linjc16/ctgov huggingface dataset:
Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to be used in future studies, assess the efficacy and safety, and the anti-inflammatory action of the test drug in the treatment of asthmatic patients who are not currently receiving chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical research sites in the US, Mexico, and Canada. Study participants will have a number of visits to a research site over approximately a 4-month period.

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

Intervention / Treatment
-----------------
* Drug: Dual Integrin Antagonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistent asthma for more than one year Current treatment for asthma with short acting inhaled beta 2 agonists (such as albuterol) only In good health ad demonstrated by medical history and physical exam Negative urine pregnancy test Commitment to use two forms of effective contraception simultaneously throughout the study duration and for one month after discontinuing therapy Exclusion Criteria: Asthma necessitating treatment with inhaled corticosteroids for at least one month before the start of the study History of severe asthma necessitating the use of oral/injectable corticosteroids within the last 2 months and/and or two bursts in the last year Undergoing allergy shots unless on a stable maintenance dose for three months before the start of the study History of chronic pulmonary diseases other than asthma Treatment of conditions other than asthma with oral corticosteroids within one month of the start of the study Current tobacco use Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked) History or evidence of drug or alcohol abuse Diagnosis or evidence of an infectious illness within one month of Visit 1 Clinically significant diseases as assessed by the study doctor Participation in another clinical study with an experimental drug within one month of start of the study

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dual Integrin Antagonist|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Of Atopic Dermatitis In Pediatrics

Study Overview
=================
Brief Summary
-----------------
To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.

Official Title
-----------------
Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: Cetirizine Dry Syrup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosed as atopic dermatitis Giving informed consent Children who have 2 grades or more pruritus score. Children who require the treatment with external steroid preparation other than face and head. Children with a pruritus severity of 2. Mild or severe on the fist day of the treatment period. Exclusion criteria: have spastic disease such as epilepsy have a history of drug hypersensitivity are lactating or possibly pregnant female Children have a skin infection, or with zooparasite such as scabies and pediculosis cannot avoid the use of external steroid classified into strong, strongest or very strong have eczematous otitis externa with perforation in the eardrum have dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2 have asthma that requires the treatment with corticosteroid have pruritus only on face and head have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cetirizine Dry Syrup|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the severity of pruritus |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic, Pediatric, Dermatitis
Persistent Platelet Reactivity in Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned.

Detailed Description
-----------------
Blood samples are performed on day 2 and 4 and collected with usual blood samples and analyzed by the laboratory. Maximal aggregation intensity and velocity are measured by light transmission aggregometry induced by arachidonic acid (AA) or adenosine diphosphate (ADP). Platelet function analyzer will be also used. No changes in treatment in response to the results is planned.

Official Title
-----------------
Persistent Platelet Reactivity in Acute Coronary Syndrome

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute coronary syndrome with elevation in troponin Exclusion Criteria: anticoagulant treatment

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 |
| --- | --- | --- |
| maximum aggregation intensity | Light transmission aggregometry following exposition to arachidonic acid 0.5mg/ml during the acute phase (day2-day 5) | day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum aggregation intensity | Light transmission aggregometry following exposition to adenosine diphosphate during the acute phase (day2-day 5) and during the chronic phase (day 30-day 60) | Day 2 | 
| Maximum aggregation intensity | Light transmission aggregometry following exposition to arachidonic acid 0.5mg/ml during the chronic phase (day 30-day 60) | Chronic phase (day 30 to day 60) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrome, persistent platelet reactivity
Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but potential side effects are concerning. Several reports point at extracorporeal photopheresis (ECP) as an efficient alternative treatment modality with few and mild side effects. However, no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.

Official Title
-----------------
Ciclosporine and Extracorporal Photopheresis (ECP) Are Equipotent in Treating Severe Atopic Dermatitis (AD): A Randomized Cross-over Study Comparing Two Efficient Treatment Modalities

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Cyclosporine A (CsA)
* Other: Extracorporeal photopheresis (ECP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Criteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, UVA, UVB, PUVA, tar). Exclusion Criteria: Criteria of exclusion were pregnancy, uncontrolled hypertension, previous malignancy, infectious disease, liver/kidney disease or active treatment with ECP or immunosuppressants within 4 weeks prior to start of trial.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CsA-ECP<br>Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given | Drug: Cyclosporine A (CsA)<br>* 3 mg/kg/day for 4 month<br>* Other names: Sandimmune;Other: Extracorporeal photopheresis (ECP)<br>* Administered two consecutive days twice a month for 4 month<br>|
| Other: ECP-CsA<br>Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given | Drug: Cyclosporine A (CsA)<br>* 3 mg/kg/day for 4 month<br>* Other names: Sandimmune;Other: Extracorporeal photopheresis (ECP)<br>* Administered two consecutive days twice a month for 4 month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of SCORAD (SCORing Atopic Dermatitis) |  | 4 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ciclosporine, Atopic dermatitis, Extracorporal photopheresis
Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

Study Overview
=================
Brief Summary
-----------------
Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

Detailed Description
-----------------
After clinical identification of patients with MVP, doctors organize 1st degree relative familial screening. A comprehensive echocardiography was carried out along with clinical examination. All echo data were stored for off-line analysis by a sonographer in our Core-lab. Blood was sample at the time of echocardiography in adult patients for DNA analyses. Follow-up for mitral valve changes will be performed after 5 years.

