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#Study Description
Brief Summary
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
Detailed Description
A bioequivalence study of a single dose of the fixed-dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder administered from Fluticasone propionate 250 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and SERETIDE DISKUS® 250/50 mcg inhalation powder/GSK (reference-R) in healthy volunteers under fasting conditions with charcoal blockade. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
#Intervention
- DRUG : Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals
- 2 inhalations in one study period
- Other Names :
- Test
- DRUG : SERETIDE DISKUS® 250/50 inhalation powder/GSK
- 2 inhalations in one study period
- Other Names :
- Reference
- OTHER : Activated Charcoal suspension
- oral suspension before and after inhalation of study Investigational Products
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers of both genders, aged >=18 and <=60 years.
* Subjects with Body Mass Index (ΒΜΙ) >=18.5 and <30.0 kg/m2.
* Healthy volunteers are declared healthy based on medical history, physical examination, ECG, pulmonary function test (a forced expiratory volume in 1 second (FEV1) >=80% of the predicted normal value), and clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator.
* Females who participate in the study are either at reproductive age i.e.pre-menopausal or unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration].
* Subjects that are non-smokers.
* Subjects that, in the opinion of the principal investigator/medical officer, are able to communicate and comply with the study procedures and protocol restrictions as evidenced by the Informed Consent Form (ICF) duly read, signed and dated by the subject prior to study initiation.
* Subjects able to use the inhalers according to given instructions, as judged by the Investigator or study nurse.
Exclusion Criteria:
* Hypersensitivity to the active substance(s) or to the excipient (lactose which contains small amounts of milk protein may cause allergic reactions) or related class (any sympathomimetic drug or any inhaled, intranasal, or systemic corticosteroid therapy) of the medicinal product
* Clinically significant illness or surgery within four weeks prior to dosing.
* Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic blood pressure <90 or >140 mmHg, seated diastolic blood pressure <50 or >90 mmHg or heart rate less than 50 or over 100 bpm) at screening.
* Clinically significant history or presence of chronic bronchitis, emphysema,asthma or any other lung disease.
* History or presence of pulmonary tuberculosis.
* Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit.
* History or presence of significant cardiovascular, endocrinal, neurologic, immunological, psychiatric or metabolic disease.
* History of significant alcohol or drug abuse within one year prior to the screening visit.
* Regular use of alcohol within six months prior to screening visit (more than 14 alcohol units per week) [1Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40% alcohol].
* Inability to abstain from alcohol for the duration of study period.
* Presence of disease markers for Hepatitis B, Hepatitis C or HIV at screening.
* Positive results for drugs of abuse (barbiturates, marijuana, opioids, benzodiazepines and methadone) in saliva before each administration.
* Positive alcohol breath test before each administration.
* Use of soft drugs (such as marijuana) within three months prior to screening or hard drugs such as crack, cocaine or heroin within one year prior to screening visit
* Intake of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers are barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors are, erythromycin, ketoconazole, indinavir, cobicistat-containing products) within one month prior to administration of the study medication. Under these circumstances, subject inclusion will be judged by the principal investigator.
* History of peptic ulcer, other gastrointestinal disorders (e.g. chronic diarrhoea, irritable bowel syndrome) or unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting) or significant hepatic, renal or other condition that is known to interfere with the absorption, distribution, metabolism or excretion of the drug.
* Use of oral or parenteral corticosteroids in the previous four 4 weeks
* Eye disorders especially Glaucoma (or a family history of glaucoma)
* Use of prescription medication (within 14 days prior to the first administration of study medication) or over-the-counter (OTC) products (including food supplements vitamins and herbal supplements) within one week (7 days) prior to the first administration of study medication, except for topical products without systematic absorption. Contraceptives are allowed.
* Vaccination for prophylaxis from seasonal flu or any other vaccination within seven days prior to administration
* History of allergy to any food, intolerance or special diet, that in the opinion of the medical sub-investigator could contraindicate the subject's participation in the study.
* A depot injection or an implant of any drug (except hormonal contraceptives) within 3 months prior to treatment administration.
* Donation of plasma (500 ml) within 7 days prior to treatment administration.
* Donation of whole blood or loss of whole blood >= 500 ml prior to administration of the study medication within 30 days prior to treatment administration.
* Participation in another clinical trial simultaneously.
* Subjects receiving special diet or having intolerance in any of the provided study meals or refusing to eat the study meals
* Application of tattoo or body piercing within 30 days prior to treatment administration.
* Non-tolerance to venipuncture.
* Breastfeeding women.
* Positive pregnancy test at screening
* Females of reproductive age that had sexual intercourse with a non-sterile male partner without protection within 14 days prior to drug administration
Reliable contraception methods are considered the following:
* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral or transdermal
* progestogen-only hormonal contraception associated with inhibition of ovulation oral or injectable
* bilateral tubal occlusion
* vasectomised partner
* sexual abstinence
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
|
NCT03894280
|
{
"brief_title": "A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade (BREATH-PK250-CC)",
"conditions": [
"Bioequivalence"
],
"interventions": [
"Other: Activated Charcoal suspension",
"Drug: Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals",
"Drug: SERETIDE DISKUS® 250/50 inhalation powder/GSK"
],
"location_countries": [
"Greece"
],
"nct_id": "NCT03894280",
"official_title": "A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study to Examine the Bioequivalence Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. SERETIDE DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers Under Fasting Conditions With Charcoal Blockade",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-09",
"study_completion_date(actual)": "2019-05-06",
"study_start_date(actual)": "2019-03-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-05",
"last_updated_that_met_qc_criteria": "2019-03-27",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-28",
"first_submitted": "2019-03-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of STR-324 infusions in healthy volunteers.
Detailed Description
Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting infusion
#Intervention
- DRUG : Placebo
- Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%
- DRUG : STR-324 Dose Level 1
- Short infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level 2
- Short infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level 3
- Short infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level 4
- Short infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level 5
- Short infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level 6
- Short infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level 7
- Short infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level 8
- Short infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level A
- Long infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level B
- Long infusion of a solution for intravenous administration
- DRUG : STR-324 Dose Level C
- Long infusion of a solution for intravenous administration
- DRUG : Placebo
- Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent prior to any study-mandated procedure
* Healthy male subjects, 18 <= age <= 45 of age, inclusive at screening.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.
* All males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment.
* Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
Exclusion Criteria:
* Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
* Subject with clinically significant abnormalities in blood pressure, heart rate, ECG recording and laboratory parameters
* Abnormal renal function (eGFR (MDRD) < 60 mL/min/1.73m2).
* Previous history of seizures or epilepsy.
* Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before the first study day.
* Positive Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies, Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
* Use of any medications (prescription or over-the-counter [OTC]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer).
* Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer).
* Participation in an investigational drug or device study within 3 months prior to first dosing.
* History of abuse of addictive substances or current use of substances (alcohol, illegal substances)
* Positive test for drugs of abuse or alcohol breath test at screening or pre-dose.
* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
* Loss or donation of blood over 500 mL within three months prior to screening
* Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold or pain
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03430232
|
{
"brief_title": "First-In-Human PainCart Study for STR-324",
"conditions": [
"Pain"
],
"interventions": [
"Drug: STR-324 Dose Level 2",
"Drug: STR-324 Dose Level 6",
"Drug: STR-324 Dose Level 8",
"Drug: STR-324 Dose Level A",
"Drug: STR-324 Dose Level C",
"Drug: STR-324 Dose Level 4",
"Drug: STR-324 Dose Level 5",
"Drug: STR-324 Dose Level B",
"Drug: STR-324 Dose Level 7",
"Drug: Placebo",
"Drug: STR-324 Dose Level 3",
"Drug: STR-324 Dose Level 1"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT03430232",
"official_title": "A First-in-Human, Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STR-324 in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-07",
"study_completion_date(actual)": "2018-11-07",
"study_start_date(actual)": "2018-02-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-12",
"last_updated_that_met_qc_criteria": "2018-02-05",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-12",
"first_submitted": "2018-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep (called 'slow wave sleep'), potentially via an increase in the stimulus required to arouse from sleep. Here the investigators test the idea that the medication called 'tiagabine' improves slow wave sleep and reduces OSA severity. The investigators will also test whether tiagabine raises the arousal threshold (more negative esophageal pressure), and whether detailed OSA 'phenotyping' characteristics can predict the improvement in OSA severity with this intervention.
Detailed Description
The current study tests the primary hypothesis that tiagabine improves sleep apnea severity in patients with moderate-to-severe sleep apnea (apnea hypopnea index measured in supine non-REM sleep; hypopneas defined by 3% desaturation or arousal). The investigators test three secondary hypotheses that tiagabine:
1. increases the proportion of total sleep time in slow wave sleep
2. raises the non-REM arousal threshold (more negative esophageal pressure) via (1).
3. is preferentially effective in patients whose OSA phenotype predicts that an increase in the arousal threshold is sufficient to resolve OSA versus those without such favorable physiology. Favorable physiology is defined here as having a low ventilatory drive at which stable breathing is theoretically feasible ('stable Vdrive' is \<100% above eupneic ventilatory drive) due to any combination of a 'high' upper airway muscle response, 'good' passive anatomy (high Vpassive), and 'low' steady-state loop gain (see Owens RL et al SLEEP 2014; Wellman A et al J Appl Physiol 2011, 2013; Eckert DJ et al 2013 AJRCCM).
#Intervention
- DRUG : Tiagabine
- GABA reuptake inhibitor
- Other Names :
- Gabitril
- DRUG : Placebo
- Placebo comparator
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)
Exclusion Criteria:
* History of seizures
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02387710
|
{
"brief_title": "Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea",
"conditions": [
"Sleep Apnea, Obstructive"
],
"interventions": [
"Drug: Placebo",
"Drug: Tiagabine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02387710",
"official_title": "Inducing Slow Wave Sleep to Treat Obstructive Sleep Apnea",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-07",
"study_start_date(actual)": "2015-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-15",
"last_updated_that_met_qc_criteria": "2015-03-12",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-13",
"first_submitted": "2015-03-09",
"first_submitted_that_met_qc_criteria": "2017-05-16"
}
}
}
|
#Study Description
Brief Summary
This study is being conducted to validate various biomarkers in patients with RA with varying levels of disease severity. Subjects with a diagnosis of rheumatoid arthritis (RA) will be included as controls. The sudy will measure the baseline levels and the intra- and inter-subject variability of exhaled nitric oxide (NO) in patients with inactive/mild and moderate/severe RA on stable therapy or during a course glucocorticoids. In addition exhaled NO levels will be correlated with intra-articular inflammation (power Doppler ultrasonography) as well as markers of systemic inflammation (CRP, ESR).
#Intervention
- PROCEDURE : Power doppler ultrasonography
- PROCEDURE : High frequency ultrasonography
- Other Names :
- Exhaled nitric oxide assessment, Power doppler ultrasonography
- PROCEDURE : Exhaled nitric oxide assessment
|
#Eligibility Criteria:
Inclusion criteria:
* Diagnosis of rheumatoid or osteo-arthritis.
* Weight greater than 45kg (females) or 50kg (males) but not overweight.
* Non-smokers.
* Taking stable anti-inflammatory medication for Rheumatoid Arthritis (RA) or Osteoarthritis (OA) for at least 8 weeks.
Exclusion criteria:
* Taking regular doses of glucocorticoid medication (greater than 5mg/day).
* Currently taking biological treatment for RA.
* Recent participation in another clinical trial.
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
|
NCT00242853
|
{
"brief_title": "A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis",
"conditions": [
"Rheumatoid Arthritis",
"Osteoarthritis"
],
"interventions": null,
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00242853",
"official_title": "An Enabling Study to Investigate the Correlation of Biomarkers of the Activity of Inducible Nitric Oxide Synthase (iNOS) With Disease Activity and Treatment Response in Patients With Rheumatoid Arthritis(RA)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "2004-10"
},
"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)": "2008-10-13",
"last_updated_that_met_qc_criteria": "2005-10-19",
"last_verified": "2008-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-10-21",
"first_submitted": "2005-10-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.
Detailed Description
Surgeons will perform arcuate incisions in the cornea in arc segment patterns using the iFS femtosecond laser to treat subjects with corneal astigmatism.
#Intervention
- DEVICE : iFS Femtosecond Laser System
- arcuate incisions placed with the iFS femtosecond laser
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, of any race, and at least 21 years at the time of pre-op exam
* Corneal astigmatism, as determined by topographic keratometry, of 0.75 D to 4.00 diopters (D)
* Best Spectacle Corrected Distance Visual Acuity (BSCVA)
1. Group 1:
* Natural astigmatism, no cataract - BSCVA of 20/25 or better
* Pre cataract or phakic IOL surgery - no BSCVA criteria
2. Group 2:
* Post IOL surgery- BSCVA of 20/25 or better
* Uncorrected Visual Acuity (UCVA) of 20/40 or worse
* Demonstration of agreement: Corneal astigmatism (as determined by topographic keratometry) must be in agreement with refractive astigmatism (as determined by manifest refractions) within <= 0.75 D in magnitude and 15 degrees axis when cylinder <= 1.5 D or 10 degrees axis when cylinder > 1.5 D.
* Preoperative central pachymetry of >=480 um
* Keratometry between 38.0 D (flat) to 48.0 D (steep)
* Corneal power (diopters) difference at the 3mm point from topographic center shall be <= 1D at the steepest meridian
* Intraocular pressure of 12 to 21 mm Hg with no glaucomatous retinal/optic nerve changes
* Subjects who have worn a contact lens within the past 30 days must remove the soft lens at least 2 weeks prior and a rigid or toric lens at least 3 weeks prior to baseline measurements
* Willing and capable of returning for follow-up examinations for the duration of the study
Exclusion Criteria:
* Angle kappa of greater than 0.5 mm, absolute value
* Prior implantation of toric or multifocal intraocular lens
* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Concurrent use of topical or systemic medications that may impair corneal wound healing
* History of any ocular or medical conditions that could affect corneal wound healing
* History of active or recurrent ophthalmic disease, including corneal dystrophy or other non-refractive abnormality such as exposure keratitis or clinically significant dry eye
* Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration in either eye
* Evidence of clinically significant corneal opacity/scar in the operative eye(s) within an 8 mm diameter zone of the visual axis
* Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
* Participation in any other conflicting clinical 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:
Yes
|
NCT01348854
|
{
"brief_title": "Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System",
"conditions": [
"Corneal Astigmatism"
],
"interventions": [
"Device: iFS Femtosecond Laser System"
],
"location_countries": [
"Austria",
"Germany",
"France"
],
"nct_id": "NCT01348854",
"official_title": "A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-04",
"study_completion_date(actual)": "2013-04",
"study_start_date(actual)": "2011-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-06-04",
"last_updated_that_met_qc_criteria": "2011-05-04",
"last_verified": "2014-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-06",
"first_submitted": "2011-05-04",
"first_submitted_that_met_qc_criteria": "2014-05-06"
}
}
}
|
#Study Description
Brief Summary
The goal of this pilot clinical trial is to test if ICU level ventilator protocols are appropriate interventions to study differences in ventilator strategies for patients with acute respiratory failure supported by VV-ECMO. The main questions it aims to answer are:
* will clinicians closely follow different ICU ventilator protocols
* will different ICU ventilator protocols change the way that patients are treated.
Participants will be assigned to one of two ventilator protocols based on the month that they are first started on ECMO. Researchers will compare standard lung-protective ventilation to ultra-lung protective ventilation protocols to see how this changes how the ventilator is set for patients.
Detailed Description
This is a pilot, open label, pragmatic cluster-crossover clinical trial testing the feasibility and exploring the clinical impact of ICU-level ventilator management protocols as interventions in patients with acute respiratory failure requiring support with extracorporeal membrane oxygenation (ECMO). The overall objective is to inform the design of a future pragmatic, cluster-randomized clinical trial. The investigators will do this by completion of the following aims:
Aim 1: Measure clinician fidelity to ICU-level ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Clinicians will have high fidelity to ICU-level ventilator management protocols for patients with severe ARDS on ECMO. To test this hypothesis, the investigators will conduct a pilot cluster-crossover study. The Duke medical ICU will be treated as a single cluster of patients. This cluster will be assigned to a standard lung-protective ventilation protocol for patients treated with ECMO, and then crossover to an ultra-lung protective ventilation protocol. The investigators will record if patient ventilator settings adhere to the assigned protocol at the time of treatment. The proportion of patients whose ventilator settings adhere to the assigned protocol will be compared to an a priori defined threshold to indicate feasibility.
Aim 2: Explore the clinical impact of using different ventilator management protocols for patients with ARDS treated with ECMO. Hypothesis: Patients managed with standard lung protective ventilation will have shorter durations of ECMO and mechanical ventilation when compared with patients managed with ultra-lung protective ventilation. To test this hypothesis, the investigators will measure the duration of ECMO and mechanical ventilation for all patients enrolled in the study. The investigators will perform an exploratory analysis examining differences in these outcomes between the two treatment groups.
#Intervention
- OTHER : Standard-Lung Protective Ventilation
- ICU ventilator protocol adhering to the following lung protective ventilation strategy:
* Plateau Pressure ≤ 30 cm of water
* PEEP and FiO2 set according to ARDSnet table
* Driving Pressure ≤ 15 cm of water
* Respiratory rate between 8 and 30 breaths per minute
- OTHER : Ultra-Lung Protective Ventilation
- ICU ventilator protocol adhering to the following lung protective ventilation strategy:
* Plateau Pressure ≤ 30 cm of water
* PEEP and FiO2 set according to ARDSnet table
* Driving Pressure ≤ 15 cm of water
* Respiratory rate between 8 and 30 breaths per minute
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients being treated with ECMO in the Duke University Hospital Medical ICU will be eligible
Exclusion Criteria:
* There are no exclusion criteria
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
|
NCT05708365
|
{
"brief_title": "Generating Evidence in ECMO Ventilation Strategies",
"conditions": [
"ARDS",
"Acute Respiratory Failure"
],
"interventions": [
"Other: Standard-Lung Protective Ventilation",
"Other: Ultra-Lung Protective Ventilation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05708365",
"official_title": "Generating Evidence in ECMO Ventilation Strategies - A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-07-21",
"study_completion_date(actual)": "2024-08-25",
"study_start_date(actual)": "2023-03-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-21",
"last_updated_that_met_qc_criteria": "2023-01-23",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-02-01",
"first_submitted": "2023-01-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Data comparing respiratory drive and effort in critically ill patients with acute respiratory distress syndrome associated to different severity of COVID-19 penumonia (CARDS) and to other risk factors are lacking. Objectives: To assess respiratory drive and effort of CARDS patients at the first transition from controlled to assisted spontaneous breathing. The second aim was the rate of a composite outcome including the need of higher level of sedation
Detailed Description
Multicenter cohort study in four Italian ICU including adults with moderate and severe CARDS (PaO2/FiO2 \<100 mmHg) at ICU admission. An historical cohort of patients with ARDS from various etiologies used for comparison. Respiratory drive (P0.1), diaphragm electrical activity (EAdi), inspiratory effort derived from EAdi (∆PmusEAdi) and from deflection in airway pressure occluded (ΔPocc) (PmusΔPocc), dynamic transpulmonary driving pressure (ΔPL,dyn, the difference between peak and end-expiratory transpulmonary pressure) measured under assisted ventilation.
The main ventilatory pattern variables:
* Airway Occlusion Pressure (P0.1): Measurement of the decrease in airway pressure during an end-expiratory occlusion.
* Pmus-EAdi-derived (∆Pmus, EAdi): Measurement of the pressure generated by the respiratory muscles during inspiration derived by electrical activity of the diaphragm measurements.
* Transpulmonary pressure EAdi-derived (∆Plung,dyn): difference between peak and end-expiratory transpulmonary pressure .
* Occlusive Pressure Difference (∆Pocc): Evaluation of the pressure difference between the initial and final airway opening during inspiration.
* Pmus-∆Pocc-derived (∆Pmus, ∆Pocc): Measurement of the pressure generated by the respiratory muscles during inspiration derived by ∆Pocc (∆Pocc\*0.75)
* Transpulmonary driving pressure ∆Pocc derived (∆Plung, ∆Pocc): calculated as (Peak airway pressure -PEEP) - 2/3 \* ∆Pocc
* Diaphragmatic Electrical Activity (EAdi): Recording of the electrical activity of the diaphragm.
* Peak EAdi (EAdiPEAK): Determination of the highest recorded value of diaphragmatic electrical activity.
* Pressure time product of the trans-diaphragmatic pressure per breath and per minute(PTP/min): the integral of Pmusc-EAdi-derived during inspiration per breath.
* Inspiratory Delay (ID): Assessment of the time delay between the start of neural inspiration and the onset of mechanical ventilation.
* Neuro-ventilatory Efficiency (NVE): Measurement of the efficiency of the neural drive to the respiratory muscles.
* Peak Airway Opening Pressure (PawPEAK): Measurement of the peak pressure in the airway during inspiration.
* Inspiratory Pressure-Time Product (PmusEAdi/b): Calculation of the work of breathing by integrating the product of diaphragmatic electrical activity and the change in airway pressure during inspiration.
* Tidal Volume (VT): Measurement of the volume of air inspired and expired during each breath.
* Respiratory Rate: Calculation of the number of breaths per minute delivered by the mechanical ventilator.
* Inspiratory and Expiratory Time (Ti,MECH and Te,MECH): Determination of the duration of mechanical inspiration and expiration.
* Inspiratory Duty Cycle (TI/TTOT-neur): Calculation of the ratio of inspiratory time to total respiratory cycle time based on neural inspiration.
#Intervention
- OTHER : Respiratory drive and effort assessment
- The use of a neurally-adjusted ventilatory assist catheter, the measurement of electrical activity of the diaphragm, ∆Pocc, P0.1, and other ventilatory parameters to assess respiratory drive and effort in three cohorts of patients
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of acute respiratory distress syndrome based on the Berlin criteria.
* Patients with ARDS due to confirmed COVID-19 through real-time RT-PCR on nasopharyngeal swabs or lower respiratory tract aspirates.
* Patients who had received invasive mechanical ventilation for more than 72 hours.
* Patients who were candidates for assisted ventilation.
Readiness for assisted ventilation, which was defined by the following criteria:
* Improvement of the condition leading to acute respiratory failure.
* Positive end-expiratory pressure lower than 10 cmH2O and inspiratory oxygen fraction lower than 0.5.
* Richmond agitation sedation scale score between 0 and -3.
* Ability to trigger the ventilator, i.e., decrease pressure airway opening by more than 3 <= age <= 4 cmH2O during a brief (5 <= age <= 10 seconds) end-expiratory occlusion test.
* Hemodynamic stability without vasopressor or inotropes, except for dobutamine and norepinephrine infusion below certain thresholds (dobutamine <5 gamma/Kg/min and norepinephrine <0.3 gamma/Kg/min).
* Normothermia.
Exclusion Criteria:
* Patients affected by neurological or neuromuscular pathology and/or known phrenic nerve dysfunction.
* Patients with any contraindication to the insertion of a nasogastric tube, such as recent upper gastrointestinal surgery or esophageal varices.
* Patients < 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06224010
|
{
"brief_title": "Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS",
"conditions": [
"ARDS, Human",
"COVID-19 Respiratory Infection",
"COVID-19 Acute Respiratory Distress Syndrome",
"Respiratory Effort-Related Arousal",
"Weaning Failure",
"Mechanical Ventilation Complication",
"Acute Hypoxic Respiratory Failure"
],
"interventions": [
"Other: Respiratory drive and effort assessment"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT06224010",
"official_title": "Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS: a Multicentric Prospective Observational Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-01",
"study_completion_date(actual)": "2023-06-20",
"study_start_date(actual)": "2020-11-21"
},
"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)": "2024-01-25",
"last_updated_that_met_qc_criteria": "2024-01-23",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-25",
"first_submitted": "2024-01-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Treatment of patients insufficiently treated with ICS or ICS + LABA.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients Insufficiently Treated With ICS Or ICS + LABA.
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
|
NCT00802789
|
{
"brief_title": "Montelukast in Chronic Asthma",
"conditions": [
"Asthma"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00802789",
"official_title": "Montelukast in Chronic Asthma: Non-interventional Study With Montelukast 10 mg",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-09",
"study_completion_date(actual)": "2008-10",
"study_start_date(actual)": "2007-04"
},
"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)": "2022-02-18",
"last_updated_that_met_qc_criteria": "2008-12-04",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-12-05",
"first_submitted": "2008-12-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is being done to test the safety and efficacy of LY3016859 for the treatment of osteoarthritis pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
#Intervention
- DRUG : LY3016859
- LY3016859 given IV.
- DRUG : Placebo
- Placebo given IV.
|
#Eligibility Criteria:
Inclusion Criteria:
* Have a visual analog scale (VAS) pain value >=40 and <95 during screening.
* Have a history of daily pain for at least 12 weeks based on participant report or medical history.
* Have a value of <=30 on the pain catastrophizing scale.
* Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).
* Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
* Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
* Have presence of index knee pain for >12 weeks at screening.
* Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee.
* Are men, or women able to abide by reproductive and contraceptive requirements.
Exclusion Criteria:
* Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
* Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
* Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
* Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
* There is an inability to rule out other causative or confounding sources of pain in the primary condition under study.
* Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
* Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
* Have congenital QT prolongation or QT interval corrected for heart rate using Fridericia's formula (QTcF) interval measurement >450 milliseconds (msec) for male participants, >470 msec for female participants, or >480 msec for participants with bundle branch block.
* Have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
* Have a positive human immunodeficiency virus (HIV) test result at screening.
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
* Have an intolerance to acetaminophen or paracetamol or any of its excipients.
* Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
* Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare.
* Have presence of surgical hardware or other foreign body in the index knee.
* Have an unstable index joint (such as a torn anterior cruciate ligament).
* Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period.
* Have fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee.
* Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
* Have clinical signs and symptoms of active knee infection or crystal disease of the index knee.
* Have a history of infection in the index joint.
* Have a history of arthritis due to crystals (e.g., gout, pseudogout).
* Have pain or functional impairment due to ipsilateral hip osteoarthritis.
* Have had an intra-articular injection of hyaluronic acid within 24 weeks of screening.
* Have an estimated glomerular filtration rate (eGFR) of less than 70 milliliters/minute/1.73m² during screening.
* Have any clinically serious or unstable cardiovascular, musculoskeletal disorder, gastrointestinal, endocrinologic, hematologic, hepatic, metabolic, urologic, pulmonary, dermatologic, immunologic, or ophthalmologic disease within 3 months of baseline.
* Have received any antibodies against nerve growth factor (NGF), or antibodies against EGFR, or EGFR tyrosine kinase inhibitors.
* Have a history of allergic reactions to monoclonal antibodies, or clinically significant multiple or severe drug allergies, including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis.
* Have a history or presence of uncontrolled asthma, eczema, significant atopy, significant hereditary angioedema or common variable immune deficiency.
* Have hade any joint replacement such as joint knee of the lower extremity such as hip, knee, or ankle in the past 6 months.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04456686
|
{
"brief_title": "Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Osteoarthritis",
"conditions": [
"Osteoarthritis"
],
"interventions": [
"Drug: LY3016859",
"Drug: Placebo"
],
"location_countries": [
"Puerto Rico",
"United States"
],
"nct_id": "NCT04456686",
"official_title": "Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3016859 for the Treatment of Osteoarthritis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-04-22",
"study_completion_date(actual)": "2021-08-26",
"study_start_date(actual)": "2020-07-01"
},
"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)": "2023-11-14",
"last_updated_that_met_qc_criteria": "2020-07-01",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-07-02",
"first_submitted": "2020-07-01",
"first_submitted_that_met_qc_criteria": "2022-05-31"
}
}
}
|
#Study Description
Brief Summary
This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.
#Intervention
- DRUG : Bepotastine besilate formulation
- Nasal Spray
- DRUG : Fluticasone propionate
- Nasal Spray
- DRUG : Bepotastine besilate-fluticasone propionate
- Nasal Spray
- DRUG : Placebo Comparator
- Nasal Spray
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female at least 12 years with a demonstrated history of Mountain Cedar pollen allergy
Exclusion Criteria:
* No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
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
|
NCT01578278
|
{
"brief_title": "Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis",
"conditions": [
"Seasonal Allergic Rhinitis"
],
"interventions": [
"Drug: Bepotastine besilate-fluticasone propionate",
"Drug: Bepotastine besilate formulation",
"Drug: Fluticasone propionate",
"Drug: Placebo Comparator"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01578278",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2012-08",
"study_start_date(actual)": "2011-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-10-05",
"last_updated_that_met_qc_criteria": "2012-04-13",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-04-16",
"first_submitted": "2012-01-18",
"first_submitted_that_met_qc_criteria": "2020-08-24"
}
}
}
|
#Study Description
Brief Summary
Retrospective analysis of data from patients with laryngeal contact granulomas in order to identify possible differences and/or similarities between the cases and in order to determine whether and which conclusions can be drawn on disease and therapy.
Detailed Description
This is a retrospective analysis of data from patients with laryngeal contact granulomas in order to identify possible differences and/or similarities between the cases and in order to determine whether and which conclusions can be drawn on disease and therapy.
#Intervention
- PROCEDURE : Retrospective analysis of data
- Retrospective data analysis
|
#Eligibility Criteria:
Inclusion criteria:
Laryngeal contact granuloma in adults with documentation of symptoms, possible causes, therapy and outcome
Exclusion criteria:
Incomplete information on the diagnosis laryngeal contact granuloma (symptoms, promotive factors, findings)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01967693
|
{
"brief_title": "Characterization of Laryngeal Contact Granulomas: Retrospective Analysis of Symptoms, Promotive Factors and Therapy",
"conditions": [
"Laryngeal Contact Granuloma"
],
"interventions": null,
"location_countries": [
"Switzerland"
],
"nct_id": "NCT01967693",
"official_title": "Characterization of Laryngeal Contact Granulomas: Retrospective Analysis of Symptoms, Promotive Factors and Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2013-08",
"study_start_date(actual)": "2008-03"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-05-16",
"last_updated_that_met_qc_criteria": "2013-10-17",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-10-23",
"first_submitted": "2013-09-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.
Detailed Description
Objective:
To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.
Method:
All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.
120 patients will be included. 15 per group of weeks of gestation: 16+0-17+6 SA, 18+0-19+6 SA, 20+0-21+6 SA, 22+0-23+6 SA, 24+0-25+6 SA, 26+0-27+6 SA, 28+0-29+6 SA, 30+0-31+6 WG.
MRI will be performed in the same hospital, during hospital stay, within 45 minutes.
Two MRI sequences will be used to measure placental perfusion:
* dynamic sequences using Gd contrast agent.
* ' spin tagging ', which do not need any contrast agent. Perfusion will be modelled using compartmental analysis. Reference ranges will be build up by statistical modelling. Gadolinium assays will be performed on amniotic fluid and placental tissue following TOP.
Duration of inclusion: 24 months.
Duration of patient participation: 45 minutes.
Expected results:
* Feasibility in routine practice.
* Reference ranges for placental perfusion.
* Comparison between the two measurements methods.
Adverse outcome measure:
Nausea, vomiting, lack of comfort and other adverse outcome.
#Intervention
- DEVICE : MRI
- MRI, 45 minutes
- Other Names :
- MRI, 45 minutes
|
#Eligibility Criteria:
Inclusion Criteria:
* Women > 18 years,
* Undergoing TOP for fetal reason,
* Informed signed consent.
Exclusion Criteria:
* Placental adhesion anomaly,
* Growth restriction,
* Contrast agent allergy,
* Absent consent,
* Contraindication of MRI or Gadolinium,
* Renal insufficiency,
* Placental abnormality at pathological examination.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01092949
|
{
"brief_title": "Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE",
"conditions": [
"Placental Insufficiency"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT01092949",
"official_title": "Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-03",
"study_completion_date(actual)": "2018-09",
"study_start_date(actual)": "2010-02"
},
"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)": "2020-07-20",
"last_updated_that_met_qc_criteria": "2010-03-24",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-03-25",
"first_submitted": "2010-02-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Ulnar neuropathy at the elbow (UNE) is the second most common neuropathy and occurs after recurrent or elongated elbow flexion. Diagnosis of UNE depends on clinical symptoms, physical examination, and electrophysiological findings. Imaging methods such as ultrasonography (USG) and magnetic resonance imaging show cross-sectional area and echogenicity of ulnar nerve and give information about to surrounding structures around the ulnar nerve. In mild and moderate cases, conservative treatments are administered up to 6 months, who do not benefit from conservative treatment are referred to surgery. There are not many options for conservative treatment. Activity modification, nerve gliding exercises and night splints are conservative treatment methods. Steroid injection is no longer recommended. Perineural dextrose injection is applied in tendinopathies and entrapment neuropathies (especially carpal tunnel syndrome). In the literature, there is no study showing effect of perineural dextrose injection in patients with UNE. The investigators design a randomized, double-blind, controlled trail to evaluate the effect after ultrasound-guided perineural injection with 5% dextrose in patients with UNE.
Detailed Description
After obtaining written informed consent, patients of clinically diagnosed with UNE were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Quick-DASH (Disabilities of Arm, Shoulder and Hand), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity and distal latency of the ulnar nerve. The evaluation was performed pretreatment as well as on the 2nd week, 1st and 3rd month after the treatment.
#Intervention
- OTHER : 5 cc 5% Dextrose solution
- Ultrasound-guided perineural injection with 5% Dextrose (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).
- OTHER : 5 cc salin
- Ultrasound-guided perineural injection with salin (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 <= age <= 65 year-old.
* Neuropathic pain on the ulnar nerve distribution area for at least 1 months
* Diagnosis was confirmed using an electrophysiological studies and ultrasonography
Exclusion Criteria:
* History of trauma to the upper extremity
* Central or peripheral neurologic disease
* Electromyography (EMG)-proven carpal tunnel syndrome, radiculopathy or any other neuropathy
* Pregnancy or any systemic disease that might cause swelling on nerves (e.g., diabetes -mellitus, renal failure, and thyroid disease)
* USG-detected bifid or trifid median nerve, persistent median artery, or space-occupying lesions
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
|
NCT03737916
|
{
"brief_title": "The Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow",
"conditions": [
"Ulnar Neuropathies"
],
"interventions": [
"Other: 5 cc salin",
"Other: 5 cc 5% Dextrose solution"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT03737916",
"official_title": "To Evaluate the Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow and to Compare the Control Group",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-18",
"study_completion_date(actual)": "2020-11-18",
"study_start_date(actual)": "2018-11-18"
},
"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)": "2022-08-23",
"last_updated_that_met_qc_criteria": "2018-11-08",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-13",
"first_submitted": "2018-11-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this research is to determine the most informative variables for detecting exercise, acute stress and sleep, identify select sensors that report these variables, and develop the algorithms to detect the occurrence of exercise, stress and sleep, to discriminate them and to determine their characteristics. Research is needed to identify which wearable devices report the most informative and predictive variables of exercise, acute stress and sleep with desired precision and accuracy, determine the best location to wear them for collecting reliable and informative data, and to distill accurate knowledge from data reported by wearable sensors. Data and their interpretation should be informative for various types of physical activities, stages of sleep, and types and intensities of acute stress, and concurrent occurrence of these factors. The investigators will use several devices (chest band, wristband and skin patches) to collect data and evaluate their information content and contribution to improvement of glucose concentration prediction, best locations for collecting accurate and reliable information by conducting clinical and free-living experiments at-home to assess the contributions of the wearable device in improving the accuracy of glucose concentration prediction and the performance of the multivariable artificial pancreas.
Detailed Description
The focus of the proposed work is to determine the most informative variables for meals, exercise, acute stress and sleep (MESS), identify select sensors that report these variables, and develop the algorithms to detect the occurrence of MESS, to discriminate them and to determine their characteristics. Research is needed to identify which wearable devices report the most informative and predictive variables of MESS with desired precision and accuracy, determine the best location to wear them for collecting reliable and informative data, and to distill accurate knowledge from data reported by wearable sensors. Data and their interpretation should be informative for various types of physical activities, stages of sleep, and types and intensities of acute stress, and concurrent occurrence of MESS factors.
In the first year of the research, the investigators will use several devices to collect data and evaluate their information content and contribution to improvement of serum glucose prediction, best locations for collecting accurate and reliable information, and their acceptance by users. In the second year of the project, we will select a single wearable device, conduct additional clinical and free-living experiments at-home to assess the contributions of the information from the wearable device selected in improving the accuracy of glucose prediction and the performance of the multivariable AP.
The objectives of the proposed research are to determine the most informative variables and sensor locations to capture reliable and accurate information that complement glucose concentration measurements (CGM) and to develop algorithms to determine the presence of exercise, stress or sleep at any given time for estimating glucose concentrations and making control decisions by a multivariable artificial pancreas system. The proposed research will be conducted by achieving the following specific aims:
To systematically perturb the MESS factors within standardized experiments in the laboratory and at home for analyzing their effects and interactions on glucose concentrations; to identify the most informative and reliable measurement approaches (i.e. types of wearable sensors and locations on body) for discriminating MESS factors; to develop quantitative relations that identify the type and features of specific MESS activities, to develop algorithms to detect the presence of specific MESS activities, identify them, and predict glucose concentrations with recursive models in real time (for future integration with adaptive AP control systems); and to evaluate the performance of the multivariable models with data from wearable devices and CGM in closed-loop control with AP during exploratory clinical experiments.
