linjc16/ctgov huggingface dataset:
Cognitive Function and Patient-Reported Quality of Life Outcomes Investigation in Patients Taking Vorinostat

Study Overview
=================
Brief Summary
-----------------
Psychological well-being and cognitive function will be measured in patients enrolled on the primary study, NCT01790568, a phase 2 trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation. Validated questionnaires will be administered to assess patients' level of depression, anxiety, quality of life, perceived cognitive functioning, and sleep quality. Cognitive testing will include reliable and valid measures of processing speed, attention, executive function, episodic memory, and visual learning and memory. The purpose of this study is to determine whether these measures are feasible to administer in patients before and at early time points after bone marrow transplantation .

Official Title
-----------------
Cognitive Function and Patient-Reported Psychological and Functional/Quality of Life Outcomes Investigation in Patients Taking Vorinostat for Graft-versus-Host Disease Prophylaxis

Conditions
-----------------
Quality of Life, Graft-vs-Host Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be enrolled on the parent study (NCT01790568; A phase 2 clinical trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation) Must speak, read and understand English Exclusion Criteria: Documented evidence of cognitive impairment prior to enrollment on this study (diagnosis of dementia, mild cognitive impairment, or other neurological illnesses that impact cognition).

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, as measured by completion of cognitive testing and validated questionnaires at all time points by 50% of newly-accrued patients. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Bone Marrow Transplantation, Hematologic Malignancies, Adults, Cognition
Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study

Study Overview
=================
Brief Summary
-----------------
Study of heterogeneity in associations between social deprivation and the initial presentation of 12 cardiovascular diseases.

Detailed Description
-----------------
This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Conditions
-----------------
Stroke, Abdominal Aortic Aneurysm, Coronary Heart Disease NOS, Unheralded Corronary Death, Intracerebral Haemorrhage, Heart Failure, Ischemic Stroke, Myocardial Infarction, Peripheral Arterial Disease, Stable Angina Pectoris, Subarachnoid Haemorrhage, Transient Ischemic Attack, Unstable Angina, Cardiac Arrest, Sudden Cardiac Death

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One year prior to study entry (up-to-standard follow-up, CPRD quality research standard). 30 years or older Recorded sex Free of symptomatic CVD at inclusion. Exclusion Criteria: Pregnant women in the 6 months before the eligibility date

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| No treatment<br> | Other: No treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hazard ratios for the associations between social deprivation and initial presentation of 12 cardiovascular diseases. | Associations studied: overall by sex by age group in high risk groups (smokers, hypertensive disease, obese, diabetic, depression) before and after the introduction of the Quality and Outcomes Framework in England | Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifetime cumulative incidence per quintile of social deprivation |  | Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years |
Vacuumtherapy After Venous Hybrid Procedures

Study Overview
=================
Brief Summary
-----------------
All patients with deep venous obstruction below the sapheno-femoral junction elective for hybrid procedure with creation of an arterio venous-fistula (AVF) in the MUMC or patients with primary percutaneous procedure (and thus venous obstruction above the sapheno-femoral junction) who present with occluded stents which need an additional AVF after thrombolysis will receive a Prevena NPWT. Incidence of wound infections and wound scoring will be performed afterwards.

Official Title
-----------------
Negative Pressure Wound Management (NPWT) System for Inguinal Wounds After Venous Hybrid Procedures

Conditions
-----------------
Wound Infection

Intervention / Treatment
-----------------
* Device: Prevena, KCI, Acelity, NPWT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with deep venous obstruction below the sapheno-femoral junction primary elective for hybrid procedure with creation of an AV-fistula in the MUMC Be able to communicate in Dutch Life expectancy >1 year Exclusion Criteria: Patients with allergies for the components of the used negative pressure incision management system (Prevena)
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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prevena<br> | Device: Prevena, KCI, Acelity, NPWT<br>* All patients will receive a Prevena NPWT (if inclusion criteria are met)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With wound infections or Adverse Events That Are Related to Prevena incision management negative pressure wound therapy | Patients will be prospectively followed and checked for development of wound infections (grade 1-5). Therapy to treat the infections will be monitored. | 3 months |
Cosopt Versus Xalacom

Study Overview
=================
Brief Summary
-----------------
To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily.