Official Title
-----------------
Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

Conditions
-----------------
Mitral Valve Prolapse, Genetic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any age with typical mitral valve prolapse relatives examined during familial screening Exclusion Criteria: Refusal of the patient
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 |
| --- | --- |
| Patients with MVP<br>The patients concerned are patients with known or recently discovered Barlow-type mitral prolapse, whatever the degree of severity. | |
| Normal relatives<br>Related healthy patients, for an average of 6 individuals per family | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MVP defined by a superior displacement of at least 2 mm | MVP defined by a superior displacement of at least 2 mm | At Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive mitral valve apparatus characterization per size of items (leaflets, chordae, annulus) | Leaflets length ; Chordae length ; Annulus diameter | At Day 0 | 
| Comprehensive mitral valve apparatus characterization per other items (papillary muscle, ventricles) | Papillary muscles aspect ; Right Ventricle function ; Left Ventricle Ejection Fraction | At Day 0 | 
| Comprehensive mitral valve apparatus characterization per size of items (ventricle and atrium sizes) | Left ventricle and atrium sizes ; right ventricle size ; right Atrium size | At Day 0 | 
| Comprehensive mitral valve apparatus characterization per size of items | Leaflets thickness | At Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mitral valve prolapse, genetic, echocardiography
Validation of a Multitask Deep Learning System at Spine Metastasis CT

Study Overview
=================
Brief Summary
-----------------
The multitask deep learning system (DLS) with five algorithms detecting five quantitative factors of Spinal Instability Neoplastic Score (SINS) was developed. Radiologists and oncologists from multicenter will be recruited to read the CT scans in picture archiving and communication system (PACS) independently, comparing with the DLS. One month after reading the CT scans in PACS, the participants will also asked to perform a web-based test in the DLS website using the same CT scans. Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the DLS were calculated with professional graders as the reference standard.

Official Title
-----------------
Multicenter Validation of a Multitask Deep Learning System for Spinal Instability at Spine Metastasis CT

Conditions
-----------------
To Evaluate the Spinal Instability Detection Performance of the DLS

Intervention / Treatment
-----------------
* Diagnostic Test: Deep Learning System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathology-proven diagnosis of solid tumor; spinal CT scan indicating spinal metastasis with at least one lesion; no previous surgery for spinal metastasis Exclusion Criteria: spinal CT scans with no sagittal reconstruction; the radiologist considered that the quality of CT image was unqualified.

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 |
| --- | --- |
| routine physicians<br> | Diagnostic Test: Deep Learning System<br>* The multitask DLS with five algorithms detecting five quantitative factors of SINS<br>|
| DLS<br> | Diagnostic Test: Deep Learning System<br>* The multitask DLS with five algorithms detecting five quantitative factors of SINS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Area under the receiver operating characteristic curve (AUC) of spinal instability detection | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity | sensitivity of spinal instability detection | 1 months | 
| specificity | specificity of spinal instability detection | 1 months |
The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

Study Overview
=================
Brief Summary
-----------------
Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.

Detailed Description
-----------------
Long-term mortality after transcatheter mitral or tricuspid valve therapy

Official Title
-----------------
The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

Conditions
-----------------
Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation

Intervention / Treatment
-----------------
* Device: edge-to-edge valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years and consentable Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision Written informed consent Exclusion Criteria: Patient's inability to fully cooperate with the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: edge-to-edge valve repair|edge-to-edge valve repair|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term mortality | Long-term mortality | 5 years |
Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients

Study Overview
=================
Brief Summary
-----------------
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV sero-negative liver recipients who are currently listed.

Official Title
-----------------
Pilot Investigation Using HCV Positive Liver Grafts in HCV Negative or Previously Successfully Treated Recipients

Conditions
-----------------
Liver Failure

Intervention / Treatment
-----------------
* Procedure: Liver Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age 18 and older Active on the transplant list Donor organ with Antibody and nucleic acid test (NAT) positive for HCV Graft with F2 fibrosis or less at time of explant HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy. Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject Exclusion Criteria: Participants co-infected with HIV Donor previously treated with a non-structural protein 5A (NS5a) containing regimen (if treatment history of donor known) Known allergies or hypersensitivity to direct acting antiviral drug (DAA) or ribavirin (RBV) Pregnancy and/or actively breastfeeding

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recipient of HCV positive liver graft<br>A single center, open-label, pilot study examining 10 adult HCV negative liver transplant subjects who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after liver transplantation, unless extenuating clinical circumstances arise (such as fibrosing cholestatic HCV, which would prompt earlier treatment, or non-hepatic comorbidities which would prompt delay in treatment). | Procedure: Liver Transplantation<br>* A HCV negative or previously successfully treated recipient with a HCV positive liver graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival rate | Will track all subjects post transplant for 15 months | From the date of transplant through the last day of 15 month post transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV