linjc16/ctgov huggingface dataset:
Cryoablation Versus Radiofrequency Ablation

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective study is to describe why and when we used cryo and why we crossed over when we used both RFA and cryo. It is also to determine if there is some predictor that would make us say one patient would be better served with one technique than another and to describe our overall acute success rate and then our 6-month recurrence rate with cryo ablation and compare it to our known success rate with RFA.

Detailed Description
-----------------
Cryotherapy (Cryo) is a new ablation energy source used instead of the radiofrequency (RFA) method for ablation of septal pathways. In the past year, we have used cryo approximately 50 times, however 50% of the cryo procedures crossed over from RFA to cryo or cryo to RFA. It appears to me that cryo use should be as an adjunct therapy to RFA instead of replacement of RFA. I would like to describe why and when we used cryo and why we crossed over when we used both RFA and cryo. I would like to determine if there is some predictor that would make us say one patient would be better served with one technique than another. I would also describe our overall acute success rate and then our 6-month recurrence rate with cryo ablation and compare it to our known success rate with RFA. All of this can be done with a chart review. This will be done through a retrospective study.

Official Title
-----------------
A Review and Comparison of Cryoablation and Radiofrequency Ablation in Children

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: charts between January 1 and 2004 to December 31, 2004 pediatric population those who were ablated Exclusion Criteria: -
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
-----------------
cryoablation, radiofrequency ablation, pediatrics, cardiology
TROLLEY Study - TRansit Opportunities for HeaLth, Livability, Exercise and EquitY

Study Overview
=================
Brief Summary
-----------------
The researchers are evaluating longitudinal changes in multiple health, economic, and environmental outcomes over a 3-year COVID recovery period and in the context of a new light rail transit (LRT) line, called the Mid-Coast Trolley, among 465 UC San Diego (UCSD) staff. The primary aim is to evaluate change in objectively measured total and moderate to vigorous physical activity (MVPA), travel mode, and vehicle miles traveled (VMT).

Official Title
-----------------
TROLLEY Study - TRansit Opportunities for HeaLth, Livability, Exercise and EquitY

Conditions
-----------------
Physical Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: are 18 years of age or older; are a full or part-time employee at UC San Diego Prior to COVID-19, you used to commute to La Jolla at least 2 days per week; have lived in the neighborhood selected for the study for at least one year; are able to walk without human assistance; are comfortable reading and writing in English or Spanish; have a reliable phone where you can be reached; spend most of your time in San Diego County; don't plan on moving in the next year; are able to give informed consent and comply with the protocol; are willing to complete all assessments and wear all devices for 7 days at 3 different time points in the next 2 years. Exclusion Criteria: 1) pregnant, 2) mental state that would preclude understanding the protocol, 3) medical condition that would affect physical activity, 4) taking part in another physical activity related research study, and 5) live or regularly travel outside of San Diego County.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Moderate to vigorous physical activity | Minutes | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active commute mode |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
active travel, equity, commute mode
Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to investigate the effects of mirabegron on the cardiovascular system in patients with overactive bladder with current or a history of cardiovascular disease.

Official Title
-----------------
Protocol for Specified Drug Use-results Survey of Betanis Tablets (for Patients With Coexisting Cardiovascular Disease)

Conditions
-----------------
Overactive Bladder, Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: Mirabegron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having coexisting cardiovascular disease or a history of cardiovascular diseases having electrocardiogram record conducted within seven days before the start of the mirabegron treatment (including the first day of administration) Exclusion Criteria: having serious cardiovascular disease having significant long QT (QTc > 500 msec)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mirabegron group<br>Subjects with overactive bladder and cardiovascular disease prescribed mirabegron | Drug: Mirabegron<br>* oral<br>* Other names: Betanis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in electrocardiogram parameters pre- and post- administration of mirabegron |  | Baseline and up to four weeks | 
| Incidence rate of cardiovascular system adverse reactions |  | Up to four weeks | 
| Safety assessed by biochemistry laboratory tests |  | Up to four weeks | 
| Safety assessed by incidence of adverse events |  | Up to four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in overactive bladder (OAB) symptoms | Clinical global impression of change from baseline of OAB symptoms by investigator | Baseline and up to four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mirabegron, Overactive Bladder, Cardiovascular Disease
YAZ, Oral Contraceptive Registration in China

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.

