linjc16/ctgov huggingface dataset:
Asan Multivessel Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate long-term prognoses of patients with multivessel coronary disease treated medically or surgically or percutaneously in real world practice.

Official Title
-----------------
Asan Medical Center Registry for Multivessel

Conditions
-----------------
Coronary Artery Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multivessel disease from 1995 in Asan Medical Center Age 19 and more Exclusion Criteria: For prospective cohort, not agreeing to participate with written informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Multivessel<br>from 1995 | Other: Treatment<br> <br> * Other names: Percutaneously;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite event | death, myocardial infarction, stroke, revascularization | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 1year | 
| Myocardial Infarction |  | 1year | 
| Stroke |  | 1year | 
| Revascularization |  | 1year | 
| Angina symptom |  | 1year | 
| Bleeding |  | 1year | 
| Re-hospitalization |  | 1year | 
| Stent thrombosis | by ARC(Academic Research Consortium) category | 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multivessel
ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
ISIS 104838 is an antisense oligonucleotide drug that reduces the production of a specific protein called tumor necrosis factor (TNF-alpha), a substance that contributes to joint pain and swelling in rheumatoid arthritis. ISIS 104838 works by blocking TNF-alpha messenger RNA, the instruction molecule that is required for the production of TNF-alpha protein. This trial will assess the safety and efficacy of ISIS 1048383 by subcutaneous injection, administered by 3 different dosing regimens for 3 months, versus placebo. Approximately 160 TNF-alpha inhibitor-naïve rheumatoid arthritis patients will be evaluated at 32 sites in the U.S. and Canada.

Official Title
-----------------
ISIS 104838-CS7, A Double-Blind, Placebo-Controlled, Randomized Trial of the Safety, Efficacy and Pharmacokinetic Profile of ISIS 104838 (TNF-alpha Antisense Oligonucleotide) Subcutaneous Injections in Active Rheumatoid Arthritis Patients

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

Intervention / Treatment
-----------------
* Drug: ISIS 104838


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age >/= 18 years. Rheumatoid arthritis for >/= 6 months. Active disease as defined by >/= 6 swollen and >/= 9 tender joints, AND an abnormal C-reactive protein or Westergren Erythrocyte Sedimentation Rate lab test, OR Morning Stiffness >/= 1 hour. Use of at least one DMARD, and ability to discontinue any current DMARD. Exclusion Criteria Onset of rheumatoid arthritis before the 16th birthday. Wheelchair or bed-bound functional level. No previous infliximab or etanercept treatment, or investigational therapy (not placebo) with other TNF-alpha inhibitors. Prednisone > 10 mg per day or more than one nonsteroidal anti-inflammatory drug. Patients with an active infection, a history of tuberculosis, multiple sclerosis, other poorly controlled medical illness, or a malignancy within the last 5 years. Patients who require intravenous heparin therapy or with a history of a bleeding problem.

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: ISIS 104838|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Prewarming on Microcirculatory Response

Study Overview
=================
Brief Summary
-----------------
Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is important for clinical outcome. The investigators hypothesized that prewarming during induction of general anesthesia would reduce drop of body temperature and change of peripheral microcirculation.

Detailed Description
-----------------
Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare the recovery slope during vascular occlusion test between prewarming treatment group and control group.

Official Title
-----------------
Effect of Prewarming on Microcirculatory Response

Conditions
-----------------
Coronary Artery Bypass Graft Triple Vessel

Intervention / Treatment
-----------------
* Device: prewarming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: off-pump coronary artery bypass surgery Exclusion Criteria: refuse to enroll cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula preoperative left ventricular ejection fraction < 35% preoperative continuous infusion of vasopressor or inotropes pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prewarming<br>prewarming during induction of anesthesia | Device: prewarming<br>* recovery slope StO2<br>* Other names: prewarming by active air heater;|
| No Intervention: control<br>no prewarming during induction of anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Slope | We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation. | 3 hours after induction of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Oxygen Saturation |  | During the surgery, an average of 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microcirculation, off-pump coronary artery bypass surgery, tissue oxygen saturation, vascular occlusion test, recovery slope
Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy

Study Overview
=================
Brief Summary
-----------------
Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation. Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia. The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.

