linjc16/ctgov huggingface dataset:
Vestibular Disorder and Visuo-spatial Functions

Study Overview
=================
Brief Summary
-----------------
The purpose of these studies is to determine whether vestibular disorders could affect visuo-spatial cognition. Visuo-spatial cognition will be evaluated using a new questionnaire and a new computerized test using a digital tablet in different studies.

Official Title
-----------------
Impact Des déficits Vestibulaires Sur le développement Des Fonctions Visuo-spatiales.

Conditions
-----------------
Vestibular Diseases, Vertigo

Intervention / Treatment
-----------------
* Behavioral: Cognitive and neuropsychological assesment


Participation Criteria
=================
Eligibility Criteria
-----------------
For participants of the questionnaire study : Participants with vertigo complaints versus participants without vertigo complaints. For patients of the behavioural study : Inclusion Criteria: Vestibular disorder (with or without vertigo) Deafness / hard of hearing Exclusion Criteria: Neurological or psychiatric conditions Cochlear Implant (for functional magnetic resonance imaging study)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient group<br>This group will consist of vestibular patients and/or participants with vertigo. | Behavioral: Cognitive and neuropsychological assesment<br> <br> |
| Sham Comparator: Control group<br>This group will consist of participants without vestibular/vertigo impairments. | Behavioral: Cognitive and neuropsychological assesment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vestibular questionnaire (Newly developed to evaluate cognitive abilities) | Participants will be recruited and tested within one week of recruitment. Testing will be online and will take around 20 minutes on average. The new questionnaire will evaluate demographic questions, and different cognition abilities using a likert-scale. | Within one week after recruitment | 
| Standard computerized cognitive assessment (For example : Test of attentional performance, digit span, visuo-spatial span, line bisection task,...) | Participants will be recruited and tested within one week of recruitment. Testing will be at the hospital and will take 2 hours maximum. Standard computerized cognitive assessment will be used such as the Test of attentional performance (TAP2.2), digit span, visuo-spatial span, line bisection task, etc. Reaction times, errors and omissions will be recorded. | Within one week after recruitment |
Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

Study Overview
=================
Brief Summary
-----------------
This is an equivalence study comparing an electric nebulizer with a human-powered nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma exacerbations in a regional clinic in San Salvador, El Salvador.

Detailed Description
-----------------
The study design is to treat individuals suffering from mild to moderate exacerbations of asthma with nebulized salbutamol (2.5mg). Subjects will receive nebulization using either an electric nebulizer compressor or a human-powered nebulizer compressor. Improvement in peak expiratory flow will be the primary endpoint. Blood oxygenation levels as measured by pulse oximetry will be a secondary endpoint of the trial.

Official Title
-----------------
Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer in the Treatment of Mild to Moderate Asthma in El Salvador

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

Intervention / Treatment
-----------------
* Device: Human-Powered Nebulizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suffering from Mild or Moderate Asthma symptoms Increased respiratory rate, but not over 30 breaths per minute Reduced peak expiratory flow rate, but not less than 60% of normal Oxygen saturation levels reduced but greater than 90% Exclusion Criteria: Any other respiratory condition that would interfere with nebulizer treatment If any other medication is being taken at the time Pregnant women or women who may think they might be pregnant Never taken salbutamol before

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electric Nebulizer<br>Pulmo-Aide Model 5650D | Device: Human-Powered Nebulizer<br> <br> |
| Experimental: Human-Powered Nebulizer<br>Human-Powered | Device: Human-Powered Nebulizer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Peak Expiratory Flow |  | From before to after nebulizer treatment lasting approximately 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in blood oxygenation as measured by pulse oximetry |  | From before to after nebulizer treatment lasting about 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Nebulizers, Salbutamol, Developing Countries
Observation of the Incidence and Natural History of MGUS in Patients Undergoing Weight Reduction Surgery

Study Overview
=================
Brief Summary
-----------------
Screening study to determine incidence of MGUS in this patient population

Detailed Description
-----------------
This study is designed to observe the incidence of monoclonal gammopathy of undetermined significance (MGUS) among obese patients planning to have weight reduction surgery or planning to enter into a physician monitored weight loss program and to follow the regression or progression of MGUS following surgery or the initiation of the weight loss program.

