linjc16/ctgov huggingface dataset:
Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease

Study Overview
=================
Brief Summary
-----------------
NPs can be used To detect subset of asymptomatic with subtle LV dysfunction for further evaluation and earlier referral for intervention and its correlation with echocardiographic finding.

Detailed Description
-----------------
Each patient included in the study will undergo: History taking: Analysis of patient symptoms and signs (dyspnea , orthopnea , Paroxysmal nocturnal dyspnea, lower limb edema , tachypalpitations,…etc ) Clinical examination: Detecion of each patient body weight , height , calculation of BMI. General examination for detection of signs of Heart failure (raised JVP , lower limb edema, ..etc) Examination to respiratory system Auscultation of the heart for detection of valvular affection before echocardiography Invesigations: Laboratory investigations: Urea and creatinine . b) ECG : for exclusion of atrial fibrillation and other arrythmias. 2D Transthorathic Echocardiography (TTE) Evaluation of valve morphology and thickness , gradients and valve area , regurgitant lesions and its severity. Evaluation of internal cardiac dimensions and function. 5- Natriuretic peptides: as a useful screening tool to differentiate symptomatic and asymptomatic patients.

Official Title
-----------------
Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease

Conditions
-----------------
Valvular Heart Disease Stenosis and Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients echocardiographically diagnosed with significant valve lesions. Rheumatic Heart disease with significant but asymptomatic valvular Heart Disease especially (Mitral valve disease )(MS and MR) Gender: male & female Exclusion Criteria: Cases with increased level of BNP as in : Renal impairment Advanced age and obesity Atrial fibrillation and acute coronary syndromes Prior lung diseases and acute illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| early detection of subclinical LV dysfunction. | early detection of subclinical LV dysfunction. | 1 year |
Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk

Study Overview
=================
Brief Summary
-----------------
This study is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity.

Official Title
-----------------
Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk

Conditions
-----------------
Obesity, Diabetes

Intervention / Treatment
-----------------
* Other: Baseline
* Other: Sleep restriction
* Other: Reduced Sleep Quality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal weight Healthy Normal sleep times Exclusion Criteria: Sleep disorders Overweight Diabetes Other health conditions Excessive caffeine and alcohol intake Smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baseline<br>Subjects are tested under normal sleep conditions for carbohydrate metabolism and appetite regulation. | Other: Baseline<br>* Subjects are allowed time in bed for sleep as their usual time at home.<br>|
| Experimental: Sleep restriction<br>Subjects are tested under sleep restriction for carbohydrate metabolism and appetite regulation. | Other: Sleep restriction<br>* Subjects sleep is reduced to 4.5 hours in bed for 4 nights.<br>|
| Experimental: Reduced sleep quality<br>Subjects are tested under a poor sleep quality condition for carbohydrate metabolism and appetite regulation. | Other: Reduced Sleep Quality<br>* Subjects sleep quality is reduced for 4 nights.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disposition Index reflecting Diabetes Risk as a result of decreased sleep duration and/or quality. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, diabetes, risk, obesity, diabetes risk related to sleep
Efficacy of Retreatments With Intravitreal Bevacizumab

Study Overview
=================
Brief Summary
-----------------
Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.

Official Title
-----------------
Evaluation of Efficacy of Intravitreal Bevacizumab Retreatments

Conditions
-----------------
Age Related Macular Degeneration, Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: Intravitreal injection of Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Any visual acuity OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid. Active angiogram leakage Exclusion Criteria: * Basal Inflammatory disease Endoftalmitis history Lesions bigger than 5400 u or with scarring greater than 50% of lesion.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 95 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravitreal injection of Bevacizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neovascularization
Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants

Study Overview
=================
Brief Summary
-----------------
Genetic mutations has been proved to be associated wth the onset of cardiomyopathy. In the present study, we intend to identify new related variants or genes. From March, 2003 to November, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their sampled were drawn from peripheral blood. Paired control group were also enrolled. The whole exome sequencing was used to find out the variants associated with the onset of cardiomyopathy and its prognosis.