The study will take place over a period of 3-4 weeks for a total of 6 study visits. The subjects will be continuously monitored using CGM (DEXCOM \[US G5 PLATINUM\]); 3 activity of the following activity monitor(s); (Empatica E4, BiostampRC™, Equivital™ Life Monitor) and Actigraph throughout the night. In addition, the subjects will use a sleep monitor (Zmachine® Insight \& Insight+ Model DT-200 and Zephyr Bioharness) throughout the 3-week period. Subjects will come in for a study visit 3 times during the first week during which the investigators will measure the subjects' oxygen capacity and muscular strength during a peak exercise stress test (peak V02) and a test of maximal muscle strength (1-RM), respectively. The results of this testing will establish a baseline from which we can calculate the intensity of submaximal aerobic and resistance exercise bouts. The next 3 study visits will occur over the following 3-4 weeks. During this time the subjects will perform activities that produce physiological and psychological stress alone, in combination or proximal to each other. Women will have a urine pregnancy test before each day of data collection. In addition, the subjects will perform a number of physical activities at home that will be scheduled with the research assistant. The research assistant will telephone the subjects periodically and have the subjects perform stressful activities, such as mental challenges.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and Women with T1DM
* 18 <= age <= 60 years
* Insulin pump user
Exclusion Criteria:
* Metabolic instability as evidenced by hospitalizations for diabetes or other diabetes-related complications (e.g., diabetic ketoacidosis and hypoglycemic seizures) within the preceding three months;
* Severe macrovascular disease, as evidenced by severe peripheral artery disease; history of myocardial infarction, heart failure, thromboembolic disease, or unstable angina; uncontrolled hypertension; abnormal resting EKG;
* Maximal exercise stress test with significant brady/tachy arrhythmia, ectopic beats, bundle branch block, or signs of acute ischemia;
* Severe microvascular disease as evidenced by history of vision-threatening proliferative or non-proliferative retinal disease; kidney disease;
* Any uncontrolled non-musculoskeletal condition that would limit the subject's ability to participate in the exercise program (e.g., chronic obstructive airways disease);
* Musculoskeletal conditions such as neurological or orthopedic conditions affecting lower limb strength and mobility (e.g., stroke; insensitive foot);
* Pregnancy;
* Documented medical condition or physical impairment that is judged by the health care practitioner to contraindicate exercise.
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:
No
|
NCT04725799
|
{
"brief_title": "Additional Signals for Exercise, Stress and Sleep and Prediction of Glucose Levels for AP Systems",
"conditions": [
"Type1 Diabetes Mellitus"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04725799",
"official_title": "Additional Signals for Detection of Exercise, Stress and Sleep Effects and Prediction of Glucose Levels for Next Generation AP Systems",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-07-13",
"study_completion_date(actual)": "2021-07-13",
"study_start_date(actual)": "2018-05-24"
},
"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)": "2022-04-01",
"last_updated_that_met_qc_criteria": "2021-01-21",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-27",
"first_submitted": "2018-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Randomized controlled double-blind trial in a child population with allergic asthma and recurring wheezing, undergoing probiotic treatment with Bifiasthm with the aim of assessing the reduction in asthma attacks.
Detailed Description
Allergic disorders have dramatically increased in prevalence over the past decade, particularly in developed countries, and primary prevention of allergic disease has proved an elusive goal. There is increasing evidence that the airway microbiome influences the development of wheezing and childhood asthma. Probiotics are increasingly considered as a promising treatment for the correction of dysbiosis, reduction of systemic inflammation, and modulation of allergic diseases. The aim of this study is, therefore, to evaluate the efficacy of Bifidobacterium breve B632 (DSM 24706) and Lactobacillus salivarius LS01 (DSM 22775) in the prevention of asthmatic allergies in human subjects.
#Intervention
- DIETARY_SUPPLEMENT : Bifiasthm
- Subjects will be instructed to take an active or placebo sachet twice daily for eight weeks, and subsequent intake of one dose daily for a further eight weeks.
- DIETARY_SUPPLEMENT : Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* The study will include all children aged 6 to 14, with slight and moderate persistent asthma according to GINA 2015 criteria (asthma classification did not change in GINA 2015 and 2016 guidelines), whether or not showing positive skin allergometric tests, as well as all children aged 2 yrs, 364 days to 5 years, 364 days, with recurring wheezing, whether or not diagnosed with asthma (positive and/or negative prick).
Exclusion Criteria:
* Severe persistent asthma
* Known congenital or acquired immunodeficiencies
* Cystic fibrosis
* Chronic pulmonary diseases (bronchodysplasia)
* Age < 1 yr, 364d and 14 yrs
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04289441
|
{
"brief_title": "Probiotics in Paediatric Asthma Management",
"conditions": [
"Asthma in Children"
],
"interventions": [
"Dietary Supplement: Bifiasthm",
"Dietary Supplement: Placebo"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT04289441",
"official_title": "Randomized Controlled Double-blind Trial With Lactobacillus Salivarius LS01 (DSM 22775) and Bifidobacterium Breve B632 (DSM 24706) for Paediatric Asthma Management",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-21",
"study_completion_date(actual)": "2019-11-25",
"study_start_date(actual)": "2017-04-21"
},
"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)": "2023-01-27",
"last_updated_that_met_qc_criteria": "2020-02-27",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-28",
"first_submitted": "2020-01-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is a prospective, multi-center, randomized, three-arm, parallel group, clinical study to evaluate the superiority of 3 weekly intra-articular (IA) doses of 2 mL of Investigational hyaluronate as compared to placebo injected into the target knee for the treatment of pain in subjects with Osteoarthritis (OA).The safety and effectiveness of the investigational product will also be compared with Euflexxa.
Detailed Description
The primary objective is to evaluate the safety and effectiveness of 3 weekly IA doses of 2 mL of hyaluronate viscosupplement as compared to placebo injected into the target knee for the treatment of pain in subjects with OA As secondary objectives, the study will evaluate the safety and effectiveness of 3 weekly IA doses of 2 mL of Viscosupplement as compared to Euflexxa injected into the target knee for the treatment of pain in subjects with OA. In addition, to assess the effect of Viscosupplement on pain, stiffness, and physical function of the target knee, as well as functional health and general well-being
#Intervention
- DEVICE : Hyaluronate Injectable Viscosupplement
- Test product of a 1% sodium hyaluronate for injection
- Other Names :
- 1% sodium hyaluronate
- DEVICE : Euflexxa IA injection
- Brand product of a 1% sodium hyaluronate for injection
- Other Names :
- 1% sodium hyaluronate
- DEVICE : Placebo
- 0.9% sodium chloride, sterile
- Other Names :
- Normal saline
|
#Eligibility Criteria:
Inclusion Criteria:
* Chronic OA of target knee confirmed by American College of Rheumatology Criteria
* Pain due to OA in target knee that had been present for at least 6 months, with a moderate to severe pain score of >50 mm recorded on a 100 mm Visual Analogue Scale (VAS) following a 50-foot walk
* Subject agrees to discontinue all pain medications for at least 7 days prior to start of study
* A bilateral standing anteroposterior x-ray confirming Grade 2 or 3 OA of the target knee
* Body mass index <=40kg/m2
* Able and willing to use only acetaminophen as the analgesic (rescue) study medication under the following conditions:
* acetaminophen dose is not to exceed 4 grams (4000mg)/day
* if the subject has known chronic liver disease, the maximum dose of acetaminophen is not to exceed 2 grams (2000 mg)/day
* subject must be able and willing to discontinue acetaminophen at least 24 hours prior to all study-specific visits
* Ability to perform procedures required of the pain index evaluations (unassisted walking for a distance of 50 feet on a flat surface and going up and down stairs)
* Agrees to use a highly effective contraception
* Able and willing to complete effectiveness and safety questionnaires and able to read and understand study instructions
Exclusion Criteria:
* Any major injury to the target knee within the 12 months prior to the Screening and Enrollment Visit
* Any surgery to the target knee within the 12 months prior to the Screening and Enrollment Visit,
* Articular procedures such as transplants or ligament reconstruction to the target knee within 12 months prior to Screening and Enrollment Visit
* Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
* Gout or calcium pyrophosphate diseases of the target knee that have flared within the 6 months prior to the Screening and Enrollment Visit
* X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
* Osteonecrosis of either knee
* Clinical signs and symptoms of active knee infection or crystal disease of the target knee
* Fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
* Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in the target knee
* Significant target knee joint, infection or skin disorder infection within the 6 months prior to study enrollment
* Symptomatic OA of the hips, spine, or ankle, that interferes with the evaluation of the target knee
* Known hypersensitivity to acetaminophen or any of the study medications or their components
* Women of childbearing potential who are pregnant, nursing, or planning to become pregnant
* History of recurrent severe allergic or immune mediated reactions or other immune disorders
* Vascular insufficiency of lower limbs or peripheral neuropathy severe enough to interfere with the study evaluation
* Intra-arterial corticosteroid (investigational or marketed) in any joint within 3 months of Screening and Enrollment Visit
* Current treatment, or treatment within the 2 years prior to the Screening and Enrollment Visit, for any malignancy
* Active liver disease based on liver profile of aspartate aminotransferase, alanine aminotransferase, and conjugated bilirubin >2 times the upper limit of normal
* Renal insufficiency based on serum creatinine >2.0mg/dL
* Any intercurrent chronic disease or condition that might interfere with the completion of the study
* Current alcoholism and/or any known current addiction to pain medications
* Participation in any experimental device study within 6 months prior to the Screening and Enrollment Visit, or participation in an experimental drug study within 1 month prior to the Screening and Enrollment Visit.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02495857
|
{
"brief_title": "A Study of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee",
"conditions": [
"Osteoarthritis"
],
"interventions": [
"Device: Hyaluronate Injectable Viscosupplement",
"Device: Placebo",
"Device: Euflexxa IA injection"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02495857",
"official_title": "A Double-Blind, Randomized, Study of the Effectiveness and Safety of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12-05",
"study_completion_date(actual)": "2016-12-05",
"study_start_date(actual)": "2015-08-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-23",
"last_updated_that_met_qc_criteria": "2015-07-10",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-07-13",
"first_submitted": "2015-07-09",
"first_submitted_that_met_qc_criteria": "2020-06-09"
}
}
}
|
#Study Description
Brief Summary
This is a phase II randomized study of 4-months induction first-line chemotherapy with FOLFOXIRI + cetuximab followed by maintenance with cetuximab or bevacizumab in patients affected by KRAS wild type (wt) mCRC.
Detailed Description
The aim of the study is to obtain a rapid disease control with the therapy and the maximum tumoral shrinkage, and than to treat patient with less intensive maintenance to inhibit tumoral regrowth.
#Intervention
- OTHER : folfoxiri+cetuximab+surgery+cetuximab
- Induction FOLFOXIRI plus cetuximab will consist of:
* CETUXIMAB 500 mg/sqm IV over 1-h\* , day 1 followed by
* IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by
* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with
* l-LV 200 mg/sqm IV over 2-h, day 1 followed by
* 5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.
Surgical revaluation will be performed after the induction phase (8 cycles).
Patients deemed unsuitable for surgery will received maintenance treatment as follows:
•CETUXIMAB 500 mg/sqm IV over 60-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal.
- OTHER : folfoxiri+cetuximab+surgery+bevacizumab
- Induction FOLFOXIRI plus cetuximab will consist of:
* CETUXIMAB 500 mg/sqm IV over 1-h\* , day 1 followed by
* IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by
* OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with
* l-LV 200 mg/sqm IV over 2-h, day 1 followed by
* 5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.
Surgical revaluation will be performed after the induction phase (8 cycles).
Patients deemed unsuitable for surgery will received maintenance treatment as follows:
•BEVACIZUMAB 5 mg/kg IV over 30-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed colorectal adenocarcinoma;
* Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis;
* KRAS wild-type status of primary colorectal cancer or related metastasis;
* Unresectable and measurable metastatic disease according to RECIST criteria;
* Male or female, aged > 18 years and < 75 years;
* ECOG PS < 2 if aged < 71 years, ECOG PS = 0 if aged 71 <= age <= 75 years;
* Life expectancy of more than 3 months;
* Adequate haematological function: ANC >= 1.5 x 109/L; platelets >= 100 x 109/L, Hb >= 9 g/dL;
* Adequate liver and renal function: serum bilirubin <= 1.5 x ULN; alkaline phosphatase and transaminases <= 2.5 x ULN (in case of liver metastases < 5 x ULN); serum creatinine <= 1.5 x ULN;
* Previous adjuvant chemotherapy containing oxaliplatin is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
* Previous adjuvant chemotherapy with fluoropyrimidine monotherapy is allowed if more than 6 months have elapsed between the end of adjuvant and first relapse;
* At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery;
* Written informed consent to experimental treatment and KRAS analysis.
Exclusion Criteria:
* Prior palliative chemotherapy;
* Prior treatment with EGFR or VEGF inhibitors;
* Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;
* Presence or history of CNS metastasis;
* Active uncontrolled infections; active disseminated intravascular coagulation;
* Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix;
* Clinically significant cardiovascular disease: cerebrovascular accidents or myocardial infarction <= 12 months before treatment start, unstable angina, NYHA >= grade 2 chronic heart failure, uncontrolled arrhythmia, uncontrolled hypertension;
* Serious, non-healing wound, ulcer, or bone fracture;
* Evidence of bleeding diathesis or coagulopathy;
* Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start;
* Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes or chronic, daily treatment with high-dose aspirin (>325 mg/day);
* Subtotal colectomy, malabsorption syndrome and chronic inflammatory bowel disease (i.e. ulcerative colitis, Chron syndrome);
* Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
* Psychiatric disorder precluding understanding of information on trial related topics,
* Serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease)
* Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry
* Definite contraindications for the use of corticosteroids and antihistamines as premedication
* Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs
* Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies
* Pregnancy
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent
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
|
NCT02295930
|
{
"brief_title": "Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient",
"conditions": [
"Metastatic Colorectal Cancer"
],
"interventions": [
"Other: folfoxiri+cetuximab+surgery+cetuximab",
"Other: folfoxiri+cetuximab+surgery+bevacizumab"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT02295930",
"official_title": "Induction Chemotherapy With Folfoxiri Plus Cetuximab and Maintenance With Cetuximab or Bevacizumab Therapy in Unresectable Kras Wild-type Metastatic Colorectal Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-03",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2011-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-03-12",
"last_updated_that_met_qc_criteria": "2014-11-19",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-20",
"first_submitted": "2014-02-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.
The primary outcome variables for this study are:
* Investigator responses to refit questions;
* Lens fit.
Detailed Description
This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.
#Intervention
- DEVICE : somofilcon A
- contact lens
- DEVICE : omafilcon A
- contact lens
|
#Eligibility Criteria:
Inclusion Criteria:
* Is at least 17 years and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day;
* Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;
* Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses;
* Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction;
* Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.
Exclusion Criteria:
* Is participating in any concurrent clinical research study;
* Has any known active* ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication);
* Is aphakic;
* Has undergone refractive error surgery;
* Is an employee of the Centre for Contact Lens Research;
* Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.
Sex :
ALL
Ages :
- Minimum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03226353
|
{
"brief_title": "Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A",
"conditions": [
"Myopia"
],
"interventions": [
"Device: omafilcon A",
"Device: somofilcon A"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03226353",
"official_title": "Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09-27",
"study_completion_date(actual)": "2017-09-27",
"study_start_date(actual)": "2017-07-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-12",
"last_updated_that_met_qc_criteria": "2017-07-20",
"last_verified": "2019-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-07-21",
"first_submitted": "2017-07-18",
"first_submitted_that_met_qc_criteria": "2019-01-31"
}
}
}
|
#Study Description
Brief Summary
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
1. metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
2. pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
3. Induction of ovulation by clomiphene citate 50 mg tablets to all participants
Detailed Description
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
1. metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
2. pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
3. Induction of ovulation by clomiphene citate 50 mg tablets once or twice dialy 12hours apart starting from the 3rd day of menstrual cycle and continue for five days during treatment with insulin sensitizing agents to group A and B.
Participants with oligomenorrhea will recieve two tablets of noreththisterone 5 mg tab every 12 hours for 5 days to allow for withdrawal bleeding before start ovulation induction
#Intervention
- DRUG : Pioglitazone
- Insulin sensitizing agents
- Other Names :
- Glustazon
- DRUG : Metformin
- Insulin sensitizing agent
- Other Names :
- Cidophage
- DRUG : Clomiphene Citrate
- Induction drug
- Other Names :
- Clomid
|
#Eligibility Criteria:
Inclusion Criteria:
* women age 20_35
* BMI 18_29.9
* Women with PCOS(diagnosed by using Rotterdam criteria
* Infertility is cause for seeking tfeatment
Exclusion Criteria:
* Causes of infertility other than PCOS.
* patient refusal.
* Contraindication of any of the drugs used in the study
* Cause of oligo/anovulation other than PCOS
* Current or previous (within the last six month) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetics, antiobesity drugs or other hormonal drugs.
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03566225
|
{
"brief_title": "Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome",
"conditions": [
"Pioglitazone"
],
"interventions": [
"Drug: Metformin",
"Drug: Clomiphene Citrate",
"Drug: Pioglitazone"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03566225",
"official_title": "Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-28",
"study_completion_date(actual)": "2021-03-30",
"study_start_date(actual)": "2018-01-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "SINGLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-06-02",
"last_updated_that_met_qc_criteria": "2018-06-20",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-06-25",
"first_submitted": "2018-05-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this open-label, randomized, 2\*2 crossover study is to compare the safety and Pharmacokinetics CG1801 and CGL1802 in Healthy Volunteers.
Detailed Description
Healthy volunteers are administrated single-dose over the period I and II (crossover) of CGL1802(Polmacoxib 2mg Tablet) and CG1801(Polmacoxib 2mg capsule) Every time before and after each medication, pharmacokinetic (PK) parameters and safety of CGL1802 and CG1801 is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
#Intervention
- DRUG : CG1801
- Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.
- DRUG : CGL1802
- Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female aged >= 19 years and <= 50 years
* Without inborn or chronic disease and no symptoms in physical examination
* BMI(Body Mass Index) result >= 18kg/m 2 and <= 30kg/m2
* Adequate clinical laboratory test results as evidenced by Hematology, Hemostasis, Biochemistry, Urinalysis, Serology and so on
* After taking a rest in sitting position for 5 minutes, subjects who have blood pressure (90 mmHg <= Systolic BP <= 139 mmHg, and 60 mmHg <= Diastolic BP <= 89 mmHg)
* Subject who understand the objective, method of the study and the characteristics of investigational drug and expected adverse events and provide written informed consent prior to study participation
* Negative pregnancy test(hCG) and agree to contraception during the trial
Exclusion Criteria:
* History of hypersensitivity to investigational products
* History of hypersensitivity or allergic reaction to sulfonamide.
* Patients with a history of asthma, acute rhinitis, nonspecific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti- inflammatory analgesics (including COX-2 inhibitors)
* Uncontrolled hypertension (over the Systolic BP 140 mm Hg or Diastolic BP 90 mmHG)
* Edema or Fluid retention
* AST / ALT > 1.5 times the normal range including additional and Screening blood tests before randomization.
* MDRD < 60mL / min / 1.73m2 including additional and Screening blood tests before randomization.
* Patient with an active peptic ulcer or gastrointestinal bleeding
* Patient with inflammatory intestinal disease such as Crohn's disease or ulcerative colitis
* Patient with Congestive Heart Failure (NYHA II - IV)
* Established ischemic heart disease patients, peripheral arterial diseases, and/or brain vascular diseases patient
* Patient performed CABG within 30 days prior to the first administration of the investigational drug
* Patient has hyperkalemia
* Patient has blood coagulation disorder or administration the anticoagulant
* Patient with gastrointestinal related disease or gastrotomy history (except appendicitis or hernia surgery) that may affect the absorption of the investigational drug.
* Patient participated in any other clinical trials or Bio-equivalence studies within 90 days prior to the screening visit.
* Patient donated whole blood within 60 days, donated blood component within 14 days, or received blood transfusion within 30 days prior to the first administration of the investigational drug.
* Taken medications like barbital or herbal medicines within 30 days or taken Over The Counter medicines within 7 days prior to the first administration of the investigational drug that may affect the clinical trial
* Over smokers (tobacco > 20 cigarettes/ days) within 30 days prior to Screening visit or patient cannot quit smoking during and until the end of the clinical trial after signed the Informed Consent Form to participate the clinical trial.
* Excessive Alcohol consumer 30 days prior to Screening visit or cannot quit drinking alcohol during and until the end of the clinical trial after signed the Informed Consent Form to participate the clinical trial.
* Excessive caffeine consumer (> 5 drinks/ day)
* Breast Feeding woman
* Patient cannot accept medically acceptable contraception during and until the clinical trial.
* Any other reasons or situations that the investigator decides the patient is not eligible to participate the clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03774355
|
{
"brief_title": "Study to Compare Safety and Pharmacokinetics of 'CG1801' and 'CGL1802' in Healthy Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: CGL1802",
"Drug: CG1801"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03774355",
"official_title": "A Randomized, Open-label, Single, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of 'CG1801' and 'CGL1802' in Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-03",
"study_completion_date(actual)": "2019-05-03",
"study_start_date(actual)": "2018-12-17"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-25",
"last_updated_that_met_qc_criteria": "2018-12-11",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-12",
"first_submitted": "2018-12-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The full program is focused on identifying and reducing risk factors surrounding falls. Based on previous research, we believe that occupational therapy group classes and adaptive yoga are an ideal pairing to reduce fall risk. The occupational therapy sessions will consist of lecture, group discussion, and activities designed to target biological, behavioral, environmental, and socioeconomic factors that contribute to fall risk specifically for people with Parkinson's disease.
#Intervention
- BEHAVIORAL : Merging Yoga and Occupational Therapy for Parkinson disease
- The group occupational therapy portion focuses on lecture, group discussion, and activities to reduce fall risk. The yoga program is part of an ongoing community yoga program specifically designed for people with Parkinson disease.
|
#Eligibility Criteria:
Inclusion Criteria:
* Individuals with a diagnosis of Parkinson's disease OR their care partners
* Individuals who read and understand English
* Individuals who can stand with or without an assistive device
* People who are willing to commit to yoga practice 2x/week for 8 weeks and pay $5/class through Raintree Athletic Club (Scholarships are available if needed!)
* People who are willing to commit to group occupational therapy 2x/week for 8 weeks free of charge
* score of at least 4/6 on the short mini mental status exam
Exclusion Criteria:
* less than 18 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03578653
|
{
"brief_title": "Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2",
"conditions": [
"Parkinson Disease"
],
"interventions": [
"Behavioral: Merging Yoga and Occupational Therapy for Parkinson disease"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03578653",
"official_title": "Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-31",
"study_completion_date(actual)": "2019-03-31",
"study_start_date(actual)": "2018-06-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-25",
"last_updated_that_met_qc_criteria": "2018-07-03",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-06",
"first_submitted": "2018-06-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
For the last 20 to 30 years, damage control laparotomy and decompressive laparotomy have emerged as part of the armamentariums for treatment of complex abdominal trauma, abdominal compartment syndrome, and critically ill surgical patients with profound acidosis. While these advances have saved lives, they have also led to a dramatic increase in patients with open abdominal cavities. Various methods have been employed to offer protection to the viscera and at the same time, encourage gradual closure of the abdominal fascia. Some of the techniques have included the Bogota bag, vacuum pack described by Barker , Wittman patch , and the use of vacuum assisted fascia-closure, including the commercially available system offered by KCI. Overall, the abdominal closure rate is approximately 50% to 90% over an average of 10 days. Unfortunately, there has been no well-designed comparison study available. Some of the best results also require returning to the operating room every 3 to 5 days.
At the University of Kentucky Medical Center, a combination of the vacuum pack dressing described by Barker, the commercially available VAC system (V.A.C.; KCI International, San Antonio, TX) and vicryl mesh closure systems are used. The primary fascial closure rate is approximately 50%. It is not standard practice to take patients to the OR every 3-5 days routinely.
Recently, a new FDA listed system (ABRA by Canica) has been introduced using a progressive tension system as a novel approach to the management of open abdomen. ABRA provides a dynamic reduction of full thickness, severely retracted midline abdominal defects with the goal of maintaining or restoring the primary closure option. This subdermal method uses button anchors and elastomer to gradually pull the wound margins together. Tension can be set and adjusted according to the desired outcome; to stabilize a retracted wound, reduce the wound, close the wound or prevent wound dehiscence (Attachment 1: Company brochure). Currently there is only one published case report of the success of this device. We hope to be the first center to prospectively report a series of patients with open abdomen managed with the new ABRA system. In this study, this system will be used in combination with a standard therapy used in abdominal wound closure at the University of Kentucky Medical Center. This system is called the V.A.C system (V.A.C.; KCI International, San Antonio, Tx). This therapy provides active exudate management and containment, assists in reducing abdominal volume and adds structural stabilization to adipose tissue.
Although no highly powered study has been done to establish data on performance, individual experiences at several institutions have reached fascial closure rates of higher than 70% using the ABRA device. One institution in Las Vegas, Nevada is using the ABRA device in combination with the VAC system and has experienced 100% closure rate to date with 12 patients. The purpose of this study is to collect information about the ABRA system in combination with the VAC technique at the University of Kentucky Medical Center. It is our belief that using this system will improve the fascial closure rate and thereby produce less chance of hernia and reduce long periods of open abdominal wounds. The objective of the study is to evaluate a novel approach for closure of open abdomen utilizing the Canica ABRA system combined with the K.C.I. VAC System to KCI VAC System alone.
#Intervention
- DEVICE : ABRA Abdominal Closure System
- ABRA Abdominal Closure System
- DEVICE : V.A.C. Therapy
- V.A.C. Therapy Alone
- DEVICE : KCI ABThera
- KCI ABThera
|
#Eligibility Criteria:
Inclusion Criteria:
* ages of 18 and 70
* patients deemed not a candidate for primary fascial closure at the second laparotomy.
Exclusion Criteria:
* High risk for imminent death, as determined by the attending surgeon and PI
* Pre-existing large ventral hernia
* Significant loss of abdominal wall fascia as a result of trauma or infection
* Known Crohn's disease
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00754156
|
{
"brief_title": "ABRA Abdominal Closure System in Open Abdomen Management",
"conditions": [
"Open Abdomen"
],
"interventions": [
"Device: ABRA Abdominal Closure System",
"Device: V.A.C. Therapy",
"Device: KCI ABThera"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00754156",
"official_title": "A Prospective, Controlled Evaluation of ABRA Abdominal Wall Closure System in Combination With V.A.C. Therapy Compared to V.A.C. Alone in the Management of Open Abdomen",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2008-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-03",
"last_updated_that_met_qc_criteria": "2008-09-16",
"last_verified": "2014-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-17",
"first_submitted": "2008-09-16",
"first_submitted_that_met_qc_criteria": "2014-02-15"
}
}
}
|
#Study Description
Brief Summary
This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity.
The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.
#Intervention
- DEVICE : Mandibular prosthesis made of a new highly biointegratable material
- Replacement of mandibular bone after partial or total mandible resection,avoiding then bone grafting. The porous titanium prosthesis is implanted under general anaesthesia in laryngeal surgeries. Bone resection and prosthesis placement is performed during the same surgical intervention. The prosthesis is attached onto the healthy bone with surgical screws. Simultaneous grafting of vascularised tissues may be done if the prosthesis surrounding area has been strongly irradiated.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female more than 18 years
Exclusion Criteria:
* Age less than 18 years
* Pregnant women
* Local carcinoma excluding radiotherapic or surgical control
* Poor general condition
* Contraindication to general anesthesia
* Uncontrolled diabetes
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
|
NCT00213837
|
{
"brief_title": "Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis",
"conditions": [
"Otorhinolaryngologic Diseases"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT00213837",
"official_title": "Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-09",
"study_completion_date(actual)": "2008-09",
"study_start_date(actual)": "2003-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-02-25",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2009-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-21",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The purpose of this dose escalation clinical study is to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at higher dosages or in two doses . Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels (low, medium, high), Bris10 M2SR at one dose level (low), or placebo in a 1:1:1:1:1 ratio. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine.
Detailed Description
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. This dose escalation clinical study is designed to assess the safety, tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for prevention of influenza, when delivered at increasing dosages or in two doses. Subjects will be enrolled in five groups in a 1:1:1:1:1 ratio. Arm 1 will receive a low dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 2 will receive a medium dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 3 will receive a high dose of Sing2016 M2SR intranasally on days 1 and 29. Arm 4 will receive a low dose of Bris16 M2SR intranasally on days 1 and 29. Arm 5 will receive a placebo intranasally on days 1 and 29. Study duration will be approximately 8 months with subject participation duration approximately 7 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine. The secondary study objectives are to evaluate systemic and mucosal immune responses induced by H3N2 M2SR vaccination.
#Intervention
- BIOLOGICAL : LD Sing2016 M2SR H3N2 influenza vaccine
- This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
- BIOLOGICAL : MD Sing2016 M2SR H3N2 influenza vaccine
- This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
- BIOLOGICAL : HD Sing2016 M2SR H3N2 influenza vaccine
- This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
- BIOLOGICAL : LD Bris10 M2SR H3N2 influenza vaccine
- This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
- OTHER : Placebo
- This group will receive saline placebo administered intranasally.
|
#Eligibility Criteria:
Inclusion Criteria:
* Give written informed consent to participate.
* Age 18 - 49 years.
* Judged suitable by the PI, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations.
* Willing to use oral, implantable, transdermal or injectable contraceptives, or sexual abstinence, from screening and until 28 days after second vaccine dose.
* Willing to adhere to the requirements of the study and willing and able to communicate with the Investigator and understand the requirements of the study.
Exclusion Criteria:
* Abnormal screening hematology or chemistry value per the FDA Toxicity Guidance.
* Pulse rate or blood pressure outside the reference range for this study population and considered as clinically significant by the Investigator.
* Has an acute or chronic medical condition or history of a medical condition that, in the opinion of the Investigator, would render the study procedures unsafe or would interfere with the evaluation of the responses.
* Presence or clinically significant history of lung disease, asthma, chronic obstructive pulmonary disease (COPD), or otherwise poor lung function.
* Any confirmed or suspected immunosuppressive or immunodeficient state.
* Presence of household member or close personal or professional (i.e., healthcare worker) who is a child under one year of age; is pregnant; has known immunodeficiency or is receiving immunosuppressant medication; is undergoing or soon to undergo cancer chemotherapy; has been diagnosed with emphysema, COPD, or other severe lung disease and resides in a nursing home; and/or has received a bone marrow or solid organ transplant.
* Females who are pregnant or lactating.
* Acute febrile illness within 72 hours prior to vaccination.
* Any condition, in the opinion of the Investigator, (such as subjects who have medically high-risk conditions) that might interfere with the primary study objectives for safety of the study subject.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03999554
|
{
"brief_title": "Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines",
"conditions": [
"Influenza A"
],
"interventions": [
"Other: Placebo",
"Biological: MD Sing2016 M2SR H3N2 influenza vaccine",
"Biological: LD Bris10 M2SR H3N2 influenza vaccine",
"Biological: LD Sing2016 M2SR H3N2 influenza vaccine",
"Biological: HD Sing2016 M2SR H3N2 influenza vaccine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03999554",
"official_title": "Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Bris10 (A/Brisbane/10/2007) M2SR and Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccines",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-07-01",
"study_completion_date(actual)": "2020-07-01",
"study_start_date(actual)": "2019-09-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-03-04",
"last_updated_that_met_qc_criteria": "2019-06-25",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-26",
"first_submitted": "2019-06-18",
"first_submitted_that_met_qc_criteria": "2021-12-10"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis
Detailed Description
This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis
#Intervention
- OTHER : Elemental Diet Therapy
- Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant must be able to understand and provide informed consent
* Males and Females >=18 <= age <= 65 of age;
* Have diagnosis of EG/EGE
* Have histologically confirmed active disease > 30 eosinophils/hpf
* Symptomatic (have experienced symptoms within the last one months prior to enrollment).
* Female subjects of childbearing potential must have a negative pregnancy test upon study entry
* Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study-specific methods may be listed, if applicable
Exclusion Criteria:
* Inability or unwillingness of a participant to give written informed consent or comply with study protocol
* Secondary causes of gastrointestinal and peripheral eosinophilia
* Eosinophilic infiltration isolated to the esophagus.
* Pregnancy
* Immunodeficiency states
* Have been treated with topical swallowed steroids within the last 6 weeks or systemic steroids within the last 2 months unless repeat endoscopy is performed and shows active inflammation on these therapies in which case these medications will be allowed to be continued without dose escalation.
* Have taken immunosuppression medication or immunomodulators within 2 months of the study unless the recent/baseline endoscopy has active histologic inflammation while on these medications. In this case, these medications will be permitted to be continued as long as the dose is not escalated during the treatment phase.
* Have been on an elemental diet previously for six weeks with follow up endoscopy completed.
* Have participated in any investigative drug study within 6 weeks prior to study entry.
* Unable to complete study procedures including endoscopy.
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
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
|
NCT03320369
|
{
"brief_title": "Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis",
"conditions": [
"Eosinophilic Gastroenteritis"
],
"interventions": [
"Other: Elemental Diet Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03320369",
"official_title": "Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-05",
"study_completion_date(actual)": "2019-10-05",
"study_start_date(actual)": "2017-09-05"
},
"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)": "2020-10-27",
"last_updated_that_met_qc_criteria": "2017-10-20",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-25",
"first_submitted": "2017-10-12",
"first_submitted_that_met_qc_criteria": "2020-09-03"
}
}
}
|
#Study Description
Brief Summary
The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.
#Intervention
- DEVICE : Endocardial Ablation Procedure
- Other Names :
- Linear Type Catheter (D-1368-01-SI), nMARQ TM Multi-channel RF generator (D-1341-07) with Software V2.4.0 or above, Linear Ablation Connection Cable (M-5948-01-I)
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years.
* Signed the Patient Informed Consent Form (ICF)
* Documented ongoing or previous symptomatic persistent AF (by physician's note indicating continuous AF >= 7 days)
* Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Exclusion Criteria:
* Previous surgical or catheter ablation for atrial fibrillation
* Current condition of continuous AF > 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF
* Any carotid stenting or endarterectomy
* Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion.
* LA size > 55 mm
* LVEF <40%
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Significant pulmonary disease (i.e. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
* Uncontrolled heart failure or NYHA function class III and IV
* MI within the past 2 months
* Any cardiac surgery (i.e. CABG) within the past 2 months
* Subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
* Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
* Documented thromboembolic event (including TIA) within the past 12 months
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Active illness or active systemic infection or sepsis
* Unstable angina
* History of blood clotting or bleeding abnormalities
* Contraindication to anticoagulation (eg, heparin or warfarin)
* Life expectancy less than 12 months
* Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
* Presence of a condition that precludes vascular access
* Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
* Currently enrolled in another device, biologics, or drug study
* Contraindication for use of the investigational devices , as indicated in the respective Instructions For Use
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
|
NCT02991313
|
{
"brief_title": "Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)",
"conditions": [
"Persistent Atrial Fibrillation"
],
"interventions": [
"Device: Endocardial Ablation Procedure"
],
"location_countries": [
"Italy",
"United Kingdom"
],
"nct_id": "NCT02991313",
"official_title": "Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI) for Endocardial Ablation of Patients With Persistent Atrial Fibrillation (LME-167)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-30",
"study_completion_date(actual)": "2018-11-30",
"study_start_date(actual)": "2016-10-01"
},
"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)": "2019-04-30",
"last_updated_that_met_qc_criteria": "2016-12-09",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-13",
"first_submitted": "2016-11-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
To assess the efficacy of the infrared therapy patch (ITP) FIRTECH for treating participants suffering from mild to moderate acute low back pain.
Secondary Objectives:
* To assess the efficacy of ITP FIRTECH on participant disability
* To assess the efficacy of ITP FIRTECH on the degree of participant mobility
* To assess the safety of ITP FIRTECH
Detailed Description
Duration of study participation is up to 6 days per participant.
