linjc16/ctgov huggingface dataset:
Effect of Omacor on Triglycerides in HIV Infected Subjects

Study Overview
=================
Brief Summary
-----------------
Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Investigate the Effect of Omacor (n-3 PUFA) on Lipid Parameters in HIV Infected Subjects Treated With HAART

Conditions
-----------------
Hyper-Triglyceridemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Triglycerides between 200 and 800 diagnosed HIV infection following HAART therapy Exclusion Criteria: other malignant disease not compliant allergy against fish oil soy or olive oil

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Omacor<br>* n-3 PUFA<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in serum triglycerides from baseline to treatment endpoint versus placebo |  | 12 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in serum triglycerides |  | 12 weeks | 
| Absolute and percent change in cholesterol and cholesterol subfractions |  | 12 weeks | 
| Absolute and percent change in apolipoprotein A and B |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV infection
Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections

Study Overview
=================
Brief Summary
-----------------
This study hypothesizes that early-onset neonatal Infections are related to premature rupture of membrane (PROM) and that early intervention can improve the prognosis of newborns. The objective of this study is to analyze the correlation between PROM and early-onset neonatal infections and to assess the prognosis of newborns. A cohort study is designed to implement the study. The subjects of study group are pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are pregnant women without PROM and chorioamnionitis. Control group and research group are paired at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal infections. (3) The pathogenesis of intrauterine infection and neonatal infection.

Official Title
-----------------
Multicenter Study on Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections

Conditions
-----------------
Premature Rupture of Membrane, Neonatal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PROM or chorioamnionitis gestational age is ≥ 24 weeks Exclusion Criteria: gestational age <24 weeks artificial rupture of membrane for labor induction natural rupture of membrane during induction before labor
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 |
| --- | --- |
| study group<br>pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks | |
| control group<br>pregnant women without PROM and chorioamnionitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of early-onset neonatal infections | The incidence of early-onset neonatal infections will be compared between study group and control group. | 7 days after birth |
Immune Monitoring in Sensitized Patients at Risk of Rejection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effect of anti-rejection medications on your immune system

Detailed Description
-----------------
Recipients of deceased or living donor transplants with calculated percent reactive antibody (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be obtained at the same true intervals including pre-transplant in patients who still produce urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core) of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior to treatment intensification and procedure. Patient's who are treated for rejection, will have additional samples obtained 2-4 weeks after treatment of rejection and at the time of any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.

Official Title
-----------------
Immune Monitoring in Sensitized Patients at Risk of Rejection

Conditions
-----------------
Kidney Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older able to consent No history of HIV, hepatitis C and active hepatitis B infection cPRA ≥ 50% Exclusion Criteria: Patients on Coumadin Human Leukocyte antigen (HLA) identical donor recipient patients

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune monitoring in sensitized patients at risk of rejection | Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney Solid Organ Response Test (kSORT) with pathological findings | Correlation of kSORT with pathological findings on kidney biopsy | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplant recipient
The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents

Study Overview
=================
Brief Summary
-----------------
In this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center of Israel (SCMCI).

Detailed Description
-----------------
Morbid obesity leads to restrictive as well as obstructive ventilatory defects via mechanisms that include mechanical, as well as inflammatory factors. We hypothesise that multiple breath nitrogen washout will be more sensitive to changes in small airway function than conventional lung function testing. We will invite adolescents with morbid obesity, scheduled to undergo bariatric surgery at SCMCI during 2016-2018, for pulmonary function testing, including spirometry, plethysmography, nitrogen multiple breath washout, lung transfer factor and 6 minute walk. These tests will be conducted prior to the operation as well as during follow-up appointments at 3, 6 and 12 months. We will also evaluate oxidative stress using highly sensitive C-reactive protein as surrogate marker.

Official Title
-----------------
The Impact of Bariatric Surgery Induced Weight Loss on Lung Function in Adolescents

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: Bariatric Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of Schneider Children's Medical Center during 2016-2018 Exclusion Criteria: Adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders)

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bariatric Surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Lung Clearance Index |  | 3 months post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline High sensitivity C reactive protein |  | 3 months post op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Lung function test, Bariatric surgery
Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer will be studied.

