linjc16/ctgov huggingface dataset:
Sleep Disordered Breathing and Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the prevalence, clinical predictors and consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung transplant recipients.

Detailed Description
-----------------
All patients with end-stage respiratory failure who are referred for lung transplantation and are older than 18 years old are enrolled. We collect: Medical history Blood pressure Anthropometrics Pulmonary function Arterial blood gas Questionnaire (QOL, ESS) Sleep diary Polysomnography

Official Title
-----------------
Sleep Disordered Breathing and Lung Transplantation

Conditions
-----------------
Sleep Disordered Breathing, Lung Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with end-stage respiratory failure who are referred for lung transplantation Informed consent from patient Exclusion Criteria: Patients who are declined for lung transplantation Patients < 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Prevalence of sleep disordered breathing | Polysomnography will be performed at discharge from the hospital (1 month average) | 1 month after lung transplantation | 
| Prevalence of sleep disordered breathing | Polysomnographic evaluation | 1 year after lung transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function | Effect of SDB on pulmonary function/BOS | 1 year after lung transplantation | 
| Investigate possible relationship between SDB and patient medical history |  | 1 year after lung transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep disordered breathing, lung transplantation
Urology Database to Evaluate Clinical Information and Improve Patient Care.

Study Overview
=================
Brief Summary
-----------------
The purpose of initiating the Urology Database is to evaluate the outcomes of urology procedures and medical management to enhance the care and treatment of urology patients.

Detailed Description
-----------------
The current study population will include all patients having had a radical prostatectomy for the treatment of prostate cancer, surgical prolapse repair as well as patients having had InterStim sacral nerve stimulator implantation. The database will house data extracted from the medical records. Patient demographics, and preoperative, intra-operative, postoperative, and follow-up clinical data will be collected.

Official Title
-----------------
Urology Database for Outcomes Research

Conditions
-----------------
Incontinence, Prostate Cancer, Interstitial Cystitis, Urinary Retention, Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing radical prostatectomy, pelvic organ prolapse repair and neurostimulator (Interstim) implantation at William Beaumont Hospital beginning January 1, 1998, as well as other urology patients as research questions are identified. Only patients who have accepted William Beaumont Hospital's Privacy Notices will be included in the database. Exclusion Criteria: Patients not acknowledging acceptance of William Beaumont Hospital's Privacy Notices.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incontinence, prostate cancer, interstitial cystitis
Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome

Study Overview
=================
Brief Summary
-----------------
Middle and inner ear malformations on two boys with velocardiofacial syndrome are discussed.Special attention should be given to the presence of hearing loss due to middle and inner ear malformations, in addition to frequent conductive hearing loss regarding mastoid and middle ear inflammatory processes.

Detailed Description
-----------------
Two boys with clinical signs of velocardiofacial syndrome, at ages of 4.7 and 6,7 years old are the subjects of this study.Audiological evaluation, including pure tone audiometry, tympanometry, acoustical reflex, and Computerized Tomography of temporal bones, and analyses of DNA sample with markers of 22q11 region were performed.

Official Title
-----------------
Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome

Conditions
-----------------
Ear Malformations in the Velocardiofacial Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with velocardiofacial syndrome
Sexes Eligible for Study
-----------------
Male

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
-----------------
Syndrome, Velocardiofacial, Middle ear, Inner ear, Malformation
Molecular Analysis of Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
Retinoblastoma is a childhood tumor of the retina that affects approximately 1 in 18,000 children. Retinoblastoma is more prevalent in Central America, where most patients present with advanced intraocular and extraocular disease. Therefore, we have formed collaboration with Central American investigators to provide us with frozen retinoblastoma tumors from patients undergoing routine enucleation. The objective of this protocol is to begin to identify the mutations and gene expression changes that occur in retinoblastoma cells following RB1 gene inactivation in order to more effectively target chemotherapy for treating bilateral retinoblastoma.

