linjc16/ctgov huggingface dataset:
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adolescents in Gaza

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized adolescents in Gaza will result in improvement of posttraumatic stress symptoms, depression, and levels of aggression compared to a control group.

Official Title
-----------------
A Randomized Controlled Study of Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adolescents in Gaza

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Mind-Body Skills Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having experienced a political violence or war-related criterion A stressor meeting the American Psychiatric Association (DSM-IV-TR) criteria for PTSD according to screening scores on the Child PTSD Symptom Scale Exclusion Criteria: former psychosocial or medical treatment for mental health conditions significant cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Skills Groups<br> | Behavioral: Mind-Body Skills Group<br>* Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child PTSD Symptom Scale |  | Change from Baseline (Week 1) at 6 weeks | 
| Child PTSD Symptom Scale |  | Change from Week 6 at 18 weeks | 
| Child PTSD Symptom Scale |  | Change from Baseline (Week 1) at 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Depression Inventory -2 Short Form |  | Change from Baseline (Week 1) at 6 weeks | 
| Children's Depression Inventory -2 Short Form |  | Change from Week 6 at 18 weeks | 
| Children's Depression Inventory -2 Short Form |  | Change from Baseline (Week 1) at 18 weeks | 
| Aggression Questionnaire |  | Change from Baseline (Week 1) at 6 weeks | 
| Aggression Questionnaire |  | Change from Week 6 at 18 weeks | 
| Aggression Questionnaire |  | Change from Baseline (Week 1) at 18 weeks |
False Positive Results in Newborn Hearing Screening

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the rate of false-positive results in Newborn Universal Hearing Screening Programs and it´s possible causes.

Detailed Description
-----------------
False-positive results in Newborn Hearing Screening(NHS) leads to unnecessary parents anxiety and increase the cost of the procedure before hospital discharge. Getting to know the possible causes will lead to solutions to decrease the number of normal hearing babies that fail NHS with Otoacoustic Emissions.

Official Title
-----------------
False-Positive Results in Newborn Hearing Screening: Possible Causes

Conditions
-----------------
Deafness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy newborns Exclusion Criteria: Risk factors for hearing loss

Ages Eligible for Study
-----------------
Minimum Age: 6 Hours
Maximum Age: 48 Hours

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 |
| --- | --- |
| 1<br>Newborns that show a Pass On the newborn hearing screening program before hospital discharge | |
| 2<br>Newborns that show a fail and will be retested in 15 days. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otoacoustic Emissions |  | At birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hearing, newborn, otoacoustic emissions
CV Events in Emetogenic Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).

Detailed Description
-----------------
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Official Title
-----------------
Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy

Conditions
-----------------
Vomiting, Cardiovascular Event, Arterial Thromboembolic Event

Intervention / Treatment
-----------------
* Drug: HEC or MEC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in IHCIS in 2006 At least one HEC or MEC claim in 2006 Exclusion Criteria: HEC or MEC claim three months before first HEC/MEC claim - wash-in period (i.e. must be enrolled for three months prior to first HEC/MEC claim. For patients whose first HEC/MEC event is between January 1,2006 and March 31, 2006, enrollment criteria for inclusion in the study may extend as far back as October 1, 2005) HEC or MEC claims prior to 45 days after last HEC or MEC claim - wash-out period. (For patients whose last claim in 2006 was seen after December 1, 2006 enrollment into 2007 to look for further treatment and the 45 day wash-out period will be required.)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients enrolled in IHCIS in 2006<br>Patients enrolled in IHCIS in 2006 | Drug: HEC or MEC<br>* Any HEC or MEC, including aprepitant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculate the frequency and percent of patients with selected cardiovascular and arterial thromboembolic events in the analysis period, stratifying by any use of aprepitant (Emend) during the analysis period. |  | First day of first HEC/MEC cycle to 30 days past first day of last cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
moderately emetogenic chemotherapy, MEC, highly emetogenic chemotherapy, HEC
Reactor Thoracostomy

Study Overview
=================
Brief Summary
-----------------
Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement, exploration of the thoracic cavity with a gloved finger, and finally insertion of a sterile tube into the intrathoracic space. The procedure is considered extremely painful despite the routine provision of systemic analgesics and local anesthetics. Cadaver and animal studies have demonstrated the use of the Reactor chest tube device, a squeeze-activated thoracostomy trochar with placement of a clear sheath for chest tube insertion, to decrease procedure time, incision size, and blood loss. Case series and observational reports suggest lower rates of procedural complication and failure as well as increased patient satisfaction due to pain reduction.

