linjc16/ctgov huggingface dataset:
Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. On completion of the seven days, they will complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and depression. A subset of participants will additionally complete a qualitative interview session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to improving sleep health.

Official Title
-----------------
Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes, Insufficient Sleep

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with T1D at least 3 months Receive clinical care at the Barbara Davis Center Exclusion Criteria: Have an active underlying sleep disorder, such as narcolepsy, insomnia, or untreated sleep apnea Participation in an interventional research protocol Unable to complete study procedures

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescents<br>Adolescents with type 1 diabetes between the ages of 11 and 17 years. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of nocturnal awakenings per week | We will identify the number of nocturnal awakenings per week for comparison of those with insufficient sleep identified by actigraphy watch to those with sufficient sleep. | One week per participant | 
| Assessment of facilitators and barriers to good sleep quality and duration | Qualitative interviews will be conducted and analyzed for themes to identify causes of sleep disruptions and any potential barriers or facilitators to improving sleep health. | One week per participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of common causes of sleep disruptors in adolescents with type 1 diabetes | Sleep diaries will be used to determine common causes of sleep disruptors in adolescents with type 1 diabetes. | One week per participant |
The Role of IL33/ST2 Axis in ARDS Patients

Study Overview
=================
Brief Summary
-----------------
The main objective is the study of the role of IL33/ST2 axis in the pathogenesis of ARDS, it´s value as prognosis marker and as therapeutic target.

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS Risk pathologies to develop ARDS (sepsis, pancreatitis, pneumonia, massive transfussion, politraumatics) Exclusion Criteria: Age under 18 Pregnancy Undergoing a clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Survivors<br> | |
| Non survivors<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value of the IL-33/ST2 axis in patients with ARDS. |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of IL33/ST2 axis to predict development of ARDS in risk patients |  | 60 days |
Hypertrophic Cardiomyopathy Pilot Study

Study Overview
=================
Brief Summary
-----------------
This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate

Official Title
-----------------
Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk

Conditions
-----------------
Hypertrophic Cardiomyopathy, Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Observational: Arrhythmogenic Substrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed HCM Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest Maximal left ventricular wall thickness of > 30mm Extensive fibrosis on cardiac MRI (>15% of total myocardial volume) >7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD Exclusion Criteria: age < 18 years Pregnancy Atrial Fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Case: Hypertrophic cardiomyopathy<br>HCM patients at high risk for ventricular arrhythmia | Other: Observational: Arrhythmogenic Substrate<br> <br> |
| Control I: Healthy<br>Healthy Controls | |
| Control II: Post-MI with arrhythmogenic substrate<br>Ischemic cardiomyopathy patients with documented history of ventricular tachyarrhythmia and left ventricular hypertrophy | Other: Observational: Arrhythmogenic Substrate<br> <br> |
| Control III: VT/VF-free ischemic cardiomyopathy<br>Ischemic cardiomyopathy patients without ventricular arrhythmia, as proven by non-inducibility and history of freedom from ventricular tachyarrhythmia during at least one ICD generator life | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasively reconstructed epicardial activation map |  | within one day |
Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Relationship between hemodynamic change and fluid removed during hemodialysis measured by non-invasive monitor

Detailed Description
-----------------
By applying non-invasive hemodynamic monitors (ex. ClearSight, I-COM), the trends of mean arterial pressure (MAP), stroke volume (SV), cardiac index (CI) and calculated systemic vascular resistance (SVR) were collected along with volume removal by hemodialysis on ESRD patients. All data were compared and analyzed to detect the sequential body volume status as well as the autonomic responses during hemodialysis.

Official Title
-----------------
Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis Measured by Non-invasive Monitor

Conditions
-----------------
Hemodialysis Complication, Hemodialysis-Induced Symptom

Intervention / Treatment
-----------------
* Device: Non-invasive hemodynamic monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1. Patients who were schedured with regular hemodialysis for end-stage renal disease. Exclusion criteria: Emergent hemodialysis Medical conditions with poor peripheral circulation such as Raynaud's disease or PAOD Skin defects or wounds over area to be applied for measurement (Wrist and fingers)

