linjc16/ctgov huggingface dataset:
Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma

Study Overview
=================
Brief Summary
-----------------
In this mono-center pilot trial, polytrauma patients admitted to intensive care will be included. Investigators are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing. Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.

Official Title
-----------------
Metabolomics Pilot Study on Intensive Care Acquired Muscle Weakness in Polytrauma (MIRACLE-II Study)

Conditions
-----------------
Metabolomics, Critical Care, Critical Illness, Critical Illness Myopathy, Critical Illness Polyneuropathy, Intensive Care (ICU) Myopathy, Muscle Weakness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute polytrauma patient age ≥ 18 years old expected intensive care stay ≥ 3 days American Society of Anesthesiologists classification I or II Exclusion Criteria: patient had received cardiopulmonary resuscitation limitation of therapy or comfort care

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 |
| --- | --- |
| Intensive Care Patients<br>Polytrauma patients who have been admitted to intensive care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomics | Blood Metabolome will be isolated from blood samples. All samples will be screened for changes in the blood metabolome during muscle wasting (i.e. Intensive Care Unit Acquired Weakness) using mass spectrometry | a median of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle histology | Immunohistochemistry will be done in muscle samples. All samples will be screened for changes in the muscular structure and correlation with blood metabolome changes. | a median of 14 days | 
| Phosphoproteomics | Phosphoproteomics will be done in muscle samples using mass spectrometry. All samples will be screened for influence of muscular changes (i.e. Intensive Care Unit Acquired Weakness (ICUAW)) and correlation with blood metabolome changes. | a median of 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pilot Trial, Muscle Biopsy, Blood Metabolome
Chronic Anterior Shoulder Instability in the Military

Study Overview
=================
Brief Summary
-----------------
Anterior shoulder instability is a chronic condition that occurs after an anteromedial dislocation. Its prevalence is high in athletes but has been little studied in the armed forces. In general, patients with a first episode of dislocation have a 1 in 2 chance of experiencing at least one recurrence. The more recurrences there are, the more damage there is to the joint and the greater the disability for the patient. The decree determining the medical aptitude of military personnel emphasizes the need to have recourse to a specialized consultation to determine the classification of the soldier after a first episode of dislocation. In the absence of data collected specifically in the military population, classification is based on the surgeon's experience and extrapolation of results obtained in the general population.

Official Title
-----------------
Chronic Anterior Shoulder Instability in the Military

Conditions
-----------------
Shoulder Dislocation

Intervention / Treatment
-----------------
* Other: Interview / questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Military member with a first episode of true anterior glenohumeral shoulder dislocation, Male or female, Major, Having a sufficient level of reading/writing of the French language, Did not object to participating in the study. Exclusion Criteria: Patient with a history of homolateral shoulder dislocation or surgery on the affected shoulder, Collagen disease confirmed by genetic testing, Inflammatory arthropathy, History of rotator cuff injury, Insufficient French reading/writing skills, Under legal protection, Objection to participating in the study.

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

| Intervention/Treatment |
| --- |
|Other: Interview / questionnaires|At each of the 4 visits, the participant will have to answer several questions regarding trauma-related data, employment and sport practice.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a new episode of true anterior glenohumeral shoulder dislocation or subluxation 1 year after the initial dislocation. | A true anterior glenohumeral shoulder dislocation is defined as a dislocation requiring reduction. Dislocation and subluxation will have to be objectified by medical examination | Through study completion (72 months) |
Examination of Efficacy and Safety of Baricitinib in RA Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients: Baricitinib treatment for 12 months Biologics treatment for 12 months Tofacitinib treatment for 12 months

Official Title
-----------------
Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Baricitinib, olumiant®
* Drug: Biologics
* Drug: Tofacitinib 5 MG [Xeljanz]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA patients Exclusion Criteria: Not RA patients RA patients who are allergic to the drugs, refused to do this research, or who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BARI<br> | Drug: Biologics<br>* To examine the effects of biologics in RA patients<br>Drug: Tofacitinib 5 MG [Xeljanz]<br>* To examine the effects of tofacitinib in RA patients<br>|
| Active Comparator: Bio<br> | Drug: Baricitinib, olumiant®<br>* To examine the effects of baricitinib in RA patients<br>Drug: Tofacitinib 5 MG [Xeljanz]<br>* To examine the effects of tofacitinib in RA patients<br>|
| Active Comparator: Tofa<br> | Drug: Baricitinib, olumiant®<br>* To examine the effects of baricitinib in RA patients<br>Drug: Biologics<br>* To examine the effects of biologics in RA patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients. |  | Change from Baseline Values of DAS28-CRP at 1 year in each group |
Epidemiology of Sudden Cardiac Arrest in Sub-Saharan Africa: Rationale and Design

Study Overview
=================
Brief Summary
-----------------
Background The burden of sudden cardiac death (SCD) in Africa is unknown. Our aim is to assess the epidemiology of SCD in Africa. Methods The sub-Saharan Africa SCD study is a prospective, multicenter, community-based registry monitoring all cases of cardiac arrest occurring in victims > 15 years old. Investigators will use the definition of established SCD if an unexpected death without obvious extracardiac cause, occurred with a rapid witnessed collapse, or if unwitnessed, occurred within 1 hour after the onset of symptoms; probable SCD if an unexpected death without obvious extracardiac cause occurred within the previous 24 hours. After approval from institutional boards, Investigators will record demographic, clinical, electrocardiographic and biological variables of SCD victims (including survivors of cardiac arrest) in several sub-Saharan African cities. All deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). Investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient populations throughout countries. Conclusion This study will provide comprehensive, contemporary data on the epidemiology of SCD in sub-Saharan Africa and will help in the development of strategies to prevent and manage cardiac arrest in this region of the world.

