linjc16/ctgov huggingface dataset:
Transcatheter Mitral Valvuloplasty Pilot Study

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation

Official Title
-----------------
Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study

Conditions
-----------------
Mitral Valve Insufficiency, Mitral Regurgitation, Mitral Valve Regurgitation

Intervention / Treatment
-----------------
* Device: MitraClip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. Age 19 and more Written informed consent Exclusion Criteria: Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen Active endocarditis of the mitral valve Rheumatic mitral valve disease Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

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 |
| --- | --- |
| Severe Mitral Regurgitation<br> | Device: MitraClip<br>* Transcatheter Mitral Valvuloplasty with MitraClip<br>* Other names: Transcatheter Mitral Valvuloplasty;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitral regurgitation |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | 1 year | 
| Stroke |  | 1 year | 
| Myocardial infarction |  | 1 year | 
| Re-hospitalization |  | 1 year | 
| Acute kidney dysfunction |  | 5 days | 
| Vascular complication |  | 5 days | 
| Bleeding |  | 5 days | 
| Successful valvuloplasty | No significant complication | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MitraClip
Rectal Misoprostol Versus Sublingual Misoprostol Prior to Myomectomy

Study Overview
=================
Brief Summary
-----------------
the aim of the study is To compare the effectiveness of rectally administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before myomectomy to decrease blood loss during and after the operation.

Official Title
-----------------
Rectal Misoprostol Versus Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial

Conditions
-----------------
Bleeding During Myomectomy

Intervention / Treatment
-----------------
* Drug: rectal misoprostol
* Drug: sublingual misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging Age ≥ 18 years and ≤ 50 years Pre-operative hemoglobin >8 g/dl Ability to understand and the willingness to sign a written informed consent. Admissible medical/surgical history Five or less symptomatic uterine myomas All myomas are subserous or intramural. Uterine size less than 24 weeks pregnancy Exclusion Criteria: Patients who have had a prior abdominal myomectomy Post-menopausal women Patients with known bleeding/clotting disorders Patients with a history of gynecologic malignancy Hypertension. Cardiac and Pulmonary diseases. Obesity (body mass index > 30 kg/m2). History of allergic reactions attributed to misoprostol Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: Group A<br>rectal misoprostol 400 microgram | Drug: rectal misoprostol<br>* patients will take 2 tablets of rectally misoprostol 400 microgram 60 minutes before the procedure<br>|
| Active Comparator: Group B<br>sublingual misoprostol 400 microgram | Drug: sublingual misoprostol<br>* patients will take 2 tablets of sublingual misoprostol 400 microgram 60 minutes before the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amount of blood loss |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of hemoglobin level |  | 24 hours |
Home-Care Needs in Liver or Renal Transplantation Recipients and Their Spouses

Study Overview
=================
Brief Summary
-----------------
Liver/renal transplantations are now tending to be the most important treatment for terminal liver and renal disease. Although transplantation can prevent recipients from suffering with critical and fatal symptoms, patients may experience the complication from surgery and immunosuppressive drugs. Furthermore, they might have many unmet needs in daily life, and so as their spouses. The purpose of this study is to explore the home-care needs among the post liver or renal transplant recipients and their spouses, and identify the significant factors for care needs. A cross-sectional correlated design will be used and patients will be recruited by purposive sampling from an organ transplant outpatient department at a medical center in northern Taiwan. A set of structured questionnaires will be used to collect data. The result of this study will be helpful for clinical nurses to understand liver or renal recipients' physical and mental distress, also identify the potential risk of home-care needs and the degree of satisfaction as well.

Official Title
-----------------
Home-Care Needs in Liver or Renal Transplantation Recipients and Their Spouses

Conditions
-----------------
Liver Transplant, Renal Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: about patients liver transplant recipients or renal transplant recipients who have regular follow up in organ transplant outpatient departments. conscious clear. above 18 years old. about spouse who live with patients. conscious clear. above 18 years old. Exclusion Criteria: about patients who suffer form cancer now. have received transplantation twice. about spouse who liver apart from patients. whose spouse(patient) did not recruited in this research.

