linjc16/ctgov huggingface dataset:
Bare Metal Stents and Drug Eluting Stents in Patients Who Underwent Blood Transfusion

Study Overview
=================
Brief Summary
-----------------
Retrospective cohort study of Korean National Healthcare Insurance Database. To investigate clinical outcomes of bare metal stents versus drug eluting stents in patients who underwent periprocedural red blood cell transfusion.

Detailed Description
-----------------
A Korean nationwide, multi-center, retrospective observational cohort study. The receipt of red blood cell transfusion is at high risk of cardiac events or death. But little is know regarding the comparative outcomes of BMS and DES implantation in patients who underwent periprocedural red blood cell transfusion. Longitudinal data is collected from administrative claims in the national health insurance services of Korea. All Korean data(N=500,591) undergoing PCI from 2006 to 2015 is extracted. BMS or DES Patients(N=28,322) who received periprocedural red blood cell transfusion is investigate. Clinical outcomes until December 31, 2017 is investigate. Primary endpoint is a time to the first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, or stroke.

Official Title
-----------------
Bare-metal Stents(BMS) Versus Drug-eluting Stents(DES) in Patients Who Underwent Periprocedural Blood Transfusion : A Nationwide Longitudinal Cohort Study

Conditions
-----------------
Erythrocyte Transfusion, Percutaneous Coronary Intervention, Revascularization

Intervention / Treatment
-----------------
* Device: Stent, red blood cell transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with percutaneous coronary intervention from 2006 to 2015 Patients with the implantation of BMS or DES Patients with the receipt of periprocedural red blood cell transfusion Exclusion Criteria: Patients without any of stent implantation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Stent, red blood cell transfusion|BMS (Bare Metal Stent) and DES (drug-eluting stent) transplants with periprocedural red blood cell transfusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence density of MACE (Major adverse clinical events) | The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke. | 3 years | 
| Incidence density of MACE (Major adverse clinical events) | The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transfusion, PCI, DES, BMS
Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and cognitive functions in healthy humans.

Official Title
-----------------
Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects

Conditions
-----------------
Memory Functions

Intervention / Treatment
-----------------
* Drug: Salbutamol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, male and female, aged between 18 and 40, BMI be-tween 19 and 27 kg/m2, normotensive (BP between 90/60 mmHg and 140/90 mmHg), native or fluent German-speaking, caucasian (European ancestry), able and willing to give written informed consent and comply with the requirements of the study protocol, willing to donate saliva sample for DNA-analysis - Exclusion Criteria: Acute or chronic psychiatric or somatic disorder, tachycardia at rest (> 100 bpm), known hypersensitivity to salbutamol, pathological ECG, pregnancy, breast-feeding, long-term medication within last 3 months (oral contraceptives are disregarded) smoking (>3 cigarettes per day), concurrent participation in another study, participation in one of our previous studies using the same memory tests, inability to read and understand the participant's information. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salbutamol<br> | Drug: Salbutamol<br>* single oral administration, 4 mg<br>|
| Placebo Comparator: Sugar Syrup<br> | Drug: Placebo<br>* single oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of emotional memory functions under Salbutamol | memory tests | two testing days within 10 days | 
| Change of episodic memory functions under Salbutamol | memory tests | two testing days within10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of emotional state under salbutamol | questionnaires | Two testing days within 10 days | 
| change of attention functions under salbutamol | attention tests | two testing days within 10 days |
Ventilator Associated Tracheobronchitis in the First 14 Days in ICU

Study Overview
=================
Brief Summary
-----------------
To investigate the clinical course and risk factors for VAT and the impact of VAT on Intensive Care Unit (ICU) morbidity and mortality.

Conditions
-----------------
Airway Colonization, Tracheobronchitis and Pneumonia Associated With Ventilator

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 48 hours mechanical ventilation Exclusion Criteria: immunodeficiency pregnancy severe COPD, chronic bronchitis, bronchiectasis recent pneumonia

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 |
| --- | --- |
| VAT patients<br>Patients developing Ventilator Associated Tracheobronchitis | |
| VAP<br>Patients presenting ventilator associated pneumonia | |
| No ventilator associated infection<br>patients who do not present ventilator associated infection during their stay in ICU | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | we assessed mortality from all causes at 4 weeks | mortality at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay |  | expected average length of stay 15 days | 
| mortality at 6 months |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
airway colonization, tracheobronchitis, pneumonia
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.

