linjc16/ctgov huggingface dataset:
Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.

Official Title
-----------------
Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Dutasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosed with benign prostatic hyperplasia Must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure. PSA (prostate specific antigen) level must be between 1.5 and 15 ng/ml. Exclusion criteria: Prostate cancer. Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication. Previous finasteride use or other investigational 5ARI within 6 months prior to screening. History of chronic UTIs (urinary tract infections) Presence of acute bacterial prostatitis at screening

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

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

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: Dutasteride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone. |  |  | 
| Changes in serum DHT (dihydrotestosterone) and T (testosterone). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Testosterone, DHT, TURP
Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles

Study Overview
=================
Brief Summary
-----------------
Chronic viral infections induce oxidative stress that can cause a number of concomitant diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient treatment of oxidative stress may be of benefit for the patient to prevent further diseases. Shingles (herpes zoster infection) have been successfully treated with antioxidative substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may be mitigated or even fully avoided.

Official Title
-----------------
PASCORBIN 7.5g in the Treatment of Viral Infection, Especially Varicella Zoster Infection: An Observational Cohort Study

Conditions
-----------------
Virus Diseases, Herpes Zoster

Participation Criteria
=================
Eligibility Criteria
-----------------
Due to the design of an Observational Cohort Study, no inclusion or exclusion criteria are named. The included patient group is described under Cohort / Group. Observational Criteria: adult patients acute viral infection (especially herpes zoster) Primary Care patient eligible for add-on therapy with vitamin C willingness to provide pseudonymized data to the Sponsor

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 |
| --- | --- |
| Vitamin C<br>Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain Measured by VAS | VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS | visit 1 - 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Herpes, Shingles, virus disease, vitamin C, ascorbic acid, antioxidant, oxidative stress
Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.

Official Title
-----------------
Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin

Conditions
-----------------
Gastric Ulcer, Duodenal Ulcer

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients taking long-term low-dose aspirin for prevention of thrombus/embolism at the start of administration of rabeprazole (including patients who start low-dose aspirin on the same day as the start of administration of rabeprazole). Patients with a history of gastric/duodenal ulcers. Patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin. Exclusion criteria: Patients with gastric/duodenal ulcers at the start of administration of rabeprazole. Patients with active upper gastrointestinal bleeding at the start of administration of rabeprazole. Patients with contraindication for rabeprazole.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br>Participants with combination therapy (rabeprazole and low-dose aspirin) | Other: No Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of peptic ulcer |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stomach ulcer, Duodenal ulcer, Rabeprazole, Recurrence
Dermabond Treatment for Gastric Variceal Bleeding

Study Overview
=================
Brief Summary
-----------------
The purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically, for the treatment of gastric variceal bleeding This data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.

Detailed Description
-----------------
Clinical outcomes research is one of the strengths of the EUS group. As a group, the physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with gastric variceal bleeding. Gastric variceal bleeding is a severe complication of portal hypertension with significant morbidity and mortality with limited therapeutic options. Currently, there is no database in existence for endoscopic ultrasound clinical research for specific procedures. Also, there is limited data regarding the outcome of endoscopic sclerotherapy with cyanoacrylate in the United States.

Official Title
-----------------
Endoscopic Ultrasound (EUS) Gastric Variceal Bleeding Database Repository

Conditions
-----------------
Gastric Varices

Intervention / Treatment
-----------------
* Procedure: DermaBond treatment of Gastric Varices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone receiving treatment with DermaBond for treatment gastric varices. Exclusion Criteria: No evidence of gastric varices. -

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric Varices treatment<br>DermaBond (glue) treatment of Gastric Varices. | Procedure: DermaBond treatment of Gastric Varices<br>* Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices.<br>* Other names: DermaBond: (cyanoacrylate tissue adhesive).;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. | Patients with gastric variceal bleeding will be treated with DermaBond injection via EUS (endoscopic ultrasound). A follow-up EUS will observe the treated varices and determine if retreatment with DermaBond is necessary, or if observation alone is required. | 36 months |
Preliminary Testing of a Novel Device to Detect Epileptic Seizures

Study Overview
=================
Brief Summary
-----------------
Official statistics report around 1000 deaths due to epilepsy in the UK each year (Hanna et al 2002). Most of these deaths are un-witnessed and in many cases are believed to have been avoidable with timely assistance (Langan et al 2000). A major problem is detecting nocturnal seizures to allow body re-positioning, to maintain an open airway and to administer rescue medication. There are several seizure alarms commercially available but are often unreliable with many false alarms. The aim of this study is to investigate a novel seizure detection system with a unique algorithm.

Detailed Description
-----------------
Two duplicate novel medical devices conforming to safety regulation BS EN 60601 containing the unique algorithm will be evaluated in clinical trials at two hospitals over a 14 month period. Each device is time synchronised with an Electroencephalographic (EEG) videotelemetry system which is the gold standard in identifying different seizure types recording from scalp electrodes. The devices will be monitoring participants from 3 months and older (children and adults). The algorithm was created from results from a PhD where 527 seizures were categorised into different seizure types. Sensitivity of identifying seizures was 91% and specificity was 75% using an optimal trigger level and algorithm. This trial will investigate how reliable the algorithm is in practice and determine an optimal trigger level..

