linjc16/ctgov huggingface dataset:
Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and vaccinated healthy volunteers

Official Title
-----------------
Phase I Study on Safety, Tolerability and Immunogenicity of the MVA-BN Vaccine Administered to Healthy Subjects

Conditions
-----------------
Smallpox

Intervention / Treatment
-----------------
* Biological: MVA-BN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects, aged 20 - 55 years Signed informed consent Exclusion Criteria: Prior vaccination against smallpox (study part I only) Abnormalities suspicious of any underlying disease, detected at routine tests prior to study inclusion. Any immune modifying therapy within 4 weeks prior to entry Participation in any other investigating drug trial Known allergy to a component which may be part of the vaccine Allergic reaction or any other severe adverse effects experienced after previous smallpox vaccination (study Part II only)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MVA-BN|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.

Official Title
-----------------
An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: midazolam
* Drug: GW876008


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or females. Normal ECG. Agree to remain in the clinic for the time defined in the protocol. Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample. Exclusion Criteria: Any serious medical disorder or condition. Any history of an endocrine disorder. Any clinically significant laboratory abnormality. History of psychiatric illness. Any history of suicidal attempts or behavior. Active peptic ulcer disease. Positive faecal occult blood. The subject smokes or has smoked or has used any nicotine-containing products in the last six months. Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: midazolam|nan|
|Drug: GW876008|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2. |  | on Day 1 of Session 1 and on Days 1 and 14 of Session 2. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-lead ECG, Continuous Lead II Telemetry & adverse events: day 1 session 1; days 1 & 14 session 2 |  | day 1 session 1; days 1 & 14 session 2 | 
| vital signs & clinical laboratory data: day 1 session 1; days 1, 7 & 14 session 2 |  | day 1 session 1; days 1, 7 & 14 session 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics,, tolerability,, healthy,, subjects
Peripheral Immunologic Response of Solid Organ Transplant Recipients to Depletion Versus Non-depletion Protocols

Study Overview
=================
Brief Summary
-----------------
Rejection and infection are primary causes of morbidity and mortality in solid organ transplant recipients. Current clinical practice relies on immunosuppressive drug levels measured in plasma to reflect the peripheral immune response in solid organ transplant recipients. Direct measurement of the number and functions of the immune cells themselves using multi-parameter flow cytometry may enable individualized immunosuppression management for organ transplant recipients. Multi-parameter flow cytometry will be used to compare levels and functional capabilities of multiple lymphocyte subsets between cohorts of patients receiving depletion induction and those receiving a non-depletion regimen. The activation state, cytotoxic potential and the functional capabilities of these cells will be examined within patients over the first six months post transplant.

Official Title
-----------------
Peripheral Immunologic Response of Solid Organ Transplant Recipients to Depletion vs. Non-depletion Protocols

Conditions
-----------------
Liver Disease, Liver Transplantation

Intervention / Treatment
-----------------
* Procedure: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver transplant recipient Exclusion Criteria: none

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 |
| --- | --- |
| depletion immunosuppression<br> | Procedure: blood sampling<br>* peripheral blood draw<br>|
| no depletion immunosuppression<br> | Procedure: blood sampling<br>* peripheral blood draw<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
-----------------
liver disease, liver transplantation, depletion immunosuppression, non-depletion immunosuppression
Long-term Radiographic and Clinic Outcomes of Ulnar Shortening Osteotomy in Patients With Ulnar Impaction Syndrome and Reverse Oblique Sigmoid Notch

Study Overview
=================
Brief Summary
-----------------
Patients with ulnar impingement are often coexisting with patients with distal ulnar and ulnar joints with a type of sigmoid notch, and ulnar shortening surgery is one of the most useful and long-lasting treatments for the treatment of ulnar impingement. Some theories point out that if ulnar shortening surgery is performed on patients with distal oblique ulnar incisional ulnar joints, it may lead to accelerated degeneration of distal ulna and ulna articular joints, resulting in worse wrist function. Some theories have pointed out this Instead, surgery will cause joint remodeling and adaptation, but no long-term studies have confirmed this. Therefore, this study plans to evaluate the long-term radiological and clinical outcomes of ulnar shortening surgery performed on patients with preexisting inverted sigmoid notch to determine whether this surgery will cause accelerated distal degeneration of the phalangeal joints or Reshaping of joints and clinically corresponding changes in results.

