linjc16/ctgov huggingface dataset:
Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial.

Official Title
-----------------
A Phase II-III Prospective, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oxypurinol Added to Standard Therapy in Patients With NYHA Class III-IV Congestive Heart Failure

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: Oxypurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria 18-85 years old, Stable NYHA Class III-IV Hospitalization or ER visits in past 18 months for worsening Heart Failure (or addition of new heart failure medication added to regimen due to lack of stability on current regimen. EF =< 40% Exclusion criteria Any condition (other than CHF) that could limit exercise Any concurrent disease likely to limit life expectancy. Participation in another clinical trial Primary valvular disease, active myocarditis, or an obstructive or restrictive cardio-myopathy Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxypurinol|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of Multidisciplinary Program on Falls in Elderly Inpatients

Study Overview
=================
Brief Summary
-----------------
Falls among elderly inpatients are common, multifactorial and associated with a significant increase of complications and morbidity. According to a recent Cochrane review, the effectiveness of fall prevention program has been assessed in community-dwelling and in long stay wards but not in rehabilitation wards (RW) and geriatric acute wards (GAW). IPR study aims to measure the impact of a multidisciplinary prevention program on falls in elderly inpatients.

Official Title
-----------------
A Multidisciplinary Program for Preventing Falls Identify, Prevent and Get up: Impact on Falls in Elderly Inpatients

Conditions
-----------------
Falls Among Elderly Inpatients

Intervention / Treatment
-----------------
* Other: The multidisciplinary prevention program called IPR (in French Identifier, Prévenir, Relever)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject aged over 65 years Admitted during the study Participation agreement Exclusion Criteria: Patients with a MMSE<10 and incapable to participate to a reeducation program Patient with an evolutionary and\or badly checked psychiatric pathology Bedridden patient

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual care<br> | Other: The multidisciplinary prevention program called IPR (in French Identifier, Prévenir, Relever)<br>* The intervention is a multidisciplinary program of fall prevention including 3 complementary interventions which focus on several stages of elderly inpatient management: Identification of patient's fall risk, Multifactorial fall prevention program (integrated actions targeted on risk factors, exercise programs and review of the hospital environment), Get up workshop and morbidity and mortality conferences related to fall cases<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of falls among elderly inpatients |  | patients will be followed for the duration of hospital stay, 15 months maximum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of fall-related mortality |  | patients will be followed for the duration of hospital stay, 15 months maximum | 
| Incidence of fall-related |  | patients will be followed for the duration of hospital stay, 15 months maximum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Accidental falls, safety management, aged, inpatient, stepped wedge design
Comparison of ADR Using NBI Versus HD White Light Colonoscopy in Screening and Surveillance Colonoscopies

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare ADR using HD-NBI or HD-WLE during screening and surveillance colonoscopies.

Detailed Description
-----------------
Background: Despite recent advances in endoscopic technology adenoma miss rate still is up to 20% and contributes to the occurrence of interval cancers. Therefore, improved imaging modalities have been introduced to increase adenoma detection rate (ADR) during screening and surveillance colonoscopies. Recently, narrow band imaging (NBI; Exera II series, Olympus Corporation) was not significantly better than high definition white light colonoscopy (WLC) for the detection of patients with colorectal polyps, or colorectal adenomas1. However, Olympus' current Exera III series is characterized by better illumination of the bowel lumen and may be associated with a higher ADR than high definition WLC. Methods: Investigators performed a prospective evaluation in patients referred to the Department of Interdisciplinary Endoscopy at Jena University Hospital for screening or surveillance colonoscopy between January and November 2015 in daily clinical practice. Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal of the colonoscope (Exera III series, Olympus Corporation).

