linjc16/ctgov huggingface dataset:
Effect of Plasma Ceramides on Peripheral Vascular Function

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to determine the effect of elevated plasma ceramides on peripheral vascular function. Subjects will consume a high fat meal consisting of long chain fatty acids (to increase plasma ceramides) or medium chain fatty acids (control). Subjects' vascular function will be assessed with laser Doppler flowmetry to measure their artery function and with the CytoCam device to assess their peripheral microvascular endothelial function.

Official Title
-----------------
Effect of Plasma Ceramides on Peripheral Vascular Function

Conditions
-----------------
Peripheral Vascular Disease, Lipid Disorder, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Other: High Saturated Fat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health adults aged 18-40 years English-speaking only Not pregnant Exclusion Criteria: Healthy individuals under 18 years or over 40 years of age Non-English speaking Pregnant individuals Heart rate <60 or >100 Systolic blood pressure <100 or >160 Subjects with visible open sores or wounds in mouth Lactose intolerant or allergy to dairy products Diabetes Mellitus Coronary Artery Disease High blood pressure High cholesterol Heart failure Current tobacco use Chemotherapy within the last 6 months

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medium Chain Fatty Acid High Fat Meal<br>This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a medium chain fatty acid high fat meal. | Other: High Saturated Fat<br>* High saturated fat meal<br>|
| Experimental: Long Chain Fatty Acid High Fat Meal<br>This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a long chain fatty acid high fat meal. | Other: High Saturated Fat<br>* High saturated fat meal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Cardiovascular Conductance | Use laser Doppler flowmetry to measure blood flow | 6 hours | 
| Endothelial-Dependent Total Vessel Density | Use a microscope (CytoCam) to look at blood vessels | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ceramide, Endothelium
Study of Welltang- a Cell Phone-based Diabetes Management Application's Effect on Blood Glucose Control

Study Overview
=================
Brief Summary
-----------------
The aim was to assess the impact of a cell phone-based diabetes management application (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure during 3 months. And hypoglycemic events, the satisfaction of the patients with Boyibang, their diabetes knowledge and self-care behaviors were also evaluated.

Detailed Description
-----------------
At baseline, all patients completed the Diabetes Self- Care Behavior Questionnaire and a Diabetes Knowledge Survey. Health, medical and demographic history, height and weight, waist and hip circumferences, and blood pressure were recorded. HbA1c and low-density lipoprotein cholesterol (LDL-C) level were tested. All of these data were measured 3 months later at the conclusion of the study intervention.

Official Title
-----------------
Study of Welltang- a Cell Phone-based Diabetes Management Application's Effect on Blood Glucose Control

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Welltang


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All diabetes, aged more than 18 years old. No limit for HbA1c was defined Exclusion Criteria: patients have any severe complications such as end phase of diabetic nephropathy or proliferative retinopathy. patients who cannot use smart phone.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Welltang<br>patients using Welltang | Other: Welltang<br>* The intervention group installed Welltang (downloaded from www.welltang.com for free) designed by Shanghai Geping Information and Technique Company Ltd (Shanghai, China) on their cell phones. Welltang is a cell phone- based diabetes management application that consists of three main parts: knowledge, self-management, communication between patients and clinicians<br>|
| No Intervention: usual standard care<br>patients under usual standard of diabetic care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 3 months | 
| low density lipoprotein cholesterol |  | 3 months |
Leuprolide in Determining the Cause of Gonadotropin Deficiency

Study Overview
=================
Brief Summary
-----------------
RATIONALE: The body's response to one injection of leuprolide may provide more information than the standard test for gonadotropin deficiency in determining whether the cause of gonadotropin deficiency is related to the hypothalamus or the pituitary gland. PURPOSE: Randomized double-blinded clinical trial to study the effectiveness of leuprolide in determining the cause of gonadotropin deficiency.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive leuprolide acetate or gonadotropin releasing hormone (GnRH) first, then cross over to receive the other test. Patients receive one subcutaneous injection of leuprolide acetate or GnRH, then have blood samples drawn periodically. One month later, patients receive the other test. Another cohort of patients are randomized to receive leuprolide acetate once daily on days 0, 4, and 8, or days 0, 5, and 10. Patients are followed for up to 2 years. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: gonadotropin releasing hormone
* Drug: leuprolide


