linjc16/ctgov huggingface dataset:
Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Clindamycin 1% Gel To Clindamycin 1% Gel (Greenstone LLC) and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris

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

Intervention / Treatment
-----------------
* Drug: Clindamycin 1% Gel
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
IInclusion Criteria: Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4. Exclusion Criteria: Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis. Subject has active cystic acne. Subject has acne conglobata. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

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 1% gel (Akorn Pharmaceuticals)<br> | Drug: Clindamycin 1% Gel<br>* Topical gel<br>|
| Active Comparator: Clindamycin 1% gel (Greenstone LLC)<br> | Drug: Clindamycin 1% Gel<br>* Topical gel<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Topical Placebo gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks |  | Percent change from baseline to 12 weeks | 
| Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week |  | Percent change in baseline to 12 weeks |
Evaluation of Attachment, Self-compassion and Coping Strategies in Chronic Pain Patients

Study Overview
=================
Brief Summary
-----------------
Compare the self-compassionate score by type of attachment, safe or insecure, in chronic pain patients.

Detailed Description
-----------------
Attachment theory proposes a theoretical model that helps us explain how the process of developing interpersonal relationships can affect the search for care and the response of individuals to an illness. Self-compassion is a concept developed by Kristin Neff. It refers to the disposition of each individual to contain their feelings of suffering by a feeling of warmth, connection and care. The coping corresponds to the answers, the reactions, that the individual will develop to control, reduce or simply tolerate the aversive situation. Coping can take the form of cognitions, affects and behaviors that an individual will put in place to deal with a situation. The three concepts (attachment, self-compassion, coping) seem to be interrelated, and they contribute to the explanation and management of chronic pain, in the spectrum of the bio-psycho-social model of pain. Yet no study has measured these three variables together in chronic pain patients Chronic and Newly Assisted Patients at CETD (Neurosurgery Department, Pain Assessment and Treatment Center) (ie any patient seen for the first time in pain center, and included in the research during one of the three medical consultations preliminary to overall care at the CETD).

Official Title
-----------------
L'évaluation de l'Attachement, de l'Auto-compassion et Des stratégies de Coping Chez Les Patients Douloureux Chroniques

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Self-Compassion Scale (SCS) questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic pain Exclusion Criteria: Legal protection measure Patients followed for cancer Patients followed for multiple sclerosis Patients followed for Parkinson's disease Patients already followed in another CETD Decompensated psychiatric pathology

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Self-Compassion Scale (SCS) questionnaire|all included patients with chronic pain will answer the Self-Compassion Scale (SCS) questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Compassion Quetionnaire | The self-compassion score level according to the Self-Compassion Scale Questionnaire (SCS). | 1 month |
Older HIV-infected Adults and Drug Interactions: French Cross-sectional Study

Study Overview
=================
Brief Summary
-----------------
Drug interactions between antiretroviral drugs and concomitants drugs and between antiretroviral need to be studied HIV-population is ageing. The referential of interactions is the Liverpool base.

Detailed Description
-----------------
Filters in the French social security system database, 2016 : Code of Pathology Human Immunodeficiency Virus (HIV) infection Age ≥ 65 years Treatment with an antiretroviral between January 1, 2016 and December 31, 2016

Official Title
-----------------
Older HIV-infected Adults and Drug Interactions: Nationwide Cross-sectional Study Based on French National Health Insurance Databases

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women over than 65 years with an HIV infection and insured at the French Primary Health Insurance fund No exclusion Criteria

Ages Eligible for Study
-----------------
Minimum Age: 66 Years

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 |
| --- | --- | --- |
| frequency of major drug-drug interactions | MDDI between 2 drugs (ARV/ARV or ARV/non-ARV) delivered during the same period yielding to a Do Not Coadminister statement, according to the University of Liverpool website (www.hiv-druginteractions.org/checker). | between Jan, 1st 2016 and Dec, 31st 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| costs associated with major drug-drug interactions | The costs were defined as all reimbursed healthcare acts recorded in the SNIIRAM | during 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SNIIRAM, HIV infection, antiretroviral, aging population, drug interactions, cross-sectional study
Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

Study Overview
=================
Brief Summary
-----------------
To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are thought to be the possible mechanisms, inducing a generalized vasculopathy associated with microalbuminuria and vascular events in type II diabetic hypertensive patients

Official Title
-----------------
Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

Conditions
-----------------
Hypertension, Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: Irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over %6.5-8 mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180 mmHg) Exclusion Criteria: congestive heart failure azotemia insulin dependent diabetes liver insufficiency pregnancy cancer The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of irbesartan on nitric oxide (NO), which has key role in the endothelial dysfunction and the development of pressure vasomotor response, compared to standard therapy (atenolol) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microalbuminaria in hypertensive patients with type II diabetes mellitus
Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on the blood levels of midazolam and caffeine in healthy volunteers

