linjc16/ctgov huggingface dataset:
The Effect of Allopurinol on Insulin Resistance and Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Studies in animals have found that allopurinol can markedly improve fructose induced metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP, reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose diet.

Detailed Description
-----------------
60 male subjects, age 40 to 65 years of age, will be placed on a 3500kcal (55% carbohydrates containing 200 g fructose) for 2 weeks. Half will receive allopurinol mg/day (randomized). At the end of 2 weeks we measure a variety of parameters including fasting glucose and insulin levels (with calculation of HOMA index), serum lipids (including triglycerides and LDL/HDL cholesterol), sitting blood pressure, serum uric acid, weight, and various other measurements (C reactive protein, adiponectin and leptin levels, and urate redox products). Primary endpoint is insulin resistance. Secondary endpoints are blood pressure, lipids, uric acid, weight.

Official Title
-----------------
Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Allopurinol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males, age 40 -65 yrs Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Other: 1<br>Placebo | Drug: Placebo<br>* Placebo given for 2 weeks<br>|
| Active Comparator: 2<br>Allopurinol given for 2 weeks with diet | Drug: Allopurinol<br>* Allopurinol 300 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance (HOMA index) |  | 2 weeks | 
| Blood pressure |  | 2 weeks | 
| Triglycerides, HDL cholesterol |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adiponectin |  | 2 weeks | 
| Leptin |  | 2 weeks | 
| CRP level |  | 2 weeks | 
| Weight gain |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uric acid, Fructose, Hypertension, Insulin, Glucose, HOMA
A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis B virus.

Official Title
-----------------
A Phase II, Randomized, Partially-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of 12 Weeks of Treatment with Clevudine (10 mg, 30 mg or 50 mg QD) in Patients Infected with Hepatitis B Virus.

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

Intervention / Treatment
-----------------
* Drug: clevudine (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBV DNA positive with DNA levels at screening greater than or equal to 3,000,000 copies/mL. Documented to be HBsAg positive for > 6 months OR HBsAg positive and IgM anti-HBc negative and anti-HBs negative. Patients may be HBeAg positive, and anti-HBe negative OR HBeAg negative (pre-core mutant) and anti-HBe positive. HBeAg positive and anti-HBe negative OR HBeAg negative (pre-core mutant) and anti-HBe positive with positive HBsAg for the previous 6 months AST and ALT levels which are less than or equal to 10 times the upper limit of normal. Bilirubin levels less than or equal to 1.5 x ULN or bilirubin levels > 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits. Exclusion Criteria: Currently receiving antiviral, immunomodulatory or corticosteroid therapy Previous treatment with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection Previous treatment with interferon must have ended at least 6 months prior to screening visit History of ascites, variceal hemorrhage or hepatic encephalopathy Co-infection with HCV or HIV Evidence of cirrhosis or hepatocellular carcinoma (alpha fetoprotein)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: clevudine (drug)|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
-----------------
clevudine, hepatitis B
A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
A Pilot of Metformin Postpartum

Detailed Description
-----------------
The overall goal of this proposal is to assess metformin initiation at the time of hospital discharge for women with a history of gestational diabetes mellitus (GDM) improves maternal health at 1 year post-partum. Our central hypothesis is that diabetes mellitus (DM) prevention with metformin can be initiated days after delivery, rather than months to years after delivery, and result in a pragmatic and efficacious means of preventing DM and improving weight loss over the first year post-partum. To test this hypothesis, we will perform a open-label randomized controlled trial of metformin compared to placebo routine care initiated at the time of hospital discharge in women with a history of GDM.

Official Title
-----------------
A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational Diabetes Exclusion Criteria: Cannot tolerate metformin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>Metformin 500 mg to be taken twice per day for two weeks and then metformin 1000 mg PO twice daily after tolerating the lower dose | Drug: Metformin<br>* Medication<br>|
| No Intervention: Routine Care<br>Discharge information about maintaining a healthy diet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediabetes or Diabetes | glycosylated hemoglobin (HgbA1c) at 1 year postpartum (>/= 5.7% defined as prediabetes, >/=6.5% defined as DM | 1 year postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediabetes or diabetes at 15 months postpartum | HgbA1c at 15 months postpartum | 15 months after delivery and study initiation |
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator

Study Overview
=================
Brief Summary
-----------------
This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for appropriate/inappropriate therapies as well as the influence of the programmed parameters on these therapies.

Detailed Description
-----------------
The registry measured the times to, and studied the determinants of, first appropriate (FAT) and inappropriate (FIT) therapy delivered by single, dual and triple chamber (CRT-D) ICD implanted for primary and secondary prevention indications.

