linjc16/ctgov huggingface dataset:
Effect of Dietary Polyphenols on Insulin Sensitivity

Study Overview
=================
Brief Summary
-----------------
A large and growing segment of the population is prediabetic. Dietary interventions that improve insulin sensitivity may be important in preventing the progression to full-blown diabetes in these individuals. Foods and dietary compounds that increase insulin sensitivity are likely to help maintain a healthier body composition. This pilot study will provide data to evaluate the role of dietary plant polyphenols in improving insulin sensitivity.

Detailed Description
-----------------
How does the amount consumed of cocoa and tea polyphenols (flavon-3-ol monomers and oligomers) affect insulin sensitivity in insulin resistant individuals?

Official Title
-----------------
Effect of Dietary Polyphenols on Insulin Sensitivity

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Other: Polyphenols (flavon-3-ol monomers and oligomers)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who are insulin resistant based on routine clinical measurements (Stern et al., 2005). Exclusion Criteria: BMI < 27 kg/m² Age < 25 and > 65 years Pregnant women or women who plan on becoming pregnant during the study Postpartum women Lactating women Diabetes mellitus Kidney disease Liver disease Certain cancers Smokers

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Polyphenols (flavon-3-ol monomers and oligomers)|Flavanols|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Modifying the Home Television Watching Environment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if limiting television (TV) and computer time will result in a stabilization or smaller increase in body mass index (BMI), lower energy intake, and increased physical activity in 4-7 year old obese (>85th BMI percentile) children over two years.

Detailed Description
-----------------
There is a positive correlation between obesity and television watching in adults and children. And, television watching, controlling for current obesity, is a predictor of future obesity. Almost half of all children watch 3 or more hours of television each day. The American Academy of Pediatrics recommends that children watch no more than 1-2 hours each day. Families will be randomized to one of two conditions. Half the families will be taught to use the TV Allowance to reduce their child's TV and computer use by one-half over a six month period and the other half will use the device to monitor TV watching (control group). This study uses TV Allowance units to monitor home television watching, video game playing, and computer use. The TV Allowance can also be used to limit the amount of TV and computer use by programming it to allow a specific number of hours for each family member. Heights, weights, food intake, and physical activity will be measured at baseline and every six months. The purpose of this study is to determine if limiting television and computer time will result in a stabilization or smaller increase in BMI, lower energy intake, and increased physical activity in 4-7 year old obese (>85th BMI percentile) children over two years.

Official Title
-----------------
Modifying the Home Television Watching Environment

Conditions
-----------------
Obesity, Body Weight Changes

Intervention / Treatment
-----------------
* Behavioral: Behavior modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Greater than the 85th BMI percentile Minimum of 15 hours of TV watching, computer use, and video game playing per week No medical conditions that may affect the child's ability to safely participate in physical activity

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior modification|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
-----------------
physical activity, television, child obesity, Reduce TV, Usual control
Bioequivalency Study of Zidovudine Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fasting Conditions

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory findings during screening. Exclusion Criteria: Allergic or adverse responses to zidovudine or any other comparable or similar products. Participation in clinical trial within 30 days of study initiation. Positive blood screen for HIV, Hepatitis B and C.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Three day washout | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections

Study Overview
=================
Brief Summary
-----------------
At the end of most urological procedures, the doctor inserts a urethral catheter for a period of up to 5 days. According to AUA's guidelines, prophylactic antibiotic is indicated during catheter removal. The aim of our study is to check the influence of the antibiotic treatment on urinary tract infections after catheter removal

Official Title
-----------------
Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections

Conditions
-----------------
Urologic Diseases, Urinary Tract Disease

Intervention / Treatment
-----------------
* Drug: Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: performing urological operation for other reason Exclusion Criteria: cannot give informed consent <18 years

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arms: antibiotic prophylaxis vs no treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotic prophylaxis<br>Single dose of p.o. antibiotic given 1 hour before catheter removal. The antibiotic of choice is Cefuroxime axetil 500 mg. For penicillin allergy, trimethoprim/sulfamethoxazole 160mg/800mg. | Drug: Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)<br>* single dose of P.O. Cefuroxime Axetil 500 mg. For penicillin allergy patients, single dose of P.O. Trimethoprim/Sulfamethoxazole 160mg/800mg<br>|
| No Intervention: No treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTI | Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive culture approved UTI | Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms, and a positive urine/blood culture taken during the time frame | 30 day | 
| Hospitalizations due to UTI |  | 30 day | 
| Bacteremia | Number of patients admitted to the hospital, that have at least 1 positive blood culture | 30 day |
Benefit of Adding Chemotherapy And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)

Study Overview
=================
Brief Summary
-----------------
To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally advanced nasopharyngeal carcinoma.

Official Title
-----------------
Prospective Randomized Study on Therapeutic Gain Achieved By Chemoradiation And/Or Accelerated Radiation For T3-4N0-1M0 Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Procedure: Conventional RT
* Procedure: Accelerated RT
* Drug: Cisplatin
* Drug: 5-fluorouracil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undifferentiated or non-keratinizing carcinoma Tumor staged as T3-4 AND N0-1 No evidence of distant metastasis (M0) Performance status: 0-2 Marrow: WBC >= 4 and platelet = 100 Renal: creatinine clearance = 60 Informed consent Exclusion Criteria: WHO type I squamous cell carcinoma or adenocarcinoma Age >= 70 Palliative intent or tumor extent mandating AP opposing facio-cervical fields Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume Previous chemotherapy Patient is pregnant or lactating

