linjc16/ctgov huggingface dataset:
The Effect of 2 Months Daily Supplementation of Orange Juice With Fibers

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that 2 Months Daily Supplementation of Orange juice with fibers will effect the weight and the plasma lipids. This will be a double-blind parallel controlled study. Study population will include 50 subjects, who will be divided randomly into two groups. The first group will get the Orange juice with fibers, and the second group will get Orange juice with out the fibers.

Official Title
-----------------
The Effect of 2 Months Daily Supplementation of Orange Juice With Fibers

Conditions
-----------------
Healthy People

Intervention / Treatment
-----------------
* Other: Dietary Fibers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers Age 60>18 years Written informed consent Consumers of orange drinks: freshly squeezed juices, commercial pasteurized juices and / or orange soft drinks Regular eating pattern Exclusion Criteria: Patients with chronic disease sach as: diabetes, cancer, C.O.P.D., metabolic syndrome, over weight, kidney failure, heart disease and osteoporosis. Antibiotic treatment in the last 4 weeks Subjects on regular probiotic or prebiotic supplementation, unless the subject will do 2 weeks of wash out before commencing the study. Subjects with intestinal disorders such as: IBD, IBS, celiac, colon cancer. Subjects after intestinal surgery. Use of medicines for lowering cholesterol (simvastatin), sugar control Pregnancy Subjects with abnormal base-line blood test results: liver functions and/or kidney functions, cholesterol level above 200 mg/dL and glucose level above 50 mg/dL (during fast)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Dietary Fibers|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect of 2 Months Daily Supplementation of Orange Juice with fibers on the weight and the plasma lipids |  |  |
DNA Microarray Study of Pancreas Cancer

Study Overview
=================
Brief Summary
-----------------
Pancreas cancer and precancerous cysts can be difficult to diagnose. Sometimes biopsies do not show cancer when cancer is actually present. We hypothesize that genetic differences exist in tissue that is malignant compared to nonmalignant. When patients present with a pancreas mass or cyst, we biopsy it by fine-needle aspiration during upper endoscopy with ultrasound guidance. We would like to use tissue obtained via endoscopic ultrasound guided fine needle aspiration to perform DNA microarray analysis, and compare the differences in gene expression level in the benign tissue compared to cancerous tissue in order to improve our diagnostic capabilities. DNA microarray measures gene expression level rather than germline mutations. The true diagnosis will be based on cytology, surgical pathology, or clinical followup. The performance of the microarray test as a diagnostic test will be compared to the performance of cytology.

Official Title
-----------------
DNA Microarray Analysis of Endoscopic Ultrasound-Guided Fine Needle Aspiration Biopsies to Discriminate Benign From Malignant Pancreatic Lesions

Conditions
-----------------
Pancreas Cancer

Intervention / Treatment
-----------------
* Procedure: fine needle aspiration biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 or older who are able to give informed consent who present for an endoscopic ultrasound to evaluate a pancreas mass or cyst or for suspicion of cancer. Exclusion Criteria: Unable to give informed consent, pregnant or nursing, contraindication to endoscopic ultrasound, no mass or cyst found on ultrasound

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: fine needle aspiration biopsy|One extra biopsy will be taken from the pancreas only in patients who are already undergoing biopsy of a mass or cyst.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression profile is 95% accurate in diagnosis of malignancy |  | after enrollment of 50 patients | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreas cancer, pancreas cyst, DNA microarray
Monitoring Strategies for the Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke

Study Overview
=================
Brief Summary
-----------------
Randomized clinical trial comparing two monitoring strategies, the use of a 48-hour Holter (routine care branch) and an event recorder for 7 days (intervention branch). Patients admitted for cryptogenic stroke will be included. Enrollment and randomization of patients will be carried out during the index case hospitalization, while follow-up will be done on an outpatient basis until day 7.

Detailed Description
-----------------
Once the diagnose of cryptogenic stroke have been carried out, informed consent will be taken and participants will be randomized to 48-hour monitoring arm or 7-day monitoring arm, followed by discharge from hospital.