Official Title
-----------------
Comparison of Adenoma Detection Rate Using Narrow Band Imaging Versus HD White Light Colonoscopy in Screening and Surveillance Colonoscopies

Conditions
-----------------
Narrow Band Imaging

Intervention / Treatment
-----------------
* Device: HD white light or NBI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Screening colonoscopies Exclusion Criteria: Insufficient bowel cleansing Age under 55years

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HD white light<br>Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal | Device: HD white light or NBI<br>* Use of NBI or HD white light<br>|
| Active Comparator: HD narrow band imaging<br>Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal | Device: HD white light or NBI<br>* Use of NBI or HD white light<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | Adenoma detection rate | up to 60min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenoma detection rate, narrow band imaging
Flash-free Brackets and Dental Plaque

Study Overview
=================
Brief Summary
-----------------
This study aimed to compare flash-free bracket system with conventional adhesive-coated bracket system in patients with maxillary crowding.

Detailed Description
-----------------
Aim: The aim of this split-mouth study was to compare conventional and adhesive flash-free-bracket systems in terms of plaque retention, white spot lesion formation, biomarker levels and select microbes in gingival crevicular fluid (GCF). Materials & Methods: Thirty-seven systemically healthy patients (18 males, 19 females) with the age range of 13-18 years were involved in this split-mouth study. Clinical evaluations, quantitative light-induced fluorescence (QLF) imaging, GCF and plaque samplings were performed at baseline and at 1-, 2-, 3-months. QLF was repeated following debonding, GCF samples were analyzed by immunoassay and real-time PCR for the biomarker and bacteria content. Data were analyzed by Wilcoxon on dependent samples.

Official Title
-----------------
Do Adhesive Flash-free Brackets Affect Bacterial Plaque? A Randomized Controlled Clinical and Microbiological Assessment

Conditions
-----------------
Orthodontic Treatment

Intervention / Treatment
-----------------
* Procedure: orthodontic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being systemically healthy having 4-7 mm maxillary crowding with a maximum of 2 mm linear displacement of contact points and non-extraction treatment planning. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flash-free bracket group<br>Orthodontic treatment with flash-free bracket system | Procedure: orthodontic treatment<br>* orthodontic treatment in maxillary crowding<br>|
| Active Comparator: Control<br>Orthodontic treatment with conventional adhesive-coated brackets | Procedure: orthodontic treatment<br>* orthodontic treatment in maxillary crowding<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of white spot lesion (WSL) | WSL is the first sign of caries | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque accumulation around the brackets | plaque deposits cause gingival inflammation | 1 month | 
| microbial composition around the brackets | presence of pathogen bacteria is important | 1 month |
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fed conditions.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions

Conditions
-----------------
Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to quetiapine or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine Fumarate|25 mg tablet|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 15 days |
The Development of an Eating Laboratory for Overweight Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to develop methods to evaluate the eating behavior of adolescents, including overweight, normal weight, and candidates for adolescent bariatric surgery.

Detailed Description
-----------------
The purpose of this study is to examine the eating behavior, meal-related perceptions and meal-related hormones in overweight adolescents, normal weight adolescents and overweight adolescents who are undergoing bariatric surgery. Subjects will be asked to consume a single-item breakfast meal of a fixed amount (Ensure) and a multiple-item meal from a luncheon buffet. During the single-item meal, subjects will fill out questionnaires assessing subjective responses to the meal (e.g. hunger, fullness, pleasantness) and blood samples will be taken before, during, and after the meal to assess hormonal responses to the meal. The multiple-item meal will permit an assessment of total caloric consumption, food and macronutrient choice and rate of eating. Overweight adolescents undergoing bariatric surgery will be asked to do the meal studies 1 to 3 months before and 3 to 6 months after their surgery. Some bariatric surgery patients will only be studied after their after their surgery. The data gathered from these pilot subjects will be used to further develop and refine our future studies on assessing eating behavior in overweight adolescents.

