_that_met_qc_criteria": "2006-06-02",
"last_verified": "2014-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-06-06",
"first_submitted": "2006-06-02",
"first_submitted_that_met_qc_criteria": "2014-11-21"
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to determine if a more intensive application of communication intervention, i.e. 5 hours per week, will result in more frequent intentional communication acts, greater lexical density, and a better verbal comprehension level than children who receive the same communication intervention only one time per week.
Detailed Description
Our research team has pioneered the development of a prelinguistic communication intervention referred to as Parent Responsivity Education-Milieu Communication Teaching (PRE-MCT). This intervention is designed to establish and enhance the development of intentional communication prior to the onset of spoken language in children with language delays and disorders. In the early stages of intervention, clinicians target children's use of gestures, vocalizations, and eye contact to produce more frequent and more complex nonverbal communication acts. As the children develop, goals shift to the direct teaching of words and sentence structures.
Our preliminary research using randomized experimental designs has tested the effects of the intervention when delivered in a very small 'dose', averaging just over one hour per week for six months. This standard dose has led to significant but modest effects in the children's use of intentional communication and early language, such that it could be adopted by speech-language pathologists as part of standard care. Unfortunately, the early benefits have not always been maintained 6 and 12 months after the therapy phase ends and have not always benefitted all children.
This research is a test of the hypothesis that a more intensive application of the intervention will have dramatically more positive outcomes than the standard dosage.
#Intervention
- BEHAVIORAL : Milieu Communication Teaching
- Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week
- Other Names :
- Parent Responsivity Education-Milieu Communication Teaching
|
#Eligibility Criteria:
Inclusion Criteria:
* must produce at least one intentional communication act during administration of the Communication and Symbolic Behavior Scale
* a minimum raw score of 34 or a composite score not greater than 75 on the cognitive subtest of the Bayley Scales of Infant Development
Exclusion Criteria:
* spontaneous production of more than 20 words
* failure of a screening test for Autism
* English is not the primary language spoken in the home
* corrected hearing or corrected vision is not within normal limits
Sex :
ALL
Ages :
- Minimum Age : 18 Months
- Maximum Age : 27 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00723151
|
{
"brief_title": "Effects of Intensity of Early Communication Intervention",
"conditions": [
"Communication Disorders",
"Developmental Disabilities"
],
"interventions": [
"Behavioral: Milieu Communication Teaching"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00723151",
"official_title": "Effects of Intensity of Early Communication Intervention",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-09",
"study_completion_date(actual)": "2010-10",
"study_start_date(actual)": "2005-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-11-01",
"last_updated_that_met_qc_criteria": "2008-07-24",
"last_verified": "2010-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-07-28",
"first_submitted": "2008-07-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study aims to identify several factors that can accurately predict the incident of intestinal infraction in patients with mesenteric vascular occlusion or ischemia.
Detailed Description
The study aims to identify several clinical, laboratory, and radiologic factors that can accurately predict the occurrence of intestinal infraction in patients with mesenteric vascular occlusion or ischemia in order to prevent unnecessary surgical intervention in patients with just intestinal ischemia and to hasten intervention in patients with actual intestinal gangrene.
#Intervention
- DRUG : Heparin injection
- Intravenous heparin injection in patients with acute mesenteric ischemia and evaluating their response within 24 hours
- Other Names :
- Low molecular weight heparin injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with acute mesenteric Ischemia
Exclusion Criteria:
* Patients with other causes of acute abdomen other than mesenteric Ischemia
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02645240
|
{
"brief_title": "Predictive Factors of Intestinal Infraction in Acute Mesenteric Ischemia",
"conditions": [
"Mesenteric Ischemia"
],
"interventions": [
"Drug: Heparin injection"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT02645240",
"official_title": "Predictive Factors of Intestinal Infraction in Patients With Acute Mesenteric Ischemia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07",
"study_completion_date(actual)": "2017-08",
"study_start_date(actual)": "2015-10"
},
"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)": "2017-08-29",
"last_updated_that_met_qc_criteria": "2015-12-31",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-01",
"first_submitted": "2015-12-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of the present study will be to assess the effectiveness of add-on perampanel in participants with focal seizures in a real-life clinical setting.
#Intervention
- DRUG : Perampanel
- Perampanel tablets.