#Intervention
- DEVICE : ITP FIRTECH
- Infrared Therapy Patch
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants suffering from mild to moderate acute low back pain
* Low back pain (lumbar back pain) is defined as pain in the back from the level of the lowest rib down to the gluteal fold
* Acute episode is defined as acute pain with less than 1 month duration
* With intensity less than or equal to 6 on 0 <= age <= 10 Numerical Rating Scale (NRS)
Exclusion Criteria:
* Participants suffering from any neurological pathology which could be responsible of the pain
* Participants suffering from leg pain irradiation
* Participants suffering from chronic lumbar pain of any etiology
* Participants with chronic arthrosis and neurological symptoms
* Participants experiencing recent significant trauma (i.e., injury related to a fall from a height or motor vehicle crash, or from a minor fall or heavy lifting in a participants with osteoporosis or possible osteoporosis)
* Participants with major or progressive motor or sensory deficit, new-onset bowel or bladder incontinence or urinary retention, loss of anal sphincter tone, saddle anesthesia, history of cancer metastatic to bone, and suspected spinal infection
* Participants clinically diagnosed with anxiety and/or depression
* Participants using any medication for their pain within the last 48 hours within enrollment into the study
* Participants taking any systemic medication for their pain within the last 24 hours (48 hours for diclofenac or corticosteroids)
* Participants currently using recreational or illicit drugs or with a recent history of drug or alcohol abuse or dependence
* Participants with any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgment
* Participants having received non-pharmaceutical lower back pain treatment (physiotherapy, heat treatment or massage) within 12 hours prior to enrollment
* Participants having received spinal injection back pain treatment within 6 months prior to enrollment
* Participants having received surgery due to back pain or rehabilitation due to back pain in the last 12 months
* Participants with a known sensitivity to paracetamol
* Participants with known cutaneous hypersensitivity to plaster
* Participants participating in another clinical study within the past 30 days
* Participants who are pregnant or breastfeeding; contraception is mandatory
* Participants having damaged, non-intact, or scarred skin in or near the point of patch application
* Participants having a known skin sensitivity
* Participants having impaired blood circulation
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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
|
NCT05137041
|
{
"brief_title": "Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain",
"conditions": [
"Low Back Pain"
],
"interventions": [
"Device: ITP FIRTECH"
],
"location_countries": [
"Germany",
"Italy"
],
"nct_id": "NCT05137041",
"official_title": "A Phase IIIB Randomized, Open Label, Two Arms and Parallel Group Clinical Trial to Assess the Efficacy and Safety of FIRTECH (Infrared Therapy Patch), for Treating Patients Suffering From Mild to Moderate Acute Low Back Pain",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-22",
"study_completion_date(actual)": "2022-11-22",
"study_start_date(actual)": "2021-11-04"
},
"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)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2021-11-18",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-30",
"first_submitted": "2021-11-18",
"first_submitted_that_met_qc_criteria": "2024-05-13"
}
}
}
|
#Study Description
Brief Summary
The goal of this observational study is to compare the composition of the human gingiva in different gingival phenotypes. The main questions to answer are:
* Is there any difference in the cellular composition of the gingiva between thin and thick gingival phenotype?
* Is there any difference in the molecular composition of the gingiva between thin and thick gingival phenotype?
The participants were divided in two groups (thin and thick phenotype) and a biopsy of healthy gingiva was obtained from each one them. The biopsies were analyzed histologically and the collected data will be analyzed statistically in order to identify possible differences between the gingival phenotypes.
Detailed Description
Healthy volunteers were assigned in one of two groups:
* Group 1: Thin gingiva, when the free gingiva was evaluated as transparent, after the insertion of a periodontal probe (Hu-Friedy XP-23/QW, Hu-Friedy,Chicago,IL,USA) in the middle of the facial dentogingival sulcus of a maxillary central incisor
* Group 2: Thick gingiva: when the free gingiva was evaluated as non-transparent, using the same methodology.
A full thickness sample of the oral mucosa of each one of the participants was collected under local anaesthesia. The sample had a rectangular shape, with a length of 4 millimeters and a width of 1 millimeter. It had a vertical orientation and it was expanding at the both sides of the mucogingival junction.
The oral mucosa samples were processed for histological and immunohistochemical analysis. Staining with haematoxylin-eosin was performed in order to describe the tissue histologically and also calculate the total number of the cells it contained. Immunohistochemical staining with anti-Vimentin,anti-Cluster of Differentiation 68, anti-Ki-67 and anti-Smooth Muscle Actin antibodies was applied for the calculation of the numbers of fibroblasts, macrophages, Ki-67-positive cells and Smooth muscle actin positive cells respectively. Immunohistochemical staining was also performed in order to determine the levels of expression of Collagen I, Collagen V, Elastin and Hyaluronic acid.
Whole slide images of the specimens were acquired with the use of the NanoZoomer 2.0HT (Hamamatsu Pho-tonics K.K., Hamamatsu, Japan). Cell counting will be performed automatically using an image analysis software (QuPath 3.0). The levels of molecular expression will be assessed with the use of the same software and will be expressed as a percentage of the area of the connective tissue that is occupied by the investigated molecules.
#Intervention
- DIAGNOSTIC_TEST : Histological analysis
- Histological staining of gingival biopsies with haematoxylin-eosin.
- DIAGNOSTIC_TEST : Immunohistochemical analysis
- Immunohistochemical staining of gingival biopsies using anti-Vimentin, anti-Collagen I, anti-Collagen V, anti-Elastin, anti-Hyaluronic acid, anti-Smooth muscle actin, anti-Cluster of Differentiation 68 and anti-ki67 antibodies.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adults
Exclusion Criteria:
* Attachment loss or Probing depths greater than 2 millimeters at the maxillary central incisors
* Altered passive eruption of the maxillary incisors
* Previous surgery or orthodontic treatment in the anterior maxilla
* Medical conditions or medication affecting soft tissue metabolism
* Tooth crowding or abnormal angulation or abrasion of the maxillary incisors
* Restorations at the buccal surface of the maxillary central incisors
* Smoking
* Pregnancy or lactation
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
|
NCT05923671
|
{
"brief_title": "Clinical and Histological Analysis of Human Gingival Phenotypes",
"conditions": [
"Healthy"
],
"interventions": [
"Diagnostic Test: Histological analysis",
"Diagnostic Test: Immunohistochemical analysis"
],
"location_countries": [
"Greece"
],
"nct_id": "NCT05923671",
"official_title": "Clinical, Histological and Immunohistochemical Characterization of Human Gingival Phenotypes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-01",
"study_completion_date(actual)": "2022-12-01",
"study_start_date(actual)": "2020-03-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-28",
"last_updated_that_met_qc_criteria": "2023-06-27",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-06-28",
"first_submitted": "2023-03-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to determine the impact of an integrated personalized dietary and wellness program which includes dietary advice, meals, and counseling on health and wellness.
Detailed Description
The objective of this study is to determine the impact of an integrated personalized dietary and wellness program, which includes personalized dietary advice, meals, and behavior guidance, on markers of health and wellness, body composition, and psychosocial measures. Behavior questionnaires, motivational interviewing, psychosocial questionnaires, and participants' self-generated data on diet, preferences, activity, and sleep will be used in combination with anthropometric and biological data (fasted blood-based measures following an oral protein glucose lipid tolerance test \[liquid meal challenge test\], and selected single nucleotide polymorphisms) to create individualized, tailored dietary advice, meal and counseling plans.
#Intervention
- OTHER : Personalized dietary and wellness program
- Single arm intervention containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, 30 <= age <= 65 years, inclusive.
* BMI 18.5 <= age <= 39.9 kilograms per meters squared.
* Willing to follow study program instructions, including consumption of meals on site (5 days/week; breakfast and lunch), consumption of all provided meals, use of a Fitbit®, self-administered capillary blood draws and dried blood spot collection, and visit schedule, where relevant.
* Willing and able to comply with the visit/contact schedule.
* Willing to avoid vigorous activity and alcohol consumption (24 h) and willing to fast (10 <= age <= 14 h, water only) prior to completion of the at-home oral protein glucose lipid tolerance test.
* Normally active and judged to be in good health on the basis of the medical history.
* Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.
* Subject has access to an internet-ready device and email.
Exclusion Criteria:
* A history or presence of clinically important endocrine, cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric or biliary disorders that could interfere with the interpretation of the study results.
* A history or presence of a gastrointestinal condition that could potentially interfere with digestion and absorption of the study product including, inflammatory bowel disease, irritable bowel syndrome, chronic constipation, and history of frequent diarrhea; and gastroparesis.
* Uncontrolled hypertension (systolic blood pressure >=160 mm Hg or diastolic blood pressure >=100 mm Hg).
* A history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
* A history of unconventional sleep patterns.
* Major trauma or a surgical event within 3 months of screening.
* Nicotine users.
* Use of medications which can alter the lipid profile with the exception of stable statin use.
* Unstable use of any thyroid medication.
* Use of antibiotics, hypoglycemic medications, and/or systemic corticosteroids.
* Signs or symptoms of an active infection.
* Current or recent history of drug or alcohol abuse.
* Known allergy and/or sensitivity to the study foods or products.
* Extreme dietary habits (e.g., very high protein diets, vegan, very low carbohydrate, etc.).
* A change (increase or decrease) in body weight of >10%.
* Females who are pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
* Study staff or those who will be involved in the conduct of the study.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03424395
|
{
"brief_title": "Personalized Dietary Program and Markers of Wellness",
"conditions": [
"Healthy",
"Metabolism"
],
"interventions": [
"Other: Personalized dietary and wellness program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03424395",
"official_title": "A Clinical Trial to Evaluate the Effects of Proprietary Personalized Dietary Programs on Markers of Health and Wellness, Body Composition, and Quality of Life",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-21",
"study_completion_date(actual)": "2018-12-21",
"study_start_date(actual)": "2017-10-28"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-25",
"last_updated_that_met_qc_criteria": "2018-01-31",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-07",
"first_submitted": "2018-01-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
MT1980 is being developed as a treatment for neuroinflammation (an inflammatory response in the brain and/or spinal cord). Much research has focused on the central role of neuroinflammation in the pathogenesis of many conditions relating to the CNS, including eg, traumatic brain injury, stroke, Alzheimer's disease, post-operative cognitive decline (POCD)/perioperative neurocognitive disorder, and now even long-term cognitive side effects from severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Current anti-inflammatories do not easily cross the blood-brain barrier from the systemic circulation to the brain, making neuroinflammation a difficult condition to treat.
This will be a Phase 1, single dose, randomized, placebo-controlled study in healthy subjects. The study will provide information on the safety of MT1980, the systemic bioavailability of the active drug, and levels of the active drug in the CSF. The study will be conducted in two parts. In Part 1, subjects will be randomized to receive a single oral dose of MT1980 or placebo in a parallel design. An interim PK and safety data analysis will be performed after Part 1 prior to dose selection in Part 2. In Part 2 subjects will be randomized to receive either placebo or a single oral dose of MT1980 at one of 2 strengths in a parallel design.
#Intervention
- DRUG : MT1980
- single dose
- DRUG : Placebo
- single dose
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers with good physical and mental health
* Body Mass Index 18 to 30 kg/m2
* Men & women of child-bearing potential must agree to use adequate contraception
* Willing & able to provide written informed consent and to communicate and participate in the study
Exclusion Criteria:
* Clinically significant abnormal biochemistry, haematology, urinalysis results
* Results of screening liver function or kidney function tests outside of normal ranges
* Heavy daily smoking or use of nicotine containing substances
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05429840
|
{
"brief_title": "Safety & PK of Single Doses of MT1980",
"conditions": [
"Neuroinflammatory Response"
],
"interventions": [
"Drug: Placebo",
"Drug: MT1980"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT05429840",
"official_title": "A Two-part, Single Dose, Randomized, Single Blinded, Placebo Controlled, Phase I Study to Assess the Safety and Pharmacokinetics of Oral MT1980 in Healthy Volunteers When Dosed in the Fasted State",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-04",
"study_completion_date(actual)": "2022-10-04",
"study_start_date(actual)": "2022-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-02",
"last_updated_that_met_qc_criteria": "2022-06-22",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-23",
"first_submitted": "2022-06-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pocket hematoma is a known complication of pacemaker (PM) implantation. Pocket hematoma is accompanied by a local discomfort associated with the infiltration of subcutaneous tissue. In some cases, this complication requires repeated surgical revisions, which increases the risk of infection, and increases the duration of a hospital stay. The search for ways to prevent bleeding from the PM pocket is of great practical interest. This question is especially acute in relation to patients who are constantly on anticoagulation and/or antiplatelet therapy. A number of authors propose to carry out complete or partial cancellation of these drugs for the period before surgery and in the early postoperative period. In our opinion, this approach in most cases carries a potential risk to the health of patients, especially in the case of patients who have previously undergone surgical correction of valve insufficiency and/or who have undergone percutaneous endovascular interventions.
The use of local hemostatic drugs is one of the promising directions for increasing the efficiency of intraoperative hemostasis. The haemostatic solution 'Haemoblock' has shown its hemostatic potential in general surgical practice. The possibilities of 'Haemoblock' in the prevention of pocket hematoma have not been studied. The hemostatic effect of 'Haemoblock' is achieved within 1-2 minutes due to the formation of a clot with blood plasma proteins, first of all with albumin. As a result of the action of the 'Haemoblock', a strong polymethacrylate membrane is formed on the surface of the wound, which, among other things, has a bactericidal effect.
Detailed Description
А multicenter research trial will be conducted at 6 medical centers:
* Ryazan State Medical University (Ryazan);
* Federal State Budgetary Institution 'Federal Center for Cardiovascular Surgery' of the Ministry of Health of the Russian Federation (Astrakhan);
* Federal State Budgetary Institution 'Federal Center for Cardiovascular Surgery' of the Ministry of Health of the Russian Federation (Penza);
* Federal State Budgetary Institution 'Federal Center for Cardiovascular Surgery' of the Ministry of Health of the Russian Federation (Chelyabinsk);
* Federal State Budgetary Institution 'Federal Center for Cardiovascular Surgery' of the Ministry of Health of the Russian Federation (Kaliningrad);
* Federal State Budgetary Institution 'Federal Center for Cardiovascular Surgery' of the Ministry of Health of the Russian Federation (Khabarovsk).
Haemostatic solution 'Haemoblock' provided by Autonomous non-profit organization 'MOSCOW REGIONAL SCIENTIFIC RESEARCH INSTITUTE OF BLOOD'.
The study will include 200 patients with indications for pacemaker implantation (atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other).
Before starting the study, the patient must give written consent to participate in this study after familiarizing him with the purpose and rules of the clinical study.
All patients during randomisation will be divided into 2 groups:
Group A 'Haemoblock' - 100 patients. Haemostatic solution 'Haemoblock' will be used after pocket formation during pacemaker implantation (sterile gauze swabs are soaked in 15 ml of 'Haemoblock' solution and applied in pacemaker pocket, then pacemaker pocket will be irrigated with 5 ml of 'Haemoblock' solution without rinsing).
Group B 'Control' - 100 patients. Same procedure will be performed with saline solution in this group.
Before surgery blood sampling, echocardiography will be performed in all patients.
3-5 days after surgery ultrasound of pacemaker pocket will be performed in all patients.
The observation period for patients will be 30 days.
#Intervention
- PROCEDURE : Pacemaker implantation
- Implantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other.
- DRUG : Haemostatic solution 'Haemoblock' application
- Haemostatic solution 'Haemoblock' will be used after pocket formation during pacemaker implantation.
- Other Names :
- "Haemoblock' application
- DRUG : Saline solution application
- Saline solution will be used after pocket formation during pacemaker implantation.
- Other Names :
- Saline application
- DIAGNOSTIC_TEST : Ultrasound of pacemaker pocket
- Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.
- DIAGNOSTIC_TEST : Blood sampling
- Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.
- DIAGNOSTIC_TEST : Echocardiography
- Heart ultrasound examination for left ventricular ejection fraction measurement.
|
#Eligibility Criteria:
Inclusion Criteria:
* availability of informed consent of the patient to participate in the study;
* men and women aged 40 <= age <= 85 years with indications for pacemaker implantation, taking oral anticoagulants before surgery for at least 7 days;
Exclusion Criteria:
* hypoalbuminemia;
* known contraindications for the study haemostatic solution 'Haemoblock';
* severe arterial hypertension: Systolic blood pressure >= 200 mmHg and/or Diastolic blood pressure >= 110 mmHg;
* unstable forms of ischemic heart disease;
* hemostasis disorders in the number of platelets, prothrombin, fibrinogen levels, or International Normalised Ratio above 3.0
* LVEF according to Simpson <35%;
* the period of pregnancy and lactation;
* chronic renal failure: creatinine clearance less than 40 ml/min;
* hemoglobin level <90 g/l;
* participation in another study.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04559646
|
{
"brief_title": "Application of the 'Haemoblock' in Pacemaker Patients",
"conditions": [
"Hematoma Postoperative"
],
"interventions": [
"Diagnostic Test: Echocardiography",
"Drug: Saline solution application",
"Drug: Haemostatic solution 'Haemoblock' application",
"Diagnostic Test: Ultrasound of pacemaker pocket",
"Diagnostic Test: Blood sampling",
"Procedure: Pacemaker implantation"
],
"location_countries": [
"Russian Federation"
],
"nct_id": "NCT04559646",
"official_title": "Application of the Haemostatic Solution 'Haemoblock' to Reduce the Risk of Pacemaker Pocket Hematoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-01",
"study_completion_date(actual)": "2023-11-01",
"study_start_date(actual)": "2021-01-01"
},
"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)": "2023-11-18",
"last_updated_that_met_qc_criteria": "2020-09-16",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-09-23",
"first_submitted": "2020-09-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The Lung HIV goal is to facilitate the data and specimen collection efforts of eight individual HIV and pulmonary studies that operate under the direction of the NHLBI. The Lung HIV study will build on existing studies to facilitate the start-up of new projects to further the understanding of the relationship between pulmonary disease and HIV infection. There is only one clinical trial being performed in this network at Ohio State University and it will be reported here.
Detailed Description
The Ohio State University Clinical Research Center (CRC), Patient Selection
Study Intervention Subjects:
365 HIV+ male and female smokers will be enrolled to the study and will be recruited over a two - four year period.
Inclusion criteria
1. 18 years of age and older
2. Diagnosis of HIV (Since the vast majority of our subjects will be recruited through the OSU Infectious disease clinics and HIV clinical research unit documentation of HIV status will not be a problem)
3. Self-reported smoking (≥ 5 cigarettes per day to avoid inclusion of occasional, 'social' users and 'chippers');
4. Able and willing to provide informed written consent.
Exclusion criteria:
1. Inability to provide informed consent
2. Inability to understand spoken English
3. Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.
Control Subjects Group A:
We will utilize normal subjects for the control study for the Diffusion Capacity of Lung for Carbon Monoxide (DLCO) and Diffusion capacity of Lung for Nitric Oxide (DLNO), recruited from the general population. We will recruit 5 males and 5 females in each decade of life from 21-30, 31-40, 41-50, 51-60, 61-70 (TOTAL= 50 subjects).
Inclusion criteria
1. 21-70 years of age and older
2. HIV Seronegative
3. Able and willing to provide informed written consent.
Exclusion criteria:
1. Inability to provide informed consent
2. Inability to understand spoken English
3. Current smoker or have smoked in the last 10 years or have a \> 10 pack year history of smoking.
4. Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.
Control Subjects Group B:
We will utilize normal subjects for the control study for DLCO and DLNO, recruited from the general population. We will recruit 5 males and 5 females in each decade of life from 21-30, 31-40, 41-50, 51-60, 61-70 (TOTAL= 50 subjects).
Inclusion criteria
1. 21-70 years of age and older
2. HIV Seronegative
3. Current or former smoker with at least a 5 pack year history of smoking
4. Able and willing to provide informed written consent.
Exclusion criteria:
1. Inability to provide informed consent
2. Inability to understand spoken English
3. Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.
#Intervention
- OTHER : Smoking Cessation
- A Motivational Interview session (\~40-50 minutes) will be delivered by a trained nurse coordinator.
Treatment with varenicline (1 mg daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12)or nicotine replacement therapy (21 mg of a skin patch + nicotine gum 4 mg ad lib added for breakthrough craving up to 20 pieces/day.
|
#Eligibility Criteria:
Inclusion Criteria
Men and women at the AIDS Clinical Trials Unit(ACTU) will be eligible to participate if they meet four criteria: (a) 18 years and older; and (b) diagnosis of HIV; and (c) self-reported smoking on a daily basis; and (d) provide informed written consent.
Exclusion criteria
Persons who meet one or more of the following criteria will be excluded from the study: (a) persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam); (b) unable to understand spoken English; (c) age less than 18 years.
Rationale: Persons with cognitive impairment may participate in the study if they are able to provide consent and answer questionnaire questions. No reason is identified to exclude persons with this characteristic. No special risks are posed to cognitively impaired persons who are able to provide consent. Persons who have active psychoses or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam are not able to provide informed written consent and are unlikely to benefit from the treatment. These persons will be referred to appropriate mental health services and invited to participate when their mental status has improved.
Persons who are unable to understand spoken English would not be able to complete the assessments or benefit from the treatments. Less than 1% of the clinic population will be excluded on this basis. However, persons excluded from the study on this basis will be referred for standard smoking cessation treatment delivered in their native tongue. These community resources may be identified through the Ohio State University Nursing Center for Tobacco Intervention.
Younger adolescents (<18 years) will not be invited to participate in the study because we believe that they require treatments that are qualitatively different from those designed for older adolescents and adults. The treatments that will be evaluated in the proposed research are well suited to older adolescents and adults, but not developmentally tailored to younger adolescents. Less than 1% of the clinic population will be excluded on this basis. Most HIV+ children living in Columbus, Ohio receive HIV medical care through the F.A.C.E.S. outpatient clinic at Columbus Children's Hospital. Standard, age appropriate, smoking cessation treatment is available through the Health and Wellness Center at Columbus Children's Hospital. In the unlikely circumstance that a child <18 years wishes to participate in the proposed study, s/he will be referred to Health and Wellness Center at Children's Hospital for treatment or the Ohio State University Nursing Center for Tobacco Intervention for age appropriate smoking cessation community resources.
Pregnant women may not be included as subjects. While smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes, little information is available on the safety or efficacy of varenicline. Therefore, participants who are pregnant will be excluded as subjects. Also, women who are breast-feeding will be excluded.
Other persons who are unable to use varenicline will be allowed to participate in the study but will not receive the varenicline component of treatment. A history and physical examination will be conducted as a component of the baseline evaluation.
People that have kidney problems or undergo kidney dialysis will not take the study drug, but will be given the option to take nicotine replacement therapy.
All persons excluded from the study will have the opportunity to receive smoking cessation treatment. We will provide referrals for treatment as clinically indicated.
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
|
NCT00933595
|
{
"brief_title": "Longitudinal Studies of HIV-Associated Lung Infections and Complications (Lung HIV)",
"conditions": [
"Pulmonary Complications",
"HIV Infections"
],
"interventions": [
"Other: Smoking Cessation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00933595",
"official_title": "Longitudinal Studies of HIV-Associated Lung Infections and Complications (Lung HIV)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-06",
"study_completion_date(actual)": "2013-11",
"study_start_date(actual)": "2007-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-01",
"last_updated_that_met_qc_criteria": "2009-07-02",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-07",
"first_submitted": "2009-07-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.
#Intervention
- DRUG : MICARDIS® (telmisartan)
|
#Eligibility Criteria:
Inclusion Criteria:
* Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
* Subjects 18 <= age <= 65 years.
* Body Mass Index (BMI) >= 28.
* Sedentary life style defined as: Does not engage in vigorous activity for more than 30 minutes per day, more than two times per week.
* Waist circumference >= 40 inches (102 cm) in men and >= 35 inches (89 cm) women.
* HbA1C assessed <= 6.5%.
* Triglycerides >= 150, and <= 500 mg/dL.
* Fasting Glucose <= 126 mg/dL.
* Blood pressure >= 110/64 and <= 140/90 mmHg.
Exclusion Criteria:
* Currently taking any antihypertensive medications (e.g., thiazide or loop diuretics), diabetic medications, medications known to alter insulin sensitivity (e.g., statins), steroids, glucocorticoids, niacin, nicotinic acid, and anti-psychotic/depressant drugs (e.g., prozocin). Including over the counter (OTC) and herbal products, which are known to affect metabolic function.
* Diagnosis of any of the following chronic diseases: hypertension, diabetes mellitus, renal insufficiency, congestive heart failure, hepatic insufficiency, biliary obstructive disorders, autoimmune disease, HIV, coronary artery disease, mental illness, and severe anemia.
* Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
* Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
* Unstable angina or myocardial infarction or cardiac surgery within the past 3 months.
* PCI (percutaneous coronary intervention) within the past 3 months.
* Stroke within the past 6 months.
* Bilateral renal artery stenosis or obstructive disorders, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
* Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* SGPT (ALT) or SGOT (AST) > 2.5 times the upper limit of normal range, or
* Serum creatinine > 2.3 mg/dL (or > 203 mol/L)
* Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
* Have a positive urine pregnancy test (UPT) prior to randomisation (Visit 2 or Visit 2.1 for subject participating in the clamp procedure)
* Are not surgically sterile, or
* Are nursing, or pregnant, or
* Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study and do not agree to periodic pregnancy testing during participation in the study. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable or injectable contraceptives and estrogen patch. No exceptions will be made.
* Hematocrit < 35%.
* Primary aldosteronism.
* Hereditary fructose intolerance.
* History of drug or alcohol dependency within the previous 6 months.
* Currently participating in a weight loss program.
* Any investigational drug therapy within one month of randomisation or during the study.
* Known hypersensitivity to any component of the study drug (telmisartan or placebo).
* Any circumstances the Investigator feels participation in the study would hinder subject safety or completion of the study.
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
|
NCT00146289
|
{
"brief_title": "The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive Subjects",
"conditions": [
"Obesity",
"Insulin Resistance"
],
"interventions": null,
"location_countries": [
"United States",
"Germany",
"Canada",
"Italy",
"Denmark"
],
"nct_id": "NCT00146289",
"official_title": "A Randomised, DB, Placebo-controlled, Parallel Group, 16-wk MICARDIS (160mg) Tab, Proof-of-concept, Evaluating Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive, Using the OGTT, With a Clamp Sub-group",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-10",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2005-02"
},
"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)": "2013-11-01",
"last_updated_that_met_qc_criteria": "2005-09-02",
"last_verified": "2013-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-07",
"first_submitted": "2005-09-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the clinical validity of a set of PROMIS pediatric person-reported outcome measures in patients with chronic kidney disease. The evaluation includes longitudinal assessments of how measures change in association with clinical changes.
Detailed Description
The National Institutes of Health (NIH)-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) network has developed over 20 pediatric instruments, both child-report and parent-proxy editions. Cross-sectional evaluations of the validity of the instruments have established that they are ready for integration into clinical research and practice. The next step in their ongoing evaluation is to assess their prospective clinical validity in a variety of health conditions. This study addresses the clinical evaluation of the measures in children with chronic kidney disease (CKD).
Through baseline surveys and six follow-up surveys over a two-year period, Investigators are collecting self-report (child) and parent-proxy report of 11 pediatric PROMIS measures. Each of these PROMIS measures is described in the Main Outcome Measures section. Investigators are also collecting assessments of disease activity from clinical data. The selection of self-report and parent proxy patient-reported outcome (PRO) measures were determined through qualitative content validation. The analytic goal of this project is to evaluate baseline (cross-sectional) and longitudinal associations between PROMIS pediatric outcome measures and changes in the clinical status of patients with CKD. Our primary hypothesis is that as kidney function declines, self-reported health will worsen.
|
#Eligibility Criteria:
Inclusion Criteria:
* Child is 8 <= age <= 21 years at time of enrollment
* Child is a Chronic Kidney Disease in Children (CKiD) patient OR a child who receives pediatric nephrology care at a CKiD site that participates in PEDSnet, a national pediatric learning health system
* Child seen by a pediatric nephrologist in the past 24 months
* Child has two eGFR readings (computed from serum creatinine) between 6 <= age <= 89 ml/min at least 3 months apart (eGFR of this level indicates CKD)
* Child speaks English
* Parent is the parent or legal guardian for the child
* Parent speaks English
Exclusion Criteria:
* Child is currently receiving dialysis
* Child received a kidney transplant
* Child has a parent-reported cognitive limitation that would preclude them from completing a questionnaire
* Child does not speak English
* Parent does not speak English
* Parent is not the parent of legal guardian for the child
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03842293
|
{
"brief_title": "Clinical Evaluation of PROMIS in CKD",
"conditions": [
"Chronic Kidney Diseases"
],
"interventions": null,
"location_countries": [
"Canada",
"United States"
],
"nct_id": "NCT03842293",
"official_title": "Clinical Evaluation of PROMIS Pediatric Person Reported Outcome Measures in Children With Chronic Kidney Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-30",
"study_completion_date(actual)": "2020-08-30",
"study_start_date(actual)": "2017-06-22"
},
"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)": "2020-11-27",
"last_updated_that_met_qc_criteria": "2019-02-13",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-15",
"first_submitted": "2019-02-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.
Detailed Description
Sub-study:
Full title: Optional Genetic Research
Date: 18 June 2010
Version: 1
Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA
#Intervention
- DRUG : fostamatinib
- fostamatinib 100 mg twice daily
- DRUG : fostamatinib
- fostamatinib 100 mg twice daily/150 mg once daily
- DRUG : placebo, fostamatinib
- Placebo for 24 weeks followed by fostamatinib 100 mg twice daily
|
#Eligibility Criteria:
Inclusion Criteria:
* Active rheumatoid arthritis (RA) diagnosed after the age of 16
* Currently taking methotrexate
* 6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
* At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)
Exclusion Criteria:
* Females who are pregnant or breast feeding
* Poorly controlled hypertension
* Liver disease or significant liver function test abnormalities
* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
* Recent or significant cardiovascular disease
* Significant active or recent infection including tuberculosis
* Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
* Severe renal impairment
* Neutropenia
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
|
NCT01197521
|
{
"brief_title": "Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.",
"conditions": [
"Rheumatoid Arthritis"
],
"interventions": [
"Drug: placebo, fostamatinib",
"Drug: fostamatinib"
],
"location_countries": [
"France",
"India",
"Slovakia",
"Ukraine",
"Mexico",
"United States",
"Chile",
"Poland",
"Hungary",
"Australia",
"Estonia",
"Bulgaria",
"Brazil",
"Argentina",
"Peru",
"Belgium",
"United Kingdom"
],
"nct_id": "NCT01197521",
"official_title": "(OSKIRA-1): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2012-11",
"study_start_date(actual)": "2010-09"
},
"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)": "2014-04-07",
"last_updated_that_met_qc_criteria": "2010-09-08",
"last_verified": "2014-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-09-09",
"first_submitted": "2010-09-08",
"first_submitted_that_met_qc_criteria": "2014-02-27"
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to assess the efficacy of nimotuzumab in combination with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer, comparing it to that of the conventional treatment with radiation and chemotherapy.
The secondary objective of this study is to assess the health-related quality of life for the nimotuzumab in combination with chemotherapy and radiotherapy regimen, compared to the standard chemoradiation regimen in the treatment of inoperable locally advanced esophageal cancer.
Detailed Description
This will be a phase II, randomized, controlled, open-label, multicenter, and two-arm study. The study will be conducted in Brazil and has the purpose of determining the activity and safety of nimotuzumab in terms of overall survival, TTP, clinical and endoscopic response rates, resectability rate, toxicity profile, and quality of life. All participating patients will sign a consent form before they undergo any study-related procedure. The eligible patients will have locally advanced esophageal cancer, and they will be randomized to one of two treatment groups. Randomization will be centrally coordinated by the sponsor and performed by means of the electronic CRF itself.
#Intervention
- DRUG : Nimotuzumab
- 200 mg, IV Weekly IV dose for up to 26 weeks.
- DRUG : Cisplatin
- 75 mg/m2, IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab.
- DRUG : Fluorouracil
- 1,000 mg/m2, IV dose in a 24-hour continuous infusion, from D1 to D4, every chemotherapy cycle, for 4 cycles.
- RADIATION : Radiotherapy
- Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years;
* Histological prove of SCC or esophageal adenocarcinoma;
* T1N1M0, T2N1M0, T3N0M0, T4N0M0, T3N1M0, T4N1M0, qqTqqNM1a stage, according to the TNM system42;
* Life expectation above 6 months;
* Inoperable superior, medial, or distal third esophageal cancer, including GE junction tumors, defined as type I and II tumors in the Siewert classification43 (see Appendix B);
* Performance status 0, 1, or 2, according to the Eastern Cooperative Oncology Group criteria44 (ECOG) (see Appendix C);
* Creatinine clearance >= 60 ml/min, according to the Cockcroft and Gault formula45 (see Appendix D);
* Adequate body functions, indicated by
* Creatinine clearance >= 60 ml/min;
* Bilirubin, transaminase, alkaline phosphatase, and gamma-GT < 1,5 x the upper limit of normal;
* leucocytes >= 3000/μl;
* granulocytes >= 1500/ μl;
* hemoglobin >= 9 g/dl;
* platelets >= 80000/ μl;
* Adequate calorie ingestion, at the investigator's discretion;
* He/she must have signed the informed consent form
Exclusion Criteria:
* Previous or planned treatment of esophageal carcinoma with surgery, radiotherapy, chemotherapy, or antineoplastic biological therapy;
* Presence of active infection;
* Knowledge of the presence of HIV seropositivity;
* Presence of severe comorbidities that, in the investigator's opinion, will put the patient at a significantly higher risk or will damage the protocol compliance;
* Presence of a significant neurological or psychiatric disease, including dementia and seizures, as per the investigator's judgment;
* History of malignant neoplasm, except for adequately treated skin basal carcinoma or SCC, and cervical carcinoma in situ;
* Presence of peripheral neuropathy;
* Knowledge of the presence of hypersensitivity or allergy to drugs that will be administered in this protocol;
* History of severe allergic reaction;
* Pregnancy or lactation;
* Presence of aerodigestive fistula (trachea and/or bronchia);
* Evident presence of trachea and/or bronchia infiltration by the tumor;
* Presence of uncontrolled hypercalcaemia >= 2.9 mmol/L (or grade >1, according to the NCI-CTCAE, version 3.0).
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
|
NCT01249352
|
{
"brief_title": "A Study of Chemoradiation Associated With Nimotuzumab as the Treatment of Locally Advanced Esophageal Cancer",
"conditions": [
"Esophageal Cancer",
"Adenocarcinoma"
],
"interventions": [
"Drug: Nimotuzumab",
"Drug: Cisplatin",
"Radiation: Radiotherapy",
"Drug: Fluorouracil"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT01249352",
"official_title": "A Phase II, Randomized, Controlled, Open-Label Study Comparing Standard Chemoradiation Versus Chemoradiation Associated With Nimotuzumab as the Treatment of Locally Advanced Esophageal Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-11",
"study_completion_date(actual)": "2013-11",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-01-06",
"last_updated_that_met_qc_criteria": "2010-11-26",
"last_verified": "2014-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-29",
"first_submitted": "2010-11-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The present proposal is to study whether Prolonged Exposure (PE) delivered via Telemedicine is as effective as PE delivered In Person for Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF) Veterans and Veterans of all theatres, particularly Vietnam era with Post-Traumatic Stress Disorder (PTSD). ).
Detailed Description
Project Background/Rationale: Approximately 15 to 17% of current Iraq war Veterans meet full diagnostic criteria for MH problems such as post-traumatic stress disorder (PTSD) (Hoge et al., 2004). Prolonged Exposure (PE) is an empirically supported treatment for PTSD (Foa 1997; Schnurr et al., 2007), and has been adopted by the Department of Veterans Affairs (DOVA) as one of the treatments of choice for the disorder, as evident by the DOVA-sponsored national training of clinicians to use PE. It is therefore important to employ treatment delivery methods that maximize the likelihood that all Veterans in need, including Veterans residing in rural settings, and Veterans who avoid DOVA settings due to the stigma of receiving mental health treatment, will receive interventions such as PE. The May, 2005 Committee on Veterans Affairs, Subcommittee on Health has identified Telemedicine as a DOVA priority area to address this need. The present proposal is to study whether PE delivered via Telemedicine is as effective as PE delivered In Person. Telemedicine has been chosen for its ability to overcome what appear to be two major barriers to mental health care (Frueh et al., 2000): the difficulty that rural-residing Veterans face in reaching VAMC facilities, and the stigma Veterans perceive related to receiving mental health treatment. Indeed, if effective, PE delivered via telemedicine may address the problem inherent in the finding that 42% of those screening positive for PTSD indicate that they are interested in receiving help, but only 25% actually receive services (Hoge, et al., 2006).
Project Objectives: Although effective treatments for PTSD exist and have been adopted by the Veterans Affairs Medical Centers (VAMC), barriers to care of a social (e.g., stigma) and geographic (e.g., rural) nature prevent many Veterans in need from receiving care. Telemedicine might address this need. The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical; (2) process; and (3) economic outcomes.
Project Methods: The investigators propose to use a randomized between groups repeated measures (baseline, post-treatment, 3\& 6-month followups) design with 226 OIF-OEF Veterans diagnosed with PTSD to assess the relative effectiveness, measured in terms of symptoms, patient satisfaction, and costs, of PE delivered via Telemedicine vs. In Person formats. The investigators hypothesize that no differences (i.e., non-inferiority) between the two formats will be evident in terms treatment gains, patient satisfaction, treatment attrition, patient satisfaction and direct health care costs.
