linjc16/ctgov huggingface dataset:
Heartfulness Meditation and Corporate Burnout

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a 4-week heart-based meditation practice wellness workshop on burnout and emotional wellness in corporate employees. Corporate employees can be defined as individuals who work in large institutions with greater than 300 employees. The specific aim of this study is to assess changes in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment using the Maslach Burnout Index. We hypothesize that the meditation wellness practice will be associated with reduction in burnout for those who take part in the meditation program in comparison to the participants who did not meditate and participate in the wellness program.

Official Title
-----------------
Effect of Heartfulness Corporate Wellness Program on Burnout Inventory Measurements

Conditions
-----------------
Burnout, Meditation, Stress, Heartfulness

Intervention / Treatment
-----------------
* Other: Heartfulness Meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults above 18 years of age willing to participate in the study. Exclusion Criteria: Individuals less than 18 years of age, active suicidal ideation, current or past diagnoses of serious psychotic disorders- schizophrenia, personality disorders and post-traumatic stress disorder.

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 |
| --- | --- |
| Control<br>Participate in filling the questionnaire but NOT the meditation/wellness session (control). | |
| Wellness Group<br>Participate in filling the questionnaire and the meditation/wellness session | Other: Heartfulness Meditation<br>* A four-week Heartfulness Wellness seminar, where people are exposed to Heartfulness Meditation and its meditation tools. Participants experience: Heartfulness Guided Relaxation, Heartfulness Meditation and Heartfulness Unwinding/Rejuvenation Technique.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Burnout Scores | Assess the difference in burnout scores between both groups at week 0 and week 4. | Week 0 & Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment, using the Maslach Burnout Inventory. | Assess the difference in specific symptoms scores between both groups at week 0 and week 4. | Week 0 & Week 4 |
Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

Detailed Description
-----------------
Registry criteria: Patients treated in the investigators hospital using teriparatide. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (< young adult mean 65%). Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants

Official Title
-----------------
Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese, Prospective Study

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe osteoporotic patients Exclusion Criteria: cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, teriparatide)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alendronate<br>Patients treated with alendronate | |
| Minodronate<br>Patients treated with minodronate | |
| Denosmab<br>Patients treated with denosmab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment | The investigators plan to analyze 500 patients who treated with bisphosphonate or denosmab following daily teriparatide treatment. We investigate changes in BMD and bone turnover markers. | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, BMD, teriparatide, bisphosphonate, denosmab
MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)

Study Overview
=================
Brief Summary
-----------------
This two part study will evaluate the safety and tolerability of MK0429 in addition to assessing it's pharmacokinetic profile and pharmacodynamic response.

Official Title
-----------------
A Phase I, Randomized, Multicenter, Double-Blind Study of MK0429 in the Treatment of Men With Hormone Refractory Prostate Cancer and Metastatic Bone Disease

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: Comparator: MK0429
* Drug: Comparator: MK0429
* Drug: Comparator: MK0429
* Drug: Comparator: MK0429


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients must have: Prostate cancer Bone metastases without symptoms Lack of response to hormone therapy as evidenced by a rising PSA or clinical progression Exclusion Criteria: Prostate cancer-related bone pain Previously received bisphosphonate therapy (e.g. zoledronate) Received any investigational treatment within the last 30 days

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

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

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

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: 1600 mg twice a day<br>MK0429 | Drug: Comparator: MK0429<br>* Part 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone. Disease.<br>|
| Experimental: 200 mg twice a day<br>MK0429 | Drug: Comparator: MK0429<br>* Part 2- MK3328 of 200 mg twice a day for 4 weeks to men with hormone refractory prostate cancer and metastatic bone disease.<br>|
| Experimental: 800 mg twice a day<br>MK0429 | Drug: Comparator: MK0429<br>* Part 1- MK3328 of 800mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.<br>|
| Experimental: 400 mg twice a day<br>MK0429 | Drug: Comparator: MK0429<br>* Part 2 - MK3328 of 400 mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of 4 weeks of MK0429 therapy. |  | up to 14 days following last dose of medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429 |  | 4 weeks | 
| Part 2: Pharmacokinetic profile of MK0429 [Time frame 4 weeks] and pharmacodynamic responses to treatment of MK0429 [Time frame 8 weeks] |  | 4 weeks and 8 weeks |
Imaging of Dissection of the Descending Aorta

Study Overview
=================
Brief Summary
-----------------
Patients with dissection of the descending aorta will be followed up according to a precise timeline.

