linjc16/ctgov huggingface dataset:
Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.

Detailed Description
-----------------
Inclusion Criteria: Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR > 150mL

Official Title
-----------------
PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA

Conditions
-----------------
Hyperplasia

Intervention / Treatment
-----------------
* Drug: Naftopidil
* Drug: Tamsulosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men ≥ 50 years Signs and symptoms of BPH IPSS of ≥ 10 Prostate volume of ≥ 20 mL PVR > 150 mL Exclusion Criteria: History of allergy to a AR antagonists Treatment with antiandrogen drugs Drugs with anticholinergic activity Significant history of orthostatic hypotension Concomitant neurological diseases Known or suspected neurogenic bladder dysfunction Carcinoma of the prostate or bladder Previous surgery for BPH or bladder neck obstruction History of recurrent UTI Concomitant active UTI

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naftopidil<br>0,25 mg (2 weeks) and 0,50 mg (10 weeks) | Drug: Naftopidil<br>* 0,25 mg (2weeks) and 0,50 mg (10 weeks)<br>|
| Active Comparator: Tamsusolin<br>0,4 mg/day | Drug: Tamsulosin<br>* 0,4 mg/day<br>* Other names: SECOTEX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score |  | 2, 4, 8 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effect |  | 2, 4, 8 and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
naftopidil, symptoms of lower urinary tract, benign prostate hyperplasia, LUTS
Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

Study Overview
=================
Brief Summary
-----------------
Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis.

Official Title
-----------------
Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis: Multicenter, Prospective, Randomized, Double-blind Phase 3 Trial

Conditions
-----------------
Hemoptysis

Intervention / Treatment
-----------------
* Drug: tranexamic acid, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: >=20 and <=75 ER visit or admission for hemoptysis no evidence of hemoptysis on screening Exclusion Criteria: anticoagulation treatment Cr >= 2.0 mg/dL or urinary protein >= 2+ or who received renal replacement treatment hepatic failure: total bilirubin >= 1.5 mg/dL or AST or ALT >= 1.5 of upper normal limit level hypersensitivity to tranexamic acid pregnant woman fertile female who don't use contraception

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tranexamic acid<br>tranexamic acid 250mg po 3 times/day for 1 months | Drug: tranexamic acid, placebo<br>* tranexamic acid 250mg tid for 1 months vs. placebo for 1 months<br>|
| Placebo Comparator: placebo<br>placebo po 3 times/day for 1 months | Drug: tranexamic acid, placebo<br>* tranexamic acid 250mg tid for 1 months vs. placebo for 1 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of recurrence of hemoptysis |  | 6 month: 1months medication + 5months observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to recurrence |  | 6 month: 1months medication + 5months observation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemoptysis, recurrence
Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective of this randomized triple blind controlled trial is to compare the effects of Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75 patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete evacuation, and bloating are measured and compared between groups at the baseline and one and two month after the intervention.

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Doxepin
* Drug: Nortriptyline
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of diarrhea predominant irritable bowel syndrome according to ROME criteria Exclusion Criteria: Gastrointestinal bleeding More than 5% weight loss in the last 6 months Presence of any finding in favor of organic disorders in the lab tests or organic disorder in colonoscopy of high risk patients
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: doxepin<br> | Drug: Doxepin<br> <br> |
| Active Comparator: nortriptyline<br> | Drug: Nortriptyline<br> <br> |
| Placebo Comparator: placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evolution of Pulse Pressure Following Initiation of Antihypertensive Therapy in Patients With Essential Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
The main purpose of this prospective, multicentre, french observational study is to analyse the evolution of pulse pressure (PP) and to identify its prognostic factors in hypertensive patients three months after initiation of a new hypertensive therapy. The PP is defined as the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP).

