linjc16/ctgov huggingface dataset:
14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man

Study Overview
=================
Brief Summary
-----------------
This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.

Detailed Description
-----------------
The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.

Official Title
-----------------
An Open-Label Study to Determine ADME of 14C Labeled SLV337 After a Single Dose of an Oral Suspension

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: SLV337 suspension
* Drug: SLV337 capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria BMI 18 - 28 kg/m2 SBP 90-140 DBP 50-90 Exclusion Criteria Seizures, Orthostatic hypotension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: A<br>400 mg suspension | Drug: SLV337 suspension<br>* 400 mg experimental<br>|
| Active Comparator: B<br>5 x 200 mg immediate release capsule | Drug: SLV337 capsule<br>* 5 x 200 mg immediate release capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2) |  | Part 1: 5 days Part 2: 8 days | 
| AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2) |  | Part 2: 8 days | 
| Excretion balance of total 14C-radioactivity (Part 2) |  | Part 2: 8 days | 
| Total 14C-radioactivity (Part 2) |  | Part 2: 8 days | 
| Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2) |  | Part 2: 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2) |  | Part 1: 19 days Part 2: 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SLV337, Diabetes, Relative bioavailability, ADME
A High Protein Diet and Weight Maintenance

Study Overview
=================
Brief Summary
-----------------
An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.

Official Title
-----------------
The Use of a High Protein Diet in Achieving Long-Term Weight Loss and Improved Cardiovascular Risk Factors

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: VLED followed by a high protein or high carbohydrate diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men and women with a BMI >27kg/m2 with co-morbities or BMI >30kg/m2 Exclusion Criteria: people with Type II diabetes or other endocrine disorders, women who were pregnant or breastfeeding or planning to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>High Carbohydrate diet | Dietary Supplement: VLED followed by a high protein or high carbohydrate diet<br> <br> |
| Other: 2<br>High Protein diet | Dietary Supplement: VLED followed by a high protein or high carbohydrate diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk factors |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Weight loss, Weight maintenance, VLED
A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

Study Overview
=================
Brief Summary
-----------------
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.

Official Title
-----------------
An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

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

Intervention / Treatment
-----------------
* Drug: Sitagliptin phosphate
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with T2DM failing metformin monotherapy Between the ages of 18 and 79 Exclusion Criteria: Participants has a history of type 1 Diabetes Mellitus or ketoacidosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin<br>Sitagliptin as add-on therapy to a stable dose of metformin | Drug: Sitagliptin phosphate<br>* Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.<br>* Other names: Januvia;Drug: Metformin<br>* Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.<br>* Other names: Glucophage;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment | Safety & tolerability were measured in terms of the # of participants with >=1 adverse event (AE), >=1 drug-related AE, >=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose at Week 4 | Calculated as the mean change from baseline in fasting plasma glucose at Week 4. | Baseline and Week 4 |
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis

Study Overview
=================
Brief Summary
-----------------
The major objective of this study is to evaluate the therapeutic effect of a topical treatment simultaneously inhibiting Dipeptidyl Peptidase IV and Aminopeptidase N (IMTM #IP10.C8) in patients with mild to moderate psoriasis of the skin

Official Title
-----------------
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis - Phase II Single Center Study

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: IP10.C8


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years of age at pre-study and Diagnosis of plaque type psoriasis at least 3 month prior to enrolment Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15cm2 for which topical treatment is indicated Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2 Exclusion Criteria: Other type of psoriasis (e.g. erythrodermic, guttate or pustular) at enrolment Drug induced psoriasis at enrolment (e.g. lithium) Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study Systemic therapy affecting PASI or phototherapy for a period of 4 weeks prior to enrolment Topical therapy affecting PASI for a period of 2 weeks prior to enrolment Treatment with biologic agents affecting PASI for a period of 3 months prior to enrolment Systemic treatment with immunosuppressive agents (e.g. methotrexate, cyclosporin) or treatment with lithium, anti-malaria medication, or intramuscular gold application for a period of 4 weeks prior to enrolment Having a history of or an ongoing uncontrolled serious or recurring bacterial, viral, fungal, or atypical mycobacterial infection Having a severe medical condition that, in the judgment of the investigator, would jeopardize in any way the subject's safety following exposure to study drug Having the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IP10.C8 Gel<br> | Drug: IP10.C8<br>* IP10.C8 Gel 1%<br>|
| Placebo Comparator: Placebo Gel<br> | Drug: IP10.C8<br>* IP10.C8 Gel 1%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index |  | 4 weeks |
CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes in patients with acute myocardial infarction with depressed ventricular function and to determine the predictive value of several invasive and non-invasive risk markers for life-threatening arrhythmia

Official Title
-----------------
Incidence and Prediction of Life-threatening Cardiac Arrhythmias in Patients With Depressed Left Ventricular Function After Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myocardial infarction (< 21 days) Ejection fraction <= 40 % or wall motion index <= 1.3 Exclusion Criteria: Implantable loop recorder can't be implanted within 3 weeks after MI NYHA class IV Planned or previous ICD implantation Planned CABG Severe valvular disease Pregnancy Life expectancy < 1 year for non-cardiac cause

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 |
| --- | --- | --- |
| ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) | ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT) | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myocardial infarction, Cardiac arrhythmias, Left ventricular dysfunction, Implantable loop recorder, Risk stratifiers
Morphine Consumption in Thoracotomy

Study Overview
=================
Brief Summary
-----------------
Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Thoracotomy operations are associated with high levels of pain. With the use of ultrasound, many regional anesthesia techniques were described to provide effective postoperative analgesia. The aim of this study was to compare the postoperative effect of paravertebral block (PVB) and erector spinal plane block (ESPB) in thoracotomies.

