linjc16/ctgov huggingface dataset:
Validation of Lower Body Negative Pressure (LBNP) Model of Human Hemorrhage in Trauma Patients

Study Overview
=================
Brief Summary
-----------------
Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in humans. The investigators hypothesize that the physiologic changes that occur with application of LBNP mimic those observed in bleeding and hemodynamically unstable trauma patients, and that LBNP is a truly valid model of human hemorrhage.

Detailed Description
-----------------
Specific aims: Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects. Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.

Official Title
-----------------
Validation of LBNP Model of Human Hemorrhage in Trauma Patients

Conditions
-----------------
Physical Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 31 days - 89 years patients cared for in the Emergency Department (ED), Operating Room (OR), or the Intensive Care Unit (ICU) at Denver Health Medical Center, Children's Hospital Colorado and San Antonio Military Medical Center Patients with report of physical trauma within 24 hours of presentation at the hospital. Exclusion Criteria: pregnant patients incarcerated patients patients who object at any time to participating in the study

Ages Eligible for Study
-----------------
Minimum Age: 31 Days
Maximum Age: 89 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 |
| --- | --- |
| Physical trauma<br>Patients with report of physical trauma within 24 hours of presentation to the hospital. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waveform data comparison | Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects. | Up to 12 months | 
| Approximation accuracy | Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients. | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical trauma
Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate an investigational medication to treat chronic asthma. The research is being conducted at 20 clinical research sites in the US and is open to both men and women ages 18 to 70 years. Participants in the study will have a number of visits to a research site over an 8-month period. All study-related care and medication is provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.

Official Title
-----------------
A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: anti-IL-4 monoclonal antibody (pascolizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least a 6-month history of asthma No use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment Exclusion Criteria: Patients with > 10 pack years of smoking history or smoking within 12 months of study enrollment No significant disease other than asthma

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: anti-IL-4 monoclonal antibody (pascolizumab)|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
-----------------
asthma, anti-IL-4 monoclonal antibody, pascolizumab
Brain Function in Children With Congenital Heart Disease (CHD)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at same age. Executive functions are higher order cognitive functions and critical for school success.

Official Title
-----------------
Brain Network Function in School-age Children With Congenital Heart Disease and Its Relation to Higher Order Cognitive Functions

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital heart disease, Cardiopulmonary bypass surgery during first three months of life, No genetic syndrome, Gestational age > 37 weeks of gestation. Exclusion Criteria: Heart surgery without cardiopulmonary bypass, Heart surgery not within first three months of life, Born <37 weeks of gestation, Any genetic syndrome detected.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| congenital heart disease<br>children with severe congenital heart disease who undergo open heart surgery during infancy | |
| healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive Functions, assessed with D-KEFS |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| slow wave activity on EEG |  | 2 years | 
| MRI volumetry |  | 2 years |
Lipid Profile in Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the TG/Hdl-c ratio in patients with acute coronary syndrome as a novel marker of atherosclerosis.

Detailed Description
-----------------
Cross sectional study to: assess triglycerides/high density lipoprotein-cholesterol ratio as a novel atherogenic marker in patients presenting with acute coronary syndrome

Official Title
-----------------
Triglyceride/High Density Lipoprotein-cholesterol Ratio as a Novel Marker of Atherosclerosis in Patients With Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Triglycerides/high density lipoprotein ratio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients presented with acute coronary syndrome Exclusion Criteria: patients less than 18 years rheumatic heart disease congenital heart disease

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Triglycerides/high density lipoprotein ratio|Lipid profile|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary care unit admission | Acute coronary syndrome hospitalization and cardiovascular deathes and estimated hazar ratios (HR) by use of multivariable Cox regression models | From date of randomization up to 1 month |
The Predictive Factors of Vision Recovery in Patients With Pituitary Tumor

Study Overview
=================
Brief Summary
-----------------
Pituitary adenomas can cause compression of optic nerves and chiasm, which will lead to damage of vision. This study aims to evaluate the predictive factors for recovery of vision in patients with pituitary adenomas following trans-sphenoidal surgery.

Official Title
-----------------
The Predictive Factors of Vision Recovery in Patients With Pituitary Tumor

Conditions
-----------------
Pituitary Adenomas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old patients with pituitary adenomas, loss of visual field patients receive trans-sphenoidal surgery Exclusion Criteria: visual damage caused by other diseases

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?
-----------------
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
-----------------
pituitary adenomas, recovery of vision, trans-sphenoidal surgery
Telavancin Observational Use Registry (TOUR)

Study Overview
=================
Brief Summary
-----------------
The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.

Detailed Description
-----------------
This is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.

Official Title
-----------------
Telavancin Observational Use Registry (TOUR)

Conditions
-----------------
Hospital Acquired Bacterial Pneumonia, Complicated Skin and Skin Structure Infections, Ventilator Associated Bacterial Pneumonia, Gram Positive Infection

Intervention / Treatment
-----------------
* Drug: Vibativ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -received at least 1 dose of telavancin since January 1, 2015 Exclusion Criteria: Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vibativ<br>This is an observational study for patients who were already prescribed Vibativ. | Drug: Vibativ<br>* This is an observational study for patients who were already prescribed Vibativ.<br>* Other names: telavancin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical response | defined as the number of days between initiation of telavancin therapy and date of cure, where cure is defined as the resolution of the signs and symptoms of infection and/or no need for additional antibiotic therapy, or clearance of the infection with a negative culture result [Mohr 2009] | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs) |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry
A Prospective Cohort of Children With HIV Infection

Study Overview
=================
Brief Summary
-----------------
To evaluate clinical and immunological outcome of children treated with HAART.

