linjc16/ctgov huggingface dataset:
Prevalence of Sleep-Disordered Breathing in Children

Study Overview
=================
Brief Summary
-----------------
To investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children.

Detailed Description
-----------------
BACKGROUND: SDB in children appears to be a common condition, affecting approximately 1 to 3 percent of children. Many aspects of childhood SDB remain understudied and poorly understood, including its precise prevalence, the optimal means of identifying children who should undergo polysomnography, and the potentially major impact of this condition on health, cognitive development, and behavior. DESIGN NARRATIVE: The population-based, cross-sectional study of 6- to 16-year-old schoolchildren in Dauphin County, Pennsylvania is a two-part study. In the first part of the study, parents of every child enrolled in local elementary schools will complete a questionnaire that will assess general sleep, behavior, and learning problems. In the second part of the study, 1,000 children will be randomly selected based on their risk for SDB, as determined by the questionnaire. They will be evaluated in a sleep laboratory to determine the presence of SDB. A thorough pediatric ear, nose, throat, and pulmonary evaluation will be conducted; school records and behavior will also be assessed. The parents of the children will be interviewed, and information will be collected on the family history of risk factors associated with childhood SDB. This strategy will be beneficial in establishing the prevalence and clinical significance of SDB in children.

Official Title
-----------------
Prevalence of Sleep Disordered Breathing in Children

Conditions
-----------------
Lung Diseases, Sleep Apnea Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phase I: Sampled all children by questionnaire completed by parent or guardian in three school districts in Dauphin County, Pennsylvania Phase II: Recruited a representative sample of 700 to complete a more detailed analysis in the laboratory

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep-Disordered Breathing
Human Milk in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.

Official Title
-----------------
Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Dietary Supplement: Human milk fortifier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weight 1000-1500 grams Admitted to NICU within 24 hours of life Maternal intent to use human milk Exclusion Criteria: Congenital anomalies Feeds not started within the first 96 hours of life Intrauterine growth restriction

Ages Eligible for Study
-----------------
Maximum Age: 4 Days

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups. 1 group will be controlled, following standard NICU feeding protocol. 1 group will be intervention, receiving early introduction of human milk fortifier to enteral feeds.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Continue current NICU feeding protocol, introducing human milk fortifier at 8 days | |
| Experimental: Intervention<br>Introducing human milk fortifier at 1 day | Dietary Supplement: Human milk fortifier<br>* Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth velocity | weight gain in grams/kg/day | at 28 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth velocity | weight gain in grams/kg/day | at 36 weeks post menstrual age |
A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of stomach acid suppression by rabeprazole and BMS-986165 on how fast and complete the drug is absorbed into the body of healthy participants.

Official Title
-----------------
An Open-Label, Single-Sequence Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole on the Pharmacokinetics of BMS-986165 in Healthy Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: BMS-986165
* Drug: Rabeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Healthy participant, as determined by medical history, physical examination, ECGs, and clinical laboratory determinations Body mass index of 18.0 kilogram per meter square (kg/m^2) to 32.0 kg/m^2 Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than (>) 80 milliliter per minute per 1.732 meter square (mL/min/1.732 m^2) Exclusion Criteria: Any major surgery within 4 weeks of study drug administration Use of any prescription drugs or over-the-counter acid controllers Positive urine screen for drugs of abuse, alcohol, or cotinine History of allergy to BMS-986165, rabeprazole, or related compounds Other protocol inclusion/exclusion criteria may apply.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165 + Rabeprazole<br> | Drug: BMS-986165<br>* Specified dose on specified days.<br>Drug: Rabeprazole<br>* Specified dose on specified days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of BMS-986165 |  | Day 1 and Day 9 | 
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) of BMS-986165 |  | Day 1 and Day 9 | 
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986165 |  | Day 1 and Day 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Events (AEs) |  | Up to Day 12 | 
| Percentage of Participants with Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs) |  | Up to Day 12 |
NCF Gene & TNFSF4 in SLE Patients

Study Overview
=================
Brief Summary
-----------------
the investigators objective is to identify the association of SNP polymorphisms in the TNFS4, and NCF gene and SLE Egyptian patients.

Detailed Description
-----------------
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by clinical heterogeneity with variable severity. Among the SLE patients, two may share the same clinical manifestations but have different phenotypes. This is why studies are searching for the different genes that might be associated with SLE susceptibility. The Neutrophil cytosolic factor (NCF) Gene provide the instruction for the synthesis of group of proteins that form the NADPH oxidase enzyme complex, that is critical for the induction of reactive oxygen species (ROS) which in turn is important in the regulation of immune system. While the Tumor necrosis factor superfamily 4 (TNFSF4) encodes the ligand for OX40 (OX40L), which delivers a strong costimulatory signal to activated effector T-cells and enhances both Th1 and Th2 responses when engaged with its receptor. Therefore, increased levels of cell surface OX40L may augment B cell differentiation and proliferation. The consequence of which is that the resulting autoantibodies and immune complexes cause disease pathology in SLE. So, NCF and TNFSF4 gene polymorphism are supposed to be associated with SLE risk and pathophysiology.

Official Title
-----------------
Polymorphisms of the Tumor Necrosis Factor Superfamily 4 and Neutrophil Cytosolic Factor Gene in SLE Egyptian Patients.