Anticipated Impacts on Veterans Health care: This study will provide important information regarding whether PE delivered via home-based Telemedicine equipment is as effective as traditional In Person delivery of PE for post-traumatic stress disorder. If shown to be as effective as In Person treatment, a new, innovative, and cost effective intervention delivery system for PTSD will have initial empirical support.
#Intervention
- BEHAVIORAL : Telemedicine
- Prolonged Exposure (PE) therapy provided at patients house via telemedicine
- BEHAVIORAL : In Person
- PE therapy delivered in person at the VAMC
|
#Eligibility Criteria:
Inclusion Criteria:
Participants will be 226 male and female:
* Operation Iraqi Freedom, Operation Enduring Freedom (OIF OEF) Veterans, and Veterans of all theatres, particularly Vietnam era Veterans.
* age 21 and above, and
* diagnosed via structured clinical interview with PTSD
Exclusion Criteria:
* Actively psychotic or demented persons,
* individuals with both suicidal ideation and clear intent, and
* individuals meeting full criteria for substance dependence will be excluded from participation
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01102764
|
{
"brief_title": "Prolonged Exposure (PE) for Post Traumatic Stress Disorder (PTSD): Telemedicine Versus In Person",
"conditions": [
"PTSD"
],
"interventions": [
"Behavioral: In Person",
"Behavioral: Telemedicine"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01102764",
"official_title": "Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2015-09",
"study_start_date(actual)": "2010-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-04",
"last_updated_that_met_qc_criteria": "2010-04-12",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-13",
"first_submitted": "2010-03-17",
"first_submitted_that_met_qc_criteria": "2016-07-20"
}
}
}
|
#Study Description
Brief Summary
Speed skating is a sport in which there´s a lack of epidemiological studies. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. Through an online survey filled by semiprofessional athletes, it is posible to obtain all this important information. This way, it will be possible to fulfill a gap in the literature and take action in the near future in order to reduce the prevalence of injuries in this sport.
Detailed Description
A retrospective study will be performed in speed skaters. 100 speed skaters will be recruited. Data of all injury along a whole season will be collected. Patients' information, including age, number of years playing, skill level and injured body part, will be analysed
|
#Eligibility Criteria:
Inclusion Criteria:
* Being a speed skater and having competed in the 2018 spanish national championship
Exclusion Criteria:
* Being unable to understand the questionaire, do not accept on participating in the study.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05175183
|
{
"brief_title": "Epidemiology of Speed Skating-related Injuries",
"conditions": [
"Sports Injury"
],
"interventions": null,
"location_countries": [
"Spain"
],
"nct_id": "NCT05175183",
"official_title": "Epidemiology of Speed Skating-related Injuries",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-01",
"study_completion_date(actual)": "2022-02-01",
"study_start_date(actual)": "2021-12-01"
},
"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)": "2022-08-09",
"last_updated_that_met_qc_criteria": "2021-12-14",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-03",
"first_submitted": "2021-12-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Suboptimal use of medications among geriatric patients is well-known problem and leads to medication errors, re-hospitalizations and death. By using a randomized controlled trial (RCT) design the investigators aim to explore a new inter-professional working structure. The working structure is based on the scientifically and clinically acknowledged integrated medicines management (IMM) model. The overall aim of the study is to explore the effect of the new working structure on the composite endpoint re-hospitalization + visit to an emergency department during 12 months after hospital discharge.
#Intervention
- OTHER : Interdisciplinary collaboration structure
- A pharmacist is integrated in the team surrounding the patient, working by the Integrated Medicines Management (IMM) model. The IMM-model consist of medication reconciliation, medication review, standardized medication reports and counseling patients about their medication at discharge. In addition a phone meeting between the primary care physician and the study pharmacist is added after discharge.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged >=70 years
* Admitted to the geriatric internal medicine ward in the University Hospital of North Norway (UNN) Tromsø or the general internal medicine ward in UNN Harstad.
* Willing to provide written informed consent during hospital stay (patient or next of kin)
Exclusion Criteria:
* Unable to communicate in Norwegian (patient or next of kind)
* Terminally ill, e.g cancer in end-life stage
* Control group patients where the physician request an assessment from a pharmacist
* Time from admittance to the ward to inclusion is more than 72 hours
* Occupying a bed in the study wards but under the care of physicians from a non-study ward.
* Planned discharged on the inclusion day
Sex :
ALL
Ages :
- Minimum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02816086
|
{
"brief_title": "A New Interdisciplinary Collaboration Structure to Improve Medication Safety in the Elderly",
"conditions": [
"Health Services for the Aged",
"Medication Therapy Management"
],
"interventions": [
"Other: Interdisciplinary collaboration structure"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT02816086",
"official_title": "A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-20",
"study_completion_date(actual)": "2020-12-20",
"study_start_date(actual)": "2016-09-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-30",
"last_updated_that_met_qc_criteria": "2016-06-27",
"last_verified": "2020-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-28",
"first_submitted": "2016-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to better understand gender differences in end-of-life communication between physicians and patients with advanced cancer in the hospital.
|
#Eligibility Criteria:
Inclusion Criteria:
* English speaking, have metastatic cancer that has progressed despite treatment
Exclusion Criteria:
* Cognitive impairment
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
|
NCT01991015
|
{
"brief_title": "Goals of Care Discussions for Hospitalized Patients With Advanced Cancer",
"conditions": [
"Metastatic Cancer"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01991015",
"official_title": "Gender Differences in Inpatient Goals of Care Discussions in Patients With Advanced Cancer",
"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)": "2013-11"
},
"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)": "2015-02-09",
"last_updated_that_met_qc_criteria": "2013-11-21",
"last_verified": "2015-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-25",
"first_submitted": "2013-11-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.
Detailed Description
PrEP will be delivered to young women according to emerging national guidelines in family planning clinics (Kisumu, Kenya), youth friendly clinics (Johannesburg, South Africa), and mobile youth friendly clinics (Cape Town, South Africa). The investigators will evaluate PrEP delivery and follow cohorts of young women at each clinic location to understand PrEP uptake and use. In the Kisumu clinics, the investigators will also offer expedited partner therapy and partner HIV self-tests to women who test positive for chlamydia and/or gonorrhea. At one clinic in Johannesburg, the investigators will evaluate the use of a decision support tool to improve the decision to initiate PrEP.
#Intervention
- DRUG : Truvada
- A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 16 <= age <= 25 (16 and 17 year olds, where permissible by national regulations and local IRB approval)
* Able and willing to provide written informed consent
* Recently sexually active (defined as having had vaginal intercourse at least once in the previous three months)
* HIV uninfected based on negative HIV rapid tests, on the date of enrollment
Sex :
FEMALE
Ages :
- Minimum Age : 16 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03490058
|
{
"brief_title": "The Prevention Options for Women Evaluation Research (POWER) Cohort",
"conditions": [
"HIV/AIDS"
],
"interventions": [
"Drug: Truvada"
],
"location_countries": [
"Kenya",
"South Africa"
],
"nct_id": "NCT03490058",
"official_title": "A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-04",
"study_completion_date(actual)": "2021-07-23",
"study_start_date(actual)": "2017-06-14"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-12-06",
"last_updated_that_met_qc_criteria": "2018-03-29",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-06",
"first_submitted": "2018-03-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if new varieties of fruits grown in Scotland which can adapt better to climate change namely, honeyberries and cherries, have the same health benefits as established fruits such as raspberries. To do this we will investigate the effects of consuming honeyberries, cherries, and raspberries on short term changes in blood glucose, and on short term memory.
Detailed Description
As humans spend most of their day in a postprandial state, it is imperative that the metabolic effects of diets are well understood if the incidence of chronic disorders such as type 2 diabetes (T2D) is to be controlled. Current estimates place global incidence of diabetes at 537 million, and this number is predicted to rise a further 45% by 2045. T2D is linked to increased risk of developing other chronic health conditions including cardiovascular disease (CVD) and dementia.
Controlling the acute glycaemic response and avoiding hyperglycaemia is essential for reducing diabetic risk. In addition, acute hyperglycaemia may provoke metabolic reactions increasing CVD risk and lower episodic memory even in non-diabetic individuals. Diet has an important role to play, and modern Western diets typically have high glycaemic loads due to excessive refined and total carbohydrate contents. As a result, the average blood glucose concentration of individuals has increased over the past three decades.
Polyphenolic constituents of foods may help to delay starch and disaccharide digestion and glucose absorption following a carbohydrate-containing meal or beverage. In vitro studies suggest that some polyphenols found in fruits are effective inhibitors of digestive enzymes, α-amylases and α-glucosidases and inhibit the action of intestinal glucose transporters. There is only a small amount of information available from human studies however, randomized controlled trials (RCTs) have shown that fruits reduced postprandial glucose concentrations following consumption of either starch, glucose or sucrose loads. Strategies to control chronic postprandial hyperglycaemia through increased consumption of such polyphenol rich foods would strengthen efforts to reduce the risk of developing T2D in the general population.
The aim of this study is to test the health benefits of new climate resistant fruit high in polyphenols grown in Scotland with and an existing crop already established in the fruit market. The hypothesis is that consumption of honeyberries and cherries grown in Scotland is as effective as raspberries in reducing the postprandial glycemic response in normal weight /overweight, healthy men, and post-menopausal women. With a secondary objective looking at the effects of these fruits on cognitive function.
This is a randomized cross over study and will aim to recruit 28 normal to overweight (BMI ≥ 18.5 and \< 39.9), men or post-menopausal women (post-menopausal defined as not having had a period for over a year), aged ≥40 and ≤ 70 years who will attend four study sessions. The first study session will be an oral glucose tolerance test (OGTT) and the remaining three will be identical in all respects except for the addition of the fruit. Consecutive blood samples will be collected in all 4 study sessions which will be used to measure glucose, insulin, C-peptide, incretins, and lipids. Cognitive function the secondary outcome will be measured using a series of memory tests.
#Intervention
- DIETARY_SUPPLEMENT : Honeyberry
- To investigate changes in postprandial glucose and cognitive performance, after consumption of honeyberries grown in Scotland.
- DIETARY_SUPPLEMENT : Cherry
- To investigate changes in postprandial glucose and cognitive performance, after consumption of cherries grown in Scotland.
- DIETARY_SUPPLEMENT : Raspberry
- To investigate changes in postprandial glucose and cognitive performance, after consumption of raspberries grown in Scotland.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy men or post-menopausal women
* Aged >=40 and <= 70 years.
* BMI >= 18.5 kg/m2
* HbA1c <6.5%
Neuropsychological screening tasks will include the Mini-Mental State Examination (MMSE), the National Adult Reading Test (NART), the Geriatric Depression Scale (GDS), the Trail Making Test (TMT), the Controlled Oral Word Association Test (COWAT), the Hopkins Verbal Learning Test (HVLT),
* MMSE >= 27
* NART, TMT, COWAT and HVLT within acceptable norms
Exclusion Criteria:
* Exclusion Criteria
Those with any of the following will be excluded from participation:
We will ask the volunteers to complete a questionnaire to state current health complaints and current medication use.
Chronic illness, including: thromboembolic or coagulation disease unregulated thyroid disease kidney disease hepatic disease severe gastrointestinal disorders pulmonary disease (e.g. chronic bronchitis, COPD, pacemaker implant) Alcohol or any other substance abuse Eating disorders a history of neurological abnormalities, Women who are lactating or breastfeeding, pregnant Allergic/intolerant to foods provided in the study (Fruit allergy). Alcohol and/or other substance abuse Smoking and the use of e-cigarettes Physically active at a competitive level (exercising strenuously on a daily basis for long periods of time)
Medication exclusion criteria Oral steroids Tricyclic antidepressants, neuroleptics Anticoagulants Digoxin and anti-arrhythmics Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin. Chronic use of anti-inflammatories (e.g. > 200mgs doses of aspirin, ibuprofen), current psycho-active medication chlorphenamine
Neuropsychological exclusion criteria
* MMSE < 27
* GDS > 5
* Self-report of prior diagnosis of dementia, probable dementia, or mild cognitive impairment
* History of stroke, severe head injury or other neurological condition which may adversely affect cognition
* history of anxiety and depression
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05513404
|
{
"brief_title": "The Scottish Fruit Study",
"conditions": [
"Postprandial Hypoglycemia",
"Age-Related Memory Disorders"
],
"interventions": [
"Dietary Supplement: Cherry",
"Dietary Supplement: Honeyberry",
"Dietary Supplement: Raspberry"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT05513404",
"official_title": "Acute Study of Polyphenol-rich Honeyberries, Cherries, and Raspberries Grown in Scotland on Postprandial Glycaemic Response",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-31",
"study_completion_date(actual)": "2024-03-31",
"study_start_date(actual)": "2022-08-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-09",
"last_updated_that_met_qc_criteria": "2022-08-23",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-24",
"first_submitted": "2022-08-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy.
#Intervention
- DRUG : Everolimus (RAD001)
- DRUG : Tacrolimus
- DRUG : Basiliximab
- DRUG : Corticosteroids
|
#Eligibility Criteria:
Inclusion criteria
* Male or female of 18 <= age <= 65 years
* Patient who has received a primary kidney transplant from a cadaveric, living unrelated or non-human leucocyte antigen (HLA) identical living related donor
* Recipient of a kidney with a cold ischemia time (CIT) < 30 hours
* Recipient of a kidney from a donor 10 <= age <= 65 years
* Patient able to receive the first dose of tacrolimus within 24 hours from graft reperfusion
* Female capable of becoming pregnant must have a negative pregnancy test and is required to practice a medically approved method of birth control for the duration of the study and for a period of three months following discontinuation of investigational drug
* Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
Exclusion criteria
* Patient who has previously received an organ transplant
* Recipient of multiple organ transplants
* Recipient of a kidney transplant from a non heart-beating donor
* Recipient of donor specific transfusions
* Recipient of A-B-O incompatible transplant or T-cell cross-match positive transplant
* Patient with current Panel Reactive Antibodies (PRA) level >= 50%
* Recipient of a kidney from a donor who tests positive for hepatitis B surface antigen or hepatitis C antibodies
* Patient who is human immunodeficiency virus (HIV) positive
* Patient who has a positive hepatitis C serology or who is hepatitis B surface antigen positive with evidence of liver injury as indicated by aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels >=2.5 times upper limit of normal (UNL). Viral serology results obtained within 6 months prior to the administration of the first dose of Certican™ are acceptable
* Patient with severe hypercholesterolemia (350 mg/dL, 9.1 mmoL/dL) or hypertriglyceridemia ( 500 mg/dL, 5.6 mmoL/L)
* Patient with white blood cell (WBC) count 3,000/mm3 or with platelet count 75,000/mm3
* Patient with any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or with hypersensitivity to drugs similar to Certican (e.g., macrolides)
* Patient who has been treated with an immunosuppressive drug or an investigational drug within 4 weeks prior to the administration of the first dose of Certican
* Patient with uncontrolled infection
* Patient with any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment in this trial
* Patient with a known malignancy or a history of malignancy within last 5 years other than successfully treated localized basal or squamous cell carcinoma of the skin
* Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to the administration of the first dose of Certican™ which at investigator's discretion would interfere with the objectives of the study
* Breast feeding women
* Patient with symptoms of significant somatic or mental illness or with unresolved history of drug or alcohol abuse
* Patient unable to cooperate or communicate with the investigator
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
|
NCT00369161
|
{
"brief_title": "A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients",
"conditions": [
"Renal Transplantation"
],
"interventions": [
"Drug: Everolimus (RAD001)",
"Drug: Tacrolimus",
"Drug: Basiliximab",
"Drug: Corticosteroids"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT00369161",
"official_title": "A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With IL-2 Receptor Antagonist, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-12",
"study_completion_date(actual)": "2008-12",
"study_start_date(actual)": "2006-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-03",
"last_updated_that_met_qc_criteria": "2006-08-25",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-08-29",
"first_submitted": "2006-08-25",
"first_submitted_that_met_qc_criteria": "2010-12-17"
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current smokers under four distinct conditions: after smoking a conventional cigarette, an electronic cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and after taking a nicotine lozenge. Participants will be asked to attend four morning study visits after overnight smoking abstinence. Standardized questionnaires will be used to assess changes under each condition, allowing for the investigation of the efficacy of e-Cigarettes in reducing craving by replacing the behavioral component of smoking with minimal risk of adverse effects.
Detailed Description
Many addiction models postulate stimuli to be linked with nicotine intake and reward after prolonged use. As such, smoking becomes more heavily based in habit, initiated by cues. Craving has been found to be a crucial component of continued smoking and relapse in response to various environmental and behavioral cues. Electronic Cigarettes (e-Cigarettes) are new smoking products emerging in consumer markets that often mimic conventional tobacco cigarettes. E-Cigarettes commonly include a cartridge, a heating element, a puff sensor, and a battery. When a user draws on the device, the heating element is activated and the cartridge fluid is vaporized. Users then inhale the aerosol containing droplets of the vaporized fluid. This study will empirically assess the efficacy of e-Cigarettes in alleviating craving by replacing the behavioral component of smoking. Using standardized questionnaires, intra-subject changes in cue- and withdrawal-induced craving after smoking an e-Cigarette without nicotine will be compared with that after either smoking a conventional cigarette, an e-Cigarette with nicotine, or taking a 4mg lozenge.
#Intervention
- DRUG : Nicotine
- E-Cigarette with nicotine cartridge
- DRUG : Placebo
- E-Cigarette with 0mg nicotine cartridge
|
#Eligibility Criteria:
Inclusion Criteria:
* Current daily smoker
* Smoke minimum of 10 cigarettes per day
* Fagerstrom Test of Nicotine Dependence Score equal or greater than 3
* Never used an e-Cigarette prior to the study
* No intention to quit smoking within the next 3 months
* Able to provide written informed consent
* Able and willing to attend scheduled appointments
Exclusion Criteria:
* Any serious medical or unstable psychiatric problems requiring treatment
* Pregnancy or lactation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02108626
|
{
"brief_title": "Electronic Cigarettes in Daily Dependent Smokers",
"conditions": [
"Substance Withdrawal Syndrome",
"Nicotine Dependence"
],
"interventions": [
"Drug: Nicotine",
"Drug: Placebo"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02108626",
"official_title": "A Behavioral Assessment of Electronic Cigarettes in Reducing Cue- and Withdrawal-induced Craving in Daily Dependent Smokers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-04",
"study_completion_date(actual)": "2015-04",
"study_start_date(actual)": "2014-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-05",
"last_updated_that_met_qc_criteria": "2014-04-07",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-09",
"first_submitted": "2014-04-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Mobile games are used as a powerful learning tool today. It is very useful as it allows students to work on their own frequently when necessary without the need for any physical environment or trainer and can be easily distributed among institutions. While the simulation laboratories established in a school can only be used by the students of that school, a game developed can be used by all students in the world who know that language.
It is reported that breech presentation, which is one of the presentation disorders of the fetus, is the fourth or fifth most common indication for delivery by cesarean section. According to the midwifery national core curriculum in our country, vaginal breech delivery management training is given within the scope of risky birth course. However, it is known that teaching and learning the labor and delivery process of a breech-presented fetus is not easy. For this reason, it is thought that teaching vaginal breech delivery management by gamifying will be beneficial and it is important to investigate the effect of students playing this game on learning.
Our study has two aims. Its primary purpose is; is to design a vaginal breech delivery management educational mobile game for midwifery students. The secondary aim is to evaluate the effect of the educational mobile game-supported teaching activity given to midwifery students about vaginal breech delivery within the scope of risky birth and postpartum period course.
Real actors and simulation models were used to fake the scenario to be used in the game. A mobile game was prepared with the film shot. It was conducted with 10 volunteer students from Marmara University Health Sciences Faculty Midwifery Department 3rd grade students in order to determine whether there is any aspect of the mobile game that requires development. The mobile game, which was shaped and organized with the pilot application, was applied to the students in the 3rd grade play group of Kocaeli University Health Sciences Faculty Midwifery Department after single-blind randomization. Introductory features form, vaginal breech birth management knowledge test, course effectiveness evaluation form, general satisfaction level test about the course and vaginal breech birth management mobile game evaluation form were used to collect data.
Detailed Description
H1: There is a statistically significant difference between the Vaginal Breech Birth Management Post-Test of Knowledge scores of the students in the play group and the students in the control group.
H2: There is no statistically significant difference between the mean scores of the students in the play group and the students in the control group in the Vaginal Breech Birth Management Post-Test of Knowledge.
H3: There is a statistically significant difference between the Vaginal Breech Birth Management Knowledge Retention Test mean scores of the students in the play group and the students in the control group.
H4: There is no statistically significant difference between the Vaginal Breech Birth Management Knowledge Retention Test mean scores of the students in the play group and the students in the control group.
Variables of the Study Independent variable Playing the vaginal breech delivery management mobile game for the students taking the Normal Birth and Postpartum Period course The dependent variable Vaginal breech birth management knowledge test, course effectiveness evaluation form, general satisfaction level test for the course, mobile game evaluation forms Research Design It is a prospective, single-blind, randomized controlled experimental type study with a pretest-posttest design.
Place and Time of Research The research is carried out with 3rd grade students within the scope of Risky Birth and Postpartum Term course in the 2021-2022 academic year spring semester at Kocaeli University, Faculty of Health Sciences, Midwifery Department, and the pilot application of the research is carried out with 3rd grade students of the Midwifery Department of Marmara University Health Sciences Faculty.
Population and Sample of the Research The universe of the research consists of 81 3rd grade midwifery students from Kocaeli University Faculty of Health Sciences in the 2021-2022 academic year in order to be the institution where the researcher works and to facilitate data collection. According to the sample calculation, it was planned to reach at least 68 students at the 5% Type 1 error level and the 95% confidence interval. It was planned to apply the study to the whole population in order to prevent possible case losses. A total of 79 students were included in the sample because two of the students did not attend the classes.
Ethical aspect of research Ethics committee approval for the study was received from Kocaeli University Non-Interventional Clinical Research Ethics Committee (approval date / decision no: GOKAEK-2022/02.11) on 28.01.2022. Written permissions were obtained from the Kocaeli University Faculty of Medicine Dean's Office for the use of the simulation laboratory, where the scenario will be filmed, from the Marmara University Faculty of Health Sciences for the pilot application of the play, and from the Kocaeli University Faculty of Health Sciences Dean's Office for the implementation phase of the study. During the preliminary and pilot implementation, the participants were informed verbally and in writing about the purpose of the research and that their personal information would be kept confidential. However, it was stated to the participants that participation in the study was on a voluntary basis and if they submitted the study forms, they would be deemed to have given their consent to participate in the study. Our study is carried out in accordance with the Principles of the Declaration of Helsinki.
Randomization and creation of groups Kocaeli University Faculty of Health Sciences, 2021-2022 academic year, 81 3rd grade midwifery students were divided into experimental and control groups using the computer-assisted (www.randomizer.org) randomization program. The experimental group was called the play group, and the other group was called the control group.
All students will be asked not to share their intervention experiences until the research process is completed by the researcher.
During the research process, the traditional education method will not be explained to the students in the play group and the delivery management of the breech-presented fetus, and the vaginal breech delivery management mobile game will not be played to the students in the control group. After the study process is completed, both education methods will be applied to the students in both groups.
Development of the Mobile Game to be Used in the Research In the prepared mobile game, the labor process of the pregnant was recorded with the actors acting, and the breech birth scene was recorded using simulation models.
The creation of mobile game content consists of five parts. In the first part, the determination of the game to be digitized and the creation of the game-specific scenario and scenario questions are included, while the second part includes the presentation of the scenario and scenario questions to expert opinions. In the third part, the film is shot by putting the scenario on the stage, and the transfer of the film shot in the fourth part to the mobile game and the pilot application of the game are included. In the fifth section, which is the last section, the effectiveness of the vaginal breech delivery management mobile game developed on the 3rd grade students of the Department of Midwifery, Faculty of Health Sciences, Kocaeli University, was evaluated.
First part: The story of the game, characters related to the game and questions about the player were created in line with the relevant literature in determining the game and creating the original scenario.
Second part: The scenario and scenario questions were sent to eight academicians who are experts in the field of midwifery and have at least five years of academic experience, and seven clinician midwives with at least five years of delivery room experience. Areas were created to evaluate the submitted scenario as positive and negative for each section's features, and experts were asked to express their views on those areas. In line with the evaluations received, the final version of the scenario and scenario questions were obtained. The draft of the script was then scripted by a screenwriter and the lines were created.
Third part: Real actors and simulation models were used to fake the script. Film and model simulation shooting was carried out with a professional team at Kocaeli University Good Physician Practices and Simulation Center, where the necessary institutional permission was obtained, with the role of professional actors, whose consent was obtained before. The creation of realistic scenes was provided by the necessary equipment (make-up, professional camera, etc.).
Pregnant and her partner were played by two professional actors. A fake pregnant belly model was applied to the woman who assumed the role of pregnant with the help of professional make-up. In applications performed from the abdominal region such as the Leopold maneuver, electronic fetal monitoring application, and FKA listening, the abdomen of the pregnant woman was opened so that only the abdominal region was visible. In midwifery practices such as vaginal examination, no demonstration was made, but the impression that vaginal examination would be performed was reflected. During the movie, a gimbal camera was used at the head of the actor who will play the role of a midwife. In this way, it was ensured that the event pattern was observed from the eyes of the midwife.
During the birth, the moment of birth was animated with models by using simulation models. The camera is set to record only maneuvers used at the time of birth and postpartum procedures.
The fourth part: In the transfer of the film to the mobile game, individual service was received from an information system engineer who is an expert in his field.
In the mobile game, questions appear on the screen at certain intervals during the movie, and the movie continues to play after the student answers the question. When the student gives a wrong answer to the question, a text is displayed stating why that answer is wrong. In cases where filming was appropriate, the results of the wrong choice were transferred to the film and the actor was able to visually and audibly watch the result of the wrong answer. Playing the game takes an average of 30-45 minutes.
In order for students to access the mobile game, a different user name and password were created for each student. The link required to download the game and the username and password that were created before to enter the game were sent to the student by the researcher over the internet (e-mail/WhatsApp).
After the game was developed, a pilot application was made. This app helped determine how long it would take to complete the mobile game and whether there were any aspects of the game that needed improvement. The pilot application of the game and measurement tools was carried out with 10 volunteer students from the 3rd grade students of the Department of Midwifery, Faculty of Health Sciences, Marmara University, for which the necessary institutional permission was obtained.
Fifth Part: The mobile game, which was shaped and organized with the pilot application, was applied to the students in the 3rd grade playgroup of Kocaeli University Faculty of Health Sciences Midwifery Department after single-blind randomization on May 13, 2022.
Data Collection Forms Introductory features form, vaginal breech birth management knowledge test, course effectiveness evaluation form, general satisfaction level test for the course, vaginal breech birth management mobile game evaluation forms were used to collect data. All forms to be used in data collection were submitted to expert opinions after obtaining ethical committee permission and institutional permissions, and they were finalized.
Introductory features form: It is the form in which the socio-demographic and previous knowledge of digital game playing of the students participating in the study are questioned.
Vaginal breech birth management knowledge test: A questionnaire was created in line with the relevant literature in line with the content of the risky birth and postpartum course in order to provide the necessary knowledge and skills for the management of the labor and delivery process of the pregnant with the fetus in breech presentation, to make appropriate interventions, and to adopt the roles and responsibilities of the midwife. The created questionnaire was presented to the expert opinion along with the scenario, and it was finalized in line with the feedback received. These questions will be evaluated with the assessment and evaluation system developed independently of the educational mobile game. Each correct answer is 1 point, and the maximum score that can be obtained from the test will be determined by the number of questions.
Course effectiveness evaluation form: The form, which was prepared by the researchers in line with the literature review, was applied to the play group after the vaginal breech delivery management mobile game was played, and to the control group after the birth management training of the breech presentation fetus, which was given through traditional education. In this questionnaire, there are statements that allow the evaluation of the education given by the student. The minimum score to be taken from the form to be evaluated with a 5-point Likert-type (1=Totally disagree, 2=Disagree, 3=Undecided, 4=Agree, 5=Totally Agree) is 11, and the maximum score is 55.
General satisfaction level test for the lesson: It was applied to the play group after the vaginal breech management educational mobile game was played, and to the control group after the birth management training of the breech presentation fetus, which was given through traditional education. The test, in which the participants will be asked to indicate their general level of satisfaction with the lesson, will be evaluated with a 6-point Likert type, and the average score of the test in both groups was calculated.
Vaginal breech delivery management mobile game evaluation form: It is a questionnaire developed by the researchers in line with the literature review to evaluate the clarity and convenience, suitability and quality of the mobile game by the players. In this survey; The harmony of the text, fonts and colors of the game, the legibility of the size and style, the attractiveness and clarity of the game design (interface, graphics, etc.), the ease of learning and playing, the state of the game's content and structure to increase the player's knowledge and self-confidence about the subject, the fluency of the game, the lesson. There are expressions that evaluate the opinions of the players, such as the situation of being a reinforcing tool. The minimum score to be taken from the form to be evaluated with a 5-point Likert type (1=I totally disagree, 2=Disagree, 3=Undecided, 4=Agree, 5=Completely Agree) is 39, and the maximum score is 195.
Statistical analysis will be performed using the IBM SPSS Statistic 22.0 (IBM Corp., Armonk, NY, USA) program. Descriptive statistical methods (number, percentage, mean, standard deviation) will be used in the evaluation of socio-demographic data. Parametric tests (chi-square, T test, etc.) will be used in the comparison of categorical variables when the data are found to be suitable for normal distribution, and non-paramedic tests (Mann-Whitney U Test, Kruskal Wallis, etc.) will be used when they are not suitable for normal distribution.
#Intervention
- OTHER : Playgroup
- The mobile game will be sent to the students via a link and the students are allowed to install it on their mobile phones with android and ios operating systems. The internet required for the download was provided by the researcher. For the students who did not have a smart phone in the playgroup, the game would be started from the researcher's phone and the game was played sequentially. All students were allowed to use headphones while playing the game. In order to log in to the game, an account was created on behalf of each student, and the game user name and password were sent to the students by e-mail. It was ensured that they did not communicate with anyone and did not receive help during the game with the supervision of the researcher. Waited until each participant completed the game. Then, the mobile game was deleted from the smartphones of all participants, and the download link was inactive until the research process was completed.
- OTHER : Control group
- The researcher gave a theoretical lesson through the presentation prepared in the powerpoint program about the birth management of a breech-presented fetus in the classroom as in the traditional education method.
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteering to participate in the research,
* Being a midwifery student,
* Being a 3rd year student at Kocaeli University, Faculty of Health Sciences, Department of Midwifery,
* To have taken the Normal Birth and Postpartum Period course.
Exclusion Criteria:
* Not having a mobile phone or using mobile games
* Leaving the research process for any reason
* To have received practical or theoretical training on breech birth before
* Being unable to speak, read and write Turkish
Sex :
FEMALE
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
|
NCT05551611
|
{
"brief_title": "Vaginal Breech Birth Management Educational Mobile Game",
"conditions": [
"Vaginal Breech Delivery Management",
"Mobile Game"
],
"interventions": [
"Other: Playgroup",
"Other: Control group"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05551611",
"official_title": "Vaginal Breech Birth Management Educational Mobile Game Design and Evaluation for Midwifery Students",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-27",
"study_completion_date(actual)": "2022-05-12",
"study_start_date(actual)": "2022-02-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-14",
"last_updated_that_met_qc_criteria": "2022-09-20",
"last_verified": "2022-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-09-22",
"first_submitted": "2022-09-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Collection of coronary images with a hybrid IVUS OCT system.
Detailed Description
A prospective observational imaging study in patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome.
#Intervention
- DEVICE : Observation group
- Collect coronary images with a hybrid IVUS OCT system.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient is at least 18 years.
* Patients arriving for coronary angiography or possible PCI with stable angina or acute coronary syndrome (including unstable angina, NSTEMI or STEMI).
* Patients with STEMI may be undergoing subsequent staged PCI to additional coronary stenoses after the index STEMI event has been successful treated with primary PCI.
* Vascular access of at least 6F.
* Patient provides informed, written consent for participation in the study.
* A target lesion is present in a suitable artery for intravascular imaging.
Exclusion Criteria:
* Angiographic evidence of severe calcification
* Marked tortuosity that precludes imaging of a target coronary artery.
* GFR (Glomerular filtration rate) <35 mL/min.
* Patients in cardiogenic shock.
* Women of child bearing potential, in whom pregnancy cannot be excluded.
* Patients of age < 18 years.
* Patients with an allergy to contrast.
* Patients unable to grant informed, written consent for participation in 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
|
NCT03484975
|
{
"brief_title": "Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)",
"conditions": [
"Stable Angina",
"Acute Coronary Syndrome"
],
"interventions": [
"Device: Observation group"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03484975",
"official_title": "Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08-06",
"study_completion_date(actual)": "2021-08-18",
"study_start_date(actual)": "2018-08-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-08-31",
"last_updated_that_met_qc_criteria": "2018-03-26",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-02",
"first_submitted": "2018-03-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Obesity in the world represents a growing share of the general population. At hospital, the management of these patients could be problematic especially when calculating the drug dosage.
According to the French guidelines, neostigmine, a cholinesterase inhibitor, should be used to reverse a residual neuromuscular blockade at a dose of 0.4 mg/kg of total body weight in non-obese patients. In morbidly-obese patients, with the modification of the fat/lean mass ratio, the optimal dose of neostigmine is non-consensual. To calculate the dose of neostigmine, some anesthesiologists use the total body weight, others use the ideal body weight and others use the adjusted body weight.
Due to this practice variability, It may be useful to observe the mean time to recovery of neuromuscular blockade and side effects after pharmacological reversal according to the dosage of neostigmine.
#Intervention
- OTHER : NO INTERVENTION, it is an observational study
- No intervention
|
#Eligibility Criteria:
Inclusion Criteria*:
* Adult obese patients (>= 18 years and BMI >= 35 Kg/m²), both sexes
* Any elective bariatric surgery
* Neuromuscular blockade with rocuronium
* Maintenance of anesthesia with a halogenated agent
* Free patient, without guardianship or subordination
* Patients with a social security coverage
* No opposition given by the patient after clear and fair information
Exclusion Criteria*:
* Patients with hypersensitivity to the active substance or to other derivatives, or to any of the excipients of neostigmine,
* Emergency surgery,
* Severe renal and / or hepatic insufficiency,
* Persons benefiting from enhanced protection, namely pregnant women, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally sick people in emergency situation.
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
|
NCT04244266
|
{
"brief_title": "Observational Study in Bariatric Surgery",
"conditions": [
"Obesity",
"Neostigmine",
"Residual Neuromuscular Blockade"
],
"interventions": [
"Other: NO INTERVENTION, it is an observational study"
],
"location_countries": [
"France"
],
"nct_id": "NCT04244266",
"official_title": "Observational Study of the Pharmacological Reversal of the Residual Neuromuscular Blockade in Bariatric Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-14",
"study_completion_date(actual)": "2023-06-14",
"study_start_date(actual)": "2020-01-29"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-06",
"last_updated_that_met_qc_criteria": "2020-01-24",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-28",
"first_submitted": "2020-01-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a pilot study of an automated, internet-based pain coping skills training (PCST) program, PainCOACH.
Detailed Description
Background and Significance: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that impacts multiple organ systems. SLE results in a variety of challenging symptoms, including flare-ups and periods of remission that are unpredictable, and it is a complex disease to manage clinically. Because of these factors, SLE often has a major impact on patients' quality of life. Notably, SLE is often associated with pain, fatigue, emotional symptoms like anxiety and depression, and disability. Because of the relatively young average age of SLE onset, many patients must navigate these challenges while maintaining work and / or caring for young children.
Prior studies show that greater use of adaptive coping strategies and greater self-efficacy for coping with SLE-related symptoms are associated with better physical and psychological outcomes. Conversely, maladaptive coping behaviors, particularly pain catastrophizing (e.g., focusing on and exaggerating the threat of pain and negatively evaluating one's ability to deal with pain), are associated with poorer SLE outcomes. Importantly, many studies in other rheumatic conditions have shown that pain coping skills training (PCST) programs can improve coping patterns, as well as physical and psychological health outcomes. However, there have been no trials of PCST among individuals with SLE, who face a unique set of disease-related challenges and are overall younger than patients with many other rheumatic conditions. Delivery of PCST programs to patients with SLE could have a tremendous impact on outcomes and quality of life, but this evidence base needs to be established, including adaptations of current PCST programs that may be important specifically for patients with SLE. Therefore, the objective of this project is to conduct a pilot study of an automated, internet-based PCST program, PainCOACH, that has been shown to improve multiple key outcomes among patients with osteoarthritis
Study Aims: This project has three specific aims: 1) Evaluate the feasibility and acceptability of PainCOACH among patients with SLE. 2) Obtain a preliminary assessment of the efficacy of PainCOACH (relative to a wait list control group) for improving pain interference and other key outcomes among patients with SLE 3) Determine appropriate adaptations to PainCOACH for patients with SLE.
