linjc16/ctgov huggingface dataset:
The Queens Library HealthLink Project

Study Overview
=================
Brief Summary
-----------------
To determine whether community based participatory action research leads to more effective cancer prevention and control in underserved communities compared to traditional, topdown programs.

Detailed Description
-----------------
To examine how communities engage in the participatory research process, in order to develop locally tailored initiatives for cancer education, prevention and control. To examine whether and how long program effects are sustained after completion of the intensive collaborative program planning intervention.

Official Title
-----------------
The Queens Library HealthLink Project

Conditions
-----------------
Multiple Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This project is intended to reach participants over the age of 18 within each sampled neighborhood, inclusive of both women and men of all ethnic and language groups. As such, our outcomes assessment strategy is similarly inclusive. Specific sources of data and sampling strategies for different measures are detailed in Section 7, as part of our assessment plan. Exclusion Criteria: Individuals younger than 18 years of age will not be included in this 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether community-based participatory action research leads to more effective cancer prevention and control in underserved communities compared to traditional, topdown programs. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine how communities engage in the participatory research process, in order to develop locally tailored initiatives for cancer education, prevention and control. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Diseases, Queens
The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The main aim of the project is to establish inter-rater reliability, internal variability and variability of results got in two different ways of the Nine Hole Peg Test administered according to the new Czech extended version manual in patients with multiple sclerosis.

Detailed Description
-----------------
At least 30 patients with multiple sclerosis will be tested by Nine Hole Peg Test according to new Czech manual for this test. The testing will take place in one session. Video of patients' performance will be obtained. The inter-rater reliability, internal variability and variability of results got in two different ways will be established.

Official Title
-----------------
The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis

Conditions
-----------------
Motor Activity

Intervention / Treatment
-----------------
* Diagnostic Test: Nine Hole Peg Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: outpatients with clinically definite multiple sclerosis Czech language as a mother tongue age from 20 to 65 years clinically stable disease (more than 30 days since the last attack of the disease) Expanded Disability Status Scale (EDSS) score between 1.5-8.0 Exclusion Criteria: inability to complete the test attempt of the Nine Hole Peg Test vision impairment uncorrectable with glasses severe hearing loss inability to understand instructions inability to complete complete testing failure to sign Informed consent for the patient and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Czech patients with multiple sclerosis<br>Czech patients with multiple sclerosis will be asked to fill in a questionnaire. Then they will be tested by the Nine Hole Peg Test. Video of their performance will be obtained. | Diagnostic Test: Nine Hole Peg Test<br>* At first, each patient will be asked to fill in the questionnaire. Then he/she will be tested by the Nine Hole Peg Test according to the new Czech version of extended manual for this test. Audio recording of verbal instructions will be used.<br>* Other names: questionnaire;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| results from the Nine Hole Peg Test | time in seconds and hundreds of seconds | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
occupational therapy, fine motor skills, Nine Hole Peg Test, inter-rater reliability, variability, multiple sclerosis
Genetic Basis of Mitral Valve Prolapse

Study Overview
=================
Brief Summary
-----------------
The investigators have successfully identified two novel genetic loci for MVP on chromosomes 11 and 13 and are searching for altered genes in these regions. This requires recruiting large families who may have MVP linked to these or other chromosomes; and obtaining DNA samples from 1,000-1,500 individually affected patients to study the relation between DNA markers throughout the genome and MVP. It is our expectation that the results of this study will lead to the discovery of gene(s) responsible for MVP. This will lead to improved understanding of the disease and, in turn, improved ability to treat and prevent progression in genetically susceptible individuals.

Detailed Description
-----------------
This is a genome-wide association study.