Official Title
-----------------
A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Drug: FERRISAT
* Drug: PLACEBO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years Crohn's disease or Ulcerative Colitis defined according to the usual endoscopic, histological, and radiological criteria Under anti-TNF therapy or indication for starting an anti-TNF therapy Anemia defined according to World Health Organization (Hemoglobin under 13g/dl for man and Hemoglobin under 12g/dl for woman) Iron deficiency anemia defined as: Ferritinemia under 100 if C-Reactive Protein under normal value OR - Ferritinemia between 30 and 100 if C-Reactive Protein above normal value Exclusion Criteria: -

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 |
| --- | --- |
| Active Comparator: Ferrisat<br>Infusion of Ferrisat (50mg/ml) at inclusion under usual practices | Drug: FERRISAT<br>* A single infusion of 50 mg/ml of Ferrisat during inclusion visit.<br>* Other names: ACTIVE FERRISAT;|
| Placebo Comparator: Placebo<br>Infusion of placebo at inclusion visit | Drug: PLACEBO<br>* A single infusion of Glucose 5% solution during inclusion visit<br>* Other names: GLUCOSE 5%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of hemoglobin | Efficacy of one-shot perfusion of Ferrisat (Iron supplementation) | 6 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of Ferrisat |  | At Inclusion | 
| Improvement of quality of life |  | 6 weeks after perfusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory Bowel Disease, Anemia, Anti-TNF alpha theray, Ferrisat perfusion
Biologics for Stricturing Crohn's Diseases

Study Overview
=================
Brief Summary
-----------------
Recent researches have reported that biologics might be also effective for stricturing CD. However, the data were largely retrospective. Prospective studied are needed for evaluate the efficacy of biologics for stricturing Crohn's diseases.

Official Title
-----------------
The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study

Conditions
-----------------
The Efficacy of Biologics for Stricturing Crohn's Diseases

Intervention / Treatment
-----------------
* Other: treat these patients with biologics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with stricturing Crohn's diseases no surgical indication patients with asymptomatic penetrating diseases written consent acquired Exclusion Criteria: patients with surgical indication patients with symptomatic penetrating diseases contraindication of biologics anticipating other trial

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with stricturing Crohn's diseases<br>Patients with stricturing Crohn's diseases | Other: treat these patients with biologics<br>* treat these patients with biologics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical remission rate at 1 year | clinical remission rate at 1 year (CDAI less than 150) | clinical remission rate at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical remission rate at 5 year | clinical remission rate at 5 year (CDAI less than 150) | clinical remission rate at 5 year | 
| surgical recurrence rate at 1 and 5 year | surgical recurrence : needing surgery for CD recurrence | at 1 and 5 year | 
| endoscopic recurrence rate at 1 and 5 year | endoscopic recurrence: rutgeerts over i2b | at 1 and 5 year | 
| quality of life of patients assessed by IBDQ | IBDQ | at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year | 
| quality of life of patients assessed by Short form 12 | Short form 12 | at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year | 
| score of obstructive | range 0-6, higher means severe | at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year |
Comparison Between Sit-to-stand Test and Six-minute Walk Test in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Comparison between sit-to-stand test and six minutes walking test in chronic obstructive pulmonary disease patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: sit-to-stand test
* Procedure: six-minutes walking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically stable for a minimum of 4 weeks no recent infectious exacerbations Exclusion Criteria: musculoskeletal or joint disorders contra-indications to perform exercises

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sit-to-stand<br>To perform a sit-to-stand test | Procedure: sit-to-stand test<br> <br> |
| Active Comparator: six minute walking test<br>To perform a six minutes walking test | Procedure: six-minutes walking test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of sit-to-stand movement |  | 1 minute | 
| walked distance |  | 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | 6 minutes | 
| fraction of oxygen-saturated hemoglobin measured by pulsed oximeter |  | 6 minutes | 
| breathlessness measured by visual analogic scale |  | 6 minutes |
Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is whether Acetazolamide is effective in prevention of contrast nephropathy

Detailed Description
-----------------
Contrast induced nephropathy is one of common causes of acute renal failure many preventive protocol existed . 240 patient that underwent coronary angiography randomly divided in three groups.Group 1,2,3 will receive Bicarbonate ,Acetazolamide+Normal salin and Normal salin respectively.We compare prevalence of contrast nephropathy in each group.

