linjc16/ctgov huggingface dataset:
Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
Comparison of efficacy in management of pain in abdominal surgery between epidural versus wound infusion catheter {catheter placed within the incision site}

Official Title
-----------------
Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery

Conditions
-----------------
Upper Gastrointestinal Surgery, Post-operative Analgesia, Wound Infusion Catheter, Upper Midline Incision

Intervention / Treatment
-----------------
* Other: Wound catheter infusion
* Other: Epidural infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA PS I-III , undergoing upper gastrointestinal surgery involving upper midline incision Exclusion Criteria: Refusal to give consent. Contraindication to epidural analgesia (e.g.localized sepsis , Raised ICP , Myelopathy , Peripheral neuropathy ,Inherited coagulopathy) Addiction to opioids, or alcohol, or history of any other substance abuse. Allergy to local anaesthetic drugs. Pregnancy. Inability to communicate (e.g. known psychiatric disorders)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural catheter infusion<br>epidural catheter in the thoracic vertebra level to provide local anesthetic infusion | Other: Epidural infusion<br>* Epidural catheter will be placed in the level T7-T9 , and local anaesthetic infusion will be given<br>|
| Experimental: Wound catheter infusion<br>A multiorificed wound infusion catheter kept within the incision site to provide continuous local anesthetic infusion | Other: Wound catheter infusion<br>* Wound catheter has multiple holes spread around 360 degrees throughout its active length. It is placed in the musculofascial plane during closure of the wound. Local anaesthetic infusion will be delivered through the catheter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS (Numerical Rating Score) in the two groups postoperatively |  | 24 hrs post surgery |
Study of Osteopathic Manipulation in the Management of Angina

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms.

Official Title
-----------------
Study of Osteopathic Manipulation in the Management of Angina

Conditions
-----------------
Angina Pectoris

Intervention / Treatment
-----------------
* Procedure: Osteopathic manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Canadian Cardiovascular Society Class II, III for a minimum of 6 months documented coronary artery disease via previous myocardial infarction, abnormal stress test, or abnormal coronary angiogram of greater than or equal to 50% luminal obstruction of at least one epicardial vessel. Exclusion Criteria: severe left ventricular dysfunction symptomatic heart failure symptomatic aortic stenosis or any valvular disease significant pulmonary disease unstable angina major surgery or angioplasty in the past three months acute myocardial infarction within past three months insulin dependent diabetes mellitus uncontrolled hypertension acute renal or hepatic failure currently being treated with osteopathic manipulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 81 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: A<br>After establishing a baseline for the first 4 weeks of trial involvement, thereby providing their own control group, all participants begin the intervention phase of osteopathic manipulation. | Procedure: Osteopathic manipulation<br>* Participant will be evaluated and treated for somatic dysfunction utilizing osteopathic manipulation once a week for 3 weeks, then once every 3 weeks for three more visits; a total of 6 interventions in 3 months.<br>* Other names: musculoskeletal model;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in angina symptoms |  | over 4 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life |  | over 4 month period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
angina pectoris, osteopathic manipulation
Efficacy of Structured Insulin Order

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an electronic order template for basal-bolus insulin will improve mean blood glucose in hospitalized general medical patients with poorly controlled type 2 diabetes.

Detailed Description
-----------------
The study randomly assigned internal medicine residents to use an electronic insulin order template plus basal-bolus ordering education versus education only. For all patients with uncontrolled type 2 diabetes treated by these physicians, mean blood glucose, rate of hypoglycemia, and rate of sliding scale insulin use were measured.

Official Title
-----------------
Efficacy of Structured Insulin Orders in Improving Glycemic Control

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

Intervention / Treatment
-----------------
* Other: Diabetes Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood glucose less than 60 mg/dl or greater than 180 mg/dl during hospital stay Exclusion Criteria: Diagnosis of Type 1 Diabetes

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: Ordering template and education<br>Internal medical residents who were asked to use the insulin order template and received education about basal-bolus insulin ordering. | Other: Diabetes Management<br>* Using electronic insulin order template for basal-bolus insulin and education<br>|
| Active Comparator: Education<br>Internal medical residents who received education about basal-bolus insulin ordering. | Other: Diabetes Management<br>* Using electronic insulin order template for basal-bolus insulin and education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood Glucose |  | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates of glucose values less than 60 mg/dl or less than 40 mg/dl |  | 6 days | 
| rate of use of sliding scale insulin |  | 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes mellitus, basal-bolus insulin, insulin ordering
An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin

Official Title
-----------------
A Prospective Descriptive, Multi-National, Multi-Centre Observational Study of Burden of Upper GI-Symptoms in Subjects With Cardiovascular Risk or Disease Receiving Treatment With Low-Dose Aspirin

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed written inform consent. Physician prescribed or recommended daily intake of Low Dose Aspirin (LDA) (75-325 mg daily) for cardiovascular disease prevention within the past 12 months. Established cardiovascular disease, such as CAD (CoronaryArtery Disease), previous TIA (Transient Ischemic Attack), ischemic stroke or subjects with known risk factors for cardiovascular disease without having experienced cardiovascular events Exclusion Criteria: Need for concomitant treatment with a non-ASA NSAID (Nonsteroidal Antiinflammatory Drugs) including acyclooxygenase-2 (COX-2) selective NSAID. Occasional use of up to 1 day/week is allowed.

