linjc16/ctgov huggingface dataset:
Epidemiology of Sleep Disordered Breathing - SCOR in Cardiopulmonary Disorders of Sleep

Study Overview
=================
Brief Summary
-----------------
To address the public health importance of sleep disordered breathing and ultimately reduce morbidity through information gained from longitudinal, population-based, epidemiologic studies.

Detailed Description
-----------------
BACKGROUND: The investigators have shown that undiagnosed sleep disordered breathing is prevalent for both men and women throughout the range of middle age; multidisciplinary research findings suggest that untreated sleep disordered breathing may lead to significant behavioral and cardiovascular morbidity. The relative risks are of direct application to public health estimates of: How much behavioral and cardiovascular morbidity would be eliminated if prevalence of untreated sleep disordered breathing were significantly reduced? How much reduction in sleep disordered breathing prevalence could be achieved by eliminating the modifiable etiologic factors? Should high risk groups be targeted for early detection of risk factor reduction programs? DESIGN NARRATIVE: The study quantified the etiologic role of hypothesized risk factors for sleep disordered breathing, described progression of the pathophysiologic process, and tested causal hypotheses of adverse health outcomes. The study was conducted on a unique, established cohort of over 800 subjects, representative of middle-aged employed adults. Extensive baseline polysomnographic and other data were available on the established cohort of 800 subjects; additional cohorts of 50 perimenopausal women and 200 older adults were added for maximum study power. The research resulted in longitudinal data, over a 5-9 year period, on multiple parameters of sleep, breathing, risk factors and outcomes. The independent relative risks were calculated with multivariate techniques to express the temporal relationships for sleep disordered breathing etiologic factors and for consequences of sleep disordered breathing. The study was renewed in 1993 and used longitudinal studies to focus on specific questions of greatest relevance to public health, namely: the roles of aging and menopause in the development of sleep-disordered breathing and the effect of sleep disordered breathing on hypersomnolence and systemic hypertension. The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System (QVR).

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

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
The Time of Positive Conversion of Interferon-γ Releasing Assay After Tuberculosis Exposure

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate the time of positive conversion after exposure to smear positive pulmonary tuberculosis (TB) in a platoon of Korean military, a closed communal setting.

Detailed Description
-----------------
In a platoon where TB outbreak occurred, we performed low dose chest CT (LDCT), QuantiFERON-TB gold in tube (QFT) and two-step (0, 4weeks) TST for outbreak investigation. We perform QFT at 0, 2, 4, 8 and 12 weeks after initial investigation for soldiers with negative QFT results, and soldiers with positive QFT and normal LDCT took isoniazid and rifampin for 3 months as treatment of latent TB.

Official Title
-----------------
The Time of Positive Conversion of Interferon-γ Releasing Assay After Tuberculosis Exposure

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All soldiers who assigned to the military platoon where a tuberculosis outbreak occurred Exclusion Criteria: Soldiers who could not complete study or refused the study protocol
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A platoon with TB outbreak<br> | |

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
-----------------
Tuberculosis, QuantiFERON, Outbreak, Conversion
Prevention of Obesity at Universities: A Randomized Trial

Study Overview
=================
Brief Summary
-----------------
This is a nutrition and behavior-based intervention conducted at Drexel University and the University of Pennsylvania with college women during their freshman year. It involves attending groups where life skills and eating behaviors are taught to help them control their weight and physical health.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Healthy Eating Behaviors Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A variety of risk factors for later life weight gain Exclusion Criteria: Current or past history of eating disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group (other group is a control without any intervention) involves 6 one-hour group sessions teaching healthy eating habits and weight gain prevention tools. | Behavioral: Healthy Eating Behaviors Training<br>* The intervention group (other group is a control without any intervention) involves 6 one-hour group sessions teaching healthy eating habits and weight gain prevention tools.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | baseline, 6 weeks, 6 months, 12 months, 24 months | 
| blood work |  | baseline, 6 months, 24 months | 
| questionnaire data |  | baseline, 6 weeks, 6 months, 12 months, 24 months | 
| Body Composition |  | baseline, 6 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dietary recalls |  | baseline, 6 weeks, 6 months, 12 months, 24 months | 
| Pedometer readings |  | baseline, 6 weeks, 6 months, 12 months, 24 months |
FilmArray and Management of ICU Patients With Pneumonia in the Covid-19 Context

Study Overview
=================
Brief Summary
-----------------
The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease. During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods. In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.

