linjc16/ctgov huggingface dataset:
Niacin and Endothelial Function in Early CKD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the good cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.

Official Title
-----------------
Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Niacin
* Drug: Active Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CKD Stage 2 (GFR >60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR 15-30) HDL-cholesterol <50 for men and <55 for women If taking a statin, stable dose for past one month Glucose <200 mg/dL and HbA1c <9% Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry Exclusion Criteria: Hospitalization within prior 3 months Any of the following conditions: uncontrolled peptic ulcer disease active liver disease OR abnormal SGOT/SGPT history of adverse reaction to niacin contra-indication to aspirin concurrent fibrate therapy history of gout serum phosphorus levels below 2.7mg/dl Nursing Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Niacin<br> | Drug: Niacin<br>* 1000 mg tablets once per day<br>* Other names: Niaspan;|
| Placebo Comparator: Placebo<br> | Drug: Active Placebo<br>* 100 mg Niacin tablets once per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Flow Mediated Dilation From Baseline | Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks | 14 weeks since baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HDL-C From Baseline to 14 Weeks |  | 14 weeks since baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Niacin, HDL, Endothelial Function
Study Comparing Two Different Tablet Formulations Of Bosutinib

Study Overview
=================
Brief Summary
-----------------
This study is comparing 2 formulations of bosutinib in healthy subjects.

Official Title
-----------------
A Single Dose Bioequivalence Study Comparing the Commercial Tablet Formulation to the Clinical Tablet of Bosutinib in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: SKI-606 (Bosutinib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of non-childbearing potential, age 18 to 50 years. Exclusion Criteria: Any significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Commercial Tablet manufactured by Excella | Drug: SKI-606 (Bosutinib)<br>* Arm 1 - Commercial Tablet manufactured by Excella Arm 2 - Clinical Tablet manufactured by Wyeth Montreal<br>* Other names: Bosutinib;|
| Experimental: 2<br>Clinical Tablet manufactured by Wyeth Montreal | Drug: SKI-606 (Bosutinib)<br>* Arm 1 - Commercial Tablet manufactured by Excella Arm 2 - Clinical Tablet manufactured by Wyeth Montreal<br>* Other names: Bosutinib;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as measured by Cmax, AUC, tmax, and t1/2 |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects
Comparison of Gonioscopy With Cirrus and Visante

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze similarities and evaluate interchangeability of Visante and Cirrus OCT (optical coherent tomography)and to compare agreement between gonioscopy and the two systems for evaluation of anterior segment parameters.

Detailed Description
-----------------
All participants underwent routine ophthalmic examination by their physician. Three independent examiners performed gonioscopy using Spaeth Gonioscopic Grading System. Findings were recorded independently along with risk assessment of angle being closed as: high, medium, and low or no risk. Patient information was not available to doctor during gonioscopy. One eye of each patient was imaged using both Visante and Cirrus OCT. Imaging was performed under scotopic and photopic conditions and obtained from horizontal (3:00 and 9:00 o'clock) and vertical (6:00 and 12:00 o'clock) meridians. The same experienced independent examiner performed all Cirrus measurements. Visante was performed by 3 trained technicians using same protocol. OCT images were exported and masked to be evaluated for presence of open or closed anterior chamber angle. Masked images were presented with no other patient information available to two examiners with glaucoma training working together to score on basis of iridocorneal angle as, closed (0 degree), high possibility (10 degree), medium risk (20 degree), and low or no risk (> 30 degree).