Detailed Description
-----------------
This is a biology protocol with no treatment regimen associated. Following routine enucleation of the retinoblastoma affected eye, a portion of the tumor will be removed and flash frozen and sent to St. Jude for RNA and DNA analysis. Some tissue will undergo histopathological analysis and tissue microarrays will be isolated.

Official Title
-----------------
Molecular Analysis of Retinoblastoma

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Other: Tissue samples taken from retinoblastoma
* Other: 5 ml peripheral blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have clinical diagnosis of retinoblastoma (to be confirmed histologically after enucleation) Legal guardians must willing to sign an informed consent indicating that they are aware of this study and its possible benefits. Legal guardians will be given a copy of the consent form. Patient is being seen at this AHOPCA institution: Exclusion Criteria: Ophthalmologist or oncologist is concerned that sampling will interfere with staging. Diagnosis other than retinoblastoma. Affiliated hospital is unable to provide pathologic evidence of retinoblastoma.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retinoblastoma<br> | Other: Tissue samples taken from retinoblastoma<br>* Tissue banking<br>Other: 5 ml peripheral blood<br>* White blood cells will be isolated from the blood sample as a source of genomic DNA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify genes exhibiting differential expression within intraocular disease tissue between patients having only intraocular involvement and those having extraocular involvement. |  | Indefinite |
Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy

Study Overview
=================
Brief Summary
-----------------
The determination of the 2D6 genotype will enable us to determine the way flecainide is metabolized by the liver. Some individuals are poor metabolizers and some individuals are extensive metabolizers of the drug. This will also determine which patients will benefit from the drug.

Detailed Description
-----------------
Pharmacogenetics is the study of genetic variations on drug metabolizing enzymes and transporters. Pharmacogenetics is one of the first clinical applications of the Human Genome Project. Pharmacogenomics is the study of the role of interindividual genomics variability on drug response, efficacy, and metabolism. It correlates the effects of the entire expressed genome to the clinical usefulness and toxicity of a drug. Pharmacogenomics has the potential to change the way patients' therapy is optimized, allowing an era of personalized medicine in which patients will be divided into groups based on genetic markers that treatment outcomes.

Official Title
-----------------
The Use of CYP 450 2D6 Genotype as a Predictor of Flecainide Efficacy in the Treatment of Patients With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with recurrent AF Patients with a structurally normal heart Patients > 18 YO Patients who signed an informed consent Exclusion Criteria: Renal failure with creatinine clearance less than 40 Elevated liver enzymes 3 times the normal range, or causing coagulation test abnormality Pregnant patients Patients treated with psychiatric agents

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no recurrence of atrial fibrillation |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the dose of flecainide used |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flecainide, pharmacogenetics
Statewide Implementation of Electronic Health Records

Study Overview
=================
Brief Summary
-----------------
To determine the effects of Electronic Health Record use on medication error rates in primary care office practices. Hypothesis: Adoption of Electronic Health Records through this program will reduce medication errors

Detailed Description
-----------------
From the practices committed to implementing EHR in early 2005, we randomly selected 15 adult community-based primary care physicians. We selected 15 similar physicians in practices that were not planning to adopt in that time period. At each of these physicians' practices we documented rates of medication errors for one week prior to the implementation of an EHR using duplicate prescription pads. Two months after the implementation in the adopting group, allowing some time for familiarization with the tool, we collected two weeks of data using computer-based information (in the adopting arm) and duplicate prescriptions (in the non-adopting arm).

Official Title
-----------------
Statewide Implementation of Electronic Health Records

Conditions
-----------------
Medication Errors

Intervention / Treatment
-----------------
* Other: Electronic Health Record Implementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients of physicians participating in the study Exclusion Criteria: Any patients who are not part of a panel of a participating physician Any patients who are younger than 18 years of age Any patients who came in for a second visit within each data collection period

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Paper prescribing, 2005 and 2007 | |
| Experimental: 2<br>Paper prescribing 2005 vs. electronic prescribing 2007 | Other: Electronic Health Record Implementation<br>* Intervention subjects implemented electronic prescribing as part of an electronic health record implementation<br>* Other names: eClinical Works;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Medication errors |  | 2005-2007 | 
| 2. Near misses |  | 2005-2007 | 
| 3. Adverse drug events |  | 2005-2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medication errors, adverse drug events, electronic health records
Periodized Resistance Training for Persistent Non-specific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
In this study the feasibility is investigated of a 16-week supervised heavy resistance training program with weekly undulating periodization for individuals with persistent non-specific low-back pain.