Study Description: Investigators will conduct a randomized pilot study, with N=60 patients age \>= 18 years with physician diagnosis of systemic lupus erythematosus (SLE), equally allocated to PainCOACH and a wait list control group that will be offered PainCOACH after completion of the 9 week follow-up assessment. This design will allow a between-group comparison as well as collection of acceptability data from the control group following their completion of PainCOACH. Outcomes will be assessed at baseline and at about 9 week follow-up as PainCOACH is designed for delivery over 8 weeks.
#Intervention
- BEHAVIORAL : PainCOACH
- PainCOACH is an eight-week, automated, internet-based training in specific pain coping skills (such as progressive muscle relaxation, pleasant imagery and activity pacing), and guided practice with each skill.
|
#Eligibility Criteria:
Inclusion Criteria:
* physician diagnosis of Systemic lupus erythematosus (SLE)
Exclusion Criteria:
* significant memory loss
* active psychosis or substance abuse
* neuropsychiatric SLE
* severe hearing impairment
* inability to speak English
* pregnant or planning to become pregnant in the next 3 months
* current participation in another SLE-related trial
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03933839
|
{
"brief_title": "Internet-Based Pain Coping Skills Training for Patients With Lupus",
"conditions": [
"Lupus Erythematosus, Systemic"
],
"interventions": [
"Behavioral: PainCOACH"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03933839",
"official_title": "Internet-Based Pain Coping Skills Training (PainCOACH) for Patients With Lupus",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-22",
"study_completion_date(actual)": "2020-04-22",
"study_start_date(actual)": "2019-05-20"
},
"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)": "2020-05-20",
"last_updated_that_met_qc_criteria": "2019-04-29",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-01",
"first_submitted": "2019-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels
Detailed Description
The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, limb preservation, and high rates of restenosis and disease progression. This study will record the use of ELUTAX SV-DEB under real life conditions in a representative sample.The investigators will generate new data in observing the outcome and the safety of the Elutax SV drug-eluting balloons for change in Rutherford clinical category from baseline to 6 and 12 month follow-up visits.
#Intervention
- DEVICE : Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV
- Angioplasty for revascularization in below-the-knee arteries
|
#Eligibility Criteria:
Inclusion Criteria:
* Paclitaxel-eluting balloon angioplasty in below-the-knee lesions with ELUTAX SV-DEB
* Age >= 18 years
* Signed informed consent
* documented Critical Limb Ischemia (CLI) in the target limb prior to the study
* Rutherford Category 4, 5 or 6
* >=70% diameter stenosis or occlusion in the target lesion, including de-novo / in-stent restenosis/occlusion of target lesion
* Patent inflow artery
* Target vessel(s) diameter between 2 and 4 mm
* Target vessel(s) reconstitute(s) at or above the ankle
Exclusion Criteria:
* Life expectancy below 50% within the next 12 months (as judged by the investigator)
* Planned major index limb amputation
* Acute limb ischemia (within last 14 days thrombectomy, atherectomy, or lysis)
* Application of DEB-eluting balloons except from ELUTAX SV in the same target limb (POBA is allowed)
* Patient unwilling or unlikely to comply with follow-up schedule
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
|
NCT02539940
|
{
"brief_title": "Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment",
"conditions": [
"Critical Limb Ischemia",
"Peripheral Artery Disease"
],
"interventions": [
"Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02539940",
"official_title": "A Prospective Observational Study Using Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04",
"study_completion_date(actual)": "2018-10",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-10",
"last_updated_that_met_qc_criteria": "2015-09-02",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-03",
"first_submitted": "2015-08-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
* The purpose of this study is to describe the safety of the study vaccine (called 13vPnC) in people who are 18-49 years of age in India.
* This study is seeking participants who are generally healthy adults ≥18 and \<50 years of age, with no prior history of pneumococcal vaccination.
* Participants will take part in the study for approximately one month which includes two visits to the study clinic.
* Participants will receive a single dose of study vaccine (13vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.
#Intervention
- BIOLOGICAL : 13-valent pneumococcal conjugate vaccine
- One dose of 13vPnC (0.5mL) will be administered intramuscularly.
|
#Eligibility Criteria:
Inclusion Criteria:
* Generally healthy participants between the ages of >=18 and <50 years at the time of consent.
* Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion Criteria:
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, or to any other diphtheria toxoid-containing vaccine.
* Congenital, functional, or surgical asplenia.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05329259
|
{
"brief_title": "A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India",
"conditions": [
"Pneumococcal Disease"
],
"interventions": [
"Biological: 13-valent pneumococcal conjugate vaccine"
],
"location_countries": [
"India"
],
"nct_id": "NCT05329259",
"official_title": "A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO DESCRIBE THE SAFETY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 TO 49 YEARS OF AGE IN INDIA",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-30",
"study_completion_date(actual)": "2022-11-30",
"study_start_date(actual)": "2022-10-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-26",
"last_updated_that_met_qc_criteria": "2022-04-07",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-14",
"first_submitted": "2022-04-07",
"first_submitted_that_met_qc_criteria": "2023-11-21"
}
}
}
|
#Study Description
Brief Summary
The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.
Detailed Description
Hemodiafiltration (HDF) is a dialysis technique that allows the removal of high molecular weight toxic solutes exploiting the convective transport through the dialyzer membrane: at the same time, the HDF has a positive impact on the systemic hemodynamic, ameliorating in this way the tolerance of the treatment. Unfortunately, also the HDF therapy can be not well tolerated, introducing in the patients serious hypovolemia during the removal of the body water accumulated in the interdialytic period.
The HemoControl system, automatically controlling the relative blood volume change of the patient, avoids the onset of the hypovolemia. Today the HemoControl system can be used only during conventional hemodialysis treatments; the objective of this study is to combine the advantages of the intradialytic hemodynamic stabilization achievable by means of HemoControl with the inherent advantages, both of depurative and cardiovascular kind, typical of the Hemodiafiltration technique.
#Intervention
- DEVICE : ARTIS hemodialysis system
- Software versions:
Control Product: 8.06.01KA. Study Product: 8.06.01B_HC01
- Other Names :
- Artis™ hemodialysis system, HEMOCONTROL™, GAMBRO
|
#Eligibility Criteria:
Inclusion Criteria:
* A subject must meet ALL of the following inclusion criteria in order to participate in this study:
* ESRD in chronic dialysis treatments for at least 3 months
* Age >= 18 years
* Body weight >= 40 kg
* Blood flow rate >= 250 ml/min with a recirculation of the vascular access < 5%
* Use of not fractioned heparin in continuous infusion as anticoagulant
* Stable anticoagulation dosage over the last 6 treatments
* Stable dialysis prescription (Qb, Qd, treatment time) over the last 6 treatments
* Informed consent for participating to the study
* Stable Haemoglobin concentration at beginning of the treatment lower than or equal to 14 g/dl.
Exclusion Criteria:
* A subject shall NOT participate in the study if he/she meets ANY of the following criteria:
* HIV positivity
* Active Hepatitis A, B or C
* Pregnancy
* Participating in other clinical investigations during the course of this study
* Failed to release consent
* Known coagulation disorders (clotting problems)
* Known bleeding risk
* Clinical or laboratory diagnosis of acute infection
* Recent (last 4 weeks) surgical intervention
* Therapy prescribed is only HD, HF or isolated UF mode
* Active phase cancer,
* Active phase immune disease.
* Serious hemostasis disorders.
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
|
NCT01582867
|
{
"brief_title": "HemoControl System Activated in Hemodiafiltration Treatments",
"conditions": [
"Renal Failure"
],
"interventions": [
"Device: ARTIS hemodialysis system"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT01582867",
"official_title": "Studio Cross-Over Controllato Randomizzato Sul Dispositivo ArTis Con Hemocontrol in Emodiafiltrazione - SOCRATHE",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-05",
"study_completion_date(actual)": "2013-05",
"study_start_date(actual)": "2012-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-04-20",
"last_updated_that_met_qc_criteria": "2012-04-19",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-04-23",
"first_submitted": "2012-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed to look at the relationship between brain glucose utilization, neurotransmission (e.g., glutamate, also known as the main excitatory amino-acid neurotransmitter in the brain), and synaptic density. This relationship will be explored in the brain's prefrontal cortex, an area important in decision-making and impulsivity.
#Intervention
- DRUG : N-acetyl cysteine
- Upon completion of baseline (abstinence) 1H-MRS scanning, CU and HC subjects will participate in two additional 1H-MRS scans, including after 2 weeks of placebo and 2 weeks of NAC administration (3600 mg/day) given in double-blind, randomized, counterbalanced order.
- DIAGNOSTIC_TEST : [18F]FDG PET scan
- All subjects will undergo \[18F\]FDG PET to establish previously demonstrated reductions in glucose utilization in PFC and assess VS/nucleus accumbent metabolism at baseline.
- DIAGNOSTIC_TEST : 1H MRS
- All subjects will undergo three magnetic resonance spectroscopy (1H-MRS) scans at 7T, including before and after two-weeks of placebo and NAC administration.
- DIAGNOSTIC_TEST : [11C]APP311 PET scan
- All subjects will undergo \[11C\]APP311 PET imaging to investigate whether there are differences in synaptic integrity / neuronal plasticity in the brains of individuals abstinent from cocaine compared to healthy controls at baseline.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 55 years;
* Voluntary, written, informed consent;
* Physically healthy by medical history, physical, neurological, ECG and laboratory examinations;
* DSM-IV criteria for Cocaine Dependence (304.20) (Note: subjects will also meet DSM-5 criteria for Cocaine Use Disorder);
* Documented evidence (by urine toxicology) of abstinence from cocaine (2 weeks for scan 1, and 2 and 4 weeks for scans 2 and 3, respectively)
* Full scale and verbal IQs > 80;
* For females, a negative serum pregnancy test (β-HCG) at screening and negative urine pregnancy test on PET scan day prior to imaging.
Exclusion Criteria:
* A history of other substance dependence (e.g., alcohol, opiates, sedative hypnotics), except for nicotine;
* A primary DSM-IV Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-IV (SCID);
* A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular, seizure, traumatic brain injury) illness;
* Current use of psychotropic and/or potentially psychoactive prescription medications;
* Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.);
* For females, laboratory (β-HCG) evidence of pregnancy, physical evidence of pregnancy;
* For subjects interested in pharmacotherapy component, history of allergies to NAC and current elevation on liver function tests above twice the normal limit;
* Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year;
* Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans;
* History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto);
* Blood donation within eight weeks of the start of the study.
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
|
NCT02124941
|
{
"brief_title": "Glutamate-Glutamine Cycling (VCYC) During Cocaine Abstinence Using 1H-MRS",
"conditions": [
"Cocaine Dependence",
"Healthy"
],
"interventions": [
"Diagnostic Test: 1H MRS",
"Drug: N-acetyl cysteine",
"Diagnostic Test: [11C]APP311 PET scan",
"Diagnostic Test: [18F]FDG PET scan"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02124941",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-08-14",
"study_completion_date(actual)": "2022-08-14",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-07",
"last_updated_that_met_qc_criteria": "2014-04-24",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-28",
"first_submitted": "2014-04-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
On Dec 31, 2019, a number of viral pneumonia cases were reported in China. The virus causing pneumonia was then identified as a new coronavirus called SARS-CoV-2. Since this time, the infection called coronavirus disease 2019 (COVID-19) has spread around the world, causing huge stress for health care systems. To diagnose this infection, throat and nose swabs are taken. Unfortunately, the results often take more than 24 hrs to return from a laboratory. Speeding diagnosis up would be of great help.
This study aims to look at the breath to find signs that might allow clinicians to diagnose the coronavirus infection at the bedside, without needing to send samples to the laboratory. To do this, the team will be using a machine called a BreathSpec which has been adapted to fit in the hospital for this purpose.
Detailed Description
Analysis of volatile organic compounds (VOCs) in exhaled breath is of increasing interest in the diagnosis of lung infection. Over 2,000 VOCs can be detected through gas chromatography and mass spectrometry (GC-MS); patterns of VOC detected can offer information on chronic obstructive pulmonary disease, asthma, lung cancer and interstitial lung disease. Unfortunately, GC-MS while highly sensitive cannot be done at the bedside and at best takes hours to prepare samples, run the analysis and then interpret the results.
Compared with other methods of breath analysis, ion mobility spectrometry (IMS) offers a tenfold higher detection rate of VOCs. By coupling an ion mobility spectrometer with a GC column, GC-IMS offers immediate twofold separation of VOCs with visualisation in a three-dimensional chromatogram. The total analysis time is about 300 seconds and the equipment has been miniaturised to allow bedside analysis.
The BreathSpec machine has been previously used to study both radiation injury in patients undergoing radiotherapy at the Edinburgh Cancer Centre (REC ref 16-SS-0059, as part of the H2020 TOXI-triage project, http://www.toxi-triage.eu/) and pneumonia in patients presenting to the ED of the Royal Infirmary of Edinburgh (REC ref 18-LO-1029). This work has developed artificial intelligence methodology that allows rapid analysis of the vast amount of data collected from these breath samples to identify signatures that may indicate a particular pathological process such as pneumonia or radiation injury.
The TOXI-triage project showed that the BreathSpec GC-IMS could rapidly triage individuals to identify those who had been exposed to particular volatile liquids in a mass casualty situation (http://www.toxi-triage.eu/).
A pilot trial assessed chest infections at the Acute Medical Unit of the Royal Liverpool University Hospital. The final diagnostic model permitted fair discrimination between bacterial chest infections and chest infections due to other agents with an area under the receiver operator characteristic curve (AUC-ROC) of 0.73 (95% CI 0.61-0.86). The summary test characteristics were a sensitivity of 62% (95% CI 41-80%) and specificity of 80% (95% CI 64 - 91%) \[8\].
This was expanded in the EU H2020 funded 'Breathspec Study' which aimed to differentiate breath samples from patients with bacterial or viral upper or lower respiratory tract infection. Over 1220 patients were recruited, with 191 patients identified as definitely bacterial infection and 671 classed as definitely not bacterial. Virology was undertaken on all patients, with 259 patients confirmed viral infection. Date processing is still on going to determine how well they can be distinguished using this methodology. More than 100 patients were recruited to this study in Edinburgh. Since then, artificial intelligence has been incorporated into our analytical processes, permitting faster and more refined analysis.
Our ambition is that this technology will identify a signature of Covid-19 pneumonia or within 10 min in non-invasively collected breath samples to allow triage of patients into high and low risk categories for Covid-19. This will allow targeting of scarce resources and complex protocols associated with high risk patients including personal protective equipment (PPE), cohorting, and dedicated medical and nursing personel.
A healthy volunteer arm was added in July 2020 - 40 particpants
#Intervention
- DIAGNOSTIC_TEST : Breath test
- collection of an exhaled breath sample
|
#Eligibility Criteria:
Inclusion Criteria:
* >=18 years with clinical features consistent with pneumonia or chest infection due to SARS-CoV-2 AND
* presenting to the Royal Infirmary of Edinburgh where they are swabbed and triaged for Covid-19.
Exclusion Criteria:
* Inability to provide informed consent
* Age 17 years or less
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
|
NCT04329507
|
{
"brief_title": "Non-invasive Detection of Pneumonia in Context of Covid-19 Using Gas Chromatography - Ion Mobility Spectrometry (GC-IMS)",
"conditions": [
"COVID-19",
"Respiratory Disease"
],
"interventions": null,
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04329507",
"official_title": "Non-invasive Detection of Pneumonia in Context of Covid-19 Using Gas Chromatography - Ion Mobility Spectrometry (GC-IMS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-31",
"study_completion_date(actual)": "2021-05-30",
"study_start_date(actual)": "2020-03-25"
},
"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)": "2021-09-08",
"last_updated_that_met_qc_criteria": "2020-03-30",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-01",
"first_submitted": "2020-03-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate the effect of food on the relative bioavailability of a single dose of imatinib given as a 800 mg modified release tablet, compared to twice-daily doses of 400 mg film-coated tablets. There will be a 8 day wash out phase between treatments and a 1 week safety period at the end of the study. Each participant will receive all four treatments.
#Intervention
- DRUG : imatinib
- Other Names :
- STI571
|
#Eligibility Criteria:
Inclusion criteria
* Healthy male or female subjects (postmenopausal women), 18 <= age <= 65 years
* Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion criteria
* Smokers within 3 months
* Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 3 weeks prior to dosing.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* A past medical history or presence of clinically significant ECG abnormalities
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* History of medications pre-disposing the subjects for GI bleedings/cerebral hemorrhage.
* Women taking any biphosphonates (Fosomax like drugs)
* History of being immunocompromised, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* Females nursing infants. Other protocol-defined inclusion/exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00420043
|
{
"brief_title": "Effect of Food on Bioavailability of Modified Release Formulations of Imatinib",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: imatinib"
],
"location_countries": null,
"nct_id": "NCT00420043",
"official_title": "A Phase I, Two Arm, Open-label, Randomized, Study to Investigate the Effect of Food on the Bioavailability of a Single 800 mg Imatinib Dose in Modified Release Formulations (MR3 and MR4) and Compare the Bioavailability Between MR3, MR4 and Imatinib 400 mg Twice Daily Immediate Release Tablet (IR) in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-11",
"study_completion_date(actual)": "2006-11",
"study_start_date(actual)": "2006-09"
},
"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)": "2016-04-05",
"last_updated_that_met_qc_criteria": "2007-01-08",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-09",
"first_submitted": "2007-01-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.
#Intervention
- DRUG : Atezolizumab
- Atezolizumab will be administered at a dose of 1200 mg intravenously on Day 1 of each 21-day cycle.
- Other Names :
- Tecentriq
- DRUG : Bevacizumab
- Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
- Other Names :
- Avastin
|
#Eligibility Criteria:
Inclusion Criteria:
* Life expectancy >= 10 months
* Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous.
* No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following exceptions:
Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR TKIs are eligible.
Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible.
Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation must have also progressed on or were intolerant to osimertinib to be eligible.
* TKIs approved for treatment of NSCLC discontinued >7 days prior to enrollment.
* Measurable disease per RECIST v1.1. PD-L1 expression of >=1% as documented through central testing of a representative tumor tissue specimen either from previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
* ECOG Performance Status of 0 <= age <= 1
* Adequate hematologic and end-organ function
* Negative HIV test at screening
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs.
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Exclusion Criteria:
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
* History of leptomeningeal disease
* Prior chemotherapy or other systemic therapy for stage IIIB, IIIC, or IV disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Active tuberculosis
* Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
* History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Prior allogeneic stem cell or solid organ transplantation
* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
* Current treatment with anti-viral therapy for HBV
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulations
* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab, 6 months after the final dose of bevacizumab
* Prior history of hypertensive crisis or hypertensive encephalopathy
* Significant vascular disease within 6 months prior to initiation of study treatment
* History of Grade >= 2 hemoptysis within 1 month prior to enrollment
* Evidence of bleeding diathesis or coagulopathy. Current or recent use of aspirin, clopidogrel or treatment with dipyramidole, ticlopidine, or cilostazol
* Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for > 2 weeks prior to enrollment
* History of stroke or transient ischemic attack within 6 months prior to enrollment
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
* History of abdominal or tracheosphageal fistula or gastrointestinal perforation within 6 months prior to enrollment
* History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitis,or colitis
* Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
* Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
* Proteinuria
* Clear tumor infiltration into the thoracic great vessels is seen on imaging
* Clear cavitation of pulmonary lesions is seen on imaging
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
|
NCT04426825
|
{
"brief_title": "A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer",
"conditions": [
"Carcinoma, Non-Small-Cell Lung"
],
"interventions": [
"Drug: Atezolizumab",
"Drug: Bevacizumab"
],
"location_countries": [
"China"
],
"nct_id": "NCT04426825",
"official_title": "A Single Arm, Phase II Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Pretreated With Epidermal Growth Factor Receptor Tyrosine-Kinase Inhibitors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-19",
"study_completion_date(actual)": "2023-02-10",
"study_start_date(actual)": "2020-09-09"
},
"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)": "2024-05-21",
"last_updated_that_met_qc_criteria": "2020-06-09",
"last_verified": "2024-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-11",
"first_submitted": "2020-06-09",
"first_submitted_that_met_qc_criteria": "2023-04-11"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.
Detailed Description
Subjects underwent screening procedures at the Screening Visit to ensure that they met the inclusion and exclusion criteria outlined in the protocol. Subjects were evaluated for eligibility criteria, and if eligible, were registered and randomized in a 1:1 into either the Concurrent Arm or the Sequential Arm.
Subjects in both arms underwent a standard 1.5 to 2.0 blood volume leukapheresis, followed approximately 3 days later by an intravenous (IV) infusion of sipuleucel-T. This process occurred at approximately 2-week intervals. A course of sipuleucel-T treatment comprised three infusions.
Following the first infusion, subjects were limited to a maximum of three total product failures for all subsequent infusions, due specifically to insufficient total nucleated cell (TNC) count and/or CD54 upregulation. These subjects received no further leukaphereses or sipuleucel-T infusions, but did receive abiraterone acetate plus prednisone per the schedule of the arm to which they were randomized. All subjects received a total of 26 weeks of abiraterone acetate plus prednisone therapy.
All immune monitoring (IM) endpoints were collected from all subjects who received at least one infusion. Cellular and serological immune responses were assessed for subjects in both arms. In both arms, IM blood samples were collected at baseline (screening); pre-leukapheresis 2 and 3; post-infusion 1, 2, and 3; and weeks 6, 10, 14, and 26, with the timing of IM visits based on the onset of treatment (Day 0). Day 0 was the day of the first infusion. Post-infusion blood draws occurred at 3 hours (allowable window 1-24 hours) after each infusion. If a subject received only one or two infusions, immune samples were still drawn at the scheduled time points based on the first infusion (Day 0). If the subject was not scheduled to undergo further leukapheresis, no other pre-leukapheresis procedures were conducted.
During the active follow-up phase, subjects were followed from registration through the Post-Treatment Visit (30-37 days post-last study treatment), or until disease progression, unacceptable toxicity, or death, whichever occurred first.
During the long-term follow-up (LTFU) phase, subjects were followed from the Post-Treatment Visit for up to 3 years from the date of registration/randomization. During the LTFU phase, only new treatment-related serious adverse event (SAE)s, cerebrovascular event (CVE)s (regardless of causality), the first anti-cancer therapy and first chemotherapy, and survival status were collected via a quarterly telephone call.
Overall survival was measured as the time from randomization until death over a 3-year period.
#Intervention
- BIOLOGICAL : sipuleucel-T
- Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
- Other Names :
- PROVENGE(R), APC8015
- DRUG : abiraterone acetate
- Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.
- Other Names :
- ZYTIGA(R)
|
#Eligibility Criteria:
Inclusion Criteria:
* histologically documented prostate cancer confirmed by a pathology report from prostate biopsy or radical prostatectomy specimen
* metastatic status as evidenced by imaging obtained <= 56 days prior to registration demonstrating bone metastasis or lymph node metastasis
* castrate resistant prostate cancer: castrate levels of testosterone (<= 50 ng/dL); evidence of disease progression concomitant with surgical or medical castration
* serum PSA >= 2.0 ng/mL
* castrate levels of testosterone (<= 50 ng/dL) achieved via medical or surgical castration
* baseline Eastern Cooperative Oncology Group (ECOG) performance status of <= 1
* systolic blood pressure (BP) <= 140 mm Hg and diastolic BP <= 90 mm Hg at screening
* adequate baseline hematologic, renal, and liver functions
* must live in a permanent residence within a comfortable driving distance (round trip within one day) of the clinical trial site
Exclusion Criteria:
* the presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites
* New York Heart Association Class III or IV heart failure
* any medical condition that may be compromised by increases in blood pressure, hypokalemia, or fluid retention
* Child-Pugh Class B or C hepatic insufficiency
* spinal cord compression, imminent long bone fracture, or any other condition likely to require radiation therapy and/or steroids for pain control
* known adrenalcortical insufficiency
* any medical contraindications to receiving prednisone
* prior treatment with sipuleucel-T
* previous treatment with abiraterone acetate (Zytiga(R)) or ipilimumab (Yervoy(TM))
* a requirement for systemic immunosuppressive therapy for any reason. Use of inhaled, intra-nasal, intra-articular, and topical steroids was allowed.
* treatment with any investigational vaccine or immunotherapy
* treatment with any chemotherapy prior to registration.
* a history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for >= 3 years at the time of registration.
* myocardial infarction or ventricular or atrial arrhythmia within 6 months prior to registration
* ongoing anti-androgen withdrawal response.
* systemic steroid use within <= 60 days of registration
* treatment with denosumab (Xgeva(R) or Prolia (R)) within <= 3 months prior to registration
* positive test for human immunodeficiency virus (HIV) or human T cell lymphotrophic virus (HTLV) infections. Subjects with a positive test for hepatitis B or hepatitis C were allowed provided they meet the liver function test (LFT) criteria and have no signs of acute infection or active disease.
* treatment with any of the following medications or interventions within 28 days prior to registration: external beam radiation or major surgery requiring general anesthetic; saw palmetto; megestrol acetate (Megace(R)), diethylstilbestrol, and cyproterone; 5-alpha-reductase inhibitors (e.g. finasteride [Proscar(R)], dutasteride [Avodart(R)]); steroidal anti-androgen therapy; any other systemic therapy for prostate cancer, except for medical castration; treatment with any other investigational product for prostate cancer; substrates of CYP2D6 (e.g. including but not limited to thioridazine); inhibitors of CYP3A4 (e.g. including but not limited to ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, and voriconazole); inducers of CYP3A4 (e.g. including but not limited to phenytoin, carbamazepine, rifampin, rifapentine, and phenobarbital)
* a requirement for treatment with opioid analgesics within 21 days prior to registration
* an active infection or infection requiring parenteral antibiotic therapy or causing fever within 7 days of registration
* any medical intervention, or other condition, or any other circumstance that, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01487863
|
{
"brief_title": "Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer",
"conditions": [
"Prostate Cancer Metastatic",
"Hormone Refractory Prostate Cancer",
"Castration-resistant Prostate Cancer"
],
"interventions": [
"Drug: abiraterone acetate",
"Biological: sipuleucel-T"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01487863",
"official_title": "A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2011-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-19",
"last_updated_that_met_qc_criteria": "2011-12-07",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-12-08",
"first_submitted": "2011-12-06",
"first_submitted_that_met_qc_criteria": "2017-05-11"
}
}
}
|
#Study Description
Brief Summary
This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.
#Intervention
- BIOLOGICAL : DT
- Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show \>=1.5 fold increase in lymphocyte proliferative response but have a humoral response.
- DRUG : Daclizumab
- The fifth dose (1 milligram per kilogram \[mg/kg\]) of daclizumab will be administered in this study to participants who already received four doses (one dose at 1 mg/kg within 24 hours post-transplant and then every other week for 3 doses).
- Other Names :
- Zenapax
- BIOLOGICAL : KLH
- KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary renal transplant recipients between 2 and 19 years
* Receiving or have received daclizumab in the previous 4 <= age <= 18 months
* Receiving or have received daclizumab less than (<) 24 hours pretransplant and additional courses every other week
* Single organ recipients (kidney only)
* Previous vaccination with tetanus toxoid (TT) prior to transplant
* Receiving a maintenance immunosuppression regimen of a calcineurin inhibitor, mycophenolate mofetil, and prednisone (or equivalent corticosteroid)
Exclusion Criteria:
* Received intravenous gamma globulin or a TT vaccination since transplant
* Experienced rejection within 3 months of receiving study vaccinations and/or treated with lymphocyte preparation or methylprednisolone to reverse suspected acute rejection within 3 months of receiving study vaccinations
* Received any vaccine within 30 days of receiving study vaccinations
* Received plasmapheresis treatment or growth hormone treatment since transplant
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02576145
|
{
"brief_title": "A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)",
"conditions": [
"Kidney Transplantation"
],
"interventions": [
"Drug: Daclizumab",
"Biological: DT",
"Biological: KLH"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02576145",
"official_title": "Immune Response to Neoantigen and Recall Antigen in Pediatric Renal Transplant Recipients Treated With the IL-2R Alfa Monoclonal Antibody, Daclizumab (Zenapax®)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-01",
"study_completion_date(actual)": "2006-01",
"study_start_date(actual)": "2003-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-01-13",
"last_updated_that_met_qc_criteria": "2015-10-12",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-15",
"first_submitted": "2015-10-05",
"first_submitted_that_met_qc_criteria": "2015-12-09"
}
}
}
|
#Study Description
Brief Summary
The investigators aim to validate if a digital tool for increased self-management of chronic pain can improve the quality of life for patients with chronic pain. The validation is based on the change in pain interference (Quality of life), pain intensity, physical functioning, depression, and anxiety based on self-reported information from baseline to study end.
Detailed Description
Chronic pain is today an increasing health problem in both Europe and US, with an estimation of about 90 million people affected in Europe (Breivik, H. et al., 2006) and 100 million people in US (Relieving Pain in America, IOM Report 2011), or 20-30% of the adult population around the world. Chronic pain is defined as a condition that lasts for at least three to six months, after the normal healing period of an injury. Medical interventions offered in clinics around the globe are unfortunately not giving the results needed to give back the quality of life the patients had prior to the onset of the pain. The treatments offered today do sometimes reduce pain, but the effect is minor, and new treatment regimens are needed (Relieving Pain in America, 2011). Recent quality assurance registry measurements in Sweden has shown that patient taken part of multi modal treatment regimens, such as the acceptance and commitment therapy, (ACT) show that less then 40% of the patients have a decline in the pain level of 1 level on the VAS scale, 55% has no effect and 9 % has an increased level of pain after going through the program (Nationel Register for Pain Rehabilitation, Sweden 2017) The study objective is to evaluate how the use of a digital pain coach, based on artificial intelligence that improves the self-management of pain will decrease the pain interference and thereby increase QoL among chronic pain patients, as measured by PROMIS pain interference 6a. We will here compare the improvement of quality of life by a decrease in pain interference, measured by PROMIS, in patients who follow their traditional treatment plan provided by the Pain Clinic with the addition of using a web application for increased self management of pain. The theory behind the study and the development of the device is supported by previously known data, showing that self-management has an effect and is important to the treatment by helping patients to believe in their own capacity to control their pain.
The present investigation aims at exploring the effect of including digital tool as an add on to standard treatment and rehabilitation and will measure the effect it has on:
Decreased pain interference Improved management of long-term pain and its consequences. Hence self-management of pain Increased function in daily life with the best possible activity and participation level Improved experience of health-related quality of life Decreased pain experience
#Intervention
- DEVICE : Digital Pain-Management Tool
- Digital Pain-Management Tool
|
#Eligibility Criteria:
Inclusion Criteria:
* Have a complex, prolonged (neck shoulder pain or lower back pain
* Have been followed by a pain management specialist for at least 6 months
* Referred for Pain Medicine Consultation
* Be >18 years
* Be able to travel to and from the clinic
* Have a goal and motivation that is adequate in relation to the program offered
* Be medically prepared and not have any other medical examination or ongoing disease that constitutes an obstacle as well as adequate pharmacological treatment
* Have no major change in pain management (e.g. medications)
* Own a smart phone, tablet or computer or have the knowledge to use one
Exclusion Criteria:
* Low back pain requiring surgical intervention in the next 3 months
* Severe or acute psychiatric illness, severe anxiety or depression
* Reported/acute psychiatric illness or acute crisis
* Ongoing abuse of alcohol, drugs and drug-based drugs. This also includes high doses of prescribed drugs
* Pain related to malignancy
* Other areas of pain exceeding the level/intensity of low back or neck pain
* Currently involved in a lawsuit or pending litigation in relation to the low back or neck pain
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
|
NCT04837794
|
{
"brief_title": "Self-Management of Chronic Pain",
"conditions": [
"Chronic Pain"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04837794",
"official_title": "Self-Management of Chronic Pain Using a Digital Pain-Management Tool",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-01-30",
"study_completion_date(actual)": "2021-01-30",
"study_start_date(actual)": "2019-08-01"
},
"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)": "2021-04-08",
"last_updated_that_met_qc_criteria": "2021-04-06",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-08",
"first_submitted": "2021-04-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is to examine the efficacy of tDCS to improving walking in people with Multiple Sclerosis (PwMS).
Our study compromises 1 group of subjects with MS which will attend the lab for three sessions. In the first session, subjects will be consented, complete the Patient Determined Disease Steps (PDDS), the Fatigue Severity Scale (FSS), and maximal voluntary contractions (MVCs) of the right and left knee extensors and flexors to determine the more-affected leg. The second and third sessions will involve whole-body FDG PET imaging. During each of these sessions, the subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS or SHAM, in a blinded manner, will be applied to the motor cortex (M1) corresponding to the more-affected leg. Approximately 2 minutes into the walking, \[18F\]fluorodeoxyglucose (FDG) will be administered by IV injection. Immediately after the walking is completed, the subject will be positioned in the PET/CT scanner and a whole body (top of head to toes) PET/CT scan will be acquired for the evaluation of glucose metabolism in the brain, spine, and lower extremities. The third session will be identical to the second session with the exception that the opposite condition (tDCS or SHAM) will be used.
Detailed Description
Prospective participants, men and women with MS, will be recruited. The plan is to enroll up to 30 to get 20 evaluable subjects. To accomplish this study, all participants will need to complete 3 sessions. The first session at the INPL and sessions 2 and 3 at PET Imaging Center (0911ZJPP) and the PET Imaging lab in Pappajohn Biomedical Discovery Building. Session 2 and 3 are separated by 5-8 days. The duration of each session will be approximately 120 minutes. We expect data collection to last 6 months.
In the first session, subjects will be consented, complete the PDDS, the Fatigue Severity Scale (FSS), and maximal voluntary contractions (MVCs) of the right and left knee extensors and flexors to determine the more-affected leg. When leg strength difference is less than 10%, the more affected side will be based on self-report. The second and the third sessions will involve 20 min walking on a treadmill at a self-selected speed during which time tDCS or SHAM will be applied to the motor cortex (M1) corresponding to the more-affected leg and \[18F\]fluorodeoxyglucose will be administered. At the end of the walking period, the subject will be imaged on a PET/CT scanner from top of head to toes.
Prior to sessions 2 and 3, all subjects will be asked to fast (water and medication can be taken during this time) for a minimum of 6 hours prior to the FDG administration. In addition, the blood glucose level will be checked (via Accuchek) prior to FDG administration and the level must be equal to or less than 200 mg/dL in order to proceed with the FDG administration on that day. At the beginning of session 2 and 3, the subject will be weighed and height measured, have a blood glucose level determined via Accuchek as described above, undergo a urine pregnancy test if the subject is of child-bearing potential, and have an IV catheter inserted for FDG administration. The subject will then be moved to the PET Scanner area in Pappajohn Biomedical Discovery Building. The subject will be asked to use the restroom prior to walking on the treadmill. A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCl). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit. The participant will receive tDCS or SHAM throughout the walking (i.e., for 20 min). In the tDCS trial, the intensity will start at 0 mA and will increase to 3 mA over the first 30 seconds. In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0.
Two min into the walking test on the treadmill, 10 mCi of \[18F\]-FDG will be injected IV. Then, the walking test continues until 20 min is reached. When the walking test is completed, the tDCS device will be removed and the subject will be positioned in the PET/CT scanner and a whole body (top of head to toes) PET/CT scan will be acquired.
Ratings of perceived exertion (RPE) will be recorded with the modified Borg 10-point scale (Borg, 1982). The subjects will be instructed to estimate the effort during walking. The scale will be anchored so that 0 denotes the resting state and 10 represents the strongest effort.
No long-term follow-up will be done.
#Intervention
- DEVICE : transcranial direct current stimulation or SHAM
- A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit.
In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0. The same tDCS device (Soterix) will be used.
|
#Eligibility Criteria:
Inclusion Criteria:
* medically diagnosed with Multiple Sclerosis (MS)
* 18 <= age <= 70 yrs. of age, moderate disability (Patient Determined Disease Steps (PDDS) core 2 <= age <= 6)
* Self-reported differences in function between legs, able to walk for 20 min.
Exclusion Criteria:
* MS relapse within last 60 days
* inability to fast for 6 hours
* hyperglycemia (fasting blood sugar > 200 mg/dL)
* insulin-dependent diabetes
* high risk for cardiovascular disease (ACSM risk classification)
* changes in disease-modifying medications within last 45 days
* concurrent neurological/neuromuscular disease
* hospitalization within last 90 days
* diagnosed depression
* inability to understand/sign informed consent, pregnant, history of seizure disorders (or on medications known to lower seizure threshold)
* hydrocephalus.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04016844
|
{
"brief_title": "tDCS and Glucose Uptake in Leg Muscles",
"conditions": [
"Multiple Sclerosis"
],
"interventions": [
"Device: transcranial direct current stimulation or SHAM"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04016844",
"official_title": "Transcranial Direct Current Stimulation to Reduce Asymmetric Glucose Uptake in Leg Muscles of Persons With Multiple Sclerosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-01",
"study_completion_date(actual)": "2020-10-01",
"study_start_date(actual)": "2019-12-06"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-01-25",
"last_updated_that_met_qc_criteria": "2019-07-08",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-12",
"first_submitted": "2019-07-08",
"first_submitted_that_met_qc_criteria": "2023-01-02"
}
}
}
|
#Study Description
Brief Summary
In this study the investigators want to find out about the effects of this drug in women with metastatic breast cancer. The study has two major parts; dose escalation and dose expansion. In the first part or dose escalation, subjects will be treated at the lowest dose effective in men: 300 mg two times daily. Orteronel (TAK-700) will be increased to reach the highest dose tolerated in men: 400 mg two times daily. This part of the study is designed to see if female subjects can safely tolerate orteronel (TAK-700), and to measure the changes in estrogens and androgens at different levels of TAK-700.