Conditions
-----------------
System; Lupus Erythematosus

Intervention / Treatment
-----------------
* Genetic: TNFS4, NCF gene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SLE patients patients older than 18 years old Exclusion Criteria: patients with other connective tissue diseases patients older than 70 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLE patients<br> | Genetic: TNFS4, NCF gene<br>* study the gene polymorphisms from the blood sample of the included SLE patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of gene polymorphism of the TNFS4 & NCF in SLE Egyptian patients. | Identify the number of Participants with SNP polymorphisms in the TNFS4, and NCF gene in SLE Egyptian patients and the relation between the concentration of polymorphism and disease activity | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TNFS4, NCF gene
The Effects of Blood Pressure Reduction on Cerebral Perfusion and Cognition in the Elderly Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a reduction in systolic blood pressure induced by anti-hypertensive medication results in changes in cerebral perfusion and cognition in hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive medication for 8-12 weeks. Changes in cerebral perfusion and cognition will be assessed before and after treatment.

Official Title
-----------------
Medication Induced Blood Pressure Reduction; Assessment of Cerebral Perfusion and Cognition in Hypertensive Elderly

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

Intervention / Treatment
-----------------
* Drug: anti-hypertensive medication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 70 years Systolic office blood pressure >= 160 mmHg Systolic home blood pressure >= 155 mmHg Exclusion Criteria: Diabetes Mellitus Atrial fibrillation Dementia Renal failure requiring dialysis Life expectancy of less than 1 year Disabling stroke Contraindication for MRI or anti-hypertensive medication Systolic blood pressure > 220 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertensive elderly<br>community dwelling hypertensive elderly from general practices | Drug: anti-hypertensive medication<br>* 8-12 weeks of anti-hypertensive treatment with 2 weekly titration using registered hypertensive medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral blood flow |  | T1, 8-12 weeks of treatment, T2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functioning assessed by neuropsychological testing |  | T1, 8-12 weeks of treatment, T2-3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure, aging, cerebrovascular circulation, hypertension
Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks. A second purpose is to evaluate the safety of the drug.

Official Title
-----------------
A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Adults

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Drug: Resiquimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of common warts Two forms of birth control Exclusion Criteria: Pregnant or breast feeding Other types of warts, ie. plantar Currently participating in another clinical study Chronic viral hepatitis B or C

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Resiquimod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of treated wart(s) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial clearance of treated wart(s) |  |  | 
| Wart recurrence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wart(s), Adults, Common Wart(s)
Patient Preferences for Leadless Pacemakers

Study Overview
=================
Brief Summary
-----------------
Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers

Detailed Description
-----------------
The purpose of this study is to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers. The preference study is designed to elicit patient preferences for risks and features that vary between a dual chamber leadless pacemaker system and a dual chamber transvenous pacemaker system, to quantify their relative importance.

Official Title
-----------------
Quantifying Patient Preferences for Leadless Pacemaker Devices

Conditions
-----------------
Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial

Intervention / Treatment
-----------------
* Other: Patient Preference Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read and speak English to consent to participate in the survey Willing and able to use a tablet or computer to complete the survey Scheduled to undergo evaluation for a de novo cardiac pacemaker at the study site (patient may or may not have a known indication for a pacemaker at the time) Exclusion Criteria: None

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 |
| --- |
|Other: Patient Preference Survey|Patient preference survey on implantable cardiac pacemaker systems|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference for Pacemaker Device Features Survey | Quantification of patient preference for pacemaker device features and characterization of heterogeneity in patient preferences | 1 year |
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)

Study Overview
=================
Brief Summary
-----------------
In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl>=1.15 g/l) to compare the efficacy and the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient motivation on diet or physical activities or both).

Official Title
-----------------
Ezetimibe Together With Any Statin Cholesterol Enhancement

Conditions
-----------------
Hypercholesterolaemia, Hyperlipidaemia

Intervention / Treatment
-----------------
* Drug: MK-0653, ezetimibe
* Drug: Duration of Treatment: 3 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations). Exclusion Criteria: pregnant or breast feeding women Lipid-lowering agents including hmg-coa reductase inhibitors other than the current statin, fish oils, cholestyramin, niacin (>200 mg/day) and fibrates taken within the 3 months preceding visit 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK-0653, ezetimibe|nan|
|Drug: Duration of Treatment: 3 months|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups. |  |  |
Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus

Study Overview
=================
Brief Summary
-----------------
The investigators want to share our study that is the Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus.

Detailed Description
-----------------
Pilonidal Sinus Disease (PSD) is a common and chronic entity of the young adults. So far, many options regarding the surgical treatment of the disease has been described, the consensus about treatment stills remains unsatisfactory, as all the surgical methods have encountered with different rate of recurrences. Our aim in this study is to compare the widely used technique in pilonidal sinus surgical treatment Modified Limberg Flap Transposition and relatively less used technique Lateral Advancement Flap Transposition with Burrow's Triangle, in the terms of VAS scores, recurrence, postoperative complications, surgical site infections in the first 6 months.

Official Title
-----------------
Interventional Study of the Relatively New Surgical Techniques on the Treatment of Pilonidal Sinus Disease

Conditions
-----------------
Sacrococcygeal Pilonidal Disease

Intervention / Treatment
-----------------
* Procedure: Flap Transposition Procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Pilonidal Sinus Disease Must be able to suitable for the surgery Exclusion Criteria: Patients with Recurrent Pilonidal Sinus disease Patient whom is not suitable for surgery

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

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: Flap Transposition Technique<br>Flap Transposition Technique | Procedure: Flap Transposition Procedures<br>* Modified Limberg Flap Transposition Procedure and Lateral Advancement Flap Transposition with Burrow's Triangle Procedure in The treatment of Pilonidal Sinus Diseases<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS) |  | 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flap, pilonidal sinus, vas, recurrence