linjc16/ctgov huggingface dataset:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0683 in patients with advanced cancer.

Official Title
-----------------
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer

Conditions
-----------------
Cancer, Advanced

Intervention / Treatment
-----------------
* Drug: vorinostat (MK0683 )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years or older Must agree to consume high fat meal and agree to fasting conditions Limit alcohol consumption Exclusion Criteria: Patient has a history of drug or alcohol abuse within 5 years of start of study Patient is known to have HIV Patient has participated in another investigational study within 4 weeks of start of study Patient cannot stop taking certain medications or herbal remedies Patient will require immunologic, radiation, surgery, or chemotherapy during the study Patient requires frequent blood transfusions Female patient is pregnant or nursing Patient has an active Hepatitis B or C infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>MK0683 | Drug: vorinostat (MK0683 )<br>* Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28 Total treatment period is 28 days<br>* Other names: Zolinza;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability, and PK of MK0683 |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary excretion of MK0683 |  | 28 days |
Restoring Non-Emergent Cardiovascular Care in the Peri- COVID-19 Era

Study Overview
=================
Brief Summary
-----------------
Pre-procedure and Short-Term COVID-19 Testing of Outpatients Undergoing Non-emergent Invasive Cardiovascular Procedures

Official Title
-----------------
Restoring Non-Emergent Cardiovascular Care in the Peri-COVID 19 Era

Conditions
-----------------
Corona Virus Infection

Intervention / Treatment
-----------------
* Diagnostic Test: COVID-19 testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Outpatients undergoing non-emergent invasive cardiac diagnostic, cardiac interventional, peripheral diagnostic, peripheral interventional, structural heart interventional, electrophysiology diagnostic, ablation, or device implantation procedures Exclusion Criteria: Previous positive COVID-19 test result Patients with symptoms concerning for COVID-19, including (but not limited to): Fever > 38˚C, shortness of breath and/or cough in greater severity from baseline, sore throat, anosmia / dysgeusia, vomiting/diarrhea within 24 hours prior to procedure Emergent status including (but not limited to) acute coronary syndromes, acute limb ischemia, stroke, need of temporary pacemaker Non-outpatient status including (but not limited to) patients evaluated in the hospital, observational unit, or emergency department
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: COVID-19 testing|Pre and post procedure COVID-19 testing for patients undergoing outpatient cardiac procedures.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures |  | Through 30 day follow up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perception of the effect of pre and post procedure COVID-19 testing on risk of contracting COVID-19 while hospitalized for an elective outpatient procedure. |  | Through 30 day follow up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 testing, outpatient procedures
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia. The anticipated time on study treatment is 16 weeks, and the target sample size is approximately 208 individuals.

Official Title
-----------------
An Open-Label Study of the Safety Of NeoRecormon in Patients With Solid Tumors Being Treated With Platinum Capable of Inducing Anemia

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Epoetin beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults at least 18 years of age Presence of solid tumor(s) Receiving platinum-based therapy capable of inducing anemia Exclusion Criteria: Red blood cell transfusion within 7 days prior to study drug Relevant acute or chronic bleeding requiring therapy within 3 months prior to study drug Women who are pregnant or breastfeeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin beta<br>Participants will receive weekly SC injection of epoetin beta (450 international units per kilogram [IU/kg]) for 16 weeks. | Drug: Epoetin beta<br>* Participants will receive weekly SC injections of epoetin beta beginning at 450 IU/kg, with doses adjusted according to hemoglobin level. Treatment will continue for a total of 16 weeks.<br>* Other names: NeoRecormon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin response rate index |  | Up to 16 weeks |
Clinical Results of Arthroscopic Repair for Massive Rotator Cuff Tears of 14 Cases

Study Overview
=================
Brief Summary
-----------------
This study retrospectively analyzed data of 14 cases of massive rotator cuff tears who were treated with arthroscopic repair by the same doctor from October 2015 to December 2017, aiming to explore the surgical methods and clinical effects of arthroscopic repair for massive rotator cuff tears.