In the second part of the study (dose expansion), seven women will be treated with the dose identified in the first part of the study as being safest and most effective. In this part of the study, the investigators want to see if orteronel (TAK-700) will routinely and significantly decrease the estrogen levels at the dose which will be used for any future studies.
#Intervention
- DRUG : TAK700
- dose is dependant on dose escalation timepoint and dose expansion cohort dose will be the RP2D determined based on the dose escalation cohort final dose recommendation
- Other Names :
- Orteronel
|
#Eligibility Criteria:
Inclusion Criteria:
* Voluntary written informed consent
* Patients >= 18 years
* Screening clinical laboratory values as specified below:
* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be the upper limit of normal (ULN).
* Total bilirubin <= 1.5 x ULN.
* Serum creatinine <= 1.5 × ULN or Estimated creatinine clearance using the Cockcroft-Gault formula must be greater than 50 mL/minute
* Absolute neutrophil count (ANC) greater than 1000/L and platelet count greater than 75,000/L.
* Serum potassium levels must be within institutional normal limits.
* Serum magnesium and phosphorous levels must be >= the institutional lower limit of normal.
* Screening calculated ejection fraction greater than or equal to the institutional upper limit of normal
* Patients must have histologically confirmed breast cancer that is Metastatic OR Incurable and locally advanced
* Patients must have histologically confirmed HR+ breast cancer.
* Patients must have measureable or evaluable disease
* ECOG performance status <2 (Karnofsky >60%)
* Patients must be postmenopausal women.
Inclusion Criteria for Dose Expansion Cohort:
* All of the criteria listed in above in addition to those below:
* Patients must have measurable disease.
* Patients may not have received more than 1 prior line of endocrine therapy in the metastatic setting.
* Patients may not have received any cytotoxic chemotherapy for treatment in the metastatic setting.
Exclusion Criteria:
* Exclusion Criteria for Dose Escalation Cohort
* Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
* Patients who have not discontinued all prior medical therapy for breast cancer (with the exception of bisphosphonates or denosumab) at least 28 days prior to first dose of orteronel.
* Patients who are taking any form of other exogenous hormonal therapy within 28 days prior to first dose of orteronel.
* Patients should not have received radiotherapy within 14 days prior to the first dose of orteronel.
* Patients should have recovered to baseline or < grade 1 for all-prior treatment related toxicities.
* EKG abnormalities of:
* Q-wave infarction, unless identified 6 or more months prior to screening QTc interval > 470 msec, the upper limit of normal for women.
* Known hypersensitivity to compounds related to orteronel or to orteronel excipients.
* Uncontrolled hypertension despite appropriate medical therapy
* Known active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
* Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.
* Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of orteronel, including difficulty or inability to swallow tablets.
* Patients with known endocrine disorders including, but not limited to, Cushing's, or Addison's disease.
* Patients with known brain metastases are excluded unless they have had definitive treatment (e.g. whole brain radiotherapy or surgery or stereotactic radiation) for brain metastases with evidence of stable/improved disease on repeat imaging following definitive treatment.
* Patients on medications with the potential for significant interaction with orteronel.
* Patients with serious medical illness
* Patients with an estimated life expectancy of less than 3 months as determined by the treating physician.
* Prior therapy with abiraterone, or aminoglutethimide.
Exclusion Criteria for Dose Expansion Cohort Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
* They are ineligible by virtue of meeting any exclusion criteria above. Patients with known brain metastases will be excluded from this portion of the clinical trial (which will assess PFS and TTP) because of their relatively poor overall prognosis.
* Patients with HER2+ breast cancer are also excluded from this portion of the study as HER2-targeted therapy would generally be considered appropriate for the HER2+ patient population meeting the entry criteria for the dose expansion cohort.
* They have received treatment with orteronel or another lyase inhibitor in the past.
* Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of in situ malignancies.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01808040
|
{
"brief_title": "A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer",
"conditions": [
"Post Menopausal, Hormone Receptor Positive Breast Cancer"
],
"interventions": [
"Drug: TAK700"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01808040",
"official_title": "A Phase 1b Study of TAK-700 in Postmenopausal Women With Hormone-receptor Positive Metastatic Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-07",
"study_completion_date(actual)": "2016-12-09",
"study_start_date(actual)": "2012-11"
},
"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)": "2019-11-18",
"last_updated_that_met_qc_criteria": "2013-03-07",
"last_verified": "2017-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-08",
"first_submitted": "2013-01-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Video laryngoscope and chest CT iminge for the placement of the Uniblocker
Detailed Description
Comparing the traditional method of Uniblocker intubation and video laryngoscope combined with chest CT iminge guide the precise localization of Uniblocker
#Intervention
- DEVICE : video laryngoscope and chest CT iminge
- DEVICE : Conventional intubation of uniblocker
|
#Eligibility Criteria:
Inclusion Criteria:
BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia
Exclusion Criteria:
* Age younger than 18 yr or older than 65 yr
* ASA class IV or V
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
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
|
NCT03008473
|
{
"brief_title": "Chest CT for the Placement of the Uniblocker",
"conditions": [
"Therapeutic Procedural Complication"
],
"interventions": [
"Device: video laryngoscope and chest CT iminge",
"Device: Conventional intubation of uniblocker"
],
"location_countries": [
"China"
],
"nct_id": "NCT03008473",
"official_title": "Placement of the Uniblocker Under the Guidence of Chest Computerized Tomography",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09-24",
"study_completion_date(actual)": "2017-09-24",
"study_start_date(actual)": "2017-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-02-23",
"last_updated_that_met_qc_criteria": "2016-12-29",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-02",
"first_submitted": "2016-12-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.
The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too.
Study population: 219 patient randomized into 3 groups
Detailed Description
Methods: Blinded , multicenter trial, ELBW infants were randomized on day 3 to one of 3 groups: early EPO group (rhEPO from the first week for 9 weeks , n= 74), late rhEPO group (rhWEPO from the fourth week for 6 weeks, n=74), or control group (no rhEPO, n= 71). All infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO ß dose was 750 IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%.
The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Clinical and nutritional data were recorded prospectively.
#Intervention
- DRUG : epoetin beta
- 250 IU/kg/week rhEPO treatment subcutaneously 3 times a week from the first week for 9 weeks, all infants received enteral iron 3-9 mg/kg/day
- DRUG : epoetin beta
- 250 IU/kg/week subcutaneously 3 times a week, from the fourth week for 6 weeks, all infants received enteral iron 3-9 mg/kg/day
|
#Eligibility Criteria:
Inclusion Criteria:
* Extremely low birth weight infants
Exclusion Criteria:
* Cyanotic heart disease
* Major congenital malformation requiring surgery
* Gestational > 30 yearsweeks
* Administration of an investigational drug during pregnancy
* Lack of parental consent
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 3 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00593801
|
{
"brief_title": "Erythropoietin Treatment in Extremely Low Birth Weight Infants",
"conditions": [
"Infant, Low Birth Weight",
"Anemia"
],
"interventions": [
"Drug: epoetin beta"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00593801",
"official_title": "Multicentre, Blinded, Randomised, Controlled Study on the Efficacy and Safety of Early or Late Epoetin Beta Treatment in Premature Infants (500- 999g Birth Weight)for Prevention or Treatment of Anaemia of Prematurity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "1999-06",
"study_completion_date(actual)": "1999-06",
"study_start_date(actual)": "1998-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-01-15",
"last_updated_that_met_qc_criteria": "2008-01-04",
"last_verified": "2008-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-15",
"first_submitted": "2008-01-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To study the pharmacokinetic properties, safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their newborns, with a view to prevention of mother-to-child transmission (PMTCT) of HIV-1 in Africa and Asia.
Detailed Description
Single-dose nevirapine (sdNVP) is the option of choice for the prevention of mother-to-child transmission (PMTCT) of HIV-1 in countries with limited resources. However, the use of sdNVP results in resistance mutations with an estimated frequency at of least 15 to 70% in women at W4-W6 postpartum. These mutations could compromise the success of subsequent treatments of mother and child with antiretroviral combinations that include NVP. Pre-clinical and clinical studies suggest that a combination of TDF and FTC, drugs with interesting pharmacokinetic properties that may be a useful alternative or complement to sdNVP.
The objectives are to study the pharmacokinetic properties, safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate {TDF, 600 mg} and emtricitabine {FTC, 400 mg}) in HIV-1-infected pregnant women and their newborns, with a view to prevention of mother-to-child transmission (PMTCT) of HIV-1 in Africa and Asia.
Phase II trial, multicentre, open-label will be conducted in two steps with 30 mother-infant pairs per step and with a balanced allocation in Abidjan (Côte d'Ivoire), Soweto (South Africa) and Phnom Penh (Cambodia):
Step 1: administration of TDF/FTC to the mother; Step 2: administration of TDF/FTC to the mother and the newborn.
#Intervention
- DRUG : Tenofovir (TDF)
- DRUG : Emtricitabine (FTC)
|
#Eligibility Criteria:
Inclusion Criteria:
* Women received voluntary counselling and testing and knows her serological status
* HIV-1 or HIV-1+2 infection whose serological diagnosis is confirmed by two samples
* Aged 18 years or over on the day of the inclusion
* Ongoing pregnancy of between 28 and 38 weeks of gestation from the day of the inclusion. This estimate will be based on the date of the last menstruation, or ultrasound scan, or uterine height measurement
* Indication for antiretroviral treatment in the Prevention of Mother-To-Child-Transmission (PMTCT), in line with international or national recommendations in force: WHO's clinical stage 1, 2 and CD4>=200/mm3or stage 3 and CD4>=350/mm3 (No indication of antiretroviral treatment)
* Haemoglobin over 8 g/dL in the month preceding inclusion
* Blood creatinine less than three times the upper limit of normal values
* Creatinine clearance > 49 mL/min
* Transaminases (ALAT or ASAT) less than five times the upper limit of normal values
* Neutrophils >=750/mm3
* No hypersensitivity to emtricitabine, tenofovir, tenofovir disoproxil fumarate, zidovudine, nevirapine or to the excipients
* Signed informed-consent form by the woman and, by the father of the child to be born
* Planned delivery in a hospital setting and stay for at least 72 hours afterwards
* Agreement to take no other medication during the trial without telling the investigator
* Naïve to all antiretroviral treatment and to antiretroviral prophylaxis for PMTCT during a previous pregnancy
* Permanent residence close enough to the study centre to enable follow-up as stipulated in the protocol
Exclusion Criteria:
* Under 18 years
* Infected by HIV-2 alone
* One of the two parents (father) refuses to sign the consent to participate (available only for Abidjan and Phnom Penh) or the mother ( for the Soweto site)
* Indication for antiretroviral treatment (stage 4 or CD4 <200/mm3 or stage 3 and CD4 <350/mm3)
* Has already taken antiretrovirals, including any exposure to previous treatment or prophylaxis for PMTCT, before inclusion in the study
* Use of drugs which can interfere with the study such as :
* nephrotoxic drugs amphotericin B, ganciclovir, valganciclovir or cidofovir, foscarnet, aminosides, pentamidine, cisplatin
* anticoagulants (heparin)
* Regular use of drug or alcohol
* Health problem requiring systematic treatment or hospitalization
* Severe pregnancy disease (pre-eclampsia) that is life-threatening for the mother, the infant, or for both
* Severe vomiting preventing ingestion of tablets
* Refuses to give birth at a study site and to stay in hospital for at least 72 hours afterwards
* Renal insufficiency defined by blood creatinine more than three times the upper limit of normal values
* Creatinine clearance under or equal to 49 mL/min
* Hepatic insufficiency defined by transaminases (ALAT or ASAT) more than five times the upper limit of normal values
* Neutrophils <750/mm3
* Haemoglobin <8 grams/dL in the month preceding inclusion
* Hypersensitivity to emtricitabine, tenofovir, tenofovir disoproxil fumarate, zidovudine, nevirapine or to the excipients
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00334256
|
{
"brief_title": "Tenofovir/Emtricitabine for PMTCT in Africa and Asia (ANRS 12109 TEmAA)",
"conditions": [
"HIV Infection",
"Pregnancy"
],
"interventions": null,
"location_countries": [
"South Africa",
"Cambodia",
"Côte D'Ivoire"
],
"nct_id": "NCT00334256",
"official_title": "Phase II Trial, Multicentre, Opened Label Evaluating the Pharmacokinetics and the Safety and Toxicity of the Tenofovir-Emtricitabine Combination in Pregnant Women and Infants in Africa and Asia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-07",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2006-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-12-05",
"last_updated_that_met_qc_criteria": "2006-06-06",
"last_verified": "2011-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-06-07",
"first_submitted": "2006-06-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research project will investigate neurofeedback training in stroke rehabilitation during which patients receive feedback in real time from their brain activity measured with ElectroEncephaloGraphy (EEG). The investigators hypothesize that the feedback training allows to internally stimulate brain motor networks in order to promote functional recovery of the hand.
Detailed Description
This study will be carried out as a pilot study in order to optimize and set parameters for a subsequent study that will involve more stroke patients. Stroke patients will be trained to mentally imagine the opening and closing of the hand (hereafter named MI, Motor Imagery). During the training, the patients will receive visual feedback in real time that reflects the neural activity related to motor processes. The NeuroFeedback (NF) will be projected with minimal time delay to maximize the neural learning. This type of brain training with feedback is thought to have significant importance to stimulate the ability of the brain to reorganize and compensate for a damaged region.
Each participant will go through the following data collection procedure (total of 27-28 measurement sessions per RP):
* Clinical baseline evaluations, 1 time/week during 3 weeks
* 1 MRI measurement during one week
* 2-3 calibration EEG recordings during one week
* MI-neurofeedback training \[3 times/week\] + Clinical intervention evaluation \[1 time/week\] during 4 weeks
* 1 MRI measurement + 1 calibration EEG recording during one week
* Clinical intervention evaluations, 1 time/week during 3 weeks
Magnetic Resonance Imaging (MRI) measurements. The MRI exam will be carried out on a Siemens MAGNETOM Prisma 3T scanner (head-coil with 20 channels) at baseline and at final assessment session at Stockholm University Brain Imaging Centre. The MRI protocol comprises i) anatomical whole brain spin-echo T1 and T2 weighted sequences for description of lesion size and location ii) acquisition of T2\*-weighted gradient echo EPI-BOLD images of the whole brain for assessment of resting state functional connectivity of sensorimotor networks (resting-state functional MRI (fMRI)), and iii) the same sequence as the previous with rest interleaved by a motor imagery paradigm further described below.
Motor Imagery (MI) paradigm. The paradigm consists of instructing RP, by the use of a mirrored computer screen, to either i) rest his/her mind with eyes open, ii) mentally imagine a hand movement (MI), or ii) execute a hand movement. The hand movements that are instructed are either to close the hand or to open the hand and extend the fingers. RP will perform several repetitions of each hand movement (MI and execution) in order to collect a statistical basis.
Calibration EEG recording. Calibration of EEG recordings will be performed at 2-3 times during 1 week prior to the intervention and one time after the intervention while the participant performs the mental imagery paradigm described above. RP will be seated in front a computer screen and ratings will be registered by the use of a button-press. During these session, EEG, EOG, EMG, and accelerometer-data will be collected and are further described below.
ElectroEncephaloGram (EEG), ElectroOculoGram (EOG), ElectroMyoGram (EMG) and accelerometer equipment. The EEG equipment consists of a 64-electrode scalp EEG acquisition system (Brain Products ActiCHamp). The 64 electrodes (active Ag/AgCl) will be distributed according to the extended 10-20 reference placement system. In addition to the EEG recording, 3 electrodes (passive Ag/AgCl, Brain Products) will be placed on each side of both eyes and on the earlob to measure eye-movements during the experiment (EOG). EMG electrodes (passive Ag/AgCl, Brain Products) will be placed over four muscles controlling the wrist and fingers according to a standardized protocol. Two accelerometer-sensors (Brain Products) will be placed on the hand and the index finger in order to record movement-related activity.
EEG, EOG, EMG and accelerometer data analysis. The recorded data will be further analyzed offline in order to evaluate the characteristic features in the data that best describe MI of hand movements. This will be performed in Matlab and Labview combining custom-made scripts with already developed toolboxes (such as EEGLab, Chronux). Features to be evaluated will include the evoked activity, the time-frequency spectra, phase, correlation coefficients, coherency among other. When the feature that best describes MI has been identified different classifier and pattern recognition methods will be evaluated in extracting the information. Intelligent algorithms, Support Vector Machine (SVM), regularized linear regression, naïve Bayes classifiers among others will be evaluated and compared. These are commonly used methods in the field of neurotechnology and a prior comparison-study using neural data from invasive recordings shows the importance of choosing a well-adapted classifier for extracting information.
MI-NeuroFeedback Training (NFT). EEG, EOG, EMG and accelerometer-data will be collected as described in the section 'EEG, EMG and accelerometer equipment'. RP will perform the MI paradigm without the execution of hand movements. Real-time feedback from recorded EEG-activity will be provided to RP during MI. The feedback consists of a virtual hand on a computer screen whose movements reflect the brain activity of RP related to MI. The recorded data will be further analyzed offline with the analytic tools that are described in previous section.
#Intervention
- DEVICE : Mental imagery neurofeedback training
- Mental Imagery (MI)-neurofeedback training, 2-3 hours, 3 times/week for 4 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* More than 6 months since first time stroke onset and with remaining hemiparesis in upper extremity;
* able to participate fully in the intervention including screening of cognitive function with the Cambridge Neuropsychological Test Automated Battery;
* able to perform Functional Magnetic Resonance Imaging (fMRI);
* able to passively extend the wrist 15 degrees and extend fingers fully with a neutral position of the wrist.
Subgroup 1 (n=2):
* be able to voluntarily control the power of their grip when requested according to the Visuomotor force tracking method and/or according to the clinical assessment of a therapist (while holding the patient´s hand).
* Fugl-Meyer Upper Extremity (UE) scale (Fugl-Meyer 1975): <14 points on the hand subscale (C) in addition to < 48 points on the total score (equivalent to moderate disability in the upper extremity
Subgroup 2 (n=2):
* no detected voluntary grip or release function
Exclusion Criteria:
* Other neurological or musculoskeletal disease/injury, contagious disease or treatment with botulinum toxin in the upper extremity during the past 3 months.
* current or history of epilepsy, hearing problems, metal implants in the brain/skull cochlear implants, any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal, infusion device.
* other neurological disorder, pregnancy, current or history of severe psychiatric disorder with need for pharmacological treatment
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
|
NCT03994042
|
{
"brief_title": "Mental Imagery Neurofeedback in Strokerehabilitation",
"conditions": [
"Stroke",
"Hemiparesis"
],
"interventions": [
"Device: Mental imagery neurofeedback training"
],
"location_countries": [
"Sweden"
],
"nct_id": "NCT03994042",
"official_title": "EEG-based Mental Imagery Feedback in Stroke Patients With Severe Hand Dysfunction",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-17",
"study_completion_date(actual)": "2020-01-17",
"study_start_date(actual)": "2019-08-05"
},
"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)": "2020-06-30",
"last_updated_that_met_qc_criteria": "2019-06-19",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-21",
"first_submitted": "2019-04-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.
#Intervention
- DRUG : Cyclosporin A
- tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months
- Other Names :
- CsA
- DRUG : Belatacept Less Intensive Regimen (LI)
- solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
- DRUG : Belatacept More Intensive Regimen (MI)
- solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is a first-time recipient of a kidney transplant from a deceased donor.
* Specific donor criteria
Exclusion Criteria:
* Donor age <10 years
* Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
* Subjects with a positive T-cell lymphocytotoxic crossmatch.
* Subjects who are positive for Hepatitis B or C, or HIV
* Active tuberculosis
* History of cancer in the last 5 years
* History of substance abuse
* Specific laboratory results are exclusionary
* Mammography suspicious for cancer
* Allergy to iodine
* For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)
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
|
NCT00114777
|
{
"brief_title": "Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant",
"conditions": [
"Renal Transplantation"
],
"interventions": [
"Drug: Belatacept Less Intensive Regimen (LI)",
"Drug: Belatacept More Intensive Regimen (MI)",
"Drug: Cyclosporin A"
],
"location_countries": [
"United States",
"Poland",
"Germany",
"Austria",
"Czechia",
"United Kingdom",
"France",
"Sweden",
"South Africa",
"Australia",
"Hungary",
"Argentina",
"Italy",
"Norway",
"Brazil",
"Chile",
"Canada",
"Spain",
"Belgium"
],
"nct_id": "NCT00114777",
"official_title": "Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-05",
"study_completion_date(actual)": "2014-09",
"study_start_date(actual)": "2005-02"
},
"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)": "2017-07-07",
"last_updated_that_met_qc_criteria": "2005-06-17",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-06-20",
"first_submitted": "2005-06-17",
"first_submitted_that_met_qc_criteria": "2017-06-28"
}
}
}
|
#Study Description
Brief Summary
This randomization discontinuation trial will allow for concomitant evaluation of the following:
* Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle
* Side effects and benefits of a drug holiday
Detailed Description
Selection part (220 patients):
Trabectedin (depending on dose reductions : between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression, intolerance or 6 cycles (according to the SPC of Trabectedin)
Randomized part (50 patients):
After the 6 first cycles, if there is not progression or unacceptable toxicity, the patients will be randomly assigned to continuous or 'intermittent/holiday' therapy with CT-scan evaluation every 6 weeks in both arms
* Arm A Continuation of Trabectedin (between 1.5 and 1 mg/m²/3 weeks; over 24 hour administration) until progression or intolerance
* Arm B 'Intermittent/holiday' therapy. Rechallenge of Trabectedin will be implemented in the event of progression; in this case administration of Trabectedin will occur until the second progression or intolerance
#Intervention
- DRUG : Trabectedin
- Trabectedin will be administered without drug holiday in Arm A until unacceptable toxicity, progressive disease or patient decision. The treatment beyond disease progression and in case of intolerance will be decided according to investigator discretion. In case of progression after drug discontinuation by patient decision, a re-challenge of Trabectedin is possible.
- Other Names :
- Yondelis
- OTHER : Drug: holiday
- A drug-holiday will start after the 6th cycle until disease progression, and then Trabectedin will be re-challenged. Trabectedin will be administered until unacceptable toxicity, second evidence of progressive disease or patient decision.
- Other Names :
- No drug
|
#Eligibility Criteria:
Inclusion Criteria (for the selection part):
* Inoperable or metastatic soft tissue sarcoma and/or uterine sarcoma
* Measurable lesions (RECIST 1.1)
* Performance status <= 2
* Age >= 18
* Normal hematological parameters (polynuclear neutrophils >= 1500, hemoglobin level >= 9 g/dl, platelets counts >= 100,000)
* Adequate biological parameters :
* Adequate hepatic function (bilirubin <= ULN , SGPT/ALT and SGOT/AST <= 2.5 x ULN)
* Alkaline phosphatases <= 2.5 x ULN, If Alkaline phosphatases >= 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range
* Albumin >= 25 g/L
* Adequate renal function : Serum creatinine <= 1.5 x ULN
* Creatine phosphokinase <= 2.5 x ULN
* Adequate central venous access
* Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods
* Patient covered by government health insurance
* Information sheet given to the patient (Patient information sheet 1)
Exclusion Criteria (for the selection part):
* Patients that have received more than one regimen of chemotherapy for metastatic or inoperable soft tissue or uterine sarcoma, after the failure/intolerance of doxorubicin and ifosfamide. Maintenance treatment does not count as treatment line
* The following histological subtypes : GIST, rhabdomyosarcoma, aggressive fibromatosis, desmoïd tumour, PNET, carcinosarcoma, and all bone sarcomas
* Single tumour in an irradiated region
* Other malignant tumour over the past five years (except basal cell carcinoma or cervical carcinoma in situ adequately treated)
* Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections
* Presence of known leptomeningeal or brain metastasis
* Patients unable to receive corticotherapy
* Any circumstance that could jeopardise compliance or proper follow-up during the trial
* Pregnant or nursing women
Inclusion Criteria (for the randomized part):
* Patient registered in the selection part
* Stable tumour or objective response (CR + PR) after 6 Trabectedin (Yondelis®) cycles, according to local assessment
* Available copies of thoraco-abdominal and pelvic scan performed prior to the first cycle and after the sixth cycle
* Performance status <= 2
* Patients receiving at least 1 mg/m²/3 weeks of Trabectedin at the time of the sixth cycle
* Normal hematological parameters (polynuclear neutrophils >= 1500, hemoglobin level >= 9 g/dl, platelets counts >= 100,000)
* Adequate biological parameters :
* Adequate hepatic function (bilirubin <= ULN , SGPT/ALT and SGOT/AST <= 2.5 x ULN)
* Alkaline phosphatases <= 2.5 x ULN, If Alkaline phosphatases >= 2.5 ULN, hepatic isoenzymes 5-nucleotidases or GGT tests must be performed; hepatic isoenzymes 5- nucleotidases and/or GGT must be within the normal range
* Albumin >= 25 g/L
* Adequate renal function : Serum creatinine <= 1.5 x ULN
* Creatine phosphokinase (CPK) <= 2.5 x ULN
* Adequate central venous access
* Pregnant or lactating women or men of reproductive potential must use effective contraceptive methods
* Informed consent form signed by the patient or the patient's legal representative (patient information sheet 2 and informed consent)
Exclusion Criteria (for the randomized part):
* Tumour progression (according to RECIST 1.1) during the first six Yondelis cycles
* Non-availability of baseline scans prior to the first cycle and following the sixth cycle
* Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] Version 4.02). Known HIV1, HIV2, hepatitis B or hepatitis C infections
* Presence of known leptomeningeal or brain metastasis
* Creatinine clearance less than 30 ml/min
* Patients unable to receive corticotherapy
* Any circumstance that could jeopardise compliance or proper follow-up during the trial
* Pregnant or nursing women
* Hypersensitivity to Trabectedin or any excipient in prior cycles
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
|
NCT01303094
|
{
"brief_title": "Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma",
"conditions": [
"Soft Tissue Sarcoma",
"Uterine Sarcoma"
],
"interventions": [
"Other: Drug: holiday",
"Drug: Trabectedin"
],
"location_countries": [
"France"
],
"nct_id": "NCT01303094",
"official_title": "Phase II Randomized Trial to Evaluate Two Strategies: Continuing Versus Intermittent (Drug-holiday) Trabectedin-regimen in Patients With Advanced Soft Tissue Sarcoma Experiencing Response or Stable Disease After the Sixth Cycle",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-16",
"study_completion_date(actual)": "2018-08-09",
"study_start_date(actual)": "2011-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-31",
"last_updated_that_met_qc_criteria": "2011-02-23",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-02-24",
"first_submitted": "2011-02-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis
#Intervention
- BIOLOGICAL : ABT-874
- SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
- BIOLOGICAL : etanercept
- SQ injection 50 mg BIW
- DRUG : placebo
- SQ placebo injections for ABT-874 and etanercept
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Psoriasis for 6 mo.
* BSA 10%, PASI 12 or above, PGA 3 or above
Exclusion Criteria:
* Previous exposure to either etanercept or ABT-874
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
|
NCT00691964
|
{
"brief_title": "Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis",
"conditions": [
"Plaque Psoriasis"
],
"interventions": [
"Drug: placebo",
"Biological: etanercept",
"Biological: ABT-874"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00691964",
"official_title": "A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03",
"study_completion_date(actual)": "2009-03",
"study_start_date(actual)": "2008-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-01-21",
"last_updated_that_met_qc_criteria": "2008-06-05",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-06",
"first_submitted": "2008-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators will enroll about 120 subjects from the hospital's healthcare center. The investigators will collect the basic informations, blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject. The investigators will collect the blood samples and then test them for fasting insulin levels, VEGF-B levels, the gene promoter region methylation status and the genomic protein methylation levels of the VEGF-B gene of the cells，and finally do the statistical analysis.
Detailed Description
The investigators will enroll about 120 subjects from the hospital's healthcare center, and these 120 subjects will be divided into four groups: normal weight with or without metabolic diseases and obesity with or without metabolic diseases. Each group has 30 subjects. The investigators will collect the basic information(name, gender，age, medical history，family history, etc.), blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject from the healthcare center. The investigators will collect the blood samples of each subject,separate the plasma and then test the fasting insulin, VEGF-B levels by ELISA. The investigators will separate the peripheral blood mononuclear cells from the blood, and then test the gene promoter region methylation status of the VEGF -B gene by PCR and the bisulfite-modified sequencing and test the genomic protein methylation level of the VEGF-B gene by chromatin immunoprecipitation assay(CHIP) and real-time quantitative PCR of the cells，and finally do the statistical analysis.
|
#Eligibility Criteria:
Inclusion Criteria:
* NA
Exclusion Criteria:
* subjects with active history insulin treatment; and female participant pregnant at the time of recruitment.
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:
Yes
|
NCT03164005
|
{
"brief_title": "The Effects of VEGF-B Signaling Pathway in Obesity and Metabolic Disease",
"conditions": [
"Obesity",
"Metabolic Disease"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT03164005",
"official_title": "The Effects of VEGF-B Signaling Pathway in Obesity and Metabolic Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09-01",
"study_completion_date(actual)": "2018-03-01",
"study_start_date(actual)": "2017-04-20"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-08",
"last_updated_that_met_qc_criteria": "2017-05-21",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-23",
"first_submitted": "2017-05-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study will examine the effectiveness of group metacognitive therapy in comparison with group meditation therapy, in patients with Generalised Anxiety Disorder. Individuals will be randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy sessions of their respective treatment condition.
#Intervention
- BEHAVIORAL : Group Metacognitive Therapy
- Other Names :
- MCT
- BEHAVIORAL : Mindfulness Meditation Therapy
- Other Names :
- MMT
|
#Eligibility Criteria:
Inclusion Criteria:
* individual's score on the GAD-7 & PHQ-9
* individuals who meet the DSM-IV (Diagnostic and Statistical Manual) criteria for generalized anxiety disorder
Exclusion Criteria:
* Individuals with major depressive disorder
* Individuals who report suicidality
* Individuals with a brain injury or neurological insult
* Individual who currently engage in substance abuse
* Individuals with bipolar disorder
* Individuals with psychotic symptoms
* Individuals who cannot converse or read English
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
|
NCT02096484
|
{
"brief_title": "A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy",
"conditions": [
"Generalized Anxiety Disorder"
],
"interventions": [
"Behavioral: Mindfulness Meditation Therapy",
"Behavioral: Group Metacognitive Therapy"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02096484",
"official_title": "Group Metacognitive Therapy Versus Mindfulness Meditation Therapy in a Transdiagnostic Patient Sample: A Feasibility Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2016-06",
"study_start_date(actual)": "2014-08"
},
"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)": "2016-10-17",
"last_updated_that_met_qc_criteria": "2014-03-21",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-03-26",
"first_submitted": "2014-03-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study retrospectively analyzed data of 14 cases of massive rotator cuff tears who were treated with arthroscopic repair by the same doctor from October 2015 to December 2017, aiming to explore the surgical methods and clinical effects of arthroscopic repair for massive rotator cuff tears.
Detailed Description
The preoperative and intraoperative data and patient information of 14 cases of arthroscopic repair of huge rotator cuff tears performed by Deputy Chief Physician Yang Yuping of the Institute of Sports Medicine of Peking University Third Hospital from January 2016 to August 2017 sort out. Collect and organize follow-up data on the recovery and motor function of patients 6 months after surgery and the latest follow-up (February 4 to March 3, 2018). Discuss the operation method, and statistically analyze the short-term curative effect of patients undergoing the operation.
#Intervention
- PROCEDURE : arthroscopic repair
- arthroscopic repair
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed as massive rotator cuff tears and treated with arthroscopic repair from October, 2015 to December, 2017
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04951375
|
{
"brief_title": "Clinical Results of Arthroscopic Repair for Massive Rotator Cuff Tears of 14 Cases",
"conditions": [
"Rotator Cuff Tears"
],
"interventions": null,
"location_countries": [
"China"
],
"nct_id": "NCT04951375",
"official_title": "Clinical Results of Arthroscopic Repair for Massive Rotator Cuff Tears of 14 Cases",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06-01",
"study_completion_date(actual)": "2018-07-01",
"study_start_date(actual)": "2018-04-01"
},
"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)": "2021-07-06",
"last_updated_that_met_qc_criteria": "2021-06-25",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-07-06",
"first_submitted": "2021-06-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this pilot study is to improve the STAR-Caregivers Virtual Training \& Follow-up (STAR-VTF) intervention for Latino caregivers of people living with dementia. The main objectives are to: (1) culturally adapt STAR-VTF online training modules, (2) pilot test Latino caregivers' responses to the adapted online training modules, and (3) develop an online survey to collect caregiver outcomes in a future study. Participants will receive the STAR-VTF intervention and asked to complete online surveys and participate in an exit interview to provide feedback on their experience.
Detailed Description
The objectives of this study are to: (1) culturally and linguistically adapt the STAR-Caregivers Virtual Training \& Follow-up (STAR-VTF) online training modules for Latino caregivers of people living with dementia (PLWD), (2) pilot test Latino caregivers' responses to the adapted online training modules, and (3) develop a REDCap survey to pragmatically collect caregiver outcomes in a future study.
The study will use a single-arm pilot trial design with Latino caregivers of PLWD. The investigators will assess self-reported outcomes at baseline and 6-8 weeks post-enrollment using a REDCap survey. Outcome measures will include the Revised Memory and Problem Behavior Checklist and Preparedness for Caregiving Scale. In addition, the investigators will assess caregivers' perceived usability of the online training modules and will conduct qualitative interviews 6-8 weeks post-enrollment. The interviews will assess caregiver satisfaction with and acceptability of the adapted online training modules.
The investigators expect to enroll up to 20 participants. The primary objective of this study is to pilot test the adapted online training modules. Therefore, it is not powered to detect an effect of the intervention.
#Intervention
- BEHAVIORAL : STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)
- For 6-8 weeks, caregivers will complete online training modules asynchronously. Caregivers will be instructed to complete one module per week. The content of the modules is as follows: Module 1 introduces caregivers to the behavioral treatment of dementia, realistic expectations, and effective communication; Module 2 covers the ABC (antecedents, behaviors, consequences) approach to problem-solving, including rationale and development of an ABC plan; Module 3 instructs caregivers to review the ABC plan and revise as needed; Module 4 covers pleasant events and managing negative thinking; Module 5 instructs caregivers to review the ABC plan, pleasant activities schedule, and to revise as needed; Module 6 covers coping with caregiving and maintaining gains. Each module takes about 45 minutes to complete. The modules use text, pictures, and illustrations with a voiceover presentation. Caregivers will receive the online training modules in their preferred language (English or Spanish).
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Lives with a person living with dementia (PLWD) or within 5 miles
* Provides at least 8 hours of care per week
* Self-identifies as Hispanic/Latino
* Caregiver self-report of PLWD having >= 3 behavioral and/or psychological symptoms of dementia occurring >= 3 in past week
Exclusion Criterion:
* PLWD lives in assisted living or skilled nursing facilities
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
|
NCT05599100
|
{
"brief_title": "Virtual Training for Latino Caregivers to Manage Symptoms of Dementia",
"conditions": [
"Caregiver Burden",
"Alzheimer Disease",
"Dementia",
"Behavioral Symptoms"
],
"interventions": [
"Behavioral: STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05599100",
"official_title": "Virtual Training for Latino Caregivers to Manage Symptoms of Dementia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-01-15",
"study_completion_date(actual)": "2024-01-15",
"study_start_date(actual)": "2023-05-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-21",
"last_updated_that_met_qc_criteria": "2022-10-27",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-31",
"first_submitted": "2022-10-23",
"first_submitted_that_met_qc_criteria": "2024-07-26"
}
}
}
|
#Study Description
Brief Summary
Sugar-sweetened beverage (SSB) consumption is associated with the development of obesity, type 2 diabetes, and dental caries. The current study attempts to explore whether an educational, science-based intervention is able to produce a measurable negative change in preferences for sugar-sweetened beverages, as well as initiate plans to reduce future SSB consumption in 12-year old children. In the first condition (SSB Intervention), participants will watch a video showing the decay of an egg in various SSBs (Coca-Cola, Sprite, Gatorade, and apple juice), followed by the evaporation of these beverages over a heat source, revealing their sugar content. In the second condition (Water Intervention), participants will watch a video showing an egg maintaining its shell in water, followed by the evaporation of water. In the third condition (Control), participants will watch a video of an egg maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol. Before and after watching their assigned video, participants will complete survey questions to assess self-reported: SSB consumption intentions, attitudes toward SSBs, and health perceptions of SSBs. Therefore, the aims of this study are to (1) quantify changes in SSB consumption intentions, attitudes towards SSBs, and health perceptions of SSBs from pre-video to post-video, (2) establish the effectiveness of the SSB Intervention and Water Intervention over the control, (3) establish the effectiveness of the SSB Intervention over the Water Intervention, (4) determine the efficacy of incorporating scientific evidence in a public health intervention, and (5) make recommendations for the future application of the method employed in this intervention to future public health campaigns.