Official Title
-----------------
Genetic Basis of Mitral Valve Prolapse

Conditions
-----------------
Mitral Valve Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mitral valve prolapse Exclusion Criteria: Other mitral valve diseases

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 |
| --- | --- | --- |
| Discovery of the genetic basis of Mitral Valve Prolapse | Genome-wide association | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MVP, mitral valve
Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

Study Overview
=================
Brief Summary
-----------------
Ciprofloxacin and levofloxacin are both in guidelines to use for prophylaxis in autologous and allogeneic Stem cell transplant.Ciprofloxacin was recently replaced by levofloxacin as the preferred agent in some transplant centers. In some small retrospective studies ciprofloxacin prophylaxis was associated with a higher rate of breakthrough gram positive bloodstream infections. However, the optimum oral agent for antibacterial prophylaxis in transplant recipients remains uncertain.

Official Title
-----------------
Ciprofloxacin Versus Levofloxacin and Rate of Breakthrough Infections in Hematopoietic Stem Cell Transplant Patients

Conditions
-----------------
Prophylaxis, Stem Cell Transplant Complications

Intervention / Treatment
-----------------
* Drug: Levofloxacin
* Drug: Ciprofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18-75 years of age with a diagnosis of a hematological malignancy. Meet the stem cell transplant program criteria to undergo autologous or allogeneic hematopoietic stem cell transplantation. Exclusion Criteria: Prolonged QT Allergies to ciprofloxacin or levofloxacin

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levo<br>Levofloxacin 500 mg once daily | Drug: Levofloxacin<br>* This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment defined as ANC >1000<br>|
| Active Comparator: Cipro<br>Ciprofloxacin 500 mg BID | Drug: Ciprofloxacin<br>* This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment defined as ANC >1000<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of bloodstream bacterial infections | to assess incidence of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant | 60 days post stem cell transplant |
Fibrin Sealant in Esophageal Surgery

Study Overview
=================
Brief Summary
-----------------
Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. The investigators aimed to investigate feasibility of additional sealing by means of autologous fibrin sealant of the esophageal anastomosis.

Official Title
-----------------
Autologous Activated Fibrin Sealant for the Esophageal Anastomosis, a Feasibility Study

Conditions
-----------------
Anastomotic Leak

Intervention / Treatment
-----------------
* Device: Autologous activated fibrin sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 - 90 years Scheduled to undergo elective minimal invasive esophageal surgery with thoracic or cervical anastomosis (i.e. Ivor Lewis, Orringer or McKeown esophagectomy). physical status (American Society of Anesthesiologists) of 3 or lower Exclusion Criteria: Other malignancies Previous esophageal surgery were excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fibrin sealant<br>Single arm pilot study | Device: Autologous activated fibrin sealant<br>* Application of fibrin sealant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leakage |  | 30-day morbidity | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagogastric anastomosis, Fibrin sealant, Sealing
Assessment of VZV-specific ELISPOT Assay for Predicting VZV Infection in Kidney Transplant Recipients (AVE-KT)

Study Overview
=================
Brief Summary
-----------------
VZV is one of the important opportunistic infection in transplant recipients.Until now, there is no laboratory method to stratify the risk of VZV reactivation after solid organ transplantation. Theoretically, VZV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of VZV development after solid organ transplantation. The investigators thus evaluate the usefulness of VZV-specific ELISPOT assay in kidney transplant candidates to predict the development of VZV infection after kidney transplantation.

Detailed Description
-----------------
We will develop VZV-specific ELISPOT assay, then perform this assay before transplantation. We will evaluate whether this assay will predict zoster reactivation after transplantation.

Official Title
-----------------
Assessment of VZV-specific ELISPOT Assay for Predicting VZV Infection in Kidney Transplant Recipients (AVE-KT)

Conditions
-----------------
Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 16 years or more agree with written informed consent WBC count 2000/uL or more Exclusion Criteria: no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 99 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 |
| --- | --- |
| high VZV ELISPOT results<br>high spot counts in ELISPOT | |
| low VZV ELISPOT results<br>low spot counts in ELISPOT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| zoster development |  | 6 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 6 months after transplantation |
Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

Study Overview
=================
Brief Summary
-----------------
Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively.