Official Title
-----------------
Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting

Conditions
-----------------
Pneumothorax, Hemothorax

Intervention / Treatment
-----------------
* Device: Reactor Device
* Procedure: Tube thoracostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects age ≥ 18 years old Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax. Hemodynamically stable Exclusion Criteria: Pregnant patients Prisoners Need for emergency thoracostomy Hemodynamic instability Respiratory distress

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional<br> | Procedure: Tube thoracostomy<br>* Traditional chest tube placement<br>|
| Experimental: Reactor Device<br> | Device: Reactor Device<br>* The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient report of pain | As measured on a 100mm VAS | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time |  | During procedure |
The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor

Study Overview
=================
Brief Summary
-----------------
In order to determine the optimal angle to perform an episiotomy, the investigators assessed the angle of marked episiotomy lines at the first stage of labor and at the time of crowning of the head. Incision lines for mediolateral episiotomy were pre-marked on the perineal skin at 30°, 45°, and 60° angles from the midline, at the first stage of labor, in women with singleton pregnancies. The angles of the marked lines were measured again at crowning of the head. Mediolateral episiotomy was performed only for obstetric indications.

Official Title
-----------------
The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor

Conditions
-----------------
Labor, Obstetric, Episiotomy

Intervention / Treatment
-----------------
* Procedure: change of medilateral angle line during crowning of the head


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women during labor above 37 weeks, Occiput presentation Exclusion Criteria: cesarean section, vacuum or forceps deliver, breech deliver, below 37 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: change of medilateral angle line<br>change of medilateral angle line during crowning of the head | Procedure: change of medilateral angle line during crowning of the head<br>* change of medilateral angle line during crowning of the head<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of medilateral angle line during crowning of the head |  | 18 months |
Sodium Sensitivity in African Americans

Study Overview
=================
Brief Summary
-----------------
To compare the effects of two levels of dietary sodium on blood pressure in Black men and women, and to determine what factors predict the degree of response.

Detailed Description
-----------------
BACKGROUND: The study permitted a more precise estimate of the effects of sodium chloride on blood pressure in Blacks and a systematic examination of sodium sensitivity defined by various methods. The results had significance in answering questions about risk factors for blood pressure in Blacks and for defining sodium sensitivity. DESIGN NARRATIVE: Double-blind, two-period cross-over. All participants were given six weeks of intensive nutritional counseling to lower 24-hour urine sodium output from an estimated 165 mEq/24 hours at baseline to less than 140 mEq/24 hours. Only those participants who excreted less than 140 mEq /24 hours after six weeks of intensive dietary sodium intervention and had greater than 70 percent adherence to study capsules were eligible for randomization. Eligible subjects were assigned to one of two treatment sequences: 100 mEq of sodium chloride capsules per day during period one followed by placebo capsules during period two; placebo capsules during period one followed by 100 mEq of sodium chloride capsules per day during period two. The major endpoint was change in diastolic and systolic blood pressure. A number of other measures were carried out, including blood chemistries, glucose tolerance (glucose and insulin), insulin resistance, urinary kallikrein, serum renin, and plasma norepinephrine. Other major aims of the trial included testing general new diagnostic criteria for sodium sensitivity, examining predictors of sodium sensitivity, and examining how changes in sodium intake influenced change in specific metabolic parameters. The trial design incorporated careful control of the dietary changes and strict standardization of blood pressure measurement with a random-zero device. The study was extended through June 1997 on FY 1995 funds.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

Intervention / Treatment
-----------------
* Behavioral: sodium, dietary


Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: sodium, dietary|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Immune Checkpoint Receptors in AML-Leukemic Initiating Cells

Study Overview
=================
Brief Summary
-----------------
This project aim at deciphering immune mechanisms that allow the immunoescape of AML initiating cells.