#Intervention
- BEHAVIORAL : Sugar-Sweetened Beverage (SSB) Video
- Participants will watch a video showing the decay of an egg in various SSBs (Coca-Cola, Sprite, Gatorade, and apple juice), followed by the evaporation of these beverages over a heat source, revealing their sugar content.
- BEHAVIORAL : Water Video
- Participants will watch a video showing an egg maintaining its shell in water, followed by the evaporation of water.
- BEHAVIORAL : Control
- Participants will watch a video of an egg maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol.
|
#Eligibility Criteria:
Inclusion Criteria:
* We will recruit a nationally representative sample of participants through the subdivision of Qualtrics, Qualtrics Panel. Participants must be 12 years and English speaking.
Exclusion Criteria:
* Any participant that is not 12 years or does not speak English will be excluded from participation.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04971317
|
{
"brief_title": "The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages",
"conditions": [
"Obesity",
"Type 2 Diabetes",
"Dental Caries"
],
"interventions": [
"Behavioral: Water Video",
"Behavioral: Sugar-Sweetened Beverage (SSB) Video",
"Behavioral: Control"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04971317",
"official_title": "The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages'",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-05",
"study_completion_date(actual)": "2018-12-30",
"study_start_date(actual)": "2018-09-05"
},
"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)": "2021-07-21",
"last_updated_that_met_qc_criteria": "2021-07-14",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-07-21",
"first_submitted": "2021-07-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults
#Intervention
- DRUG : Clocortolone Pivalate
- Cream, 0.1%
- Other Names :
- Clocortolone
|
#Eligibility Criteria:
Inclusion Criteria:
* Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing;
Exclusion Criteria:
* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
* History of hypersensitivity to the study products or any topical or systemic corticosteroids;
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
|
NCT04358770
|
{
"brief_title": "Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream",
"conditions": [
"Bioequivalence Study"
],
"interventions": [
"Drug: Clocortolone Pivalate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04358770",
"official_title": "Single Exposure Bioequivalence Study to Evaluate the Vasoconstriction Activity of Topically Applied Cloderm® (Clocortolone Pivalate) 0.1% Cream and Clocortolone Pivalate 0.1% Cream (Taro Pharmaceuticals) in Healthy Male and Female Volunteers With Normal Skin Under Occlusive Conditions.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-27",
"study_completion_date(actual)": "2018-05-11",
"study_start_date(actual)": "2018-03-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-24",
"last_updated_that_met_qc_criteria": "2020-04-22",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-24",
"first_submitted": "2020-04-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy, quality of life and safety of switching from monthly (3.6 mg) or quarterly (10.8 mg) goserelin acetate (Zoladex®) to semiannual leuprorelin acetate 45 mg (Eligard® 45 mg) in prostate cancer patients with adequate hormonal castration level (plasma testosterone levels ≤50 ng/dL).
Detailed Description
When systemic treatment is indicated, androgen deprivation therapy is the standard treatment for patients with prostate cancer. This condition occurs when the patient is diagnosed with metastatic disease or disseminated disease based on PSA values.The exchange of androgen hormone deprivation therapies in patients with metastatic prostate cancer may be required in different situations in clinical practice, such as: lack of medication available at the institution or on the market; alteration of the clinical protocol of the health institution due to economic factors and/or aiming to gain adherence to the treatment, often related to the posological convenience and/or logistics necessary for the administration of the medication, among others.
Additionally, although there is evidence on the efficacy and safety of switching hormone treatments in patients with prostate cancer clinical data on this type of management of patients in Brazil are scarce. There are no data on how the management and switching of treatments is approached, nor on the clinical outcomes related to such a switch of therapy (time to progression, treatments used in combination with androgen deprivation therapy, time to onset of disease symptoms, time to start chemotherapy and costs involved).
#Intervention
- DRUG : Leuprorelin Acetate (Eligard® 45 mg).
- Semiannually Leuprorelin Acetate (Eligard® 45 mg).
- Other Names :
- Leuprorelin Acetate
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient able to understand the process of the informed consent form (ICF);
* Male aged >=18 years;
* Having a histologically confirmed diagnosis of prostate adenocarcinoma;
* Having an indication of androgen deprivation treatment:
1. Being on treatment with monthly or quarterly goserelin acetate depot formulation for at least 3 months and for a maximum of 18 months OR;
2. Having an indication to start treatment with quarterly goserelin acetate depot formulation.
* Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2;
* Patient with appropriate castration level, defined by a serum testosterone level <=50 ng/dL (<=1.73 nmol/L) demonstrated before V1.
* Appropriate hematologic function in the screening period: neutrophil count >1,500/μL, platelets >100,000/μL, hemoglobin >10 g/dL;
* Appropriate liver function in the screening period of the study: total serum bilirubin <=1.5 x upper normal limit, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) <=40 U/L, alkaline phosphatase <130 U/L, gamma-GT (glutamyl transferase) <100 U/L;
* Appropriate kidney function in the screening period of the study: serum urea within normal limits for the method used at the institution, serum creatinine between 0.6 and 1.3 mg/dL, creatinine clearance calculated by the Cockroft- Gault formula > 40 mL/min;
Exclusion Criteria:
* Patients who did not have or do not have an indication for treatment with goserelin acetate;
* Patients with goserelin treatment for over 18 months;
* Patients who have received previous chemotherapy;
* Patient unable to follow the foreseen study visit schedule;
* Suspected or proven brain metastasis or active leptomeningeal disease;
* Uncontrolled arterial hypertension defined as systolic pressure >=160 mmHg or diastolic pressure >=95 mmHg;
* Long-term use of estrogen therapy or peripheral blockade;
* Another concomitant neoplasm;
* Any medical condition which, at the investigator's discretion, offers risk to the patient's participation in the study;
* Having participated in another clinical study within less than 12 months.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05304169
|
{
"brief_title": "Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Drug: Leuprorelin Acetate (Eligard® 45 mg)."
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT05304169",
"official_title": "PRospective, Multicenter Study to Evaluate Safety and Efficacy of Switching Treatments of Prostate Cancer Patients, Initially on Use of Monthly or Quarterly Goserelin Acetate (Zoladex®), to Semiannually Leuprorelin Acetate (Eligard®)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06-15",
"study_completion_date(actual)": "2020-06-15",
"study_start_date(actual)": "2017-11-14"
},
"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)": "2022-03-31",
"last_updated_that_met_qc_criteria": "2022-03-21",
"last_verified": "2022-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-31",
"first_submitted": "2022-03-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, 'novel' cardiovascular risk factors and safety parameters will be also evaluated.
#Intervention
- DRUG : Atorvastatin
- 10 mg of atorvastatin once daily for six months
- DRUG : Placebo
- placebo once daily for six months
|
#Eligibility Criteria:
Inclusion Criteria:
* LDL-C>130 or >160 mg/dL (depending on the total risk according to the most recent recommendations25).
* no previous hypolipidemic medication
* ability to provide Informed Consent.
Exclusion Criteria:
* pregnancy or lactation
* myocardial infarction or unstable angina within the past 6 months
* heart failure NYHA class III-IV
* renal disease (SCr>3 mg/dL or proteinuria>3g/d)
* liver disease
* history of malignancy
* history of drug or alcohol abuse
* treatment with corticosteroids
* any other condition with poor prognosis
* inability to provide Informed Consent.
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
|
NCT01126684
|
{
"brief_title": "Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion",
"conditions": [
"Hypertension",
"Hypercholesterolemia"
],
"interventions": [
"Drug: Placebo",
"Drug: Atorvastatin"
],
"location_countries": [
"Greece"
],
"nct_id": "NCT01126684",
"official_title": "EFFECTS OF ATORVASTATIN ON BLOOD PRESSURE AND URINARY ALBUMIN EXCRETION IN PATIENTS WITH ESSENTIAL HYPERTENSION",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2008-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-05-20",
"last_updated_that_met_qc_criteria": "2010-05-19",
"last_verified": "2010-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-05-20",
"first_submitted": "2010-05-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men (MSM).
#Intervention
- BEHAVIORAL : Prepmate
- A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-uninfected as determined by a negative/non-reactive laboratory test within 7 days of Enrollment (as defined in the study-specific procedures (SSP) Manual).
* Interested in initiating PrEP
* Eligible to initiate PrEP
* Creatinine clearance > 60 ml/min as estimated by the Cockcroft-Gault equation within 6 weeks of enrollment
* Hepatitis B surface antigen (HBsAg) negative within 6 weeks Enrollment
* No other medical contraindications to PrEP
* Age 18 years - 29 years
* Willing and able to provide written informed consent
* Report having had anal sex with a man in the previous 6 months
* Meet any of the following risk criteria for the prior 6 months:
* Any condomless anal sex
* Three or more anal sex partners
* Self-reported new STI
* Known HIV-infected sex partner
* Have regular access to a computer and/or a smart phone to access the internet and/or apps
* Have the ability to send and receive text messages
* Able to read and speak in English
Exclusion Criteria:
* PrEP use within the past year (PrEP naïve participants will be prioritized).
* Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
* Prior or current participation in the active arm of an HIV vaccine trial
* At Enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
* Signs or symptoms of acute HIV infection (as described in the SSP Manual)
* History of pathological bone fracture not related to trauma.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 29 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02371525
|
{
"brief_title": "Enhancing PrEP in Community Settings (EPIC)",
"conditions": [
"HIV"
],
"interventions": [
"Behavioral: Prepmate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02371525",
"official_title": "Enhancing PrEP in Community Settings (EPIC)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-11",
"study_completion_date(actual)": "2017-01",
"study_start_date(actual)": "2015-04"
},
"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)": "2017-10-26",
"last_updated_that_met_qc_criteria": "2015-02-24",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-02-25",
"first_submitted": "2015-02-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A single center randomized controlled trial to evaluate the effect of a post-discharge mobile health application on 30-day re-admission and patient reported outcomes following elective colorectal surgery
Detailed Description
Background: Following elective colorectal surgery, rates of re-admission are high and result in significant healthcare resource use. However, up to 20% of these re-admissions may be preventable. This represents an opportunity to improve patient outcomes, reduce health care utilization and costs through targeted interventions.
Home To Stay is an integrated discharge monitoring program using a mobile app platform that was developed to support the needs of patients following discharge after colorectal surgery. In the initial pilot testing, the 30-day re-admission rate for patients using Home to Stay was reduced from 18% to 6% and patient anxiety was reduced in over 75% of the participants.
Methods: This study is a two arm, single center, randomized control trial that will be conducted in the colorectal unit of an academic tertiary care center. Patients will be randomized1:1 using a single randomized consent design to either usual follow up in the control group or post discharge monitoring with Home to Stay in the intervention group.
Objective: The objective of this study is to evaluate the Home to Stay app and its effect on healthcare utilization and patient reported outcomes.
#Intervention
- OTHER : Home To Stay Mobile Health Application
- Home to stay is an integrated discharge monitoring system with a mobile application. Features of the application include a 'Daily Health Check' to report on post-operative recovery, picture taking capability to photograph incisions/wounds and educational information on post-operative care at home.
Patients will complete a 'Daily Health Check' on post-discharge Day #1-14, #21 and #30. The Daily Health Check consists of a series of questions specific to colorectal surgery as well as the Quality of Recovery (QoR-15) questionnaire. After completion, the participant will receive a list of recommendations tailored to their responses including relevant education modules, to contact the surgical team or in urgent cases to go to the nearest emergency room. The participants' responses will be monitored daily via a secure web site. Any participants' responses in the extreme ranges are automatically 'red flagged' and notify the health care team that a follow up telephone call is required.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing elective, inpatient colorectal surgery
* Able to speak and read in English
* Able to provide informed consent
* Have access to a smartphone/tablet or desktop computer with internet access
Exclusion Criteria:
* Patients undergoing semi-elective/emergent procedure
* Patients undergoing elective day surgery
* Expected post operative admission of less than 3 days
* Discharge to another institution (rehabilitation facility/nursing home/long term care).
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
|
NCT04968145
|
{
"brief_title": "Home To Stay: a Randomized Trial Evaluating a Post-discharge Mobile App for Elective Colorectal Surgery",
"conditions": [
"Colorectal Cancer",
"Inflammatory Bowel Diseases",
"Utilization, Health Care",
"Surgery",
"Post Discharge Monitoring"
],
"interventions": [
"Other: Home To Stay Mobile Health Application"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT04968145",
"official_title": "Home To Stay: a Randomized Controlled Trial Evaluating the Effect of a Post-discharge Mobile App on 30-day Re-admission Following Elective Colorectal Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-21",
"study_completion_date(actual)": "2020-01-21",
"study_start_date(actual)": "2017-07-19"
},
"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)": "2021-07-20",
"last_updated_that_met_qc_criteria": "2021-07-13",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-07-20",
"first_submitted": "2021-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to test whether addition of aquatic exercise to conventional treatment helps reduce the adverse outcomes of chronic venous insufficiency including CVI resulting from venous thrombosis.
Detailed Description
Post-thrombotic syndrome (PTS) develops in approximately 25-60% of patients with acute lower extremity deep venous thrombosis (DVT) depending on severity, chronicity, anatomic level of involvement and efficacy of anticoagulation.The frequency increases with occlusive iliac venous thrombosis. PTS results in significant morbidity and a staggering toll on health careresources . PTS is reduced by early percutaneous endovenous intervention and administration of new oral anticoagulants. There are conflicting results on the efficacy of exercise . In general, exercise has been useful in activation of the muscle pump and improvement of symptoms. There are no data about exercise in a swimming pool. Both walking in water or swimming reduce the effect of joint contact and therefore pain which is particularly useful in patients with arthritis or heavyweight. Furthermore with less effect of gravity, absorption of dependent edema would be faster. Dry skin becomes hydrated and the chlorine of water can exert antiseptic properties. There are no data on the role of aquatic activity in the reduction of measures of venous insufficiency.The purpose of this study is to assess whether encouragement of patients to perform aquatic activity in addition to baseline treatment would positively impact chronic venous insufficiency.
#Intervention
- OTHER : exercise in water
- The patients will be instructed to perform walking or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management
- Other Names :
- aquatic activity
- OTHER : aquatic activity plus conventional management
- walking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management
|
#Eligibility Criteria:
Inclusion Criteria:
age>18 years; a Villalta score of ˃5 or a modified Venous Clinical Severity Score (VCSS) of ˃5 plus ongoing symptoms of ˃3 months despite receiving conservative management (minimum of 2 of the following: compression stockings, leg elevation, physical activity on land and use of non-steroidal anti-inflammatory drugs where appropriate, for the preceding 3 months).
Exclusion criteria consisted of unwillingness or inability to use or no access to a swimming pool; open ulceration; planned intervention for arterial or superficial venous reflux, deep venous thrombosis (DVT), venous stenosis, pelvic congestion syndrome, within the first 3 months of enrolment; or using a swimming pool on a regular basis.
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
|
NCT02553720
|
{
"brief_title": "The ATLANTIS Trial",
"conditions": [
"Chronic Venous Hypertension Due to Deep Vein Thrombosis",
"Venous Reflux"
],
"interventions": [
"Other: aquatic activity plus conventional management",
"Other: exercise in water"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02553720",
"official_title": "Aquatic Therapy to Lower Adverse and Negative Effects of Venous Thrombosis and InSufficiency",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07",
"study_completion_date(actual)": "2018-01",
"study_start_date(actual)": "2015-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-07-23",
"last_updated_that_met_qc_criteria": "2015-09-17",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-18",
"first_submitted": "2015-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.
#Intervention
- DRUG : Sugammadex
- Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
- Other Names :
- Bridion
- DRUG : Placebo
- Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing surgery with general anesthesia
* Patients weighing > or = 80 pounds
* Patients not intubated prior to surgery
* Patients who are able to give informed consent
Exclusion Criteria:
* Patients unable to give informed consent.
* Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
* Patients who are anticipated to remain intubated in recovery period.
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
|
NCT02728726
|
{
"brief_title": "Sugammadex vs Placebo to Prevent Residual Neuromuscular Block",
"conditions": [
"General Surgery"
],
"interventions": [
"Drug: Placebo",
"Drug: Sugammadex"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02728726",
"official_title": "Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12",
"study_completion_date(actual)": "2019-12",
"study_start_date(actual)": "2016-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-07-14",
"last_updated_that_met_qc_criteria": "2016-04-04",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-05",
"first_submitted": "2016-03-15",
"first_submitted_that_met_qc_criteria": "2022-06-21"
}
}
}
|
#Study Description
Brief Summary
VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections following FDA-approved psoriasis treatment regimen.
#Intervention
- DRUG : Adalimumab
- Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.
- Other Names :
- Humira
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females 18 years and older.
* Subject completed the VIP Study
* Subject willing and able to avoid prolonged exposure of skin affected by psoriasis to natural or sunlight or tanning beds during the course of the study
* Subject is willing and able to avoid topical or systemic prescription treatments for psoriasis besides adalimumab during the course of the study
* Women are eligible to participate in the study if they meet one of the following criteria:
1. Women of childbearing potential must undergo pregnancy testing during the baseline visit and agree to use one of the following methods of contraception throughout the 13-month study:
* Oral contraceptives;
* Transdermal contraceptives
* Injectable or implantable methods
* Intrauterine devices
* Barrier methods (for example but not limited to a diaphragm with spermicide, condom with spermicide); or
* Vasectomized partner
* Subjects using oral or parental forms of contraceptives must have been using those methods of birth control for at least three months prior to the baseline visit.
2. Women who have undergone tubal ligation
3. Women who are postmenopausal (for at least one year), sterile, or hysterectomized are eligible to participate
4. Women who agree to be sexually abstinent, defined as total abstinence from sexual intercourse, as a form of contraception are eligible to participate in the study.
* Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, and physical examination.
* Able and willing to give written informed consent and to comply with requirements of this study protocol.
Exclusion Criteria:
* Previous adverse event following exposure to a TNF-alpha antagonist that led to discontinuation of the TNF inhibitor and contraindicates future treatment.
* Previous lack of response to a TNF-alpha antagonist led to discontinuation.
* Diagnosis of erythrodermic psoriasis, generalized pustular psoriasis, or medication-induced or medication-exacerbated psoriasis.
* Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
* Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
* Poorly controlled medical condition, such as unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the subject at risk by participation in the study.
* History of diabetes mellitus, type 1 or type 2 (patients with type 2 diabetes may be enrolled if the duration of diabetes is <10 years and HbA1c is <7.0%)
* Uncontrolled hypertension, with measured systolic blood pressure >180 mmHg or diastolic blood pressure >90 mmHg
* History of demyelinating diseases or lupus.
* Subject has infection or risk factors for severe infections, for example:
* Known history of HIV, hepatitis B or C, or other severe, recurrent, or persistent infections;
* Excessive immunosuppression or other factors associated with it, including human immunodeficiency virus infection;
* Active tuberculosis (TB) disease;
* Evidence of latent TB infection demonstrated by Purified Protein Derivative (PPD) >= 5 mm of induration or positive Quantiferon-GOLD results as determined within 6 months of the baseline visit for VIP-E; except if prophylactic treatment for TB, as recommended by local guidelines, is initiated prior to administration of study drug or if there is documentation that the subject has received prophylactic treatment for TB previously.
* Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Baseline;
* Infection requiring treatment with oral or parenteral antibiotics within 14 days prior to Baseline;
* Subject will require a live vaccination during study participation including up to 30 days after the last dose of study drug.
* Subject has history of hematological or solid malignancy within the past five years other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical carcinoma in situ.
* Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
* Clinic laboratory analyses showing any of the following abnormal results:
* Hemoglobin (Hgb) < 10 g/dL in females or <12 g/dL in males;
* White blood cell (WBC) count <2.5 x 109/L
* Subject can be included if WBC count is <2.5 x x 109/L and absolute neutrophil count (ANC) is >1000 cells / mm3.
* WBC count > 15 x 109/L;
* Platelet count < 100 x 109/L;
* Serum aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 upper limits of normal (ULN);
* Serum total bilirubin >=2 mg/dL (>=26 µmol/L)
* Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
* If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to baseline and remain stable throughout the duration 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
|
NCT01866592
|
{
"brief_title": "Vascular Inflammation in Psoriasis - Extension Study",
"conditions": [
"Psoriasis",
"Cardiovascular Disease"
],
"interventions": [
"Drug: Adalimumab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01866592",
"official_title": "Vascular Inflammation in Psoriasis - Extension Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08-08",
"study_completion_date(actual)": "2016-10-27",
"study_start_date(actual)": "2013-04"
},
"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)": "2018-05-22",
"last_updated_that_met_qc_criteria": "2013-05-28",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-05-31",
"first_submitted": "2013-05-16",
"first_submitted_that_met_qc_criteria": "2018-04-23"
}
}
}
|
#Study Description
Brief Summary
To test the hypothesis that there is no difference in change in HbA1C among men with type 2-diabetes after an exercise intervention with strength versus endurance training.
Detailed Description
Exercise training is well documented as part of effective treatment for type 2-diabetes patients. Endurance training has been suggested as the most suitable form of exercise. There are reasons to believe that strength training also has a positive effect. However, comparisons of endurance training and strength training regimes are limited.
Therefore we randomized 26 men with type 2-diabetes to either an endurance training group or a strength training group. Both groups exercised three sessions per week for three months. The training was supervised.
#Intervention
- BEHAVIORAL : Endurance training
- supervised endurance training. Three sessions per week in three months.
- Other Names :
- Aerobic training
- BEHAVIORAL : strength training
- Supervised strength training. Three sessions per week in three months.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with type 2-diabetes
* Male, 35 <= age <= 71 years
* Managing their diabetes through a lifestyle and/or the drug metformin only
* Able to participate in either of the exercise groups
Exclusion Criteria:
* Symptomatic cardiovascular disease
* Uncontrolled hypertension
* Physical or cognitive disabilities that will interfere with participating in the exercise regimes.
* Trained consistently during the last six months.
Sex :
MALE
Ages :
- Minimum Age : 35 Years
- Maximum Age : 71 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00666094
|
{
"brief_title": "A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes",
"conditions": [
"Diabetes Mellitus, Type 2",
"Hyperglycemia"
],
"interventions": [
"Behavioral: strength training",
"Behavioral: Endurance training"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT00666094",
"official_title": "A Randomized Controlled Trial of Strength Versus Aerobic Exercise Training to Improve Glycemic Control in Men With Type 2-diabetes",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03",
"study_completion_date(actual)": "2010-03",
"study_start_date(actual)": "2008-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-02-09",
"last_updated_that_met_qc_criteria": "2008-04-23",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-24",
"first_submitted": "2008-04-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Integrated eHealth is an innovative, proactive approach to the management of patients with chronic cardiopulmonary disease. Our overall goal is to improve the health of patients by integrating guideline-based education, remote disease monitoring, coordinator-based disease management and healthcare provider-initiated therapy. Patients enrolled in the program receive a set of equipment, including a Health Buddy® telemonitor that connects to a normal telephone, as well as instruments to measure oxygen levels (pulse oximeter), lung function (spirometer) and activity (pedometer). Through the Health Buddy® patients receive guideline-based disease education in their own homes. The Health Buddy® also allows patients to transmit daily information about their symptoms, oxygen levels, lung function and ability to walk to program coordinators located at the University of Colorado Hospital. Our program coordinators are highly experienced nurses or respiratory therapists with expertise in the management of chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Through this remote disease education/monitoring program, patients learn to take a more active role in the management of their own disease. However, once the coordinators identify early warning signs of a potential problem, patients are contacted and connected to their primary healthcare provider for early intervention. By this integrated approach to care, patients learn self-management techniques, physician communication is enhanced, and early interventions for problems are possible. We propose to target the Integrated eHealth Program to areas of Colorado that are highly impacted by COPD.
Key Objectives: The key objectives are to improve COPD care in the 16 Colorado counties with high COPD mortality rates.
Target Population: We will target patients with severe or very severe COPD.
Expected Outcomes: We expect that this study will increase the use of evidence-based guidelines in the screening, diagnosis and treatment of COPD, resulting in improved quality-of-life and a reduction in healthcare utilization.
#Intervention
- OTHER : Integrated Care
- Study looking at the efficacy of a combination of Guideline-based COPD education, self-management training, remote telemonitoring and enhanced communication with a coordinator.
|
#Eligibility Criteria:
Inclusion Criteria:
* COPD Diagnosis by Gold Guidelines
* Airflow obstruction on spirometry defined by an FEV1/FVC less than or equal to 70% and an FEV1 less than 50% predicted, or and FEV1 greater than or equal to 50% predicted with a history of a COPD exacerbation within one year, or an FEV1 greater than or equal to 50% predicted and on long-term oxygen therapy.
* Standard land-line telephone
* Legal US residency status residing in Adams, Alamosa, Bent, Crowley, Dolores, El Paso, Fremont, Kiowa, Logan, Morgan, Montezuma, Otero, Prowers, Rio Blanco, or Washington counties in Colorado
Exclusion Criteria:
* Asthma
* Co-existing conditions that are likely to cause death within two years. Patients with CXR evidence of interstitial lung disease, or other pulmonary diagnoses at the time of enrollment, aside from COPD-related bronchiectasis. Patients with end-stage liver, renal or muscle disease, HIV, or a diagnosis of dementia.
* Participation in another treatment study
* Inability or unwillingness to cooperate with self-monitoring and reporting components
* Prisoners, pregnant women, institutionalized patients
* Current alcohol or drug abuse
* Non-English speakers
* Inability to complete a consent
* Illegal alien, non-Colorado resident, or non-resident of targeted counties
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01045213
|
{
"brief_title": "Integrated Care Program for Chronic Obstructive Pulmonary Disease",
"conditions": [
"Chronic Obstructive Pulmonary Disease"
],
"interventions": [
"Other: Integrated Care"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01045213",
"official_title": "Phase 3 Study of the Efficacy of Proactive Integrated Care in Advanced COPD Patients Located in Areas With High COPD-related Mortality",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2008-10"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-10-05",
"last_updated_that_met_qc_criteria": "2010-01-07",
"last_verified": "2012-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-08",
"first_submitted": "2010-01-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Falling is one of the most common consequences of vestibular dizziness. Most of patients with vestibular dysfunction suffer from balance disorders, postural instability and vertigo that may lead to life threating complications as fractures and brain injuries. Non invasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been investigated as therapeutic interventions for various neurological disorders like motor deficits and balance disorders after various neurological deficits. To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) added to supervised vestibular rehabilitation program on balance and postural stability in patients with vestibular dizziness
Detailed Description
The subjects of both genders with age 40 to 65 will be allocated randomly into two equal groups A and B. Group A Outcomes measure will include : Berg balance scale, computerized dynamic posturography (CDP) . Assessment will be done before and after treatment sessions.
#Intervention
- DEVICE : rTMS group
- Twenty eight randomly assigned patients with peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises
- Other Names :
- repetitive transcranial magnetic stimulation
- DEVICE : placebo rTMS group
- Twenty eight randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.
- Other Names :
- placebo rTMS
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis with peripheral vestibular disorders from audiologist or neurologist.
* The patient's age will be ranged from forty five to seventy years old.
* Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.
* Symptoms of vertigo and nystagmus lasting from seconds to one minute.
* Vertigo that arises from changes in head position related to gravity.
* Patients who experienced symptoms for more than three months (chronic patients)
* Patients were selected to be ambulant.
* Patients suffer from balance disturbance with low risk falling (41 <= age <= 56) and moderate risk falling ranges (21 <= age <= 40) according to berg balance scale.
* All patients were medically stable, controlled with medical drugs for at least three months and failed to medical treatment with no other physical, mental or cognitive disorders.
Exclusion Criteria:
* Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome 'PICA').
* Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency 'VBI').
* Previous surgery of the ear.
* Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.
* Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension >190/110...).
* Pacemaker or other implanted electrically sensitive device.
* Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn't permit to completion of any of the tests).
* Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer's disease , depression....).
* Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic).
* Alcohol abuse.
* Epilepsy.
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05871385
|
{
"brief_title": "rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients/ Chronic Labyrinthitis",
"conditions": [
"Peripheral Vestibular Disorders"
],
"interventions": [
"Device: rTMS group",
"Device: placebo rTMS group"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05871385",
"official_title": "rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients, Double Blinded RCT",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-27",
"study_completion_date(actual)": "2023-12-27",
"study_start_date(actual)": "2023-04-23"
},
"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)": "2025-01-06",
"last_updated_that_met_qc_criteria": "2023-05-12",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-23",
"first_submitted": "2023-04-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Plaque erosion is associated with myocardial infarction (MI) in about 30% of cases and may require a different management approach to plaque rupture. The investigators hypothesise that plaque erosion leads to higher levels of apoptotic circulating endothelial cells (CECs) compared to plaque rupture.
Aims: To compare associations between plaque erosion and plaque rupture with numbers and types of apoptotic CECs in patients with non-ST elevation MI (NSTEMI) and stable coronary artery disease controls (CAD). Additional aims are to explore signals of cellular stress (mitochondrial dsDNA), sub-populations of activated neutrophils, circulating endothelial progenitor cells and erosion-specific plasma biomarkers.
Methods: Prospective observational study of 80 patients with NSTEMI and 40 patients with stable CAD. Plaque erosion or rupture will be identified by intracoronary Optical Coherence Tomography (OCT). CECs and neutrophils will be quantified and characterised using flow cytometry looking at markers of cell death and neutrophil activation. Plasma will be analysed by proteomic methods (Olink) and for mitochondrial dsDNA.
Potential importance of findings: This study will provide evidence for the hypothesised mechanism of plaque erosion and clarify if biomarker analysis in NSTEMI patients provides a basis for non-invasive diagnosis of plaque erosion versus rupture.
Detailed Description
This is a prospective observational pilot study to assess the feasibility of studying endothelial cell and neutrophil differences between coronary atherosclerotic plaque rupture and plaque erosion in patients presenting with NSTEMI. The data obtained from this study will be used to determine the feasibility of a larger study, if appropriate.
Patients presenting with a diagnosis of NSTEMI within 24 hours of chest pain will be approached to take part in the study if an invasive strategy is planned. A control group of patients scheduled to undergo elective PCI for stable angina will also be recruited.
Following written informed consent peripheral venous blood samples will be taken as soon as possible after admission (or immediately prior to elective PCI in the control group) this will be analysing using flow cytometry to determine circulating cell sub-populations. Stored plasma will be used for proteomic analysis (separate funding to be sought). Cellular populations will be isolated and characterised by transcriptome analysis using RNA-seq (separate funding to be sought).
The culprit lesion will be identified by coronary angiography in the NSTEMI group, and if feasible OCT will be undertaken in the culprit and non-culprit vessels. If OCT is not feasible (eg lesion requires pre-dilatation with a balloon, or vessel is too tortuous) the patient will be excluded from the study and no further study related procedures will be undertaken. Blood samples from such patients will also be discarded.
OCT data will be analysed off line by two independent experts to classify plaque morphology (rupture, erosion, other). Endothelial cell populations will be analysed in coronary and peripheral arterial blood using flow cytometry: results will be analysed according to OCT-defined plaque pathology.
Blood samples will be stored with a view to proteomic analysis using the Olink Cardiovascular panel.
The patients will be contacted at 1 month by telephone to determine vital status and adverse events.
#Intervention
- DIAGNOSTIC_TEST : Optical Coherence Tomography (OCT)
- Optical Coherence Tomography (OCT) can undertake detailed characterisation of plaque morphology in patients with myocardial infarction at the time of percutaneous treatment. This allows plaque rupture, erosion and other mechanisms of myocardial infarction to be differentiated
|
#Eligibility Criteria:
Inclusion Criteria:
* Provision of written informed consent, < 75 years
* NSTEMI group: Admission to hospital within 24 hr of pain onset. Scheduled to undergo invasive angiography ± PCI during index admission
* Stable angina group: Scheduled to undergo elective PCI
Exclusion Criteria:
* Cardiogenic shock or haemodynamic instability,
* NSTEMI due to stent thrombosis restenosis, coronary dissection or embolism
* Previous CABG
* Requirement for mechanical ventilation
* Known severe renal impairment (eGFR <45 ml/min/1.73m2)
* Known haematological malignancy or systemic inflammatory disorder
* Requirement for emergency cardiac surgery
* Inability to carry out OCT
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
|
NCT04701385
|
{
"brief_title": "Plaque Erosion Prospective Study ii",
"conditions": [
"Atheroma; Myocardial"
],
"interventions": [
"Diagnostic Test: Optical Coherence Tomography (OCT)"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT04701385",
"official_title": "Plaque Erosion Prospective Study ii",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-31",
"study_completion_date(actual)": "2023-01-31",
"study_start_date(actual)": "2020-10-15"
},
"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)": "2023-12-18",
"last_updated_that_met_qc_criteria": "2021-01-07",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-08",
"first_submitted": "2020-10-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to identify genetic or other factors in the subjects blood that may predispose them to getting a particular disease or tell researchers how the disease will behave, for example how fast it will progress or what areas of the body might be affected. A second goal is to relate such factors to how such a condition affects the subjects clinically as well as how it affects the electrical functions of nerves and muscles.
Detailed Description
The etiology of many neurological and neuromuscular disorders is largely unknown. Contributions likely come from both inherited and environmental factors. Amyotrophic lateral sclerosis ('ALS') is a prototypical example. In 5-10% of cases, genetic mutations exert a strong enough influence on disease development that the syndrome is transmitted in a clearly Mendelian fashion. Investigations in these 'familial' ALS cases have identified more than 20 causative disease genes. Intensive study of these genes has helped identify several key cellular pathways as important for disease, not only in cases with obvious gene mutations, but even in the 90% of ALS cases that appear to be 'sporadic.' Further insights have come from investigating blood biomarkers in ALS such as gene and protein expression and lymphocyte profiling. It is hoped that further genetic and biomarker analysis will identify additional genetic risk factors or biomarkers to better understand the disease and improve therapeutic development. These advances can be applied not just to ALS but to the broad range of neurological and neuromuscular diseases, including Charcot Marie Tooth neuropathy, the muscular dystrophies, epilepsies, Parkinson's disease, and Alzheimer's disease.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects will be individuals with neurologic or neuromuscular disease who are deemed well-enough for sample collection.
Exclusion Criteria:
* Subjects who are not willing to undergo sample collection, genetic analysis, or unwilling to share clinical information or their samples.
* Pregnant women will also be excluded.
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02780531
|
{
"brief_title": "Genetic and Blood Biomarkers in Neurological and Neuromuscular Diseases",
"conditions": [
"Neurological Disorders",
"Neuromuscular Disorders"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02780531",
"official_title": "Genetic and Blood Biomarkers in Subjects With Neurological and Neuromuscular Diseases",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-16",
"study_completion_date(actual)": "2018-10-17",
"study_start_date(actual)": "2015-12"
},
"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)": "2018-12-26",
"last_updated_that_met_qc_criteria": "2016-05-19",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-05-23",
"first_submitted": "2016-04-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
ORAMED has developed an oral insulin that, in preliminary studies, has shown promise. In the present study investigators will perform a pharmacodynamic/pharmacokinetic study to evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
Detailed Description
Insulin therapy is an absolute requirement in type 1 diabetic patients. Multiple injections present a barrier to achieving normal/near-normal glucose control in diabetic patients (1). Therefore, there has been considerable interest in developing alternative routes of insulin administration. ORAMED has developed an oral insulin that, in preliminary studies, has shown promise. In the present study investigators will perform a pharmacodynamic/pharmacokinetic study to evaluate this novel insulin preparation as a potential therapeutic option in type 1 diabetic patients.
10 type 1 diabetic subjects will be studied.
Each subject will be studied on three occasions with an interval of 3 days to 4 weeks between each study. During each study subjects will receive one intervention at a time in random order: (i) two 8 mg ORAMED capsule containing insulin; (ii) three 8 mg ORAMED capsules containing insulin; (iii) one 16 mg ORAMED capsule containing insulin. If the fasting plasma glucose is \>200mg/dl on the procedure day, the procedure will be rescheduled.
