linjc16/ctgov huggingface dataset:
A Comparison of Continuous Moderate Training and Reduced High Intensity Interval Training in Obese Young Adults

Study Overview
=================
Brief Summary
-----------------
Exercise is a key component of obesity management. Obese subjects cannot attend or sustain exercise program because of increased general fatigue, dyspnea and muscle fatigue. And they feel more exertion when comparing with normal weight subjects. Reduced-exertion high-intensity interval training (REHIT) is a alternative method to continuous exercise programs. The investigators aimed comparing metabolic effects of REHIT and continuous exercise in young adults, in this study.

Official Title
-----------------
A Comparison of Reduced HIIT and Moderate Intensity Continuous Exercise in Obese Young Adults

Conditions
-----------------
Obesity, Exercise, Oxygen Consumption

Intervention / Treatment
-----------------
* Other: REHIT Exercise
* Other: Continuous Aerobic Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18-22, BMI ≥ 30, Female gender, Exclusion Criteria: Smoking history, Having any metabolic disease except obesity,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
Female

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

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: Continuous Exercise<br>At %60 of maximal heart rate, 30-60 minutes exercise | Other: Continuous Aerobic Exercise<br>* At %50 of maximum heart rate, 30-60 minutes aerobic exercise<br>|
| Experimental: REHIT Exercise<br>At %100 of heart rate 15 seconds, after this period 15 sec recovery period for all step | Other: REHIT Exercise<br>* -Start with warm-up period --> %50 of maximum work rate, 3 minutes One Exercise Cycle consists of: 15 seconds exercise period: %100 of maximum work rate 15 seconds recovery period: %50 of maximum work rate Total Duration: 10 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic Capacity | Maximum Oxygen Uptake | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Exercise Duration | Exercise Test Duration | 1 year |
Efficacy and Safety of BGG492 in the Treatment of Migraine

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of BGG492 used to treat migraine pain.

Official Title
-----------------
A Multi-centre, Randomized, Double-blind, Parallel Group, Active and Placebo Controlled, Proof of Concept Study in Patients With Acute Migraine to Assess the Efficacy, Safety and Tolerability of Single Oral Doses of BGG492

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: BGG492
* Drug: Sumatriptan
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe migraine for at least 1 year At least 1 migraine episode, but not more 15 migraine days per month Past use of triptans Migraine onset before 50 years of age Exclusion Criteria: Diagnosis of basilar, ophthalmoplegic or hemiplegic migraine. More than 6 non-migraine headaches per month Patients receiving migraine prophylaxis treatment Patients receiving regular treatment with psychoactive drugs Smokers Patients with a very high or low body weight Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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 |
| --- | --- |
| Experimental: Active<br> | Drug: BGG492<br> <br> |
| Active Comparator: Comparator<br> | Drug: Sumatriptan<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in migraine pain |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Headache
Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis

Official Title
-----------------
A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis

Conditions
-----------------
Psoriatic Arthritis

Intervention / Treatment
-----------------
* Biological: Human anti-TNF monoclonal antibody/adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject completed study M02-518 or M02-570 Exclusion Criteria: Subject prematurely discontinued study M02-518 or M02-570 Female subject who is pregnant or breast-feeding or considering becoming pregnant Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Human anti-TNF monoclonal antibody/adalimumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters |  |  | 
| ACR 20/50/70 |  |  | 
| PsARC |  |  | 
| HAQ |  |  | 
| SF-36 |  |  | 
| FACTIT Fatigue Scale |  |  | 
| Disease progression measurements |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes |  |  | 
| Clinical response indicators |  |  |
Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma

Study Overview
=================
Brief Summary
-----------------
The study's chief objective is to observe the evolution of cellular (in terms of expression of transmembrane transporters and their transcriptional regulators) and viral resistance (in terms of development of mutations in the HIV genome that may confer resistance to future treatment for HIV) in HIV-infected patients with lymphoma.

Detailed Description
-----------------
The study team will take two or three tubes of blood on three occasions during the course of chemotherapy. The total amount of blood required for this research project is 64mL (approximately 4 tablespoons). This will allow better understanding of the changes that take place in the blood and the HIV virus itself. It is hoped that this will provide new insights that may aid the understanding and treatment of HIV patients with lymphoma.

