linjc16/ctgov huggingface dataset:
Reducing HIV Risks in African American Teens

Study Overview
=================
Brief Summary
-----------------
This study is developing and testing an innovative, parent education intervention, Preparing Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among African American and other Black youth living in high-poverty urban neighborhoods. Investigators, working with a community advisory board and focus groups of youth and parents, will develop a multi-year set of audio-CDs to promote positive parenting practices that support young adolescents in establishing healthy patterns of behavior. This parent education intervention will be tested in a field trial with families of 6th graders recruited from multiple schools in New York City. Baseline and annual follow up surveys will be conducted until youth enter high school. Families receiving the intervention will be compared to those assigned to either an attention-controlled print materials condition or a non-attention controlled condition. It is hypothesized that youth whose parents receive the intervention will delay sexual initiation and report fewer sexual risks, and that their parents will report more positive parenting practices.

Official Title
-----------------
Reducing HIV Risks in African American Teens in High Poverty Urban Settings

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

Intervention / Treatment
-----------------
* Behavioral: Healthy Futures parent education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attendance at selected schools 6th graders and their parents Exclusion Criteria: Non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 11 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 |
| --- | --- |
| Active Comparator: health promotion materials<br>Parents receive health promotion booklets | Behavioral: Healthy Futures parent education<br>* Multi-year audio CD parent education<br>|
| Active Comparator: attention-controlled parent print materials<br>Booklets on adolescent sexuality and health | Behavioral: Healthy Futures parent education<br>* Multi-year audio CD parent education<br>|
| Experimental: audio-CD parent education<br>audio-CDs on parenting practices | Behavioral: Healthy Futures parent education<br>* Multi-year audio CD parent education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| youth risk behaviors |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sexual health, adolescent health, parent education, HIV Seronegativity, treatment experienced
Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of estrogen treatment on adipocytic and osteoblastic parameters by histomorphometrically measuring adipocyte volume (AV/TV) and adipocyte numbers in goldner's stained iliac crest bone biopsy specimens collected from subjects recruited in the study (IRB number 21B85). The adipocytic parameters will be then correlated with osteoblastic parameters obtained previously during the course of the initai study involving the effect of transdermal estrogen on bone turnover in postmenopausal osteoporotic women.

Official Title
-----------------
Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: estrogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Post-menopausal osteoporotic women

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of estraderm treatment on osteoporotic women |  |  |
Current Situation on the Consumption of Hypnotic Substances at the Pharmacy

Study Overview
=================
Brief Summary
-----------------
In France, consumption of hypnotic drugs is high. In this context, and given the planned regulatory modifications, it seems essential to make an inventory of the consumption of drugs taken for a hypnotic purpose. This study aims to identify the substances (medical or not) used for a hypnotic purpose in the adult population going to a pharmacy.

Official Title
-----------------
Current Situation on the Consumption of Hypnotic Substances at the Pharmacy

Conditions
-----------------
Substances Used for a Hypnotic Purpose

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult going to the pharmacy and who accepts to complete the questionnaire Exclusion Criteria: Minor Who is not able to complete a questionnaire Who does not accept to complete the questionnaire

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Adult population going to a pharmacy<br>Adult population going to a pharmacy will be asked to complete a questionnaire. | Other: Questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The name of the substance (medical or not) used for a hypnotic purpose |  | One day |
Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL

Study Overview
=================
Brief Summary
-----------------
Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL

Conditions
-----------------
B-cell Non Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: HLX01
* Drug: Rituximab
* Drug: CHOP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Untreated CD20-positive DLBCL confirmed. IPI score of 1 to 2, Stage I   IV, Score 0 needs to accompanied by bulky disease, which is defined as the presence of a tumor mass with a diameter of more than 7.5 cm. ECOG performance status of 0 to 2. More than 6 months life expectancy. At least one measurable lesion: For nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; For extranodal tumor mass, more than 1.0 cm in the long axis. 18 years to 70 years; Male or female patients. Exclusion Criteria: Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins. Known allergic reactions against any component of CHOP regimen. Previous treatment for NHL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, monoclonal antibody therapy or surgical treatment (excluding lymph node biopsies and surgical resection for non-lymphoma lesions). History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis). Prior use of any monoclonal antibody within 3 months. Primary central nervous system(CNS) lymphoma, secondary CNS involvement, grey zone lymphoma (GZL) between burkitt and DLBCL, primary effusion lymphoma, plasmablastic lymphoma, primary cutaneous DLBCL, anaplastic lymphoma kinase(ALK) positive DLBCL or transformed lymphoma.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: HLX01<br>375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks) | Drug: HLX01<br> <br> Drug: CHOP<br> <br> |
| Active Comparator: Rituximab<br>375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks) | Drug: Rituximab<br> <br> Drug: CHOP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Overall Response Rate (ORR) |  | 18 weeks |
Alternative Treatment of Giant Spinal Schwannomas

