linjc16/ctgov huggingface dataset:
Prevalence of Hepatitis B Infection in the Galilee Region, Israel

Study Overview
=================
Brief Summary
-----------------
Primary Aims: Evaluate HBV (Hepatitis B Virus) infection prevalence among Druze in the Galilee. Educate the population in order to reduce transmission Increase awareness among primary care providers Secondary Aims: Identify chronic HBV infected patients who need to be followed and treated, Identify HBV infected women in a childbearing age Identify non immunized individuals and recommend vaccination Identify previously vaccinated individuals who are not immunized Identify previously vaccinated individuals who became infected Study Design: Study population is targeted to native Israeli Druze. We aim for evaluating up to 20,000 people from Druze communities in the Galilee area This work will be divided into three sections: Increasing awareness: lectures and local events will be taken place in the communities. Written information will be given and primary care-providers mainly family doctors, nurses and obstetric surgeons will be involved. All participants, upon signing a consent will: Fill up a questioner Checked for weight, height and waist circumflex Have a blood sample taken Results and recommendations will be forwarded to all participants

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consent adults who are 18 year old or older Exclusion Criteria: Individuals younger than 18 year old Individuals who cannot or will not sign consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B, Prevalence, HBsAg, Vaccination, Galilee
A Cohort Study for Occupational Stress Induced Early Embryonic Death

Study Overview
=================
Brief Summary
-----------------
Occupation stress can be the risk factors of early embryonic death

Conditions
-----------------
Etiology, Cohort Study, Early Embryonic Death, Occupational Stress, Occupational Epidemiology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women and their spouses in the gynecology clinic patients and wish to create the cards in the hospital; the gestational age is less than 14 weeks; pregnant women and their spouses have jobs before treatment. Exclusion Criteria: Do not sign the informed consent.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Occupational Stress<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early embryonic death |  | 20 weeks |
Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

Study Overview
=================
Brief Summary
-----------------
Transfusion of stored blood has been associated with increased pulmonary vascular resistance in lambs. The investigators hypothesize that transfusion of one unit of red blood cells stored under standard conditions in intensive care patients will increase pulmonary arterial pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh red blood cells.

Official Title
-----------------
Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Biological: Blood transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has a pulmonary artery catheter in place Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy The patient has an arterial catheter Exclusion Criteria: Age < 18 years Clinical prediction that the patient will not survive at least 48 hours Acute bleeding: > 2 units of packed red blood cells/hour Vasopressor use: noradrenalin > 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors Sepsis

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fresh blood transfusion<br>One unit of blood stored for less than 14 days | Biological: Blood transfusion<br>* One unit of red blood cells will be transfused over the course of 20 minutes<br>|
| Experimental: Standard issue blood transfusion<br>One unit of blood stored under standard conditions | Biological: Blood transfusion<br>* One unit of red blood cells will be transfused over the course of 20 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary arterial pressure |  | Change from baseline to immediately after transfusion (time frame of 20 min) | 
| Pulmonary vascular resistance |  | Change from baseline to immediately after transfusion (time frame of 20 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic pressure |  | Change from baseline to immediately after transfusion (time frame of 20 min) | 
| Systemic vascular resistance |  | Change from baseline to immediately after transfusion (time frame of 20 min) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transfusion, pulmonary hypertension, intensive care medicine
Sympathetic and Parasympathetic Responses to Specific Chiropractic Adjustments

Study Overview
=================
Brief Summary
-----------------
A study to determine if a chiropractic adjustment in the cervical spine will effect the parasympathetics and a chiropractic adjustment in the thoracic spine will effect the sympathetics.