Detailed Description
-----------------
NMR baseline A PET Scanner will be performed minimum 3 months post dissection 6 months and every year during three years after PET scanner : CT scanner and blood sample

Official Title
-----------------
Dissection of Aorta: Descending Part, Imaging

Conditions
-----------------
Dissection of the Descending Aorta

Intervention / Treatment
-----------------
* Radiation: TEP-18FDG for every patient after aortic dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years Seen for dissection of the descending aorta Dissection of the descending aorta within the last three months Affiliation to social security Signed informed consent Exclusion Criteria: intervention programmed in relation with dissection of the descending aorta Pregnant female Adults without legal capacity

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

| Intervention/Treatment |
| --- |
|Radiation: TEP-18FDG for every patient after aortic dissection|Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). For example, interventions involving drugs may include dosage form, dosage, frequency and duration. Example: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
App-guided Training in eFAST Ultrasound

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the cost-effectiveness of app-based self-directed ultrasound training compared to self-directed training with written handouts on subsequent performance on simulated patient cases and theoretical cases.

Official Title
-----------------
Cost-effectiveness of Mobile App-guided Training in Extended Focused Assessment With Sonography for Trauma (eFAST): A Randomized Trial

Conditions
-----------------
Learning Outcome, Training Efficiency

Intervention / Treatment
-----------------
* Other: App-based training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First year medical doctor Provided written informed consent Exclusion Criteria: Prior practical ultrasonography experience such as performing independent ultrasonography scans, or participation in any post-graduate ultrasonography courses.
Sexes Eligible for Study
-----------------
All

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Self-guided training without app-based training (written hand-outs) | |
| Active Comparator: Intervention group<br>Self-guided training with app-based training | Other: App-based training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Video recording of ultrasound skills, rated by consultant radiologists. | The video-recordings of the technical performances are merged with the ultrasonography screen-recordings to one anonymized video-clip. These combined video-clips are rated with the OSAUS rating by two raters. The OSAUS scale (Objective Structured Assessment of Ultrasound Skills) is used for all performance assessments. The raters are consultant radiologists. | Ratings are to be completed within three months of performance. | 
| Cost-effectiveness of mobile app guided versus textbook guided training |  | September 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Participants are given five videocases, to assess for eFAST verifiable pathology. | On site via checklist, evaluated on average one day after performance. |
Registry of Dupuytren's Contracture Treatment Outcomes

Study Overview
=================
Brief Summary
-----------------
Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to randomised controlled studies.While such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality of life and other patient-related outcomes) in the typical real-life setting under clinical practice conditions.Thus, the present study aims to collect data on the Drug utilization of Microbial Collagenase in the hand of physicians, with focus on feasibility, treatment patterns, and effectiveness in clinical practice Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant treatment, follow-up therapy) Effectiveness (with focus on functionality) Tolerability Patient-related outcomes: patient satisfaction, health-related quality of life Physician satisfaction with therapy Resource utilization (hospital stays, drug consumption, concomitant medication etc.) Long-term outcomes

Official Title
-----------------
Registry of Dupuytren's Contracture Treatment Outcomes

Conditions
-----------------
Dupuytren's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: palpable cord due to Dupuytren's Disease (pretreated or untreated) satisfactory knowledge of German to be able to fill out questionnaires written informed consent Exclusion Criteria: contraindication to Microbial Collagenase (according to Prescription Information)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Study the metabolism of pyruvate and related problems in patients with lactic acidemia. II. Define the nature of the metabolic defect.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients fast for 6 hours. Glucagon IM is administered after the 6 hour fast. Glucose level is measured at 0, 15, 30, 45, 60, and 90 minutes. In children of sufficient size, alanine and lactic acid should also be measured at each or most of these time points. Fasting continues for at least 18 hours. Glucagon IM is administered again at end of fast. Glucose level is measured at time 0, 15, 30, 45, 60, and 90 minutes.