Official Title
-----------------
Prospective Observation of the Incidence and Natural History of Monoclonal Gammopathy in Patients Undergoing Weight Reduction Surgery

Conditions
-----------------
Monoclonal Gammopathy of Undetermined Significance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients 30 years or older planning to undergo weight reduction surgery or planning to enter into a physician monitored weight loss program Patients must be obese, defined as a BMI ≥ 30 as calculated by the formula: weight in pounds / height squared x 703 = BMI Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines. To remain in the study for the follow-up phase, the baseline screening test must indicate that a patient has MGUS. Exclusion Criteria: No history of any malignancy except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years. No concurrent or planned participation in randomized trials of weight loss. A patient will be excluded from the follow-up phase if the baseline screening test indicates they do not have MGUS

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
| Rate of MGUS | The primary analysis focuses on the estimation of the rate of MGUS for this specific population. | 5 years |
Prognostic Factors , Morbidity and Mortality in Patients With Neuromuscular Disorders Admitted in ICU

Study Overview
=================
Brief Summary
-----------------
Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary failure and cardiomyopathy affect prognosis.The investigators aim to establish predictive factors for mortality and morbidity in Intensive care unit (ICU ) and to describe the long term follow up after ICU discharge.

Detailed Description
-----------------
Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary failure and cardiomyopathy affect prognosis. Little is known about morbidity and mortality of patients with muscular dystrophies admitted in intensive care unit (ICU).The investigators aim to describe the spectrum of patients with muscular dystrophies admitted in ICU , to establish predictive factors for ICU mortality and morbidity and to describe the long term follow up after ICU discharge.

Official Title
-----------------
Prognostic Factors, Morbidity, Mortality and Long Term Survival in Patients With Neuromuscular Disorders Admitted in Intensive Care Unit

Conditions
-----------------
Muscular Dystrophies, Intensive Care (ICU) Myopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted in ICU Duchenne muscular dystrophy Becker muscular dystrophy LGMD Steinert disease Pompe disease FSHD metabolic disease mitochondrial disease congenital myopathy others neuro-muscular diseases Exclusion Criteria: brain injury minor patient

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| ICU mortality |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tracheostomy in ICU |  | 1 month | 
| predictive factors for re admission in ICU |  | 1 year | 
| long term survival after ICU stay |  | 5 years | 
| decline of vital capacity after ICU stay |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care unit, muscular dystrophy, mortality, prognosis, tracheostomy
Integrated Diabetes Management Protocol Using Smartphone

Study Overview
=================
Brief Summary
-----------------
The investigators aim to assess whether using integrated diabetes management protocol using smartphone would increase glucose control among diabetes patients.

Detailed Description
-----------------
Smartphones and digital healthcare is expected to provide better diabetes care. The investigators aim to assess whether using integrated diabetes management protocol using smartphone would increase glucose control among diabetes patients. Smartphone apps for food diary, activity monitor, blood glucose will be used for three months. Blood glucose control and patient satisfaction will be assessed.

Official Title
-----------------
Integrated Diabetes Management Protocol Using Smartphone

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Behavioral: Integrated Diabetes Management Protocol
* Behavioral: Standard Diabetes Management Protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes, type 1 diabetes, gestational diabetes Exclusion Criteria: Medications which interfere glucose control Cancer Chronic kidney injury

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Diabetes Management Protocol<br>Smartphone apps for food diary, activity monitor, blood glucose will be used for three months. | Behavioral: Integrated Diabetes Management Protocol<br> <br> |
| Active Comparator: Standard Diabetes Management Protocol<br>Subjects will receive standard diabetes management protocol with standard education and standard blood glucose measurement devices. | Behavioral: Standard Diabetes Management Protocol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose Control Status Measured by HbA1c | Blood test results for HbA1c after three months. | After three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Measured by Questionnaire | Summary of Diabetes Self-Care Activities Measure (SDSCA) Questionnaire (Toobert et al., 2000) | After three months |
Sarcoid Genetic Analysis (SAGA)

Study Overview
=================
Brief Summary
-----------------
To identify sarcoidosis susceptibility genes and to determine how these genes and environmental risk factors interact to cause sarcoidosis.