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination
* Drug: latanoprost 0.005%/timolol maleate 0.5% fixed combination
* Drug: timolol maleate 0.5%
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2 visual acuity should be 6/60 or better in the study eye(s) Exclusion Criteria: any anticipated change in systemic hypotensive therapy during the trial use of any corticosteroids by any route for more than two weeks during the study contraindications to study medicines

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination|nan|
|Drug: latanoprost 0.005%/timolol maleate 0.5% fixed combination|nan|
|Drug: timolol maleate 0.5%|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754)

Study Overview
=================
Brief Summary
-----------------
This study will be an exploratory study of long term immunogenicity of INVAC-1 in patients who participated in the INVAC1-CT-101 phase I study (between 2014 and 2018).

Detailed Description
-----------------
The primary goal of the study is to analyze anti-telomerase specific memory responses in blood of long term survival patients and to correlate these immune responses to their subsequent treatment since the end of INVAC1-CT-101 phase I study. Six patients are expected to participate in this study.

Official Title
-----------------
AN EXPLORATORY FOLLOW-UP STUDY OF LONG TERM ANTI-TELOMERASE IMMUNE RESPONSE AFTER INVAC-1 VACCINATION IN PATIENTS WITH LONG TERM SURVIVAL. Addendum to INVAC1-CT-101 PROTOCOL - EUDRACT NUMBER : 2013-004369-15

Conditions
-----------------
Solid Tumor, Adult

Intervention / Treatment
-----------------
* Drug: INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who participated in the phase I study and are still alive at the present time Ability to provide written informed consent and to understand and comply with the requirements of the study. Exclusion Criteria: Anemia (Hgb < 7g/dL) according to L-1121-1 annexe 2 of Code de Santé Publique Systolic blood pressure below 90 mm Hg

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INVAC-1<br>All patients have been treated by INVAC-1 vaccine during the previous phase 1 NCT02301754. No new treatment injection is required in this study. | Drug: INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study.<br>* blood sampling will be drawn once in order to analyse long term memory immune response to INVAC-1 vaccine<br>* Other names: blood sampling;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long term anti telomerase specific memory responses | will be measured by ELISPOT on blood of patients who were treated by INVAC-1 in the phase I NCT02301754 study and are still alive at the present time | 1 day visit |
Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study

Study Overview
=================
Brief Summary
-----------------
The research project aims to try to answer the many questions raised by the identification of new early repolarization syndrome. The questions are varied with both taking optimal clinical management of patients, the frequency and significance of this anomaly in the population on the electrophysiological and molecular basis responsible for this electrocardiographic abnormality. To try to answer these many questions, the approach will be twofold: clinical and genetic. Establishment of a clinical database containing information of patients who have been identified as carriers of the anomaly based on the initial clinical presentation in order to determine their prognoses. Physiological approach will be based on a molecular approach to identify genetic abnormalities may be involved in this syndrome. 200 asymptomatic patients and an unlimited number of patients who presented syncope or aborted sudden death will be included. A blood sample (15 ml) will be performed at inclusion.

Official Title
-----------------
Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study

Conditions
-----------------
Early Repolarization Syndrome

Intervention / Treatment
-----------------
* Genetic: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of early repolarization aspect, determined by the J point elevation of at least 0.1 mV above the isoelectric line, with or without extra-ST segment elevation in at least two leads and / or lateral. Parameters ECG D2 level of the bypass measurable for the presence of long QT syndrome. Late potentials ventricular analyzable. For patients with ventricular fibrillation, negative search for other causes of ventricular fibrillation. For patients with syncope, clinical assessment should included at a minimum, performing a cardiac ultrasound and a stress test. Exclusion Criteria: Impossibility to receive clear information (patient's intellectual default). Refusal to sign the informed consent for participation. Under protective measure of justice.