Official Title
-----------------
Evolution of Cellular and Viral Resistance in HIV-infected Patients With Lymphoma

Conditions
-----------------
HIV, Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The ability to understand and sign a written informed consent form, prior to participation in any screening procedure and must be willing to comply with all study requirements. Documented HIV-1 infection. Diagnosis of lymphoma (with the exclusion of the five subjects that will be controls). On cART or about to start cART as part of clinical routine care before the initiation of chemotherapy. Exclusion Criteria: - Receiving anti-tuberculosis treatment.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV patients without lymphoma<br>HIV-infected subjects on cART without a diagnosis of lymphoma | |
| HIV patients with lymphoma<br>HIV seropositive individuals with lymphoma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of multi-drug resistance (in terms of expression of transmembrane transporters and their transcriptional regulators) in HIV-infected patients with lymphoma. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of mutations in the HIV genome that may confer resistance to future treatment for HIV. |  | 3 years |
Efficacy of the CLP® Hip - Retrospective

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip stem in a group of no more than 200 patients from whom data has already been collected.

Official Title
-----------------
Post-Market Study: The Efficacy of the CLP® Hip

Conditions
-----------------
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: Encore CLP® Hip stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 18 years of age or older. Noninflammatory degenerative joint disease including Osteoarthritis of the natural femoral head Avascular necrosis of the natural femoral head Rheumatoid arthritis Correction of functional deformities Femoral fracture Patients must be able and willing to complete all study-related visits. Exclusion Criteria: Anyone who is under 18 years of age Infection or sepsis Insufficient bone quality which may affect the stability of the implant Muscular, neurological or vascular deficiencies, which compromise the affected extremity Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock, poor skin coverage around hip joint which would make the procedure unjustifiable Osteomyelitis Rapid joint destruction or bone absorption apparent on roentgenogram Pathological conditions of the acetabulum which would prevent achieving proper range of motion, appropriate head stability, and/or a well-seated and supported smooth articulation of the head within the acetabulum Alcoholism or other addictions Materials sensitivity Loss of ligamentous structures High levels of physical activity (e.g., competitive sports, heavy physical labor) Pregnancy

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 |
| --- | --- |
| CLP Hip<br> | Device: Encore CLP® Hip stem<br>* Subjects with osteoarthritis, rheumatoid arthritis or avascular necrosis of the natural femoral head who have received the Encore CLP® Hip stem and are willing to participate in the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The survivorship and efficacy of the Encore CLP® Hip stem |  | 2 year |
Investigation of Protein Biomarkers of Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This study is looking at biomarkers in prostate cancer.

Detailed Description
-----------------
To establish primary culture of epithelial cells isolated from prostatectomy samples To study biomarkers in prostate cancer

Official Title
-----------------
Investigation of Protein Biomarkers of Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with prostate cancer.

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

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

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 |
| --- | --- | --- |
Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)

Study Overview
=================
Brief Summary
-----------------
This study prospectively observed the complications intended as diarrhea or sti-sis that critically ill patients developed within 7 days after ICU admission. In addition, secondary aims investigated through bioimpedenziometry the loss of lean body mass and changes in phase angle during the same period of ICU stay.

Official Title
-----------------
Gastrointestinal Complications of Artificial Nutrition in ICU: a Prospective Observational Study (NUTRITI)

Conditions
-----------------
Critical Illness, Nutritional and Metabolic Disease, Nutritional Deficiency, ICU Acquired Weakness, Enteral Feeding Intolerance, Diarrhea, Constipation

Intervention / Treatment
-----------------
* Other: ARTIFICIAL NUTRITION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU ANTICIPATED LENGTH OF STAY > 72 HOURS AGE > 18 YEARS NEED FOR ARTIFICIAL NUTRITION Exclusion Criteria: AGE < 18 YEARS ICU ANTICIPATED LENGTH OF STAY < 72 HOURS NO NEED FOR ARTIFICIAL NUTRITION BMI<16 KG/M2