Official Title
-----------------
Impact of the Syndromic PCR System FilmArray on Management of ICU Patients With Severe Pulmonary Disease in the Context of the Covid-19 Pandemic.

Conditions
-----------------
Infectious Disease, Pneumonia, Molecular Diagnosis, Covid-19, Antibiotic Stewardship

Intervention / Treatment
-----------------
* Diagnostic Test: FilmArray PCR on respiratory samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years affiliated to a social security system Patients who have received complete information about the research and who have not objected to the use of its data Patients with suspected SARS-Cov-2 infection Patients for which a FilmArray test has been realized on its respiratory samples between 1st of March and 1st of July 2020. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: FilmArray PCR on respiratory samples|Molecular test performed on respiratory samples realized for microbiological routine testing as part of the care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic decision | Antibiotic prescription modification following the FilmArray results as: No prescription No change in antibiotic utilization Antibiotic initiation Antibiotic escalation Antibiotic de-escalation Antibiotic discontinuation | 24 h following the FilmArray results |
Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention

Study Overview
=================
Brief Summary
-----------------
To monitor changes in indicators of red cell damage such as extracellular hemoglobin, potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.

Detailed Description
-----------------
Traumatic brain injury (TBI) causes significant morbidity and mortality, accompanied by high related costs. Recent hypotheses concerning the pathophysiology of TBI invoke Strain Shear Theory and Cavitation Theory. The invbestigators propose to test the importance of the latter by directing blast waves into containers that are either partially or completely filled with blood and measuring markers of lysis. These experiments are designed to better understand the demonstrated effectiveness of mild jugular compression according to the principle of the Queckenstedt Maneuver to reduce the likelihood of TBI by filling up the compliance of the cranial space. A device (C-Collar) is being developed by Q30 Labs, LLC (Q30), to accomplish this effect.

Official Title
-----------------
Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention

Conditions
-----------------
Brain Injuries

Intervention / Treatment
-----------------
* Other: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Normal healthy volunteer Able to provide written consent Must be 18 years or older Exclusion Criteria: • Unable to provide written consent Recent penetrating brain trauma (within 6 months) Under the age of 18 years

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subject blood drawns<br>subjects will have blood drawn which will then be exposed to blast via CO2 cartridge | Other: blood draw<br>* subjects will have blood drawn done. This blood will then be exposed to blasting with CO2 cartridge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysis of blood cells | measure the lysis of blood cells exposed to blast from CO2 cartridge | within 2 hours |
Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
This extension study will investigate the long-term safety and tolerability of multiple intravitreal injections of ranibizumab administered to patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration who have been previously treated in either of the two ongoing ranibizumab studies CRFB002A2302 (EXCITE) or CRFB002A2303 (SUSTAIN

Official Title
-----------------
A Phase IV, Long-term, Open-label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

Conditions
-----------------
Subfoveal Choroidal Neovascularization (CNV), Secondary to Age-related Macular Degeneration (AMD)

Intervention / Treatment
-----------------
* Drug: ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of 12-month treatment period of study CRFB002A2302 (EXCITE) or CRFB002A2303 Exclusion Criteria: Concurrent participation in another clinical trial, i.e. use of other investigational drugs

Ages Eligible for Study
-----------------
Minimum Age: 50 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: 1<br>ranibizumab | Drug: ranibizumab<br> <br> * Other names: rhuFab V2, Lucentis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by incidence and severity of treatment emergent ocular and non-ocular adverse events over 24 month study period with ranibizumab monthly prn (0.5mg/0.05ml) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessed by mean change in BCVA from Baseline at M 6, 12, 18, and 24. Number of injections with ranibizumab. Safety assessed by AEs and SAEs leading to premature discont. of study drug, vital signs, and ophthalmic exams. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age-related macular degeneration (AMD),, choroidal neovascularization (CNV),, vascular endothelial growth factor (VEGF)
Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Measured by EUROIMMUN Allergy and ImmunoCap

