linjc16/ctgov huggingface dataset:
Genetic Determinant of Blood Pressure Sensitivity to Salt Intake

Study Overview
=================
Brief Summary
-----------------
Nedd4.2 is a regulator of ENac, a transporter of sodium involved in the regulation of salt retention by the kidney. The study address the consequence of a frequent genetic variation leading expected to impact the function of Nedd4 and in turn, the ability of kidneys to excrete salt intake. Our hypothesis is that the genetic variants of Nedd4.2 could constitute a genetic predisposition to (or protection against) salt-sensitive hypertension.

Detailed Description
-----------------
Subjects were submitted one week to a low sodium-high potassium diet, and then switch to a high sodium,-low potassium diet for two weeks. the last week, subject were taken a 20 MG daily dose of amiloride, a potassium sparing diuretic.

Official Title
-----------------
Clinical, Pharmacological and Biological Investigations of a Polymorphism of Nedd4 , a Regulatory Protein of the Epithelial Sodium Channel

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Diet Amiloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers between 18 and 35 years odl BMI between 18 and 28 Kg per m2 non smokers no active disease no alcool or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet Amiloride<br>One week Low Na diet (10 mmol/d) followed by ine week high Na diet (200 mmol/d) followed by 2 weeks administration of amiloride (10 mg the 1 st week and the 20mg). | Other: Diet Amiloride<br>* only arm of the trial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Blood Pressure among genotypes | 24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks | 24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory Blood Pressure (AMBP) | 24h AMBP was measured fourth : at the beginning of the study,at the end of the low sodium-high potassium diet, after one week under the high sodium-low potassium diet and at the end of amiloride treatment under high sodium-low potassium diet | three weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nedd4-2, blood pressure, polymorphism, salt intake, between 18 and 35 years old, BMI between 18 and 28 Kg per m2, no active disease, no alcool or drug abuse or smoke
White Matter Pathology in Parkinson's Disease (PD)

Study Overview
=================
Brief Summary
-----------------
The relationship between WM lesions (WM) and Postural Instability Gait Disorders (PIGD-PD)in Parkinson's disease patients is largely unknown. We hypothesize that sub-clinical WM pathology may be a major contributing factor to PIGD-PD. We will compare two groups of patients with Parkinson's disease (PD): those with PIGD and patients with dominant tremor (n=120)to assess the role of brain WM changes.

Detailed Description
-----------------
To compare brain WM burden using MRI in PD patients with and without PIGD. Diffusion tensor imaging (DTI) analysis techniques will be applied.We will quantify PIGD-related symptoms including cognitive function, balance and gait and their associations with MRI findings.

Official Title
-----------------
The Role of White Matter Pathology in the Development of the Postural Instability and Gait Disturbance (PIGD) Type of Parkinson's Disease (PD)

Conditions
-----------------
White Matter Lesions, Postural Instability Gait Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of idiopathic PD, as defined by the UK Brain Bank criteria Age between 50 and 80 years Hoehn and Yahr stage II-III On anti-parkinsonian medications Mini-Mental State Exam score ≥ 25 Exclusion Criteria: Brain surgery in the past including implanted Deep Brain Stimulation Clinically significant co-morbidities likely to affect gait e.g., acute illness, significant rheumatic, orthopedic disease, dementia, or major depression Unable to walk independently Inability to comply with the protocol

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| Patients with Parkinson's Disease<br>Consecutive patient sampling | |

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
-----------------
PIGD, tremor, falls, white matter
Seroquel in Bipolar Depression Versus SSRI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.

Official Title
-----------------
Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)

Conditions
-----------------
Bipolar Disorder, Bipolar Depression, Depression

Intervention / Treatment
-----------------
* Drug: quetiapine fumarate (Seroquel)
* Drug: paroxetine
* Behavioral: mood stabilizing activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female out-patients aged 18 to 65 years inclusive Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed Exclusion Criteria: Current period of depression lasting less than 4 weeks or more than 12 months Use of prohibited medication Substance or alcohol dependence or abuse Current suicide risk or suicide attempt within 6 months Breast feeding or pregnancy Clinically relevant disease or clinical finding

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: quetiapine fumarate (Seroquel)|nan|
|Drug: paroxetine|nan|
|Behavioral: mood stabilizing activity|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary variables supportive to the primary objective: |  |  | 
| MADRS total score response |  |  | 
| MADRS total score remission |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, bipolar depression, depression
Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias

Study Overview
=================
Brief Summary
-----------------
This post-marketing study is conducted to characterize the ability of Apple Watch rhythm analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical evaluation among users who contact AppleCare.

