linjc16/ctgov huggingface dataset:
Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea

Study Overview
=================
Brief Summary
-----------------
The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.

Official Title
-----------------
Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: Exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Male or female at least 18 years of age Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information Exclusion Criteria: Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug Are pregnant or have intentions of becoming pregnant within the duration of the study Contraindications

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 |
| --- | --- |
| Group1:Type 2 diabetic patients treated with Exenatide therapy<br>Korean patients who are at least 18 years old, diagnosed with type 2 diabetes, and are treated with Exenatide in an ambulatory care setting according to the approved label | Drug: Exenatide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus |  | At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in Hemoglobin A1c (HbA1c) |  | Baseline (Day 1) and 12 or 24 weeks ± 4 weeks | 
| Change from baseline to endpoint in Body weight |  | Baseline (Day 1) and 12 or 24 weeks ± 4 weeks | 
| Change from baseline to endpoint in Fasting plasma glucose |  | Baseline (Day 1) and 12 or 24 weeks ± 4 weeks | 
| Change from baseline to endpoint in subjective measures include improvement of main indication |  | Baseline (Day 1) and 12 or 24 weeks ± 4 weeks |
Methadone in Post-Herpetic Neuralgia Pain

Study Overview
=================
Brief Summary
-----------------
Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an opioid agent to their current drug regimen.

Official Title
-----------------
Methadone in Post-Herpetic Neuralgia Pain

Conditions
-----------------
Post-herpetic Neuralgia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic (>6 months) symptomatic PHN with visual analogical scale >40/100mm use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids) Exclusion Criteria: Don't full the criteria above

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methadone<br>in this arm patients will take methadone 5mg. | Drug: Methadone<br>* patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.<br>|
| Experimental: Placebo<br>in this arm patients will take placebo pills. | Drug: Placebo<br>* patients with post-herpetic neuralgia take placebo to treat the pain symptoms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline Pain | Assessing by verbal analog scale (VAS) | baseline (visit inclusion) and three moths latter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuropathic pain,, post-herpetic neuralgia,, methadone,
Colorectal Resection in Emergency General Surgery

Study Overview
=================
Brief Summary
-----------------
Primary anastomosis is associated with higher rates of perioperative morbidity/mortality and that fecal diversion improves overall mortality, decreases length of stay, and lowers rates of surgical complications requiring unplanned operative intervention.

Detailed Description
-----------------
This is a prospective observational study. All patients undergoing colon resection in the urgent/emergent setting meeting our inclusion/exclusion criteria will be enrolled in the study. Data will be collected prospectively and the decision to perform proximal diversion or anastomosis is solely the responsibility of the managing acute care surgeon. No guidelines or protocols will be suggested so as to avoid any influence on practitioner decision-making. The plan is to complete the data collection and analysis by 03/01/2020

Official Title
-----------------
Colorectal Resection in Emergency General Surgery - To Anastomose, or Not to Anastomose

Conditions
-----------------
Colorectal Resection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing urgent/emergent colon resection (less than 24 hours after decision to operate) by an acute care surgeon Exclusion Criteria: Elective operations performed by acute care surgeons within 24-hours of the decision to operate (e.g., scheduled resection of non-obstructed, non-perforated malignancy) Prisoners Pregnancy Wards of the state Patients less than 18-years of age Traumatic mechanisms of injury Death within 24-hours of index operation

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

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 |
| --- | --- | --- |
| Perioperative mortality and need for unplanned procedural intervention | Perioperative mortality and need for unplanned procedural intervention (intervention by a surgeon, radiologist, or interventional radiologist). | 1 days to 12 months |
A Long-Term Monitoring Study of the IMT-002 Patients

Study Overview
=================
Brief Summary
-----------------
This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.

Detailed Description
-----------------
Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.

Official Title
-----------------
Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Device: IMT - Implantable Miniature Telescope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have participated in the IMT-002 trial. Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study. Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form. Exclusion Criteria: Patients who have not participated in the IMT-002 trial.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT<br> | Device: IMT - Implantable Miniature Telescope<br>* Implantation of the telescope prosthesis (performed under the initial study)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures) |  | 5 years from implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular Degeneration, Visual Impairment, Quality of Life, Telescope Prosthesis
Isokinetic Testing Protocol in Elderly and Young Men

Study Overview
=================
Brief Summary
-----------------
An age-related decrease in muscular strength may have a detrimental effect on muscle fatigue and recovery. To date, only one study has determined the effect of varied rest intervals (RI) between exercise sets in active younger and older women. They reported that active younger and older women require similar RI between sets to recovery full isokinetic knee extension peak torque (PT). However, we are unaware of any published studies comparing RI PT recovery between younger and older men. Thus, the purpose of this study was to compare the effect of two different RI's between sets of isokinetic knee extension exercise on PT, and Total Work (TW) between untrained younger and older men.