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| With Clear Sight<br>record and observe the data including SVI, CI, SVR with clearSight during hemodialysis | Device: Non-invasive hemodynamic monitor<br>* MAP, HR, CO, SVI, from Non-invasive hemodynamic monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid removed along with hemodialysis | the fluid volume removed from hemodialysis (mL/hour), | 4 hours | 
| changes of mean arterial pressure along with hemodialysis | record of mean arterial pressure (mmHg) per 30 minutes | 4 hours | 
| changes of heart rate along with hemodialysis | record of heart rate (beats/ minute) per 30 minutes | 4 hours | 
| changes of stroke volume along with hemodialysis | record of stroke volume (SV, (mL/ beat)per 30 minutes | 4 hours | 
| changes of cardiac output along with hemodialysis | record of cardiac output ( liter/ minute)per 30 minutes | 4 hours |
Dietary Factors and Disfluency: A Look Into Food Allergies and Other Environmental Triggers Associated With Variations in Severity of Vocal Cord Tension.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether participants with persistent developmental disfluency who report fluctuational disfluency due to vocal cord tension on a day to day basis of can achieve a more normalized fluency by identifying dietary allergen responses and subsequently eliminating these dietary triggers from their daily consumption.

Official Title
-----------------
Dietary Factors and Disfluency. A Look Into Causes and Variations in Severity of Disfluency in Regards to Vocal Cord Tension.

Conditions
-----------------
Vocal Cord Tension, Dysfluency Developmental

Intervention / Treatment
-----------------
* Other: Food Allergy Testing and Elimination Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients reporting persistent developmental disfluency. Exclusion Criteria: Patients reporting no changes in disfluency severity or frequency

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 Years

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

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

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: Food allergy and vocal cord tension<br>To determine if dietary allergen responses and frequency and severity of vocal cord tension. | Other: Food Allergy Testing and Elimination Diet<br>* Food allergy testing and elimination diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Factors and Disfluency: Variations in Severity of Vocal Cord tension | Initial fluency samples are taken prior to treatment protocol of study. Food sensitivity panel will be assessed for potential allergans. Allergan responses are graded from 0 being no response to food allergen to 3 being the strongest response and subsequent removal of sensitive allergan from diet. Speech sample and disfluency severity will be evaluated qualitatively again via the SSI-3 on repeat office visit at fixed interval scale. Erickson S-24 repeated at end of study and final conclusions made. | 1 Year |
Multimodal Modeling of the Knee Joint

Study Overview
=================
Brief Summary
-----------------
The trial will contribute to the development of an innovative algorithm that aims to simplify and improve preoperative knee surgical decision. This will be made by automatically extracting anatomical informations from different images acquired on the patient (scanner, MRI, radiography).

Detailed Description
-----------------
The source population will consist of at least 50 patients whose following modalities of images of the leg are present in the database: scanner, MRI, radiography. No restrictions on age or gender are required. A dedicated algorithm adapting statistical models of appearance to the specific morphology of the patient acquired through an MRI and / or scanner and radios will then be developed.

Official Title
-----------------
Multimodal Modeling of the Knee Joint

Conditions
-----------------
Knee Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having the 3 modality of images : scanner, MRI, radiography Patients having osteoarthritis or knee trauma Images showing the articualtion of the knee having formulated his non opposition Exclusion Criteria: Presentation of a partial view of the knee or any view that does not allow a good segmentation of the total knee joint. Refusal to participate
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtaining a similar knee segmentation for all patient regardless of the input image (MRI, CT or radiography) | Creation of an algorithm that will automatically segment and provide the same knee anatomical informations for all patients studied regardless of the input image. This multimodal modeling will be carried out via the exploitation of an active model of appearance type algorithm. | Inclusion - Day 0 |
Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice

Official Title
-----------------
Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Drug: Berodual®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of either sex, including children over 6 years Chronic obstructive respiratory tract disease. Every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI) Exclusion Criteria: Contraindications listed in the Instructions for Use/Summary of Product Characteristics of Berodual® metered-dose inhaler