Official Title
-----------------
Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias

Conditions
-----------------
Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter

Intervention / Treatment
-----------------
* Device: Ambulatory ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Possession of the following at time of eligibility screening: iPhone (5s or later) with iOS version 12.1.1 or later defined as iPhone model/iOS version used to complete screening eligibility. Apple Watch (Series 1-4) with watchOS version 5.1.2 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility At least one of the following by self-report before consent: Irregular Rhythm Notification ECG app classification of Atrial Fibrillation ECG app classification of Inconclusive defined as Inconclusive, Heart Rate Over 120, or Heart Rate Under 50 Age ≥ 22 years at time of eligibility screening Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study Proficient in written and spoken English Valid phone number associated with iPhone, ascertained from self-report Valid email address, ascertained from self-report Exclusion Criteria: Shared iCloud account Shared AppleWatch

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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 |
| --- | --- |
| Other: Ambulatory ECG<br> | Device: Ambulatory ECG<br>* Eligible participants are asked to wear the ambulatory ECG monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration | Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification | During ambulatory ECG Monitoring (up to 8 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmias Other Than AF | Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification | During ambulatory ECG Monitoring (up to 8 days) | 
| Self-reported Contact With Healthcare Provider |  | Between 15 to 90 days following enrollment |
Corneal Thinning During Topical Bevacizumab Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether topical bevacizumab is safe or not when used in corneal neovascularization for long term period.

Conditions
-----------------
Corneal Neovascularization

Intervention / Treatment
-----------------
* Drug: bevacizumab (Avastin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of corneal neovascularization must be able to apply eyedrop Exclusion Criteria: have active keratitis
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bevacizumab (Avastin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Phase II Study of MK0457 in Patients With T315I Mutant CML and Ph+All (0457-008)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate MK0457 in patients with chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Efficacy and safety will be evaluated.

Official Title
-----------------
A Phase II Study of MK0457 in Patients With T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Drug: MK0457


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study will evaluate MK0457 in patients with CML (chronic myelogenous leukemia) and Ph+ALL (Philadelphia chromosome-positive acute lymphoblastic leukemia) Patients must have adequate organ function Patients must have documented T315I mutation Exclusion Criteria: Patients within 3 months of allogeneic bone marrow transplant or not fully recovered from previous anti-leukemia therapy Patients with uncontrolled congestive heart failure Patients with active or uncontrolled infection or active Hepatitis B or C Patients with known HIV positivity or AIDS related illness Patients with currently active second malignancy, other than non-melanoma skin cancer.

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 |
| --- | --- |
| Other: 1<br>continuous infusion every 14 days | Drug: MK0457<br>* IV infusion 32 mg/m2/hour; 5-day continuous infusion every 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  | 24 Months |
Computerized Cardiotocography and Maternal Coffee Habits

Study Overview
=================
Brief Summary
-----------------
The study includes pregnant women referred for foetal antepartum computerized cardiotocography (cCTG) monitoring as outpatients. Pregnant women were divided into two groups based on their coffee intake: the coffee group and the control group. Each pregnant woman had cCTG. Two doctors assessed and recorded the amount of coffee taken by pregnant women before the CTG.