Official Title
-----------------
Long-term Radiographic and Clinic Outcomes of Ulnar Shortening Osteotomy in Patients With Ulnar Impaction Syndrome and Reverse Oblique Sigmoid Notch

Conditions
-----------------
Distal Radioulnar Joint

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The distal ulnar joint of the wrist contains a patient with an inverted sigmoid notch of the sacrum, and the ulnar impaction causes ulnar wrist pain. Therefore, the ulnar shortening surgery is accepted. Exclusion Criteria: Patients with diagnosed diseases of immune rheumatism, patients with ischemic necrosis of the carpus, patients with this lesion caused by infection or tumor.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| 4-Item Pain intensity Measure | Each item is scored 0-10(0=no pain;10=pain as bad as can be) | 5 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteotomy, reverse oblique sigmoid notch, ulnar impaction syndrome, ulnar shortening
Chronic Pain After Shoulder Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Chronic pain is relatively common after different types of surgery. The investigators intend to study prevalence, characteristics and risk factors of chronic pain after shoulder arthroplasty, focusing on neuropathic pain characteristics, and risk factors such as preoperative pain, severe acute postoperative pain, age, gender, and pain elsewhere.

Official Title
-----------------
Chronic Pain After Shoulder Arthroplasty: Epidemiology and Risk Factors.

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated with any shoulder prosthesis between april 2011 and april 2012 in Denmark Exclusion Criteria: Secondary prosthesis Bilateral prosthesis Age below 18 Reoperated in the same shoulder after the prosthesis

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 |
| --- | --- |
| Shoulder prosthesis bearer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current pain intensity | Pain score by Numeric Rating Scale 0-10 | At time of completing the questionnaire, which is sent to patients 1-2 years after their shoulderprosthesis. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative pain intensity | Pain intensity by Likert scale | recalled |
Protein Supply in Elderly

Study Overview
=================
Brief Summary
-----------------
Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to provide further insight into the responsiveness of the muscle protein synthetic machinery to food intake in relation to age.

Official Title
-----------------
Overnight Protein Supply as a Dietary Strategy to Improve Muscle Mass in Elderly.

Conditions
-----------------
Muscle Synthesis

Intervention / Treatment
-----------------
* Dietary Supplement: Protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males Age between 65 and 80 years BMI < 30 kg/m2 Exclusion Criteria: Type 2 diabetic patients Use of medication All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. artrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis). Use of anticoagulants, blood diseases, allergy for lidocain. Contra indications for the use of a nasogastric tube: high risk of aspiration, gastric stasis, gastro-oesophageal reflux, upper gastrointestinal stricture, nasal injuries and base of skull fractures. Patients suffering from PKU (Phenylketonuria).

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein<br>Protein drink | Dietary Supplement: Protein<br>* Protein drink<br>* Other names: casein vs water;|
| Placebo Comparator: Placebo<br>water | Dietary Supplement: Protein<br>* Protein drink<br>* Other names: casein vs water;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein synthesis | Overnight protein synthesis | overnight (12 h) |
Open-Label Safety Study of AXS-05 in Subjects With Alzheimer's Disease Agitation

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with agitation associated with Alzheimer's disease (AD).

Detailed Description
-----------------
Eligible subjects may enroll into this open label study upon completing their final study visit of Study AXS-05-AD-302 or AXS-05-AD-304.

