linjc16/ctgov huggingface dataset:
Plexus Anesthesia in Lateral, Head-Down Position for Elective Surgery of the Shoulder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the axillary plexus block performed in lateral, head down position is effective in the perioperative analgesia in patients scheduled for elective surgery of the shoulder.

Official Title
-----------------
Axillary Plexus Block for Perioperative Analgesia in Patients Scheduled for Elective Surgery of the Shoulder: Influence of Lateral, Head-Down Position

Conditions
-----------------
Shoulder Surgery

Intervention / Treatment
-----------------
* Procedure: Positioning and anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for elective surgery of the shoulder Exclusion Criteria: lateral, head down position not possible

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 |
| --- | --- |
| Experimental: 1<br>lateral, head-down position during axillary plexus block | Procedure: Positioning and anesthesia<br>* Positioning during axillary plexus block<br>|
| Active Comparator: 2<br>standard position during axillary plexus block | Procedure: Positioning and anesthesia<br>* Positioning during axillary plexus block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) score |  | 8 hours after start of axillary plexus block | 
| VAS Score |  | 24 hours after start of axillary plexus block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption |  | intraoperatively | 
| Patient comfort |  | six months after surgery | 
| Opioid consumption |  | during hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nerve block/*methods, Anesthetics, Local/pharmacokinetics, *Brachial Plexus
Metformin Plus Insulin on Non-obese Autoimmune Diabetes

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.

Official Title
-----------------
The Effect of Metformin as add-on to Insulin in Non-obese Patients With Autoimmune Diabetes

Conditions
-----------------
Type 1 Diabetes Mellitus, Autoimmune Diabetes

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes according to ADA criterias <5 years. Age≥ 18 years and less than 70 years. Non-obese: defined as BMI less than 28 kg/m2 Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A Fasting or postprandial plasma C-peptide more than 100 pmol/L Written informed consent from the patient or family representative. Exclusion Criteria: History of any malignancy or other severe diseases Female patients who are pregnant or breastfeeding before or during the three-year follow-up Poor compliance or refusal to participate.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin + Insulin<br> | Drug: Metformin<br>* Patients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy.<br>Drug: Insulin<br>* Patients will continue insulin therapy following physicians' instructions.<br>|
| Active Comparator: Insulin alone<br> | Drug: Insulin<br>* Patients will continue insulin therapy following physicians' instructions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amplitude of glycemic excursions (MAGE) | MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this 6-month study. | 6 months | 
| Change in C-peptide | C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 6 months | 
| Change in daily insulin dose |  | 6 months | 
| Change in body mass index (BMI) |  | 6 months | 
| Change in lipid profiles | Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol | 6 months | 
| Adverse effects | Adverse effects are recorded at each time-point of the follow-up | 6 months |
Swedish Antibiotic Nursing Home Trial

Study Overview
=================
Brief Summary
-----------------
Main aim and objective The aim was to present the treatment of infectious diseases in elderly, especially in nursing homes and further to evaluate the effect of an intervention package aiming at improving treatment with antibiotics in Swedish nursing homes Specific objectives Present the treatment patterns regarding infectious diseases, including gender aspects in elderly, especially in nursing homes. Through focus group discussions elucidate the decision making process in nursing homes and target the intervention. Based on the above information develop an educational intervention to contribute to the improvement of the prescribing of antibiotics in nursing homes Evaluate the effect of the intervention on quality of prescribing, knowledge and attitudes in relation to available guidelines

Conditions
-----------------
Infections, Urinary Tract Infections

Intervention / Treatment
-----------------
* Behavioral: Educational intervention on antibiotic prescribing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nursing homes where residents have a common dining room and staff, and a self-assessed stable staff situation Exclusion Criteria: specialised nursing homes or wards (e.g. oncology wards)

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

Design Details

Primary Purpose: Health Services Research


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational intervention on antibiotic prescribing<br>The participants in this group received an educational intervention. | Behavioral: Educational intervention on antibiotic prescribing<br>* Small educational group sessions with nurses and physicians, feedback on prescribing, presentation of guidelines and written materials<br>|
| No Intervention: No educational intervention<br>The participants in this group did not receive the educational intervention | |

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
-----------------
Infections in nursing homes, especially urinary tract infections
Maintenance Study on the Long Term Safety of XL999

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999. The secondary objectives of this study are as follows: To evaluate tumor response after long term repeat administration of XL999 in two subjects rolled over from other XL999 studies. To characterize the long term safety and tolerability of XL999 after repeat administration in two subjects rolled over from other XL999 studies. To characterize the long term effects of XL999 on cardiac function after repeat administration in two subjects rolled over from other XL999 studies.