Official Title
-----------------
Comparison of Visante and Cirrus Optical Coherent Tomography for Assessment of the Anterior Segment

Conditions
-----------------
Open Angle Glaucoma, Narrow Angles, Angle Closure Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • 18 years of age and older with open angle, narrow angle and angle closure Exclusion Criteria: • All lasers or intraocular surgery (cataract, glaucoma, retina, cornea)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open angle glaucoma<br>patients diagnosed with open angle glaucoma | |
| Narrow angle<br>patients diagnosed with narrow angles | |
| Angle Closure Glaucoma<br>patients diagnosed with angle closure glaucoma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anterior angle measurement | comparison of AS assessment by Cirrus, Visante, gonioscopies | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open angle glaucoma, narrow angles, angle closure glaucoma, gonioscopy, anterior segment OCT
Immunological Change and the Single Nucleotide Polymorphism (SNP) in Children With Irritable Bowel Syndrome (IBS)

Study Overview
=================
Brief Summary
-----------------
Currently, the pathophysiology of Irritable bowel syndrome( IBS) remains unclear . The purpose of this study is want to investigate the immunological changes in the children with IBS.

Detailed Description
-----------------
Irritable bowel syndrome (IBS) is a highly prevalent functional gastrointestinal disorder.Many children suffered from this disease and had impact on their daily life. However, the underlying pathophysiologic mechanisms remain to be elucidate. Dysregulation of the gut immune system is considered an important pathophysiology. We want to investigate the immunological changes in the IBS children.

Conditions
-----------------
Irritable Bowel Syndrome, Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (5-18y/o) with IBS, All patients had chronic or relapsing symptoms of IBS consistent with the ROME II criteria Exclusion Criteria: A history of psychologic disorders, probiotics, anti-inflammatory, analgesic, or immunosuppressive medication (nonsteroidal anti-inflammatory drugs, steroids) within the past 3 months were excluded

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The patient group<br> | |
| healthy control group<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
-----------------
immune
Sonographic Assessment and Visualization of Ectopics in Emergency Medicine

Study Overview
=================
Brief Summary
-----------------
Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.

Detailed Description
-----------------
Emergency Physicians who have undergone training according to the American College of Emergency Physicians Guidelines will be evaluated in the accuracy of performing pelvic ultrasounds among patients at risk for ectopic pregnancy.

Official Title
-----------------
Sonographic Assessment and Visualization of Ectopics in Emergency Medicine (SAVE'EM)

Conditions
-----------------
Ectopic Pregnancy

Intervention / Treatment
-----------------
* Device: Pelvic Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant females in 1st trimester present to emergency department complaint of abdominal/pelvic pain or vaginal bleeding Exclusion Criteria: previous ultrasound diagnostic of location of pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 55 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 |
| --- | --- |
| At Risk of Ectopic Pregnancy<br>Women who present to the emergency department at UCSF who are at risk of ectopic pregnancy. | Device: Pelvic Ultrasound<br>* Pelvic ultrasound performed by the emergency physician<br>* Other names: Pelvic Sonogram;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome of the pregnancy | To measure the outcome of the study, we will base our results on Sensitivity and Specificity. Sensitivity which relates to the number of positive results defined as no intrauterine pregnancies, ectopic pregnancy compared to the Radiologic Gold standard ultrasound which provides us 100% sensitivity. The goal is to reach a sensitivity of (>95%) by our ED physicians. Specificity which will be defined as the number of negative studies identified as intrauterine pregnancies compared to the results of the Gold standard radiology ultrasound and by telephone follow up. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bedside ultrasound
Screening Of Adult urBan pOpulation To diAgnose Heart Failure

Study Overview
=================
Brief Summary
-----------------
Screening Of adult urBan pOpulation To diAgnose Heart Failure (SOBOTA-HF) is a cross-sectional prevalence study in a representative sample of Murska Sobota residents aged 55 years or more. Individuals will be invited to participate in a screening with NT-proBNP. All subjects with NT-proBNP ≥ 125 pg/mL will be invited for a diagnostic visit that will include history and physical examination, electrocardiogram, echocardiography, ankle brachial index, pulmonary function tests, body composition measurement, physical performance tests and questionnaires. To validate the screening procedure, a control group (NT-proBNP < 125 pg/mL) will undergo same diagnostic evaluation. An external center will validate echodardiography exams and the HF diagnosis will be adjudicated within an independent HF expert panel. Overall and age specific HF prevalence will be calculated in individuals ≥ 55 years and extrapolated to the whole population.