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Prepubertal children with constitutionally delayed puberty At least 2 years retardation of bone age Spontaneously progress into puberty within 1 year Boys: Testes long diameter 2.5-3.5 cm and plasma testosterone 40-300 ng/dL Girls: Breast development, but premenarcheal OR Hypogonadotropinism Delayed onset of pubertal milestones associated with anterior panhypopituitarism OR Kallman's syndrome No spontaneous progression into puberty within 2 years after 6 months replacement sex steroid treatment --Prior/Concurrent Therapy-- At least 2 months since prior sex hormone treatment --Patient Characteristics-- Age: 14-18 for children with hypogonadotropinism 9-13 for normal children Other: No chronic systemic disease No metabolic disease No endocrine disease No growth hormone deficiency

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum 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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gonadotropin releasing hormone|nan|
|Drug: leuprolide|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
-----------------
endocrine disorders, hypogonadism, rare disease
Ke Ala Lokahi Demonstration Project for Sexual and Domestic Violence Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of the project is to examine the efficacy of a culturally-based intervention, compared to standard agency services, in enhancing self-care among Native Hawaiian women and decreasing IPV/SV perpetration and related factors among Native Hawaiian men.

Detailed Description
-----------------
Turning Point for Families in Hilo, Hawaii is developing, implementing, and evaluating a culturally-based intervention using Native Hawaiian values, beliefs, and practices to address intimate partner and sexual violence among Native Hawaiian perpetrators and victims/survivors.

Official Title
-----------------
Ke Ala Lokahi Demonstration Project for the Early Intervention and Prevention of Sexual and Domestic Violence Among Racial and Ethnic Populations

Conditions
-----------------
Domestic Violence

Intervention / Treatment
-----------------
* Behavioral: Ke Ala Lokahi (Native Hawaiian cultural intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women self-identified as Native Hawaiian referred for agency services due to intimate partner or sexual violence Exclusion Criteria: See above. No other exclusion criteria.
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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Ke Ala Lokahi (Native Hawaiian cultural intervention)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subsequent incidents of intimate partner or sexual violence for up to 2 years post-intervention |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes, behaviors, and cultural identity assessed at 3-months, 6-months, and 15-months following treatment initiation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intimate partner violence, Sexual violence, Cultural intervention, Native Hawaiian
The Effect of Continuous Passive Motion Training on Neuromuscular Adaptation

Study Overview
=================
Brief Summary
-----------------
After spinal cord injury (SCI), the muscular property altered due to the immobilization adaptation. The purpose of this study was to investigate the effect of remobilization with continuous passive exercise on the adapted paralyzed muscle properties after SCI.

Conditions
-----------------
Spinal Cord Injury(SCI)

Intervention / Treatment
-----------------
* Procedure: Ankle continuous passive motion machine.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of chronic spinal cord injury

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCI<br> | Procedure: Ankle continuous passive motion machine.<br>* A rehabilitation program of machine driven passive stretch.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle tone tests | Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS) and Patient Reported Impact of Spasticity Measure (PPSIM). | Baseline, 1, 2,3, and 4 months. | 
| Fatigue index of muscle | Measure of changes in Fatigue index of soleus and tibialis anterior (TA) muscles. | Baseline, 1, 2,3, and 4 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Injury, Passive motion, Fatigue index, Hypertonia
Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential pediatric subjects for appropriate ADHD clinical research studies.

Detailed Description
-----------------
The ADHD Clinical Research Program at Massachusetts General Hospital currently offers a range of protocols addressing different aspects of ADHD in children and adolescents. Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs often makes it difficult to ask subjects and their parents to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we are proposing that potential subjects and their parents undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program.

Official Title
-----------------
A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

Conditions
-----------------
Pediatric ADHD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ages 6-17 Family/guardian contacting the Clinical Research Program in Pediatric Psychopharmacology, with concerns regarding ADHD symptoms in his/her child Exclusion Criteria: History of significant head trauma with loss of consciousness, organic brain disorders, seizures, or neurological intervention Any significant medical condition, in the judgment of the investigator Mental retardation Pregnancy or lactation Subjects with current, uncontrolled (within the past 3 months) illicit drug or alcohol dependence Sensory difficulties such as deafness or blindness

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening Protocol | This is a prescreening for potential participation in research studies. | Screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, pediatric, children
Brain Metabolism in Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether higher insulin resistance in young women with Polycystic ovary syndrome (PCOS) is associated with reduced cerebral metabolic rate of glucose (CMRglu). Brain volumes using magnetic resonance imaging (MRI) and quantitative cerebral glucose uptake using dynamic positron emission tomography (PET) were obtained.