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 |
| --- | --- |
| CRITICALLY ILL PATIENTS<br>ADULTS PATIENTS ADMITTED TO ICU DUE TO ACUTE ILLNESS THAT REQUIRE AT LEAST 72H OF STAY. FOR THE FIRST 7 DAYS OF STAY IN ICU, DATA ABOUT NUTRITIONAL INTERVENTION WILL BE RECORDED SUCH AS: ROUTE OF NUTRITION ADMINISTRATION, AMOUNT OF NUTRITION DELIVERED PER DAY, CALORIC TARGETS, PROTEIN REQUIREMENTS, diarrhea, CONSTIPATION, BIA ANALYSIS. | Other: ARTIFICIAL NUTRITION<br>* ARTIFICIAL NUTRITION<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION | REGISTER DIARROHEA (EMISSION OF FAECES> 200 ML IN 24 HOURS) EPISODES | 7 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FREQUENCY OF CONSTIPATION WITHIN 7 DAYS AFTER ICU ADMISSION | REGISTER CONSTIPATION EPISODES WITHIN 7 DAYS AFTER ADMISSION IN ICU | 7 DAYS | 
| LOSS OF LEAN BODY MASS AFTER 7 DAYS IN ICU | Loss of at least 7% of lean body mass | 7 DAYS | 
| CHANGES IN PHASE ANGLE AFTER 7 DAYS IN ICU | Measure of phase angle | 7 DAYS |
Cardiovascular Risk in General Practice in France: Cardiovascular Risk Week

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the proportion of patients which present a high cardiovascular risk estimated by the SCORE scale, in general practice consultations of the 7 French regions (Paris area, North-East, Paris basin, West, South-West, South- East, Mediterranean area)

Detailed Description
-----------------
MC MD

Official Title
-----------------
Cardiovascular Risk in General Practice in France

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Without any personal history of coronary disease Non treated with lipid-lowering agents Lipid test = 1 year old Presenting at least one cardiovascular risk Visiting their General Practitioner Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>For this group of patients, the cardiovascular risk will be evaluated by several tools: the SCORE scale, the Framingham 2008 scale d'Agostino and the 1998 scale Wilson ; | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of cardiovascular risk in general practice in France estimated by the SCORE scale |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of cardiovascular risk in general practice in France estimated by the Framingham 2008 scale D'Agostino |  | 1 week | 
| Evaluation of cardiovascular risk in general practice in France estimated by the Framingham 1998 scale Wilson |  | 1 week | 
| Evaluation of arteries age evaluation by SCORE |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular risk, France, General practice, Primary prevention, Non treated patients
Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Also biomarkers will be studied and validated as early predictors of AKI (Acute Kidney Injury).

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled Exclusion Criteria: Age < 18 or > 70 years Preexisting Chronic Renal Disease Patients with obstructive uropathy. Cirrhosis with HCC (HepatoCellular Carcinoma). Advanced cardiopulmonary disease Pregnancy Patients with extrahepatic malignancy

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 |
| --- | --- |
| cirrhosis with baseline renal function<br>500 patients of cirrhosis with normal baseline renal function will be enrolled. | |
| Cirrhosis with Acute Kidney Injury (AKI).<br>Cirrhotics patients who present with AKI (Acute Kidney Injury) will be enrolled. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis | Incidence is defined as No. of AKI (Acute Kidney Injury) patients during the follow up period of 1 year. Spectrum is defined as Grading of AKIN (Acute Kidney Injury Network) 1,2,3 in different child status (Child A,Child B and Child C) at the end . Natural History is defined as Occurrence of AKI (Acute Kidney Injury) and its recovery during the follow up period of 1 year. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study predictive value of Cystatin C in comparison to serum creatinine as early predictor of development and outcome of AKI in a cohort of Cirrhotics. |  | 1 Years | 
| To study predictive value of Cystatin C to determine progression or resolution of Acute Kidney Injury |  | 1 Years |
Safety and Pharmacokinetic Characteristics of DP-R202 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 300mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after oral administration in healthy male volunteers.

Detailed Description
-----------------
The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)first, DP-R202(Sarpogrelate HCL 300mg, qd) Second or DP-R202(Sarpogrelate HCL 300mg, qd) first, anplag tablet(Sarpogrelate HCL 100mg, tid) second.

Official Title
-----------------
A Randomized, Open-label, Two-Sequence, Two-Period Crossover Study to Assess the Pharmacokinetic Characteristics of Sarpogrelate HCl Controlled Release Tablet Compared With Sarpogrelate HCl Immediate Release Tablet in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: Anplag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 55 years of healthy volunteers Exclusion Criteria: Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anplag<br> | Drug: Anplag<br>* Sarpogrelate HCl 300mg once a day or 100mg three times a day<br>* Other names: Anplag : 0007;|
| Experimental: DP-R202<br> | Drug: Anplag<br>* Sarpogrelate HCl 300mg once a day or 100mg three times a day<br>* Other names: Anplag : 0007;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUClast |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax, t1/2, AUC0-∞ |  | 24h |