Official Title
-----------------
Evolution of Pulse Pressure Following Initiation of Antihypertensive Therapy

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Micardis®
* Drug: Other hypertensives


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with essential arterial hypertension needing a new antihypertensive therapy A patient was included by the physician only if he/she had agreed after being informed about the study Exclusion Criteria:
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Essential arterial hypertension<br>Patients with essential arterial hypertension needing a new antihypertensive therapy | Drug: Micardis®<br> <br> * Other names: Telmisartan;Drug: Other hypertensives<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in pulse pressure |  | Up to 3 months after start of treatment | 
| Number of patients with adverse drug reactions |  | Up to 3 months after start of treatment |
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Detailed Description
-----------------
This study is a multi-center trial consisting of a 24-week open-label period, followed by a 4-week double-blind, placebo-controlled, randomized withdrawal period. At the Week 24 visit, subjects will be randomized in a 1:1 ratio either to continue to receive AXS-12 or to switch to placebo, for the next 4 weeks. Eligible subjects will have previously participated in the AXS-12-301 study.

Official Title
-----------------
A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy

Conditions
-----------------
Narcolepsy, Cataplexy, Excessive Daytime Sleepiness

Intervention / Treatment
-----------------
* Drug: AXS-12 (reboxetine)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the treatment period of Study AXS-12-301 Willing and able to comply with the study requirements Exclusion Criteria: Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 75 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
Interventional Model Description: Open-label treatment period, followed by a double-blind treatment period.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-12 (reboxetine)<br>Up to 24 weeks in open-label period Up to 4 weeks in randomized double-blind period | Drug: AXS-12 (reboxetine)<br>* AXS-12 tablets, taken twice daily<br>|
| Placebo Comparator: Placebo<br>Up to 4 weeks in randomized double-blind period | Drug: Placebo<br>* Placebo tablets, taken twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety as measured by the incidence of treatment-emergent adverse events |  | Up to 28 weeks | 
| Efficacy as measured by change in frequency of cataplexy attacks from baseline. |  | Baseline to Week 27 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AXS-12, Narcolepsy, Cataplexy, Excessive Daytime Sleepiness, Reboxetine, Axsome
Assessment of Retinal Nerve Fibre Layer by Optical Coherence Tomography in Uveitis Patients With Papilloedema

Study Overview
=================
Brief Summary
-----------------
Assessment of optic disc morphology can be difficult in patients with uveitis and papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning techniques may help to detect damage to the retinal nerve fibre layer.

Official Title
-----------------
Retinal Nerve Fibre Layer in Uveitic Secondary Glaucoma

Conditions
-----------------
Uveitis, Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anterior or intermediate uveitis papilloedema glaucoma Exclusion Criteria: dense cataract dense vitreous opacification circular posterior synechiae

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| papilloedema without glaucoma<br> | |
| papilloedema with glaucoma<br> | |
| glaucoma without papilloedema<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations of retinal nerve fibre layer by optical coherence tomography | Baseline comparision of retinal nerve fibre layer thickness in patients with uveitis and with or without papilloedema at study entry. No follow-up examination scheduled | once at study entry | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior and intermediate uveitis, papilloedema
Observatory of Pulmonary Arterial Hypertension of Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The complex congenital cardiac malformations are a significant number of different diseases, each having specific natural histories. The interface with pulmonary arterial hypertension (HTAP) is high since the physiology of many of these disorders comprises alterations in pulmonary vasculature. This observatory is a cohort of 400 patients enrolled in 3 years, older than one month, having been informed and have agreed to participate in the study and with congenital heart disease other than patent foramen ovale as well as a diagnosis of pulmonary hypertension confirmed by cardiac catheterization. The main objectives of this report are to know Incidence of congenital heart disease in HTAP France. Describe the natural history of HTAP in a large population of patients Congenital heart disease in France The characteristics of HTAP congenital heart disease Having a cohort study

Official Title
-----------------
Observatory of Pulmonary Arterial Hypertension of Congenital Heart Disease

Conditions
-----------------
Pulmonary Arterial Hypertension of Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has a congenital heart disease other than patent foramen ovale The diagnosis of pulmonary hypertension was confirmed by cardiac catheterization. Only patients with Eisenmenger syndrome can be included without catheterization. The catheterization was done after 1 January 2009 A mean pulmonary artery pressure > 25 mm Hg Pulmonary vascular resistances > 3 piece Wood m2 Pulmonary capillary pressure available Consent for inclusion in the study must be signed by parents or legal guardians for minors, by the patient for adults. The patient he had a surgical procedure or interventional catheterization cardiac catheterization between his diagnosis and inclusion in the observatory? If yes, it can only be included if a new catheterization confirmed the persistence of HTAP at least 6 months after the procedure. Patient follow-up (at least once a year) in the center for its HTAP associated with congenital heart disease its