Official Title
-----------------
Computerized Cardiotocography and Fetal Heart Response to Maternal Coffee Intake: A Prospective Study

Conditions
-----------------
Prenatal Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestationale age >37 weeks Exclusion Criteria: fetal malformations, stillbirths preterm labour preterm and term premature rupture of membranes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coffe group<br>Pregnant women who referred caffeine intake. | |
| Control group<br>Pregnant women without caffeine intake. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computerized cardiotocography | Computerized cardiotocography (cCTG) parameters evaluate the fetal heart rate. We analyzed the cCTG between the two groups: pregnant who took coffee and pregnant with no coffee intake. | 1 day (cardiotocographic's test) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
computerised cardiotocography, Fetal monitoring, nutrition in pregnancy, prenatal care, fetal heart rate
Long-term LASIK Follow up Study

Study Overview
=================
Brief Summary
-----------------
Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed for correction of myopia. There are very few studies that have been performed to evaluate long-term outcomes after LASIK. In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability of visual outcomes and long-term effect on corneal morphology with in vivo confocal microscopy. Clinical and corneal morphology outcomes will also be compared between patients who had flaps created with the microkeratome and femtosecond laser.

Detailed Description
-----------------
Volunteers will be eligible for enrollment into the study if have had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 5 and 10 years prior. A complete ophthalmic examination and corneal confocal microscopy will be performed. The study visit will take approximately one hour.

Official Title
-----------------
Long-term Outcomes After Laser in Situ Keratomileusis (LASIK): Mechanical Microkeratome vs Femtosecond Laser

Conditions
-----------------
Lasik Eye Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lasik surgery at the kellogg eye center between 2002 and 2005; at least 3 months of follow up after surgery Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Microkeratome<br>mechanical microkeratome | |
| Intralase<br>femtosecond laser | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare flap creation with mikrokeratome and Intralase |  | 8 to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lasik, intralase, microkeratome
Genetic Epidemiology of CHD Risk Factors in Blacks

Study Overview
=================
Brief Summary
-----------------
To determine the genetic epidemiology of coronary heart disease (CHD) risk factors in Blacks.

Detailed Description
-----------------
DESIGN NARRATIVE: The study used two well defined African populations from Nigeria to determine the contribution of 14 polymorphic genes involved in lipid metabolism in determining quantitative lipoprotein-lipid and apolipoprotein levels as these are major risk factors for coronary heart disease. The study also investigated how differences in life styles and dietary habits modulate the genetic contribution of these quantitative risk factors. Phenotypes in the gene products of APOs A-IV, C-II, D, H, J and (a) were determined by IEF and SDS/immunoblotting. Genotypes at the B,E, AI-CIII- AIV cluster, lipoprotein lipase, hepatic lipase, LDL-receptor, and cholesterol ester transfer protein were determined by polymerase chain reaction protocols. The quantitative levels of total cholesterol, HDL-cholesterol and its subfractions, HDL2- and HDL3-cholesterol, triglycerides and LP(a) were used in the genetic analyses. Estimates of the effect of alleles at each of the candidate loci on quantitative lipoprotein-lipid levels employed the measured genotype approach. The effect of multisite haplotypes for RFLP at various loci, where applicable, was also estimated using the same method. The interaction of alleles at various independent loci in determining quantitative lipoprotein-lipid and apolipoprotein levels was estimated. In addition to the measurements of environmental effects, measurements were also made of the genotype-environmental interaction in determining quantitative risk factor traits. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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 |
| --- | --- | --- |
Efficacy of Oral Ibandronate in Osteoporosis

Study Overview
=================
Brief Summary
-----------------
There has been no comparative data between oral ibandronate and oral ibandronate plus active vitamin D

Official Title
-----------------
Examination of Bone Metabolism and Bone Mineral Density in Primary and Secondary Osteoporosis Treated by Oral Ibandronate

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Ibandronate
* Drug: Oral Ibandronate and Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporotic patients who want to take oral ibandronate Exclusion Criteria: Patients who are allergic to oral ibandronate or vitamin D Patients who have not taken oral ibandronate for the last 2 years

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Oral Ibandronate alone<br>Monthly Oral Intake of Ibandronate | Drug: Ibandronate<br>* To examine the efficacy of oral Ibandronate in osteoporosis<br>|
| Active Comparator: Oral Ibandronate and Vitamin D<br>Monthly oral intake of Ibandronate and daily oral intake of Vitamin D | Drug: Oral Ibandronate and Vitamin D<br>* To examine the efficacy of oral Ibandronate and Vitamin D in osteoporosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density |  | Change from Baseline Values at 1 year |