linjc16/ctgov huggingface dataset:
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

Study Overview
=================
Brief Summary
-----------------
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Detailed Description
-----------------
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia

Conditions
-----------------
Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
-----------------
* Drug: Silodosin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia. Exclusion Criteria: Medical conditions that would confound the efficacy evaluation. Medical conditions in which it would be unsafe to use an alpha-blocker. The use of concomitant drugs that would confound the efficacy evaluation. The use of concomitant drugs that would be unsafe with this alpha-blocker.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silodosin<br>Silodosin 8 mg once daily with food | Drug: Silodosin<br>* 8 mg daily for 12 weeks<br>* Other names: Rapaflo;|
| Placebo Comparator: placebo<br>Matching Placebo capsule once daily with food | Other: Placebo<br>* 1 capsule daily for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) | Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Urine Flow Rate (Qmax) | Change from baseline in maximum urine flow rate (Qmax)at Week 12 | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign prostatic hyperplasia, BPH, alpha blocker
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis

Official Title
-----------------
A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis

Conditions
-----------------
Primary Biliary Cholangitis

Intervention / Treatment
-----------------
* Drug: 18-22mg/kg/d Ursodeoxycholic
* Drug: 13-15mg/kg/d Ursodeoxycholic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with primary biliary cholangitis Treated with Ursodeoxycholic Acid in West China Hospital for at least 6 month and suboptimal response to Ursodeoxycholic Acid Exclusion Criteria: Autoimmune hepatitis Primary sclerosing cholangitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18-22mg/kg/d Ursodeoxycholic group<br> | Drug: 18-22mg/kg/d Ursodeoxycholic<br>* 18-22mg/kg/d Ursodeoxycholic<br>|
| Placebo Comparator: 13-15mg/kg/d Ursodeoxycholic group<br> | Drug: 13-15mg/kg/d Ursodeoxycholic<br>* 13-15mg/kg/d Ursodeoxycholic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) | Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms. | Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alkaline phosphatase | (ALP) | Week 2 and Month 1, 3, 6,9,12 | 
| Glutamyltransferase | (GGT) | Week 2 and Month 1, 3, 6,9,12 | 
| Alanine transaminase | (ALT) | Week 2 and Month 1, 3, 6 | 
| Aspartate transaminase | (AST) | Week 2 and Month 1, 3, 6, 9,12 | 
| Total bilirubin | (TB) | Week 2 and Month 1, 3, 6, 9,12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ursodeoxycholic Acid
Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C

Study Overview
=================
Brief Summary
-----------------
To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.

Official Title
-----------------
A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: VX-950
* Drug: ribavirin
* Drug: peginterferon alfa-2a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infected with hepatitis C virus Exclusion Criteria: Contraindications to peginterferon or ribavirin therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VX-950|nan|
|Drug: ribavirin|nan|
|Drug: peginterferon alfa-2a|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of triple combination therapy. |  | retrospective and prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin. |  | retrospective and prospective | 
| Plasma HCV RNA levels |  | retrospective and prospective |
Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to discover how often certain bacteria are found in the rectum at the time of a prostate needle biopsy to diagnose prostate cancer. Certain bacteria are of importance because they can cause serious infection. Antibiotics that urologists commonly use to prevent these bacteria from causing infection are no longer effective. Many physicians around the world are noting increased infections with antibiotic resistant bacteria. Therefore; despite treating patients who are to undergo prostate biopsy with antibiotics, certain patients are being readmitted to the hospital with a serious infection. In order to study the incidence of these particular bacteria, the best method is to culture the bacteria at the time of the biopsy. This involves one rectal culture swab just prior to needle biopsy of the prostate. Once the incidence of these bacteria is known we may take steps to prevent the serious infections that occur as a result of prostate biopsy.

