linjc16/ctgov huggingface dataset:
Efficacy of Topical Cyclosporine A for Treatment and Prevention of Graft Rejection in Corneal Grafts With Previous Rejection Episodes

Study Overview
=================
Brief Summary
-----------------
The use of topical Cyclosporine A early after an episode of endothelial graft rejection after penetrating keratoplasty and continuing its administration for 6 months can reduce the course of that episode and recurrence of the rejection.

Conditions
-----------------
Endothelial Graft Rejection

Intervention / Treatment
-----------------
* Drug: Sandimmune
* Drug: Artelose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Penetrating keratoplasty in eyes without vascularization Exclusion Criteria: History of previous intraocular surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Cyclosporine A 2%<br> | Drug: Sandimmune<br> <br> |
| Placebo Comparator: Artificial tears<br> | Drug: Artelose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of rejection after drop sessation |  | 3 years |
European Survey of Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the current management strategies in a pan-European real-life setting to uncover the unmet need in this area: non-variceal gastrointestinal bleedings.

Official Title
-----------------
European Survey of Non-Variceal Upper Gastro Intestinal Bleeding

Conditions
-----------------
Non-variceal Upper Gastrointestinal Bleeding, Gastrointestinal Ulcer, Gastrointestinal Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the hospital or inpatients with an overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia, as well as other clinical/laboratory evidences of acute blood loss from the upper GI tract Evidence that an upper GI endoscopy was performed The complete medical record is available for study related hospitalization. Exclusion Criteria: NA

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 |
| --- | --- |
| 1<br>Patients admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe clinical outcomes associated with current strategies of endoscopic and pharmacological treatment in several European countries, in respect of bleeding continuation, rebleeding, surgery and in-hospital mortality |  | Up to 30 days after the episode (bleeding) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe clinical management and how this compares across countries and Hospital types |  | Up to 30 days after the episode (bleeding) | 
| To assess predictive factors for clinical management strategies and predictive factors related to clinical outcomes |  | Up to 30 days after the episode (bleeding) | 
| To assess health care resource consumption in patients admitted with non-variceal upper gastrointestinal bleeding and the main drivers |  | Up to 30 days after the episode (bleeding) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleeding, ulcer, hemorrhage, gastrointestinal diseases, digestive system disease, peptic ulcer, proton pump inhibitor
Cardio-Respiratory Health and Indoor Pollution

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess in the sample of population resident in the KHUMBU valley (NEPAL): the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance the presence of markers of early atherosclerosis with ultrasound and to estimate the value of systolic pulmonary pressure in comparison with not exposed subjects. The investigators hypothesize that the chronic exposure to indoor pollution can accelerate the physiological respiratory function decline, usually around 15-20mL/year in healthy subjects induce cardiovascular impairment The population of high altitude villages is a unique sample to study the effect of the only indoor pollution. In fact, the absence of traffic, due to the lack of roads, and the very low level of smoking habits allow to have no other confounding factors to study and analyze how the architectural features of the buildings of the village (distribution of domestic locals, natural or non natural ventilation systems, domestic activities, materials used, etc.) affect the indoor pollution from carbon monoxide, which necessarily is developed indoor during the daily life activities. What the project prospects is to gather information focused on the scale of the building, independently from the typology, to study a model that will help to describe which aspects are most important to what concern the genesis of the pollution of the indoor air.

Official Title
-----------------
Cardio-Respiratory Health in High Altitude Residents Exposed to Indoor Pollution

Conditions
-----------------
Pulmonary Disease, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: residents in the villages of the valley Exclusion Criteria: under the age of 14

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High altitude, respiratory function, cardiorespiratory health, indoor pollution
ECMELLA vs. ECMO on 30-day Mortality

Study Overview
=================
Brief Summary
-----------------
This international, multicenter cohort study aims to investigate outcomes after treatment with extracorporeal cardiopulmonary resuscitation (eCPR) during cardiac arrest.

Detailed Description
-----------------
Left ventricular unloading with Impella® micro-axial pump has been shown to improve survival in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This study aims to investigate whether treatment with VA-ECMO and Impella ® (so called ECMELLA) during extracorporeal cardiopulmonary resuscitation is associated with improved outcomes.

Official Title
-----------------
Treatment With Leftventricular Impella® Micro-axial Pump and Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) During Extracorporeal Cardiopulmonary Resuscitation (eCPR) on Mortality - An International Multicenter Cohort Study

Conditions
-----------------
Cardiac Arrest, Cardiopulmonary Arrest, Extracorporeal Membrane Oxygenation Complication, Cardiogenic Shock, Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: VA-ECMO
* Device: ECMELLA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Cardiac arrest Treatment with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or ECMELLA (that is VA-ECMO plus left ventricular Impella® micro-axial pump) Exclusion Criteria: Non-adult patients No treatment with VA-ECMO or ECMELLA

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 |
| --- | --- |
| VA-ECMO<br>Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) during cardiac arrest. | Device: VA-ECMO<br>* Treatment with veno-arterial extracorporeal membrane oxygenation<br>|
| ECMELLA<br>Patients who were treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Impella® micro-axial pump. | Device: ECMELLA<br>* Treatment with veno-arterial extracorporeal membrane oxygenation plus Impella® micro-axial pump.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Mortality within 30 days after cardiac arrest event. | Mortality within 30 days after cardiac arrest event. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Number of days between hospital admission and hospital discharge. | Through study completion - an average of 1 year. | 
| Intensive Care Unit (ICU) length of stay | Number of ICU days between ICU admission and ICU discharge. | Through study completion - an average of 1 year. |
Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.