Study Overview
=================
Brief Summary
-----------------
Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of these cases differ from those of small schwannomas. The aim of this study was to review the diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of patients who underwent surgery.

Official Title
-----------------
Alternatives to The Surgical Approach for Giant Spinal Schwannomas: A Clinic Trial

Conditions
-----------------
Spinal Cord Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with benign spinal schwannoma Sridhar Type III, IV and V Exclusion Criteria: Malign spinal schwannoma Sridhar Type I and II

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 76 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 |
| --- | --- | --- |
| Effects of the alternative surgical techniques to the amount of the tumor mass which measured by Nurick Scale |  | 3 years |
REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Enbrel® or Kineret® will have a positive effect on subject functionality as measured by the Health Assessment Questionnaire Disability Index (HAQDI).

Official Title
-----------------
Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE)

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Enbrel®
* Drug: Kineret®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects with active rheumatoid arthritis as defined by ACR criteria - Able to start Enbrel® or Kineret® therapy (per the approved product monographs) within approximately 30 days of confirmed enrolment Exclusion Criteria: - Active infections at the time of initiating Enbrel® or Kineret® therapy - Malignancy other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years - Known hypersensitivity to E. coli derived products - Known hypersensitivity to Enbrel® or any of its components - Subjects receiving, or who received:* Enbrel® in the previous 30 days; * Remicade® in the previous 3 months; * Humira® in the previous 3 months; * Kineret® in the previous 15 days. - Subjects beginning Enbrel® therapy, or treated with prior or current treatment using Enbrel® - Subjects beginning Kineret® therapy, or treated with prior or current treatment using Kineret® - Treatment with any investigational therapy in the 30 days prior to enrolment confirmation - Presence of any significant and uncontrolled medical condition which, in the investigator's opinion, precludes the use of Enbrel® - Sepsis or at risk of septic syndrome

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 |
| --- |
|Drug: Enbrel®|nan|
|Drug: Kineret®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula

Study Overview
=================
Brief Summary
-----------------
There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). The aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, Neutrophil to Lymphocytes Ratio (NLR), at postoperative days 1 and 3) to exclude the diagnosis of CR-POPF.

Detailed Description
-----------------
From January 1, 2012 to December 31, 2020, consecutive patients underwent PD performed at Institut Paoli-Calmettes for various pathologies. Data were entered prospectively into a clinical database (NCT02871336). The cohort was split into 3 groups: a training cohort ; an internal validation cohort (Paoli Calmettes institute); an external validation cohort (Rennes Pontchaillou Hospital).

Official Title
-----------------
The Neutrophil-to-Lymphocyte Ratio at Post-operative Day 3: a Simple Tool to Exclude Clinically Relevant Postoperative Pancreatic Fistula After Pancreatoduodenectomy

Conditions
-----------------
Pancreas Neoplasm

Intervention / Treatment
-----------------
* Procedure: pancreatoduodenectomy (PD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent pancreatoduodenectomy Exclusion Criteria: Total pancreatectomy Enucleation

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 |
| --- |
|Procedure: pancreatoduodenectomy (PD)|A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinically relevant pancreatic fistula | Clinically relevant postoperative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery definition | at hospital discharge assessed up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological markers | Identification of biological markers to exclude clinically relevant postoperative pancreatic fistula | Postoperative day one and three | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic fistula, Neutrophil-to-Lymphocyte Ratio, Pancreatoduodenectomy
Auditory Evoked Potential Monitoring on Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
To compare the difference of sedation monitoring for bronchoscopic examination monitoring by auditory evoked potentials (AEP) or Ramsay Sedation Scale (RSS) in mechanical ventilated patients.