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?
-----------------
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
-----------------
care needs
Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids

Study Overview
=================
Brief Summary
-----------------
The study is a single-center, randomized, un-blinded treatment study in which patients (>78 years) with the use off a heart-lung machine were provided into two study arms. Patient wit precoating have a filling of the machine with their own blood. In the comparator arm, a standard priming is used.

Conditions
-----------------
Priming, Cardiac Surgery, Cardio Pulmonary Bypass

Intervention / Treatment
-----------------
* Procedure: Precoating
* Procedure: Standard priming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 78 years CPB Exclusion Criteria: Hb <12 mg/dl Off pump surgery

Ages Eligible for Study
-----------------
Minimum Age: 78 Years
Maximum Age: 95 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: Precoating<br> | Procedure: Precoating<br>* preoperative filling of heart lung machine with patients blood<br>|
| Active Comparator: Standard priming<br> | Procedure: Standard priming<br>* preoperative filling of heart lung machine with colloids<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory response |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
priming, cardiac surgery, cardio pulmonary bypass, precoating
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluate voice and swallowing outcomes post operatively.

Detailed Description
-----------------
Anterior Cervical Decompression and fusion is one of the most common spinal surgical procedures performed in the United States. Common complications of this type of surgery are difficulty swallowing and nerve dysfunction that can effect voice. The chance of having voice and swallowing disturbances increases if this type of surgery has to be repeated. The purpose of this study is to document the voice and swallowing function of patients undergoing this type of surgery in an effort to find better ways to identify and treat these common complications.

Official Title
-----------------
Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery

Conditions
-----------------
Dysphagia, Dysphonia

Intervention / Treatment
-----------------
* Other: Voice and Swallowing evaluations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing revision anterior cervical spine surgery Exclusion Criteria: Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.

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 |
| --- | --- |
| Voice and Swallowing Evaluations<br> | Other: Voice and Swallowing evaluations<br>* Fiberoptic exam to evaluate vocal cord and swallowing function<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vocal cord and swallowing function as measured by fiberoptic exam in the otolaryngology clinic pre-op and approximately 3 weeks post op. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as measured by a self-administered 10 point questionnaire. |  | 4 weeks |
Adjunct Inversion for Lower Pole Stone

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.

Official Title
-----------------
A Prospective, Randomized, Double Blind, Controlled Study Comparing Extracorporeal Shock Wave Lithotripsy (ESWL) With and Without Simultaneous Adjunct Controlled Inversion Therapy in the Treatment of Lower Pole Caliceal Stone

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Procedure: Inversion
* Procedure: Shock Wave Lithotripsy
* Drug: Hydration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solitary lower pole caliceal stone which is > 5 mm and < 20mm Not contraindicated for intravenous urogram (IVU) and subsequent X-rays Patient able to comply strictly with visits/medications Patient willing and agrees to enter study Exclusion Criteria: Impaired function of the affected kidney Gross hydronephrosis of the affected kidney Associated distal obstruction Multiple stones Stone more than 2 cm in size Diverticular stone Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy Patients who are unable to tolerate the procedure Significant cardiac condition that does not allow the administration of force hydration or inversion. Uncontrolled hypertension

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inversion, Hydration, ESWL<br>ESWL with hydration and inversion | Procedure: Inversion<br>* Patients inverted 30 degree head down in Trendelenburg position<br>Procedure: Shock Wave Lithotripsy<br>* Shock wave lithotripsy<br>* Other names: ESWL;Drug: Hydration<br>* Hydration of patient with 0.5L NaCl and 20mg frusemide IV<br>* Other names: Frusemide 20mg;|
| Active Comparator: ESWL, Hydration<br>ESWL with hydration | Procedure: Shock Wave Lithotripsy<br>* Shock wave lithotripsy<br>* Other names: ESWL;Drug: Hydration<br>* Hydration of patient with 0.5L NaCl and 20mg frusemide IV<br>* Other names: Frusemide 20mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Are Stone Free at 3 Months | To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR) | 3 months |
The Influence of HDL Function on Cognitive Function

Study Overview
=================
Brief Summary
-----------------
Older people with diabetes mellitus are at risk of cognitive decline and dementia. We therefore propose to examine the potential influence of HDL function on global cognitive function and brain structures in older people with DM.