Official Title
-----------------
Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants

Conditions
-----------------
Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Patients diagnosed as cardiomyopathy according to the definition of American Heart Association Exclusion Criteria: Uncontrolled hypertension significant valvular disease Mild ischemic heart disease Significant systemic infection Thyroid-induced cardiomyopathy Excessive alcohol consumption Precious cancer treatment including irradiation Refusal to participate in the study
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 |
| --- | --- | --- |
| Cardiovascular death confirmed by death comfirmation or interview with the relatives | Death from cardiovascular causes and any unknown death unless there was another certain cause | up to 24 months | 
| Heart transplantation confirmed by medical record | Heart transplantation within 24 months | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death confirmed by death comfirmation or interview with the relatives | Any death at hospital or after discharge | up to 24 months | 
| Heart failure recurring confirmed by medical record | Recurrence of heart failure at hospital or after discharge | up to 24 months |
Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb)

Study Overview
=================
Brief Summary
-----------------
Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France in 2016.

Detailed Description
-----------------
Study of seroprevalence of hepatitis E among patient followed and treated in centre Hospitalier de la Côte Basque for HIV infections. Study of acquisition of hepatitis E , and determination of liver status using fibrotest in co-infected patients with hepatis C and / or B.

Official Title
-----------------
Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb): a Prospective Cohort Study

Conditions
-----------------
HIV, Hepatitis E

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive > 18 Exclusion Criteria: patient refusal for participation

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 |
| --- | --- | --- |
| Prevalence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) for hepatitis E in blood sample of each patients. Positive sample for both IgM and IgG will be confirmed using polymerase chain reaction (PCR) techniques | Blood samples will be tested for specific immunoglobulins against hepatitis E virus | 6 months time period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fibrotest score | patients infected with hepatitis B or hepatitis C viruses will have their liver status determined using fibrotest score. | 6 months time period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Hepatitis E
Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study seeks to evaluate a multiparametric test including 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) to predict the cumulative incidence of death or progression on treatment with pembrolizumab+first line chemotherapy in metastatic non-small cell lung cancer, regardless of the PD-L1 status and in the absence of ALK, ROS1 or EGFR alteration.

Official Title
-----------------
Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years at time of diagnosis Affiliation to a social insurance Obtaining the patient's non opposition Patients with non-small cell lung carcinoma, confirmed by anatomopathological, metastatic or locally advanced unresectable, not eligible for local curative treatment Cellular or tissue FFPE available Indication of treatment with pembrolizumab + first line chemotherapy in multidisciplinary consultation meeting No mutation of the EGFR gene, no rearrangement of ALK and ROS, At least one measurable tumor according to RECIST criteria Exclusion Criteria: Tissue or cellular FFPE not available Systemic anti-neoplastic or immunotherapy previously received except neoadjuvant or adjuvant treatment completed 6 months or more

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 |
| --- | --- | --- |
| The dependent variable will be the cumulative incidence of death or progression under immunotherapy + chemotherapy at 1 year. | Progression will be evaluated by CT imaging every 12 weeks and then every 9 weeks according to RECIST 1.1. The independent variables will be the 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) evaluated prior to the first injection of pembrolizumab + chemotherapy from the diagnostic tissue material. | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discrimination index (concordance index=C-statistics) of the multiparametric model and model including that of the PD-L1 test. | Compare the discriminant power of the multiparametric model to that of the PD-L1 test alone. | At 1 year |
Standard Versus Mnemonic Counseling for Fecal Incontinence

Study Overview
=================
Brief Summary
-----------------
This study compares standard versus mnemonic counseling for the treatment of fecal incontinence. A mnemonic is a word or rhyme used to aid memory. Our hypothesis is that women randomised to mnemonic counseling will higher recall of treatments, satisfaction with the physician visit and greater improvement in their quality of life when compared to women who received standard counseling.