Official Title
-----------------
Comparison of Morphine Consumption at Postoperative 24th Hour in Thoracotomy: A Randomized Controlled Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: PVB
* Procedure: ESPB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III patients undergo elective thoracotomy surgeries. Exclusion Criteria: Obesity (BMI > 35 kg/m2) Infection of the skin at the site of the needle puncture area Patients with known allergies to any of the study drugs Coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVB Group<br>Paravertebral block administered group | Procedure: PVB<br>* Paravertebral block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.<br>|
| Active Comparator: ESPB group<br>Erector spinae plane block administered group | Procedure: ESPB<br>* Erector spinae plane block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Morphine consumption (mg) of patients with patient controlled analgesia device | Postoperative 24th hour | 
| NRS score | Numerating rating scale of the patients (between 0 and 10, 0 represents no pain and 10 represents the worst pain ever possible. | Postoperative 24th hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, Thoracotomy, Paravertebral block, Erector spina plane block
The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death

Study Overview
=================
Brief Summary
-----------------
Adult Patients with Severe Sepsis

Detailed Description
-----------------
Compared with placebo, drotrecogin alfa (activated) reduces 28-day all-cause mortality in adult patients with severe sepsis at low risk of death (for example, with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score <25 or single organ dysfunction).

Official Title
-----------------
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: Drotrecogin alfa (activated)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction. Exclusion Criteria: Are indicated for the treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country. Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country. Platelet count less than 30,000/mm3.

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: 1<br>24 microgram/kg/hr for 96 hours (+ or - 1 hour) | Drug: Drotrecogin alfa (activated)<br>* Drotrecogin Alfa (activated)<br>* Other names: Xigris;|
| Placebo Comparator: 2<br>0.9% sodium chloride | Drug: Placebo<br>* 0.9% sodium chloride<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 20 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe Sepsis
Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and therapy. METHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI; Doppler-echocardiography; and vascular ultrasound.

Official Title
-----------------
Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction, Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: Enalapril
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants will be 60 years of age or older. Exclusion Criteria: systolic dysfunction patients with evidence of significant ischemic or valvular heart disease chronic pulmonary disease. Participants who appear preliminarily eligible are invited to a formal screening visiting with an investigator cardiology physician. They also undergoing a rest and exercise electrocardiogram and echocardiogram and pulmonary function testing as well as blood hematology and chemistry tests. Final eligibility will be based upon all information available at the conclusion of the screening visits test, including hospital and outpatient records, history, physical examination, echocardiogram and exercise test.

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enalapril<br>2.5mg titrated up to 10mg- twice daily | Drug: Enalapril<br>* 2.5mg titrated up to 10mg twice daily<br>|
| Placebo Comparator: placebo<br>2.5 mg titrate up to 10mg twice daily placebo comparator | Drug: placebo<br>* 2.5mg titrated up to 10mg twice daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity and aortic distensibility | MRI and expired gas analysis | 9 months |
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether whole body exercise training alters the immunity in the lungs of people with COPD and reduces the incidence of chest infections over the longer term.

Detailed Description
-----------------
Patients will undertake an 8 weeks pulmonary rehabilitation program of exercise and education. Those who decline to take part in pulmonary rehabilitation will have the same outcome measures collected at the same timepoints.

Official Title
-----------------
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: Pulmonary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD (FEV1/FVC < 70), smoking Hx of minimum of 10 pack years Exclusion Criteria: Diagnosis of asthma, bronchiectasis, attendance at pulmonary rehabilitation within last 12 months, exacerbation of COPD within last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary rehabilitation<br>8 weeks of pulmonary rehabilitation (twice weekly training) Exercise and education sessions accompanied by home exercise program | Other: Pulmonary rehabilitation<br>* 8 weeks of exercise training (twice weekly) of education and exercise<br>|
| No Intervention: Control group<br>Usual medical treatment for 8 week period | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Salivary Immunoglobulin A levels | SIgA | Change over 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in circulatory inflammatory markers |  | Change over 8 weeks | 
| Change in physical activity levels |  | Change over 8 weeks | 
| Health status | COPD assessment test | Change over 8 weeks | 
| Exercise capacity (6MWT) | Distance walked in 6 minutes | Change over 8 weeks | 
| Number of acute exacerbations |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD,, Pulmonary rehabilitation,, Airway immunity