linjc16/ctgov huggingface dataset:
Effects of Qigong, Tai Chi and Yoga Practice in Older Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of an 8-week intervention using YiRen Qigong, Tai Chi or Hatha yoga in older adults (age 70 and above) residing at a Gencare senior living facility. Outcome measures completed at the beginning and end of each intervention period will be blood pressure, heart rate, perceived quality of life (PQOL)and a symptoms questionnaire (SF-36), ability and speed of walking 20 feet (for ambulatory participants), and neck and arm range of motion.

Official Title
-----------------
Effects of Qigong, Tai Chi and Yog Practice on Indicators of Health and Quality of Life in Older Adults

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

Intervention / Treatment
-----------------
* Other: YiRen Qi gong
* Other: Tai Chi
* Other: Hatha yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be a resident of a Gencare Senior Living facility in Granite Falls, Lynnwood, Renton, Ballard and Lake City, WA Be at least 70 years of age Be willing to participate in the tai chi, qi gong and/or yoga classes Willing to complete study-related outcomes assessments Exclusion Criteria: Not medically able to participate in the mild level of activity involved in the 3 interventions as determined by the resident's physician Unable to complete study questionnaires or study procedures at screening

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>YiRen Qi gong weekly class for 8 weeks | Other: YiRen Qi gong<br>* One hour weekly class for 8 week duration<br>|
| Experimental: 2<br>Tai Chi weekly class for 8 weeks | Other: Tai Chi<br>* One hour weekly class for 8 week duration<br>|
| Active Comparator: 3<br>Hatha yoga weekly class for 8 weeks | Other: Hatha yoga<br>* One hour weekly class for 8 week duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | End of 8-week class | 
| Heart rate |  | End of 8-week class | 
| Quality of life (SF-36 and PQOL) |  | End of 8-week class | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | End of 8-week class | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Geriatric, Qi gong, Yoga, Tai chi, Geriatric Assessment
Rollover Protocol for Prior SU011248 Protocols

Study Overview
=================
Brief Summary
-----------------
The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol

Official Title
-----------------
A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: Sunitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior SU011248 Protocol. Eligible to continue SU011248 treatment. Exclusion Criteria: Uncontrolled CNS metastasis. Unfit to receive SU011248.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunitinib<br> | Drug: Sunitinib<br>* Sunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Treatment |  | Baseline up to Day 28 after last dose of study treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid tumors
Buprenorphine Pharmacology Related to Addiction Treatment - 21

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine if chronic buprenorphine administration will generate supersensitivity to opiates.

Official Title
-----------------
Buprenorphine Pharmacology Related to Addiction Treatment

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Opioid agonist effects |  |  | 
| Opiate withdrawal |  |  | 
| Physiological changes in: pupil diameter, blood pressure, heart rate, respiration |  |  |
Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to identify the maximum tolerated dose (MTD) of BMS-690514 once daily orally in Japanese subjects with advanced or metastatic solid tumors.

Official Title
-----------------
Phase I Study of BMS-690514 in Japanese Patients With Solid Tumors

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: BMS-690514


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate, with adequate kidney, liver and cardiac function.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: BMS-690514<br>* Tablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514 |  | administered orally every day 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety, exposure levels of BMS-690514 in the body & anticancer activity of BMS-690514 administered orally every day for 28 days. |  | throughout the study | 
| Safety evaluations and laboratory assessments will be performed |  | throughout the study | 
| Preliminary markers of efficacy will also be assessed |  | throughout the study |
Hemodynamic Effects of ARNI on Noninvasive Pressure-volume Analysis in Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
Sacubitril-Valsartan reduced heart failure hospitalizations and cardiovascular mortality compared to enelapril in chronic heart failure. Furthermore, quality of life is improved. The decrease of NT-proBNP levels during Sacubitril-Valsartan treatment is associated with reverse left ventricular remodeling and improved left ventricular systolic function. However, the underlying mechanisms that contribute to these symptomatic and prognostic benefits are largely unknown. The aim of this study is to evaluate left ventricular hemodynamics in patients treated with Sacubitril-Valsartan using non-invasive pressure-volume analysis.

