linjc16/ctgov huggingface dataset:
Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to compare repaglinide and metformin administered alone or in combination in subjects with type 2 diabetes.

Official Title
-----------------
A 3-month, Open-label, Randomized, Multi-center Study of Repaglinide in Combination With Metformin as Compared to Metformin or Repaglinide Given as Monotherapy for the Treatment of Type 2 Diabetes.

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

Intervention / Treatment
-----------------
* Drug: repaglinide
* Drug: metformin
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously treated with oral hypoglycaemic agents (OHA) as monotherapy (if metformin, less than 1500 mg daily) Body Mass Index (BMI) of 21-35 kg/m^2 HbA1c (glycosylated haemoglobin A1c) between 7.0-10% Exclusion Criteria: Treatment with insulin within the last 3 months preceding the trial Uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg, and/or diastolic blood pressure above 105 mm Hg) Participation in any other clinical trial within 30 days of screening

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rep<br> | Drug: repaglinide<br>* Dose individually adjusted<br>|
| Active Comparator: Met<br> | Drug: metformin<br>* Dose individually adjusted<br>|
| Active Comparator: Rep + met<br> | Drug: repaglinide<br>* Dose individually adjusted<br>Drug: metformin<br>* Dose at 1000 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated haemoglobin A1c) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose (FBG) |  |  | 
| 1-hour post prandial blood glucose (PPBG) |  |  | 
| Incidence of hypoglycemic episodes |  |  |
The Effect of Strength Training on the Hip Adduction Strength Measured With Hand-held Dynamometry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of strength training with elastic bands on hip strength in soccer players, the effect measured with hand-held dynamometry. The primary outcomes are isometric and eccentric hip adduction strength. The hypothesis is that strength training with elastic bands will result in a clinical relevant increase in hip adduction strength.

Conditions
-----------------
Hip Adduction Strength

Intervention / Treatment
-----------------
* Other: Strength training of the hip adductors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sub-elite danish soccer players Exclusion Criteria: Injury in the lower back or legs with a duration of more than 6 weeks within the last year before the study was initiated. Systematic strength training of the hip adductors more than once a week within the last 6 months before the study was initiated. Groin pain during soccer play with a duration of more than 1 week and witch resulted in loss of soccer training/game within the last 3 months before the study was initiated. Groin injuries within the last month before the study was initiated.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br> | Other: Strength training of the hip adductors<br>* Adductor strength training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric hip adduction strength |  | 8 weeks | 
| Eccentric hip adduction strength |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip adduction strength training, Improvement in adductor strength
Electromyographic Activity of Masseter Muscle During Deglutition in Total Laryngectomized Subjects

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the electromyographic activity of masseter muscle during deglutition in laryngectomized subjects.

Official Title
-----------------
Electromyographic Activity of Masseter Muscle During Deglutition in Total Laryngectomized Subjects

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laryngectomy Exclusion Criteria: neurological diseases no oral feeding

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total Laryngectomized<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
-----------------
electromyography, laryngeal neoplasms, masticatory muscles
Effects on Physical Fitness, Immunity, and Quality of Life of Yoga Training in Breast Cancer Survivors.

Study Overview
=================
Brief Summary
-----------------
This study wants to prove that Yoga Training can improve physical Fitness, immunity, and quality of Life of in Breast Cancer Survivors. In summary, our findings show potential benefits of yoga for people with cancer in improvements of psychological health. Because of the small number of studies having been conducted and the methodological limitations, the results should be regarded as preliminary and treated with caution. Our preliminary findings also provide practitioners with important information that yoga may be a possible adjunctive therapy for cancer patients to help manage psychological distress and to improve quality of life.

Official Title
-----------------
Effects on Physical Fitness, Immunity, and Quality of Life of Yoga Training in Breast Cancer Survivors.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer with stage1 or stage2, Sedentary life style, no orthopaedic disease and medical disease Exclusion criteria recurrent or metastasis, medical or current psychiatric illness which would make compliance with the study protocol difficult or dangerous, medications which would alter training response
Sexes Eligible for Study
-----------------
Female

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

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 |
| --- | --- |
| Experimental: yoga training<br>Yoga training | Other: yoga<br> <br> |
| No Intervention: control<br>no yoga training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline immunological factors, cardiorespiratory and muscle fitness, questionnaire for physical activity, fatigue and quality of life at 13th weeks |  | 13th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline immunological factors, cardiorespiratory and muscle fitness, questionnaire for physical activity, fatigue and quality of life at 25th weeks |  | 25th week |
Effect of Nutrition on Muscle Protein Synthesis

Study Overview
=================
Brief Summary
-----------------
The present proposal is designed to examine the effect of carbohydrate and protein co-ingestion on muscle protein synthesis during endurance type exercise activities. We hypothesize that muscle protein synthesis is higher when protein is co-ingested during exercise.

Official Title
-----------------
The Effect of Carbohydrate and Protein Intake on Muscle Protein Synthesis During Endurance Exercise

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

Intervention / Treatment
-----------------
* Dietary Supplement: carbohydrate and protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recreationally endurance trained Exclusion Criteria: BMI > 25 kg/m2 Not physically active

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 28 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: carbohydrate and protein<br>* The intake of carbohydrate and protein during endurance type exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in muscle protein synthesis rates between carbohydrate and carbohydrate + protein. |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in whole-body protein synthesis and breakdown between carbohydrate and carbohydrate plus protein. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle protein synthesis, whole-body protein breakdown, nutrition
Comparison of IgA Levels in the Bronchoalveolar Lavage Fluid of Patients With and Without Antibiotic Therapy

Study Overview
=================
Brief Summary
-----------------
Investigators hypothesize that Immunoglobine (Ig) production is influenced by the microbiota of the gut. Investigators will compare microbiota-dependent Ig production in the bronchoalveolar lavage fluid of patients with and without antibiotic therapy in order to detect significant differences.