Official Title
-----------------
48-hour Versus 7-day Monitoring for the Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke

Conditions
-----------------
Stroke, Atrial Fibrillation

Intervention / Treatment
-----------------
* Diagnostic Test: 7-day electrocardiographic monitoring
* Diagnostic Test: 48-hr electrocardiographic monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have studies that classify stroke or TIA as cryptogenic and who can carry out monitoring for 48 hours or 7 days will be included. Age ≥ 18 years Exclusion criteria History of atrial fibrillation (or atrial flutter) documented. Patients who already have an event recorder in place, permanent pacemaker, or implantable cardioverter-defibrillator Evidence of lacunar infarction. Hemorrhagic stroke Patient for palliative care

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 48-hr<br>48-hr electrocardiographic monitoring | Diagnostic Test: 48-hr electrocardiographic monitoring<br>* 48-hr external electrocardiographic monitoring<br>|
| Experimental: 7-day<br>7-day electrocardiographic monitoring | Diagnostic Test: 7-day electrocardiographic monitoring<br>* 7-day external electrocardiographic monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation | Detection of one episode of atrial fibrillation or atrial flutter >30 seconds up to 7 days | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supraventricular arrhythmia | Count of beats per day of non-sustained irregular atrial tachyarrhythmia or supraventricular extrasystoles up to 7 days | 7 days |
Endometrial Dating by Ex-vivo Imaging of Endometrial Biopsies of In-vitro Fertilization Candidate Participants

Study Overview
=================
Brief Summary
-----------------
To evaluate the correlation between cycle day determination by clinical signs, study participant testimony, endometrium histopathology biopsy and ex-vivo imaging of the uterus endometrium.

Detailed Description
-----------------
In order to assess the efficacy of using ex-vivo endometrial imaging to determine optimal time for embryo transfer, two to four separate analyses, including imaging, and the current standard method of endometrial dating (ultrasound, histological and blood tests) will be performed as well as participant's testimony. Dating by hormonal profile (blood tests) will be contingent on availability of the tests for each subject. So shall be the ultrasound test. During the analysis data will be acquired for subsequent correlation analysis. In addition, a parallel in-vivo analysis, similar in methodology to the ex-vivo analysis, may be performed via imaging by hysteroscopy.

Official Title
-----------------
Endometrial Dating by Ex-vivo Imaging of Endometrial Biopsies of In-vitro Fertilization Candidate Participants

Conditions
-----------------
Endometrium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: Female Age: 18-40 Belong to one of the three following groups: Women undergoing fertility treatment, and are regularly ovulating Women whose fertility status is unknown Women proved to be fertile (previous spontaneous successful pregnancy) Exclusion Criteria: Women with known existing endometrial pathology Women with known history of infertility due to oligo-ovulation or anovulation. Women with medical history of malignant tumors in their reproductive system Women that are on any hormonal medications or treatments (excluding hormonal contraception in previous cycles) Women that are on hormonal contraception treatment in their current cycle Women with intrauterine device Women menstruating on the day of the biopsy collection
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Correlation between image-based endometrial dating and that of histology | Correlation coefficients and/or P-value levels | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between image-based endometrial dating and other collected data | Collected data: hormonal profile, ultrasound images, subject self-reporting of cycle date | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial dating
Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).

Official Title
-----------------
A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Troriluzole (BHV-4157)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Eligible subjects are those subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile. Determined by the investigator to be medically stable at the week 10 visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study Key Exclusion Criteria: Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study. Acute suicidality or suicide attempt or self injurious behavior in the last 12 months. Patients who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to entry, other than what was received in BHV4157-302 or BHV4157-303;

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Troriluzole (BHV-4157)<br>200 mg daily first 2 weeks, 280 daily for following 46 weeks | Drug: Troriluzole (BHV-4157)<br>* 200 mg daily first 2 weeks, 280 daily for following 46 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenfaxine treatment | Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline. | Change from Baseline to week 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obsessive compulsive disorder, OCD, troriluzole, Biohaven
Predictive Model of Clinical Outcomes Using Web-based Self-reporting Symptom Diary for Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and validate a predictive model of clinical outcomes based on the results of web-based self-reporting symptom diary for Crohn's disease.

Official Title
-----------------
Development and Validation of Predictive Model of Clinical Outcomes Using Pattern Analysis of Web-based Self-reporting Symptom Diary for Crohn's Disease

Conditions
-----------------
Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed of Crohn's disease within 6 months Must record their symptom in a web-based symptom diary at least 4 consecutive times for 2 months. Exclusion Criteria: Not able to use smart phone.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization |  | 2 years | 
| Unscheduled visit |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel resection surgery |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, disease outcomes
Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction

Study Overview
=================
Brief Summary
-----------------
To evaluate the prevalence of long-life catheters dysfunction and identify the risk factors associated to premature withdrawal in pediatric population. For that: retrospective study, during 3 years, in CHU Nancy. Data collection by informatics file after patient agreement. Primary objective: mesure prevalence of long-life catheter dysfunction Secondary objectives: identify risk factors associated to premature withdrawals by thrombotic, infectious, accidental, mechanical complications. mesure de time spent by anethesist to put long-life catheters in emergency. Benefit of creating à vascular access unit.

Official Title
-----------------
Long-term Venous Catheterization in Pediatric Anesthesia: Prevalence and Risk Factors of Dysfunction.

Conditions
-----------------
Catheter Dysfunction

Intervention / Treatment
-----------------
* Other: catheter dysfunction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: long-life catheter (midline, piccline, central venous catheter) placed in operating room by anesthesist in pédiatric population: 0 to 18 years Exclusion Criteria: more than 18 years peripheral venous access not placed by anesthesist placed outside operating room

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pediatric population<br>pediatric population of CHU of Nancy, France. | Other: catheter dysfunction<br>* prevalence of catheter dysfunction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of premature withdrawals of long-term vascular device | the pourcentage of premature withdrawals of these catheters | Baseline (J0) is the day when the catheter is placed, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identify risk factors associated to premature withdrawal long-life catheter | descriptive disfunction of catheter in the medical file | Baseline (J0) is the day when the catheter is placed, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, thrombotic, catheter infection, mechanical complication of catheter
Predictors of OSA in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea(OSA) are common disorders ,the co-existence of both conditions is called overlap syndrome Smoking , obesity , airway resistance and inflammation are considered risk factors for both conditions ,interestingly either COPD and OSA are associated with increased cardiovascular complications with further increased risk in overlap syndrome Multiple theories could explain that one disorder can predispose or exaggerate the other. For example, in COPD cigarette smoking and inhaled steroids are linked to myopathy of upper airway dilator muscles. Moreover in core-pulmonale redistribution of edema fluid in supine position during sleep can also contribute to or exacerbate OSA . On the other hand , OSA patients might smoke frequently and more heavily to compensate for excessive daytime sleepiness and to help them to lose weight , which results in exaggerated airway inflammation and exacerbate COPD. Rationale of the study was to assess the prevalence and predictors of OSA among patients with stable COPD.

Official Title
-----------------
Predictors of Obstructive Sleep Apnea in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
OSA, COPD

Intervention / Treatment
-----------------
* Diagnostic Test: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All stable COPD patients Exclusion Criteria: Patients with end organ failure

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 76 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD associated with OSA<br> | Diagnostic Test: Polysomnography<br>* over nightSleep study<br>|
| COPD without OSA<br> | Diagnostic Test: Polysomnography<br>* over nightSleep study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screening for OSA among COPD | to assess the percentage of OSA among COPD patients | 6 months |
Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pedometer use by overweight women during pregnancy. The study will show if a pedometer will help women to limit weight gain during pregnancy. It will also show if it there are other benefits such as decreased diabetes, decreased high blood pressure, decreased rates of cesarean section, and decreased complications for the baby.

Official Title
-----------------
Effective Pedometer Use to Prevent Excessive Gestational Weight Gain in Overweight/Obese Women

Conditions
-----------------
Overweight, Obesity, Pregnancy

Intervention / Treatment
-----------------
* Other: Pedometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Pregnant Less than 16 weeks gestation Body mass index 25 or greater at first prenatal visit Exclusion Criteria: History of spontaneous preterm delivery between 20-32 weeks gestation Medical contraindication to exercise or walking during 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine care<br>ACOG Exercise in Pregnancy pamphlet | |
| Experimental: Pedometer<br>ACOG Exercise in Pregnancy pamphlet, pedometer use, ultimate goal of 10,000 steps per day | Other: Pedometer<br>* Pedometer provided, counseling on pedometer use and step recommendations of 10,000 steps per day, handouts given every 4 weeks to encourage exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excessive gestational weight gain | Gestational weight gain greater than Institute of Medicine recommendations | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum weight |  | 6 weeks postpartum | 
| Weight at 1 year postpartum |  | 1 year postpartum | 
| Gestational diabetes |  | During pregnancy | 
| Hemoglobin A1c |  | 24-28 weeks gestation | 
| Infant birth weight |  | At delivery | 
| Mode of delivery |  | At delivery | 
| Hypertensive disorders of pregnancy |  | During pregnancy | 
| Neonatal intensive care unit admission or neonatal complications |  | Up to 1 week after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Obesity, Pregnancy, Weight gain, Pedometer, Exercise