Official Title
-----------------
Effect of Acetazolamide in Prevention of Contrast Nephropathy

Conditions
-----------------
Contrast Induced Nephropathy

Intervention / Treatment
-----------------
* Drug: sodium bicarbonate
* Drug: Acetazolamide
* Drug: normal salin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient that underwent coronary angiography Exclusion Criteria: serum Cr. more than 3 mg/dl electrolyte and acid-base imbalance pulmonary edema allergy to Acetazolamide

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>150 meq/l NaHco3 3cc/kg/hr one Hour before and 1cc/kg/hr 6 hour after angiography | Drug: sodium bicarbonate<br>* 150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography<br>* Other names: no other name;|
| Active Comparator: 2<br>Acetazolamide 250 mg + 1cc/kg/hr normal salin 6 hour before and after angiography | Drug: Acetazolamide<br>* Acetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography<br>* Other names: Diamox;|
| Active Comparator: 3<br>normal salin 1cc/kg/hr before and after angiography | Drug: normal salin<br>* 1 cc/kg/hr 6 hour before and after angiography<br>* Other names: no other name;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased base line creatinine at least 25% |  | 24 hr later |
Structural Orbital Changes in Anophthalmic Socket Syndrome

Study Overview
=================
Brief Summary
-----------------
Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.

Official Title
-----------------
Structural Orbital Changes in Anophthalmic Socket Syndrome

Conditions
-----------------
Anophthalmos; Acquired, Anophthalmic Socket Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Unilateral anophthalmic socket syndrome (superior sulcus grading 0 till 4) Enucleation/evisceration with primary implant more than 5 years ago After informed consent Exclusion Criteria: MRI absolute and relative contraindications such as metallic fragments or metallic containing devices, history of orbital trauma, previous anophthalmic socket and eyelid surgery, inflammation, infection, buphthalmos, congenital anophthalmos and radiation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Diagnostic Test: MRI<br>* Patients with unilateral ASS, with and without the prosthesis in situ, are analysed by 3D- magnetic resonance imaging (MRI) with 64 channel head coil using T1 and T2 weighted, DIXON/ IDEAL, and T2 inversion recovery sequences.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Displacement of orbital structures | mm in x,y,z axis | At least 5 years after enucleation or evisceration | 
| Volumetric orbital difference | ml | At least 5 years after enucleation or evisceration | 
| Surface comparisson of bony orbits | mm | At least 5 years after enucleation or evisceration |
Manipulation of Dietary Protein and the Anabolic Response

Study Overview
=================
Brief Summary
-----------------
In the present study, the effect of habitual dietary protein on the anabolic response will be investigated.

Official Title
-----------------
The Manipulation of Dietary Protein Intake on the Anabolic Response in Healthy Young Men

Conditions
-----------------
Focus: Anabolic Response to Food Intake in Young Individuals, Condition Relevance: Skeletal Muscle Health, Sarcopenia

Intervention / Treatment
-----------------
* Dietary Supplement: High protein intake
* Other: Placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males Aged between 18-35 years Healthy, recreationally active BMI < 30 kg/m2 Exclusion Criteria: Smoking Allergies to milk proteins (whey or casein) Vegetarians Diagnosed GI tract diseases Female Arthritic conditions A history of neuromuscular problems Previous participation in amino acid tracer studies Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein intake<br>High protein intake: large bolus of protein in teh diet the day before testing | Dietary Supplement: High protein intake<br> <br> |
| Placebo Comparator: No protein intake<br>No protein in the diet the day before testing | Other: Placebo comparator<br>* No protein intake<br>* Other names: control group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle protein fractional synthetic rate following protein ingestion | The ability of the muscle to synthesise new proteins will be assessed over a 3 h period following protein ingestion and will be compared between groups. This only occurs on one occasion. | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle protein synthesis, Dietary protein