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Victims of cardiac arrest, either SCD or aborted SCA Exclusion Criteria: Age ≤ 15 years. Refusal of consent (by the family).

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Victims of cardiac arrest, either SCD or aborted SCA<br> | |
| Premature death<br>All residents of districts of interest will be surveyed during 3 years. premature deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). Investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient populations throughout African countries. The arm group of the study is every resident of the district of interest | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sudden Cardiac Death |  | 3 years |
CMAB vs IMAB in Metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy, safety and survival of two treatment regimens: Continuous Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated. QoL evaluation is also included.

Official Title
-----------------
Longitudinal, Randomized, Open and Prospective Clinical Trial to Evaluate the Efficacy of Continuous vs Intermittent Maximum Androgen Blockade (CMAB vs IMAB) With Goserelin-Bicalutamide Combination in the Treatment of Hormonal naïve With Metastatic Prostate Cancer

Conditions
-----------------
Metastatic Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Goserelin
* Drug: Bicalutamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of D2 of Adenocarcinoma, Naivety to treatment Valuable bone metastasis Exclusion Criteria: Hematological, liver or renal toxicity Grade IV Severe and active infections

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Goserelin|nan|
|Drug: Bicalutamide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Quality of Life |  |  |
PRIMA PFO Migraine Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

Detailed Description
-----------------
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

Official Title
-----------------
Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)

Conditions
-----------------
PFO, Migraine, Migraine With Aura, Patent Foramen Ovale

Intervention / Treatment
-----------------
* Device: AMPLATZER® PFO Occluder Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are age 18 to 65 Subjects who have migraine headaches with aura diagnosed by a doctor Subjects who have not responded to or cannot take common migraine preventive medications Exclusion Criteria: Subjects with a clinical history of stroke Subjects who cannot take aspirin and clopidogrel (Plavix) Subjects who are pregnant or desire to become pregnant within the next year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Medical Management<br> | |
| Experimental: PFO Closure<br> | Device: AMPLATZER® PFO Occluder Device<br>* PFO device closure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine headache frequency |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Migraine with aura, Patent foramen ovale, PFO
Prospective Biceps Study

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to determine if surgical repair of the distal biceps fully restores the supination strength of the forearm. Secondarily, the investigators want to examine the insertion site location of the tendon and determine if it correlates with the patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.

Official Title
-----------------
Prospective Biceps Study

Conditions
-----------------
Biceps Tendon Rupture

Intervention / Treatment
-----------------
* Procedure: Distal Biceps Re-Insertion Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary distal biceps repair with endobutton Exclusion Criteria: any ipsilateral wrist, forearm, or elbow condition any contraindication to having an MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Distal Biceps Ruptures<br> | Procedure: Distal Biceps Re-Insertion Surgery<br>* Surgical Repair of the Distal Biceps Tendon<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
-----------------
Rupture of Distal Bicep Tendon
The Findings of Magnetic Resonance Imaging in Subtypes of Tics-related Disorders

Study Overview
=================
Brief Summary
-----------------
The findings of resting-state functional magnetic resonance imaging and diffusion spectrum imaging in subtypes of tics-related disorders

Official Title
-----------------
The Findings of Resting-state Functional Magnetic Resonance Imaging, Diffusion Spectrum Imaging, and Wideband Magnetic Resonance Imaging in Subtypes of Tics-related Disorders

Conditions
-----------------
Tourette Syndrome in Children

Intervention / Treatment
-----------------
* Diagnostic Test: Brain MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age less than 18 years old Diagnosed as Tourette syndrome or chronic tic disorders Exclusion Criteria: History of neuropsychiatric disorders Already receive treatment for Tourette syndrome/chronic tics disorder Have some device not allowed for MRI scan

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 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 |
| --- | --- |
| Tourette<br>Age less than 18 years old Diagnosed as Tourette syndrome or chronic tic disorders No other neuropsychiatric disorders | Diagnostic Test: Brain MRI<br>* All participants receive brain MRI evaluation and clinical evaluation of tic severity.<br>|
| Healthy<br>Age less than 18 years old No other neuropsychiatric disorders | Diagnostic Test: Brain MRI<br>* All participants receive brain MRI evaluation and clinical evaluation of tic severity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between healthy and Tourette group | Difference of MRI result between healthy and Tourette group | 2 years after enrollment for primary evaluation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, pediatric neurology
Comparing MRI to CT on Pediatric Craniosynostosis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and test the effectiveness and diagnostic quality of Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) in comparison to CT.

Official Title
-----------------
Comparative Analysis of Zero Echo-time MRI and CT for Pediatric Craniosynostosis

Conditions
-----------------
Craniosynostosis

Intervention / Treatment
-----------------
* Diagnostic Test: Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients 0-18 of age will be recruited by our surgical colleagues based on the clinical concern for craniosynostosis and possible need for calvarial reconstruction. Exclusion Criteria: Lack of consent Contraindication/inability to undergo both examinations within the designated time period and/or undiagnostic image quality.

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

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

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

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: ZTE MRI Imaging<br>Pediatric patients that have gotten a clinically indicated CT within a 6 week time period will receive a Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) | Diagnostic Test: Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)<br>* Magnetic Resonance Imaging (MRI) with zero echo-time (ZTE) that uses proton density differences rather than T2 relaxation time differences to achieve contrast.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between ZTE and CT imaging diagnosis | 90% or greater concordance between ZTE and CT findings, established by evaluating at least 37 patients over the course of two years | 2 years |