Detailed Description
-----------------
BACKGROUND: Sarcoidosis is a rare systemic granulomatous disease that mainly affects young to middle aged adults, and more severely affects African Americans than Caucasians. The etiology of sarcoidosis is not yet known, and epidemiological studies have only identified general risk factors including age, sex, race, and family history. Sarcoidosis may also be influenced by environmental factors, although the particular environmental agents have not yet been clearly defined. While previous studies have provided evidence for familial clustering, little is known about the genes that influence predisposition to sarcoidosis. DESIGN NARRATIVE: This is a multicenter consortium genetic epidemiology study. The investigators will accomplish their goal by organizing a 10-site multi-center consortium to recruit an adequate sample of sarcoidosis families for analysis. They plan to use the affected sibling pair linkage analysis to scan the genome for linked chromosomal regions, transmission disequilibrium testing to evaluate candidate genes in those regions with evidence for linkage, and an environmental questionnaire to collect data to test for possible interactions of susceptibility genes with exogenous risk factors. Genotyping and analysis of data are scheduled to begin in July, 2001 with completion of all analysis by April, 2004. The study consists of a Clinical Core, a Data Coordinating Core, and a Genetics Core with a DNA Processing Center and a Genotyping Center. Eight of the ten clinical centers comprising the Clinical Core are members of the ACCESS, A Case Control Etiology of Sarcoidosis Study. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Lung Diseases, Sarcoidosis

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 |
| --- | --- | --- |
Ear Temperature as Predictor of Rectal Temperature Measured With Modern Devices in the Emergency Department.

Study Overview
=================
Brief Summary
-----------------
Ear thermometers are often requested to be used rather than rectal thermometer (gold standard) for measuring the body temperature, as this method is faster and more user friendly. Former ear thermometers did not meet the required standards of accuracy for clinical use. However, a new generation of ear thermometers have been developed and widely used in the Emergency departments in Denmark. The devices have only been evaluated in two studies on adult populations, with conflicting results. This cross-sectional study will examine patients by measuring both ear and rectal temperature in the same patient at the same time on admission to an emergency department, to evaluate if temperature measured in the ear can be used as the standard temperature measurement.

Official Title
-----------------
Ear Temperature, Measured With 3. Generation Tympanic Thermometers as Predictor of Rectal Temperature in the Emergency Department Population

Conditions
-----------------
Fever

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission to emergency department Exclusion Criteria: no rectum

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| The Body Temperature in Celcius degrees |  | Up to 24 hours after arrival to Emergency Department |
Infections Associated With the Use of Alemtuzumab

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to propose infection prophylaxis from Asian multinational retrospective analysis of infectious complications in patients who were treated with alemtuzumab

Official Title
-----------------
Asian Multinational Retrospective Analysis for Infectious Complications in Patients Treated With Alemtuzumab

Conditions
-----------------
Patients Treated With Alemtuzumab

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients received alemtuzumab as a treatment for hematologic malignancy ex. non-Hodgkin lymphoma Acute myeloid leukemia Aplastic anemia Exclusion Criteria: Patients did not receive alemtuzumab

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 90 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 |
| --- | --- |
| Alemtuzumab<br>Patients treated with alemtuzumab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious event | Any infectious complication occurred within one year after the use of alemtuzumab | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alemtuzumab, infection, prophylaxis, treatment
Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma

Study Overview
=================
Brief Summary
-----------------
In pediatric age groups communication difficulties very sometimes may present further obstacles in obtaining a detailed injury history and early identification of TBI symptoms. Most emergency management protocols are focused exclusively on the identification of the relatively small number of patients who may require operative intervention, as early surgery is believed to improve outcome.

Detailed Description
-----------------
However early rehabilitation can also be effective for the much larger number of patients who do not require surgery[1] In addition, Hall and others recently reported that low doses of ionizing radiation to the brain in infancy may influence cognitive abilities in adulthood. [2] Accordingly, increased serum concentrations of, for example S100B ( a calcium-binding protein present in high concentrations in glial cells) and neurone-specific enolase ( NSE: a cytoplasmatic enzyme occuring predominantly in neurones ) have been demonstrated to reflect the presence and severity of brain tissue damage in acute head injuries. [3] In both pediatric age and adults.

Official Title
-----------------
Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma Injury in Acute Phase in Relation to Head CT and Post Concusion Syndrome.

Conditions
-----------------
Biomarkers

Intervention / Treatment
-----------------
* Other: Following S100B and NSE in head trauma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only head trauma without any other body injury Exclusion Criteria: Blood thinner, hydrocephalus , previous brain infarcts, encephalopathy, birth trauma.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Following S100B and NSE in head trauma|Following S100B and NSE in head trauma in correlation with Head CT and post concussion syndrome and Lisat11|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Role of concentration of biomarkers S100B and NSE in serum in mild and moderate head trauma injury in acute phase in relation to head CT and post concusion syndrome. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
S100B, NSE, moderate brain trauma, mild brain trauma