Official Title
-----------------
A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies

Conditions
-----------------
Advanced Malignancies

Intervention / Treatment
-----------------
* Drug: XL999


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is currently enrolled in Protocols XL999-001 or XL999-204 The subject has received XL999 for at least one year prior to enrollment Per the respective parent XL999 protocol, the subject is eligible to continue to receive XL999 in the absence of progressive disease (PD) or unacceptable drug-related toxicity Exclusion Criteria: Progressive disease Any development(s) that would meet the exclusion criteria from the subject's respective XL999 protocol (XL999-001 or XL999-204)

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 |
| --- |
|Drug: XL999|XL999 for injection will be supplied as a brown, sterile injectable solution at a concentration of 5 mg/mL|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999. |  | Progressive disease or end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate tumor response after long term repeat administration of XL999 Characterize long term safety and tolerability of XL999 after repeat administration Characterize long term effects of XL999 on cardiac function after repeat administration |  | Progressive disease or end of study |
Certoparin in Renal Patients Undergoing Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis.

Official Title
-----------------
A Multi-center, Prospective, Open-label, 8-weeks Study to Investigate the Efficacy, Safety and Pharmacokinetics of Certoparin (3000 IU Anti-Xa Bolus, With the Option to Titrate Dose)in the Prophylaxis of Clotting in the Extracorporeal Circuit in Patients Undergoing Chronic Hemodialysis

Conditions
-----------------
Renal Dialysis

Intervention / Treatment
-----------------
* Drug: Certoparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring hemodialysis Patients requiring anticoagulation therapy during hemodialysis Written informed consent Exclusion Criteria: Hypersensitivity to study medication Genetic abnormality or disease of clotting system Prior major surgery or bleeding Other protocol-defined inclusion/exclusion criteria may apply

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Certoparin<br> | Drug: Certoparin<br>* Certoparin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients requiring uptitration |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of Certoparin |  | Day 1, Week 4 | 
| Safety and tolerability of Certoparin |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Certoparin
Respiratory Health of Elite Athletes

Study Overview
=================
Brief Summary
-----------------
Eleven National Sports Teams are located in the Quebec Metropolitan Area. In these groups, many athletes are aiming for Olympic medals in Beijing 2008 and Vancouver 2010 Olympic Games. A consultation of the coaches of these National Teams revealed that although a large proportion of these athletes present various cardio-respiratory symptoms, they do not have a rapid access to a systematic medical evaluation and follow-up. Furthermore, little is done in regard to prevention and optimization of treatment of pulmonary and cardiac conditions in the elite athlete's population of the Quebec area. Cardiorespiratory problems are therefore commonly found in high-level athletes. However, these pathologies are not well characterized in athletes and the associated symptoms often not well perceived. These problems can be serious and it is important to detect them before they appear1 while setting up a systematic medical follow-up. Health professionals should monitor health of the young athletes and help to reduce the risks associated with high level exercise. The following project is an evaluation and follow-up program of high-level athletes, aiming at gathering key-information on long-term effects of high-level training on cardio-respiratory and metabolic parameters. Our aims will be to establish a long-term program of systematic evaluation and follow-up of cardiorespiratory health and performance of high elite athletes. to evaluate the prevalence of respiratory, circulatory and metabolic problems among high-level athletes to evaluate the effects of treatments on cardiorespiratory conditions and exercise performance in athletes who need asthma medication.

Official Title
-----------------
Center of Excellence in CardioRespiratory Health of High-level Athletes: Evaluation of Long-term Effects of Training.

