linjc16/ctgov huggingface dataset:
Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers

Study Overview
=================
Brief Summary
-----------------
Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with wholebody MRI etc.

Official Title
-----------------
Adalimumab in Rheumatoid Arthritis. An Investigation of Changes in Disease Activity and Course of Joint Destruction by Use of 3 Tesla Whole-Body MRI, Dedicated 3 Tesla MRI and CT of the Hand, and Soluble Biomarkers

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

Intervention / Treatment
-----------------
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old and < 85 years old RA in accordance with American College of Rheumatology 1987 criteria Moderate or highly active RA defined as DAS28 > 3,2 (CRP based) Clinical indication for TNF-α inhibitor treatment by the treating physician No contraindications for TNF-α inhibitor treatment No contraindications for MRI Serum creatinine in normal range Sufficient contraception for fertile women Capable of giving informed consent Capable of complying with the examination program of the protocol Exclusion Criteria: Other DMARDs than MTX from less than 4 weeks before inclusion and throughout the study period Cyclophosphamide, Chlorambucil or other alkylating agents from less than 4 weeks before inclusion and throughout the study period Intramuscular or intravenous injection of glucocorticoid from less than 4 weeks before inclusion and throughout the study period Pregnancy wish, pregnancy or breast-feeding Contraindications for TNF-α inhibitor treatment Contraindications for MRI Known recent drug or alcohol abuse Failure to provide written consent Incapable of complying with the examination program for physical or mental reasons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Rheumatoid arthritis<br> | Drug: Adalimumab<br>* sc. inj. Humira 40 mg every other week from week 0 to 52<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EULAR response criteria |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of joints with inflammation on MRI |  | 16 and 52 weeks | 
| Erosions on X-rays and CT |  | 52 weeks | 
| Biomarkers |  | 16 and 52 weeks |
Nitrocamptothecin in Treating Patients With Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic melanoma.

Detailed Description
-----------------
OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with metastatic melanoma. OUTLINE: Patients are stratified according to disease (choroidal vs nonchoroidal). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for at least 8 weeks (2 courses) in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per stratum) will be accrued for this study.

Official Title
-----------------
Phase II Evaluation of RFS 2000 (9-Nitro-Camptothecin, 9NC) in Metastatic Melanoma

Conditions
-----------------
Melanoma (Skin)

Intervention / Treatment
-----------------
* Drug: rubitecan


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic melanoma Choroidal (no prior chemotherapy required) OR Nonchoroidal No more than 3 chemotherapy regimens Bidimensionally measurable disease No symptomatic uncontrolled CNS involvement including extensive brain metastases, spinal cord compression, or meningeal carcinomatosis Not eligible for treatment protocol of higher priority PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Zubrod 0-2 Life expectancy: Greater than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Transaminase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study No serious concurrent illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 16 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: rubitecan|nan|

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
-----------------
stage IV melanoma, recurrent melanoma
Pilot Study Evaluation of 2 Artificial Tears. Evaluation of TBUT, Tear Meniscus Height and Tear Thickness

Study Overview
=================
Brief Summary
-----------------
To determine baseline tear thickness and improvement immediately post installation of two artificial tear solutions:(9582X) and Allergan Refresh Tears.

Conditions
-----------------
Tear Film Thickness

Intervention / Treatment
-----------------
* Drug: Refresh Tears, 9582X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal, healthy volunteers 18 years or older Males or females Any race or ethnic background Exclusion Criteria: Corneal refractive surgery within 6 months of this study. Contact lens use on day of examination. Corneal ectasia

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Refresh Tears, 9582X|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Improving Adherence to Interventions for Hypertension

Study Overview
=================
Brief Summary
-----------------
To develop effective strategies for enhancing adherence to therapeutic interventions designed to improve care for hypertensive minority populations.

Detailed Description
-----------------
BACKGROUND: The study was in response to a demonstration and education initiative, Improving Hypertensive Care for Inner City Minorities, which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992. DESIGN NARRATIVE: An aggressive Hypertension Intervention Project (HIP) was developed in the Hypertension Research Section of King/Drew Medical Center in South-Central Los Angeles. The private CHUER clinic (located in the same cachement area) subcontracted with the Drew University Center in a community coalition consisting of several large health advocacy organizations. All subjects were randomized into usual care (controls) or interventional care (experimental) at the initiation of the HIP. The cornerstone of the aggressive intervention was the development of a computerized patient tracking system and the introduction into the clinic of several educational activities including a) exit interviews; b) home visits; c) support group sessions, and d) community health seminars/fairs. Community Health Workers performed the bulk of the patient tracking and educational intervention field work. Outcome measures of pre and post-study blood pressure, renal function, body weight change, and all-cause mortality were compared between experimental and controls at two, three and four years into the study. Quality-of-life questionnaires were obtained pre- and post-study and analyzed for new insights into needs assessment, awareness of hypertension, attitudes towards treatment, compliance with drug therapy, and effectiveness of various educational interventions employed in the study. Concurrent efforts to reduce co-morbid risk factors such as obesity, cigarette smoking, excessive alcohol consumption and stress were assessed as secondary outcomes. The HIP hoped to demonstrate cost-effective innovations for the adaptation of these Medical Center-targeted strategies to community physicians and health clinics of the inner city. 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
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity

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 Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene

Study Overview
=================
Brief Summary
-----------------
To investigate the correlation between four well-known polymorphisms of the glucocorticoid receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with exacerbation of COPD.

