linjc16/ctgov huggingface dataset:
A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery

Study Overview
=================
Brief Summary
-----------------
In this prospective, randomized, clinical trial, we have investigated the effects of ketamine-based and remifentanil-based anesthetic protocol on perioperative serum cystatin-c levels, and creatinine and/or cystatin-c based eGFR equations in terms of acute kidney injury in CABG surgery.This study was approved by the Ethics Committee of Hospital and all patients were informed and gave written consent. Patients scheduled for elective CABG with cardiopulmonary bypass. Patients were randomly allocated to anesthesia with remifentanil-propofol-midazolam (RPM) group or ketamine-propofol-midazolam (KPM) group. Blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1, 2, and 4.

Official Title
-----------------
A Comparison of the Effects of Ketamine and Remifentanil on Serum Cystatin-c Levels in CABG Surgery

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

Intervention / Treatment
-----------------
* Drug: remifentanil
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective CABG with cardiopulmonary bypass Exclusion Criteria: patients undergoing emergency operation, combined operation, off-pump surgery, repeat surgery or valve surgery, patients presenting with chronic kidney disease or renal impairment, patients younger than 18 years old and neurological and/or psychiatric disturbances.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: remifentanil<br>remifentanil, short acting opioid | Drug: Ketamine<br>* renal function<br>* Other names: ketalar;|
| Active Comparator: ketamine<br>ketamine, intravenous anesthetic | Drug: remifentanil<br>* renal function<br>* Other names: Ultiva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| creatinin, BUN |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystatin-c level |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
troponin t,cystatin-c,ketamine,remifentanil
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809-T2

Study Overview
=================
Brief Summary
-----------------
Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study

Official Title
-----------------
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW1809-T2 and DW1809-1 in Healthy Adult Volunteers

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis, Back Pain, Acute Upper Respiratory Tract Infection

Intervention / Treatment
-----------------
* Drug: DW1809-T2
* Drug: DW1809-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers who are ≥19 years old Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and Exclusion Criteria: Clinically significant Medical History In the case of women, pregnant(Urine-HCG positive) or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>cross-over | Drug: DW1809-T2<br>* pelubiprofen 25mg<br>* Other names: Test;Drug: DW1809-1<br>* pelubiprofen 30mg (PELUBI tab.)<br>* Other names: Reference;|
| Experimental: Sequence B<br>cross-over | Drug: DW1809-T2<br>* pelubiprofen 25mg<br>* Other names: Test;Drug: DW1809-1<br>* pelubiprofen 30mg (PELUBI tab.)<br>* Other names: Reference;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Pharmacokinetics of Pelubiprofen | up to 8 hour | 
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetics of Pelubiprofen | up to 8 hour |
Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma

Study Overview
=================
Brief Summary
-----------------
Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis

Conditions
-----------------
Pulmonary Fibrosis, Scleroderma, Systemic

Intervention / Treatment
-----------------
* Drug: Bosentan


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: Systemic Sclerosis diffuse or limited Significant Interstitial Lung Disease on HRCTscan DLco < 80% predicted Dyspnea on exertion Walk not limited by musculoskeletal reasons Main exclusion criteria: Interstitial Lung Disease due to other conditions than SSc End stage restrictive or obstructive lung disease Severe cardiac or renal diseases Significant pulmonary arterial hypertension Smoker (> 5cig./day) Treatment with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks of randomization)

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to End-of-Study in 6-minute walk distance. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to death (all causes) or to worsening of PFTs up to End-of-Study. |  |  | 
| Worsening of PFTs (on 2 consecutive tests at least 4 weeks apart) is defined as: decrease from baseline ≥ 10% in FVC OR decrease from baseline ≥ 15% in DLco AND ≥ 6% in FVC |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scleroderma, Fibrosing alveolitis, Build, bosentan
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Study Overview
=================
Brief Summary
-----------------
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM

Detailed Description
-----------------
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.

