linjc16/ctgov huggingface dataset:
Matrix Metalloproteinases in Atherosclerosis of Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether matrix metalloproteinases are associated with atherosclerosis in the different stages of chronic kidney disease.

Detailed Description
-----------------
The purpose of this study is to determine the correlation of matrix metalloproteinases and atherosclerosis of chronic kidney disease. Patients with diabetes mellitus type 2,as a non-inflammatory leading cause of end stage renal failure and patients with chronic glomerulonephritis and similar course of proteinuria,as an inflammatory leading cause of end stage renal failure are enrolled.

Official Title
-----------------
The Role of Matrix Metalloproteinases -2 and -9 in Atherosclerosis of Patients With Chronic Kidney Disease

Conditions
-----------------
Diabetic Nephropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease Diabetes mellitus type 2 Exclusion Criteria: Malignancy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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 |
| --- | --- |
| Diabetic nephropathy<br>Diabetic nephropathy in patients with type 2 diabetes | |
| chronic glomerulonephritis<br>chronic glomerulonephritis in patients without diabetes mellitus | |
| controls<br>participants without diabetic nephropathy and chronic glomerulonephritis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of matrix metalloproteinases with atherosclerosis in patients with chronic kidney disease | Matrix metalloproteinases associated with atherosclerosis in chronic kidney disease;patients with diabetes mellitus type 2 and others with chronic glomerulonephritis.Serum levels of MMPs-2 and -9 are measured by an ELISA system.Intima Media Thickness(IMT) of carotid and femoral arteries is measured with a high resolution ultrasonography. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Matrix metalloproteinases and atherosclerosis associated with pro-inflammatory and oxidative stress markers in chronic kidney disease | Matrix metalloproteinases associated with atherosclerosis markers,pro-inflammatory markers and markers of oxidative stress in chronic kidney disease | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gelatinases, kidney disease, diabetes mellitus type 2
Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

Study Overview
=================
Brief Summary
-----------------
Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode. This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up. The secondary end points are the cost and the cost/effectiveness ratio of these two approaches.

Official Title
-----------------
Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Procedure: Radiofrequency catheter ablation of typical atrial flutter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first episode of symptomatic typical atrial flutter > 18 years old Exclusion Criteria: Prior antiarrhythmic drug treatment for atrial flutter History of cavotricuspid isthmus ablation Pregnancy Hyperthyroidism contraindication for anticoagulant therapy Life expectancy < 1 year contraindication to catheter ablation or to electrical cardioversion

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

| Intervention/Treatment |
| --- |
|Procedure: Radiofrequency catheter ablation of typical atrial flutter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of typical atrial flutter recurrence at 6 and 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost/effectiveness ratio at 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia, atrial flutter, catheter ablation
Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.

Official Title
-----------------
A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia

Conditions
-----------------
Community Acquired Pneumonia, Bacterial Pneumonia, Cross Infection

Intervention / Treatment
-----------------
* Drug: tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects ≥ 18 years of ag. Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated The presence of fever (within 24 hours prior to randomization), defined as oral temperature >38°C/100.4°F, axillary temperature >38.1°C/100.6°F, tympanic temperature >38.5°C/ 101.2°F, or a rectal/core temperature >39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature <35°C/95° Exclusion Criteria: Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy <30 days) Hospitalization within 14 days prior to the onset of symptoms Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms

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
Masking: Double


Arms and Interventions

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

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
-----------------
Bacterial Pneumonia
The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

Study Overview
=================
Brief Summary
-----------------
Dysphagia is one of severe complications among stroke survivors. Dysphagia is usually associated with high levels of morbidity, mortality, and financial cost. In recent years, repetitive transcranial magnetic stimulation (rTMS) has shown promise to facilitate poststroke dysphagia. However, most researches were preliminary studies in the past. The present study aims to investigate the immediate and long-term efficacy of high frequency rTMS on chronic dysphagic patients.

Detailed Description
-----------------
rTMS protocol: 5 Hz real or sham stimulation, 10 minutes per day, for 10 week-days.

Official Title
-----------------
Phase 2 Study of rTMS on Poststroke Dysphagia

Conditions
-----------------
Stroke, Dysphagia

Intervention / Treatment
-----------------
* Device: rTMS, Magstim Rapid2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Poststroke dysphagia more than 3 months Exclusion Criteria: Hx of seizure or a metalic device in brain or chest

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real 5 Hz rTMS<br>real 5 Hz rTMS, 10 minutes per day, for 10 weekdays. | Device: rTMS, Magstim Rapid2<br>* 5 Hz rTMS<br>|
| Sham Comparator: sham 5 Hz rTMS<br>sham 5Hz rTMS, 10 minutes per day, for 10 weekdays. | Device: rTMS, Magstim Rapid2<br>* 5 Hz rTMS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia severity on Aus TOMs swallowing score |  | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging evidence with video-esophagography |  | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, dysphagia, rTMS
A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.