Official Title
-----------------
The Development of an Eating Laboratory for Overweight Adolescents

Conditions
-----------------
Adolescent Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI Index Enrollment in bariatric surgery program Ages 12-18 Exclusion Criteria: Pervasive developmental or psychological disorder Current use of weight loss medication Clinically significant medical condition Pregnancy Food allergy to single-item meal

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese Control<br> | |
| Normal Control<br> | |
| OVERWEIGHT ADOLESCENT PATIENTS UNDERGOING BARIATRIC SURGERY<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caloric intake |  | post-meal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescent, obesity, bariatric surgery, eating
Paricalcitol in Fabry Disease

Study Overview
=================
Brief Summary
-----------------
Proteinuria is the predominant risk factor for renal disease progression in Fabry disease (FD). When urine protein excretion is controlled to <0.50 g/24 hr, the rate loss of glomerular filtration rate (GFR) is not significantly different from 0. However, enzyme replacement therapy (ERT) alone does not decrease proteinuria and it has been recommended that patients receiving ERT also receive anti Renin-Angiotensin-System (RAS) therapy. Emerging evidences show that paricalcitol (PCT) reduces proteinuria in presence of intensified inhibition of RAS; however, there is no evidence in FD. The aim of this study is to evaluate the antiproteinuric effect of PCT in FD patients with proteinuria >0.50 g/24 hr persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage.

Conditions
-----------------
Fabry Disease, Proteinuria

Intervention / Treatment
-----------------
* Drug: Paricalcitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: genetically proven FD stable dose of ERT for at least 12 months stable dose of ACEi or ARB titrated to maximum tolerated dosage for at least 6 months persistent proteinuria >0.50 g/24 h despite the use of ERT and ACEi/ARBs in 2 consecutive samples within 12 weeks Exclusion Criteria: steroid/immunosuppressive treatment or glomerular filtration rate change >30% in the past 3 months PTH levels <20 pg/mL serum phosphorus >5.0 mg/dL serum calcium (adjusted for albumin) >10.0 mg/dL active malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paricalcitol<br>In patients identified by the inclusion criteria, data will be collected at baseline , during administration of oral Paricalcitol (PCT) (after 1, 3 and 6 months), and three months after PCT withdrawal. PCT will administered at dosage of 1 mcg/day; this dosage was chosen as it is not associated with excessive decline of parathyroid hormone (PTH) levels in most patients | Drug: Paricalcitol<br>* Paricalcitol was administered at the dose of 1 mcg/die<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of paricalcitol on proteinuria reduction | Fourteen Fabry patients will be selected and studied in the first six months of add-on oral PCT (1 mcg/day) and, in order to verify the dependence of proteinuria reduction on PCT, three months after drug withdrawal. | 6 months |
Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the upper airway muscles in patients with obstructive sleep apnea.

Official Title
-----------------
Randomised Controlled Trial of Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Transcutaneous electrical stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Obstructive apnea-hypopnea index > 15 events/hour Patients who do not tolerate or do not accept positive airway pressure therapy Main exclusion criteria: Body mass index < 18.5 or > 32 kg/m2 Unable or incapable of providing informed written consent Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires Significant co-morbidities making the patient unable or inappropriate to participate in the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous electrical stimulation<br>Participants will be asked to use the stimulator for 6 weeks at home. The study objectives will be evaluated after 6 weeks post-activation of the device. | Device: Transcutaneous electrical stimulation<br>* Transcutaneous electrical stimulation of the upper airway muscles<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index (AHI) | Change from baseline to 6 weeks in the apnea-hypopnea index (AHI) | 6 weeks |
Uremic Toxins in the ICU: Patients After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients after cardiac surgery.The sampling of blood and dialysate will be done during dialyses with different durations (4, 6 and 8h)

Official Title
-----------------
Study of the Kinetics of Uremic Toxins in the ICU Patients With Acute Renal Failure, in Order to Optimize the Dialysis Dose: Patients After Cardiac Surgery

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Procedure: Dialysis during 4 hours
* Procedure: Dialysis during 6 hours
* Procedure: Dialysis during 8 hours


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients after cardiac surgery with acute renal failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dialysis during 4 hours | Procedure: Dialysis during 4 hours<br>* Blood and dialysate sampling<br>|
| Active Comparator: 2<br>Dialysis during 6 hours | Procedure: Dialysis during 6 hours<br>* Blood and dialysate sampling<br>|
| Active Comparator: 3<br>Dialysis during 8 hours | Procedure: Dialysis during 8 hours<br>* Blood and dialysate sampling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxin removal |  | During dialysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU patients with acute renal failure after cardiac surgery