Official Title
-----------------
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Dementia of the Alzheimer's Type

Conditions
-----------------
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor

Intervention / Treatment
-----------------
* Drug: AXS-05 (dextromethorphan-bupropion)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in Study AXS-05-AD-302 or Study AXS-05-AD-304. Caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment. Exclusion Criteria: Caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions. Subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone. Any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being. Initiation of a new medication since enrolling in AXS-05-AD-302 which may pose a safety risk when taken concurrently with AXS-05.

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-05 (dextromethorphan-bupropion)<br>Up to 24 weeks | Drug: AXS-05 (dextromethorphan-bupropion)<br>* AXS-05 tablets, taken twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Safety | Incidence of treatment-emergent adverse events following dosing with AXS-05. | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AD agitation, AXS-05, NMDA receptor antagonist, dextromethorphan, bupropion, Axsome
Precursors of CVD Risk Factors--Project Heartbeat

Study Overview
=================
Brief Summary
-----------------
To elucidate the changes in body size, composition, and configuration occurring in adolescence, because these are important precursors of change in blood pressure and blood lipids.

Detailed Description
-----------------
BACKGROUND: Project HeartBeat! was uniquely designed to investigate the course of change in cardiovascular disease risk factors and several categories of covariates, including the anthropometric indicators addressed in this study. The data pertained to the 678 participants who entered the Project in 1991-93 at ages 8, 11 or 14 years of age, of whom 49.1 percent were female and 20.1 percent were black. Of the 395 participants who became eligible for 10 or more 4-monthly examinations, 349 (88.4 percent) completed at least 10 occasions; 538 participants of 556 who were eligible for seven or more examinations (96.8 percent) completed at least seven. Multi-level (MLn) analytic methods previously tested with other data were utilized for this analysis. DESIGN NARRATIVE: Data from Project Heartbeat were analyzed. Hypotheses tested included: (1) the time patterns of change in several indicators of body size, composition and configuration over the period of observation; (2) the relations between the time patterns of change in these indicators and the corresponding patterns for change in selected endocrine factors; and (3) the explanatory contributions of energy intake and expenditure to variation between individuals in their observed time patterns of change in these indicators. The anthropometric indicators addressed were: weight (total mass), height, body mass index (BMI, wt/ht2), fat-free mass, fat mass, per cent body fat, and fat distribution (waist/hip ratio). Each of these indicators were examined first separately and then in relation to selected endocrinologic measures (testosterone, estradiol, and DHEAS) and to energy intake and expenditure (from interview histories of diet and physical activity). Existing data from up to twelve 4-monthly examinations over the age range from 8-17 years conducted in Project HeartBeat! were analyzed. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 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 |
| --- | --- | --- |
Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia

Official Title
-----------------
A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of the Fix-dose Combination Therapy With Gemigliptin 50mg and Rosuvastatin 20mg With Type 2 Diabetes and Dyslipidemia

Conditions
-----------------
Type 2 Diabetes, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Gemigliptin and/or Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus with Dyslipidemia Adults who are at least 19 years old Exclusion Criteria: Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma Patients with gestational diabetes or secondary diabetes Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment Patients with thyroid gland dysfunction deviating from the normal TSH range Patients with pituitary insufficiency or adrenal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Placebo Comparator: Gemigliptin<br>only Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo) | Drug: Gemigliptin and/or Rosuvastatin<br> <br> |
| Placebo Comparator: Rosuvastatin<br>only Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo) | Drug: Gemigliptin and/or Rosuvastatin<br> <br> |
| Experimental: FDC<br>Gemigliptin & Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo) | Drug: Gemigliptin and/or Rosuvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change |  | Baseline(Day 0) to Treatment (last visit, w24) | 
| LDL-C change rate |  | Baseline(Day 0) to Treatment (last visit, w24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | (Gemigliptin/Rosuvastatin FDC vs. Gemigliptin) | Baseline(Day 0) to Treatment (last visit, w24) | 
| LDL-C change rate | (Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin) | Baseline(Day 0) to Treatment (last visit, w24) |