- Other Names :
- Fycompa, E2007
|
#Eligibility Criteria:
Inclusion Criteria:
* Prescribe perampanel according to the approved indication
* Participants with focal seizures with or without secondary generalization
* Participants with seizure frequency data available at the baseline visit
* Based on the physician's clinical judgment, the participant seizure activity is not controlled sufficiently with the current treatment with 1 <= age <= 3 AEDs and it is in the participants best interest to be prescribed adjunctive perampanel
* The decision to prescribe perampanel is made by the physician before and independently of his/her decision to include the participant in the study
* Treatment with perampanel is not yet started before baseline
Exclusion Criteria:
* Participants contraindicated for perampanel use (according to SmPC)
* Participants with moderate to severe renal impairment
* Participants with severe hepatic impairment
* Pregnant or lactating women
* Participants suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation
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
|
NCT04257604
|
{
"brief_title": "A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures",
"conditions": [
"Partial Seizures"
],
"interventions": [
"Drug: Perampanel"
],
"location_countries": null,
"nct_id": "NCT04257604",
"official_title": "A Multicenter, Prospective, Real-life Observational Study of Perampanel as Add-on Therapy in Adult and Adolescent Patients With Focal Seizures (A Mirroring Clinical Practice Study of Perampanel in Adults and Adolescents) (The AMPA Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-30",
"study_completion_date(actual)": "2019-04-30",
"study_start_date(actual)": "2016-01-03"
},
"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)": "2020-02-06",
"last_updated_that_met_qc_criteria": "2020-02-05",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-06",
"first_submitted": "2020-01-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of treatments (massage therapy or ultrasound) directed at skeletal muscle for alleviating pain associated wtih tension headache.
Detailed Description
Chronic or episodic forms of tension-type headache affect a high percentage of the population. Pain from tension-type headache (TTH) not only impacts personal well-being, but also poses a significant socioeconomic burden in terms of workdays lost and decreased worker productivity. Although TTH is the most prevalent of the headache disorders, there is a distinct lack of research with regards to specific treatments for this ailment in comparison to all other headache classifications, such as migraine. A muscular involvement is associated with TTH and is reported in the research literature as elevation in skeletal muscle tenderness, increased presence of active myofascial trigger point's, and physical abnormalities in cervical and cranial muscles. Thus, a treatment approach that addresses the skeletal musculature could be an important component in the management of TTH. The purpose of this randomized trial is to determine the effectiveness of two muscle oriented treatments on reducing pain and disability associated with TTH: massage therapy and ultrasound.
#Intervention
- OTHER : ultrasound
- Twice weekly ultrasound sessions for 6 weeks
- OTHER : massage
- Twice weekly massage sessions for 6 weeks
- Other Names :
- myofsacial trigger point therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* 2 or more tension-type headache episodes per week
* Headache episodes of 2 hours or longer
* Experiencing tension-type headache for 6 months or longer
Exclusion Criteria:
* Migraine >1/month
* Presence of alternate forms of headache (e.g. cluster headache, medication-induced headache, headache caused by injury)
* The diagnosis of fibromyalgia, major depression, other neurological or cardiovascular disease
* Pregnancy
* Prior massage or ultrasound treatment for headaches
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
|
NCT01244555
|
{
"brief_title": "Muscle Treatment for Management of Pain & Disability in Tension-type Headache",
"conditions": [
"Tension-type Headache"
],
"interventions": [
"Other: ultrasound",
"Other: massage"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01244555",
"official_title": "Muscle Treatment for Management of Pain & Disability in Tension-type Headache",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-07",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2010-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-12-02",
"last_updated_that_met_qc_criteria": "2010-11-18",
"last_verified": "2015-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-19",
"first_submitted": "2010-11-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.
#Intervention
- DRUG : Rifaximin
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed IBS diagnosis per Rome II for diagnosis of IBS.
* Colonoscopy within 2 years as part of IBS diagnostic evaluation.
* Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.
Exclusion Criteria:
* Symptoms of constipation.
* History of other gastrointestinal diseases.
* Type 1 or 2 diabetes.
* Lactose intolerance not controlled by lactose-free diet.
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
|
NCT00731679
|
{
"brief_title": "Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)",
"conditions": [
"Non-Constipation Irritable Bowel Syndrome"
],
"interventions": [
"Drug: Placebo",
"Drug: Rifaximin"
],
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT00731679",
"official_title": "A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin 550 mg TID in the Treatment of Subjects With Non-Constipation Irritable Bowel Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-08",
"study_completion_date(actual)": "2009-09",
"study_start_date(actual)": "2008-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-11-29",
"last_updated_that_met_qc_criteria": "2008-08-08",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-11",
"first_submitted": "2008-07-16",
"first_submitted_that_met_qc_criteria": "2014-06-30"
}
}
}
|
#Study Description
Brief Summary
The SPECIFIC AIM of this research study is to evaluate the utilization, effectiveness, and safety of osteopathic manipulative treatment (OMT) using data collected from patients receiving OMT in the clinical setting within the established practice-based research network DO-Touch.NET.