Official Title
-----------------
A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: YAZ (SH T00186, BAY86-5300)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 30 years of age. Exclusion Criteria: The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study. Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment) Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea Any disease or condition that may worsen under hormonal treatment Other contraceptive methods such as sterilization or IUD/IUS Substantial overweight (BMI > 30 kg/m2).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: YAZ (SH T00186, BAY86-5300)<br>* 20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment. |  | 13 cycles (1 cycle= 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding pattern indices |  | 13 cycles | 
| Cycle control parameters |  | 13 cycles | 
| Adverse events |  | Whole study period | 
| Laboratory tests |  | Whole study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraceptives,, Oral Hormonal;, Contraceptive Methods;, Female
Indwelling vs Immediate Removal of Foley Catheter After Robotic Assisted Laparoscopic Sacrocolpopexy: a Prospective Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, comparative randomized study. Our study population includes women with pelvic organ prolapse undergoing a robotic assisted laparoscopic sacrocolpopexy. The two groups will include the study group, who will have their Foley catheter removed 6 hours post-op, and the control group who will have an indwelling Foley catheter overnight. The two groups will be assigned according REDCap randomization system.

Official Title
-----------------
Indwelling vs Immediate Removal of Foley Catheter After Robotic Assisted Laparoscopic Sacrocolpopexy: a Prospective Study

Conditions
-----------------
Urinary Retention

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19-75 Pelvic organ prolapse requiring robotic assisted, laparoscopic sacrocolpopexy. Exclusion Criteria: Intraoperative complications necessitating a post-operative Foley Cystotomy EBL >500mL Bowl injury Pre-operative urinary retention requiring an indwelling catheter

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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 |
| --- | --- |
| No Intervention: Foley<br>Patients will have Foley in place overnight after completion of surgery, which is currently standard of care at our institution. | |
| Active Comparator: No Foley<br>Patients will have Foley catheter removed 6 hours post-op. | Other: No Foley<br>* Patients will have Foley catheter removed 6 hours post-op.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary retention | Patients in the intervention group will have their Foley catheter removed up to 6 hours after discharge from the PCA. They will then have to undergo a voiding trial | 6 hours after discharge from PACU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Tract Infections | All UTIs will be documented up to 30days post op. | 30 day post op | 
| Post-operative complications | Post-operative complications | 30 days post op |
Correcting Platelet Dysfunction After Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
This study evaluates the impact of platelet transfusion on geriatric patients with platelet dysfunction from Traumatic Brain Injury. The authors hypothesize that patients will recover better if their platelet dysfunction is corrected with platelet transfusion.

Detailed Description
-----------------
The geriatric population is subject to traumatic brain injury, often occurring as a result of falls. This patient population is also often receiving anticoagulants and platelet inhibitors increasing their risk of post-injury hemorrhage. Following Traumatic Brain Injury, even without platelet inhibitor medications, platelets become dysfunctional and are no longer able to assist with clot formation. Therefore risk of hemorrhage is increased, both in the brain, and other hemorrhagic sites. Clinical practice at Carolinas Medical Center is to transfuse platelets in patients with platelet dysfunction following brain injury. The current study is investigating the impact of transfusion on correction of platelet dysfunction and patient outcome. Furthermore, stored platelet dysfunction can be corrected by supplementation with cytochrome c, which supports mitochondrial function. Therefore, the ability of cytochrome c to correct dysfunction in ex vivo platelets from patients with Traumatic Brain Injury will be assessed.

Official Title
-----------------
Correction of Platelet Dysfunction Following Traumatic Brain Injury in Geriatric Patients

Conditions
-----------------
Platelet Dysfunction, Traumatic Brain Injury

Intervention / Treatment
-----------------
* Diagnostic Test: Platelet mapping Thromboelastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic brain injury with Glasgow Coma Scale Score (GCS) <=13 Exclusion Criteria: Previously know coagulation dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Platelet mapping Thromboelastography|These diagnostic tests will be acquired in patients with brain injury, to determine prediction of clinical, functional and psychological outcome.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet function | Correction of platelet inhibition measured before and after transfusion through platelet mapping thromboelastography | Within 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality will be compared to admission platelet inhibition | 1-3 months | 
| Functional Independence Measure | Patient function as measured by Functional Independence Measure compared to platelet inhibition | 6-12 months |
Evaluation of Cow Milk-Based Formulas - Functional Proteins

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the function of infant formula components to optimize the nutritional content and functionality of a marketed routine infant formula.