Official Title
-----------------
Screening Of Adult urBan pOpulation To diAgnose Heart Failure

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

Intervention / Treatment
-----------------
* Diagnostic Test: NT-proBNP, echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >55 living in Murska Sobota part of representative sample as selected by Statistical Office of the Republic of Slovenia Exclusion Criteria: NONE.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: NT-proBNP, echocardiography|screening|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart failure diagnosis as per 2016 ESC guidelines |  | at diagnostic visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, prevalence
Naltrexone, Craving, and Drinking

Study Overview
=================
Brief Summary
-----------------
This 5-week study will examine the effects of naltrexone on alcohol craving, drinking rates, and reaction to drinking-related triggers, or cues, in participants' everyday environment and in laboratory sessions. Participants will monitor and record their daily desires to drink, environmental circumstances in which urges occur, and drinking behavior using a palm top computer. Participants will receive naltrexone or a placebo. One week after receiving medication, all participants will be asked to respond to alcohol-related cues that may or may not arouse the desire to drink.

Official Title
-----------------
Naltrexone, Craving, and Drinking: Ecological Assessment

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: naltrexone (Revia)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Drink at least 4 days per week with 2 heavy drinking days (more than 6 standard drinks for men, more than 5 drinks for women) per week on average during the month prior to the study. Exclusion Criteria: Current interest in treatment or a history of treatment for alcohol problems. History of liver disease or current liver function tests greater than five times normal. Opiate abuse or dependence, any opiate use two weeks before the study or a urine test screen that is positive for opiates. Females, who are pregnant, nursing, or not using reliable birth control method. Daily use of acetaminophen. Living with someone who participated in this study.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naltrexone (Revia)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis

Study Overview
=================
Brief Summary
-----------------
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief

Official Title
-----------------
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Cetrorelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal female, history of regular menstrual periods, any of the symptoms dysmenorrhea, dyspareunia or pelvic pain assessed as moderate to severe, endometriosis confirmed by histology within 36 months, use of barrier contraception throughout the study Exclusion Criteria: Insufficient wash out period for other endometriosis treatments, resection or destruction of endometriotic lesions less than 12 weeks prior to screening, need for strong opioid analgesics, need for immediate surgical treatment of endometriosis, any condition that interferes with adherence to study procedures or study assessments

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cetrorelix|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
-----------------
Endometriosis, Cetrorelix, Hormone, Symptoms relief, Safety, Tolerability, Pharmacodynamic, Pharmacokinetic
Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC

Study Overview
=================
Brief Summary
-----------------
A central challenge in the fight against breast cancer is how to detect disease in a noninvasive manner before it is detectable by imaging methods. Although inroads have been made with more sensitive imaging techniques for earlier detection of breast cancer, these techniques are limited by the size of lesion that could be detected. Alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of breast cancer are urgently needed. The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in breast cancer patients.

Official Title
-----------------
Breast Cancer Screening Using DNA Methylation Changes in Circulated Tumor, PBMC and T-cells DNA.

Conditions
-----------------
Breast Cancer, Breast Cancer Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmed breast cancer subtypes (DCIS and invasive) Exclusion Criteria: Pregnant women Minors (subjects less than 18 years of age) Prisoners Patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C Patients having other than one cancer Subjects unable to consent for themselves

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer<br>Early stage luminal A and triple negative breast cancer [TNBC] (estrogen receptor-negative (ER-), progesterone receptor-negative (PR-) and HER2-negative (HER2-) | |
| Control<br>Age matched control females | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of breast cancer | We will develop the linear model and a threshold value differentiating breast cancer from control based on the 100 patient training set. The model will be provided to the researchers: Methylation score=CG1*b1+CG2*b2+ CG3*b3 + e CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept. We will develop the regression coefficient and intercept as well as the DNA methylation values for each patient for each CG. We will first compute the polygenic methylation score for each patient. Then based on the computer threshold based on the training cohort will call the samples as breast cancer or not. | 6 months to 1 year |