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the correlation of specific IgE levels to common foods and aeroallergens measured by EUROIMMUN Allergy and ImmunoCap

Detailed Description
-----------------
Children aged 0-15 years old who was diagnosed as asthma and/or allergic rhinitis, atopic dermatitis, food allergy, and underwent to measured specific IgE levels to suspicious relevant allergen, were invited to join the study. Specific IgE levels of each patient was measured by EUROIMMUN Allergy and ImmunoCap. The levels of specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, American cockroach, Bermuda, Johnson, Cat dander, Cow's milk, Egg white and wheat were determined the correlation between these two methods.

Official Title
-----------------
Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Among Thai Children Measured by EUROIMMUN Allergy and ImmunoCap

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Other: EUROIMMUN Allergy
* Other: ImmunoCap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosed as asthma and/or allergic rhinitis and/or atopic dermatitis and/or food allergy and have to measured specific IgE levels to relevant allergens Exclusion Criteria: Having underlying disease including cardiovascular disease, chronic lung disease and immunodeficiency disease Denied to enrolled to the study

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- |
| EUROIMMUN Allergy<br>Immunoblot assay | Other: EUROIMMUN Allergy<br>* Immunoblot assay<br>|
| ImmunoCap<br>Fluoroallergosorbent test | Other: ImmunoCap<br>* Fluoroallergosorbent test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specific IgE levels measured by EUROIMMUN Allergy and ImmunoCap |  | 14 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunoglobulin E, food hypersensitivities, child, allergens
Radioimmunoimaging of Light Chain (AL) Amyloidosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

Detailed Description
-----------------
To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 days after infusion of the antibody. A 5-ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Official Title
-----------------
Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody (mAb) Murine (Mu) 11-F4

Conditions
-----------------
AL Amyloidosis

Intervention / Treatment
-----------------
* Biological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a confirmed diagnosis of AL amyloidosis. Exclusion Criteria: New York Heart Association class IV On renal dialysis Serum antibodies to mouse protein

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 124I-labeled anti-amyloid mAb 11-1F4<br>124I-labeled anti-amyloid mAb 11-1F4 will be infused on day 0. Two and 5 days later, PET/CT scans will be performed. | Biological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)<br>* Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT in up to 30 patients with AL amyloidosis. | PET/CT images will be taken 2 and 5 days post-radiolabeled antibody infusion to evaluate if there is organ/tissue uptake (greater than blood pool) and to determine if the presence of radiolabeled antibody correlates with clinically proven amyloid deposition. | Five days post PET/CT scan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radioimmunoimaging, AL Amyloidosis, PET/CT
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.

Official Title
-----------------
A Randomized Trial of Synthetic vs Normal Saline for the Flow-based Algorithmic Hemodynamic Resuscitation of Patients Post-cardiac Surgery

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Other: Pentaspan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: status post cardiac surgery pulmonary artery occlusion catheter in place informed consent morning case (must be out of OR by 2:00 PM Exclusion Criteria: excessive bleeding (> 200 cc/hr) intraaortic balloon pump refusal by treating team emergency cases patients with known adverse reactions to starch solutions
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 colloid<br>Boluses of fluids are a pentastarch (up to 1000 ml) | Other: Pentaspan<br>* When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment<br>|
| Active Comparator: 2. Crytalloid<br>Boluses are given as normal saline | Other: Pentaspan<br>* When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of catecholamines at 8:00 the morning after surgery |  | first post operative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total use of catecholamines |  | Time in ICU | 
| Time in the ICU |  | Time in ICU | 
| Post-operative complications |  | Hospital stay or 28 days | 
| Bleeding |  | Hospital stay or 28 days | 
| Renal failure |  | Hospital stay or 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colloid, crystalloid, hemodynamics, flow-directed, resuscitation