Detailed Description
-----------------
The preoperative and intraoperative data and patient information of 14 cases of arthroscopic repair of huge rotator cuff tears performed by Deputy Chief Physician Yang Yuping of the Institute of Sports Medicine of Peking University Third Hospital from January 2016 to August 2017 sort out. Collect and organize follow-up data on the recovery and motor function of patients 6 months after surgery and the latest follow-up (February 4 to March 3, 2018). Discuss the operation method, and statistically analyze the short-term curative effect of patients undergoing the operation.

Official Title
-----------------
Clinical Results of Arthroscopic Repair for Massive Rotator Cuff Tears of 14 Cases

Conditions
-----------------
Rotator Cuff Tears

Intervention / Treatment
-----------------
* Procedure: arthroscopic repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as massive rotator cuff tears and treated with arthroscopic repair from October, 2015 to December, 2017 Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: arthroscopic repair|arthroscopic repair|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Pain visual analog scale | 6 months after surgery | 
| DASH | Arm, shoulder and hand dysfunction score | 6 months after surgery | 
| OSS | Oxford University Shoulder Score | 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder joint, Arthroscopy, Massive rotator cuff tears
The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia

Study Overview
=================
Brief Summary
-----------------
Study to assess the risk of incident heart failure associated with the use of pramipexole compared with other dopamine agonists and additionally, to assess the risk of incident heart failure associated with the use of dopamine agonists in comparison with no use of dopamine agonist therapy

Official Title
-----------------
The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Mirapexin® (Sifrol®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients between 40 and 89 years of age who received at least one prescription for anti-parkinsonian drugs during the period 1997-2009 Exclusion Criteria: Patients with a diagnosis of heart failure or with prescriptions for two or more among the digitalis, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blocker (ARB), and diuretic drug classes prior to cohort entry

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 89 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 |
| --- | --- |
| users of anti-parkinsonian drugs<br> | Drug: Mirapexin® (Sifrol®)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of first-time clinical diagnosis of heart failure |  | 150 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall rate of heart failure |  | 150 months |
HCV-796 and Midazolam Drug Interaction Study in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential PK interaction of multiple oral doses of HCV-796 and a single oral dose of midazolam when coadministered to healthy subjects.

Official Title
-----------------
An Open Label, Single-Dose Midazolam, Multiple-Dose HCV-796, Sequential 3-Period Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Midazolam

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

Intervention / Treatment
-----------------
* Drug: HCV-796
* Drug: midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12-lead ECG.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HCV-796|nan|
|Drug: midazolam|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety PK |  |  |
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).

Detailed Description
-----------------
The primary objective of this study is to determine long term safety of the Lifespan® ePTFE Vascular Graft and Vascular Wrap(TM) Paclitaxel-Eluting Mesh in comparison to the Lifespan® graft alone.

Official Title
-----------------
A Long Term Safety Study of the Vascular Wrap(TM) Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® Graft in the Upper Extremity for Hemodialysis Vascular Access

Conditions
-----------------
End Stage Renal Failure on Dialysis, Hyperplasia

Intervention / Treatment
-----------------
* Device: Graft, Vascular Wrap
* Device: Lifespan® ePTFE Vascular Graft Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be considered for enrollment, subjects must: have been randomized in protocol 012-VWAV06; have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study; be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion; allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records. Exclusion Criteria: Subjects who withdrew or were withdrawn from study 012-VWAV06.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Graft, Vascular Wrap<br>Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel) | Device: Graft, Vascular Wrap<br>* Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)<br>* Other names: Vascular Wrap;|
| Placebo Comparator: Graft<br>Lifespan® ePTFE Vascular Graft Only | Device: Lifespan® ePTFE Vascular Graft Only<br>* Vascular Graft only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dialysis, hemodialysis, neointimal hyperplasia
Public Health Concerns of Elderly Fallers and Non-fallers in a Community

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the prevalence and the characterization of health of elderly fallers and non-fallers in the southeastern community of Brazil in the state of São Paulo.