Conditions
-----------------
Asthma, Cardiovascular Diseases, Metabolic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Athletes training more than 10 hours per week- Exclusion Criteria: asthma or other pathologies that may interfere with the study Smokers Obese of with a BMI more than 29

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 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>Triathletes | |
| 2<br>Cold air athletes | |
| 3<br>Swimmers | |
| 4<br>Other sports elite athletes | |
| 5<br>Control subjects | |

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
-----------------
Asthma, Environment, Type of sport, Cardiovascular disease, Athletes
OmegAD (Omega-3 and Alzheimer's Disease)

Study Overview
=================
Brief Summary
-----------------
Memory loss and difficulties with thinking associated with Alzheimer's disease (AD) may be due to a deficiency in the brain of a fatty acid named DHA. The aim of this trial is to see if dietary supplementation with a preparation, rich in DHA, will halt cognitive impairment in AD patients

Official Title
-----------------
Omega-3 Fatty Acid Treatment of 174 Patients With Mild to Moderate Alzheimer's Disease (OmegAD): a Randomized Double-blind Trial

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: EPAX 1050TG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer's disease with MMSE 15-30, living in own homes, treated with stable dose of acetylcholine esterase inhibitor for >3 months and remaining on that treatment for the study period Exclusion Criteria: Already treated with omega-3 fatty acids, NSAIDs, warfarin, being an alcohol abuser, suffering from serious concomitant disease or not having a caregiver
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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EPAX 1050TG|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition measured according to ADAS-cog, MMSE scales |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability, blood pressure |  |  | 
| Gene expression | mRNA expression and DNA methylation changes in blood leukocytes in relation to changes of plasma and cerebrospinal concentrations of omega-3 fatty acids | 2007-2018 | 
| Dose-response studies in relation to APOE4 status, to body weight and to gender | Analysis of changes of plasma and cerebrospinal fluid concentrations of omega-3 fatty acids in relation to APOE4 status, body weight and gender, as well as to changes in ADAS-cog and MMSE as measures of cognition. | 2007-2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, Omega-3 fatty acid, Dietary supplementation, Cognition, Safety
Study on Serum Cystatin C and PET-DAT in Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the relationship between serum cystatin C and dopamine receptor(DAT) loss in patients with parkinson's disease(PD)

Detailed Description
-----------------
Number of people suffered from Parkinson disease (PD) is increasing every year. PET imaging of dopamine transport receptors（DAT） serves as the gold standard for the diagnosis and monitoring of PD development. However, due to high costs and radiation reasons, it is not suitable for long-term follow-up. Serum cystatin C can be easily obtained and cheap as an indicator. In recent years, studies have gradually found that it is related to the progression of H&Y staging of Parkinson's disease. To this extent, we want to further explore whether it can reflect the loss of DAT in the brain. Explore whether it can partially replace the role of DAT imaging for future clinical evaluation.

Official Title
-----------------
The Relationship Between Serum Cystatin C and PET-DAT Study in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged between 20 and 80 years and whose laboratory results included the levels of serum Cystatin C within a month from the PET-DAT were recruited. Exclusion Criteria: To make the study cohort more homogeneous, PD patients with either a long-standing duration (≥5 years) or advanced Hoehn and Yahr (H&Y) staging (≥3) were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Cystatin C assesses the loss of dopaminergic neurons | Explore whether Cystatin C can respond to the loss of dopaminergic neurons | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystatin C, PET-DAT
A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

Study Overview
=================
Brief Summary
-----------------
To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

Official Title
-----------------
Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

Conditions
-----------------
Arthritis, Juvenile Rheumatoid

Intervention / Treatment
-----------------
* Drug: Celecoxib
* Drug: Celecoxib
* Drug: Naproxen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2-18 years old with active JRA Exclusion Criteria: other experimental meds, recent changes in arthritis meds

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose<br> | Drug: Celecoxib<br>* Higher dose, 6 mg/kg/dose BID<br>|
| Experimental: Low Dose<br> | Drug: Celecoxib<br>* Active drug at lower dose<br>|
| Active Comparator: Naproxen<br>Control comparator, 15 mg/kg/dy target dose | Drug: Naproxen<br>* Control comparator, 15 mg/kg/dy target dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR Pediatric 30 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peds QOL |  | 12 weeks | 
| composites of acr 30 |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthritis, juvenile