linjc16/ctgov huggingface dataset:
Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.

Official Title
-----------------
Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients With Iron Deficiency

Conditions
-----------------
Iron Deficiency, Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: Ferinject (ferric carboxymaltose)
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF Reduced exercise capacity Reduced left ventricular ejection fraction At least 18 years of age and with written informed consent prior to any study specific procedures Exclusion Criteria: Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months Chronic liver disease and/or elevated liver enzymes Vitamin B12 and/or serum folate deficiency Subject is not using adequate contraceptive precautions during the study No other significant cardiac or general disorder that would compromise participation in the study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferinject (ferric carboxymaltose)<br> | Drug: Ferinject (ferric carboxymaltose)<br>* Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12<br>|
| Other: Standard of Care<br>Standard of care. IV iron is not permitted | Other: Standard of Care<br>* Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak VO2 (mL/kg/min) from baseline to Week 24 |  | Week 24 |
Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1

Study Overview
=================
Brief Summary
-----------------
In the present study we will measure and compare the unbound, i.e. microbiologically active concentrations of doripenem after a single dose of 500mg in plasma, subcutaneous adipose tissue and muscle tissue and saliva of healthy volunteers. We will use the microdialysis technique, which allows for the continuous measurement of unbound drug concentrations in the interstitial space fluid. The findings of the present study will help to assess whether currently employed therapy regimens with doripenem provide effective antimicrobial concentrations in different compartments in man

Official Title
-----------------
Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers - a Pilot Study

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

Intervention / Treatment
-----------------
* Drug: doripenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male Exclusion Criteria: Female Ill

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doripenem i.v.<br>no comparator, PK study | Drug: doripenem<br>* doripenem once i.v.500mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time versus unbound doripenem concentration profiles in the interstitial space fluid of non inflamed subcutaneous adipose tissue, muscle tissue, saliva and plasma |  |  |
Cytokine Response in Septic Shock

Study Overview
=================
Brief Summary
-----------------
This study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease. The specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).

Detailed Description
-----------------
Patients must be on vasopressors Patients cannot be on pressors for > 24 hrs prior to consent

Official Title
-----------------
Cytokine Response in Septic Shock

Conditions
-----------------
Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ICU patients: . 18 years admitted with septic shock Receiving Vasopressors < 24 hrs Exclusion Criteria: Consent refused by patient or SDM Received Vasopressors > 24hrs

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 |
| --- | --- | --- |
| Cytokine response in septic shock | his study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease. The specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc). | Hours 0, 3, 6, 12, 18, 24, 36, 48, 96 and day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU population
Cocaine Abuse and ADHD - 10

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of buproprion in treating individuals with adult attention-deficit hyperactivity disorder (ADHD) and cocaine dependence.

Official Title
-----------------
Cocaine Abuse and ADHD

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Flupenthixol


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Drug use |  |  | 
| Cocaine craving |  |  | 
| ADHD symptoms |  |  | 
| Improvement in functioning |  |  | 
| Tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Heated Pool Exercise Groups for Patients With Rheumatic Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of heated pool group exercises for patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue, stiffness and ability to carry out daily activities).

Detailed Description
-----------------
The patients receive text messages on mobile phones twice a week for circa 40 weeks. The text messages ask for pain, fatigue, stiffness and ability to carry out everyday activities. The patients should respond with a number from 0 to 10, where 0 is no symptoms/no hindering of activity and 10 is worst symptoms/worst hindering of activity.

Official Title
-----------------
Better Everyday-life With Heated Pool Exercise Groups for Patients With Inflammatory Rheumatic Diseases

Conditions
-----------------
Rheumatic Disease

Intervention / Treatment
-----------------
* Procedure: Pool exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral from a medical doctor to group exercises in heated pool Inflammatory rheumatic joint disease > 18 years Stable disease Mobile phone owner Understand and use text messages on mobile phones Exclusion Criteria: Independent living Joint surgery previous to the study start

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 |
| --- | --- |
| Pool exercise group<br>Patients with inflammatory rheumatic disease | Procedure: Pool exercise<br>* Group exercise in heated pool one hour per week for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity | How much do your health problems affect your ability to conduct daily activities? The outcome is assessed on a ten-point rating scale ranging from zero to ten with 0 representing no affect and 10 representing extreme affect. | 40 weeks | 
| Pain | How much pain do you have at present? The outcome is measured on a ten-point numeric rating scale (NRS) ranging from zero to ten with 0 representing no pain and 10 representing extreme pain. | 40 weeks | 
| Fatigue | How much fatigue do you have at present? The outcome is assesses on a ten-point rating scale ranging from zero to ten with 0 representing no fatigue and 10 representing extreme fatigue | 40 weeks | 
| Stiffness | How much stiffness do you have at present? The outcome is assessed on a ten-point numeric rating scale with 0 representing no stiffness and 10 representing extreme stiffness. | 40 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory rheumatic joint disease, text message, > 18 years, Norwegian speaking
Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%

Study Overview
=================
Brief Summary
-----------------
A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%

Official Title
-----------------
Three Month Safety and Efficacy Study of TRAVATAN® vs Travoprost Ophthalmic Solution, 0.004%