Detailed Description
-----------------
This is a long term cohort study that was started in 2002. Currently, there are 120 children enrolled in the study and are receiving HIV care according to standard practice set by the Thai Ministry of Public Health. HIV-infected parents also receive care at the same clinic.

Official Title
-----------------
Treatment Outcome of Children With HIV Infection

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Zidovudine, Stavudine, Didanosine, Lamivudine
* Drug: Nevirapine, Efavirenz
* Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who are part of the ATC program at Chulalongkorn hospital and at HIV-NAT, The Thai Red Cross AIDS research center Children who fulfil criteria to start HAART according to the ATC program Children who are switched to second regimen or salvage therapy Children who are on any antiretroviral regimens, including post trial children from other HIV-NAT study (both at HIV-NAT and Khon Kaen University sites) Children with HIV infection who are not on antiretroviral therapy Caretakers understand the purpose of data and plasma samples collection, and have signed the consent form Exclusion Criteria: Patients and caretakers may choose to stop HAART at anytime during the study. If they agree, we would continue to follow them in this study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 20 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 |
| --- | --- |
| Long-term pediatric cohort<br>Long-term follow-up cohort since 2003 | Drug: Zidovudine, Stavudine, Didanosine, Lamivudine<br>* Refer to the Thai guideline for HIV management 2007<br>Drug: Nevirapine, Efavirenz<br>* Refer to the Thai guideline for HIV management 2007<br>Drug: LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir<br>* Refer to the Thai guideline for HIV management 2007<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. To collect clinical and immunologic data of children treated with HAART 2. To collect clinical outcome data on children with HIV infection 3. To provide the best possible care to children with HIV infection |  | every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV children, HAART, ARV, Second line HAART, Viral Load, Combination drug, Treatment Experienced, Treatment Naive
Narcolepsy - New Potential Treatment

Study Overview
=================
Brief Summary
-----------------
The overall aim of the study is to investigate the effect of a new, non-pharmacological method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the use of medications with potentially serious side effects in patients with this disease.

Conditions
-----------------
Narcolepsy

Intervention / Treatment
-----------------
* Device: Kinetic Oscillation Stimulation Device
* Device: Kinetic Oscillation Stimulation Device in placebo mode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Diagnosed with narcolepsy (diagnose code G47.4) 16 - 60 years of age MSLT has shown hypersomnia (sleeping latency < 8 min) & 1 episode REM HLA-type associated with increased occurrence of narcolepsy Exclusion Criteria: Reduced cognitive function Other relevant organ disease (that could affect the study results or put the patient at risk) Ongoing bacterial infection in the nose Comorbidity that can increase the risk of bleeding Has received treatment with an implantable stimulator or other implantable product in the head and / or in the neck Known pronounced septal deviation Known allergy to polyvinylchloride or medicinal liquid paraffin Women not using adequate contraceptives Participated in a clinical investigational drug trial within the previous 30 days

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active medical device<br> | Device: Kinetic Oscillation Stimulation Device<br> <br> |
| Placebo Comparator: Inactive medical device<br> | Device: Kinetic Oscillation Stimulation Device in placebo mode<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scale Epworth Sleep Scale (ESS) | Change in ESS scale between baseline before treatment and at 15-21 days after treatment. | 15-21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in multiple sleep latency test (MSLT) | Change in MSLT (mean sleep latency, number of sleep onset rapid eye movement (SOREM), and mean SOREM latency) between registration at baseline and 14 days after treatment. | 14 days |
Evaluating Chronic Pain Management Program

Study Overview
=================
Brief Summary
-----------------
This interventional study seeks to evaluate the overall outcomes of a novel, integrated yoga based intervention for people with chronic musculoskeletal pain and assess the experience of patient to the self care using yoga practices.

Official Title
-----------------
Evaluating Outcomes of a Integrative Yoga Therapy for People With Chronic Pain

Conditions
-----------------
Chronic Musculoskeletal Pain

Intervention / Treatment
-----------------
* Other: Integrative Yoga Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with chronic musculoskeletal pain, not accounted for by disease or underlying pathology Self referred or referred willing to give informed consent Exclusion Criteria: Autoimmune disorder Malignancies Cognitively impairment

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Support Group<br>This is the only group in the study consisting of patients with chronic musculoskeletal pain who are receiving the Integrative Yoga Therapy Program | Other: Integrative Yoga Therapy<br>* Individualised intervention developed, consists of a six one to one sessions with patients, followed by home self practiced sessions. The intervention includes yoga movements, yoga breathing, relaxation techniques, reasoning, and other techniques designed to enhance awareness and acceptance of the psychological factors underlying the chronic pain problem.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of pain and its impact on functioning: Brief Pain Inventory | Brief Pain Inventory | From baseline to 6-week post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Quality of Life: Nottingham Health Profile | Nottingham Health Profile | From baseline to 6-week post intervention | 
| Pain Service Satisfaction: The Pain Service Satisfaction Test (PSST) | The Pain Service Satisfaction Test (PSST) | From baseline to 6-week post intervention |
Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)

Study Overview
=================
Brief Summary
-----------------
To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in subjects with mild to moderate Alzheimer's disease.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics Trial of Multiple Ascending Fixed Doses of SRA-333 in Subjects With Mild to Moderate Alzheimer's Disease.

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: SRA-333


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of probable AD according to the NINCDS-ADRDA criteria. Men and postmenopausal or surgically sterile women aged from 50 to 85 inclusive. Able to give informed consent. Patient's caregiver must consent to participate in the study. Exclusion Criteria: Significant neurologic disease other than AD that may affect cognition. Current clinically significant systemic illness which is likely to deteriorate or affect the subject's safety during the study. Other exclusions apply

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SRA-333|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of multiple ascending fixed oral dose in subject with mild to moderate Alzheimer's Disease |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics and pharmacodynamics of multiple ascending fixed dose. |  |  |