linjc16/ctgov huggingface dataset:
Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada

Study Overview
=================
Brief Summary
-----------------
the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.

Detailed Description
-----------------
The trial is a phase II, open label, non-randomized, prospective multicenter trial to assess the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.

Official Title
-----------------
Pilot Study to Measure Exposure to Atazanavir, as a Component of Pharmacokinetic Parameters and Adherence Measured With MEMS in Naive HIV-infected Patients Treated Once Daily With Atazanavir Combined to Ritonavir and to Tenofovir/Emtricitabine. ANRS 134 Cophar 3

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

Intervention / Treatment
-----------------
* Drug: Atazanavir
* Drug: Ritonavir
* Drug: Tenofovir/emtricitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Naïve of treatment HIV -1 infected patients CD4 above 100/mm3 Exclusion Criteria: pregnancy renal failure hepatitic disease ongoing opportunistic disease Hb under 8g/dl; platelets under 50 000/mm3; neutrophils under 750/mm3; Prothrombin index under 80%, Ca or Ph > 2.5 N drugs interacting with investigational drugs

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atazanavir|2pills/day|
|Drug: Ritonavir|1 pill/day|
|Drug: Tenofovir/emtricitabine|1 pill/day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine |  | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics of emtricitabine and tenofovir; intraindividual variability in ARVs concentrations; adherence measured with MEMS records and validated ANRS observance autoquestionnaire; relationships between virological response or side event occurrence |  | Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV infections, atazanavir, Pharmacokinetics, Treatment Naive
Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to present the outcomes of patients with giant cell tumor of bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.

Detailed Description
-----------------
The investigators retrospectively review patients treated for GCTB of the extremities between 1990 and 2013 in a single institution. We evaluate the recurrence free survival rate after surgical and medical treatment of patients with GCTB of the extremities to determine the influence of the surgical approach, denosumab therapy, local tumor presentation, and demographic factors on the risk of recurrence.

Official Title
-----------------
Il Tumore a Cellule Giganti Delle estermità

Conditions
-----------------
Giant Cell Tumor of Bone

Intervention / Treatment
-----------------
* Procedure: curettage and resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: giant cell tumors of the extremities Exclusion Criteria: giant cell tumors of the spine and pelvis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: curettage and resection|the investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence rate after surgical and medical treatment |  | within the first 36 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone tumors, giant cell tumor, treatment
V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck S. Aureus Vaccine (V710) in Healthy Male Japanese Subjects

Conditions
-----------------
Staphylococcal Infection

Intervention / Treatment
-----------------
* Biological: V710
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally Good Physical Health Exclusion Criteria: Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational S. Aureus Antibodies Before Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48 Hours

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V710<br>V710 vaccination (60 mcg) single dose on Day 1 | Biological: V710<br>* V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1<br>|
| Placebo Comparator: Placebo<br>Placebo single dose on Day 1 | Biological: Placebo<br>* Saline placebo (0.5 ml) single injection on Day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level | Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers. | Baseline (Day 1) to Day 14 postvaccination | 
| Number of Participants With Vaccine-related Serious Adverse Experiences | Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related. | Baseline (Day 1) to Day 84 postvaccination |
The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients

Study Overview
=================
Brief Summary
-----------------
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction (UPJO) patients. We are trying to analyze whether it is related with the grade of renal injury in UPJO patients.

Conditions
-----------------
Ureteropelvic Junction Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <Group 1> 0-3 year old patients with SFU grade 2 or more hydronephrosis without ureteral dilatation needs pyeloplasty due to differential renal function (DRF)<40%, decreased DRF by more than 5%, development of urinary tract infection, development of urinary stone, and development of pain related with UPJO <Group 2> 1. 0-3 year old patients with SFU grade 3 or 4 hydronephrosis without ureteral dilatation 2. doesn't meet the above criteria for the indication of pyeloplasty <Group 3> 1. 0-3 year old children without any abnormality of urinary tract Exclusion Criteria: <Group 1> patients with contralateral disease affecting DRF history of previous urinary tract surgery follow up loss before diuretic renogram performed at 6-12 months from operation <Group 2, 3> 1. patients with contralateral disease affecting DRF 2. history of previous urinary tract surgery