Official Title
-----------------
Hemodynamic Effects of Angiotensin Receptor Neprilysin Inhibition on Noninvasive Pressure-volume Analysis in Patients With Heart Failure With Reduced Ejection Fraction

Conditions
-----------------
Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
-----------------
* Drug: Sacubitril-Valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic heart failure (NYHA functional class II to IV) Reduced LV ejection fraction (≤ 40%) Clinical indication for therapy with Sacubitril-Valsartan Exclusion Criteria: catecholamine therapy at inclusion existing therapy with Sacubitril-Valsartan planned cardiac resynchronization therapy (CRT) within 6 months; inclusion at least 3 months after CRT planned mitral or aortic valve procedure within 6 months; inclusion at least 3 months after valve procedure participation in another randomized heart failure trial severe aortic or mitral valve lesion

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 |
| --- |
|Drug: Sacubitril-Valsartan|Observational study during the clinically indicated treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular contractility, afterload and ventricular-arterial coupling | Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic LV function, symptom status and biomarkers | Echocardiography: Left ventricular (LV) remodeling und function (LVEDV, LVESV, LVEF, GLS), diastolic LV function (LAESV, E/e', LVEDP) Symptoms: NYHA functional class, 6 minute walk test Biomarker: NT-proBNP | 3, 6 and 12 months | 
| Left ventricular contractility, afterload and ventricular-arterial coupling | Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees) | 3 and 12 months |
Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

Study Overview
=================
Brief Summary
-----------------
To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.

Detailed Description
-----------------
Single-center, prospective, randomized, investigator-initiated study 250 cataract patients, aged 60 or older, will be tested for ocular surface inflammation with the InflammaDry® immunoassay Patients with bilateral positive MMP-9 will be randomized into a group treated with Xiidra two weeks preoperatively and six weeks postoperatively or a group not treated with Xiidra The investigator hypothesizes that treatment with Xiidra prior to routine cataract surgery will significantly improve the quality of keratometry readings and BCVA.

Official Title
-----------------
The Incidence of Ocular Inflammation as Defined by the Inflammadry Assay in 250 Consecutive Cataract Patients and Their Response to Treatment With Xiidra

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Lifitegrast 5% Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive for MMP-9 bilaterally as assessed by the Inflammadry assay Exclusion Criteria: Negative Inflammadry assay in either eye Active diabetic retinopathy, uncontrolled glaucoma, uncontrolled uveitic inflammation Ocular surface diseases that might confound the interpretation of the InflammaDry assay

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifitegrast<br>One drop of Lifitegrast Ophthalmic Solution 5% will be instilled into each eye twice daily (approximately 12 hours apart) using a single-use conainer. | Drug: Lifitegrast 5% Ophthalmic Solution<br>* BID OU<br>|
| No Intervention: Control<br>No treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra | Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, lifitegrast, dry eye syndrome, ocular surface inflammation, hyperosmolarity, MMP-9
Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Neoadjuvant treatments (nCRT) are becoming the standard treatment for patients with stage II or stage III mid-low rectal cancer. In fact, with the introduction of total mesorectal excision, the local recurrence has been reduced significantly. Recently few studies have shown that surgery alone is enough for patients with T3 rectal cancer. These issues raised the question of whether nCRT is needed for all T3 rectal cancer patients. Therefore, this study was designed to compare the long-term oncological outcomes between surgery and surgery following nCRT among patients with MRI-defined T3, clear MRF mid-low rectal cancer.