Official Title
-----------------
Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial

Conditions
-----------------
Fecal Incontinence, Counselling, Patient Satisfaction

Intervention / Treatment
-----------------
* Other: Type of Counselling (Mnemonic)
* Other: Standard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Diagnosed with fecal incontinence by on of the attending physicians Bothersome fecal incontinence symptoms for at least 3 months Able to give informed consent Able to speak, read and comprehend English Exclusion Criteria: Younger than 18 years Fecal Incontinence <3 months Unable to give informed consent Unable to speak, read and comprehend English Diagnosis of active colorectal or anal malignancy, inflammatory bowel disease, recto-vaginal fistula, and rectal prolapse

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

Sexes Eligible for Study
-----------------
Female

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: Standard Counselling<br>Patients in this arm are randomised to standard counselling. | Other: Standard<br> <br> |
| Experimental: Mnemonic Counselling<br>Patients in this arm are randomised to counselling with the aid of a mnemonic. | Other: Type of Counselling (Mnemonic)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall | Patients will be asked to recall treatments recommended for fecal incontinence. | We are measuring the difference in recall the day of the physician counseling and 2 months after physician counselling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionare on the Quality of the Physician and Patient Interaction |  | Patients will complete this questionnaire following the physician counseling on day 1 of enrollment. | 
| Modified Manchester |  | We are comparing the score change from after the physician counselling on day 1 of enrollment and at 2 month follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fecal Incontinence, Treatment options, Patient Satisfaction
Microalbuminuria Predicting CIAKI After CAG

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the association between pre-existing microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary angiography (CAG).

Official Title
-----------------
Pre-existing Microalbuminuria Predicting Contrast-induced Acute Kidney Injury (CIAKI) Following Coronary Angiography (CAG)

Conditions
-----------------
Contrast-induced Acute Kidney Injury, Microalbuminuria

Intervention / Treatment
-----------------
* Other: microalbuminuria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with eGFR≥30ml/min and without macroalbuminuria undergoing CAG. Exclusion Criteria: Pregnancy Lactation Allergic history of contrast media Having been received contrast media within 7 days Use of nephrotoxic medications within 7 days eGFR <30 ml/min, macroalbuminuria (ACR >300 mg/g) Renal transplantation, emergent coronary angiography Cardiogenic shock, pulmonary edema Use of intra-aortic balloon pump (IABP) or mechanical ventilation Multiple myeloma and other malignant tumor Life expectancy less than 12 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| microalbuminuria with eGFR≥60ml/min<br>microalbuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min. | Other: microalbuminuria<br> <br> |
| normal-albuminuria group with eGFR≥60ml/min<br>normal-albuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min. | |
| microalbuminuria group with eGFR<60ml/min<br>microalbuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min. | Other: microalbuminuria<br> <br> |
| normal-albuminuria group with eGFR<60ml/min<br>normal-albuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of serum creatinine (SCr, umol/L) | the difference of SCr before and after CAG. | 24-48 hours after CAG | 
| number of participants with increase in SCr of at least 44.2 umol/L higher than before | number of participants with the difference of SCr before and after CAG over 44.2 umol/L. | 24-48 hours after CAG | 
| number of participants with increase of SCr over 25% higher than before | number of participants with an increase of SCr over 25% higher than before. | 24-48 hours after CAG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of urine albumin to creatinine ratio (ACR, mg/g) | the difference of ACR before and after CAG | 24-48 hours after CAG | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary angiography, contrast-induced acute kidney injury, microalbuminuria
Sofia RSV FIA Field Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of age.

Official Title
-----------------
Sofia RSV FIA Field Study

Conditions
-----------------
Respiratory Syncytial Virus

Intervention / Treatment
-----------------
* Device: In Vitro Diagnostic device to aid in diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female Children less than nineteen (19) years of age can participate (assuming appropriate consent is obtained). Must currently be exhibiting symptoms characteristic of respiratory syncytial virus (RSV) illness. Subjects must present with one or more of the following to be eligible for enrollment: Fever, ≥ 37.8º C (100º F) at present or within past 24 hours Moderate to severe runny nose* Moderate to severe congestion* Decreased appetite Coughing Sneezing* Wheezing Irritability Decreased activity Labored breathing Exclusion Criteria: Subjects nineteen years of age or older. The parent or legal guardian is unable to understand and consent to participation. Current or prior treatment during this infection with anti-RSV Synagis®.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: In Vitro Diagnostic device to aid in diagnosis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High level of sensitivity and specificity for performance vs. culture | Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture. | Culture results within 48 hours of plating |