Official Title
-----------------
Comparison of IgA Levels in the Bronchoalveolar Lavage Fluid of Patients With and Without Antibiotic Therapy

Conditions
-----------------
Immunoglobulin A

Intervention / Treatment
-----------------
* Drug: Anti-Bacterial Agents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endotracheal intubation antibiotic therapy for 2 weeks OR no antibiotic therapy for at least 3 months Exclusion Criteria: active infection pregnancy immunodeficiency

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 |
| --- | --- |
| Patients with antibiotic therapy<br>Patients with antibiotic therapy for 2 weeks. | Drug: Anti-Bacterial Agents<br>* administration of any antibiotic substance(s) over the course of 2 weeks<br>|
| Patients without antibiotic therapy<br>Patients without any antibiotic therapy in the last 3 months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgA levels in the bronchoalveolar lavage fluid |  | 2 weeks of ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of detected bacterial, viral, and fungal infections per patient |  | through study completion, an average of 2 months |
Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers

Study Overview
=================
Brief Summary
-----------------
Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an acid-blocking drug (called a proton pump inhibitor [PPI]) either by mouth every 3 hours for 24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach will be used to determine intragastric pH (a measure of the acid production in the stomach) at baseline and during the 24 hours of therapy. The purpose of the study is to determine if the continuous intravenous administration of the drug provides better reduction of acid in the stomach than the oral administration.

Official Title
-----------------
Prospective Randomized Comparison of the Effect of Frequent Oral Dosing Versus Constant IV Infusion of Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers

Conditions
-----------------
Peptic Ulcer Hemorrhage

Intervention / Treatment
-----------------
* Drug: Proton pump inhibitor (lansoprazole)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting to hospital with overt upper GI bleeding and found to have an ulcer as the cause on endoscopy Exclusion Criteria: Previous gastric surgery Active bleeding at end of endoscopy (despite hemostatic therapy) Recent PPI or H2RA use

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oral PPI | Drug: Proton pump inhibitor (lansoprazole)<br>* 120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs 90 mg IV bolus followed 9 mg/hr infusion for 24 hrs<br>|
| Active Comparator: 2<br>Intravenous PPI | Drug: Proton pump inhibitor (lansoprazole)<br>* 120 mg PO and then 30 mg PO q 3 h from 3 to 21 hrs 90 mg IV bolus followed 9 mg/hr infusion for 24 hrs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intragastric pH > 6 |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intragastric pH |  | 24 hrs |
Promoting Physical Activity for Persons With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine whether a group wellness intervention or individualized physical rehabilitation was more effective in improving health and physical activity in persons with multiple sclerosis.

Detailed Description
-----------------
Evidence from this study shows that both interventions were effective in improving health and physical activity in persons with multiple sclerosis. The results also show that participants may benefit more physically from individualized physical rehabilitation and more mentally from group wellness interventions. Interventions that combine individualized therapeutic exercise with group health education might be most effective for persons with multiple sclerosis.

Official Title
-----------------
Comparing Individualized Rehabilitation to a Group Wellness Intervention for Persons With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Group wellness intervention
* Other: Individualized physical rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A physician-confirmed diagnosis of MS Between the ages of 18 to 75 years Ability to ambulate 25 meters with or without the use of an adaptive aide Exclusion Criteria: Pregnant Cardiovascular disease Had fallen more than twice in the past month Significant cognitive deficits

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Group wellness intervention|nan|
|Other: Individualized physical rehabilitation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Fatigue Impact Scale SF-36 Mental Health Inventory |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical assessments |  | 16-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Chronic Disabling Condition, Comparative Evaluation, Physical Activity, Physical Therapy
3D Animation and Models to Aid Management of Fetal CDH

Study Overview
=================
Brief Summary
-----------------
We wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH. This will both help the parents see what the problem is and also allow the surgeons, who will operate on the baby once it has been born, to see the size of the hole and what organs are in the wrong place.

Official Title
-----------------
The Role of 3D Images and Models to Aid Management of Cases of Congenital Diaphragmatic Hernia Diagnosed in the Antenatal Period. Consecutive Patients Studied From Diagnosis to Post Operative Period.

Conditions
-----------------
Congenital Diaphragmatic Hernia

Intervention / Treatment
-----------------
* Other: No intervention data collected through routine scans


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Target Population: pregnancy women attending Jessop Wing Fetal medicine unit. Accessible population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI. Study population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI and agree to take part in the study. Exclusion Criteria: Not able to give informed consent due to any reason including poor understanding of English Under 18 years of age. Unable to complete the fetal MRI process due to either metal implants or claustrophobia.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Congenital Diaphragmatic Hernia referred for fetal MRA<br> | Other: No intervention data collected through routine scans<br>* No intervention, we wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient demographics | Gestational age at time of scan and health outcomes from patient notes. This will be used to assess the accuracy of the 3D models developed. | Baseline |
Effect of APC and Epo on the Inflammatory Response During Sepsis

Study Overview
=================
Brief Summary
-----------------
An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis.

Detailed Description
-----------------
An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis. Patients already prescribed either drug will be enrolled. The microcirculation of the sublingual vascular bed will be observed with a microscope to detect the alterations in the inflammatory response.

Official Title
-----------------
Effect of Activated Protein C and Erythropoietin on the Microvascular Inflammatory Response During Severe Sepsis.

Conditions
-----------------
Sepsis, Systemic Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in the ICU in severe septic shock undergoing APC and/or Epo treatment Exclusion Criteria: any severe comorbid conditions

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic Inflammation, Microvascular Perfusion, Septic Shock