. The HYPOTHESES of this research study are the following:
* OMT is primarily used in the treatment of musculoskeletal pain disorders.
* Patients receiving OMT will have decreased symptoms and improved quality-of-life.
* The most common side effect reported by patients receiving OMT will be muscle soreness.
Detailed Description
While many physicians and patients are convinced of the efficacy of osteopathic manipulative treatment (OMT), strong evidence supporting such a claim is sparse.
The objectives of this study are to determine the scope of conditions currently being treated with OMT, identify conditions that are responsive and unresponsive to OMT, determine which osteopathic manipulative techniques are most beneficial in responsive conditions, determine if certain patient characteristics are present in those who are responsive to OMT, and determine which physicians have consistently positive outcomes with OMT for certain conditions.
As an observational study, this study will not impact any aspect of the care received by the patient participants. Data will be collected from patients and physicians through a series of questionnaires incorporated into an online data collection system. DO-Touch.NET will be utilized for physician recruitment, site personnel training, members portal for accessing study materials, coordination, and physician data collection. Assessment Center will be used for participant registration, data collection and study tracking/reporting. Patients aged 18 years and older who receive OMT from a participating physician at a DO-Touch.NET site will be recruited to participate in the study. Background data will be collected from the patients including demographics, presenting symptoms and severity, and impact on quality of life. Data on medical history, examination, diagnosis, treatment, and home instructions/plan will be gathered from the physician. On a daily basis for a week after OMT, data will be collected from the patient regarding symptom severity and health changes. Impact of symptoms on quality of life will be reassessed after one week. These data will be collected from a patient over a series of office visits when applicable.
Ongoing observation of both positive and negative outcomes associated with OMT directly from patients will be increasingly more valuable, producing and sustaining a current evidence base for OMT and identifying priorities for further osteopathic research.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged 18 years and older
* Patients receiving OMT at a participating clinic
Exclusion Criteria:
* Patients with difficulty communicating in English, have dementia, or have psychological conditions that may impact their ability to provide accurate information
* Research team members and participating clinic employees
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
|
NCT02395965
|
{
"brief_title": "OMM Utilization in the Clinical Setting",
"conditions": [
"Conditions Treated With OMT"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02395965",
"official_title": "Use and Effectiveness of Osteopathic Manipulative Medicine (OMM) in the Clinical Setting",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2014-08",
"study_start_date(actual)": "2011-07"
},
"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)": "2015-03-24",
"last_updated_that_met_qc_criteria": "2015-03-18",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-24",
"first_submitted": "2015-02-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
#Intervention
- DRUG : risankizumab
- Subcutaneous (SC) injection
- Other Names :
- ABBV-066, BI 655066, SKYRIZI
- DRUG : secukinumab
- Subcutaneous (SC) injection
- Other Names :
- Cosentyx
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit
* Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
* Subject must be a candidate for systemic therapy as assessed by the investigator;
* Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.
Exclusion Criteria:
* History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
* Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein derivative (PPD) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
* Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold)
* History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix
* Previous exposure to risankizumab
* Previous exposure to secukinumab
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03478787
|
{
"brief_title": "Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis",
"conditions": [
"Psoriasis"
],
"interventions": [
"Drug: risankizumab",
"Drug: secukinumab"
],
"location_countries": [
"France",
"Netherlands",
"United States",
"Poland",
"Germany",
"Canada",
"Spain",
"Italy",
"United Kingdom"
],
"nct_id": "NCT03478787",
"official_title": "A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-08",
"study_completion_date(actual)": "2020-07-08",
"study_start_date(actual)": "2018-05-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-13",
"last_updated_that_met_qc_criteria": "2018-03-23",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-27",
"first_submitted": "2018-03-23",
"first_submitted_that_met_qc_criteria": "2021-06-21"
}
}
}
|
#Study Description
Brief Summary
The investigators will investigate in a sham controlled design antidepressant effects and safety of DBS to the superolateral branch of the main medial forebrain bundle (slMFB).
Detailed Description
The target point for DBS in major depression disorder is located lateral to the ventral tegmental area (VTA) in the midbrain at the branching point of the superolateral branch (slMFB) from the main medial forebrain bundle (MFB).