Ages Eligible for Study
-----------------
Maximum Age: 3 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 |
| --- | --- |
| UPJO<br>0-3 year old hydronephrosis patients without ureter dilatation who undergo pyeloplasty | |
| Hydronephrosis<br>0-3 year old hydronephrosis patients without ureter dilatation who does not meet the indication of pyeloplasty | |
| Normal<br>0-3 year old children without hydronephrosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of urinary NGAL and the degree of renal injury | Analysis of correlation between the level of urinary NGAL and the degree of renal injury | 6 month after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hydronephrosis, biopsy, biomarker
Assessement of Capacity to Consent

Study Overview
=================
Brief Summary
-----------------
Any patient can request euthanasia in many of our neighbouring European countries as long as informed consent is given. Psychiatric evaluation is not always mandatory. Faced with the increasing emergence of euthanasia requests in different countries from patients under psychiatric care in France for severe depressive episodes, question arises of a possible alteration in the capacity to give consent in the context of a severe depressive episode. This is a Social and Human Sciences study which does not aim to modify the usual management of patients.

Official Title
-----------------
Assessement of Capacity to Consent in Depressed Patients

Conditions
-----------------
Major Depressive Episode

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 18 and 75 Ability to understand and participate in the interview French-speaking Presence of a current characterized depressive episode according to DSM-5 diagnostic criteria Exclusion criteria: - Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Capacity to consent (MacCAT-T) | aassessment of the capacity to consent based on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T). The questionnaire assesses four competences in consent : understanding (score ranges from 0 to 6), appreciation (score ranges from 0 to 4), reasoning (score ranges from 0 to 8) and expressing a choice (score ranges from 0 to 2). A low score on each of these dimensions calls into question the patient's ability to consent. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insight (BCIS) | insight assessement based on the Beck Cognitive Insight Scale (BCIS). The questionnaire contains two sub-scales : self- reflection (9 items) and self-certainty (6 items). Each items ranges from 0 (do not agree at all) to 3 (agree completely) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Capacity to consent, Euthanasia
Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

Study Overview
=================
Brief Summary
-----------------
Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor

Detailed Description
-----------------
To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes.

Official Title
-----------------
Nifedipine for the Maintenance Tocolysis of Preterm Labor: Comparison to Placebo in a Prospective, Randomized Double Blind Trial

Conditions
-----------------
Obstetric Labor, Premature, Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: Nifedipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - arrested preterm labor Exclusion Criteria: - ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nifedipine<br>Maintenance tocolysis with nifedipine. | Drug: Nifedipine<br>* Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.<br>|
| Placebo Comparator: Placebo<br>Maintenance tocolysis with placebo tablets. | Drug: Nifedipine<br>* Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving 37 weeks gestation |  | delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of recurrent preterm labor |  | Delivery | 
| Neonatal outcomes |  | Discharge of neonate |
Effect of Liraglutide on Weight Loss in Patients Who Have Undergone Revisional Bariatric Surgeries.

Study Overview
=================
Brief Summary
-----------------
Our primary objective is to assess the effect of Liraglutide on weight loss in patients who have undergone secondary bariatric surgeries. We set out to assess if Liraglutide is a viable option to augment weight loss in said category.

Official Title
-----------------
Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study.

