linjc16/ctgov huggingface dataset:
Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level

Study Overview
=================
Brief Summary
-----------------
The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency

Detailed Description
-----------------
The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency. Specifically, the investigators will assess the consistency of the quantitative data by measuring hepatic blood Inflow (hepatic artery + portal vein) and outflow (inferior vena cava differential flow). According to the mass conservation physical property, blood inflow must equals blood outflow. The relative gap between the measured values will characterize the consistency of the acquisition.

Official Title
-----------------
Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level

Conditions
-----------------
Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Other: 4D flow imaging sequence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants have fasted for 6 hours before examination Adult participants Exclusion Criteria: Anyone with a classic contraindication to MRI Recanalized umbilical vein Severe obesity Gadolinium chelate allergy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>In addition to the standard clinical MR protocol, 2 added sequences: 4D flow imaging sequence standard 2D-PhaseContrast at portal trunk level as reference | Other: 4D flow imaging sequence<br>* 4D flow imaging sequence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic blood flow difference | difference between (hepatic artery + portal vein flows) and inferior vena cava differential flow (infra and supra hepatic) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between 4D and 2D flow | Comparison between 4D and 2D flow values measured at the portal trunk level | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phase-contrast MRI, blood flow, velocity mapping, abdominal imaging, Quantitative MRI
Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection

Study Overview
=================
Brief Summary
-----------------
The primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. The secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes.

Official Title
-----------------
Myocardial Perfusion Echocardiography to Detect Human Heart Transplant

Conditions
-----------------
Heart Transplantation

Intervention / Treatment
-----------------
* Drug: Optison


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult subjects (ages 18 to 75) who have undergone heart transplant at Brigham and Women's Hospital Exclusion Criteria: hemodynamic instability (e.g., systolic blood pressure < 90 mmHg) atrial fibrillation with rapid ventricular response (e.g., heart rate > 120 bpm) premature atrial or ventricular complexes of a frequency that will not allow adequate echocardiographic assessment poor acoustic windows inability to provide informed consent any contraindication listed in the Optison package insert (i.e., history of an allergic reaction)

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 Transplant Rejection<br>Patients presenting with acute cellular rejection | Drug: Optison<br>* Echocardiogram with IV contrast<br>* Other names: Echocontrast agent;|
| Heart Transplant Control<br>Patients presenting for routine office visit | Drug: Optison<br>* Echocardiogram with IV contrast<br>* Other names: Echocontrast agent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global and regional microvascular myocardial perfusion | Myocardial blood flow (dB/s) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute rejection, myocardial blood flow
A Study of Aripiprazole in Patients With Schizophrenia in General Psychiatric Practices

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to evaluate the overall effectiveness of 8 week of aripiprazole treatment.

Official Title
-----------------
A Prospective Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices

Conditions
-----------------
Schizophrenia and Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of schizophrenia or schizoaffective disorder being treated as outpatients,no response to past antipsychotic treatment and patients who symptoms are notoptimally controlled defined as CGI- S<7 Exclusion Criteria: pregnant or breastfeeding,patients at risk for committing suicide,diagnosis of mood disorders, delirium, dementia and other cognitive disorders,patients treatment resistant to otherantipyschotic medications and treatment with a long acting psychotic in which the last dose was within 3 months of treatment phase

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

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-Improvement at endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression scale |  |  | 
| Investigator's Assessment Questionnaire |  |  | 
| Patient preference of medication at endpoint |  |  |
Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the performance of the GlucoTrack device (non invasive device) in measuring blood glucose levels

Detailed Description
-----------------
Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Consistently high blood sugar levels can, over time, lead to complications such as blindness, kidney disease, heart disease, and nerve damage.In addition, low blood sugars may lead to immediate dangers. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics. Currently, there is no commercially available reliable non-invasive glucose measurement device that being marketed. The GlucoTrack, non-invasive device for determining glucose levels based on the simultaneous measurement of three independent orthogonal parameters. The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes

Official Title
-----------------
Evaluation of the Performance and Use of the GlucoTrack(TM), Non-Invasive Glucose Monitoring Device

Conditions
-----------------
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes

Intervention / Treatment
-----------------
* Device: GlucoTrack


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 1, Type 2, or Gestational Diabetes Above the age of 10 Exclusion Criteria: Does not meet inclusion criteria Patients requiring dialysis Participation in other clinical investigations within the previous month. Pregnancy(excluding patients that intend to participate in the gestational group)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GlucoTrack|GT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clarke Error Grid |  | Clarke Error Grid | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Blood glucose monitoring, Non invasive Blood glucose monitoring
Study of a Pandemic Influenza Vaccine in Children

Study Overview
=================
Brief Summary
-----------------
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.

