linjc16/ctgov huggingface dataset:
Cocoa Flavanols in Renal Disease

Study Overview
=================
Brief Summary
-----------------
Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD). Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day long-term, double blind, placebo-controlled parallel study the chronic effects of dietary flavanols on vascular function in 52 patients with ESRD will be evaluated.

Official Title
-----------------
The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease

Conditions
-----------------
End Stage Renal Disease, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Other: Cocoa
* Other: Cocoa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: end stage renal disease >18 years chronic intermittent hemodialysis Exclusion Criteria: acute Infection acute renal failure heart failure (NYHA IV) pregnancy anuria

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flavanol rich cocoa<br> | Other: Cocoa<br>* dissolved in water twice daily<br>|
| Experimental: Flavanol poor<br> | Other: Cocoa<br>* dissolved in water twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion. | To study the effect of flavanols on flow mediated dilation of the brachial artery after 5 minutes of forearm ischemia and reperfusion in patients with ESRD | 30 days |
A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Study Overview
=================
Brief Summary
-----------------
The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.

Official Title
-----------------
A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Conditions
-----------------
Atypical Hemolytic Uremic Syndrome (aHUS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients of any age who have been diagnosed with aHUS. Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial. Exclusion Criteria: 1. Patients who have participated or are currently participating in a controlled clinical trial of eculizumab
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events. |  | Through 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess eculizumab treatment affect based on change in laboratory parameters (platelets, hemoglobin, LDH and parameters associated with renal function and intravascular hemolysis) and reduction of thrombotic microangiopathy (TMA). |  | Through 26 weeks |
Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution OCT

Study Overview
=================
Brief Summary
-----------------
The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes with Keratoconus.

Official Title
-----------------
Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution Optical Coherence Tomography (UHR-OCT) Based Corneal Epithelium Thickness Mapping

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Device: OCT-scanning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 Existence of Keratoconus written informed consent obtained Exclusion Criteria: Earlier surgery such as PK, CXL, relaxing incisions Systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| OCT-scanning<br>Patients with Keratoconus are scanned with an OCT-Prototype | Device: OCT-scanning<br>* All participants will be scanned with a OCT-device<br>|
| OCT-scanning for volunteers<br>Volunteers with healthy eyes are scanned with an OCT-Prototype | Device: OCT-scanning<br>* All participants will be scanned with a OCT-device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Epithelium Thickness | Parameters collected from epithelium thickness data and maps | One visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratoconus, Optical Coherence Tomography, Corneal Epithelium Thickness Maps
Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application

Study Overview
=================
Brief Summary
-----------------
The main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients.

Official Title
-----------------
Phase IV - Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Other: Emollient - Cetaphil Advanced


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients 2 to 10 years old. with light to moderate with no signs of acute/ sub-acute eczema or in activity. Subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens. Subjects can present light to moderate dryness. Exclusion Criteria: Subjects presenting any serious systemic disease Subjects with medical history regarding serious asthma Subjects with known or suspected allergy to one of the investigational products Subjects with acute atopic eczema or in activity, needing systemic antibiotics Subjects with signs of active infections on skin Subjects whose parents or legal guardian seem to have difficulty in understand the informed consent form (ICF) Female subjects who are not in pre-menarche period. Subjects who need topic corticoids or any other medication that can interfere on Atopic Dermatitis during the study. Patient with a wash-out period for treatment less than: injectable corticoids: 60 days systemic corticoids: 15 days topic corticoids: 8 days topic immunomodulator: 8 days antihistaminic : 48 hours

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Emollient<br>Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day | Other: Emollient - Cetaphil Advanced<br>* Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical evaluation |  | Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dermatitis, Atopic, Corticoids, topic, Corticosteroids
Determination of Biomarkers of Exposure and Biomarkers of Potential Harm in Asian Adult Cigarette Smokers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in smokers and non smokers.

Detailed Description
-----------------
Since Japanese mortality associated with cardiovascular disease (CVD) is lower than that in the USA although Japan is one of the top four tobacco consuming countries, this study aims to determine biomarkers of both level of exposure and CVD-related biological effects in Japanese smokers compared to non-smokers. Biomarkers of Exposure (BoExp) include 2-naphthylamine (2-NA), 4-aminobiphenyl (4-ABP), 4-(methylnitrosaminoi)-1-(3-pyridil)-1-butanone (NNK), carbon monoxide (CO), nicotine, pyrene and 0-toluidine (o-TOL). CVD-related biomarkers include white blood cell (WBC) count, high sensitivity C-reactive protein (hs-CRP) and homocysteine in plasma; complemented with urinary 8-epi-prostaglandin F2α (8-epi-PGF2α), plasma malondialdehyde (MDA), urinary 11-DTXB2, plasma fibrinogen, high-density lipoprotein-cholesterol, triglycerides, sICAM-1, sVCAM-1 and von Willebrand Factor.