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Drug: Liraglutide Pen Injector [Saxenda]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergone primary bariatric surgery Need secondary bariatric surgery due to either weight regain (regained weight to have BMI > 35) or medical associated diseases Exclusion Criteria: Prior use of GLP-1 agonist Past history of pancreatitis Personal or family history of medullary thyroid cancer Pregnancy or lactation Acute coronary syndrome Hepatic or renal dysfunction Active malignancy
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: Liraglutide<br>drug starts 6 weeks post-operative until 6 months SC injection dose starting 0.6 mg/day and weekly up titrated until 3.0 mg/day | Drug: Liraglutide Pen Injector [Saxenda]<br>* Subcutaneous injection of GLP-1 agonist<br>|
| No Intervention: Control<br>Patients with no weight loss drug intervention after bariatric surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Total weight loss |  | 6 months | 
| Percentage Excess body weight loss |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidities |  | 6 months | 
| Weight |  | 6 months | 
| BMI |  | 6 months | 
| HbA1C |  | 6 months | 
| Fasting Blood Glucose (FBG) |  | 6 months | 
| HOMA-IR |  | 6 months | 
| Resolution of type 2 Diabetes Mellitus |  | 6 months | 
| Blood pressure |  | 6 months | 
| Lipid profile |  | 6 months | 
| Sleep apnea |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liraglutide, Morbid obesity, secondary bariatric surgery, revisional bariatric surgery
The Foot Exercises in Patellofemoral Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the additional effects of Short Foot Exercises on pain, biomechanical characteristics and functionality of lower extremity in patients with patellofemoral pain.

Official Title
-----------------
The Effects of Foot Exercises on Pain, Biomechanical Characteristics and Functionality of Lower Extremity in Patients With Patellofemoral Pain

Conditions
-----------------
Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Pronation Deformity of the Foot, Exercise, Pain, Biomechanics, Functionality

Intervention / Treatment
-----------------
* Other: SFE
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 25-60 diagnosed as patellofemoral pain syndrome Exclusion Criteria: Pregnancy Having walking disability Having a trauma, knee surgery or other arthritis

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ex+SFE Group<br>Individuals in this group who will perform exercises for knee and also short foot exercise | Other: SFE<br>* The 'short foot exercise' has been described as a means to isolate contraction of the plantar intrinsic muscles.<br>Other: Exercise<br>* Exercises which improves muscle strength, ROM...<br>|
| Active Comparator: Ex Group<br>Individuals in this group who will perform exercises for knee only | Other: Exercise<br>* Exercises which improves muscle strength, ROM...<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Asked for expression of pain | Change from baseline pain at 6th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patellofemoral pain, foot deformity, foot pronation, short foot exercise
Rehabilitation Required Due to Clinical Disorders After Severe Covid-19 Infection

Study Overview
=================
Brief Summary
-----------------
Due to the emergence of an epidemic cluster in Mulhouse, a city located 100 km south of Strasbourg, Alsace was one of the first French regions to be affected by the coronavirus (SARS-CoV-2 or COVID-19). As a result, all hospitals in the region, including both Strasbourg University Hospitals, had to deal with the epidemic wave earlier and more intensely than the rest of France. At the time of writing this article, 6 weeks after the start of the epidemic, we have counted 998 hospital deaths in our region, i.e., an intrahospital mortality rate linked to COVID-19 of 5.3 deaths per 10,000 inhabitants (https://dashboard.covid19.data.gouv.fr/). Currently, our intensive care unit still has a large number of patients hospitalized for COVID-19. Some of these patients have severe damage to one or more organs, and in particular a neurological or respiratory deficit suggesting that they will need post-resuscitation rehabilitation. The primary aim is to assess the neurological disorder after severe SARS-CoV-2 infection and the second is the respiratory impairment evaluation.

Official Title
-----------------
Rehabilitation Required Due to Functional Neurological Impairment and Respiratory Disorders After Severe SARS-CoV-2 Infection in ICU Units

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (≥18 years old) Patient hospitalized in surgical intensive care at the New Civil Hospital between February 24 and April 15, 2020. Patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT. Patient who has given his consent for the use of his data for the purposes of this research Exclusion Criteria: Patient without documentation of SARS-CoV-2 infection (RT-PCR or chest scanner) Patient who expressed his opposition to participating in the study Subject under safeguard of justice Subject under guardianship or guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retrospective analysis of the neurological disorder after severe SARS-CoV-2 infection |  | The files analysed retrospectily from February 24, 2020 to April 15, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, SARS-CoV-2, COVID-19, Neurological function, Respiratory disorder, Intensive care unit