Official Title
-----------------
Phase II Study of a Pandemic Influenza Vaccine in Children

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: H5N1 pandemic influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children aged greater or equal to 6 months to less than 9 years Normal gestation period Exclusion Criteria: History of clinically significant medical conditions History of Guillain Barre syndrome or active neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 8 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: H5N1 pandemic influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and immunogenicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza
Prevention of Delirium Among Elderly Patients With Hip Fractures

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures. Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of 2017 to June 30th of 2017．There were 11 males and 69 females, with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose delirium after surgery, the subjects were randomized divided into experimental group (n=43) and control group (n=37). The parameters next were recorded and analyzed, including age, gender, type of fractures, type of internal instrument, amount of bleeding, time between injured to surgery, time length of operation, type of operation, VAS, incidence of delirium, perioperative complications and adverse events.

Official Title
-----------------
Effect of Prospective Care Bundle on Prevention of Delirium Among Elderly Patients With Hip Fractures

Conditions
-----------------
Delirium, Hip Fractures

Intervention / Treatment
-----------------
* Other: Care bundle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥65 years with hip fractures treated surgically Exclusion Criteria: <65 years psychiatric history ICU post-operation refuse to join this study have delirium pre-operation

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Experimental: experimental group<br>Care bundle | Other: Care bundle<br>* Care bundle<br>|
| No Intervention: control group<br>routine care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of delirium among elderly patients with hip fractures | study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip fractures, Delirium, Aged, Care bundle
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
This research study is being done to examine how meditation and the relaxation response (RR) may change brain activity in attention-deficit/hyperactivity disorder (ADHD).

Official Title
-----------------
Functional MRI of an Open Trial of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Behavioral: Meditation/Relaxation Response Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adults (ages 18 - 49). Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by the Diagnostic and Statistics Manual of Mental Disorders (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview. Exclusion Criteria: Any current, non-ADHD Axis I psychiatric conditions Baseline Beck Depression Inventory (BDI) > 19. Any clinically significant chronic medical condition. Mental retardation Organic brain disorders Seizures or tics. Pregnant or nursing females. Clinically unstable psychiatric conditions (suicidal behaviors, psychosis). Current or recent (within the past 2 years) substance abuse or dependence. Patients currently or recently (within past 1 month) on psychotropic medication. Subjects with current or prior adequate psychopharmacologic treatment for ADHD. Regular practice of an Relaxation Response-inducing technique within the past year History of claustrophobia or any of the standard contraindications to magnetic resonance imaging (MRI) scanning(metal objects within body).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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: Meditation/Relaxation Response Training<br> | Behavioral: Meditation/Relaxation Response Training<br>* 1 hour weekly sessions with 20 min daily home practice for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional magnetic resonance imaging (fMRI) activation from baseline after a 6-week intervention | functional magnetic resonance imaging (fMRI) activation in dorsal anterior medial cingulate cortex (daMCC) & dorsolateral prefrontal cortex (DLPFC) during multi-source interference task (MSIT) | 2 sessions, 2 hours each to be conducted before and after the 6-week intervention |
Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)

Study Overview
=================
Brief Summary
-----------------
This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.

Official Title
-----------------
Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence

Conditions
-----------------
Alcoholism, Smoking

Intervention / Treatment
-----------------
* Drug: naltrexone (Revia)
* Drug: nicotine replacement patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for alcohol and nicotine dependence. Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours. Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day. Motivated to quit smoking. Willing and able to participate in the 12 week outpatient treatment. Acceptable health. Able to provide a collateral informant. Willing to be followed for 6 months after treatment ends. Willing and able to provide the names of three family members or friends to aid in locating participants for follow-up. Exclusion Criteria: Current diagnosis of dependence on other substances except nicotine and alcohol. Having moderately severe or severe alcohol withdrawal symptoms. Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males). History of opioid abuse. Recent use of cocaine. Not desiring to quit smoking. Recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems. History of psychosis. Current suicidality, homicidally or psychiatric symptoms requiring other medications. Presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy. Current treatment with psychotropic medications. Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naltrexone (Revia)|nan|
|Drug: nicotine replacement patch|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Meditoxin® Treatment in Patients With Cervical Dystonia

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)

Official Title
-----------------
A Prospective, Randomized, Multi-center, Phase III, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia

Conditions
-----------------
Dystonia, Dystonic Disorder

Intervention / Treatment
-----------------
* Drug: Meditoxin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 20 to less than 75 years Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score >=20 and TWSTRS-Severity score >=10 Exclusion Criteria: Subjects with pure anterocollis Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome) A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: MEDITOXIN<br> | Drug: Meditoxin<br>* Meditoxin (Botulinum toxin type A)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo (Normal saline)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline |  | week 4 follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline |  | week 4 follow-up visit | 
| Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline |  | week 4 follow-up visit | 
| Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline |  | week 4 follow-up visit |