Ages Eligible for Study
-----------------
Maximum Age: 70 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Conventional RT|nan|
|Procedure: Accelerated RT|nan|
|Drug: Cisplatin|nan|
|Drug: 5-fluorouracil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure free survival rate |  | 5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | 5-year | 
| Disease-specific survival rate |  | 5-year | 
| Complication-free rates |  | 5-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal Carcinoma, T3-4N0-1M0
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

Study Overview
=================
Brief Summary
-----------------
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

Official Title
-----------------
A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Ferric Carboxymaltose
* Drug: Standard Medical Care (SMC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female with iron deficiency anemia Hg </= 11 g/dL Exclusion Criteria: Previous participation in a FCM trial Known Hypersensitivity to FCM History of anemia other that anemia due to heavy uterine bleeding or the post partum state current history of GI bleeding Received IV Iron within the month prior Anticipated need for surgery Malignancy history AST or ALT greater than normal Received an investigational drug within 30 days of screening Pregnant or sexually active females who are not willing ot use an effective form of birth control
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric Carboxymaltose (FCM)<br>Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) | Drug: Ferric Carboxymaltose<br> <br> |
| Active Comparator: Standard Medical Care (SMC)<br>Varied as determined by the Investigator | Drug: Standard Medical Care (SMC)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. | Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's). | From Day 0 through 30 days after the last dose of study drug. |
Drug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)

Study Overview
=================
Brief Summary
-----------------
The study is about drug patch tests in patients who have history of severe cutaneous drug reaction including Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), Drug-induced eosinophilia and systemic symptoms (DRESS), AGEP (Acute generalized exanthematous pustulosis) and generalized bullous fixed drug eruptions. This study also investigate in Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test. We also trying to prove the correlation among result of drug patch tests, ELIspot and LTT.

Official Title
-----------------
Drug Patch Tests, Enzyme-linked Immunosorbent Spot Assay (Elispot) and Lymphocyte Transformation Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)

Conditions
-----------------
Drug Reaction

Intervention / Treatment
-----------------
* Other: patch test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug-induced eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), generalized bullous fixed drug eruption in the past 24 months. Age more than 18 years old Exclusion Criteria: Receiving immunosuppressive drugs or more than 10 mg/day of prednisolone within 1 month. Pregnancy and lactation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patch test arm<br>Patch test by selected allergens and drawing blood for ELIspot and LTT | Other: patch test<br>* Patch test allergen from chemotechnique diagnostics, pure drug and drug as is combine with petrolatum or aqueous.<br>* Other names: Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test (LTT);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of positive drug patch test results. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of drug patch test results, ELIspot and lymphocyte transformation test. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug patch tests
Role of Skin Cleansing and Prophylactic Antibiotic in Preventing Infectious Morbidity After Cesarean Section Delivery

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the effectiveness of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity and to assess potential maternal adverse effects and any impact on the infant.

Official Title
-----------------
Role of Skin Cleansing and Prophylactic Antibiotic in Preventing Infectious Morbidity After Cesarean Section Delivery

Conditions
-----------------
Postpartum Infectious Morbidity in Cesarean Section Delivery

Intervention / Treatment
-----------------
* Procedure: Women undergo cesarean section delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing cesarean delivery, both elective and non-elective. Rupture of membranes and labor contractions will be allowed. Exclusion Criteria: Unknown outcome from the patient. Refusing to participate in the study from the admission conse Allergy to antibiotics. Any visible infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Women undergo cesarean section delivery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| role of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity |  | 2 weeks following cesarean section |
Multimodal Investigation of Intracranial Clot Environment

Study Overview
=================
Brief Summary
-----------------
Analysis of peri clot blood collected at the acute phase of stroke in order to understand physiopathological mechanisms involved in the cerebrovascular damage

Detailed Description
-----------------
It has been shown that immune cells accumulate around the clot at the acute phase of stroke. Leukocytes and their specific chemokines and cytokines regulation may impact cerebrovascular integrity.

Official Title
-----------------
Multimodal Investigation of Intracranial Clot Environment

Conditions
-----------------
Acute Ichemic Stroke, Brain Ischemia

Intervention / Treatment
-----------------
* Other: Analysis of the clot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Over 18 years of age, Non-dependent for activities of daily living prior to the onset of the MI (Modified Rankin Score >2) Having an occlusion of a large arterial trunk proven by imaging (angio-MRI or angio-scanner). Exclusion criteria: Patients initially admitted but for whom endovascular treatment will not finally be performed (re-infusion, catheterization failure...) will be excluded from the study. Major patients under guardianship or curatorship or patients deprived of liberty

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Patients with acute ischemic stroke<br>Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke | Other: Analysis of the clot<br>* Blood sampling at the site of intracranial occlusion during Mechanical Thrombectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metalloproteinase 9 quantification |  | 60 months | 
| Metalloproteinase 2 quantification |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines levels | Proteomic analysis of cytokines IL-1β, TNF-α, IL-6 | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Blood Brain Barrier, Ischemia, Thrombus, Interventional Neuroradiology
Non Invasive Arrhythmia Detection in Hospital Settings

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.

Detailed Description
-----------------
The system will continuously monitor the patient's cardiac activity which will be compared to standard telemetry system.

Official Title
-----------------
Evaluating Ventricular Events With Adherent Patient Monitoring Study

Conditions
-----------------
Arrhythmias

Intervention / Treatment
-----------------
* Device: Avivo System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is female or male, 18 years of age or older Undergoing ICD implant with ventricular arrhythmia induction OR undergoing EP study with ventricular arrhythmia induction Exclusion Criteria: Is participating in another clinical study that may confound the results of this 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Avivo System|Non invasive external monitoring deive|

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

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