Official Title
-----------------
Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer: A Retrospective Cohort Study

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: total mesorectal excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eighteen- to eighty-year-old patients. T3 rectal cancer with clear mesorectal fascia (MRF), within 12 cm from the anal verge at initial diagnosis by magnetic resonance imaging (MRI) Exclusion Criteria: emergency surgery due to bleeding, perforation, and bowel obstruction, recurrent rectal cancer, inflammatory bowel disease, Stage IV.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TME<br>patients only underwent TME | Procedure: total mesorectal excision<br> <br> * Other names: neoadjuvant treatment;|
| nCRT+TME<br>patients underwent TME following neoadjuvant treatment | Procedure: total mesorectal excision<br> <br> * Other names: neoadjuvant treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year diseases free survival |  | 3 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Margin-free （R0）resection rate |  | Immediately after the surgery | 
| 3-year overall survival rate |  | 3 years after surgery | 
| Number of participants with surgical complications |  | 30 days after surgery | 
| Local recurrence rate |  | 3 years after the surgery |
The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy

Study Overview
=================
Brief Summary
-----------------
Pregnancies that extend beyond 42 weeks of gestation are at an increased risk for poor fetal and maternal outcomes. For decreasing the number of these cases, some labor induction techniques are used. The status of the cervix is an indicator for the success of the induction. In these study, investigators investigate the effect of membrane sweeping on the need of induction and the delivery time in term pregnancy.

Official Title
-----------------
The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy

Conditions
-----------------
Delivery, Obstetric

Intervention / Treatment
-----------------
* Other: Membran Sweeping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-35 years Vertex presentation No contraindication for vaginal delivery No contraindication for labor induction Exclusion Criteria: Active vaginal infection Previous uterine surgery Systemic disease Multiple pregnancy Fetal anomaly and suspicious fetal health status

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Membrane Sweeping Group<br> | Other: Membran Sweeping<br>* Cervical Membrane Sweeping by digital examination<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of Labor Induction. | Patient need induction for delivery or not. If the patient reach 40 weeks 6 days for gestational age and spontaneous delivery doesn't begin spontaneously, labor induction is needed. | During pregnancy. 40 weeks and 6 days for gestational age | 
| Duration of delivery | The time of the latent and active stage of delivery | During delivery |
Rapid Versus Prolonged Inpatient Up-Titration of Captopril

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to establish a safe and effective method of up-titration of captopril for hospital inpatients.

Detailed Description
-----------------
Angiotensin converting enzyme inhibitors (ACEi) are one of the most frequently prescribed pediatric cardiac medication and overall their safety in children is widely accepted. Pediatric formulary recommendations for ACEi suggest starting with a low initial dose (0.1 mg/kg), to avoid hypotension, and up-titration for a maintenance dose. However, side ranges are quoted for maintenance doses and no guidance is given as to the best method of up-titration, The physician is left uncertain of the optimal dose and how best to achieve it. The ultimate goal of this study is to be in a position to provide physicians caring for children with heart disease information about how to safely up-titrate this widely used medication, and by doing so to improve dosing in the wider pediatric population.

Official Title
-----------------
Rapid Versus Prolonged Inpatient Up-Titration of Captopril: A Randomized Clinical Trial

Conditions
-----------------
Heart Disease

Intervention / Treatment
-----------------
* Drug: Captopril
* Drug: Captopril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric cardiology in-patients at The Hospital for Sick Children Primary physician has decided to commence ACEi (the division has agreed that our institutional choice will be to start patients on captopril and up-titrate to optimal dose before converting to other ACEi) Patients who have been initiated on captopril within the prior 24 hours, but have not yet started up-titration, will be eligible to be randomized Exclusion Criteria: Known sensitivity to ACEi Infants on the neonatal intensive care unit Treatment with any ACEi for more than 24 hours within the preceding 6 months Age > 18 years

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Captopril<br>* A rapid 3-day up-titration protocol<br>|
| Active Comparator: 2<br> | Drug: Captopril<br>* A slower 9-day up-titration protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients reaching a target dose of 1mg/kg/dose (given three times a day). |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
up-titration, captopril, pediatric, cardiac patients