Official Title
-----------------
Retrospective, Multi-center, Observational Study of Daily Practice Patterns and Outcomes of the Management of Rheumatoid Arthritis Patients Without Documented Erosions Treated With RoACTEMRA in Belgium

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >=18 years of age Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 >=5.1 Inadequate responder to at least 2 non-biological DMARDs Absence of documented erosions at start of RoActemra/Actemra treatment Received RoActemra/Actemra treatment for at least 6 months Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit Exclusion Criteria: Contraindications for treatment with RoActemra/Actemra

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint erosion assessment in clinical practice |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score 28 |  | 6 months | 
| C-reactive protein assessment |  | 6 months | 
| Swollen joint counts |  | 6 months | 
| Tender joint counts |  | 6 months | 
| Erythrocyte Sedimentation Rate |  | 6 months | 
| Evolution of the pattern of joint erosion |  | 6 months | 
| Patient's global assessment of disease activity (Visual Analogue Scale) |  | 6 months |
Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

Study Overview
=================
Brief Summary
-----------------
Pupillar diameter variation to predict success or failure of external ventricular derivation clamping. Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in neurological ICU should improve patients care in several ways : earlier use of ventriculo-peritoneal or ventriculo-atrial shunts to shorten the external ventricular treatment duration and thus reduce risks of infection and hospital stay duration limit the medical imagery prescription and radiation exposition avoid neurological deterioration linked to the external ventricular drain clamping in case of the pupillometric parameters variation would be earlier than clinical signs

Official Title
-----------------
Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

Conditions
-----------------
Brain Damage, External Ventricular Drain, Hydrocephalus

Intervention / Treatment
-----------------
* Diagnostic Test: Pupillometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neurologic ICU hospitalization Traumatic brain injury External ventricular drain Exclusion Criteria: Legal protection refusal therapeutics limitation craniectomy pupillar anomaly

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Pupillometry|Pupillar diameter variation measurement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupillar diameter variation to predict success or failure of external ventricular clamping | Pupillar diameter variation twenty-four hours after external ventricular drain clamping | 24 hours after clamping |
Phase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis treated for 28 days.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of VX-765 in Subjects With Chronic Plaque Psoriasis Requiring Systemic Therapy

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: VX-765


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with chronic plaque psoriasis for at least 6 months Prior systemic therapy Exclusion Criteria: Current or prior history of illness precluding use of immunomodulatory therapy.

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

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

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: VX-765|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  |  | 
| Abnormal laboratory values |  |  | 
| Abnormal ECGs and vital signs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK/PD |  |  | 
| Target lesion score after 28 days of treatment |  |  | 
| Proportion of subjects meeting clear or almost clear criteria utilizing a static Physician's Global Assessment (sPGA) |  |  | 
| Proportion of subjects demonstrating ≥ 50% and ≥ 75% decrease from baseline in Psoriasis Area and Severity Index (PASI) to the end of 28 days of treatment |  |  | 
| Change in PASI from baseline to the end of 28 days of treatment |  |  |
Inflammation and Vascular Function in Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function.

Detailed Description
-----------------
To test the hypothesis that inhibition of I [kappa] B kinase [beta] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis.

Official Title
-----------------
Inflammation and Vascular Function in Atherosclerosis

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: salsalate
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoking adult subjects with known atherosclerosis Exclusion Criteria: Uncontrolled hypertension (> 140/90 mmHg) Untreated hypercholesterolemia (LDL > 160 mg/dL) Diabetes mellitus Alanine Aminotransferase > 150 Creatinine > 1.4 mg/dL Concommitant use of warfarin

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Salsalate first, then Placebo<br>In this crossover study, this group was randomly allocated therapy with salsalate first, a 4 week washout, then 4 weeks of placebo therapy in a double-blinded fashion. | Drug: salsalate<br>* 1.5 grams orally 3 times daily<br>* Other names: Disalcid;|
| Placebo Comparator: Placebo first, then Salsalate<br>In this crossover study, this group was randomly allocated therapy with placebo first, a 4 week washout, then 4 weeks of salsalate therapy in a double-blinded fashion. | Drug: placebo<br>* matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated, Endothelium-dependent Vasodilation | Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared. | Upon completion of 4 weeks of salsalate and placebo treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vascular inflammation, endothelium-dependent flow-mediated blood vessel function
Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State

Study Overview
=================
Brief Summary
-----------------
This study will test two different formulations. The results will be used to select formulation for phase 3.

Official Title
-----------------
A Phase 1, Open-Label, Randomized, 3-Way Crossover Study In Healthy Subjects To Estimate The Pharmacokinetics Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State

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

Intervention / Treatment
-----------------
* Drug: Pharmacokinetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers. Exclusion Criteria: Standard for healthy volunteers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-00868554<br> | Drug: Pharmacokinetics<br>* Single dose of 750 mg PF-00868554 as a solution and tablets.<br>* Other names: pharmacokintics;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC inf, Cmax |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 2 days |