Detailed Description
-----------------
Leukemic Initiating Cells (LIC) were shown to play a key role in AML relapses, and are characterized by resistance to treatment and a high capacity to escape to immune system. Immune checkpoints (ICP) maintain self-tolerance and physiological amplitude of the immune response. We decided to focus our work on ICP receptors and ligand that could be expressed by AML LIC and lymphocytes subsets. The tumor cells are able to express these ligands to exploit the ICP to overcome the anti-cancer immune response. Few studies are published in AML in the field of ICP, some studied limited cohort and others analyzed the expression of these ligands in total leukemic population, with a limited interest since the LIC fraction represents a small subset but mainly contributes to relapse. These cells are rare and their profile of expression could be highly different but not detectable in these studies because of technical limits. We aim at analyzing ICP ligands and receptors expression at diagnosis and relapse, the phenotype of BM cells will be analyzed by flow cytometry according to different panels of monoclonal antibodies using standard immunostaining protocols.

Official Title
-----------------
Analysis of Immune Checkpoint Receptors Expression in the LIC Fraction pf AML Cells - ICAML-LIC

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age newly diagnosed AML Exclusion Criteria: isolated extramedullary AML mixed phenotype acute leukemia

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 |
| --- | --- | --- |
| Immune checkpoints (ICP) ligand expression | Compare large panel of ICP ligand expression between LIC and HSC by flow cytometry | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of ICP ligand expression | Compare levels of ICP ligand expression according to FAB classification, cytogenetic classification and molecular abnormalities | At inclusion | 
| Levels of ICP ligand expression | Study levels of ICP ligand expression on minimal residual disease | At inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myeloid Leukemia, Immune Checkpoint Ligand, Flow Cytometry
DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of DUR-928 in Subjects Infected With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury

Conditions
-----------------
SARS-CoV-2

Intervention / Treatment
-----------------
* Drug: DUR-928
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized with moderate, severe, or early critical COVID-19 illness diagnosed by RT- PCR Acute liver injury (including acute on chronic liver disease) or acute kidney injury or moderate COVID-19 pneumonia Exclusion Criteria: Critical COVID-19 illness (MAP < 60 mm Hg, on mechanical ventilator for ≥ 5 days) On maintenance hemodialysis or peritoneal dialysis Child Pugh C cirrhosis Hepatorenal syndrome Ascites and/or hepatic encephalopathy History of end stage renal disease or CKD with eGFR < 15 mL/min/1.73m2 Women who are pregnant or breast feeding Receipt of other concomitant experimental therapies

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
Interventional Model Description: 3:1 randomization DUR-928:placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DUR-928<br> | Drug: DUR-928<br>* IV infusion<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Endpoint of Alive and Free of Organ Failure at Day 28 | Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alive at Days 28 and 60 |  | Day 28 and Day 60 | 
| Alive, Out of ICU, at Day 28 |  | Day 28 | 
| Alive, Out of Hospital, at Days 28 and 60 |  | Day 28 and Day 60 |
Effects of Black Tea on Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy of different doses of black tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in improving oxidative stress, lipid profiles and insulin sensitivity.

Detailed Description
-----------------
A total of 45 patients of known T2DM (16 males and 29 females) were introduced into the controlled clinical trial and randomly assigned to either test (57.0 ± 7.9 yrs, n=23) or control (55.4 •± 8.3 yrs, n=22) group. Patients in control group were instructed to have only one cup (150 ml) of black tea/day, as a 2.5 g tea bag that had to be prepared in a standard way for one week (washout period). Patients in the test group were instructed to have 300, 450, and 600 ml (2, 3, and 4 cups, respectively) in weeks 2, 3 and 4 respectively. We assessed the change in serum glutathion, superoxidismutase, total antioxidant capacity, FBS, CRP, HbA1C, lipid profiles and fibrinogen during the end of each week.

Official Title
-----------------
Effects of Black Tea Consumption on Oxidative Stress, Serum Lipid Profile and Insulin Sensitivity in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Dietary Supplement: Black Tea Extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of type 2 diabetes mellitus Exclusion Criteria: Intake of antioxidant supplements during previous six months
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Black Tea-Four Doses<br>One, 2, 3 and 4 cups (150 ml/cup) of Black tea/day for week 1, 2, 3, and 4, respectively. | Dietary Supplement: Black Tea Extract<br>* Amount/dose depends on Arm assignment.<br>* Other names: BTE;|
| Active Comparator: Black Tea-One Dose<br>One cup (150 ml) of Black tea/day during study. | Dietary Supplement: Black Tea Extract<br>* Amount/dose depends on Arm assignment.<br>* Other names: BTE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity, oxidative Stress, lipid Profile |  | 4 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Black Tea, Oxidative Stress, Blood Lipids, Insulin Sensitivity