Official Title
-----------------
The Evaluation of Cow Milk-Based Formulas - Functional Proteins

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10-18 days of age 37-42 weeks gestation birth weight 2500 g or more consuming one source of nutrition Exclusion Criteria: metabolic or chronic disease acute infection feeding difficulties consumed complementary foods or donor milk steroid use

Ages Eligible for Study
-----------------
Minimum Age: 10 Days
Maximum Age: 18 Days

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 |
| --- | --- |
| Experimental milk-based infant formula<br> | |
| Control milk-based infant formula<br> | |
| Breastfed Reference Group<br> | |

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
-----------------
optimize nutritional content of infant formula, Infant
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)

Detailed Description
-----------------
This is a single-arm, multi-center study with three years of follow-up.

Official Title
-----------------
A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding

Conditions
-----------------
Menorrhagia

Intervention / Treatment
-----------------
* Device: AEGEA Vapor System(TM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subject from (and including) age 30 to 50 years Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months Predictable cyclic menstrual cycles over past 6 months Excessive uterine bleeding Premenopausal at enrollment Normal PAP Normal endometrial biopsy Willing to use reliable contraception Not currently taking hormonal medication Agree to use sponsor provided catamenial product (sanitary pads/tampons) Exclusion Criteria: Pregnant Desires future childbearing Presence of an IUD Previous endometrial ablation procedure Evidence of STI Evidence of PID Active infection of genitals, vagina, cervix, uterus or urinary tract Active endometritis Active bacteremia, sepsis or other active systemic infection Gynecologic malignancy Endometrial hyperplasia Known clotting defects or bleeding disorders On anticoagulant therapy Hemoglobin <8gm/dl Prior uterine surgery Currently on medication that could thin myometrial muscle Severe dysmenorrhea, secondary to adenomyosis Abnormal uterine cavity Hydrosalpinx Uterine length <6cm or >12cm Currently in other clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vapor endometrial ablation<br>endometrial ablation using the AEGEA Vapor System | Device: AEGEA Vapor System(TM)<br>* vapor endometrial ablation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Reduction of menstrual blood loss | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Effectiveness Endpoint | Quality of Life | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial ablation with vapor
Prospective Randomized Clinical Trial Evaluating the Impact of Vinegar on High Density Lipoprotein

Study Overview
=================
Brief Summary
-----------------
This is a double-blinded randomized placebo controlled prospective clinical trial evaluating the impact of apple cider vinegar on serum HDL. 112 participants will be randomized to consume either 2 tablespoons of vinegar daily or a placebo containing a 2% balsamic vinegar solution in water. Baseline, two month and 4 month blood samples will be obtained for fasting lipids. The primary endpoint is met if HDL levels increase in the treatment arm versus baseline after 2 month intervention.

Conditions
-----------------
Cholesterol, HDL

Intervention / Treatment
-----------------
* Dietary Supplement: Vinegar
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those older than 18 years of age Park Nicollet Health Services patient Exclusion Criteria: Because of a potential positive effect of vinegar on improving diabetes mellitus8 and the subsequent change in medication regime for diabetes diabetic patients will be excluded from this study. If this study finds that vinegar does increase HDL levels, a subsequent study of diabetic patients will be conducted. History of allergy to apple cider vinegar Those with a terminal illness Diagnosis of Inflammatory bowel disease Those with Immunosuppression diseases Patients on dialysis Severe psychiatric illness who are unable to consent or reliably participate No evidence of end stage renal disease Those who use alcohol greater than or equal to 2 drinks per day Those who take in >3 tsp vinegar/day supplement Plans to increase exercise or begin diet during the protocol period Any use of niacin or niacin-like compounds Initiation of niacin, fibrates (eg gemfibrozil); statin or ezetimibe medication within the last 6 weeks or during the trial Inability to read English Age less than 18 years given clinical events would be unlikely in this population LDL greater than 160mg/dL and requires adjustment or addition of statin therapy (which could reduce HDL) History of liver failure in medical history review Current smoking (as this can reduce HDL levels and it would be unethical to require people to continue smoking during the study)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Vinegar|Apple cider vinegar 2 TBlsp/day|
|Other: Placebo|Water placebo colored with balsamic vinegar|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HDL-Cholesterol level |  | 12 months |