linjc16/ctgov huggingface dataset:
Gastric Tissue Stapler Comparison Study

Study Overview
=================
Brief Summary
-----------------
This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, Echelon) stapler and the Titan SGS (Standard Bariatrics, Titan). The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.

Official Title
-----------------
Gastric Tissue Stapler Comparison Study

Conditions
-----------------
Gastric Resection

Intervention / Treatment
-----------------
* Device: gastric tissue resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80 Exclusion Criteria: Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.) Gastric lesion recognized during surgery (entire specimen would be sent to pathology) Stomach damaged during extraction

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A - Echelon Stapler<br>Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, Echelon) and evaluated for burst pressure and staple malformation | Device: gastric tissue resection<br>* human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment<br>|
| Arm B - Titan Stapler<br>Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, Titan) and evaluated for burst pressure and staple malformation | Device: gastric tissue resection<br>* human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Evaluation | Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded. | immediately post operative | 
| Staple Malformation | Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor. | through study completion, anticipate within 2 months |
A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.

Official Title
-----------------
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ETC-1002 at Doses Above 120 mg/Day in Healthy Subjects

Conditions
-----------------
Safety Evaluation of Escalating Doses

Intervention / Treatment
-----------------
* Drug: ETC-1002


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements Body Mass Index of 18-32 kg/m2 inclusive with body weight >50 kg Major Exclusion Criteria: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.2 x Upper Limit of Normal(ULN), serum creatinine >ULN, Hemoglobin <12.0 g/dL Clinically significant disease that requires a physician's care and/or would interfere with study evaluations History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization Other exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>8 Healthy Subjects in Phase I Unit | Drug: ETC-1002<br>* escalating doses<br>|
| Experimental: Cohort 2<br>8 Healthy Subjects in Phase I Unit | Drug: ETC-1002<br>* escalating doses<br>|
| Experimental: Cohort 3<br>8 Healthy Subjects in Phase I Unit | Drug: ETC-1002<br>* escalating doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood. |  | 14 days |
Adherence to Prescribed Medication: Elucidating the Gap Between Guideline Recommendation and Real Life in Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the adherence to prescribed post-infarction medication and to cardiac rehabilitation in patients after acute myocardial infarction. In addition, their impact on cardiovascular events will be investigated.

Official Title
-----------------
Adherence to Prescribed Medication: Elucidating the Gap Between Guideline Recommendation and Real Life in Myocardial Infarction

Conditions
-----------------
Myocardial Infarction, Adherence, Medication

Intervention / Treatment
-----------------
* Other: Investigating Adherence to Standard of Care Medication and Cardiac Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myocardial infarction Willingness to participate Exclusion Criteria: Inclusion in an interventional study interfering with standard of care medication

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Investigating Adherence to Standard of Care Medication and Cardiac Rehabilitation|Information from health care insurance providers on how many patients adhered to prescribed medication and how many underwent cardiac rehabilitation and how adherence influenced cardiovascular outcome will be retrieved|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Event | Composite of re-hospitalization due to acute MI, heart failure, stent thrombosis, fatal MI, and overall mortality | 3 years |
Surgical Admission at the Weekend and 30-day Mortality in Ontario, Canada: a Matched Cohort Study

Study Overview
=================
Brief Summary
-----------------
Surgery is performed at the weekend for risk to life or limb, when mandated by clinical guidelines, or depending on resource availability. Weekend healthcare interventions have been associated with increased mortality and adverse clinical outcomes in the majority of the literature examining the weekend effect, but these findings are not consistent. Results from recent observational studies argue against a true weekend effect. Higher rates of adverse outcomes associated with hospital activity at weekends do not appear to be due to altered medical staffing as commonly hypothesized, but are thought to be in part a result of data artefact and confounding by severity or indication. For this study, we hypothesized that patients who are admitted to hospital at the weekend and require surgery have an increased risk of death compared with patients who are admitted and undergo surgery on weekdays. The primary aim was to examine whether patients who underwent surgery and were admitted at the weekend had an increased risk of 30 day all-cause mortality compared with patients who were admitted and underwent surgery on weekdays; secondary aim was to examine whether the timing of surgery (i.e., surgery on the same weekend or surgery on a subsequent weekday) for patients admitted at the weekend is associated with increased risk of 30 day all-cause mortality.

Official Title
-----------------
The Association Between Weekend Admission and Perioperative Adverse Outcomes for Adults Undergoing Surgery: A Matched Cohort Study

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: Hospital admission and surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any hospital admission associated with an eligible surgical procedure in the Ontario discharge abstract database between 2005 and 2015 Exclusion Criteria: cardiothoracic or cardiology therapeutic procedures non-surgical therapeutic interventions (e.g. dialysis) obstetric procedures.

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 |
| --- | --- |
| Weekend admission<br>Adults admitted to hospital at the weekend (Saturday or Sunday) and who underwent surgery | Other: Hospital admission and surgery<br>* Hospital admission and noncardiac surgery<br>|
| Weekday admission<br>Adults admitted to hospital on a weekday (Tuesday to Thursday) and who underwent surgery | Other: Hospital admission and surgery<br>* Hospital admission and noncardiac surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day all cause mortality | death | 30 days from surgery |
Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.