Conditions
-----------------
Mitochondrial Myopathy, MELAS Syndrome, Lactic Acidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Diagnostically documented elevation in lactate, pyruvate, and/or alanine levels in lactic acidemia patients
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
-----------------
MELAS syndrome, inborn errors of metabolism, lactic acidosis, mitochondrial myopathy, rare disease
Cohort Study for Atrial Fibrillation Risk Stratification

Study Overview
=================
Brief Summary
-----------------
AFHRI is planned as a prospective, single-center cohort study in patients at high risk of AF.

Detailed Description
-----------------
The primary aim of the study is to evaluate and improve atrial fibrillation risk predcition, which takes into account clinical, psycho-social, environmental and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint, AF (paroxysmal or permanent).

Official Title
-----------------
An Epidemiologic, Prospective, Single Center Cohort Study for the Improvement of Atrial Fibrillation Risk Stratification in High Risk Individuals

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 85 years; Personally signed informed consent Exclusion Criteria: Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation; Physical or psychological incapability to cooperate in the investigations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident atrial fibrillation | 12-lead Electrocardiogram (ECG) tracing, diagnosis of AF will be made if at least two cardiologists verify the rhythm abnormality using clinic visit, outside physician or hospital records, or ambulatory ECG reports. | up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction | Typical rise and gradual fall (Troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis | up to 4 years | 
| Cardiovascular death | if no other underlying cause of death is diagnosed: hypertension, coronary heart disease, other cardiovascular disease, atherosclerosis, diabetes mellitus, dyslipidemia, obesity, sudden death and cardiac symptoms | up to 4 years | 
| Heart failure | Echocardiographicy including Doppler-flow measurement | up to 4 years |
Radial Versus Femoral Arterial Access for Cardiac Catheterization: Comparison of Complications at 30 Days

Study Overview
=================
Brief Summary
-----------------
Cardiac catheterization has traditionally been performed via access to the arterial circulation from the femoral artery located in the groin. As an alternative to this approach, the radial artery, located in the arm, is gaining wider use in clinical practice. Multiple studies have demonstrated that cardiac catheterization via the radial approach has a very low complication rate, in the short term. This study is intended to determine if there are any differences in the long term complication rate between radial artery cardiac catheterization as compared with femoral artery cardiac catheterization.

Official Title
-----------------
Radial Versus Femoral Arterial Access for Cardiac Catheterization: Comparison of Complications at 30 Days

Conditions
-----------------
Radial Artery Occlusion

Intervention / Treatment
-----------------
* Other: Allen's test
* Other: Distal pulses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 19 years old or older candidate for radial or femoral cardiac catheterization

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Femoral<br>Subjects receiving femoral artery cardiac catheterization | Other: Distal pulses<br>* Practitioner will check that the dorsalis pedis and posterior tibialis are palpable.<br>|
| Radial<br>Subjects receiving radial artery cardiac catheterization | Other: Allen's test<br>* The Allen's test checks to make sure that radial and ulnar arteries that supply blood to the hand are not blocked. A pulse oximeter is placed on the index finger of the hand. The subject is asked to make a fist for 10 seconds.At this time, pressure is applied over the ulnar and radial arteries as to occlude (block) both of them. The pulse oximeter reading will begin to fall. Radial arterial pressure is then released. If the artery is patent (working), the pulse oximeter reading will begin to rise.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if there is a difference in complication rate measured at 30 days between radial and femoral catheterization |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radial vs femoral, radial artery cardiac catheterization