The exact stimulation coordinates are:
MNI152 coordinates:
left: x(lat.)=-5, y(ap)=-14, z(vert.)=-8 right: x(lat.)=5, y(ap)=-14, z(vert.)=-9
MCP coordinates:
eft: x(lat.)=-6, y(ap)=-1, z(vert.)=-6 right: x(lat.)=4, y(ap)=-1, z(vert.)=-7
All coordinates refer to the MNI152 brain. Legend: slMFB = superolateral branch of medial forebrain bundle, MNI152=Montreal Neurologic Institute brain 152 coordinates, MCP = mid-commissural point coordinates, lat. = lateral, ap= antero-posterior, vert. = vertical.
More information can be found at: http://goo.gl/n9sWV
In addition to the described intervention, we will record EEG activity within the implanted regions during cognitive paradigms (Fell and Axmacher, Nat Rev Neurosci 2011). Specifically, we will investigate the neural mechanisms underlying classification learning, working memory and exploration of rewarded spatial locations and explore oscillatory responses following stimulation of the target regions. These experimental paradigms will be conducted on the first day after electrode implantation.
#Intervention
- DEVICE : DBS
- 130Hz, 90us pulsewidth, 4V Amplitude
- Other Names :
- INS
- DEVICE : No Stimulation (Sham)
- 130Hz, 90us pulsewidth, 0V Amplitude
- Other Names :
- INS
|
#Eligibility Criteria:
Inclusion Criteria:
* Major depression (MD), severe, unipolar type
* German mother tongue
* Hamilton Depression Rating Scale (HDRS24) score of > 20
* Global Assessment of Function (GAF) score of < 45
* At least 4 episodes of MD or chronic episode > 2 years
* > 5 years after first episode of MD
* Failure to respond to
* adequate trials (>5 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes;
* adequate trials (>3 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant);
* an adequate trial of electroconvulsive therapy [ECT] (>6 bilateral treatments) and;
* an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist).
* Able to give written informed consent
* No medical comorbidity
* Drug free or on stable drug regimen at least 6 weeks before study entry
Exclusion Criteria:
* Current or past nonaffective psychotic disorder
* Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
* Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
* Any surgical contraindications to undergoing DBS
* Current or unstably remitted substance abuse (aside from nicotine)
* Pregnancy and women of childbearing age not using effective contraception
* History of severe personality disorder
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01095263
|
{
"brief_title": "Effects of Deep Brain Stimulation in Treatment Resistant Major Depression",
"conditions": [
"Major Depression"
],
"interventions": [
"Device: No Stimulation (Sham)",
"Device: DBS"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT01095263",
"official_title": "Assessment of Efficacy, Safety and Effects on Quality of Life of Deep Brain Stimulation to the Medial Forebrain Bundle in Patients With Treatment Resistant Major Depression (FORESEE: FOREbrain Stimulation dEprEssion)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2013-01",
"study_start_date(actual)": "2011-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-06",
"last_updated_that_met_qc_criteria": "2010-03-29",
"last_verified": "2018-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-30",
"first_submitted": "2010-03-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of this study is to assess the usability and efficacy of receiving therapy with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral palsy condition. It will be valued the impact of rehabilitation with the exoskeleton at the physical level on parameters such as joint range, spasticity, as well as the impact in quality of life. It is also assessed the impact at the level of functionality of the participants, through the administration of different functional assessment scales.
#Intervention
- DEVICE : ATLAS 2030 exoskeleton
- Individualized Rehabilitation Treatment with the ATLAS 2030 Exoskeleton consists of the following phases:
1. Telephone contact phase (1 session)
2. Inclusion Phase (1 session)
3. Signing of informed consent (1 session)
4. Initial Evaluation Phase (1 session)
5. Treatment Phase (1st part) (7 sessions)
6. Monthly Evaluation Phase (1 session)
7. Treatment Phase (2nd part) (7 sessions)
8. Monthly Evaluation Phase (1 session)
9. Treatment Phase (3rd part) (7 sessions)
10. Final Evaluation Phase and results (2 sessions)
|
#Eligibility Criteria:
Inclusion Criteria:
* Medical authorization to for standing, gait training and weight bearing.
* Maximum user weight of 35 kg.
* Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 24cm to 33cm.
* Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23cm to 32cm.
* Hip width (between greater trochanteres) less than or equal to 35 cm.
* Do not have an allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
* Ability to achieve the neutral position of the ankle, during the use of the device with or without technical aids.
* Informed consent signed by legal guardians.
* Confirmed diagnosis of cerebral palsy affecting the ability to walk.
* Stable medical condition without modifications of the specific medication for the disease in the last 6 months, and other additional medication in the last month.
* Patient in follow-up according to the normal standards recommended for his illness.