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HTAP of Congenital Heart Disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence HTAP of congenital heart disease in France. | Number of HTAP of congenital heart disease in France after 3 years of inclusions | 3 years |
Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol

Study Overview
=================
Brief Summary
-----------------
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Combination With Zetia® Compared to Zetia® Alone in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Colesevelam Hydrochloride
* Drug: Ezetimibe
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years of age, inclusive; A history of primary hypercholesterolemia Exclusion Criteria: Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data; Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Colesevelam Hydrochloride|nan|
|Drug: Ezetimibe|nan|
|Drug: Simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change in LDL-C from the start of the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - The absolute change in LDL-C from baseline |  |  | 
| - The percent change in LDL-C from baseline |  |  | 
| - The absolute changes and percent changes in TG, non-HDL- |  |  | 
| C, HDL-C, total cholesterol and other lipid measures |  |  | 
| - The percentages of patients who achieve target levels of LDL-C at the end of the study |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Efficacy, WelChol®, Zocor®, Zetia®
Mammography SPECT With Rotating Slant Hole Collimator

Study Overview
=================
Brief Summary
-----------------
The goal is to conduct a pilot study to determine the feasibility of the clinical use of RMSSH SPECT imaging technology for breast imaging and to develop a standardized clinical protocol.

Detailed Description
-----------------
The goal of this protocol is to develop and evaluate a novel SPECT imaging technique for imaging the breast using rotating multi-segment slant-hole (RMSSH) collimators. The motivation is the requirement of a low cost RMSSH collimator and a conventional Large-Field-Of-View (LFOV) camera. It is believed that RMSSH SPECT is particularly suitable for applications in breast imaging.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women seen at Johns Hopkins Avon Division of Breast Imaging who have been diagnosed with breast cancer. Exclusion Criteria: Pregnant (or possibly pregnant) Lactating Unable to give consent Weights over 300 pounds Women who have already undergone definitive surgical treatment to their breast for breast cancer will not be eligible.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
Group Hypnosis for Stress Reduction

Study Overview
=================
Brief Summary
-----------------
This prospective feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects.

Detailed Description
-----------------
In a pre- post comparison the feasibility of a standardized weekly 90 minutes group hypnosis training including CDs/MP3 recordings as homework to reduce perceived psychological stress in healthy subjects is investigated. Outcomes are measured quantitatively and qualitatively.

Official Title
-----------------
Group Hypnosis for Stress Reduction - a Feasibility Study

Conditions
-----------------
Stress, Psychological

Intervention / Treatment
-----------------
* Behavioral: Group hypnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy or health-stable participants between 18 and 70 years with subjective increased intensity of stress in the last four weeks on the visual analogue scale rated between 40 -100 mm (VAS 0 - 100 mm) Ability to consent and sign declaration of informed consent Exclusion Criteria: Current or planned participation in a stress management program within the next 17 weeks Current use of psychotherapeutic treatment presence of moderate or severe acute or chronic disease presence of an acute or chronic mental disorder Participation in a study within the last 2 months prior to enrollment Lack of understanding of the German language

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Hypnosis<br>5 sessions of group hypnosis, each 90 minutes; plus CDs/MP3 recordings to train at home | Behavioral: Group hypnosis<br>* 5 session of group hypnosis, each 90 minutes, to reduce subjective stress and increase relaxation. Additional auditapes of hypnosis sessions as hoemwork<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress on Visual Analogue Scale | VAS 0-100 mm | 5 weeks | 
| Cohens Perceived Stress Scale 10 Items |  | 5 weeks | 
| Likert-Skala | about stressreduction | 5 weeks | 
| ADS-K (Depression) |  | 5 weeks | 
| General Self Efficacy Scale (Schwarzer) |  | 5 weeks | 
| SF 36 Quality of Life |  | 5 weeks |