linjc16/ctgov huggingface dataset:
A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study

Study Overview
=================
Brief Summary
-----------------
This study will evaluate whether the use of an electronic diabetes tracker by both patients and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with technology and health data privacy issues. As part of the study, the investigators will be able to test whether practices that use computers perform any better than practices using paper. The investigators also will be developing the first Canadian computerized chart summary for each patient that can be communicated securely in emergencies (the Emergency Health Record) and read by all current electronic systems.

Official Title
-----------------
A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Electronic disease management decision support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, cognitively intact, consenting people with diabetes within enrolled practices Exclusion Criteria: Non-english speaking Cognitively impaired

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Electronic disease management decision support<br>An electronic Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS). | Other: Electronic disease management decision support<br>* A Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS)<br>* Other names: Intervention;|
| No Intervention: 2<br>Usual care by Family Physician | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of change in diabetes quality of care between intervention and usual care group. |  | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diabetes risk factor variables, satisfaction with care and technology, quality of life and health care utilization, health data privacy issues. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Computerized clinical decision support, shared care, patient self-monitoring, quality of care, complex interventions, composite outcomes
Frailty and Postoperative Shock

Study Overview
=================
Brief Summary
-----------------
To find an objective, affordable and manageable way to measure frailty in elderly patients and to examine relationship between peri-operative metabolism of frail older people and outcome after hip surgery.

Conditions
-----------------
Frailty, Elderly

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized in St-Luc Hospital (Belgium) for hip surgery between 2013 and 2015 Exclusion Criteria: non-traumatic hip fracture refusal

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip surgery, frail older people
Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

Study Overview
=================
Brief Summary
-----------------
To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback.

Official Title
-----------------
Physiologically Relevant Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

Conditions
-----------------
Prosthesis User, Amputation

Intervention / Treatment
-----------------
* Device: Tactor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria are adults (18 years or over) with major limb amputation (at or above wrist or ankle). - Exclusion Criteria: Exclusion criteria are any skin or pain conditions that would preclude ability to withstand pressures on their limb or to wear a prosthetic socket, or cognitive barriers precluding providing informed consent. -

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amputee and Able Bodied Subjects<br>Map the locations in the skin or deeper muscle where limb movement perceptions occur. Use tactors (small robots providing touch and vibration) to mechanically provide sensation to the residual muscles in amputees and the intact muscles in able-bodied. The functional experiments will occur concurrently with development and application of new prosthetic socket designs to incorporate control and feedback. | Device: Tactor<br>* The tactor is a small robot providing touch and vibration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin or tendon location | Locations in the skin or muscle of the residual where percepts of touch or movement occur. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sorting Task | Performance on a sorting task with and without tactor feedback. | 36 months | 
| Sense of Agency Questionnaire | Agreement with statements of agency and ownership related to perceptions of limb movement including unstructured self-reports. | 36 months |
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures

Study Overview
=================
Brief Summary
-----------------
This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice. This will be assessed postoperatively following the foot and ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament reconstruction (LAR).

Official Title
-----------------
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures: An Evaluation of Narcotic Consumption, Pain, Wound Healing, and Patient Satisfaction

Conditions
-----------------
Narcotic Consumption, Pain, Wound Healing, Patient Satisfaction

Intervention / Treatment
-----------------
* Device: Iceman® Cold Therapy unit (djOrtho)
* Other: Ice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled to have either lateral ankle ligament reconstruction (LAR) surgery or primary first metatarsal osteotomy surgery Patients who agree to be compliant and to keep a patient diary daily for 2 weeks and to return to the clinic for a 2 week postoperative follow- up appointment Exclusion Criteria: Patients with Diabetes Mellitus, peripheral vascular disease, Reynauds Syndrome, hypersensitivity to cold Patients allergic to hydrocodone or oxycodone Patients who are unwilling to complete the patient diary and/or follow their specific cold therapy instructions
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 |
| --- | --- |
| Other: Foot and Ankle Surgery<br>Please note that the study was terminated prior to randomization of patients. | Device: Iceman® Cold Therapy unit (djOrtho)<br>* postoperative cold therapy<br>Other: Ice<br>* postoperative cold therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Pain Scores |  | postop day 1 up to postop day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Pain Medication Usage |  | postop day 1 up to postop day 14 | 
| Patient Satisfaction |  | first postoperative visit (between postop day 10 and 14) | 
| Surgical Complications |  | Day of Surgery | 
| Postoperative Complications |  | postop day 1 up to postop day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cryotherapy, postoperative pain, Iceman, primary first metatarsal osteotomy (PMO), lateral ankle ligament reconstruction (LAR)
Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the relationship between periodontal disease and coronary artery disease through changes in the gut microbiome. In addition, the investigators aim to find possible periodontal pathogens that have association with cardiovascular disease.

Detailed Description
-----------------
The previous studies have reported the associations among cardiovascular disease, periodontitis, and gut microbiome dysbiosis. However, there is a lack of evidences about the axis of association from oral-gut-cardiovascular disease. The investigators hypothesized that periodontal disease might induce dysbiosis of gut microbiome and dysbiosis might have a role in cardiovascular disease (as called oro-gut-vascular axis). The investigators aim to prove this hypothesis through this case-control, cross-sectional study.