Detailed Description
-----------------
18 young men (24.22 ± 2.58 yrs) and 20 older men (66.85 ± 4.02 yrs) performed 3 sets of 10 unilateral isokinetic knee extension repetitions at 60°/s. The rest intervals between sets were 1 and 2 minutes and were counterbalanced across 2 testing days, separated by a minimum of 48 hours. The work-to-rest ratio was 1:3 and 1:6. All subjects were not involved in exercise programs that included resistance exercises within the last 6 months. Statistical evaluation of the data was performed using a 2x 2 x 3 mixed factor repeated measures ANOVA [age (younger and older) x rest interval (1 and 2 min) x set (1st, 2nd, and 3rd)]. Statistical significance was set at p < 0.05 for all comparisons.

Official Title
-----------------
The Effects of Rest Interval on Quadriceps Torque During an Isokinetic Testing Protocol in Elderly and Young Men

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

Intervention / Treatment
-----------------
* Device: Isokinetic Dynamometer (Biodex system III)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 75 years Independent Exclusion Criteria: History of cardiovascular disease Hypertension Orthopedic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Isokinetic Dynamometer (Biodex system III)|Biodex system III Isokinetic Dynamometer (Biodex Medical, Inc., Shirley, NY).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Torque |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Isokinetic, Fatigue, Strength, Older
Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)

Study Overview
=================
Brief Summary
-----------------
Most literature on ICU infections and the resistant patterns comes from the western literature. This data may not truly reflect the incidence, epidemiology and resistance patterns in developing countries such as India. However, empiric antibiotic therapy is generally initiated using western guidelines. This can potentially lead to inadequate, inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian setting. Hence in this multi-center observational study, we seek to: To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India To explore the microbiology, resistance and treatment patterns of these infections

Official Title
-----------------
Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)

Conditions
-----------------
Nosocomial Infections

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU stay >48 hours One of the following infections (VAP, CAUTI or CRBSI) Exclusion Criteria: Index ICU stay < 48 hours Re-admissions to the ICU within the same hospitalization Age >18 years or <70 years Known HIV serology positivity Burns Solid organ or Bone-marrow transplant No ICU-acquired infections (specifically VAP, CAUTI and CRBSI)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| ICU infections<br>Infections acquired during the ICU stay | Other: No intervention<br> <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
-----------------
India, Ventilator associated pneumonia, Catheter related blood stream infection, Catheter associated urinary tract infection, ICU-related infections (VAP, CAUTI and CRBSI)
The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
There is evidence that inhibition of FFA-release by acipimox is associated with a significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation. Since that phenomenon, better known as metabolic inflexibility has been mainly described in patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and cardiac function in patients with overt type 2 diabetes.

Official Title
-----------------
HYPOglycemia Linked to Cardiac sTEatoSIS? - Identifying Mechanisms That Explain Adverse Cardiovascular Outcome Associated With Intensive Glucose Control in Patients With Diabetes (HYPOTESIS)

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: acipimox
* Drug: Placebo Oral Capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes HbA1C >6% Exclusion Criteria: Insulin therapy (except: BOT=basal supported oral therapy) Known heart disease including coronary artery disease, cardiomyopathy, history of cardiac surgery Known intolerance against niacins Known contra-indications against magnetic resonance (MR-) examinations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acipimox+<br>250 mg at 0 and 180 minutes (one day) | Drug: acipimox<br> <br> |
| Placebo Comparator: Placebo<br>1 Tablet at 0 and 180 minutes (one day) | Drug: Placebo Oral Capsule<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MYCL | Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo | 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection Fraction | Left ventricular ejection fraction before and after administration of acipimox or placebo | 180 minutes |
National Register Studies in Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The overall project aim is to study risk and outcomes following thoracic surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.

Detailed Description
-----------------
The purpose of this research project is to study risks and outcomes in patients who underwent thoracic surgery, primarily for lung cancer. We aim to establish a fundament for the conduct of nationwide population-based studies by linking patient-level data from the Swedish quality register for thoracic surgery (ThoR) and other national health-data registers maintained by the government agencies Statistics Sweden and the National Board of Health and Welfare. Cross-linking patient-level data is possible through the Personal Identity Number assigned to every individual who has resided in Sweden on a permanent basis. The Swedish Personal Identity Number is the unique identifier in all national registers. Specifically, we aim: To analyze the association between socioeconomic factors and prognosis in patients undergoing pulmonary resection for lung cancer. To investigate the implementation of minimally invasive surgery for lung cancer in Sweden.

Official Title
-----------------
National Register Studies in Thoracic Surgery

Conditions
-----------------
Lung Cancer, Pulmonary Metastasis, Surgery

Intervention / Treatment
-----------------
* Procedure: Thoracic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients who underwent thoracic surgery in Sweden during the study period Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Thoracic surgery|Thoracic surgery, pulmonary resection, minimally invasive thoracic surgery, video assisted thoracic surgery (VATS)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Death from any cause | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Complications related to surgery | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic surgery, Lung surgery, Epidemiologic Methods