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| chronic obstructive respiratory tract disease patients<br> | Drug: Drug: Berodual®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall severity of the clinical picture rated on a 4-point scale |  | after 3 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dyspnea and/or asthma attacks rated on a 4-point scale |  | after 3 and 6 weeks | 
| Number of dyspnea episodes rated on a 4-point scale |  | after 3 and 6 weeks | 
| Number of awakenings due to night-time dyspnea rated on a 4-point scale |  | after 3 and 6 weeks | 
| Assessment of morning coughing with expectoration rated on a 4-point scale |  | after 3 and 6 weeks | 
| Assessment of tolerability on a 4-point scale |  | after 3 and 6 weeks | 
| Number of patients with adverse drug reactions |  | up to 6 weeks | 
| Changes in pathological auscultation findings rated on a 3-point scale |  | after 3 and 6 weeks | 
| Changes in concomitant medication |  | up to 6 weeks | 
| Assessment of efficacy on a 4-point scale |  | after 3 and 6 weeks |
A Registered Cohort Study on Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
Dystrophinopathy is a term of X-linked recessive genetic disease, including Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, and the X-linked dilated cardiomyopathy. The aim of this study is to determine the clinical spectrum and natural progression of dystrophinopathy in a prospective multicenter natural history study, to assess the clinical, genetic of patients with dystrophinopathy to optimize clinical management.

Official Title
-----------------
A Registered Cohort Study on Duchenne Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Beyond 2 years old Diagnosis with Duchenne Muscular Dystrophy, and female carriers, genotypically confirmed Diagnosis should be supported by muscle biopsy, if no genetic confirmation. Exclusion Criteria: Presence of other clinically significant illness

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- | --- |
| Age at death | the time when patient die | 20 years |
Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.

Official Title
-----------------
Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region

Conditions
-----------------
Cholestasis

Intervention / Treatment
-----------------
* Other: proteomic urine analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant <1 year suffering from cholestasis Exclusion Criteria: Rejection or inability for parent to give their informed consent

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cholestasis<br>infant suffering from cholestasis proteomic urine analysis | Other: proteomic urine analysis<br>* proteomic urine analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gathering mother epidemiologic characteristics as assessed by pregancy informations collection | Date of child birth, course of pregnancy, occurrence of twin pregnancy, serology abnormalities, family background of liver desease, course of previous pregnancies | Day 1 (inclusion) | 
| Gathering new born epidemiologic characteristics as assessed by birth informations collection | Birth anamnesis, inclusion age, hepatic desease history, hemostasis workup, validated etiologic diagnosis and criteria for the diagnosis, specific and non-specific therapeutic care | Day 1 (inclusion) | 
| Epidemiologic characteristics follow up as assessed by medical monitoring | Desease evolution in the first year of life, clinical evaluation, biological evaluation, final diagnosis, complications of the sickness, existence of transplatation, death | When children are between 12 and 18 months old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte | Homogenize the care pathway of neonatal and infant cholestasis | Up to 3 years | 
| Extend the study to the national french territory using the hepatology association network | Use this study to start a national study | Up to 3 years | 
| Identification of proteomic profiles using the biologic collection gathered in the cohorte population | Identify one or more specific proteomic profile of neonatal cholestasis | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholestasis, neonatal, infant
How Well Does the 30-Second Chair Stand Test Predict Rehabilitation Needs in Acutely Admitted Elderly Patients

Study Overview
=================
Brief Summary
-----------------
The aims are to identify predictive indicators of hospitalized elderly medical patients' need for rehabilitation and to validate (known group validity) the Chair Stand Test

Detailed Description
-----------------
In the emergency department the assessment of acutely admitted elderly medical patients' need for rehabilitation is difficult as it has to been performed within 48 hours. Is it possible to use the the Chair Stand Test in combination with admission complaints and identified risk factors to predict the need for rehabilitation? An investigating of the Chair Stand Test is needed, as its validity with hospitalized patients is undocumented.

Official Title
-----------------
How Well Does the 30-second Chair Stand Test Predict Rehabilitation Needs in Acutely Admitted Elderly Patients?

Conditions
-----------------
Acute Disease

Intervention / Treatment
-----------------
* Other: 30 sec chair stand test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Can speak and understand Danish Can report personal data Within the first 48 hours of admission are able to sin on an ordinary chair Exclusion Criteria: Patients ordinarily unable to walk

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 30 sec chair stand test<br>all patients in this Group receives a diagnostic test for functional impairment | Other: 30 sec chair stand test<br>* diagnostic test for functional impairment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Second Chair Stand Test |  | 14 days after admission at the hospital |