Exclusion Criteria:
* More than 20º of hip flessum at the time of using the exoskeleton.
* More than 20º of knee flessum at the time of using the exoskeleton.
* Severe skin lesion on parts of the lower extremities that are in contact with the device.
* Scheduled surgery (rachis, limbs) for the duration of the study or surgery performed (rachis, extremities) in the last 6 months.
* History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
* Refusal of the patient or legal guardian to include the child in the study.
* Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the patient's skin.
* Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05551364
|
{
"brief_title": "Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy",
"conditions": [
"Cerebral Palsy"
],
"interventions": [
"Device: ATLAS 2030 exoskeleton"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT05551364",
"official_title": "Usabilidad y Efectividad Del Exoesqueleto ATLAS2030 en Variables físicas, Emocionales y Funcionales en niños Con parálisis Cerebral",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-02",
"study_completion_date(actual)": "2023-08-30",
"study_start_date(actual)": "2022-09-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-27",
"last_updated_that_met_qc_criteria": "2022-09-19",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-22",
"first_submitted": "2022-09-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of lower limb intermittent claudication.
Detailed Description
The circulation of blood around the body is dependent on effective pumping of the heart. Patients with claudication experience pain or discomfort in their legs usually during activity such as walking, which goes away at rest. Claudication is a symptom of peripheral arterial disease (PAD). If left untreated, patients can develop arterial insufficiency which can lead to various complications such as swelling, painful legs, reduced healing of injuries and the loss of limbs in extreme conditions.
PAD can be defined as a narrowing of the arteries reducing blood flow. It is most commonly due to atherosclerosis, and has associations with heart disease, stroke, and diabetes. Its incidence is estimated at 7-14% in the general population, increasing with age to about 20% in the over-seventies. It is associated with effects on mobility, skin condition and quality of life. Symptoms include pain in the legs on walking (intermittent claudication), pain at rest (particularly at night), gangrene, and limb loss. Management of PAD is based on encouraging exercise, and modification of risk factors such as smoking, high blood pressure, high cholesterol and diabetes.
In patients with PAD, exercise tolerance is often limited. Severe symptoms and disease can be treated by procedures such as balloon angioplasty, stenting or surgical bypass, but these procedures have risks. There also remains a percentage of patients who are not suitable for revascularisation, and have few options besides amputation available to them.
Some trials have shown that increasing the blood flow in the legs over time using medical devices (intermittent pneumatic compression, muscle stimulators), in addition to maximal medical and surgical therapy, can increase claudication distance, absolute walking distance, decrease rest pain, and reduce amputation rates. In our unit it has become apparent that there are an increasing number of medical devices available for circulatory support, either for use as an inpatient, out-patient, or a member of the general public. The supporting evidence for these is variable in scientific and clinical content or relevance, and requires clinical trials to evaluate further.
The device being used in this study, activates the pumping action of the leg muscles by providing neuromuscular electrical stimulation (NMES) to cause foot muscle contraction and relaxation. This squeezes blood back towards the heart, improving circulation.
The study will evaluate whether NMES using this device has the same beneficial effects in patients with intermittent claudication.
#Intervention
- DEVICE : Neuromuscular Electrical Stimulation
- Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.
|
#Eligibility Criteria:
Inclusion Criteria:
* All ethnic groups, male or female above the age of 18 years.
* Diagnosis of mild intermittent claudication
* Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device.
* Blood pressure currently under moderate control (< 160/100mmHg)
* No current foot ulceration
Exclusion Criteria:
* Patients meeting any of the following criteria are to be excluded:
* Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol.
* Has diabetes
* Ankle Brachial Pressure Index > 0.9
* Has any metal implants
* Pregnant
* Has a cardiac pacemaker or defibrillator device
* Has recent lower limb injury or lower back pain
* Has current foot ulceration or other skin ulcers
* Has foot deformities
* Has any disorder that, in the opinion of the Investigator, might 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
|
NCT02436200
|
{
"brief_title": "Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication",
"conditions": [
"Intermittent Claudication",
"Peripheral Vascular Disease"
],
"interventions": [
"Device: Neuromuscular Electrical Stimulation"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02436200",
"official_title": "Neuromuscular Electrical Stimulation in Patients With Intermittent Claudication",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-10",
"study_completion_date(actual)": "2015-10",
"study_start_date(actual)": "2014-12"
},
"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)": "2020-09-29",
"last_updated_that_met_qc_criteria": "2015-05-01",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-05-06",
"first_submitted": "2015-04-24",
"first_submitted_that_met_qc_criteria": "2019-08-19"
}
}
}
|
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