linjc16/ctgov huggingface dataset:
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels

Study Overview
=================
Brief Summary
-----------------
The collection of human specimens from both patients and healthy volunteers is necessary for the development of laboratory assays to further basic and clinical research studies. This protocol defines the purposes for which specimens will be collected and establishes general conditions under which sample collection will be performed.

Detailed Description
-----------------
The collection of human specimens from both patients and healthy volunteers is necessary for the development of laboratory assays to further basic and clinical research studies. This protocol defines the purposes for which specimens will be collected and establishes general conditions under which sample collection will be performed.

Official Title
-----------------
Human Specimen Collection to Support Basic and Clinical Research

Conditions
-----------------
Sickle Cell Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Males or females of age 18 years and older can be included in the study. EXCLUSION CRITERIA: Individuals without sickle cell disease or other chronic anemias who wish to donate blood will be excluded if the hemoglobin is less than 10 g/dL for women or less than 12g/dL for men. Individuals with sickle cell disease or other chronic anemias will be excluded from donating blood samples if the hemoglobin is less than 6 g/dL. A participant s most recent CBC result, obtained in the past 12 months, will be used to determine eligibility. There are no exclusion criteria for participants donating saliva or urine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Group1<br>Clinical Center Patients, Healthy Volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluating the role of nitric oxide, inflammatory mediators, and endothelial function in inflammatory diseases of the vasculature such as sickle cell disease, coronary artery disease, pulmonary vascular or advanced lung disease, malaria, and sep... |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA, RNA, Endothelial Function, Leukocyte Gene Expression, Natural History, Sickle Cell, Coronary Artery Disease, CAD, Healthy Volunteer, HV
A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion

Official Title
-----------------
A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion

Conditions
-----------------
Symptomatic Focal Vitreomacular Adhesion

Intervention / Treatment
-----------------
* Drug: 2.0mg of ALG-1001
* Drug: Balanced Salt Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic focal vitreomacular adhesion Vitreomacular traction syndrome Stage 1 and 2 macular holes, ≤ 350 µm BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study eye BCVA of 20/800 ETDRS or better in the fellow eye Male or female subjects, 18 years of age or older Signed Informed Consent Exclusion Criteria: High myopes > -8.0 D spherical equivalent History of prior vitrectomy in the study eye History of photocoagulation to the retina in the study eye Macular hole in the study eye > 350 µm Subjects with epiretinal membranes in the study eye Subjects with broad VMA, defined as VMA of >1500 µm Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular Degeneration (AMD), or retinal vascular occlusion in the study eye Subjects with aphakia in the study eye Subjects with uncontrolled glaucoma Subjects with lenticular or zonular instability Subjects with prior ocular surgery or intravitreal injection in the study eye within 90 days of study enrollment Pregnant or nursing women

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2.0mg of ALG-1001<br>2.0mg of ALG-1001 | Drug: 2.0mg of ALG-1001<br> <br> |
| Placebo Comparator: Intravitreal injection in 0.05cc balanced salt solution.<br>Balanced Salt Solution | Drug: Balanced Salt Solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT) | The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT. | 90 Days |
Phase IIa Safety and Efficacy Study of SPP635 in Mild to Moderate Hypertension

Study Overview
=================
Brief Summary
-----------------
This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.

Detailed Description
-----------------
Renin-Angiotensin system blockade is a well established target for treatment of high blood pressure. Blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor, SPP635.

Official Title
-----------------
A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Parallel-Design, Four-Week Study to Investigate the Safety and Efficacy of the Oral Renin Inhibitor SPP635 Once Daily in Patients With Mild to Moderate Hypertension

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

Intervention / Treatment
-----------------
* Drug: SPP635 (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female patients with mild to moderate hypertension Exclusion Criteria: female patients of child-bearing potential or breast-feeding

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPP635 (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering of systolic office blood pressure |  | four weeks | 
| Lowering of diastolic office blood pressure |  | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering of systolic and diastolic blood pressure (ABPM) |  | four weeks |
The Effects of Sleep on Human Microbiota: Implications for Health and Disease

Study Overview
=================
Brief Summary
-----------------
The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. This may precede clinically detectable disease; and thereby, could be used to predict disease onset and additionally monitor response to treatment and predict prognosis. The primary hypothesis of this pilot study is that the human microbial communities are influenced by sleep and altered in humans with abnormal sleep patterns, and they may ultimately relate to disease risk.

Official Title
-----------------
The Effects of Sleep on Human Microbiota: Implications for Health and Disease

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Behavioral: Sleep restriction
* Dietary Supplement: Weight gain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol. Exclusion Criteria: Pregnant or breast-feeding women Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover; Single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sleep restriction<br>Sleep restriction | Behavioral: Sleep restriction<br> <br> |
| No Intervention: normal sleep<br>Normal sleep | |
| Experimental: weight gain<br>Weight gain | Dietary Supplement: Weight gain<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in human microbiota induced by sleep manipulation in healthy subjects |  | 1 year | 
| Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects |  | 20 weeks |
Study of Aripiprazole in the Treatment of Patients With Acute Symptoms in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if aripiprazole is effective for the treatment of patients with acute symptoms of Bipolar disorder.

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute symptoms of Bipolar Disorder

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aripiprazole|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
-----------------
Bipolar I Disorder
Cerebral Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while changes of cerebral oxygenation are measured. The investigators hypothesise that slower sampling decrease changes in cerebral blood flow.