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 |
| --- | --- |
| 1<br>Patients who have been prescribed Low Dose Aspirin (LDA) usage in the past 12 months, or those about to begin LDA, will complete a one-time in-office survey using an electronic personal digital assistant (PDA) device (termed SitePro). | |
| 2<br>420 subjects stratified into three groups varying on length of time using Low Dose Aspirin (LDA) | |
| 3<br>Up to 20 subjects from the three EMA groups will be interviewed to further debrief their experience with Low Dose Aspirin (LDA) and upper GI symptoms. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-sectional survey, SitePro Survey Domains including; background, UGI screening, PPI and H2 blocker usage, interaction between UGI and LDA ,UGI symptoms, HADS, Morisky Medication Taking Behavior Scale, SF12, SSA-P |  | Once at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization |  | Four times daily for three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Dose Aspirin (LDA), Cardiovascular disease, Low Dose Aspirin (LDA) use in in subjects with cardiovascular risk or disease
Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control

Study Overview
=================
Brief Summary
-----------------
This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes.

Detailed Description
-----------------
This proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes who are physically active and exercising for health benefits. The investigators hypothesize that insulin requirements will be inversely related to intensity of activity and an algorithm will be able to detect physical activity and automatically adjust insulin doses. Once such an algorithm has been determined for an individual, it can be applied to future similar situations, but ideally the algorithm will be dynamically refined based on closed-loop feedback information.

Official Title
-----------------
Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control

Conditions
-----------------
Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria for subjects with diabetes Type 1 diabetes or insulin requiring type 2 diabetes for at least 1 year Use insulin to control diabetes Physically active (regularly work out, swim, run, walk, bike, etc.) Free of major micro- and macrovascular complications of diabetes 18-75 years of age A1C < 9.0% Inclusion criteria for subjects without diabetes No evidence of diabetes and physically active Exclusion Criteria: unwilling to perform repeated glucose checks or take insulin as instructed abnormal thyroid function, kidney function, liver function pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| exercise in individuals without diabetes<br>exercise in individuals without diabetes | Other: exercise<br>* Sprinting, walking on a treadmill, and stationary bicycle riding<br>|
| exercise in type 1 diabetes<br>exercise in type 1 diabetes | Other: exercise<br>* Sprinting, walking on a treadmill, and stationary bicycle riding<br>|
| exercise in type 2 diabetes<br>exercise in type 2 diabetes | Other: exercise<br>* Sprinting, walking on a treadmill, and stationary bicycle riding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes |  | 7 days |
Acupuncture in Mothers of Very Low Birth Weight Infants

Study Overview
=================
Brief Summary
-----------------
Does ear acupuncture reduce anxiety in mother of very low birth weight infants?

Official Title
-----------------
Ear Acupuncture for Anxiety in Mothers of Very Low Birth Weight Infants

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Procedure: Ear acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: can read and write in portuguese Exclusion Criteria: breastfeeding contraindication use of lactogogues

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ear acupuncture<br> | Procedure: Ear acupuncture<br>* Ear acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation.<br>|
| Placebo Comparator: Placebo acupuncture<br>No needle insertion, only stickers on acupuncture points. | Procedure: Ear acupuncture<br>* Ear acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced anxiety |  | at least 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Anxiety, Human Milk, Very low birth weight infants, Mother of very low birth weight infants
Education Against Tobacco Randomized Trial in Bosnia and Herzegovina

Study Overview
=================
Brief Summary
-----------------
A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the change in smoking prevalence between the two groups.

Official Title
-----------------
Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Bosnia and Herzegovina - Randomized Trial

Conditions
-----------------
Tobacco Prevention, Tobacco, Schools

Intervention / Treatment
-----------------
* Behavioral: Education Against Tobacco School-Based Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visiting grades 7-9 of regular secondary schools in Bosnia and Herzegovina. Exclusion Criteria: Not fulfilling inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group receives a school-based module taking about two hours delivered by medical students in the schools. | Behavioral: Education Against Tobacco School-Based Intervention<br> <br> |
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking prevalence measured via questionnaire. |  | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking onset: Difference in the number of new smokers at 12 months of follow-up who were not present at baseline |  | Baseline and 12 months | 
| Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline |  | Baseline and 12 months | 
| Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire. | Difference in attitude towards smoking between the two groups at 12 months follow-up measured via questionnaires. | Baseline and 12 months |
Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis

Study Overview
=================
Brief Summary
-----------------
Lupus and vasculitis are autoimmune conditions which can be life threatening. In order to treat these conditions toxic therapies such as cyclophosphamide and steroids are often required. These standard treatments are associated with significant side effects. Furthermore a proportion of patient do not respond to these conventional therapies. Newer safer therapies are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one part of the human immune system that helps prevent infections. Abnormal activity of the immune system is responsible for autoimmune disease although the exact mechanisms in lupus and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this context. It has recently been used to treat some autoimmune conditions with positive results. In this pilot study we wish to assess the effectiveness and safety of rituximab in patients with lupus and vascultis that are resistant to conventional therpies.

Official Title
-----------------
Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy

Conditions
-----------------
Systemic Lupus Erythematosus, ANCA Associated Vasculitis

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of SLE or ANCA associated vasculitis Active disease refractory to 6 months conventional therapy with cyclophosphamide, prednisolone and at least one other immunosupressive agent ( or a lesser period if this therapy cannot be tolerated) Age 18-70 Exclusion Criteria: HbeAg or HCV Ab positive or known HIV positivity ( HIV testing not necessary for this study) Pregnancy, inadequate contraception or lactation Malignancy Current enrolment in pother clinicla trials -

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Clinical remission at 6 or 12 months |  |  | 
| 2. Absence of a severe life threatening adverse event |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rituximab, ANCA, vasculitis, lupus,