Ages Eligible for Study
-----------------
Maximum Age: 60 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 |
| --- | --- |
| Early repolarization syndrome<br>Patients with an aspect of early repolarization syndrome or belonging to a family in which the diagnosis of early repolarization was identified. | Genetic: Blood samples<br>* Blood samples at baseline.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ventricular fibrillation or sudden death |  | 36 months |
Indirect Measurement of Respiratory Quotient in Unipulmonary Ventilation.

Study Overview
=================
Brief Summary
-----------------
The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis. A study has been conducted in our department to demonstrate the ability of the indirectly measured respiratory quotient (RQ) from the inspired and exhaled breath analysis of the anesthetic respirator to predict the onset of anaerobic metabolism and postoperative complications in the operating room. Unipulmonary ventilation is the rule in thoracic surgery: it improves surgical exposure and protects the operated lung. However, no study has examined the impact of these mechanisms on the indirect measurement of RQ in unipulmonary ventilation. The main objective of our work is to validate indirect RQ measurement during unipulmonary ventilation. The secondary objective was to assess the predictability of postoperative complications of indirect QR.

Official Title
-----------------
Validation of the Respiratory Quotient Measurement Measured Indirectly in Unipulmonary Ventilation (UNIQ Study)

Conditions
-----------------
Respiratory Quotient Measurement

Intervention / Treatment
-----------------
* Procedure: unipulmonary ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years old Adults admitted to the operating room for thoracic surgery requiring unipulmonary ventilation Exclusion Criteria: Cardiac surgery Laparoscopy Preoperative oxygen therapy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: unipulmonary ventilation|observational study based on the computation of respiratory quotient in patient cohort treated by unipulmonary ventilation in routine thoracic surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indirect respiratory quotient |  | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of at least one post-operative complication | the aim is to predict the occurrence of at least one complication with the use of indirect respiratory quotient | through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unipulmonary ventilation, complications, respiratory quotient.
Duke Urology Database and Specimen Bank

Study Overview
=================
Brief Summary
-----------------
The proposed project is aimed to build a Duke University-specific longitudinal urologic surgery database. It will be used as the main resource to support future research within Urology and Duke University.

Detailed Description
-----------------
Specifically, the database will be used for the following future studies. (i) To characterize the biomarkers/protein signature associated with urological diseases; (ii) To clarify the clinical role of the risk factors and their interactions for early detection and optimized treatment of urological diseases, and improvement of post-treatment quality of life; (iii) To develop algorithms and nomograms to accurately predict the outcome of urological diseases. Retrospective review of subjects data prior to Institutional Review Board approval and prospective review of data on those consented after Institutional Review Board approval.

Official Title
-----------------
Duke Longitudinal Urologic Surgery Patient Outcome Database

Conditions
-----------------
Prostate Cancer, Bladder Cancer, Erectile Dysfunction, Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duke Urology patients Exclusion Criteria: None
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign prostate hyperplasia, Erectile dysfunction
Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study

Study Overview
=================
Brief Summary
-----------------
Obesity is a disease not always attributable to nutritional imbalance, frequently associated with changes in key hypothalamic-pituitary (HP) axes. The regain of weight loss after hypochaloric diets has been ascribed to these HP disregulations. The aim of the study is to explore pituitary morphology and its association with pituitary function and metabolic phenotype in outpatient obese individuals evaluated in the period 2010-2013 at the Department of Experimental Medicine of the University of Rome La Sapienza, with features of HP disease in a cross-sectional .

Official Title
-----------------
Growth Hormone Deficiency, Empty Sella and Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study.

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult obese Exclusion Criteria: psychiatric disturbances, pregnancy, lactation, or drugs known to affect pituitary function

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients, no treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cranio-caudal pituitary diameter in millimeters |  | Participants will be followed for the duration of day hospital stay, an expected average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth hormone releasing hormone plus arginine test for GH secretion μg/L |  | Participants will be followed for the duration of day hospital stay, an expected average of 1 week |