linjc16/ctgov huggingface dataset:
Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices.

Official Title
-----------------
A Multicenter, 26-Week, Prospective Observational Study in Adult Patients With Prediabetes Assessing Patient Treatment and Outcomes in Community-Based Clinical Practice

Conditions
-----------------
Prediabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Diagnosis of prediabetes based on hemoglobin A1C and/or fasting plasma glucose Established patient of Principal Investigator's clinical practice BMI greater than or equal to 25 kg/m2 Physically able to participate in a diabetes prevention program Exclusion Criteria: Has prior diagnosis of diabetes Is pregnant or is planning to become pregnant in the next 6 months Is currently taking a medication prescribed for diabetes prevention Is currently enrolled in a formal diabetes prevention or weight loss program

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 |
| --- | --- | --- |
| Diabetes prevention treatment decisions by physician | The physician's clinical decision (e.g., counseling, referral to dietician, diet and exercise program) at the time of study subject visits will be recorded, summarized descriptively, and ranked in order of intensity based on pre-specified criteria. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject initiation and persistence with diabetes prevention interventions | Whether or not the study subject initiates physician recommended diabetes prevention efforts and study subjects persistence with prevention recommendations will be assessed throughout the 6-month duration of the study. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prediabetes, Diabetes prevention
The Scanner in the Coronary Evaluation

Study Overview
=================
Brief Summary
-----------------
Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with heart valve disease referred for surgery.The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with heart valve disease referred for surgery.

Detailed Description
-----------------
The diagnostic accuracy of multislice spiral computed tomography coronary angiography in terms of sensitivity, specificity, negative and positive predictive value, the conventional coronary angiography being the gold standard.50 patients scheduled for valve surgery will be screened to conduct an additional multislice spiral computed tomography.

Official Title
-----------------
Contribution of the Scanner in the Coronary Evaluation Before Valvular Replacement

Conditions
-----------------
Valvular Disease, Coronary Stenosis

Intervention / Treatment
-----------------
* Procedure: Coronary scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for valve surgery who need a conventional coronary angiography Informed Content Patients affiliated to the social security system Exclusion Criteria: Instable condition Arrhythmia including atrial fibrillation Impaired renal function Known contrast allergy Patients unable to hold an apnea during 20 seconds Pregnancy Emergency People unable to sign the informed content such as major under supervision

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Coronary scanner|multislice spiral computed tomography coronary angiography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic accuracy of coronary scanner (sensitivity, specificity, positive and negative predictive values) in the detection of the coronary stenosis higher than 50%. |  | a month at the latest after the signature of consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic accuracy of coronary scanner to detect the patients requiring or not a coronary revascularisation in more of the valvular surgery. |  | a month at the latest after the signature of consent | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valvular surgery, Diagnostic accuracy of coronary angiography, Coronary stenosis, Coronary revascularisation
Intensive Short-Term Dynamic Psychotherapy (ISTDP) in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Objective: Somatization of emotions accounts for excess Emergency department (ED) visits. Intensive Short-term Dynamic Psychotherapy (ISTDP) has methods to diagnose and manage somatization. We examined the feasibility, acceptability and effectiveness of ISTDP diagnostic and treatment methods used for patients with repeated ED presentations for medically unexplained physical symptoms (MUS)

Detailed Description
-----------------
Herein we report the methods and outcomes of rapidly-accessed, emotion-focused diagnostic and treatment services for patients presenting to the ED with medically unexplained symptoms (MUS). Patients who were assessed and referred by ED physicians will serve as a non-randomized condition controlling for some relevant variables. Our a priori hypotheses were that assessed and treated patients would have a reduction in ED visits and self reported symptoms after this intervention and that controls would have a smaller reduction in ED visits if any.