Detailed Description
-----------------
MRI and FDG PET scan for each participant were obtained within an average time frame of 3 weeks. Isulin resistance were assessed with the updated homeostasis model assessment (HOMA2-IR).

Official Title
-----------------
Brain Metabolism in Women With Polycystic Ovary Syndrome: a PET/MRI Study

Conditions
-----------------
Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PCOS Age ≤ 35 y BMI ≤ 35 Exclusion Criteria: Taking medications for diabetes or insulin-sensitizing drugs Drug addictions Psychiatric illness Smoking Overt evidence of heart, liver or renal disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POLYCYSTIC OVARY SYNDROME (PCOS)<br>FDG PET scan,T1-weight MRI and blood were obtained for each participant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Brain Glucose PET Uptake | Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography. | Single point in time (day 1) | 
| Brain MR Volumes | T1-weighted brain MR images were obtained on a 1.5 Tesla scanner. Regional volumes were determined using FreeSurfer Suite 5.0 software. | Single point in time (day 2) | 
| Insulin Resistance (HOMA2-IR) | The homeostasis model assessment computational method was used to estimate insulin resistance (HOMA2-IR) from fasting plasma glucose and insulin. The HOMA2-IR is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (normal young adult). A higher score indicates a lower insulin sensitivity. | Single point in time (day 1 during the FDG PET) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin Resistance, Brain metabolism, PET, MRI
ACT-HF: Attention, Cognition and Self-Management in Heart Failure

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure.

Detailed Description
-----------------
Eligible participants are those 75 years of age or less, with left ventricular ejection fractions of 40% or less, english speaking and no known cognitive deficits. Participants will be administered the Repeatable Battery for the Assessment of Neuropsychological Status and the Controlled Oral Word Association test at the study visit. They will also be asked to complete the Self-Care in Heart Failure Index and the Anosognosia Questionnaire for Dementia at their convenience and mail back to investigator. Participants will be contacted in 90 days to determine if they have been hospitalized, and if so, for how many days.

Official Title
-----------------
ACT-HF: Attention, Cognition and Self-Management in Heart Failure

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 75 years of age or less ejection fraction 40% or less heart failure 6 months or more English speaking no known dementia no active substance abuse presence of caregiver/support Exclusion Criteria: neurologic disorders potentially causing cognitive dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Heart failure<br>Outpatients with heart failure, age 75 or less, left ventricular ejection fraction 40% or less, english speaking with no known dementia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-management of heart failure as measured by the Self-Care in Heart Failure Index |  | at time of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization(s) |  | 90 days after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Self management, cognitive dysfunction, Self management of heart failure
General Investigative MRI Protocol

Study Overview
=================
Brief Summary
-----------------
This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software being evaluated. If they agree, they can receive their MRI exam with the new coil, sequence or software instead of the standard one.

Official Title
-----------------
General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T

Conditions
-----------------
Cardiac, Multiple MRI Exams, Including, Abdominal, Lumbar, Neck, Pelvis

Intervention / Treatment
-----------------
* Device: 16 Channel SPEEDER Flex Coil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients that are scheduled for a clinically necessary MRI exam provided the subject meets the criteria of the department MRI screening procedure and their study is appropriate for the use of the 4 Channel Flex SPEEDER coil of the 16 Channel Metaflex SPEEDER coil. Exclusion Criteria: Any contraindication to MRI procedures

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic Coil<br>This coil is a lightweight, flexible coil which can be used for many pediatric MRI exams | Device: 16 Channel SPEEDER Flex Coil<br>* This is a 16 element MRI coil, flexible, lightweight. Multiple uses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16 Channel Flex Coil | The 16 Channel Flex Coil will be evaluated for how well it performs on pediatric patients. | May 2012-May 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8 Channel Value Breast Coil | clinical evaluation to determine if an 8 channel mri breast coil meets industry standards. | 6 months |