Official Title
-----------------
A BIOEQUIVALENCE STUDY OF THE GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION COMPARED TO REFERENCE LISTED DRUG AZOPT® (BRINZOLAMIDE) OPHTHALMIC SUSPENSION 1% IN SUBJECTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION

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

Intervention / Treatment
-----------------
* Drug: brinzolamide 1% ophthalmic suspension
* Drug: Azopt 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension. Exclusion Criteria: Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma, ocular hypertension.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azopt 1% ophthalmic suspension<br>Ophthalmic suspension | Drug: Azopt 1%<br>* Azopt 1%, RLD<br>* Other names: brinzolamide;|
| Experimental: Brinzolamide 1% ophthalmic suspension<br>ophthalmic suspension | Drug: brinzolamide 1% ophthalmic suspension<br>* brinzolamide 1% ophthalmic suspension<br>* Other names: brinzolamide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) |  | 6 weeks |
Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in preterm babies. During the past two decade, the introduction of protocols for prophylactic antibiotics for women with a high risk for GBS infection, have led to a decline of 65% in GBS cases(0.32 for 1000 live birth compared to 1.8 cases in 1000).The purpose of the study is to check the morbidity and mortality at Sheba medical center in the last 12 years in children with positive blood culture for GBS. We assume that in our hospital the morbidity and mortality is less then expected. If proven right, we would then check the reasons for that outcome considering the type and length of treatment and the different virulence of the streptococcus.

Detailed Description
-----------------
This is a retrospective case control study. We will review from archive the charts of all the neonates with positive blood culture for GBS, reviewing the course and severity of their illness.

Official Title
-----------------
Clinical Outcome of Neonate With GBS Positive Culture-12 Year Retrospective Study

Conditions
-----------------
Infants With Positive GBS Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GBS positive blood culture neonate and preterm babies Exclusion Criteria: Congenital malformations

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 2 Weeks

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Group B streptococci, virulent, morbidity, mortality
Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke

Study Overview
=================
Brief Summary
-----------------
The investigators compared the activity and fatigue of upper extremity muscles, pain levels, subject satisfaction levels, perceived exertion, and number of repetitions in Task-Specific Training (TST) compared with Robot-Assisted Training (RAT) in individuals post-stroke.

Detailed Description
-----------------
Twenty sub-acute post stroke subjects received one TST and one RAT. They marked the pain level in their paretic extremity before and after each session. Muscle activity levels and fatigue and number of repetitions were monitored during each session. The subjective assessment questionnaire of treatment and the Borg scale were administered post-session.

Official Title
-----------------
Differences in Muscle Activity and Fatigue of the Upper Limb Between Task-Specific Training and Robot Assisted Training Among Individuals Post Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: The RAT and The TST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 85 year old individuals up to three months following stroke National Institutes of Health Stroke Scale (NIHSS) score 3-15 Intact cognitive function mild to moderate weakness of the affected hand normal or corrected eyesight Exclusion Criteria: neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restricts upper limb function a pace-maker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Post stroke patients<br> | Diagnostic Test: The RAT and The TST<br>* The RAT (ReoGo; Motorika Medical, Caesarea, Israel) The TST protocol included the conventional, repetitive, task-oriented training of the affected arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle activity | The activity levels of electromyographic signal (in millivolts) will be averaged for the duration of the recording. | 30 minutes | 
| Muscle fatigue | Fatigue expressed by calculation of the the difference between the median frequency in the first 5 minutes and last five minutes of a 30 minute session | 30 minutes |
Second Bowel Preparation for Colonoscopy Failure

Study Overview
=================
Brief Summary
-----------------
Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due to bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second colonoscopy can be performed with either adding a colon cleansing solution immediately, or it can be performed after a few days with colon cleansing agent together with prokinetics. These different kinds of bowel preparations after first colonoscopy failure have not been compared.