Official Title
-----------------
Incidence of Fluoroquinolone Resistant Enterobacteraciae in Patients Undergoing Repeat Ultrasound Guided Prostate Biopsy

Conditions
-----------------
Bacterial Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult males repeat prostate biopsy Exclusion Criteria: first time prostate biopsy minors

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Repeat Prostate Biopsy<br>Men who undergo repeat prostate biopsy | |

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
-----------------
E. Coli, Prostate Biopsy
Clinical Trial to Evaluate the Efficacy and Safety of DWKH

Study Overview
=================
Brief Summary
-----------------
Randomized, Double-blind, Parellel, Multicenter, Active-controlled

Official Title
-----------------
Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWKH

Conditions
-----------------
Respiratory Infection

Intervention / Treatment
-----------------
* Drug: DWKH
* Drug: DWKH-R
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female aged between 19 and 80. Patients whose BSS score is over 5. Exclusion Criteria: Patients allergic to any ingredients of the study drugs. Moderate liver disease (ALT or AST > UNLx3). Moderate lung disease. Uncontrolled HTN. Uncontrolled DM. Uncontrolled thyroidism. Patients who is needed antibiotics during the study period. In the case of women, pregnant(Urine-HCG positive) or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: DWKH<br> | Drug: DWKH<br>* Administration of DWKH three times daily<br>|
| Active Comparator: DWKH-R<br> | Drug: DWKH-R<br>* Administration of DWKH-R three times daily<br>|
| Placebo Comparator: PLACEBO<br> | Drug: Placebo<br>* Administration of Placebo three times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchitis severity score (BSS) | Difference of the BSS score (0 to 4, higher score means more severe) | 0,4,7 days |
Does Assessment of Ambulance Medical Service Leads to Reduced Number of Transports to the Emergency Room?

Study Overview
=================
Brief Summary
-----------------
There is a need to reduce the number of ambulance transports to the Emergency Room to the patients who are not in need of urgent medical care. There are currently no studies and the aim of the study is to investigate if the ambulance transports to the Emergency Room can be reduced by a dialogue between a Registered Nurse in ambulance and a Medical Doctor in the Primary Care (called Ambulant assessment). In this connection there is also a need to follow up patients that not have been transported to the Emergency Room, secondary ambulance transport, relapse within 48 hours, type of examination and treatment and mortality.

Conditions
-----------------
Emergency Medical Service, Assessment, Registered Nurse

Intervention / Treatment
-----------------
* Other: Ambulant assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients >18 years ambulance missions in the Community of Borlänge/Falun (case) and Community of Leksand (control) weekday and weekend, 08:00 to 22:00 initially evaluated not to need urgent Medical care according RETTS Exclusion Criteria: initially evaluated need urgent Medical care according RETTS the patient unable to give consent to the study patient with existing care plan ambulance mission without patient

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Assessment of Ambulance Medical Service | Other: Ambulant assessment<br> <br> |
| No Intervention: Control<br>Local treatment guidelines | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of visits to the Emergency Room |  | Up to 24 months |
A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the blood levels of valproic acid in subjects with different body weights and to evaluate whether the pharmacokinetic parameters of this drug is altered in the obese population.

Detailed Description
-----------------
Many pharmacologic agents are dosed based on the weight of the patient, and studies are conducted to determine the appropriate doses of drugs for patients with different weights in order to find the safest and most effective dose for various weights. Valproic acid is a commonly used agent for the treatment of epilepsy, as well as migraine headaches and psychiatric disorders. This prospective study is designed to evaluate the effects of obesity on the pharmacokinetic parameters of valproic acid when compared to individuals at their healthy weight.