Official Title
-----------------
Periodized Resistance Training for Persistent Non-specific Low Back Pain: A Mixed Methods Feasibility Study

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: 16-week supervised heavy resistance training program with weekly undulating periodization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persistent non-specific low back pain with a duration >3 months average low back pain intensity last two weeks >= 4 on numerical pain rating scale (0-10 scale) no experience with heavy resistance training. Exclusion Criteria: previous surgery of the low back radiculopathy structural spinal changes and/or specific spinal conditions that limit function (spinal stenosis, ankylosing spondylitis, spondylolisthesis/spondylolysis, protrusion, structural scoliosis) autoimmune and systemic inflammatory diseases cardiovascular disease neurological diseases severe osteoporosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Heavy resistance training program<br> | Behavioral: 16-week supervised heavy resistance training program with weekly undulating periodization<br>* Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain intensity on 0-10 Numerical Pain Rating Scale | From questionnaire: current pain, pain the last two weeks and pain the last four weeks, scale from 0-10 were 0 equals no pain and 10 equals the worst pain imaginable | 8 weeks | 
| Low back pain intensity on 0-10 Numerical Pain Rating Scale | From questionnaire: current pain, pain the last two weeks and pain the last four weeks, scale from 0-10 were 0 equals no pain and 10 equals the worst pain imaginable | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise therapy, Resistance training
TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Double-blind, Placebo-controlled Efficacy (as Assessed by Post-bronchodilator FEV1) and Safety Study of RAR Gamma in Subjects With Smoking-related, Moderate to Severe COPD With Emphysema Receiving Concurrent Optimised COPD Drug Therapy.

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RAR Gamma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of >44 years of age, with >10 pack-year smoking history; women not of child-bearing potential; ex-smokers (must have stopped smoking for >=12 months) with clinical diagnosis of emphysema; willing to be switched to optimal COPD therapy. Exclusion Criteria: off oral steroids >28 days prior to enrollment; >2 exacerbations of pulmonary symptoms requiring outpatient treatment, or >1 exacerbation requiring hospitalization, within 12 months prior to screening; exposure to synthetic oral retinoids in past 12 months; history of allergy or sensitivity to retinoids.

Ages Eligible for Study
-----------------
Minimum Age: 44 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>po daily | Drug: Placebo<br>* po daily<br>|
| Experimental: RAR Gamma<br>5mg po daily | Drug: RAR Gamma<br>* 5mg po daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-bronchodilator FEVI |  | At intervals throughout study, and 2 and 6 months after cessation of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation. |  | At intervals throughout study | 
| AEs, SAEs, retinoid side effects, lab parameters. |  | Thoughout study |
Chronic Hepatitis C and Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with >200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity and heart disease are extremely common. This study will examine the relationship between insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to CHC

Official Title
-----------------
Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection

Conditions
-----------------
Hepatitis C, Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian male Age: 25-55 years Chronic Hepatitis C (PCR positive) and fibrosis ≤ F2 (if liver biopsy done) Genotypes 1 or 3 Due to commence antiviral therapy BMI < 30 Exclusion Criteria: Cirrhosis or F3 fibrosis on liver biopsy (if done) > 20 g ETOH per day Type 2 Diabetes (need an OGTT if fasting BGL> 5.7) Concurrent HIV Other cause of liver disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatitis C subjects<br>Due to start therapy for Hepatitis C | |
| Controls<br>Healthy males | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance post treatment of Hep C |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin resistance, Liver fat, Muscle fat, Abdominal fat, Cytokines