Official Title
-----------------
Preliminary Testing of a Novel Device to Detect Epileptic Seizures

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Frequent epileptic seizures 3 months and older Informed consent for participation Exclusion Criteria: Infrequent seizures Attacks are of a non-epileptic nature Younger than 3 months Has an implantable device No informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

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 |
| --- | --- | --- |
| Reliable detection of epileptic seizures (Trigger level to be determined for total seizures) | Trigger level to be determined for total seizures | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliable detection of epileptic seizures (Trigger level to be determined for different types of seizures.) | Trigger level to be determined for different types of seizures. | 14 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seizure detection
A Study of YM178 in Patients With Symptomatic Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

Detailed Description
-----------------
To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.

Official Title
-----------------
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study in Patients With Symptomatic Overactive Bladder

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Drug: YM178
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 20 years suffering from overactive bladder Exclusion Criteria: Pregnant and breastfeeding women Any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral | Drug: YM178<br>* Oral<br>|
| Experimental: 2<br>Oral | Drug: YM178<br>* Oral<br>|
| Experimental: 3<br>Oral | Drug: YM178<br>* Oral<br>|
| Placebo Comparator: 4<br>Oral | Drug: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder symptoms |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder symptoms (QOL) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM178, Urinary Bladder, Overactive
Inflammation and Infection in Trauma, Role in Posttraumatic Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the relationship between trauma, the immune system, biochemical changes in the first 24 h and subsequent complications and mortality

Detailed Description
-----------------
The immune system plays a role in the development of complications after severe trauma, but we do not know how. Equally, biochemical changes measured in the blood after trauma (eg. bloodglucose, GC-globulin, coagulation parameters etc.) may predict the prognosis and the degree of complcations. Two significant complications are infection and organ failure, which may prolong hospitalisation and increase mortality. In the study we collected samples from blood and body surfaces to determine changes in cytokines, biochemistry, bacterial flora, and subsequent complications. We compare the changes in between groups of the cohort.

Conditions
-----------------
Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical suspicion of multiple trauma Age >/= 18 years Direct referral from scene of accident Exclusion Criteria: Major burn injury HIV positiv Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
Thrombophilic Risk Factors in Preterm and Infants Treated at Ha'Emek Medical Center Between the Years 1990 to 2010

Study Overview
=================
Brief Summary
-----------------
There are several factor that can be related to Neonatal Thrombotic events. Among them hypercoagulability can be the cause of those events. Factor V Leiden (FVL) and Prothrombin mutation are the most common causes of hereditary thrombophilia. The incidence of in the arab population is known to be higher than the incidence in another western populations. The purpose of this study is to review retrospectively the thrombophilic risk factors that were found in a cohort of premature babies and term newborns treated and investigated at the Neonatal Intensive Care Unit and at the Pediatric Hematology Unit.

Detailed Description
-----------------
All the demographic and clinical data will be summarized. Factors non related to the coagulation system like catheters, severe infections or congenital heart defects will be recorded. Also a full workup of prothrombotic risk factors are routinely performed in those infants. The study included basic coagulation analysis, Protein C, S and Antithrombin III activity, Activated Protein C Resistance, serum homocystein, lipoprotein (a) and Lupus Anticoagulant. Also the three common genetic factors are analysed including Factor F Leiden (G1691A), Prothrombin Mutation (G20210A) and MTHFR polymorphism (C677T).

Official Title
-----------------
Thrombophilic Risk Factors in Preterm and Infants Treated at Ha'Emek Medical Center Between the Years 1990 to 2010

Conditions
-----------------
Thrombosis, Premature

Intervention / Treatment
-----------------
* Other: Medical Records study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -All newborns (Term and Premature) diagnosed with Neonatal Thrombotic events between year 1990 to 2010.

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with thrombotic events<br>All infants (premature and term) diagnosed at the Neonatal Intensive Care Unit with thrombotic events | Other: Medical Records study<br>* No interventions will be done related to the study besides summary of the Medical Files.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of thrombophilic risk factors in preterms and infants | Recruitment of all premature and term infants born at Emek Medical Center and suffer from thrombotic events. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Newborns
Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to several drugs, including propofol. Few studies, however, have tested if propofol pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic effect of propofol after CPB. This study was designed to test the hypothesis that changes in the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced by changes in bispectral index (BIS) values. Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1) CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood samples for plasma propofol concentration measurements will be collected along the surgery and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral index values and propofol PK will be compared between the groups.

Official Title
-----------------
Effects of Cardiopulmonary Bypass on Plasma Propofol Concentrations and Bis Values During Coronary Surgery

Conditions
-----------------
Coronary Artery Disease, Cardiopulmonary Bypass, Coronary Artery Bypass Graft

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Isolated coronary artery bypass indication Left ventricular ejection fraction greater than 50 % Absence of preoperative pulmonary dysfunction Exclusion Criteria: Intra and postoperative circulatory shock Postoperative pulmonary dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| CABG group<br>Patients undergoing coronary artery bypass graft with cardiopulmonary bypass | |
| OPCAB group<br>Patients undergoing off-pump coronary artery bypass graft | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol pharmacodynamics and pharmacokinetics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiopulmonary bypass, coronary artery bypass graft, coronary artery disease, propofol, pharmacokinetics, pharmacodynamics