Official Title
-----------------
Impact of Auditory Evoked Potential Index Monitoring on Bronchoscopic Examination in the Mechanical Ventilated Patients - A Prospective, Randomized, Controlled Study

Conditions
-----------------
Sedation Method

Intervention / Treatment
-----------------
* Device: AEP monitor
* Procedure: Ramsay Sedation Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated patients with aged 18 or over and they needed bronchoscopic examination in the ICU were eligible for this study. Exclusion Criteria: patients with pacemaker, neuromuscular blockades, propofol allergy or hearing impairment.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AEP monitoring<br> | Device: AEP monitor<br>* In AEP monitoring group, nurses adjusted propofol dose according to AAI values. If AAI>40, titrate up propofol dosage, AAI<25, titrated down propofol dosage.<br>|
| Active Comparator: RSS monitoring<br> | Procedure: Ramsay Sedation Scale<br>* During bronchoscopy, nurses adjusted propofol dose according to Ramsay Sedation Scale.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mean arterial pressure, heart rate and AAI | During bronchoscopy, we recorded AAI number, blood pressure and heart rate every 5 minutes, totally up to 40 minutes. | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean propofol dose use during examination, times of propofol dose adjustment |  | 40 minutes |
Genetic Predisposition for Chronic Non-specific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Patients with inflammatory back pain were shown to differ from healthy controls in genotype of the Angiotensin-converting enzyme (ACE), which regulates vasoconstriction/-dilatation. The aim of this study is to investigate whether genetic reduction of muscle perfusion might be a pathophysiological pathway of how genes influence chronic non-specific low back pain (LBP).

Detailed Description
-----------------
The following genes will be investigated: Insertions-/deletions-polymorphism of the angiotensin-converting enzyme (ACE-I/D gene polymorphism; 3 genotypes: ACE-II, ACE-ID, ACE-DD). Anti-adhesive extracellular matrix protein Tenascin-C: gene polymorphism rs2104772 The goals of this study are to investigate whether these genotypes correlate with 1) endurance of back muscles, 2) comorbidities such as asthma and diabetes and 3) the risk for LBP as assessed by a LBP-classification tool.

Official Title
-----------------
Genetic Predisposition for Reduced Back Muscle Strength and Back Muscle Endurance in Patients With Chronic Non-specific Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 Exclusion Criteria: Spinal surgery Spinal fracture Inflammation Tumour Severe chronic disease which make intensive physical activity impossible (osteoporosis, cardiovascular heart diseases)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Low back pain patients<br>Low back pain since more than 3 months Age: 18-65 Caucasian race | Other: no intervention<br>* observational case-control study<br>|
| Controls without low back pain<br>no low back ain Age: 18-65 Caucasian race | Other: no intervention<br>* observational case-control study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polymorphism ACE Gene |  | baseline | 
| Polymorphism Tenascin Gene |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back muscle endurance in Sorensen test |  | baseline |
Behavioral and Neurofunctional Correlates of Intentional Motor Behaviors Towards Edible Stimuli in Normal-weight Subjects

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate, through behavioural tests combined with advanced neurofunctional methods, the neural bases of intentional behaviours towards edible stimuli using explicit and implicit paradigms in normal-weight subjects. This knowledge will then be expanded with the study of associations between behavioral/neurofunctional measures and blood/hummon parameters.

Official Title
-----------------
Behavioral and Neurofunctional Correlates of Intentional Motor Behaviors Towards Edible Stimuli in Normal-weight Subjects

Conditions
-----------------
Food Oriented Behavior

Intervention / Treatment
-----------------
* Other: Neurofunctional imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal weight (Body mass index - BMI - comprised between 18.6 and 24.99. Absence of usual contraindications to MRI examination (e.g. pacemakers, fixed hearing implants, presence of metallic foreign bodies, intrauterine bodies, metallic splinters or fragments, metallic prostheses, screws, nails, fixed or mobile dental prostheses). Signature of informed consent and consent to cooperate in all study procedures. Exclusion Criteria: Previous diagnosis of significant neurological disorders (brain damage or dementia), major psychiatric disorders or eating disorders (binge-eating disorder, bulimia). BMI less than 18.5 and greater than or equal to 25 Kg/cm2. Serious medical conditions, including but not limited to: hypertension, significant heart disease, disorders or illnesses that may compromise patient safety. Pregnancy and Claustrophobia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal-weight subjects<br> | Other: Neurofunctional imaging<br>* Subjects will be submitted to a functional neuroimaging scanning procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD Response | We will record the BOLD response during the visualization of edible stimuli | 3 years |