linjc16/ctgov huggingface dataset:
Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens, is more accurate than other noninvasive options and can report fungal genomic load.

Detailed Description
-----------------
The Sponsor aims to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population. Secondarily, the Sponsor will correlate results of the NGS analysis to other approved fungal tests if performed at the discretion of the treating provider (e.g. blood culture results, radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results or b-D-glucan (BG) results as evaluated via FDA-approved Fungitell assay). The Sponsor will use these other fungal tests, in addition to clinical criterion, to classify subjects as having possible, probable and proven IFD according to established criteria, and compare these categories against results from NGS analysis. Lastly, to quantitatively evaluate follow-up test results to determine fungal DNA genomic load in subjects with positive results.

Official Title
-----------------
Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients

Conditions
-----------------
Invasive Fungal Disease, Fever and Neutropenia, Invasive Fungal Infections, Immunocompromised

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prolonged FN (≥96 hours) despite broad-spectrum antibiotic therapy with anticipated delayed neutrophil recovery Any findings that trigger the primary team to consider new fungal infection in a given inpatient, such as abnormal imaging results, recrudescent fevers in the setting of neutropenia or characteristic skin rashes Exclusion Criteria: -Those without concern for fungal infection or those currently being treated for a presumed or documented fungal infection will not be recruited for this study
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 |
| --- | --- | --- |
| Incidence of positivity for fungal specific pathogens on NGS analysis | We aim to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population. | 7 months |
Bio-Feedback to Improving Stability in Elderly Population

Study Overview
=================
Brief Summary
-----------------
Our hypothesis is that intensive training with positive biofeedback may enhance postural control and stability in Parkinson's disease patients and in elderly fallers.

Detailed Description
-----------------
The aim of the study is to treat Parkinson's patients and elderly fallers. The intervention is intensive training with Biofeedback to try to correct stooped posture, and to improve stability in standing and in walking.

Official Title
-----------------
Using Bio-Feedback for Improving Stability in Walking and Everyday Activity

Conditions
-----------------
Parkinson's Disease Patients

Intervention / Treatment
-----------------
* Device: McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic PD for >2 yrs Between 50-90 Yrs On anti-Parkinsonian medication Hoehn & Yahr 2-3 in ON Free of serious co-morbidities Able to walk but reports difficulties in gait Can use assistive device Exclusion Criteria: Significant orthopedic disturbances or pain Major depression (DSM IV) Dementia (MMSE<24) Clinically significant hearing problems Unstable medical condition (2 wks from meds change) Deep Brain Stimulation

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes|Training with the Audio-feedback device for about 30 minutes, 3 times per week for 6 weeks|

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
-----------------
Parkinson's disease, Audio feedback, postural control
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA

Study Overview
=================
Brief Summary
-----------------
This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Two sessions will be held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program participation on child BMI, quality of life, and executive function.

Official Title
-----------------
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA

Conditions
-----------------
Fitness, Overweight and Obesity, Physical Activity, Quality of Life, Executive Function

Intervention / Treatment
-----------------
* Other: BOKS Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in the BOKS program Participating school Age 5-14 Exclusion Criteria: No valid consent Not enrolled in BOKS

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spring 2018 Participation<br>Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018. | Other: BOKS Program<br>* 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.<br>|
| Experimental: Fall 2018 Participation<br>Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018. | Other: BOKS Program<br>* 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index (kg/m^2) | calculated from height and weight | Baseline, Follow-up for each session (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Executive Function | Executive function and attention/concentration as measured by the Flanker Task | Baseline, Follow-up for each session (12 weeks) | 
| Change in Quality of life PedsQL | Measured by PedsQL, a validated measure of pediatric self-rated quality of life with higher score indicating higher quality of life. | Baseline, Follow-up for each session (12 weeks) |
Nocturnal Hypertension and Non-Dipping Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if high salt diet contributes to high nighttime blood pressure. The investigators will determine if high compared to low salt diet increases 24-hour blood pressure levels. The investigators will also determine if high salt diet affects blood vessel stiffness, cardiac output, and sleep apnea. The study will also determine how high salt diet affects the activity of certain genes related to control of blood pressure. A total of 60 participants will be enrolled in the study.

Official Title
-----------------
Mechanisms of Nocturnal Hypertension and Non-Dipping Blood Pressure Patterns

Conditions
-----------------
Hypertension, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Dietary Supplement: Dietary sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nocturnal hypertension Exclusion Criteria: Stage 2 clinic hypertension History of congestive heart failure Chronic kidney disease, Diabetes with insulin use History of a cardiovascular event Pregnant or nursing Current use of continuous positive airway pressure Shift work A known circadian rhythm disorder

Ages Eligible for Study
-----------------
Minimum Age: 48 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: Crossover Assignment
Interventional Model Description: Crossover study of high (6 g) and low (1.5 g) sodium diet
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High sodium diet<br>High sodium diet is 6 g sodium per day for 10 days | Dietary Supplement: Dietary sodium<br>* High (6 g) versus low (1.5 g) sodium diet<br>|
| Experimental: Low sodium diet<br>Low sodium diet is 1.5 g sodium per day for 10 days | Dietary Supplement: Dietary sodium<br>* High (6 g) versus low (1.5 g) sodium diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour blood pressure | Blood pressure measured by an ambulatory blood pressure monitor | Baseline to 7 days after start of dietary period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive sleep apnea | Severity of obstructive sleep apnea as determine by the apnea hypopnea index | Baseline to 7 days after start of dietary period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nocturnal hypertension, non-dipping blood pressure, obstructive sleep apnea
Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds

Study Overview
=================
Brief Summary
-----------------
This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.