Official Title
-----------------
Emotion-Focused Diagnosis and Treatment of Somatization in the ED

Conditions
-----------------
Somatic Complaints of Multiple Types

Intervention / Treatment
-----------------
* Behavioral: Intensive Short-term Dynamic Psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unexplained symptoms Exclusion Criteria: Psychosis, substance abuse, suicidality

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ISTDP therapy was provided | Behavioral: Intensive Short-term Dynamic Psychotherapy<br>* A brief psychotherapy format<br>* Other names: Short-term Psychotherapy;|
| No Intervention: 2<br>People referred but never seen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency department visits pre and post |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Symptom Inventory |  | pre and post | 
| Patient Satisfaction |  | post | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
somatization, psychosomatic, short-term, dynamic, psychotherapy
Changes of Body Temperature During Shoulder Arthroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of electrically heated humidifier on the body temperature during shoulder arthroscopy.

Detailed Description
-----------------
On the control group, use only routine anesthetic respiratory circuit for mechanical ventilation On the comparative group, use electrically heated humidifier for mechanical ventilation And compared the changes of body temperature durgin shoulder artheroscopy.

Official Title
-----------------
Effect of Heated Humidifier on the Body Temperature During Shouler Arthroscopy

Conditions
-----------------
Hypothermia

Intervention / Treatment
-----------------
* Procedure: heated circuit
* Procedure: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American society of anesthesiologist physical status 1 or 2 20-60 years old Exclusion Criteria: body mass index over 30 kg/m2 peripheral vascular disease uncontrolled cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control<br>use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy | Procedure: heated circuit<br>* use electrically heated respiratory circuit (set at 37oC)during mechanical ventilation of anesthetic machine during shoulder arthroscopy<br>* Other names: heat circuit;|
| Active Comparator: electrically heated circuit<br>use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy | Procedure: control<br>* use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of body temperature | record the changes of esophageal and peripheral body temperature every 15 minutes from base line during shouler arthroscopy | every 15 minutes from base line | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heated circuit, body temperature
Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients

Study Overview
=================
Brief Summary
-----------------
This study is a cross-sectional observational study to evaluate the prevalence of HLA-B*5701 in the European area and in major European ethnotypes. Any HIV-1 infected patient will be eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B*5701. Patients will be approached during a standard clinic visit, and will be consented prior to any study specific procedure. They will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B*5701 status by local and central laboratories. In selected sites patients may be asked to provide an additional blood sample. This sample will be used to develop and validate different methodologies for assessing HLA-B*5701 status.

Official Title
-----------------
Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected Patients

Conditions
-----------------
Infection, Human Immunodeficiency Virus I, HIV Infection, HIV-1 Infection

Intervention / Treatment
-----------------
* Procedure: Cheek cells sample
* Procedure: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: HIV-1 infected patients over the age of 18 years Patient is willing and able to understand and provide written informed consent Exclusion criteria: None

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-1 infected adults<br>HIV-1 infected adults | Procedure: Cheek cells sample<br>* Cheek cells sample<br>Procedure: Blood sample<br>* Blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of HLA-B*5701 in European HIV-1 population |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of HLA-B*5701 in major European ethnotypes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, HLA-B*5701, prevalence, Treatment Experienced, Treatment Naive
A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Study Overview
=================
Brief Summary
-----------------
Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In preparation for a definitive randomized controlled trial this pilot study will assess feasibility and variance data to be used for sample size estimation

Official Title
-----------------
A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Conditions
-----------------
Kidney Neoplasm

Intervention / Treatment
-----------------
* Procedure: Hypothermia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology. Bilateral renal function on radiographic imaging. Willing to consent to randomization. Willing to comply with study protocol. Exclusion Criteria: Anatomically or functionally solitary kidney Multiple renal tumours Bilateral renal tumours Life expectancy < 3 months as deemed by treating physician Age less than 18 years old Pregnancy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normothermia<br>After arterial clamping, no ice slush will be used | |
| Experimental: Hypothermia<br>After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes | Procedure: Hypothermia<br>* Surround kidney in ice slush for 10 minutes after arterial clamping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measures of renal function uCrCl be performed for estimation of renal function |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complication |  | 3 months |
Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic

Study Overview
=================
Brief Summary
-----------------
SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France, including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most affected regions on the metropolitan territory with a large number of patients hospitalized at the University Hospital of Strasbourg. In view of the seriousness of the epidemic and the rapid arrival of new patients requiring mechanical ventilation, 3 new intensive care units have been created on the NHC site alone, making it possible to accommodate a maximum of 111 patients (compared to 52 during normal periods).