Official Title
-----------------
Sympathetic and Parasympathetic Responses to Specific Chiropractic Adjustments of Subluxation of the Cervical and Thoracic Spine

Conditions
-----------------
Autonomic Nervous System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 25-55, asymptomatic Exclusion Criteria: HBP, heart condition

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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 |
| --- | --- |
| 1<br>Cervical adjustments | |
| 2<br>Thoracic adjustments | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure, Pulse Rate, Heart Rate Variability |  |  |
Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker

Study Overview
=================
Brief Summary
-----------------
Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators will characterize 40 patients with muscle-invasive bladder cancer regarding the existence and frequency of tumorspecific T-cells and regulatory T cells. The found data will be correlated to clinical data such as the cancer-specific survival and the response to chemotherapy. It is hypothesized that those patients with a high number of Tregs and no tumor-specific T-cells have a worse prognosis.

Official Title
-----------------
Prospective Characterization of Tumor-specific T-cell Immunity in Muscle-invasive Bladder Cancer and Its Correlation With Clinical Parameters

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed muscle-invasive urothelial carcinoma Age > 18 years Hemoglobin > 10g/dl Signed Informed Consent Karnofsky index < 70% Exclusion Criteria: Clinically relevant second malignancy Severe comorbidities (e.g. NYHA III, end-stage renal disease) Chronic infectious disease (HIV, Tuberculosis) Immunosupression Severe psychiatric diseases Blood donation in the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder cancer, chemotherapy, T cells, Immunotherapy, Tumor-specific immunity in bladder cancer
Carbamazepine Treatment for Cocaine Dependence - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess carbamazepine as a pharmacotherapy for cocaine dependence.

Official Title
-----------------
Carbamazepine Treatment for Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Carbamazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 51 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine Dependence, Carbamazepine
Registry of Patient With M. Dupuytren and Validation of the Brief MHQ

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the validation of the Brief Michigan Hand Questionnaire by patient with Morbus Dupuytren and to build up a register.

Detailed Description
-----------------
examination of the characteristics of Patient with Morbus Dupuytren and the psychometric properties of the Brief Michigan Hand Questionnaire by this patients

Official Title
-----------------
Buildup of a Registry of Patient With M. Dupuytren and Validation of the Brief Michigan Hand Questionnaire

Conditions
-----------------
Dupuytren Contracture, Collagen Shrinkage, CRF

Intervention / Treatment
-----------------
* Procedure: Xiaflex surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M.Dupuytren, over 18y, able to speak and understand german Exclusion Criteria: recurrence, pregnancy, incapable of contracting

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 |
| --- | --- |
| Patient with M. Dupuytren<br>Xiaflex Surgery | Procedure: Xiaflex surgery<br>* Xiaflex surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Michigan Hand Questionnaire | Patient reported outcome measurement by hand disorders | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint mobility | Measuring the joint mobility of the fingers with the goniometer | 3 years |
Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures

Study Overview
=================
Brief Summary
-----------------
Subjects receiving LEV as adjunctive therapy to 1 or 2 other AEDs for partial onset seizures and subjects who are temporarily unable to take oral LEV, may require alternative routes of administration. The purpose of this trial was to evaluate the safety and tolerability of 1000 to 3000 mg/day LEV administered as a 15-min IV infusion b.i.d. after switching from the same oral dose.

Official Title
-----------------
Trial Evaluating the Safety and Tolerability of Levetiracetam Intravenous 15-minute Infusion, Administered in b.i.d. Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 65 Years Suffering From Partial Onset Seizures

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult in- or out-subjects suffering from partial onset seizures according to the ILAE classification of Epileptic Seizures; intake of levetiracetam as an adjunctive antiepileptic oral treatment in addition to one or two antiepileptic drugs (AED). Exclusion Criteria: Had problems of venous accessibility; showed safety issues related to the administration of one of the concomitant AEDs requiring medical intervention; clinically significant ECG/lab abnormalities; administered vigabatrine; administered felbamate for less than 18 months; had contraindication to any component of the study medication treatment as IV formulation or known allergic reaction to or intolerance of pyrrolidone derivatives.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of levetiracetam after switching from oral formulation to 15-minute IV infusion during repeated dosing (4 days b.i.d.) |  | Adverse events after each infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levetiracetam, Keppra
Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).