Official Title
-----------------
The Outcome of a Second Preparation for Colonoscopy After Preparation Failure in the First Procedure: a Prospective Randomized Controlled Study

Conditions
-----------------
Colonoscopy Failure, Poor Bowel Preparation

Intervention / Treatment
-----------------
* Drug: polyethylene glycol, Bisacodyl
* Drug: polyethylene glycol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First colonoscopy failure due to inadequate bowel preparation Exclusion Criteria: younger than 18 years old presence of inflammatory bowel disease pregnant lactating refusal

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEG<br>2L of polyethylene glycol addition immediately after first colonoscopy failure | Drug: polyethylene glycol<br>* Immediately after first colonoscopy failure, polyethylene glycol 2L addition<br>|
| Experimental: PEG + bisacodyl<br>One week after initial colonoscopy failure, conventional amount (5L) of polyethylene glycol together with bisacodyl administration | Drug: polyethylene glycol, Bisacodyl<br>* After failure of first colonoscopy, bowel preparation with polyethylene glycol and bisacodyl one week after<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group) |  | one week | 
| second colonoscopy failure due to inadequate bowel preparation (PEG group) |  | within the same day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, bowel preparation
Magnet for Corneal Foreign Bodies

Study Overview
=================
Brief Summary
-----------------
This is a prospective, interventional study to assess the effectiveness and safety of a commercially available eye magnet to remove corneal foreign bodies.

Detailed Description
-----------------
The vast majority of corneal foreign bodies are metallic and thus are frequently ferromagnetic. Consequently, it may be possible to use a magnet to remove most corneal foreign bodies. There are commercially available products for removing corneal foreign bodies, but there are no published studies assessing these devices. This will be a prospective interventional study to assess the use of an eye magnet for the removal of metallic corneal foreign bodies in the emergency department. After the patient signs written, informed consent, the physician will attempt to remove the corneal foreign body with the North by Honeywell 326734G Eye Magnet with Loop. If the physician is unable to remove the corneal foreign body with the magnet, he or she may proceed with standard care. The treating physician will fill out a brief data collection form for each patient to track various outcomes as discussed below.

Official Title
-----------------
The Use of a Magnet to Remove Corneal Foreign Bodies

Conditions
-----------------
Corneal Foreign Body

Intervention / Treatment
-----------------
* Procedure: Corneal Foreign Body Removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: present to the emergency department with a metallic corneal foreign body Exclusion Criteria: prisoners pregnant women have pacemakers or metallic facial implants possible globe rupture

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnet<br>The physician will attempt to remove the corneal foreign body using an eye magnet for these patients. | Procedure: Corneal Foreign Body Removal<br>* An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | The percentage of patients in whom the magnet successfully removed the foreign body. | 5 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelial Damage | The percentage of patients in whom the amount of fluorescein uptake on exam was more after the procedure compared to before the procedure. | 5 minutes |
The Effect of Whey Protein and Its Hydrolysate on Pre- and Post-Fixed Meal Glycemia and Insulin in Young Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe relationships among whey protein and its hydrolysate when consumed before a meal on pre- and post-fixed meal satiety, blood glucose and insulin in healthy young adults.

Detailed Description
-----------------
A randomized, cross-over design study was conducted. Whey protein preloads (5-40 g) and hydrolysate whey protein (10 g) were provided in 300 ml water. At 30 min following consumption, subjects were fed a preset pizza meal (12 kcal/kg, experiment 2). Satiety, insulin and blood glucose were measured at baseline and selected intervals pre- and post-meal.

Official Title
-----------------
The Effect of Whey Protein and Its Hydrolysate on Pre- and Post-Fixed Meal Glycemia and Insulin in Young Adults

Conditions
-----------------
Diabetes Prevention, Obesity Prevention

Intervention / Treatment
-----------------
* Other: dietary intervention
* Other: water control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal body weight Exclusion Criteria: breakfast skippers smokers dieters or individuals with diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 27 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whey protein, 5g<br> | Other: dietary intervention<br>* whey protein<br>|
| Experimental: whey protein, 10g<br> | Other: dietary intervention<br>* whey protein<br>|
| Experimental: whey protein, 20g<br> | Other: dietary intervention<br>* whey protein<br>|
| Experimental: whey protein, 40g<br> | Other: dietary intervention<br>* whey protein<br>|
| Experimental: water control<br> | Other: water control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose, Insulin, Subjective appetite |  | 0-170 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical comfort |  | 0-170 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Whey protein, Hydrolysate whey protein, Blood glucose, Insulin