Official Title
-----------------
Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic

Conditions
-----------------
Sars-CoV2

Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria for inclusion : Major patient (≥18 years old) Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a VD session of which at least one is performed by the dedicated team. patient who has not expressed, after information, his or her opposition to the re-use of his or her data for the purposes of this research Exclusion criteria : Subject who expressed opposition to participating in the study Subject under guardianship, curatorship or safeguarding of justice

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the effect of prone position in patients with covid-19 in intensive care |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical ventilation, ICU, Covid-19, SARS-CoV-2, ARDS
Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI

Study Overview
=================
Brief Summary
-----------------
Premature luteinization in patients undergoing IUI can occur in up to 24% of cycles. These patients, according to recent data, have a lower pregnancy rate than controls. The possibility to avoid premature luteinization with GnRH antagonist may restore the chances of achieving a pregnancy in these women.

Detailed Description
-----------------
The purpose of this study was to investigate whether a subset of patients benefits from GnRHa administration during IUI. PL was tested for in patients who were undergoing artificial insemination procedures, and the effect of GnRHa on PR in patients who

Official Title
-----------------
GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Ganirelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous failed IUI cycle with premature luteinization Exclusion Criteria: 39 years or older not eligible for IUI (patent tubes, > 3 million capacitated spermatozoa) 4 previous IUI cycles

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Ganirelix<br>Patients with premature lutenization (progesterone >1,2 ng/ml) who did not get pregnant during the first IUI underwent a second IUI. | Drug: Ganirelix<br>* Ganirelix 0.25mg s.c every 24 h starting stimulation day 6<br>* Other names: Orgalutran;|
| Control<br>Patients without premature lutenization (progesterone >1,2 ng/ml) underwent a only one IUI. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 2 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| premature luteinization |  | at the time of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GnRH antagonist, IUI
Long Term Results of 450 Percutaneous Closures of PDA in a Single Center

Study Overview
=================
Brief Summary
-----------------
Percutaneous closure is one of the methods used to treat, among other congenital heart disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years 1998-2013 four hundred and fifty patients were catheterized in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus, using various devices. In this retrospective research, the investigators analyze data from patients' medical files, to estimate and define the correlation between the patients' demographic and morphologic data to the type and size of chosen closure device. Aim of study: To create an algorithm that can be used to choose the proper device for percutaneous closure of the PDA, based on the characteristics of the patient and the PDA type.

Detailed Description
-----------------
The investigators analyze the demographic characteristics of patients before the procedure (Age, gender, weight, height, co-morbidities etc.), the type and characteristics of PDA and the chosen device, success and failure rates of the procedure, and adverse effects. The data is taken from patients' medical files - based on medical reports regarding physical examination, blood tests and imaging studies including cineangiograms and echo-doppler studies.

Official Title
-----------------
Long Term Results of 450 Percutaneous Closures of PDA in a Single Center

Conditions
-----------------
Patent Ductus Arteriosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients that underwent percutaneous closure of PDA between January 1998 and august 2013 in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus Exclusion Criteria: None
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 |
| --- | --- | --- |
| Success of implantation | due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013)and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well. | one day, 10 days and a year after PDA closure and then last check-up exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual shunt | due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013) and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well. | one day, 10 days and a year after PDA closure and then last check-up exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patent Ductus Arteriosus