Official Title
-----------------
Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)

Conditions
-----------------
Periodontitis, Coronary Heart Disease, Human Microbiome, Dysbiosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity, with informed consent Exclusion Criteria: Patients with prosthetic valve pregnancy active malignancy active autoimmune disease active inflammatory bowel disease chronic kidney disease (eGFR<30, or on dialysis) Active liver disease or liver cirrhosis consistent use of probiotics prior gastrointestinal surgery within 1 year

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary artery disease<br> | |
| control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between periodontal disease and cardiovascular disease | The association between periodontal disease and cardiovascular disease by chi-square test The difference of relative abundance in gut microbiome by PERMANOVA test Safety Issue: No | within 3 years after enrollment (until the completion of dataset) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The associations among periodontitis, gut microbiome and biomarkers | The association between periodontal disease and biomarkers by independent t-test | within 3 years after enrollment (until the completion of dataset) | 
| The associations between periodontitis and cognitive function | The associtation between periodontal disease and cognitive function by chi-square test | within 3 years after enrollment (until the completion of dataset) |
Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.

Study Overview
=================
Brief Summary
-----------------
The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.

Official Title
-----------------
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (12.5 mg, 50 mg, 200 mg) of BI 135585 XX (Tablet) in Chinese and Japanese Healthy Male Volunteers (Randomised, Double-blind,Placebo-controlled Within Dose Groups)

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

Intervention / Treatment
-----------------
* Drug: Matching placebo
* Drug: BI 135585 XX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male volunteers, Chinese or Japanese ethnicity Exclusion criteria: Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement Any evidence of a clinically relevant concomitant disease Intake of drugs with long half life (>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 135585 XX<br>single dose of BI 135585 | Drug: BI 135585 XX<br>* single dose of low, medium or high dose of BI 135585 XX<br>|
| Placebo Comparator: matching placebo<br>single dose of matching placebo | Drug: Matching placebo<br>* single dose of matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR)) |  | up to 21 days | 
| Changes in 12-lead ECG (electrocardiogram) |  | up to 21 days | 
| Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis) |  | up to 21 days | 
| Occurrence of Adverse events |  | up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | 10 days | 
| Tmax (maximum measured concentration of the analyte in plasma) |  | 10 days | 
| AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | 10 days |
Muscle Strength and Exercise Capacity in Sarcoidosis Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine exercise capacity, muscle strength and fatigue in sarcoidosis. In this longitudinal study the changes in prevalence of exercise intolerance, reduced muscle strength and fatigue will be established in a two-year follow-up. Also the relation between these physical impairments in time and other clinical parameters, such as QOL, will be established.

Detailed Description
-----------------
The aim of this study is to examine exercise capacity, muscle strength and fatigue in sarcoidosis. In this longitudinal study the changes in prevalence of exercise intolerance, reduced muscle strength and fatigue will be established in a two-year follow-up. Also the relation between these physical impairments in time and other clinical parameters, such as QOL, will be established. Study design: sarcoidosis patients referred to the ild care team of outpatient clinic of the department of Respiratory Medicine of the MUMC and also participated in the baseline study between November 2008 and September 2009 will be included in this longitudinal study. A six-minute walk test and peripheral muscle strength measurements (included in the regular clinical work-up of sarcoidosis patients) will be performed under supervision of a physical therapist at the department of physical therapy of the MUMC. Moreover, the patients will be asked to complete the WHOQOL-bref questionnaire and the Fatigue Assessment Scale. A maximum of 124 patients will be included.

Official Title
-----------------
Exercise Capacity, Muscle Strength and Fatigue in Sarcoidosis: a Two-year Follow-up Study

Conditions
-----------------
Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines Exclusion Criteria: not being able to walk
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 |
| --- | --- |
| sarcoidosis patients<br>Sarcoidosis patients referred to the ild care team of the outpatient clinic of the department of Respiratory Medicine of the MUMC and also participated in the baseline study between November 2008 and September 2009 will be included in this study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity, muscle strength and fatigue in sarcoidosis: a two-year follow-up study | 6MWD and muscle strength measurements of arm (isometric strength of the elbow flexors) and leg (isokinetic peak torques of the hamstrings and quadriceps) muscles. Questionnaires: WHOQOL-bref and Fatigue Assessment Scale (FAS). | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcoidosis, muscle strength, exercise intolerance, QOL
Pupillary Pain Index and Reaction to Skin Incision

Study Overview
=================
Brief Summary
-----------------
During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Then, variations in heart rate, blood pressure and bispectral index during the three minutes following skin incision were recorded, as well as the occurrence of movements.

Official Title
-----------------
Relationship Between the Pupillary Pain Index Measured One Minute Before Incision and the Motor, Hemodynamic and Electroencephalographic Reaction to Skin Incision in Patients Under General Anesthesia

Conditions
-----------------
Pain, Anesthesia, Surgery

Intervention / Treatment
-----------------
* Device: videopupillometer
* Procedure: skin incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient requiring general anesthesia surgical procedure involving a skin incision no regional anesthesia written informed consent Exclusion Criteria: - neurologic or ophthalmic disease

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: videopupillometer|Measure of pupillary diameter and pupillary pain index via an infrared camera Each measure lasts approximately 20 seconds|
|Procedure: skin incision|performed under general anesthesia by the surgeon, at the beginning of an elective or emergency surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between pre-incision pupillary pain index and post-incision heart rate increase |  | 4 minutes: one minute before incision, 3 minutes after incision | 
| Relationship between pre-incision pupillary pain index and post-incision blood pressure increase |  | 4 minutes: one minute before incision, 3 minutes after incision | 
| Relationship between pre-incision pupillary pain index and post-incision bispectral index increase |  | 4 minutes: one minute before incision, 3 minutes after incision | 
| Relationship between pre-incision pupillary pain index and post-incision movement occurrence |  | 4 minutes: one minute before incision, 3 minutes after incision |