linjc16/ctgov huggingface dataset:
A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

Study Overview
=================
Brief Summary
-----------------
This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

Official Title
-----------------
A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.

Conditions
-----------------
Gastrointestinal Hemorrhage

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signs of a bleeding in the stomach One endoscopically confirmed bleeding ulcer in the stomach or duodenum Exclusion Criteria: Malignancy or other advanced disease. Major cardiovascular event. Severe hepatic disease

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
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo |  | Within 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Significant Rebleeding Within 7 Days |  | Within 7 days | 
| Clinically Significant Rebleeding Within 30 Days |  | Within 30 days | 
| Death Within 72 Hours |  | Within 72 hours | 
| Death Within 30 Days |  | Within 30 days | 
| Death Related to Rebleeding Within 30 Days as Judged by the EpC |  | Within 30 days | 
| Requirement for Surgery Within 72 Hours |  | Within 72 hours | 
| Requirement for Surgery Within 30 Days |  | Within 30 days | 
| Requirement for Endoscopic Re-treatment Within 72 Hours |  | Within 72 hours | 
| Requirement for Endoscopic Re-treatment Within 30 Days |  | Within 30 days | 
| Number of Blood Units Transfused Within 72 Hours |  | Within 72 hours | 
| Number of Blood Units Transfused Within 30 Days |  | within 30 days | 
| Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period |  | Within 30 days |
Challenging the Gold Standard: Pilot Study Comparing Continuous Glucose Monitoring System (CGMS), Capillary Glucose Monitors and 3 Hour Glucose Tolerance Test (GTT) to Diagnose Gestational Diabetes Mellitus (GDM)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare 3 methods of measuring blood glucose (blood sugar) levels to see if the finger-stick method or the continuous glucose monitoring system is better than or as good as the 3 hour glucose tolerance test (GTT) for the diagnosis of gestational diabetes.

Detailed Description
-----------------
The rate of gestational diabetes and fetal macrosomia is increasing. Moreover, it appears that many macrosomic infants are born to non-diabetic mothers. However, this presents the question of whether our current accepted means of diagnosis is reflecting the true prevalence of GDM. The 3-hour GTT measures glycemic control over a limited period of time. A more prolonged period of monitoring makes more physiologic sense, as it would paint a picture of a patient's overall trend before a diagnosis can be confirmed or excluded. Given the ability of the CGMS and capillary glucose monitor to follow glycemic trends over an extended time period, these methods may prove more effective at identifying patients with abnormal glucose tolerance. As these modalities test the patients in their native environments, the effect of dietary changes prior to the testing period may be minimized, potentially providing an more accurate assessment of abnormal glucose utilization. Furthermore, both modalities should be more cost-effective than the 3- hour GTT.

Official Title
-----------------
Challenging the Gold Standard: A Pilot Study Comparing CGMS and Capillary Glucose Monitors Versus 3 Hour GTT to Diagnose Gestational Diabetes Mellitus

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant patients seen in the Center for Women's Health at University Hospital in Cincinnati, Ohio between 24-28 weeks gestation One hour 50-g Glucose Challenge Test (GCT) value greater than 130 mg/dL. Exclusion Criteria: Patients with known diabetes mellitus Patients receiving steroids or oral terbutaline therapy Patients entering prenatal care later than 20 weeks gestation

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

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

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 glucose levels |  | Over 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GDM, Gestational Diabetes, GTT, CGMS
Level of HER2-neu Gene Amplification an Response to Trastuzumab

Study Overview
=================
Brief Summary
-----------------
Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.

Official Title
-----------------
Retrospective Study of the Level of HER2-neu Gene Amplification as Predictive Factor of Response in Patients With HER2-positive Advanced Breast Cancer Treated With Trastuzumab Containing Regimens.

Conditions
-----------------
Advanced Breast Cancer

Intervention / Treatment
-----------------
* Genetic: Fluorescent in-situ hybridization (FISH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive Exclusion Criteria: HER2-negative advanced breast cancer Pretreatment with trastuzumab

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1<br>HER2-positive advanced breast cancer | Genetic: Fluorescent in-situ hybridization (FISH)<br>* Dual color FISH test to assess ratio of HER2/neu amplification<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of tumor cytogenetic paremeters with TTP and OS. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of cytogenetic parameters evalued by FISH test and patients' characteristics. |  | one year |
The Effect of Obesity on Endometrium in PCOS

Study Overview
=================
Brief Summary
-----------------
The effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few attentions. There is a lack of evidence to whether the BMI affects the endometrial blood flow, which is necessary for implantation.

Official Title
-----------------
Effect of Body Weight on Endometrial Ultrasonographic Characteristics in Polycystic Ovary Syndrome Patients

Conditions
-----------------
Body Weight, Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Device: Doppler evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with PCOS are diagnosed according to Rotterdam criteria, (Rotterdam and ASRM-Sponsored, 2004)by the presence of two out of the following three: oligomenorrhea (absence of menses for 35-182 days) or amenorrhea (absence of menses for >182 days), signs or symptoms of hyperandrogenism (acne, hirsutism), US showing polycystic ovaries. Fertile women had regular menstruation, with at least one previous spontaneous pregnancy. Exclusion Criteria: Women known to have hepatic or renal dysfunction, Diabetes mellitus, hypertension, or cardiovascular disease. If they have used induction of ovulation drugs for the last three months. If they have used hormonal contraception in the last three months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| obese/PCO<br>Women with PCOS who are overweight\obese with BMI ≥ 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
| normal weight/PCO<br>Women with PCOS who are normal weight with BMI < 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
| Obese/fertile<br>Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are overweight\obese with BMI ≥ 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|
| normal weight/fertile<br>Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are normal weight with BMI < 25 kg/m2. | Device: Doppler evaluation<br>* Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean difference in Doppler indices (VI-FI-VFI) |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrium
TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

Study Overview
=================
Brief Summary
-----------------
Randomized, double-blind study of the tolerability of three different doses of rifapentine

Detailed Description
-----------------
Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.