Prior to each study subjects will refrain from eating (except water) after 10 at night and report to the Clinical Research Center at approximately 7 in the morning. A catheter will be placed in an antecubital vein and a prime (40 microCuries x fasting plasma glucose/100) - continuous (0.4 microCuries/min) infusion of tritiated glucose will be started and continued until the end of the study. Plasma glucose will be monitored and if necessary during the 1st hour of tracer equilibration, a small amount of IV regular insulin will be administered to obtain a fasting plasma glucose of 100-130mg/dl. After a 3-hour tracer equilibration, subjects will ingest the ORAMED capsule containing insulin and a variable infusion of 20% glucose will be started to maintain the plasma glucose concentration between 100-120 mg/dl. Plasma samples for glucose, insulin, glucagon, and free fatty acid (FFA) concentrations and tritiated glucose radioactivity will be obtained every 5-15 minutes for 4 hours following the ingestion of the ORAMED capsule containing insulin.
Calculations: Following an overnight fast, steady state conditions prevail and the basal rate of glucose appearance equals the rate of glucose disappearance and is calculated as the tritiated glucose infusion rate divided by the tritiated glucose specific activity. Under postabsorptive conditions, Basal rate of glucose appearance primarily reflects hepatic glucose production (2). Following the ingestion of oral insulin, non-steady state conditions prevail and Ra and Rd are calculated using Steele's equation (3). Endogenous (primarily reflects liver) glucose production is calculated by subtracting the exogenous glucose infusion rate from the tracer-derived rate of glucose appearance. Endogenous rate of glucose disappearance reflects glucose uptake by all tissues in the body, but primarily reflects skeletal muscle (4).
Sample Size: The present study represents a pilot study to gain information about the absorption of oral insulin and its effect on hepatic and peripheral (skeletal muscle) glucose metabolism. This information will be used to determine whether the ORAMED oral insulin preparation represents a viable option to treat diabetic subjects, to gain information about the dose response effect of ORAMED insulin on glucose metabolism, and to provide quantitative data about the effect of oral insulin on hepatic and peripheral (muscle) glucose metabolism. Therefore, the investigators conservatively have set the sample size at 10.
#Intervention
- DRUG : ORMD-0801 capsules- 2x8mg
- Participants who receive this intervention first, then receive either ORMD-0801- 3x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
- Other Names :
- Oral Insulin Capsules
- DRUG : ORMD-0801 capsules- 3x8mg
- Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
- Other Names :
- Oral Insulin Capsules
- DRUG : ORMD-0801 capsules- 1x16mg
- Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 3x8mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
- Other Names :
- Oral Insulin Capsules
|
#Eligibility Criteria:
Inclusion Criteria:
* Must be between 18 and 70 years
* Must have type 1 diabetes
* Must be in good general health by routine history and physical exam
* A1c <10.0%
* BMI = 18 <= age <= 40 kg/m2
* On no medications known to affect glucose metabolism other than insulin
* Hematocrit >= 34 vol%
* Liver Function Tests < 3 x Upper Normal Limit
* Plasma creatinine < 1.8 mg/dl
Exclusion Criteria:
* Under 18 years and > 70 years
* Does not have type 1 diabetes
* A1c > 10.0%
* BMI < 18 or > 40 kg.m2
* On medications known to affect glucose metabolism other than insulin
* Hematocrit <= 34 vol%
* Liver Function Tests >3 x Upper Normal Limit
* Plasma creatinine > 1.8 mg/dl
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02535715
|
{
"brief_title": "A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)",
"conditions": [
"Type 1 Diabetes"
],
"interventions": [
"Drug: ORMD-0801 capsules- 3x8mg",
"Drug: ORMD-0801 capsules- 2x8mg",
"Drug: ORMD-0801 capsules- 1x16mg"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02535715",
"official_title": "A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04",
"study_completion_date(actual)": "2017-04",
"study_start_date(actual)": "2015-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-21",
"last_updated_that_met_qc_criteria": "2015-08-27",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-31",
"first_submitted": "2015-08-12",
"first_submitted_that_met_qc_criteria": "2019-03-19"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound \[IVUS\] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.
#Intervention
- DRUG : Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]
- Zetia 10 mg/dl + Lipitor. The dosage of Lipitor will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL-C below 70 mg/dl.
- DRUG : Lipitor (Atorvastatin) monotherapy
- The dosage will be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan, with a treatment goal of lowering LDL-C below 70 mg/dl.
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent,
* 30 <= age <= 85 old,
* Plan to undergo PCI and LDL-C >= 100 mg/dL
Exclusion Criteria:
* Familial hypercholesterolemia
* Being treated with Zetia (Ezetimibe)
* Being treated with Fibrates
* Renal insufficiency (serum creatinine >= 2.0 mg/dl)
* Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase >= 3-folds of standard value in each institute)
* Undergoing hemodialysis or peritoneal dialysis
* Allergic to Lipitor and/or Zetia
* Severe underlying disease
* Lack of decision-making capacity
* Recognized as inadequate by attending doctor
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01043380
|
{
"brief_title": "Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound",
"conditions": [
"Hypercholesterolemia",
"Coronary Artery Disease"
],
"interventions": [
"Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]",
"Drug: Lipitor (Atorvastatin) monotherapy"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT01043380",
"official_title": "Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-03",
"study_completion_date(actual)": "2014-09",
"study_start_date(actual)": "2010-01"
},
"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)": "2015-04-01",
"last_updated_that_met_qc_criteria": "2010-01-05",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-06",
"first_submitted": "2010-01-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study was to evaluate the efficacy, safety, and dose-response of ASP4070 vaccinated in patients with cedar pollinosis.
Detailed Description
Subjects were vaccinated with ASP4070 or placebo at 2 week intervals. Clinical symptoms were evaluated after cedar pollen exposure in a chamber at 4, 8 and 12 weeks after the last vaccination to identify the timing of the onset of therapeutic effect.
#Intervention
- DRUG : ASP4070
- Intradermal vaccination at 2-week intervals
- DRUG : Placebo
- Intradermal vaccination at 2-week intervals
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject who has exhibited symptoms of cedar pollinosis, consisting of nasal symptoms (sneezing, nasal discharge or nasal obstruction) and eye symptoms (itchy eyes or watery eyes) during the pollen dispersal seasons in 2016 and 2017
* Subject who is positive for the Japanese red cedar (JRC) pollen-specific serum IgE antibody test
* At screening, subject whose score has worsened compared to baseline over 120 to 180 minutes after cedar pollen exposure in a chamber
Exclusion Criteria:
* Subject who has positive the test result of serum IgE antibody specific to other antigen than JRC pollen at screening
* Subject who has received specific immunotherapy (including desensitization therapy) for cedar pollinosis in the past
* Subject who has received specific or non-specific immunotherapy within 5 years prior to screening
* Subject who has received laser therapy or surgery for the treatment of nasal symptoms within 3 years prior to screening.
* Subject who has a history of allergic reactions such as anaphylactic shock and exanthema generalized caused by food and/or medical products in the past
* Subject who has a positive test result for hepatitis B surface (HBs) antigen or anti-hepatitis C virus (HCV) antibody
* Subject who has nasal disease that may interfere with the evaluation
* Subject who has autoimmune disease or other serious primary disease
* Subject who was diagnosed with immunodeficiency in the past
* Subject who has a complication of seasonal allergic rhinitis (due to allergens other than Japanese cedars or cypress), perennial allergic rhinitis, rhinitis medicamentosa, or non-allergic rhinitis that requires medical treatment
* Subject who has a complication of cardiovascular disease
* Subject who has a complication of hepatic disease
* Subject who has a complication of renal disease
* Subject who has a complication of respiratory disease
* Subject has a complication of malignant tumor or has been diagnosed with or has received treatment for malignant tumor within 5 years prior to the first vaccination of the study drug
* Subject who was diagnosed with schizophrenia, other mental conditions
* Subject who has a complication that may have an impact on the results of the local or systemic reaction
* Subject who has received a vaccination of Cry j 2-LAMP vaccine
* Subject who has participated in a clinical study of ASP4070 and received a vaccination of the study drug.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03101267
|
{
"brief_title": "A Dose-finding Study of ASP4070",
"conditions": [
"Rhinitis, Allergic, Seasonal"
],
"interventions": [
"Drug: ASP4070",
"Drug: Placebo"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT03101267",
"official_title": "Phase 2 Dose-finding Study of ASP4070 - A Randomized, Double-blind, Placebo-controlled, Dose-finding Study in Patients With Cedar Pollinosis Using an Environmental Exposure Chamber -",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-01-26",
"study_completion_date(actual)": "2018-10-27",
"study_start_date(actual)": "2017-04-13"
},
"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)": "2024-11-26",
"last_updated_that_met_qc_criteria": "2017-04-02",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-04-05",
"first_submitted": "2017-04-02",
"first_submitted_that_met_qc_criteria": "2020-06-16"
}
}
}
|
#Study Description
Brief Summary
The objectives of the present investigation are; to compare the dimensional changes and the histological composition after the use of an allograft or xenograft and a resorbable membrane in ridge preservation in molar sites, to evaluate the influence of bone plates thickness on dimensional changes and the effectiveness of ridge preservation in limiting the need of sinus elevation.
Detailed Description
Twenty-four patients in need of maxillary or mandibular molar extraction and subsequent implant placement were included and randomly assigned to a group; allograft or xenograft, plus a collagen membrane. Cone Beam Computed Tomographies were obtained after molar extraction and after five months. A bone sample was harvested at the time of implant placement and analysed by histomorphometry.
#Intervention
- PROCEDURE : Ridge preservation
- Ridge preservation in molar areas using a xenograft or an allograft in combination with a barrier collagen membrane
- DEVICE : bone graft plus a collagen membrane
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients, > 18 years.
* In need of removal of a maxillary or mandibular molar first or second molar.
* The molars to be extracted had to be bordered by at least one tooth.
* The molars had to have a presence of > 2 mm of keratinized gingiva and three intact bony walls.
* A dehiscence on the fourth wall, if any, had to be equal or less than 2 mm in height.
* Only one extraction per patient was accepted.
Exclusion Criteria:
* Acute periodontal or periapical infection.
* Pregnancy or lactancy.
* Smokers of more than 10 cigarettes per day.
* Previous adverse reactions to the biomaterials used in the study.
* Metabolic diseases affecting the mechanism of bone remodelling.
* Medications or treatments taken in the last twelve months and known to affect bone 'turnover'.
* Patients with poor plaque control -more than 20% (O'Leary, Drake, Naylor, 1972).
* Patients with absence of periodontal health maintenance or postoperative recommendations compliance.
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
|
NCT05107141
|
{
"brief_title": "Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft",
"conditions": [
"Alveolar Ridge Preservation"
],
"interventions": [
"Device: bone graft plus a collagen membrane",
"Procedure: Ridge preservation"
],
"location_countries": null,
"nct_id": "NCT05107141",
"official_title": "Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft: a Randomized Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-07",
"study_completion_date(actual)": "2019-06-07",
"study_start_date(actual)": "2013-12-09"
},
"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)": "2021-11-04",
"last_updated_that_met_qc_criteria": "2021-10-24",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-11-04",
"first_submitted": "2021-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of aerosol pentamidine versus placebo when used as a prophylactic agent in patients who have recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).
#Intervention
- DRUG : Pentamidine isethionate
|
#Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Zidovudine (AZT). If AZT is started during the study, patients must have received = or > 15 days of aerosol pentamidine before beginning AZT.
Prior Medication:
Allowed:
* Zidovudine (AZT). If AZT began prior to study entry, patients must have received = or > 15 days of AZT before beginning aerosol pentamidine.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
* Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
* Toxoplasmosis.
* Cryptococcosis.
* Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
* Pulmonary Kaposi's sarcoma (KS).
* Uncontrolled asthma.
* Active therapy for tuberculosis.
Patients with the following are excluded:
* Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
* Toxoplasmosis.
* Cryptococcosis.
* Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
* Pulmonary Kaposi's sarcoma (KS).
* Uncontrolled asthma.
Prior Medication:
Excluded within 30 days of study entry:
* Antiretroviral agents other than zidovudine (AZT).
* Immunomodulating agents.
* Corticosteroids.
Active therapy for tuberculosis.
Patients must:
* Have AIDS and recovered from their first episode of Pneumocystis carinii pneumonia (PCP).
* Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP.
* Have positive antibody to HIV by a Government-approved ELISA test kit, or confirmed Western blot test.
* Adequate pulmonary function (vital capacity = or > 80 percent of predicted; forced expiratory volume (FEV), 1 s = or > 65 percent of total FEV; and corrected pulmonary diffusion capacity > 60 percent of predicted).
* Free of acute medical problems.
Active substance abuse.
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
|
NCT00002053
|
{
"brief_title": "A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP",
"conditions": [
"Pneumonia, Pneumocystis Carinii",
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00002053",
"official_title": "A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP",
"recruitment_information": null,
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": "DOUBLE",
"phase": [
"NA"
],
"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": "1989-10"
},
"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
Cerebral blood flow (CBF) is of paramount importance to human brain function, as the brain relies on a continuous blood supply to meet its energy needs. Blockage of a cerebral blood vessel during neurosurgery, even if transient and short-lived, may result in irreversible brain tissue damage (i.e. stroke) and loss of cortical function, if not identified quickly enough.
Laser speckle contrast imaging (LSCI) has been demonstrated to provide the ability to visualize flow in vessels in real time and continuously without the need for contrast agents. In LSCI, the tissue of interest is illuminated with low power laser light at red or near infrared wavelengths and the light reflected from the tissue surface is imaged onto a camera. The resulting images are laser speckle patterns and a computer processes the images to produce speckle contrast images, which are images of the motion within the field of view (ie, blood flow).
The purpose of this clinical investigation is to assess the usefulness and accuracy of LSCI compared to ICGA and/or FA during neurovascular surgery. LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.
Detailed Description
Cerebral blood flow (CBF) is of paramount importance to human brain function, as the brain relies on a continuous blood supply to meet its energy needs. Blockage of a cerebral blood vessel during neurosurgery, even if transient and short-lived, may result in irreversible brain tissue damage (i.e. stroke) and loss of cortical function, if not identified quickly enough.
Neurosurgery involves the treatment of blood-vessel related pathologies within the brain, like intracranial aneurysms, arteriovenous malformations and dural arteriovenous fistulas, but also the handling of vessels during brain tumor resections. For these operations, assessment of flow in vessels is of paramount importance. So far, the surgeon can not 'see' blood flowing inside the artery or vein. Real-time flow visualization during surgery could help neurosurgeons better understand the consequences of vascular occlusion events during surgery, recognize potential adverse complications, and thus prompt timely intervention to reduce the risk of stroke. The current standard for visualizing flow in arteries during surgery is indocyanine green angiography (ICGA) and fluorescein angiography (FA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Both ICGA and FA provide only a punctual view of perfusion over several seconds, being far away from a continuous assessment.
Laser speckle contrast imaging (LSCI) has been demonstrated to provide the ability to visualize flow in vessels in real time and continuously without the need for contrast agents. In LSCI, the tissue of interest is illuminated with low power laser light at red or near infrared wavelengths and the light reflected from the tissue surface is imaged onto a camera. The resulting images are laser speckle patterns and a computer processes the images to produce speckle contrast images, which are images of the motion within the field of view (ie, blood flow).
With these properties LSCI has the potential to deliver for the first time continuous visualisation of blood flow in large and small vessels and to overcome limitations of ICGA and FA. LSCI is an established technique for studies of CBF and has predominantly been used to study microcirculation of the cerebral cortex during neurosurgical procedures. However, the spatial resolution in the clinical setting and its accuracy compared to ICGA and FA are unclear.
The purpose of this clinical investigation is to assess the usefulness and accuracy of LSCI compared to ICGA and/or FA during neurovascular surgery. LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.
#Intervention
- DEVICE : Laser speckle contrast imaging (LSCI)
- LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.
|
#Eligibility Criteria:
Inclusion Criteria:
* Vascular pathology of the brain or brain tumors requiring elective microsurgical treatment (e.g., aneurysm, arteriovenous malformation, dural arteriovenous fistula, glioma, meningioma, metastasis)
* Adults (>= 18 years)
* Informed consent signed by the subject
Exclusion Criteria:
* Patients lacking capacity to consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05028400
|
{
"brief_title": "Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery",
"conditions": [
"Aneurysm",
"AVM",
"Dural Arteriovenous Fistula",
"Glioma",
"Meningioma",
"Metastasis"
],
"interventions": [
"Device: Laser speckle contrast imaging (LSCI)"
],
"location_countries": [
"Switzerland"
],
"nct_id": "NCT05028400",
"official_title": "Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-11",
"study_completion_date(actual)": "2022-03-11",
"study_start_date(actual)": "2022-02-01"
},
"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)": "2022-04-12",
"last_updated_that_met_qc_criteria": "2021-08-24",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-31",
"first_submitted": "2021-08-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Anesthesia induction in the opioid group Sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and remifentanil 1 ug/kg/h.
Detailed Description
Before anesthesia induction, radial artery puncture and catheterization under local anesthesia for manometry, and intravenous pentethylquine hydrochloride 1 mg and dexamethasone 5 mg were given. Anesthesia-induced opioid group (group A) received intravenous sufentanil 0.5 ug/kg, and esketamine group (group E) received intravenous esketamine 0.5 mg/kg. Subsequently, both groups were sequentially injected with intravenous propofol 2 mg/kg and rocuronium bromide 0.9 mg/kg. After the onset of rocuronium bromide, the left double-lumen bronchial intubation was guided by a video laryngoscope, the correct position of the catheter was confirmed by bronchoscope, and the anesthesia machine was connected to the anesthesia machine for mechanical ventilation after fixation, with a tidal volume of 6 mL/kg (ideal body weight), a respiratory rate of 12\~18 breaths/min, and end-expiratory carbon dioxide partial pressure at 35\~40 mmHg.
Intraoperative anesthesia maintenance opioid group was injected with intravenous injection of propofol (5 mg/kg/h) and remifentanil (1 ug/kg/h), and esketamine group was pumped with propofol (5 mg/kg/h) and esketamine (0.5 mg/kg/h). After the lateral decubitus position is set up and the lateral paravertebral nerve block (T4, T6 levels 0.5% ropivacaine 10 ml each) is performed under ultrasound guidance, and the anesthesiologist is responsible for the complications and accidents that occur during the routine management of anesthesia. After the operation, they were given 200 mg of sugammadex sodium as an antagonistic residual muscle relaxant, and after being extubated awakely, they were sent to PACU for continued PCIA treatment and observation, and returned to the thoracic surgery ward for further treatment after reaching the discharge criteria.
#Intervention
- DRUG : Esketamine
- The esketamine group used esketamine as an analgesic during induction and maintenance of anesthesia.
- DRUG : Sufentanil
- In the opioid group, sufentanil was used as an analgesic during anesthesia induction and remifentanil was used as an analgesic during anesthesia maintenance.
|
#Eligibility Criteria:
Inclusion Criteria:
* ASA scores 1 ~ 2
* Age > 18 years and < 70 years
* Thoracoscopic segmentectomy or lobectomy is proposed under general anesthesia
* Patient controlled intravenous analgesia was planned
* Sign informed consent.
Exclusion Criteria:
* BMI>30 kg/m2 or < 19 kg/m2;
* preoperative use of opioids, acute and chronic pain or hyperalgesia;
* Preoperative coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular disease or other heart disease;
* severe hepatic and renal insufficiency before operation;
* A history of mental illness or alcoholism;
* A history of alcohol or drug abuse;
* cranial pressure, intraocular pressure or suffering from glaucoma;
* Poorly controlled or untreated hypertension;
* Preeclampsia or eclampsia;
* untreated and undertreated hyperthyroidism;
* The Numerical Rating Scale (NRS) cannot be used.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06310785
|
{
"brief_title": "Esketamine Anesthesia in Thoracic Surgery",
"conditions": [
"General Anesthesia",
"Thoracic Surgery"
],
"interventions": [
"Drug: Esketamine",
"Drug: Sufentanil"
],
"location_countries": [
"China"
],
"nct_id": "NCT06310785",
"official_title": "Opioid-Free Anesthesia Utilizing Esketamine for Thoracoscopic Pulmonary Nodule Surgery: A Randomized Controlled Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-10-31",
"study_completion_date(actual)": "2024-10-31",
"study_start_date(actual)": "2023-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2025-01-03",
"last_updated_that_met_qc_criteria": "2024-03-13",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-03-15",
"first_submitted": "2024-01-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to collect data to help researchers better understand the various causes of obesity, which may lead to the development of new obesity treatment options.
Detailed Description
Obesity is major metabolic health concern and the potential beneficial effects of natriuretic peptides, specifically B-type natriuretic peptide (BNP) on adipocyte biology, energy expenditure and body weight could be of great significance. This study will provide insight into the mechanisms of dysregulation of the natriuretic peptides system in obesity and will contribute to delineate the roles and the clinical importance of BNP in the treatment of obesity.
#Intervention
- DRUG : Nesiritide
- DRUG : Saline
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 65 years, inclusive
* Men and women
* Able to provide written, informed consent
* Weight stable (± 3 kg) during the 3 months prior to enrollment
* BMI <= 25 kg/m2 for lean subjects or >= 30 kg/m2 for obese subjects
Exclusion Criteria:
* 1) Diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or Chronic obstructive pulmonary disease (COPD), g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder
* Pregnant or nursing women
* Presence of clinically significant abnormalities on electrocardiogram;
* Smoking
* Known hypersensitivity to nesiritide or any of its excipients
* Poor intravenous access
* Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents.
* Your blood pressure at your screening visit is less than or equal to 100/60 or greater than or equal to 160/100.
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
|
NCT01977859
|
{
"brief_title": "BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects",
"conditions": [
"Obesity",
"Cardiovascular Disease",
"Hypertension",
"Diabetes"
],
"interventions": [
"Drug: Nesiritide",
"Drug: Saline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01977859",
"official_title": "BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02-15",
"study_completion_date(actual)": "2017-02-28",
"study_start_date(actual)": "2013-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-02-14",
"last_updated_that_met_qc_criteria": "2013-10-31",
"last_verified": "2018-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-07",
"first_submitted": "2013-10-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Burnout among healthcare workers is frequently reported, and one of the factors cited is the stress caused by end-of-life care. It has been reported that nursing staff experience decreased well-being as a result of being involved in end-of-life care, and this is also true in intensive care units. This decrease in well-being is said to lead to lower quality of care, poor communication with patients and their families, absenteeism, and high turnover. Although palliative care interventions such as education and communication tools have been reported to improve the well-being of healthcare professionals involved in end-of-life care, few reports have evaluated the association with burnout. We investigated whether communication-based palliative interventions in end-of-life care in intensive care units (ICUs) improve the risk of burnout among nurses working in ICUs.
Detailed Description
A before-and-after study was conducted in a single hospital to evaluate burnout risk and satisfaction with end-of-life situations in 2022 (phase 1) and 2023 (phase 2). The Japanese version of the Burnout Scale was used to assess the risk of burnout, and the QODD (Quality of Dying and Death) was used to assess nurse satisfaction. All nurses who agreed to participate received the questionnaire in a sealed envelope, completed it, and returned it anonymously to the principal investigator. Data from those who declined to participate were not recorded. During the first and second phases, an intensive communication strategy on end-of-life practice was implemented based on the framework developed at the International Delphi Conference. The following data were recorded for all participating nurses: age, gender, marital status, years of practice since certification, and years of critical care experience; the following data on ICU status were also collected from the electronic system: total number of patients, length of ICU stay, ICU mortality rate, in-hospital mortality rate, ICU admission APACHE-II score, SOFA score at ICU admission, and medical costs at ICU admission. Continuous variables without normal distribution are shown as median and interquartile range. Categorical data were summarized numerically or as percentages. In univariate analyses, Mann-Whitney's U test was used to compare continuous variables and Fisher's exact test to compare categorical variables. Data were assumed to be missing at random, and no imputation or interpolation of missing values was performed. Statistical tests were two-tailed and statistical significance was set at p\<0.05. All statistical analyses were performed using EZR (R Foundation for Statistical Computing, Vienna, Austria), a graphical user interface for R. The study was approved by the Maebashi Red Cross Hospital Ethics Committee (ID: 2022-47), which waived the requirement for informed consent from patients and their relatives, given the retrospective and observational nature of the study.
#Intervention
- OTHER : communication strategy
- an intensive communication strategy on end-of-life practice was implemented, based on a framework developed by the International Delphi Conference.
|
#Eligibility Criteria:
Inclusion Criteria:
* Registered nurses working in our ICU
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06211816
|
{
"brief_title": "Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit",
"conditions": [
"Palliative Care"
],
"interventions": [
"Other: communication strategy"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT06211816",
"official_title": "Efficacy of End-of-life Communication Strategies on Nurses in the Intensive Care Unit: A Single-center Before and After Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-01",
"study_completion_date(actual)": "2023-12-01",
"study_start_date(actual)": "2022-09-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-18",
"last_updated_that_met_qc_criteria": "2024-01-16",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-18",
"first_submitted": "2023-12-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Infraclavicular brachial plexus block has been used more frequently with the development of high-resolution ultrasound. Compared with peripheral nerve block using landmark technique or nerve stimulator technique, ultrasound-guided peripheral nerve block decreases the required dose of local anesthetics. As the dose of the drug used decreases, the systemic toxic effects of local anesthetics are reduced. However, the decreased dose of the drugs might have influence on the onset time of local anesthetics. Thus, the investigator aimed to evaluated the onset time of the two equipotent local anesthetics, 0.375% ropivacaine and 0.25% levobupivacaine.
#Intervention
- DRUG : Ropivacaine solution
- ultrasound-guided infraclavicular brachial plexus block with 0.375% ropivacaine solution
- Other Names :
- rop
- DRUG : Levobupivacaine solution
- ultrasound-guided infraclavicular brachial plexus block with 0.25% levobupivacaine solution
- Other Names :
- levo
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists physical status 1 <= age <= 3
* Patients undergoing upper extremity surgery with infraclavicular brachial plexus block
Exclusion Criteria:
* Patients who do not agree to participate in clinical trial
* Patients presenting with neurological deficits of the upper arm, severe coagulopathy, chronic renal failure, cardiopulmonary compromise, cerebral vascular disease, hypersensitivity to hyaluronidase or local anesthetics or local infection at the site of the infraclavicular block, pregnancy
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03679897
|
{
"brief_title": "Comparison of 0.375% Ropivacaine and 0.25% Levobupivacaine for Infraclavicular Brachial Plexus Block",
"conditions": [
"Regional Anesthesia"
],
"interventions": [
"Drug: Ropivacaine solution",
"Drug: Levobupivacaine solution"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT03679897",
"official_title": "0.25% Levobupivacaine Versus 0.375% Ropivacaine: a Comparative Study in Ultrasound-Guided Infraclavicular Brachial Plexus Block",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-07",
"study_completion_date(actual)": "2018-12-08",
"study_start_date(actual)": "2018-09-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-12-20",
"last_updated_that_met_qc_criteria": "2018-09-19",
"last_verified": "2018-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-21",
"first_submitted": "2018-09-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study is tested the validity of placental vascular indices obtained from placenta ultrasonographic sphere biopsy and entire placenta investigation.
Detailed Description
Although, to this date, there have been a number of human placental studies that concerned the evaluation of placental 3 dimensional power Doppler vascularization with the use of VOCAL technique, but there was no one in which placental vasculature has been compared between the sonobiopsy and whole placental volume.
#Intervention
- DIAGNOSTIC_TEST : 3 dimensional ultrasound investigation
- Images that contributed to the determination of placental volume and 3-DPD indices were obtained at the time of visit. All 3-D scans ultrasound measurements were performed by a Voluson 730 Expert ultrasound machine equipped with a multifrequency probe (2-5 MHz) to acquire images. Each sample was examined using 3-D rendering mode, in which the colour and gray value information was processed and combined to supply 3-D image. For laterally located placentas, the investigator positioned the transducer on a slight lateral inclination to obtain proper images. Power Doppler window was placed over the placenta to map the vascular tree from basal to chorionic plates. The 3-D static volume box was placed over the entire placenta volume. The sweep angle was set at maximum 70°. Each image was recovered from the disk in succession for processing. During gestation, the investigator recorded one sample from each patient.
- DIAGNOSTIC_TEST : 2 dimensional ultrasound investigation
- The two-dimensional (2-D) transabdominal conventional study provided data about fetal position, biometry, body movements and fetal heart rate as well as placental localization. The factorial default setting 'Obstetrics' was applied in 2-D mode.
|
#Eligibility Criteria:
Exclusion criteria:
* multiple pregnancy,
* abnormal (> 3mm) nuchal translucency from 11+0 to 13+6 weeks of gestation,
* the fetal or neonatal structural or chromosomal anomaly,
* inadequate localization of the placenta (placenta praevia),
* self-reported drugs, alcohol, caffeine or nicotine abuse,
* exposed to circulatory medication (oxerutins, calcium dobesilate)
* or not signing the consent form.
* If the mother suffer from er systemic disease (e.g. diabetes, autoimmune disease, vasculitis, haemophilia, thrombophilia, HIV infection, etc)
Inclusion clriteria:
* single pregnancy
* healthy pregnant women
* no anatomical alteration of fetus
* no genetical abnormality of fetus
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
|
NCT05245279
|
{
"brief_title": "Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound",
"conditions": [
"Placenta Diseases"
],
"interventions": [
"Diagnostic Test: 2 dimensional ultrasound investigation",
"Diagnostic Test: 3 dimensional ultrasound investigation"
],
"location_countries": [
"Hungary"
],
"nct_id": "NCT05245279",
"official_title": "Correlation Between the Placental Perfusion Measured in the Entire Placenta and With Sonobiopsy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-01",
"study_completion_date(actual)": "2021-01-01",
"study_start_date(actual)": "2018-01-01"
},
"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)": "2022-02-17",
"last_updated_that_met_qc_criteria": "2022-02-16",
"last_verified": "2022-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-02-17",
"first_submitted": "2021-12-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The Foresee Home is used in the recent years to detect age-related macular degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV). The Foresee Home demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.
The OCT may be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.
The Foresee Home can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.
|
#Eligibility Criteria:
Inclusion Criteria:
* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed with CNV
* Did not perform more then 4 anti- VGEF injections
* VA with habitual correction better then 6/45 in the study eye
* Ability to understand instructions
* Familiar with computer usage
Exclusion Criteria:
* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study
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
|
NCT01073592
|
{
"brief_title": "Comparison Between Foresee Home and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)",
"conditions": [
"Age Related Macular Degeneration"
],
"interventions": null,
"location_countries": [
"Israel"
],
"nct_id": "NCT01073592",
"official_title": "Comparison Between Home Macular Perimeter (FORESEE HOME) and OCT Visual Field Defects in Patients With CNV",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-01",
"study_completion_date(actual)": "2013-03",
"study_start_date(actual)": "2009-08"
},
"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)": "2013-05-17",
"last_updated_that_met_qc_criteria": "2010-02-22",
"last_verified": "2013-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-23",
"first_submitted": "2010-02-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
BEYOND is aiming to demonstrate how by enrichment of the available SPECIFY score, patients at great likelihood for CDI with unfavorable outcome are early detected
Detailed Description
In a previous project, following GWAS analysis of the DNA and measurement of serum biomarkers coming from 134 patients a prediction score named SPECIFY was developed. The SPECIFY score comprises four elements: low hemoglobin, increased urea, increased IL-8 and carriage of G alleles of rs2091172. The score has 80% positive predictive value and 95.8% specificity for the early detection of unfavorable outcome but the sensitivity is low. Unfavorable outcome is defined as any of: presentation or progression into severe CDI, relapse; and death. Stool samples of day 1 before start of therapy of the patients are stored refrigerated. Microbiome analysis will be done aiming to the integration of the Shannon diversity index to the already developed score in order to improve sensitivity.
#Intervention
- DIAGNOSTIC_TEST : Microbiome analysis
- Stool microbiome analysis of 16S rRNA sequencing to an anticipated number of 8,000,000 reads
|
#Eligibility Criteria:
Inclusion Criteria:
* Age more than or equal to 18 years
* Both genders
* Diarrhea defined as at least 3 episodes of unformed stools in the last 24hours according to the Bristol stool chart
* Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.
Exclusion Criteria:
* No exclusion criteria apply
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
|
NCT04725123
|
{
"brief_title": "Addressing Personalized Needs in Clostridioides Difficile Infection",
"conditions": [
"Clostridioides Difficile Infection"
],
"interventions": [
"Diagnostic Test: Microbiome analysis"
],
"location_countries": [
"Greece"
],
"nct_id": "NCT04725123",
"official_title": "Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection: Study Phase 1",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-27",
"study_completion_date(actual)": "2022-03-27",
"study_start_date(actual)": "2021-01-26"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-12-12",
"last_updated_that_met_qc_criteria": "2021-01-25",
"last_verified": "2023-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-26",
"first_submitted": "2021-01-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study was to assess the effectiveness of the intraoperative periarticular solution in reducing blood loss and minimizing transfusion requirements in patients with femoral neck fractures who underwent hemiarthroplasty.
Detailed Description
Hip fractures in the elderly represent a significant public health challenge, marked by elevated rates of morbidity and mortality. The worldwide increase in life expectancy has led to a corresponding rise in the incidence of hip fractures. Notably, increased perioperative blood loss has been identified as a critical factor that heightens the risk of complications and mortality. Consequently, contemporary research efforts have focused on addressing this pivotal issue. Various strategies have been developed, including controlled hypotensive anesthesia and the utilization of pharmacological agents aimed at reducing the perioperative blood products. The necessity for the efficacy of tranexamic acid (TXA) in mitigating blood loss has been well-established across numerous surgical specialties. This study is motivated by the need for an effective and safe approach to perioperative blood salvage. To date, there appears to be a lack of research examining the effectiveness of the intraoperative periarticular injection technique (100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles before femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers) regarding blood loss reduction. Therefore, this study aims to investigate the following questions: 1) Is intraoperative periarticular injection an effective technique for minimizing blood loss in patients with hip fractures? and 2) What proportion of the salvaged blood loss can be attributed to hidden blood loss?
#Intervention
- PROCEDURE : Periarticular Injection (PAI)
- Patients in the periarticular injection group were administered a 100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles prior to femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers.
- PROCEDURE : Control (Standard treatment)
- The control group received the conventional treatment protocol.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of femoral neck fracture
Exclusion Criteria:
* Anti-aggregant, anti-coagulant or anti-thrombotic therapy
* Pathological fractures, periprosthetic fractures, or revision procedures
* Intolerance or allergy to the medications utilized in the study
* Refused to participation
Sex :
ALL
Ages :
- Minimum Age : 58 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06701695
|
{
"brief_title": "Efficacy of Intraoperative Periarticular Injections in Hip Fracture Hemiarthroplasty",
"conditions": [
"Femoral Neck Fractures",
"Hemiarthroplasty",
"Blood Loss Requiring Transfusion"
],
"interventions": [
"Procedure: Periarticular Injection (PAI)",
"Procedure: Control (Standard treatment)"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06701695",
"official_title": "Efficacy of Intraoperative Periarticular Injections in Reducing Blood Loss and Transfusion Requirements in Hip Fracture Hemiarthroplasty: A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-13",
"study_completion_date(actual)": "2022-02-13",
"study_start_date(actual)": "2020-05-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-25",
"last_updated_that_met_qc_criteria": "2024-11-20",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-11-22",
"first_submitted": "2024-11-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ) questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of modified polycystic ovary syndrome quality of life questionnaire (MPCOQ).
Detailed Description
* All statistical analyses will be conducted using the Statistical Product and Service Solution version 21 software.
* Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage.
* In this study, factor structure of the (MPCOQ) will be analyzed using the principal component factor analysis with varimax rotation.
* Intraclass Correlation Coefficient (ICC) (95% confidence interval) will be used for test-retest value and Cronbach's Alpha will be used for internal consistency analysis.
* Measurement error will be determined by calculating the standard error of measurement (SEM) and the Smallest Detectable Change (SDC). Independent t-test will be used to determine the differences between groups
|
#Eligibility Criteria:
Inclusion Criteria:
*
* Age 18 - 30
* Married
* Female patients diagnosed with PCOS, having 2 of the following Rotterdam diagnostic criteria:
I. Polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume >10ml II. Clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score >7 or obvious acne) III. Having an interval between menstrual periods >35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days Patients who are willing to participate
Exclusion Criteria:
*
* Non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia
* Female undergoing Hormone Replacement Therapy
* Female with malignancies
* Any recent fractures, surgeries
* Patient with nephrological and neurological conditions
* Dementia or cognitive impairments
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT05010551
|
{
"brief_title": "Translation and Validation of MPCOSQ in Urdu Language",
"conditions": [
"PCOS- Polycystic Ovary Syndrome"
],
"interventions": null,
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05010551",
"official_title": "Translation and Validation of Modified Polycystic Ovary Syndrome Questionnaire in Urdu Language",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-05-30",
"study_completion_date(actual)": "2021-08-30",
"study_start_date(actual)": "2020-11-20"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-04-28",
"last_updated_that_met_qc_criteria": "2021-08-11",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-08-18",
"first_submitted": "2021-08-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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