Official Title
-----------------
Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid

Conditions
-----------------
Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated with elective, primary, unilateral total knee arthroplasty (TKA) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients) Exclusion Criteria: Bilateral / revision arthroplasty Disease affection central or peripheral nerve function Alcohol and medical abuse Daily use of glucocorticoids Malignancy BMI > 40 Dementia or other cognitive dysfunction Treatment of anxiety or depression

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Strong opioids<br>Patients taking strong opioids preoperatively | |
| Weak opioids<br>Patients taking weak opioids preoperatively | |
| Opioid native<br>Patients not taking opioids preoperatively | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain during ambulation and at rest | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain during ambulation and at rest | 7 days | 
| Opioid consumption |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, Postoperative opioid requirements
Study to Compare the Overall Survival of Patients Receiving INGN 201 (Study Drug) With Patients Receiving Methotrexate

Study Overview
=================
Brief Summary
-----------------
There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.

Conditions
-----------------
Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Genetic: INGN 201


Participation Criteria
=================
Eligibility Criteria
-----------------
18 years or older Not eligible for surgery Must have had radiation and chemotherapy treatments No prior methotrexate treatments

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: INGN 201|nan|

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
-----------------
Refractory Squamous Cell Carcinoma of the Head and Neck
Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in the age group of 6 and less and about 1.5% above. The in-lab sleep study using full Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the commonly used procedure of split-night for OSAS patients, as well as to the development of a variety of ambulatory sleep study systems. The primary study objective is to compare the efficacy of the WatchPAT (WP), as an ambulatory device for aiding in the diagnosis of sleep disorders for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a gold standard.

Official Title
-----------------
Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory

Conditions
-----------------
Sleep Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 5-90 Subjects that are able to read understand and sign the informed consent form to undergo an overnight sleep study in the clinical sleep laboratory Exclusion Criteria: Permanent pacemaker. Severe lung disease. Peripheral neuropathy. Finger deformity that precludes adequate sensor appliance. Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Compare sleep data collected from the Watch-PAT device to PSG data |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep disorders, sleep apnea, ambulatory device, polysomnography, WatchPAT
Follow-up-study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers

Study Overview
=================
Brief Summary
-----------------
Between 2012 and 2014, a cohort of 90 COPD subjects of disease severity grades GOLD I-IV as well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined regarding different clinical and blood/ sputum derived biomarkers at the investigators' research center. This observation study will follow-up/re-examine all available subjects regarding disease course and treatment changes after 3 years (+/-6 months) for the investigation of ncRNA/ transcriptome biomarkers for their potential to indicate disease progression. In addition, biobanking of respective biosamples for potential future COPD biomarker research will be conducted.

Official Title
-----------------
Follow-up-study of Participants (COPD Patients and Healthy Control Subjects) From the Cross-sectional Study 11-03 Ribolution for the Evaluation of Predictive Biomarkers Based on Non-coding RNA

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants in Study 11-03 Ribolution Able and willing to give written informed consent Not pregnant, as confirmed by pregnancy test Exclusion Criteria: Past or present disease occurred since participation in 11-03 Ribolution, which as judged by the investigator, may affect the outcome of the study. Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety Has experienced a significant upper or lower respiratory tract infection incl. moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks. All courses of oral corticosteroids and antibiotics must be completed at least 4 weeks before study start Clinically significant pathological findings in safety laboratory tests having an impact on study participation. Actual drug or alcohol abuse. Suspected inability to understand and follow protocol requirements, instructions, study-related restrictions, and to understand nature, scope, and possible consequences of the study. Being a vulnerable subject (dependent, in detention, or without mental capacity)
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 |
| --- | --- |
| Healthy volunteers<br> | |
| Healthy smokers<br> | |
| COPD GOLD1<br> | |
| COPD GOLD2<br> | |
| COPD GOLD3/4<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung volumes by pulmonary function testing | forced expiratory volume in 1 second | after 3 years ± 6 months |