Official Title
-----------------
The Influence of HDL Function on Cognitive Function and Brain Structures in Older People With Diabetes Mellitus

Conditions
-----------------
Older People With Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with DM Exclusion Criteria: Participants refuse blood taking

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive test domain scores |  | 2 years |
A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners.

Official Title
-----------------
Sitagliptin Phosphate/Metformin HCl (JANUMET®) Post Marketing Surveillance Protocol

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

Intervention / Treatment
-----------------
* Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be taking sitagliptin phosphate/metformin HCl (JANUMET®) for the treatment of type 2 diabetes mellitus Treating physician must agree to provide information regarding the participant's treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants treated with sitagliptin phosphate/metformin HCl<br> | Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®)<br>* Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Adverse Event |  | Up to approximately 28 months | 
| Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl |  | Up to approximately 28 months | 
| Number of Participants With Concomitant Conditions |  | Up to approximately 28 months | 
| Number of Participants Taking Concomitant Medications |  | Up to approximately 28 months |
Volunteering and Cardiovascular Risk in Adolescents

Study Overview
=================
Brief Summary
-----------------
This study tested whether getting youth engaged in helping others (volunteering) would benefit youth's physical health. 106 predominantly minority and low socioeconomic status (SES) youth were randomized to either volunteer weekly with elementary school children in after school programs or to a wait-list control group. The investigators hypothesized that cardiovascular risk markers of C-reactive protein (CRP), interleukin-6 (IL-6), total cholesterol, and body mass index (BMI) would be lower at post-intervention (4 months after baseline) in the volunteer group compared to the control group. The investigators also hypothesized that the intervention might work through pathways such as reducing negative mood, improving self esteem, and increasing prosocial behaviors (empathy, altruism).

Official Title
-----------------
How Volunteer Programs Affect Health and Well-being in Low-income Youth

Conditions
-----------------
Cardiovascular Risk Factors

Intervention / Treatment
-----------------
* Behavioral: Volunteering


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10th grade high school student English speaking No chronic illnesses Exclusion Criteria: Chronic medical illness
Sexes Eligible for Study
-----------------
All

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volunteering<br>Weekly volunteering with elementary school children in after school programs | Behavioral: Volunteering<br>* Weekly volunteering with elementary school children in after school programs<br>|
| No Intervention: Control<br>Wait-list control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | Baseline-adjusted post-intervention scores at 4 months | 
| C-reactive protein |  | Baseline-adjusted post-intervention scores at 4 months | 
| Interleukin-6 |  | Baseline-adjusted post-intervention scores at 4 months | 
| Total Cholesterol |  | Baseline-adjusted post-intervention scores at 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteering, cardiovascular health
Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate the analgesic efficacy of pulsed radiofrequency on the thoracic paravertebral nerves for patients with chronic mastalgia of fibrocystic disease of the breast

Official Title
-----------------
for Patients With Fibrocystic Disease of the Breast, Does Pulsed Radiofrequency on Thoracic Paravertebral Nerve Reduce Pain Severity

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Procedure: PRF
* Procedure: SHAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic mastalgia due to fibrocystic disease of the breast the pain duration maintained for more than 1 year the pain intensity is more than 5 on VAS pain score Exclusion Criteria: coagulopathy infection at the site of the procedure

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF<br> | Procedure: PRF<br>* patients will receive pulsed radiofrequency, 4 cycles (each cycle, 2 minutes) on the thoracic paravertebral nerves number 2,3, and 4 under fluroscopic guidance<br>|
| Sham Comparator: SHAM<br> | Procedure: SHAM<br>* patients will be subjected to the same procedure like PRF group without giving PRF<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes in pain intensity measured by VAS pain score | VAS pain score, is a scale for pain measurements scored from 0 to 10 in which 0 = no pain and 10 = the worst imaginable pain | patients will be evaluated at 3 months postoperatively |