Official Title
-----------------
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator

Conditions
-----------------
Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
-----------------
* Device: Prizm, Vitality, Renewal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for an ICD according to current guidelines, incl. prophylactic indication Exclusion Criteria: pregnant or at birth bearing age without contraception, participation in another clinical trial, short life expectancy, geographically unstable for a follow-up at the investigational center

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: Prizm, Vitality, Renewal|Follow-up during 2 years|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first appropriate therapy |  | 2 year-follow-up | 
| Time to first inappropriate therapy |  | 2 year-follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of cardiopathy, EF, NYHA Class, Type of ventricular arrhythmia (MVT, PVT, VF), History of atrial and ventricular arrhythmias, medical treatment (betablockers and/or Amiodarone). |  | 2 year-follow-up | 
| Type of treatment ATP/shock |  | 2 year-follow-up |
Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT

Study Overview
=================
Brief Summary
-----------------
Multicentric, observational, registry-based study of 0.9 mg/kg i.v. thrombolysis in wake-up stroke or stroke with unknown onset based on non-contrast CT appearance only

Detailed Description
-----------------
Thrombolysis in wake-up stroke (WUS) or stroke with unknown onset (SUO) has been recently proven to be safe and effective using magnetic resonance imaging (MRI). However, in most of the thrombolyzing hospitals worldwide MR imaging is not available. We hypothesize that pragmatic non-contrast CT (NCCT)-based WUS/SUO thrombolysis may be feasible and safe. Methods: TRUST-CT is an international multicenter registry-based study. WUS/SUO patients undergoing NCCT-based thrombolysis with NIHSS ≥ 4 and initial ASPECTS ≥ 7 are included and compared to propensity score matched non-thrombolyzed WUS/SUO controls. Primary endpoint is symptomatic intracranial hemorrhage (ICH); secondary endpoints include 24-hour NIHSS change of ≥ 4 and modified Rankin Score (mRS) at 90 days.

Official Title
-----------------
Thrombolysis in stRoke With Unknown onSet Based on Non-contrasT CT (TRUST CT). An International, Multicenter, Registry-based Study

Conditions
-----------------
Stroke, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Ischemic stroke with NIHSS ≥ 4 Wake-up stroke or unknown onset stroke Age ≥ 18 years rtPA Bolus within 4.5h of awakening and/or within 4.5 of discovering symptoms rtPA Bolus within 30 min. of admission CT Exclusion: Noncontrast cranial CT scan with ASPECTS < 7 Evidence of intracranial or subarachnoid hemorrhage Inability to control systolic BP >185mm Hg, or diastolic BP >110mm Hg with IV antihypertensive medication Known coagulopathy or evidence of active bleeding Surgical procedures, subclavian arterial puncture, trauma, and gastrointestinal or genitourinary bleeding within 14 days of the event Patients taking oral anticoagulants and having an INR >1.7 A platelet count <100 000, venous glucose either <50 or >450 Premorbid mRS > 3

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sICH | symptomatic ICH according to ECASS3 | 72hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS 90 days | mRS 90 days | 90 days |
National Survey Among Egyptian Pain Practitioners

Study Overview
=================
Brief Summary
-----------------
Coronavirus pandemic health restrictions has deleteriously affected the rates of all interventional procedures even for emergency cases. This study tried to evaluate the impact of the outbreak of SARS-CoV-19 infection on rates of interventional pain therapy (IPT).

Detailed Description
-----------------
Background: Coronavirus pandemic health restrictions has deleteriously affected the rates of all interventional procedures even for emergency cases. This study tried to evaluate the impact of the outbreak of SARS-CoV-19 infection on rates of interventional pain therapy (IPT). Methods: Setting: Multicenter Study. Design: Prospective observational study, approved by the Local Ethical Committee (RC:2-1-21). Materials: Two 20-item questionnaires with five choices for probable answer using a Likert-5 point scale were constructed as self-assessment questionnaire. The questionnaires were uploaded to the Google drive, and the links and identification codes were sent using the WhatsApp to 500 IPT providers. The feedback answers were scored and statistically analyzed. Statistical analyses will be performed using IBM® SPSS® Statistics (Version 22, 2015; Armonk, USA) for Windows statistical package. P value <0.05 was considered statistically significant.