Official Title
-----------------
TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Drug: rifapentine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusions: Drug susceptible culture-positive tuberculosis Adequate induction therapy Age >18 Normal screening labs Karnofsky >=60 Informed consent Birth control if of child bearing potential Exclusions: SilicoTB Skeletal or CNS TB Pregnant or breastfeeding Intolerance to INH or rifamycins Over 70 days TB treatment just prior to enrollment

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who fail to complete therapy in each of the dosing groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Rate of serious adverse events in each of the dosing groups |  |  | 
| 2. Rate of total adverse events in each of the groups |  |  | 
| 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberculosis, tb, rifapentine, safety, dose
Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics

Study Overview
=================
Brief Summary
-----------------
Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.

Detailed Description
-----------------
Thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. The children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment. The children will give a faecal sample in the beginning and at the end of the study. The samples will be used for the analysis of microbiota and differences in the microbiota between the groups.

Official Title
-----------------
Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics

Conditions
-----------------
Changes in the Gut Microbiota During an Antibiotic Treatment

Intervention / Treatment
-----------------
* Dietary Supplement: Prebiotic product
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An infection requiring antibiotic treatment assessed by a doctor Exclusion Criteria: Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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: Double blind placebo controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prebiotic<br> | Dietary Supplement: Prebiotic product<br>* Prebiotic product used during the course of antibiotic treatment<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of gut microbiota during antibiotic treatment | Gut microbiota and antibiotics - Prevention of side effects by new prebiotics | One week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibiotics, prebiotics, dysbiosis
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to determine if hyperinsulinemia attenuates sympathetic nervous system-mediated vasoconstriction in the human leg.

Official Title
-----------------
Impact of Insulin on Sympathetic Nervous System-mediated Peripheral Vasoconstriction

Conditions
-----------------
Vasoconstriction, Healthy, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult men and women; 18-45 years of age; BMI 18-30 kg/m2; non-pregnant/non-breastfeeding; non-nicotine users; Exclusion Criteria: taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic functions Self-reported history of: hepatic, renal, pulmonary, cardiovascular, or neurological disease; stroke or neurovascular disease; bleeding/clotting disorders; sleep apnea or other sleep disorders; diabetes; smoking; history of alcoholism or substance abuse, excessive alcohol consumption; hypertension; active cancer; autoimmune disease; immunosuppressant therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin<br>Participants will complete a 60 minute hyperinsulinemic-euglycemic infusion. | Drug: Insulin<br>* Priming dose then a constant infusion at 40 mU•m-2•min-1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of leg blood flow | Measured with Doppler ultrasound (mL/min) | Change from baseline at minute 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of muscle sympathetic nerve activity (MSNA) | MSNA burst incidence (bursts/100 heart beats) | Change from baseline at minute 60 | 
| Amount of cerebral blood flow | Measured with trans-cranial Doppler ultrasound (cm/s) | Change from baseline at minute 60 |
Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis

Study Overview
=================
Brief Summary
-----------------
Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.

Detailed Description
-----------------
To retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. Divided into 2 groups according to the diameter of the optical zone. The vector analysis method was used to analyze the changes and errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE) model is used for multiple regression analysis to evaluate the potential factors related to the error value.

Official Title
-----------------
Evaluating the Effect of Optical Zones on Myopia and Astigmatism Correction in SMILE: Vector Analysis

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Procedure: small incision lenticular extraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no ocular conditions normal topography central corneal thickness, >500µm residual stromal thickness, >280 µm pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm); Exclusion Criteria: history of intraocular surgery pupil diameter, >4.9 mm or <2.78mm keratoconus or corneal ectasia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| group A<br>small optical zone | Procedure: small incision lenticular extraction<br>* In patients with the same degree of myopia, different optical zones were designed for operation<br>|
| group B<br>large optical zone | Procedure: small incision lenticular extraction<br>* In patients with the same degree of myopia, different optical zones were designed for operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| astigmatic changes | Observe the effect on changes in astigmatism by target induced astigmatism (TIA) versus surgically induced astigmatism (SIA) | 2021.03 | 
| error value | Target refraction (TR) and surgically induced refraction (SIR) under different optical zones | 2021.04 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
small incision lenticule extraction, vector analysis
Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)

Study Overview
=================
Brief Summary
-----------------
Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome. Patients recruited by year: 2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5

Conditions
-----------------
Chronic Congestive Heart Failure

Intervention / Treatment
-----------------
* Other: Lung impedence-guided treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from CHF, NYHA II-IV class LV lower than 35% to LV lower than 45% Exclusion Criteria: Patients with additional disease with life-expectancy of less than 2 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional treatment CHF patients<br>One hundred and fifty patients with CHF will be treated according to current guidelines (conventional treatment). | |
| Experimental: Lung impedence-guided treatment<br> | Other: Lung impedence-guided treatment<br>* One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hospitalization for acute heart failure |  | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved clinical outcome for CHF patients |  | Five years |