Official Title
-----------------
A Double-Blind, Randomized, Crossover Evaluation of the Pharmacokinetics of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R); and an Open-Label Safety and Efficacy Evaluation of rFIX-R in Previously Treated Patients With Moderate to Severe (FIX:C≤2%) Hemophilia B

Conditions
-----------------
Hemophilia B

Intervention / Treatment
-----------------
* Drug: rFIX
* Drug: rFIX-R


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe hemophilia B (FIX: C ≤2%) Previously treated patients (PTPs) with ≥150 documented exposure days Age ≥ 12 years (US sites only) Exclusion Criteria: Detectable factor IX inhibitor defined as ≥0.6 Bethesda Units for pooled plasma reported by the local laboratory (family history of inhibitors will not exclude the patient) Patient history of factor IX inhibitor replacement therapy Patient unable to be off factor IX replacement therapy for at least 5 days without bleeding

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Crossover Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rFIX|nan|
|Drug: rFIX-R|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Open Label Study of TRx0014 in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each individual patient will continue for as long as the treating physician feels there is benefit to the patient. This current protocol covers each patient for 12 months in the first instance.

Official Title
-----------------
An Open Label Continuation Study of the Effects of TRx0014 30 mg TID and 60 mg TID in Patients With Alzheimer's Disease

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

Intervention / Treatment
-----------------
* Drug: TRx0014


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments. The carer must provide written consent to his or her own participation in the study. Patients with capacity must give written informed consent to participate in this study. Patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation. The patient must have been ongoing in TRx-014-001 at time of study termination. Exclusion Criteria: There are no exclusion criteria. All patients taking medication at the termination of study TRx-014-001 and who wish to participate are eligible for recruitment.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>30mg tid TRx0014 | Drug: TRx0014<br>* Gelatin capsule, tid<br>|
| Active Comparator: 2<br>60mg tid TRx0014 | Drug: TRx0014<br>* Gelatin capsule, tid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE). |  | 0, 26 and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb). |  | 0, 26 and 52 weeks | 
| Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS) |  | 0, 26 and 52 weeks |
Comparison of Endotracheal Intubation Success Rates Using Video Laryngoscopes in Entrapped Patients - a Manikin Study

Study Overview
=================
Brief Summary
-----------------
The investigators will compare the success rates of endotracheal intubation in a simulated entrapped car accident victim (manikin) using different video laryngoscopes by experienced emergency physicians. The investigators hypothesized that video laryngoscopes may improve success rates.

Official Title
-----------------
Comparison of Endotracheal Intubation Success Rates Using Video Laryngoscopes in Entrapped Patients - a Manikin Study

Conditions
-----------------
Endotracheal Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: experienced emergency physicians Exclusion Criteria: no experience in out-of-hospital emergency medicine

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| glidescope<br> | |
| storz c-mac<br> | |
| mcgrath vl<br> | |
| ambu pentax aws<br> | |
| macintosh laryngoscope<br> | |
| others<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful endotracheal intubation | We compare the success rates of endotracheal intubation with the different devices | 2 months |
Efficacy of Two Liquid Oxygen Devices in Deambulation

Study Overview
=================
Brief Summary
-----------------
Some oxygen conserving devices have been developed to diminish oxygen expense. These devices offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients.

Official Title
-----------------
Efficacy of Two Liquid Oxygen Devices in Deambulation

Conditions
-----------------
To Determine the Efficacy of Two Liquid Oxygen Device

Intervention / Treatment
-----------------
* Device: Oxygen conserving devices
* Device: Oxygen conserving devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with arterial oxygen desaturation to effort. COPD with TLC > 90% EPID with TLC < 90% and FEV1/FVC > 70% Exclusion Criteria: Patients with long-term oxygen therapy (LTOT) in deambulation. Not clinically stable during last month. Smokers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with chronic obstructive pulmonary disease who show arterial oxygen desaturation to effort. | Device: Oxygen conserving devices<br>* Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated.<br>* Other names: Oxygen conserving devices in COPD.;|
| Experimental: 2<br>Patients with interstitial lung disease who show arterial oxygen desaturation to effort | Device: Oxygen conserving devices<br>* Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated<br>* Other names: Oxygen conserving devices in interstitial lung disease.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of correcting desaturation during effort and the acceptance of two different oxygen conserving devices during deambulation,one system with reservoir an another one with oxygen demand valve. |  | 2 years |
Impact of Muscle Fat Accumulation on the Genomic Profile of Skeletal Muscle in Older Adults

Study Overview
=================
Brief Summary
-----------------
Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different testing days for 2.5 hours each day. On one day the subjects participated in blood pressure and body weight measurements as well as a muscle biopsy from the thigh. On the second day the subjects underwent an MRI and MRS scan of the thigh and calf.

Conditions
-----------------
Intermuscular Adipose Tissue Quantification

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60-80 years old, men and women, normal body weight or obese, Exclusion Criteria: Certain medical conditions could have placed them at risk

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| MRI | To determine the within day reproducibility of MRI scans for intermuscular adipose tissue (IMAT) quantification in older men and women. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genomic profile | To examine the influence of IMAT accumulation on the genomic profile of skeletal muscle of normal weight or obese adults. | 1 day |