Official Title
-----------------
A Multi-center Study to Determine the Levels of Biomarkers of Potential Harm and Biomarkers of Exposure to Cigarette Smoke in Asian Adult Smokers and Non-smokers

Conditions
-----------------
Smoking, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smokers have smoked commercially available conventional cigarettes (CC) With a minimum consumption of 10 CC per day for the last 5 years Exclusion Criteria: Any prior medical condition or chronic disease Recent infection History of cancer Use of concomitant medication History of alcohol abuse Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of biomarkers of Exposure (BoExp) to HPHCs - present in cigarette smoke - in Asian smokers compared to non smokers | To measure the level of smoking, at baseline the Fagerstrom nicotine dependence test and urinary cotinine are measured. For measurement of biomarkers of exposure, blood and 24 hour urine sampling are performed at V2. | At Visit 2 (up to14 days after Visit 1) | 
| The level of CVD-related biomarkers in Asian smokers compared to non smokers |  | At Visit 2 (up to14 days after Visit 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers, HPHCs, CVD, smoking, Smokers, non-smokers
BAY59-7939 in Atrial Fibrillation Once Daily (OD)

Study Overview
=================
Brief Summary
-----------------
This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).

Official Title
-----------------
BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese subjects with non-valvular AF who met all of the following criteria: Male subjects aged 20 years or older and postmenopausal female subjects Subjects with persistent or paroxysmal non-valvular AF with >/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization Subjects who were at risk for stroke as follows: Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure). Subjects aged 60 years old and above regardless of the existence of above risk factors. Exclusion Criteria: History or presence of stroke or transient ischemic attack. History of intracerebral hemorrhage. History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Xarelto (Rivaroxaban, BAY59-7939)<br>* 10mg od<br>|
| Experimental: Arm 2<br> | Drug: Xarelto (Rivaroxaban, BAY59-7939)<br>* 15mg od<br>|
| Active Comparator: Arm 4<br> | Drug: Warfarin<br>* Dose-adjusted warfarin based on target INR values<br>|
| Experimental: Arm 3<br> | Drug: Xarelto (Rivaroxaban, BAY59-7939)<br>* 20mg od<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Safety) Incidence of bleeding |  | Throughout treatment and followup period | 
| (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST |  | Day 14 and Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BAY59-7939, Rivaroxaban, Non-valvular atrial fibrillation, Japanese Patients, Phase II
Pain and Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.

Official Title
-----------------
Pain and Schizophrenia

Conditions
-----------------
Pain, Schizophrenia

Intervention / Treatment
-----------------
* Other: unpleasant stimuli


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with schizophrenia (criteria DSM IV) or healthy controls matched with patients on age, sex and education level 18-55 years old Exclusion Criteria: Past history affecting CNS Intake of psychotropic drugs, except for patients Metabolic disorder affecting sensory processing (diabetes) Intake of benzodiazepines

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with schizophrenia<br> | Other: unpleasant stimuli<br> <br> |
| Active Comparator: Healthy controls<br>controls matched with patients on age, sex and education level | Other: unpleasant stimuli<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unpleasant stimuli | acute electrical stimulation | during experimental session | 
| Unpleasant stimuli | emotional pictures | during experimental session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, DSM IV criteria, Pain insensitivity, Painful perception, Opioid receptors
The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity

Study Overview
=================
Brief Summary
-----------------
Women suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. The vaginal tactile imager assists in evaluation of the changes in the pelvic floor after physiotherapy.

Detailed Description
-----------------
Women with stress urinary incontinence will undergo 6-10 pelvic floor strengthening physiotherapy sessions. The participants will undergo a short examination of vaginal elasticity using a vaginal tactile imager prior to beginning physiotherapy and additional examinations after 6 treatments, 10 treatments and 3 and 6 months post-treatment cessation.

Official Title
-----------------
The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity as Measured by a Vaginal Tactile Imager

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Diagnostic Test: Vaginal tactile imager


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women suffering from stress urinary incontinence. Exclusion Criteria: women suffering from urge urinary incontinence. women suffering of mixed urinary incontinence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stress urinary incontinence<br>Women suffering from stress urinary incontinence | Diagnostic Test: Vaginal tactile imager<br>* Vaginal elasticity evaluation using a vaginal tactile imager<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Elasticity | Changes in vaginal elasticity post physiotherapy | From the treatment cessation up to 6 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress urinary incontinence | Improvement in the urogenital distress inventory questionnaire score (range 0-15) | From the treatment cessation up to 6 months post-treatment |
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Detailed Description
-----------------
Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Official Title
-----------------
A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Clindamycin Phosphate
* Drug: Clindamycin Phosphate RLD
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris. Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA). Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clindamycin Phosphate<br>Topical, once daily, for 84 days. | Drug: Clindamycin Phosphate<br>* A thin film of investigation product will be applied to the affected areas of the face once daily<br>* Other names: Lotion;|
| Active Comparator: Clindamycin Phosphate RLD<br>Topical, once daily, for 84 days | Drug: Clindamycin Phosphate RLD<br>* A thin film of investigation product will be applied to the affected areas of the face once daily<br>* Other names: Lotion;|
| Placebo Comparator: Vehicle of the test product<br>Topical, once daily, for 84 days | Drug: Placebos<br>* A thin film of investigation product will be applied to the affected areas of the face once daily<br>* Other names: Vehicle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of Bioequivalence | Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts | Week 12 |