Detailed Description
-----------------
Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.

Official Title
-----------------
A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds

Conditions
-----------------
Nasolabial Folds

Intervention / Treatment
-----------------
* Device: experimental
* Device: comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 to 75 years of age. Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS. Exclusion Criteria: Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications. Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational medical device<br>Neuramis® Deep Lidocaine | Device: experimental<br>* Neuramis® Deep Lidocaine<br>|
| Active Comparator: Comparator device<br>YVOIRE® Volume Plus | Device: comparator<br>* YVOIRE® Volume Plus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WSRS improvement rate at Week 24 | WSRS improvement rate at Week 24 | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of WSRS from Week 4, 12, 24, 36, and 52 | Change of WSRS from Week 4, 12, 24, 36, and 52 | Week 4, 12, 24, 36, and 52 | 
| WSRS improvement rate on Week 4, 12, 36, and 52 | WSRS improvement rate on Week 4, 12, 36, and 52 | Week 4, 12, 36, and 52 | 
| GAIS improvement rate on Week 4, 12, 24, 36, and 52 | GAIS improvement rate on Week 4, 12, 24, 36, and 52 | Week 4, 12, 24, 36, and 52 |
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine

Detailed Description
-----------------
Primary insomnia will be diagnosed according to DSM-IV-TR After consenting, cases will be divided (double blind randomization)in to two arms 2.1 sleep hygiene with placebo group 2.2 sleep hygiene with Quetiapine group outcome measurement: sleep diary, sleep satisfaction visual analog scale and sleep satisfaction likert scale statistical method: dependent T test

Official Title
-----------------
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Drug: Quetiapine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary insomnia Patients by DSM-IV-TR criteria cases enrolled: age 18-65 educated Exclusion Criteria: Currently receiving Quetiapine or other hypnotic drugs Liver disease Patients with heart Dz, Hypertension, thyroid disease History of epilepsy or febrile convulsion pregnant cognitive impairments History of Orthostatic Hypotension Patient with other Psychiatric conditions or Drug dependence

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Quetiapine | Drug: Quetiapine<br> <br> |
| Placebo Comparator: B<br>Placebo | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Latency Period, Sleep satisfaction |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary insomnia, Quetiapine, Randomized controlled trial, Double blind
Retinoblastoma Survivor Study: Assessment of General Health and Quality of Life

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out about the quality of life and health in a group of adults who had retinoblastoma when they were children. By quality of life, we mean how you are feeling about being satisfied with things in your life, including your physical health, your emotional health, and your ability to carry out daily activities. We hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.

Official Title
-----------------
Retinoblastoma Survivor Study: Assessment of General Health and Quality of Life

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Behavioral: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with retinoblastoma at any age At least five years from completion of all retinoblastoma-directed therapy Able to provide informed consent and/or assent, if indicated

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1<br>Long term survivors of retinoblastoma | Behavioral: Questionnaires<br>* The survey will be administered by mail or telephone interview, based upon the participant preference. The survey has been adapted from the 2008 questionnaire being administered through the CCSS (11); it has been supplemented with questions addressing areas of interest specific to the retinoblastoma survivor population (eg, validated instruments that assess visual impairment).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the long-term health status of long term survivors of childhood retinoblastoma, General medical outcomes, vision status, Rates of second cancer |  | conclusion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the quality of life and psychosocial functioning of long term survivors of childhood retinoblastoma Fear of disease recurrence/development of other cancers, Health behaviors, Body image, etc. |  | conclusion of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eye, Survivor, Quality of Life
Renal Mechanism of Action/Splay vs. TmG

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus

Official Title
-----------------
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, NOS

Intervention / Treatment
-----------------
* Drug: Dapagliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects Age 18 to 65 years BMI 18 to 35 kg/m2 Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin No evidence of impaired renal function Exclusion Criteria: Unwilling or unable to use an acceptable method of birth control Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B Exposure to insulin Use of exclusionary concomitant medications Evidence of significant kidney disease or any other significant medical or psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Subjects with T2DM - Dapagliflozin 5 mg | Drug: Dapagliflozin<br>* Tablets, Oral, Once Daily, up to 29 days:<br>* Other names: BMS-512148;|
| Active Comparator: Group 2<br>Subjects with T2DM - Dapagliflozin 20 mg | Drug: Dapagliflozin<br>* Tablets, Oral, Once Daily, up to 29 days:<br>* Other names: BMS-512148;|
| Active Comparator: Group 3<br>Healthy Subjects - Dapagliflozin 20 mg | Drug: Dapagliflozin<br>* Tablets, Oral, Once Daily, up to 29 days:<br>* Other names: BMS-512148;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in urinary glucose excretion dynamics |  | after 7 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in urinary glucose between healthy and diabetic subjects |  | at 7 days | 
| Changes in liver glucose production |  | at one day | 
| Glucose effects on tubular markers |  | at one day |