Detailed Description
-----------------
The population consisted of 638 elderly individuals enrolled and attended by the teams of the Family Health Strategy in the city of Araraquara, São Paulo state. The sample was selected in a systematic way, considering the order of micro-areas, 1-7, which 10% sampling error, 15% rate answer. To this, instruments were used based SABE Study, Health Wellbeing and Aging modified, and the International Physical Activity Questionnaire (IPAQ), short version.

Official Title
-----------------
Public Health Concerns of Elderly Fallers and Non-fallers in a Southeastern Community of Brazil

Conditions
-----------------
Accidental Falls, Aging

Intervention / Treatment
-----------------
* Other: descriptive analysis of characteristics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People aged 60 years and over Exclusion Criteria: Vestibular alteration Postoperative requiring continuous home Low vision or complete blind Bedridden Empty house Subjects without registration at the health family unity

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly fallers or non-fallers<br>characteristics of these groups | Other: descriptive analysis of characteristics<br>* comparison between elderly fallers and non-fallers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy, Well-being and Aging questionnaire |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fall, elderly, characteristics
Osteoarthritis: Weakness From Inflammation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the factors that lead to muscle weakness with arthritis and aging.

Detailed Description
-----------------
Through this study, we hope to learn about the natural history of knee osteoarthritis and the disability that arises from it. We hope to better understand why people with knee osteoarthritis develop difficulty with mobility (e.g. walking, standing) in hopes of finding a cure. This study requires 1 four-hour visit to Harbor Hospital. The visit involves a physical exam, a DEXA bone density scan, blood and urine testing, knee x-rays, strength testing and a surface electromyography (EMG). Samples of muscle, joint fluid and joint tissue will be collected during your planned surgery. Participation in this study is entirely voluntary.

Official Title
-----------------
Weakness From Inflammation: A Basis of Disability From Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 years of age or older Normal body weight (a Body Mass Index (BMI) of 30 or less) Osteoarthritis of the knee (prior to knee surgery) Planning to have knee surgery at a MedStar Hospital Exclusion Criteria: History of a stroke History of muscle weakness or paralysis History of Rheumatoid Arthritis or Inflammatory Joint Disease History of a Bleeding Disorder History of Gout Diabetes for which you take insulin Polymyalgia rheumatica (total body muscle aching/stiffness)

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>Participants with symptomatic knee osteoarthritis | |
| 2<br>Participants without symptomatic knee osteoarthritis, age-matched as controls | |

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
-----------------
Knee Osteoarthritis, Muscle, Cytokine, Mobility, Function
Evaluation of the School Kids Influenza Prevention Project

Study Overview
=================
Brief Summary
-----------------
Children whose parents receive text reminders are more likely to be consented to participate in the school located influenza vaccination clinic than children whose parents do not receive text reminders.

Official Title
-----------------
Evaluation of a Text Based Reminder Recall System to Increase Utilization of the School Kids Influenza Prevention Project and Increase Influenza Vaccination Rates in Monroe County, NY

Conditions
-----------------
Childhood Influenza Vaccination, School-located Influenza Vaccination

Intervention / Treatment
-----------------
* Other: Text message notification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Enrolled in the urban school district Exclusion Criteria: - Attends a school in the urban district containing a school-based health center

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SLIV will be offered at all schools in an urban school district. Students will be randomized into either SLIV + standard communication about SLIV or SLIV + standard communication + text message reminders.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: SLIV + usual communication<br>Parents receive usual communication from school (paper consent packets & automated voice mails) about SLIV | |
| Active Comparator: SLIV + usual communication + text<br>Parents receive usual communication from school (paper consent packets & automated voice mails) about SLIV plus a series of text messages informing them about the usual communication for SLIV | Other: Text message notification<br>* Three text messages will be sent to 50% of the parents, scheduled around the standard methods of communication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza vaccination status | Vaccination status for the 2017/2018 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic | Through January, 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccination rates, Respiratory Tract Diseases