Official Title
-----------------
An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid

Conditions
-----------------
Healthy, Obesity, Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Valproic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female age 21-60 years Normal healthy volunteers as per interview at screening Willing and able to provide written informed consent and comply with the study protocol Exclusion Criteria: Inability to take oral medications pregnant or lactating females known hypersensitivity to valproic acid BMI less than 18.5 kg/m^2 BMI between 25 and 29.9 kg/m^2, inclusive Taking any drug or dietary supplement within one week prior to study period Consumption of food 6 hours prior to study drug ingestion Know family history or history of urea cycle disorders Past history of pancreatitis Past history of liver disease

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valproic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration time curve (AUC) from zero time to the 54-hour blood sampling and clearance in obese verses non-obese subjects after taking valproic acid. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Healthy, Obesity
Dairy Product Consumption and Impact on Nutritional Adequacy, Environment and Diet Cost

Study Overview
=================
Brief Summary
-----------------
This is a secondary analysis of dietary, demographic and health parameter data collected in the 2008/09-2011/12 National Diet and Nutrition Survey (NDNS), UK to determine the roles of dairy products in sustainable diets by modelling nutritional adequacy, financial cost and environmental impact of UK diets containing varying amounts of dairy products.

Official Title
-----------------
What Are the Roles of Dairy Products in Sustainable Diets? Modelling Nutritional Adequacy, Financial and Environmental Impacts

Conditions
-----------------
Diet Pattern Analysis, Environmental Impact, Nutrient Intakes, Cardio-metabolic Health, Dietary Cost

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible respondents were adults aged 19-64 years. Exclusion Criteria: Younger than age 18 or older than age 65

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake |  | 4 days |
Effect of Genetic Polymorphisms on Platinum Based Chemotherapy in Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This Study evaluate the effect of Polymorphism in the Excision repair cross-complementing group 5 (ERCC5) (rs1047768 and rs751402) gene on the clinical outcome of Platinum-based regimens used in the treatment of Non-Small Cell Lung Cancer (NSCLC) patients

Official Title
-----------------
Effect of Genetic Polymorphisms on Clinical Outcome of Platinum Based Chemotherapy in Non-Small Cell Lung Cancer Patients

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed with immunohistochemically and pathologically confirmed non-small cell lung cancer (NSCLC). Eastern Cooperative Oncology Group performance status (ECOG PS) = 0-2. Chemotherapy naïve. Age >18 years. Adequate bone marrow reserve Exclusion Criteria: Presence of Central nervous system(CNS) metastases. Inadequate liver function Inadequate renal function Serious comorbid systemic disorder incompatible with the study. 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 |
| --- | --- | --- |
| Progression-free survival (PFS) | It's defined as the time from day 1 of chemotherapy to the day of documented disease progression or death from any cause. | From the date of starting the chemotherapy until the date of documented disease progression or date of death from any cause assessed up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, non small cell lung cancer, Platinum
Cardiac Implantable Electronic Device (CIED) Research Study

Study Overview
=================
Brief Summary
-----------------
The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) implant and patient characteristics to support development of future CIED products and procedures.

Detailed Description
-----------------
This is a data collection, non-randomized, multi-center study. The study will consist of different cohorts with each cohort being independent from another cohort. Each cohort may have a distinct objective, cohort-specific subject population, procedures, and assessments. The study will follow subjects receiving routine care, who meet all of the inclusion criteria and none of the exclusion criteria.

Official Title
-----------------
Cardiac Implantable Electronic Device (CIED) Research Study

Conditions
-----------------
Arrhythmias, Cardiac, Bradycardia, Tachycardia

Intervention / Treatment
-----------------
* Device: cardiac implantable electronic devices (CIEDs)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age. Subject or legally authorized representative is willing and able to provide written informed consent. Subject is willing and able to complete the study procedures and visits for the duration of data collection requirements Exclusion Criteria: Subject is unwilling or unable to comply with study procedures as defined in the protocol. Subject with a medical condition that precludes the patient from participation in the opinion of the investigator. Subjects who cannot tolerate lying supine for long periods period of time per investigator discretion. Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CIED Indicated Subjects<br>Subjects indicated to receive a cardiac implantable electronic devices (CIEDs) | Device: cardiac implantable electronic devices (CIEDs)<br>* Subjects will be implanted with various cardiac implantable electronic devices and followed according to their standard of care. Medical imaging will be collected at various stages of the implant procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Development | Characterize Cardiovascular Implantable Electronic Device (CIED) implant and patient characteristics to support development of future CIED products and procedures. | 3 years |