Conditions
-----------------
Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost Ophthalmic Solution, 0.004% (New Formulation)
* Drug: TRAVATAN®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older Either gender Any race/ethnicity Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension Exclusion Criteria: Patients with any form of glaucoma other than open-angle glaucoma. Patients with a central cornea thickness greater than 620 μm Patients with Shaffer angle Grade < 2 Patients with a cup/disc ratio greater than 0.80 Patients with severe central visual field loss Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent) Chronic, recurrent or severe inflammatory eye disease Clinically significant or progressive retinal disease Other ocular pathology

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: Travoprost Ophthalmic Solution, 0.004% (New Formulation)<br> | Drug: Travoprost Ophthalmic Solution, 0.004% (New Formulation)<br>* Travoprost Ophthalmic Solution, 0.004% given one drop once daily<br>|
| Active Comparator: TRAVATAN®<br>TRAVATAN® administered one drop once daily | Drug: TRAVATAN®<br>* TRAVATAN® administered one drop once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: mean IOP Efficacy as measured by mean IOP |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open angle glaucoma, ocular hypertension
Concomitant Tricuspid Repair in Patients With Left Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform concomitant tricuspid-valve repair during left heart surgery in patients who have mild tricuspid regurgitation. To inform decision making, we will conduct a multicenter, randomized trial to assess the benefits and risks of tricuspid-valve repair at the time of left heart diseases in patients with mild tricuspid regurgitation who were undergoing surgery for left heart surgery.

Official Title
-----------------
Concomitant Tricuspid Repair in Patients With Left Heart Surgery: Randomized Controlled Trial

Conditions
-----------------
Tricuspid Regurgitation, Mitral Regurgitation, Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Device: Tricuspid repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing left heart valve surgery with mild tricuspid regurgitation; Patients aged 18-80 years; Agree to participate in this study and sign the informed consent form. Exclusion Criteria: Infective endocarditis within 3 months; Primary tricuspid regurgitation; Isolated tricuspid regurgitation Lactating women and suspected pregnant or pregnant women; Patients with mental disorders, drug and alcohol dependence; Those who participated in other clinical trials one month before the trial; Refusal to participate in this study without informed consent.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tricuspid repair<br>Tricuspid repair techniques included suture placement and the type of prosthetic annuloplasty with specified the use of an approved rigid, incomplete, nonplanar, and undersized (ranging 26, 28, or 30, 32, 34 mm) ring. | Device: Tricuspid repair<br>* Tricuspid repair included suture placement and the type of prosthetic annuloplasty.<br>|
| No Intervention: Blank control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite of adverse cardiovascular events | a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation from baseline by two grades or the presence of severe tricuspid regurgitation, or death. | 2 years after surgery at follow-up |
Acute Diverticulitis and C-Reactive Protein as a Prognostic Marker

Study Overview
=================
Brief Summary
-----------------
The management of acute diverticulitis maybe better if we have prognostic markers of evolution. Hypothesis: C-reactive protein maybe a good prognostic marker of evolution of acute diverticulitis. The investigators need to know the values of C-reactive protein to predict evolution of acute diverticulitis.

Detailed Description
-----------------
A prospective observational study. All the patients with TC-diagnosis of acute diverticulitis (AD) had a C-reactive protein (PCR) in the initial blood test. The investigators will predict evolution of AD with the PCR initial.

Official Title
-----------------
Predictive Value of C-Reactive Protein in Acute Diverticulitis

Conditions
-----------------
Acute Diverticulitis

Intervention / Treatment
-----------------
* Other: C-reactive protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Diverticulitis Exclusion Criteria: Other Abdominal Pathologies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Acute Diverticulitis<br>We measured C-reactive protein in all the patients diagnosed with acute diverticulitis | Other: C-reactive protein<br>* measured C-reactive protein in all patients with acute diverticulitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive Protein |  | 24 Hours |
Epidemiology of Injuries Caused by the Practice of Artificial Structure Climbing

Study Overview
=================
Brief Summary
-----------------
This study aims to precisely describe epidemiology of injuries than occur during practice of climbing in artificial structure. Each participant will complete questionnaires in order to identify injuries. The first questionnaire will be completed at the moment of the inclusion and the second questionnaire will be completed if participant has injuries every 3 months until month 12.

Official Title
-----------------
Epidemiology of Injuries Caused by the Practice of Artificial Structure Climbing: Prospective Cohort Study in Réunion Island

Conditions
-----------------
Sport Injury

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - person who practices artificial structure climbing Exclusion Criteria: person who refuses to participate person under tutorship or curatorship person who cannot read and write person who wants to leave Reunion Island within 12 months

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

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Participant must complete a questionnaire about injury during climbing practice in an artificial structure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| location of injury |  | at month 3 | 
| laterality of injury |  | at month 3 | 
| mechanism of injury | it will be identified as a traumatic injury or an overuse. Traumatic injury is due to an acute identified event. An overuse is due to repetitive train injury. | at month 3 | 
| circumstance of injury occurence |  | at month 3 | 
| injury relapse or not | injury relapse is classified as early relapse if occurs within 2 months after the healing, as late relapse if occurs from 2 months to 12 months after the healing or as very late relapse if occurs after more 12 months. | at month 3 | 
| diagnosis of injury | diagnosis will be claissified according to the OSICS 10 classification | at month 3 | 
| record of exposure to injury | Training volume will be recorded by level of practice (leisure practice, club practice and competition practice) | at month 3 |