Official Title
-----------------
A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: ELND005 (scyllo-inositol)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication. Exclusion Criteria: Subject has no new medical contraindications to continued participation in the study.
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: ELND005<br> | Drug: ELND005 (scyllo-inositol)<br>* Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks After 15Dec2009: ELND005 250 mg PO BID for 48 weeks<br>* Other names: scyllo-inositol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events (TEAEs) | Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs) | 12 months |
A Study to Explore Prognoses of NSCLC Patients Complicated With Oligometastases

Study Overview
=================
Brief Summary
-----------------
An observational study to explore prognoses and clinical treatments of the patients with non-small cell lung cancer complicated with oligometastases

Detailed Description
-----------------
A multi-centre real-world non-interventional observational study to explore prognoses and clinical treatments of the patients with non-small lung cancer complicated with oligometastases

Official Title
-----------------
A Multi-centre Real-world Non-interventional Observational Study to Explore Prognoses of the Patients With Non-small Cell Lung Cancer Complicated With Oligometastases

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Surgeries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically diagnosed patients with non-small cell lung cancer; Tumor metastases in one organ (no more than 3 metastases); Exclusion Criteria: Patients with intrapulmonary metastases or multiple primary tumors; Patients with pleural dissemination or invasion of extrapulmonary organs; Patients with supraclavicular lymph node metastasis; Patients with systematic diseases that would influence patient survivals; Patients with no records for visits;
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with surgeries<br>NSCLC patients with surgeries | Procedure: Surgeries<br>* Surgeries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | 2014 - 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Disease-free survival | 2014 - 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chinese, non-small cell lung cancer, oligometastases
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

Study Overview
=================
Brief Summary
-----------------
A preliminary Study in Subjects Undergoing Low Anterior Resection

Official Title
-----------------
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Device: LifeSeal™ Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject, or authorized representative, signed a written Informed Consent Subject is at least 18 years of age Subject is scheduled for elective open resection Stapled anastomosis created within 10cm of the anal verge Subject is willing to comply with the follow-up requirements of the study Exclusion Criteria: Subject has a history of hypersensitivity to porcine derived gelatin or collagen Subject has unacceptable baseline hematological results Subject on chronic preoperative treatment with steroids and anticoagulants Subject with elevated liver function tests Subject with abnormal kidney function Subject with a BMI higher than 35 Subject participating in any other study for either drug or device which can influence collection of valid data under this study Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year Anastomosis was performed differently from what was defined Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™ Subject has intraoperative bleeding in excess of 500cc Subject has peritoneal carcinomatosis

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard of Care Arm - subjects treated by routine manner | |
| Experimental: LifeSeal™ Kit<br>LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment | Device: LifeSeal™ Kit<br>* Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of subject's safety by incidence of related Adverse Events |  | Approx. 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the device's application technique | Surgeon will complete a questionnaire regarding the device use and ease of application | Intra-operative |
Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.

Detailed Description
-----------------
Patients with biopsy proven active lupus nephritis will be randomized to receive tacrolimus or mycophenolate mofetil, on top of corticosteroids, for initial treatment. Efficacy and adverse effects will be compared.

Official Title
-----------------
To Compare the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Drug: tacrolimus
* Drug: mycophenolate mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who fulfill at least 4 of the ACR criteria for SLE Age >= 18 years Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V) Serum creatinine < 200 umol/L at the time of randomization Exclusion Criteria: Patients who refuse to be randomized for treatment Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons Serum creatinine >= 200 umol/L at the time of randomization Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI Patients who are pregnant or plan for pregnancy within 12 months after 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tacrolimus<br>Tacrolimus treatment | Drug: tacrolimus<br>* 0.06-0.1 mg/kg/day<br>* Other names: Prograf;|
| Active Comparator: mycophenolate mofetil<br>mycophenolate mofetil | Drug: mycophenolate mofetil<br>* 2-3 gm/day<br>* Other names: Cellcept;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate |  | month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function deterioration, relapse and mortality |  | month 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lupus, nephritis, tacrolimus, mycophenolate mofetil
Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.

Official Title
-----------------
A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: CTP-692


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males and females between 18 and 55 years of age, inclusive Body weight ≥ 55 kg and body mass index within the range of 18 to 32 kg/m2, inclusive Exclusion Criteria: Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions Positive drug or alcohol test at screening or prior to the first dose of study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-692 Low Dose or Matching Placebo<br>Once daily dosing | Drug: CTP-692<br>* Placebo or CTP-692<br>|
| Experimental: CTP-692 Mid Dose or Matching Placebo<br>Once daily dosing | Drug: CTP-692<br>* Placebo or CTP-692<br>|
| Experimental: CTP-692 High Dose or Matching Placebo<br>Once daily dosing | Drug: CTP-692<br>* Placebo or CTP-692<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety |  | Assessments done Day 1 - 9 | 
| Measurement of CTP-692 exposure in plasma |  | Assessments done Day 1 - 9 |
Effect of Pain Control on the Diagnosis of Acute Appendicitis on the Diagnostic Accuracy of General Surgeon

Study Overview
=================
Brief Summary
-----------------
The pain control in surgical abdomen has been in debate in masking the correct diagnosis. We would like to investigate the effect of pain control on the diagnostic accuracy of surgeon in suspicious appendicitis patients. We would give morphine or placebo to the patients suspected of appendicitis randomly and in double-blinded manner, and then surgeons would exam the patient and give the impression for the possibility of the appendicitis(grading 1 to 4). With this grading, we compare these impression between two groups.

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients suspected of acute appendicitis over 15 years Exclusion Criteria: less than 15 years pregnant allergic to morphine systolic blood pressure<100mmHg received pain killer prior to ED visit do not consent

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine<br> | Drug: Morphine<br> <br> |
| No Intervention: Placebo<br> | Drug: Morphine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of ROC of the impression of diagnosis for the appendicitis by surgeon |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
appendicitis, diagnosis