Official Title
-----------------
A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide Exclusion Criteria: Subjects who are or have previously been on liraglutide Subjects who have previously been enrolled in the study Subjects with a hypersensitivity to liraglutide or to any of the excipients Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods Subjects with cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial Known or suspected abuse of alcohol or narcotics
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liraglutide<br> | Drug: liraglutide<br>* Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of SADRs (Serious Adverse Drug Reactions) |  | After 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate and type of SAEs (Serious Adverse Events) |  | At month 1, 3, 6, 12, 24 and 36 | 
| The incidence rate and type of ADRs (Adverse Drug Reactions) |  | At month 1, 3, 6, 12, 24 and 36 |
ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

Study Overview
=================
Brief Summary
-----------------
Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy have not been clearly established. The aim of the present study is to describe the nature and frequency of these mutations in a series of patients with intrahepatic cholestasis of pregnancy and to compare with a control group of pregnant women without intrahepatic cholestasis of pregnancy.

Detailed Description
-----------------
Intrahepatic cholestasis of pregnancy was defined by pruritus and elevated serum alanine aminotransferase activity or bile acid concentration, with recovery after delivery. Patients with intercurrent liver disease were excluded. The entire ABCB4 gene coding sequence and the promoter region were analyzed, during the routine medical management, by single strand conformation polymorphism and/or sequencing in 50 unrelated Caucasian patients with intrahepatic cholestasis of pregnancy. The genomic variants detected in these patients with intrahepatic cholestasis of pregnancy will be sought in 100 control women from Caucasian origin recruited in the same hospital.

Official Title
-----------------
Mutations and Polymorphisms of Gene ABCB4 Among Women Suffering From Intrahepatic Cholestasis of Pregnancy. A Study With a Control Group.

Conditions
-----------------
Intrahepatic Cholestasis of Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
For the control group : Inclusion Criteria: pregnant woman (age > 18 years) during the third trimester caucasian and born in France multiparous (with at least 2 full term pregnancies) with informed written consent Exclusion Criteria: generalized pruritus and/or liver disease during pregnancy liver disease secondary to oral contraception Chronic liver disease disease during current pregnancy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Normal multiparous pregnant women without intrahepatic cholestasis of pregnancy (control group) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetics, gene expression, MDR3, estrogens, cholestasis, pregnancy, controls
Quick Questionnaire to Evaluate Physical Activity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test and validate a new questionnaire (SAPHIR) in order to get an evaluation of patients physical activity.

Detailed Description
-----------------
Two questionnaires the SAPHIR and the International Physical Activity Questionnaire (IPAQ) are submitted (self completion) to patients referred for consultation. Retrival of physical activity data on podometer if available

Official Title
-----------------
Simplification de l'évaluation de l'Activité PHysique Par Interrogatoire Rapide

Conditions
-----------------
Sedentary Behavior

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French Native language Covered by the French social care system Be referred for a consultation to the Sports Medicine Service of Angers Hospital or to the CRSS of Angers Exclusion Criteria: Person opposed to participating in the research Person unable to understand the objectives of the study

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?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Self completion of questionnaire in the waiting room
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active adults<br>Adults coming for a visit for sports activity participation and submitted the SAPHIR questionnaire | Other: Questionnaire<br>* Scoring of the IPAQ is performed according to references. Scoring of the SAPHIR has been submitted for copyright protection (involves a series of 23 additions)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of questionnaires with errors after self completion | Estimation of the percentage of errors with 90% confidence interval Comparison of the two percentages | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facility of the filling of the questionnaires | Ease of use évaluation for the patient using Likert scale (from Totally agree to not agree at all in 5 grades) | 1 day | 
| Correlation of the SAPHIR questionnaire to the IPAQ questionnaire | Correlation coefficient with the IPAQ questionnaire | 1 day | 
| Correlation of the SAPHIR questionnaire to the number of weekly steps for patients who have a pedometer available | The correlation coefficient with the number of steps will be studied | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, Questionnaire