Detailed Description
-----------------
200 patients with breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Official Title
-----------------
Evaluation of Prognostic Monitoring for Women Who Have Completed Standard Treatment for Breast Cancer Via Analysis of Immunoinflammation-related Protein Complexes in Blood

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Postoperative pathology confirmed invasive breast cancer after surgery for breast tumors Breast cancer-related chemotherapy and radiotherapy completed axillary lymph node metastasis ≥ 4 age ≤ 60 years old Exclusion Criteria: Male Aged above 60 Breast Carcinoma in situ Women in pregnancy or breastfeeding Suffering from other malignant tumors Non-compliant patient

Ages Eligible for Study
-----------------
Maximum Age: 60 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 |
| --- | --- |
| Lymph node metastasis<br>Axillary lymph node metastasis ≥ 4 Lymph nodes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune inflammation-related protein complexes | The change of immune inflammation-related protein complexes which is measured by gel permeation chromatography. | 2 years | 
| blood markers | The expression of CA153, CEA, CA125 in the blood of the patients, which are measured by electro-chemiluminescence immunoassay. | 2 years |
Effect of Eplerenone on Endothelial Function in Patients With Stable Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate wether endothelial dysfunction associated with stable coronary artery disease is altered by selective aldosterone antagonism with Eplerenone as potential anti-inflammatory drug versus placebo. Additionally we hypothesize that selective aldosterone antagonism reduces systemic inflammatory response such as C-reactive proteine, oxidative stress and pro-inflammatory cytokines.

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male patients (> 30 years of age) with history of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test) Stable cardiovascular medication for at least 4 months Evaluation of the patients will take place at the Department of Internal Medicine, Cardiology, University Hospital Zurich. Exclusion criteria: Evidence for myocardial infarction, unstable angina, stroke within 3 months prior to study entry coronary intervention/re-vascularisation procedure within 3 months prior to study entry long acting nitrates uncontrolled arterial hypertension, defined as RR>160/90 mmHg congestive heart failure (> NYHA I) Ejection fraction <50% AV-Block>I˚ creatinine clearance <50 mL/min insulin-dependent diabetes mellitus type 2 diabetes with microalbuminuria age < 30 years anemia (Hb<10 g/dl) malignancy chronic infection smoking serum potassium >5.5 meq/L drug abuse potassium supplements or potassium-sparing diuretics (amiloride, spironolactone, or triamterene) concomitant use of strong inhibitors of CYP450 3A4 (e.g., ketoconazole, itraconazole) known history of Cushing disease or Morbus Addisons or diseases of the thyroid gland

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.

Study Overview
=================
Brief Summary
-----------------
Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination rate against influenza are low in spite of national programs. Study goal is to evaluate the effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents about the importance of influenza vaccination.

Official Title
-----------------
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate and Morbidity in Infants Born Premature.

Conditions
-----------------
Prematurity, RSV, Influenza, Upper Respiratory Tract Infection, Lower Respiratory Tract Infection

Intervention / Treatment
-----------------
* Behavioral: Educational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants coming for RSV prophylaxis Exclusion Criteria: Already vaccinated against influenza Contraindication for influenza vaccination

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 2 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>Educational intervention with the parents | Behavioral: Educational intervention<br> <br> |
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza vaccination rate |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory morbidity | Upper and lower respiratory tract events during study period | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccination, RSV, Influenza, Prematurity
Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.

Detailed Description
-----------------
To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure. The study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.

Official Title
-----------------
Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study

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

Intervention / Treatment
-----------------
* Other: Cleaning capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject's age is between 23-75 years. Subject is healthy. Subject agrees to sign the Informed Consent Form Exclusion Criteria: Contraindication to capsule endoscopy Contraindication or allergy to any of the products and materials used for bowel preparation Subject is not able to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colon-targeted cleaning capsule<br> | Other: Cleaning capsule<br>* Capsules containing the tested materials aimed to improve colon cleansing<br>* Other names: Active cleaning capsules;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleansing grading |  | within 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of time |  | within 10 days | 
| GI tract segment of capsule disintegration |  | within 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bowel prep, PillCam
Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas

Study Overview
=================
Brief Summary
-----------------
GMX1777 is a water-soluble, intravenously-administered prodrug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.

Detailed Description
-----------------
This is a single-center, open-label, Phase I study of single-agent GMX1777 administered every 3 weeks to patients with CLL, MM, refractory solid tumors or lymphomas. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Official Title
-----------------
A Single-Center, Open-Label, Phase I Study of Single-Agent GMX1777 Administered as a 24-Hour Infusion Every 3 Weeks to Patients With Refractory Solid Tumors or Lymphomas

Conditions
-----------------
Solid Tumors and Lymphomas

Intervention / Treatment
-----------------
* Drug: GMX1777


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a histologically or cytologically confirmed solid tumor or lymphoma No limitations on allowable type and amount of prior therapy. Patients must have a life expectancy of greater than 8 weeks Patients must have normal organ and marrow function Patients must be willing to submit blood sampling for planned PK analysis Patients must have the ability to understand and willingness to sign a written informed consent form Exclusion Criteria: No other agents or therapies administered with the intent to treat malignancy Patients with prior exposure to GMX1777 or GMX1778 Uncontrolled, intercurrent illness Pregnant women and women who are breast feeding

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GMX1777|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe observed tumor responses |  | 52 weeks |