Official Title
-----------------
A Phase I Open-labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD6280
* Drug: Midazolam
* Drug: Caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects aged 18 to 45 years (inclusive) on Day 1. Exclusion Criteria: Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor. Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD6280<br>* oral<br>Drug: Midazolam<br>* oral<br>Drug: Caffeine<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of repeated doses of AZD6280 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite). |  | Blood samples will be taken throughout the 19-day inpatient period of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine. |  | Observations taken post dosing. | 
| Evaluation of the pharmacodynamic effects of AZD6280 |  | Test batteries will be performed before and following study drug administration. | 
| To evaluate the pharmacokinetics of AZD6280 |  | Blood samples will be taken throughout the 19-day inpatient period of the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I
An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety, efficacy and delineate the pharmacokinetic properties of nelfinavir in HIV/ Hepatitis C coinfected subjects with Child Pugh A compensated cirrhosis and or Hepatic fibrosis

Official Title
-----------------
A Phase Iv Single-Arm Open-Label Non-Randomized Study To Evaluate The Safety And Pharmacokinetics Of Nelfinavir (Viracept, A430) 1250mg Twice Daily (250mg Or 625mg Forms) With Lamivudine/Zidovudine (Combivir) Background Therapy In Hiv/Hepatitis C Virus (Hcv) Co-Infected Subjects With Hepatic Dysfunction.

Conditions
-----------------
HIV Infection, Hepatitis C

Intervention / Treatment
-----------------
* Drug: nelfinavir 1,250 mg twice daily
* Drug: Zidovudine 300 mg twice daily
* Drug: Lamivudine 150 mg twice daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV/ Hepatitic C co infected with documented HCV viremia evidence for cirrhosis and or hepatic fibrosis on liver biopsy, positive fibrosis index, stable health Exclusion Criteria: Decompensated cirrhosis (Child Pugh B or C) Pregnant or lactating women History of previous antiretrovirals > 14 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Drug: nelfinavir 1,250 mg twice daily|nan|
|Drug: Zidovudine 300 mg twice daily|nan|
|Drug: Lamivudine 150 mg twice daily|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the safety of nelfinavir 1,250 mg orally taken twice daily in HIV/HCV co infected adult subjects with compensated cirrhosis (Child Pugh A) or hepatic fibrosis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite. |  |  |
TRACY - Track My Cycle

Study Overview
=================
Brief Summary
-----------------
The primary aim of the pilot study is to collect data for the fine-tuning and evaluation of the Ava algorithm. Secondary outcomes are the estimation of the accuracy in detecting the fertility status of each cycle day.

Official Title
-----------------
TRACY - Track My Cycle

Conditions
-----------------
Fertility Monitor, Cycle Tracking

Intervention / Treatment
-----------------
* Device: Ava Fertility Tracker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 40 at the time of admission Not pregnant and no pregnancy wish during the pilot study period Have a regular sleep pattern (sleep at least four hours per night and not working nightshift) Have regular menstrual cycles Exclusion Criteria: Pregnant at study admission Currently breastfeeding or have breastfed in the past 6 months before study admission Currently using hormonal contraception or hormonal medication Health-related conditions that may affect menstrual cycle length and variability (e.g. PCOS, menopause, thyroid dysfunction) Unable to understand study instructions and/or not able to understand English or German More than one international overseas travel per month Unwilling to sign the ICF.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ava Fertility Tracker|All women aged 18 to 40 years using Ava Fertility Tracker to track their cycles.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fine-tuning Ava algorithm | Number of days within a menstrual cycle that are correctly predicted as 'fertile' by the Ava algorithm. Number of study participants who have their 'fertile window' accurately predicted by the Ava AG app. | 5 months |
Location and Anatomic Characterization of the Sacrospinous Ligaments in Women With Pelvic Organ Prolapse

Study Overview
=================
Brief Summary
-----------------
Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during childbirth trauma. The sacrospinous ligaments are commonly employed surgical structures employed to repair vaginal prolapse. Despite the frequent use of these structures in prolapse surgery, there is a paucity of information regarding the identification of these structures outside of surgical dissection. Furthermore, there is no published data describing the relative distances between the apex of the vagina and these ligaments in women with prolapse. Recent developments in imaging have enabled the identification of the distal subdivisions of the levator ani, classifying as: pubovaginalis, puboanalis, and the puboperinealis as the subdivisions of the pubovisceralis. The visualization of these structures is possible using a 3D ultrasound technique (BK medical, Wilmington, MA), that has been validated in cadavers and in live humans, with excellent interrater reliability. The investigators propose to use this technology to explore the anatomy of the sacrospinous ligaments.

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 21-80 years old Stage III or higher pelvic prolapse Exclusion Criteria: -Prior pelvic surgery

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 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 |
| --- | --- |
| Pelvic prolapse<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging |  | Real time during procedure |
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.

Official Title
-----------------
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: rabeprazole
* Drug: rabeprazole
* Drug: rabeprazole
* Drug: rabeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19 Exclusion criteria: Subjects with allergy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: rabeprazole<br>* 10 mg normal tablet<br>|
| Experimental: 2<br> | Drug: rabeprazole<br>* Type 1 granule containing rabeprazole 10 mg<br>|
| Experimental: 3<br> | Drug: rabeprazole<br>* Type 2 granules containing rabeprazole 10 mg<br>|
| Active Comparator: 4<br> | Drug: rabeprazole<br>* Type 3 granules containing rabeprazole 10 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC) |  | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rabeprazole, Japan, healthy Japanese male