Official Title
-----------------
The Rate of Interventional Pain Procedures During Covid 19: A National Survey Among Egyptian Pain Practitioners

Conditions
-----------------
Survey

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: registered pain practitioners in Egypt. - Exclusion Criteria: Non registered pain practitioners
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 |
| --- | --- | --- |
| number of interventional pain procedures | questionnaire | June 1st 2020 till June 1st 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wearing protective clothing | during covid 19 pandemic | june 1st 2020 to june 1st 2021 |
The Nutritional Effect of Parental Use of Food as a Reward

Study Overview
=================
Brief Summary
-----------------
Control rules are common parental practices that use food as reward to encourage children to conduct parents' preferred behaviors. This field observational study aims to examine whether control rules are associated with children's increased fat, carbohydrate and total energy intake in everyday eating, and whether this effect is moderated by individual differences in sensitivity to reward, and by gender differences.

Detailed Description
-----------------
Control rules are parental practices that use food as an instrumental reinforcer to encourage children to behave in a normative manner in non-food domains. Since food high in fat or sugar is usually chosen as a reinforcer for control rules, these rules may lead to children's increased preference and every day intake of food high in sugar/fat. Research propositions were examined in 207 six to twelve-year-old children (97 boys and 110 girls). Their parents reported the children's everyday dietary intake through a food frequency questionnaire, and provided information regarding the children's sensitivity to rewards as well as an indication of how frequently they enforce family control rules.

Official Title
-----------------
Field Observation of Adverse Nutritional Effect of Parental Use of Food as a Reinforcer for Non-food Related Behavior

Conditions
-----------------
Children's Nutrition Intake

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants have 6-12 years old children Exclusion Criteria: N.A.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Frequency Questionnaire | A web-based Food Frequency Questionnaire was used to aske participants' parents to recall their children's food intake over the last month based on a list of 136 individual food items or food clusters, which covered eight categories of food and beverages. For each individual food item or cluster, participants were asked to indicate how frequently their children consumed that food and the typical portion size. | last month recall | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children dietary pattern, control rules, instrumental learning, food reinforcement
The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese Patients

Study Overview
=================
Brief Summary
-----------------
This study was to find out whether laparoscopic colorectal surgery is detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL ,which gives earlier information than creatin in renal ischemic injury, was used.

Detailed Description
-----------------
Our object in this study was to find out whether laparoscopic colorectal surgery is detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL ,which gives earlier information than creatine in renal ischemic injury, was used. Patients undergoing elective laparoscopic colorectal surgery, 18 to 75 years old, planned surgery duration longer than 2 hours, were included in this study. Patients were divided into 2 groups with respect to their fluid resuscitation, Group 1: goal directed fluid therapy via PVI monitoring Group 2: conventional fluid resuscitation. Blood samples were drawn from both groups for NGAL measurement before CO2 insufflation (T0), and at 6th(T1) and 12th(T2) hours after CO2 insufflation. At the end of the surgery, sugammadex was given to all patients for reversal of muscular blockade.

Official Title
-----------------
The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese

Conditions
-----------------
Laparoscopic Colorectal Surgery, Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: pulse variability index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic surgery obese patient Exclusion Criteria: patient refusal major comorbidity renal failure diabetes mellitus

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pulse variability index<br>fluid management performed by pulse variability index | Other: pulse variability index<br>* fluid management with pulse variability index or conventional<br>* Other names: conventional;|
| Placebo Comparator: conventional fluid management<br>fluid management performed by conventional fluid management | Other: pulse variability index<br>* fluid management with pulse variability index or conventional<br>* Other names: conventional;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of acute kidney injury | following up diagnosis of acute kidney injury | postoperative 6 th hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NGAL, PVI
Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?

Study Overview
=================
Brief Summary
-----------------
The objectives of this work are: 1/to estimate the frequency of a positive glucose breath test in favour of a small intestinal bacterial overgrowth in a population of patients consulting for gaz incontinence by comparison to a population of control subjects; 2/to estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz incontinence

Conditions
-----------------
Anal Incontinence

Intervention / Treatment
-----------------
* Drug: Metronidazole
* Drug: CArbosylane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gaz incontinence for more than 3 months Afflilied to national health security Having read and sign the information letter and consent form Exclusion Criteria: Pregnancy use of antibiotics, probiotics, IPP for less tha n 3 months past of small intestinal bacterial overgrowth ischemic, inflammatory colitis,colo-rectal cancer diabetes allergy to metronidazole psychiatric disease patients who do not speak or read french

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metronidazole<br>3 intakes per day during 10 days | Drug: Metronidazole<br>* Metronidazole,per os,500mg, 3 per day during 10 days<br>|
| Active Comparator: Carbosylane<br>3 intakes per daysduring 10 days | Drug: CArbosylane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of gaz incontinence episodes |  | 3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment |