linjc16/ctgov huggingface dataset:
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect on cholesterolemia profile of a low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins.

Official Title
-----------------
Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia

Conditions
-----------------
Mildly Hypercholesterolemic Subjects

Intervention / Treatment
-----------------
* Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)
* Other: 2-Low fat fermented dairy product (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female aged 18-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy and without any other hypocholesterolemic treatment, accepting to follow the AFSSAPS dietary recommendations for hypercholesterolemic patients, affiliated to a health coverage system, agreeing to a written informed consent Exclusion Criteria: Subject with plasma triglycerides (TG) levels>250 mg/dL, with any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with any acute or chronic disease which could impact on results of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 = Tested product<br> | Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)<br>* 1 = Intervention 1 (2 test products / day)<br>|
| Placebo Comparator: 2 = Control product<br> | Other: 2-Low fat fermented dairy product (control)<br>* 2 = Intervention 2 (2 control products/day)<br>|

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
-----------------
Plant sterol - Cholesterol absorption - diet - dairy - LDL
Quercetin in the Prevention of Covid-19 Infection

Study Overview
=================
Brief Summary
-----------------
Quercetin is a flavonol, a subclass of flavonoid compounds. Of the flavonol molecules, quercetin is the most abundant in fruit and vegetables. Quercetin flavonol is characterized by 3 crucial properties: antioxidant, anti-inflammatory and immunomodulatory. The combination of these 3 properties makes quercetin an excellent candidate for dealing with situations in which oxidative stress, inflammation and the immune system are involved. The purpose of the study is to evaluate the effectiveness of an oral nutritional supplement based on quercetin in the prevention of Covid-19 infection.

Official Title
-----------------
Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of an Oral Nutritional Supplement Based on Quercetin in the Prevention of Covid-19 Infection for a Duration of 3 Months

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Dietary Supplement: Quercetin
* Combination Product: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Absence of Covid-19 infection Exclusion Criteria: Previous Sars-Cov-2 infection demonstrated with antibody positivity through venous sampling Demonstrated presence of Sars-Cov-2 through a nasopharyngeal antigenic swab before the start of oral nutritional supplementation

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br> | Dietary Supplement: Quercetin<br>* Quercetin (500 mg), 2 times a day for 3 months<br>|
| Placebo Comparator: Placebo<br> | Combination Product: Placebo<br>* 500 mg, 2 times a day for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of Covid-19 infection | A nasopharyngeal antigenic swab | Absence of Covid-19 infection at 3 months |
Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning

Study Overview
=================
Brief Summary
-----------------
This study aims at describing the systemic arterial hypotension secondary to intraoperative beach chair positioning. This is a non-interventional prospective study. The primary endpoint will be the intraoperative systemic arterial pressure measured at the arm. The secondary endpoints will include postoperative mortality, intensive care admission, post anesthesia care unit length of stay,

Official Title
-----------------
Intraoperative Systemic Arterial Hypotension Secondary to Beach Positioning : an Observational Study

Conditions
-----------------
Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years Patient operated in a sitting position at Hopitaux Universitaires de Strasbourg Patient willing to participate in the study Exclusion Criteria: Refusal to participate in the study

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 |
| --- | --- | --- |
| Blood pressure |  | 10 min after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypotension, Systemic blood pressure
Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity.

Official Title
-----------------
Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity

Conditions
-----------------
Cardiotoxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage I-III breast cancer or lymphoma with a >2 year life expectancy A treatment plan that includes anthracyclines and/or trastuzumab Age >45 years Able to hold breath for 10 seconds Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: Refusal or inability to provide informed consent Known heart failure or LVEF <50% Heart rate over 100 bpm Renal dysfunction with GFR <30 mL/min/1.73m2 Participants with pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices Symptomatic claustrophobia Plans to move within 24 months of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Cardiotoxicity assessed clinically or by cardiac MRI |  | 24 months |
Furosemide and Coarctation Surgery Lung Complications

Study Overview
=================
Brief Summary
-----------------
in our study the investigators give furosemide during surgery for repair of aortic coarctation via lateral thoracotomy and evaluated lung complications in comparison to control group

Official Title
-----------------
Furosemide: Would it Help to Improve the Lungs During Aortic Coarctation Surgery

Conditions
-----------------
Pulmonary Complication

Intervention / Treatment
-----------------
* Drug: Furosemide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coarctation of aorta Exclusion Criteria: heart failure, bleeding diathesis, associated cardiac congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F group<br>Furosemide group | Drug: Furosemide<br>* Administering furosemide<br>|
| No Intervention: C group<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung ultrasonography scale > 24 |  | a 1 year study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pao2/ Fio2 ratio |  | a 1 year study |
Tai Chi/Qigong Exercise Persistence Among Residents of Senior Housing

Study Overview
=================
Brief Summary
-----------------
This randomized field trial uses a self-report daily exercise log to answer the research question: Does frequency of instruction influence tai chi/qigong home practice exercise persistence among residents of Senior housing?

Official Title
-----------------
Tai Chi/Qigong Exercise Persistence Among Residents of Senior Housing: a Randomized Field Trial

Conditions
-----------------
Physical Activity

Intervention / Treatment
-----------------
* Behavioral: Instructor contact
* Behavioral: Instructor contact


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of Senior housing, Ability to engage in mild exercise Vision sufficient to view TV medium Willingness to engage in tai chi/qigong training and practice. Exclusion Criteria: Unable to provide informed consent Unable to attend initial training session

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Instructor contact 1 class<br> | Behavioral: Instructor contact<br> <br> |
| Active Comparator: Instructor contact 4 classes<br> | Behavioral: Instructor contact<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise persistence |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceived benefits |  | 3 months | 
| barriers to exercise |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tai chi, exercise, older adults, exercise persistence
The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The objectives are to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis. to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.

Official Title
-----------------
The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Diagnostic Test: Medical imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Patients with heart failure Exclusion Criteria: Renal failure Contraindications to Cardiac MRI

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart Failure Patients<br>Patients with Heart Failure | Diagnostic Test: Medical imaging<br>* Medical Imaging consisting of 1 MRI and 1 echocardiography at baseline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure | Hospitalization due to heart failure | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, strain, echocardiography
Study of XL820 Given Orally Daily to Subjects With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors.

Official Title
-----------------
A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of the KIT Inhibitor XL820 Administered Orally Daily to Subjects With Solid Tumors

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: XL820


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival Subject is at least 18 years old Subject has ECOG performance status ≤ 2 Subject has a life expectancy of > 3 months Subject has adequate organ and marrow function In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH Subject has given written informed consent Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study. Female subjects of childbearing potential must have a negative pregnancy test at screening. Exclusion Criteria: Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade ≤ 1 from adverse events due to agents administered more than 30 days earlier Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of XL820 treatment Subject has received an investigational agent within 30 days of the first dose of XL820 Subject has known brain metastases Subject has known uncontrolled intercurrent illness Subject is pregnant or lactating Subject is known to be positive for HIV Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: XL820|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerated dose |  |  | 
| safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma pharmacokinetics |  |  | 
| pharmacodynamic effects |  |  | 
| long-term safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid tumor
Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on inflammatory response after abdominal hysterectomy.

Official Title
-----------------
Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy: A Prospective Randomized Clinical Trial.

Conditions
-----------------
Hysterectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Abdominal hysterectomy ASA class I or II Exclusion Criteria: psychiatric disorders ASA III and IV Chronic inflammatory disorders Pregnancy Local anesthetics allergy Coagulation disorders patients receiving anticoagulants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Conventional therapy<br> | |
| ERAS<br>Oral intake of solid food restriction 6 hours before surgery. Oral intake clear fluids restriction 2 hours before surgery. Intravenous 5% Dextrose-500 ml 1 hour before surgery. Intravenous dexamethasone -4mg before anesthesia. Combined spinal-epidural anesthesia. Intraoperatively 10 ml/kg intravenous of crystalloids. Paracetamol intravenous 1g. Early mobilization of patient. Oral solid food intake 4 hour postoperative. Postoperative continuous epidural analgesia. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Serum level of IL-1beta,IL-6,CRP,Cortisol,IL-4 by immuno-ferment analysis. |  | baseline, 24 hour post-operative and 7 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of postoperative pain, fatigue and postoperative nausea and vomiting | Postoperative pain will be assessed by visual analogue scale. Postoperative fatigue will be assessed by modified analogue scale. incidence of postoperative of nausea and vomiting | baseline,6,12,24,48 hour and 7 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal hysterectomy, enhanced recovery after surgery, inflammatory response, ERAS, combined spinal-epidural anesthesia
Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

Study Overview
=================
Brief Summary
-----------------
Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease. Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and thought to play a major role in the metabolic disturbances associated with obesity and metabolic syndrome. Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and is associated with obesity, insulin resistance and metabolic syndrome. Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.

Official Title
-----------------
A Prospective, Longitudinal Multicenter, Nontreatment, Exploratory Biomarker Study of Metabolic Syndrome in Subjects Undergoing Laparoscopic Roux-En-Y Gastric Bypass Bariatric Syndrome

Conditions
-----------------
Morbid Obesity, Metabolic Disease

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Roux-en-Y Gastric Bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects must be approved by both insurance and site standard of care to undergo the Roux-en-Y gastric bypass procedure Male and Female Candidates for Roux-en-Y Bariatric Surgery Must be diagnosed with Metabolic Syndrome; having abdominal obesity and at least 2 other features of the syndrome per IDF (International Diabetes Foundation) Obese control group:Subjects should be obese and should not have any other features of metabolic syndrome. Exclusion Criteria: Any subjects with prior bariatric surgery No other major surgery within the last 6 months Diabetes on treatment with hypoglycemic medication in the previous 6 months Other exclusions apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic Roux-en-Y Gastric Bypass|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
-----------------
Metabolic Syndrome, Obesity, Nonalcoholic fatty liver disease, Nonalcoholic steatohepatitis, Bariatric Surgery