Official Title
-----------------
Measurement of Cerebral Oxygenation With Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants With Gestational Age <37+0

Conditions
-----------------
Cerebral Oxygenation, Cerebral Blood Flow, Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infant (Gestational Age <37+0) Peripheral arterial catheter (ulnary or radial artery) Exclusion Criteria: Complex organ malformation

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 7 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pretem infants (GG < 37+0)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy

Study Overview
=================
Brief Summary
-----------------
To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level.

Detailed Description
-----------------
children aged 2-16 years diagnosed with idiopathic epilepsy will be randomized to receive either cholecalciferol doses (400IU vs 1000IU) with follow up at 3 and 6 months post supplementation.

Official Title
-----------------
Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy: a Randomized Controlled Clinical Trial

Conditions
-----------------
Epilepsy, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: Vitamin D 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged between 2-16 years who were diagnosed with Epilepsy and being treated with AEDs Followed up in the outpatient pediatric neurology clinic at King Khalid University Hospital during the period of two years. Exclusion Criteria: Children with pre-existing vitamin D metabolism problems; because they are known to need different vitamin D doses and monitoring for clinical improvement: Vitamin D dependent rickets Malabsorption syndromes like celiac disease, inflammatory bowel disease Renal disease Hepatic disease Children who are not safe to start vitamin D supplementation; because vitamin D supplementation will causes toxicity and induces nephrocalcinosis: Hypercalcemia at baseline total corrected calcium >2.5mg/dl Vitamin D level > 250 nmol/L Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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 |
| --- | --- |
| Active Comparator: 400 IU<br> | Drug: Vitamin D 3<br>* oral drops<br>|
| Active Comparator: 1000 IU<br> | Drug: Vitamin D 3<br>* oral drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D level < 75 nmol/L |  | 6 months of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure rate |  | 6 months of supplementation | 
| bone mineral density (BMD) measurement |  | 6 months of supplementation | 
| Cost- effectiveness of vitamin D supplementation | cost of vitamin D supplementation compared to the cost of poor bone health, hospital admission | 6 months of supplementation | 
| Safety: Prevalence of hypercalcemia total calcium >2.7mg/dl, 25 OH vit D level> 250 nmol/l, and Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g. |  | 6 months of supplementation |
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.

Official Title
-----------------
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Device: Endoscopically Guided Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic, Paroxysmal Atrial Fibrillation (AF) 18 to 70 Years of age Others Exclusion Criteria: Generally good overall health as determined by multiple criteria Willing to participate in a study Others

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeartLight Ablation<br> | Device: Endoscopically Guided Ablation<br>* Visually Guided Ablation using EAS-AC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Isolation of Pulmonary Veins. | 99% of pulmonary veins were isolated (72/73) | Acute PVI measured on the day of treatment |
Vitamin D in Ectopic Pregnancies

Study Overview
=================
Brief Summary
-----------------
According to recent evidences, vitamin D was found to have important roles in female reproductive system, both in physiological and also pathological mechanisms. Since vitamin D is tightly related with calcium metabolism, both molecules were reported to be associated with some pregnancy complications including preeclampsia, gestational diabetes, low birth weight, preterm delivery, and cesarean section rates. The aim of the present study was to evaluate the vitamin D levels in ectopic pregnancies, which may have clinical importance in the etiology of this disorder.

Official Title
-----------------
The Effect of Serum Vitamin D and Calcium Levels in Ectopic Pregnancies

Conditions
-----------------
Ectopic Pregnancy, Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ectopic pregnancies and women with normal 1st trimester pregnancies Exclusion Criteria: Patients without any known operations or disease history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| vitamin D level | vitamin d level value will be evaluated in ectopic pregnancies. 25-OH vitamin D (ng / ml) will be looked at in terms of vitamin levels. | at the time of diagnosis of ectopic pregnancy | 
| vitamin D level | vitamin d level value will be evaluated in first trimester. 25-OH vitamin D (ng / ml) will be looked at in terms of vitamin levels. | first trimester | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcium, Magnesium, Inflammation
Freedom Inguinal Hernia Repair System Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. Carolinas Comfort Scale (CCS) assessments will be held at regular intervals. The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.

Official Title
-----------------
Freedom Inguinal Hernia Repair System Study

Conditions
-----------------
Primary Inguinal Hernia

Intervention / Treatment
-----------------
* Device: Freedom ProFlor Inguinal Hernia Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergo routine inguinal hernia repair Competent to give consent Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa) Defect size at operation is between 5mm and 35mm Diagnosed with unilateral, direct, indirect or mixed inguinal hernia Primary hernia at the operative site Male or female Life expectancy of at least 12 months At least 18 years of age Exclusion Criteria: Signs of obvious local or systemic infection Any previous surgery on the hernia operative site Hernia is not in the inguinal area Hernia is not identified as indirect or direct Femoral hernias Known collagen disorder Presenting with unstable angina or NYHA class of IV Known Pregnancy Active drug user Recurrence of a repair by any method Patients with giant inguinoscrotal hernia or abdominal wall defect >35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3 Immunosuppression, prednisone>15 mg/day, active chemotherapy End stage renal disease Abdominal ascites Skin infection in area of surgical field BMI >35 Peritoneum cannot be closed

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freedom ProFlor Inguinal Hernia Implant<br> | Device: Freedom ProFlor Inguinal Hernia Implant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals | Measure quality of life for patients undergoing inguinal hernia repair. | 1 week, 3, 6, 9, 12, 18, 24, and 36 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the 14-day pain and medication log | Patient will record pain score and medications for 14 consecutive days. | 14 days |