Official Title
-----------------
Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients

Conditions
-----------------
Epiretinal Membrane, Macular Hole

Intervention / Treatment
-----------------
* Drug: OT-551 ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Imminent vitrectomy to repair macular holes or puckers Ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery Best corrected ETDRS visual acuity equivalent to Snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye Exclusion Criteria: Artificial lens or no lens in the surgical eye Cataract (greater than slight opacity or thickness) in the surgical eye Any other retinal abnormality which may be vision-threatening Serious heart, kidney, or liver disease Recent ophthalmic surgery (within 6 months) or ocular infection (within 30 days) Poorly controlled diabetes or unstable glaucoma

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OT-551 ophthalmic solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in visual acuity |  |  | 
| change in lens opacity |  |  |
Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients

Study Overview
=================
Brief Summary
-----------------
The success rate of unguided nasojejunal feeding tube insertion will be determined in acute brain injured patients. Factors influencing tube self-progression will be evaluated.

Detailed Description
-----------------
Nutrition support is important in brain injured patients. Several studies have shown that small bowel feeding compared with gastric feeding may be associated with a reduction in pneumonia in critically ill patients. The Canadian Clinical Practice Guidelines recommended that small bowel feedings should be considered for patients at high risk for intolerance to enteral nutrition. There are several methods to place postpyloric tube, but there is a high success rate with endoscopic or radiological assistance. However, they are time consuming procedures, which is of limited availability at bedside and requires trained staff. Nasojejunal tube with spiral end (Flocare Bengmark NJ tube) has been used for bedside placement for 10 years. But only limited data are available for success rate, especially in brain injured patients. The aim of this study is to access the success rate and influencing factors of spiral end nasojejunal tube in such a population.

Official Title
-----------------
Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients

Conditions
-----------------
Acute Brain Injury

Intervention / Treatment
-----------------
* Procedure: placement of spiral nasojejunal tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute brain injured patients admitted to Neuro-ICU Exclusion Criteria: Patients' stay in ICU shorter than 3 days Patients with contraindication to naso-feeding tube placement

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 |
| --- | --- |
| 1<br>Successful progression of spiral tube to duodenum within 3 days | Procedure: placement of spiral nasojejunal tube<br>* spiral nasojejunal tube will be placed after enrollment of the patients<br>|
| 2<br>Failure of progression to duodenum within 3 days | Procedure: placement of spiral nasojejunal tube<br>* spiral nasojejunal tube will be placed after enrollment of the patients<br>|

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
-----------------
nutrition, enteral access
Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.

Detailed Description
-----------------
The success of total knee arthroplasty depends on restoration of limb alignment, precise implant positioning and optimal gap balancing. The advent of computer aided surgery (CAS) has improved limb alignment and implant positioning. The objective of this study was to evaluate the functional outcome of computer aided soft tissue gap balancing in total knee arthroplasty.

Official Title
-----------------
Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty- 2-Year Results of a Prospective Randomised Trial

Conditions
-----------------
Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Procedure: Computer aided total knee arthroplasty
* Procedure: Conventional total knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary osteoarthritis of the knee Exclusion Criteria: rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining TKA and a short stem tibial implant

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Conventional total knee arthroplasty | Procedure: Conventional total knee arthroplasty<br>* Conventional method of total knee arthroplasty<br>|
| Active Comparator: 2<br>Computer aided total knee arthroplasty | Procedure: Computer aided total knee arthroplasty<br>* Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty<br>* Other names: Computer aided surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sagittal stability of knee |  | 2 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status of postoperative patients |  | 2 YEARS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, Computer, Gap, Soft tissue, Balancing, Replacement, Arthroplasty
Evaluation of QTc Interval by Continuous Holter ECG Recording in Antipsychotic Drug-treated Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions

Conditions
-----------------
Schizophrenia, Schizoaffective, Bipolar Disorder

Intervention / Treatment
-----------------
* Device: Holter Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be males or females between 18 - 65 years of age. Patient subjects will have a definite diagnosis by DSM-IV criteria, schizophrenia, schizoaffective disorder, or bipolar disorder. Patient subjects are currently under treatment with any antipsychotic, any mood stabilizer, any antidepressant or any combination of the above at the therapeutic dose for at least 3 months. Patients have a history of taking the medications listed in item 3 as prescribed. The subjects must be able to provide written informed consent Exclusion Criteria: Subjects with a DSM-IV diagnosis of substance dependence as defined by DSMN within three months prior to selection. Subjects who are currently taking other medications that have been shown to prolong the QTc, including tricyclic antidepressants (e.g. amitriptyline, imipramine, maprotiline), fluoroquinolones, or antiarrhythmics (e.g. quinidine, procainamide, amiodarone, sotalol). -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Holter Monitor|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions. |  |  |
Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
This study looked at the role of cardiac CT in improving risk factor control in those with diabetes.

Detailed Description
-----------------
This study examined whether doing a cardiac screening test, the cardiac CT, would result in patients paying more attention to controlling their risk factors.

Official Title
-----------------
Role of Cardiac CT in Risk Factor Control in Asymptomatic Patients With Diabetes

Conditions
-----------------
Diabetes, Metabolic Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiac CT
* Behavioral: Usual medical care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Diabetes Metabolic Syndrome Exclusion Criteria: Symptoms of heart disease Heart Disease Renal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac CT<br>Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries. | Diagnostic Test: Cardiac CT<br>* A cardiac CT involves a non-invasive test of the coronary arteries.<br>|
| Active Comparator: Usual Care<br>Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician | Behavioral: Usual medical care<br>* Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.<br>* Other names: Usual medical care would include control of blood pressure, blood glucose, and cholesterol by the primary care physician.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic BP Pressure | After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure. | Five year follow up |