Detailed Description
-----------------
COPD patients who have received systemic glucocorticoid exceeding the equivalent of 180 mg prednisolone which are homo / heterozygous for the BclI and / or N363S polymorphisms (associated with increased glucocorticoid sensitivity) will have a lower cortisol response in a synacthen® test (greater suppression of adrenal corticosteroid) than the corresponding patients there are wild-type or homo- or heterozygous for the polymorphic ER22 / 23EK and / or 9β (associated with decreased sensitivity). Information from the results of the investigation will be able to help clinicians to identify patients with acute exacerbation of COPD (AECOPD) at risk of of secondary adrenal insufficiency.

Official Title
-----------------
The Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene

Conditions
-----------------
Adrenal Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients > 18 years Caucasian classified with COPD Patients with AECOPD being treated with at least 5 days of glucocorticoid (minimum of 180 mg) Exclusion Criteria: Treated with estrogen-containing medications, including anticonceptiva 6 weeks prior to Synacthen® Pregnancy or lactation on regular systemic glucocorticoid therapy before admission to the hospital People who are detained under the act on the use of coercion in psychiatry Severe language problems or inability to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Secondary Adrenal insufficiency | test for adrenal function by stimulation test | average 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome | blood lipids, blood pressure, plasma glucose, abdominal obesity, body composition | average 1 month | 
| Bone mineral loss | bonemarkers | average 1 month | 
| Onset of Diabetes Mellitus |  | average 1 month | 
| Quality of life | test by questionnaires | average 1 month |
Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children

Study Overview
=================
Brief Summary
-----------------
This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.

Official Title
-----------------
A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).

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

Intervention / Treatment
-----------------
* Drug: Enbrel (Etanercept)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion in this study will be as per the approved indications in the package insert. Patients with moderately to severely active RA. Children with JRA who have had an inadequate response to one or more DMARDs. Exclusion Criteria: Known hypersensitivity to etanercept or any of its components. Known significant concurrent medical disease, including: Congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction Cancer or history of cancer Active infection Sepsis or risk of sepsis Active tuberculosis or a past history of tuberculosis Pancytopenia Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception. Patients who are planning to undergo elective surgery during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enbrel (Etanercept)|nan|

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
-----------------
rheumatoid arthritis, juvenile rheumatoid arthritis
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia

Study Overview
=================
Brief Summary
-----------------
This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL

Official Title
-----------------
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: asparaginase
* Drug: recombinant asparaginase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated T-lineage or precursor B-lineage ALL Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with more than 25% blasts Written informed consent Treatment according to DCOG ALL 10 protocol Exclusion Criteria: Mature B-lineage ALL Patients with secondary ALL Known allergy to any ASNase preparation General health status according to Karnofsky / Lansky score < 40% Pre-existing known coagulopathy (e.g. haemophilia) Pre-existing pancreatitis Liver insufficiency (Bilirubin > 50 µmol/L; SGOT/SGPT > 10 x ULN) Other current malignancies Pregnancy (planned or existent), breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: asparaginase medac<br> | Drug: asparaginase<br>* 5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33<br>|
| Experimental: recombinant asparaginase<br> | Drug: recombinant asparaginase<br>* 5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter |  | March 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment |  | March 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children with previously untreated acute lymphoblastic leukemia
TAVR for Aortic Valve Disease

Study Overview
=================
Brief Summary
-----------------
Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement (SAVR). However, many different issues have emerged: TAVR in younger patients? valve leaflet thrombosis? transcatheter valve durability? coronary reaccess after TAVR? TAVR in bicuspid aortic valve? TAVR in aortic regurgitation? etc. Hence, a prospective, multicenter database is created to provide the real-word data for these questions.

Official Title
-----------------
Transcatheter Aortic Valve Replacement for Severe Aortic Valve Disease: Multi-center, Real-word Registry

Conditions
-----------------
Aortic Valve Disease

Intervention / Treatment
-----------------
* Device: transcatheter heart valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of severe aortic stenosis or aortic regurgitation Patients undergo transcatheter aortic valve replacement Exclusion Criteria: patients refuse the clinical follow-up

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 |
| --- | --- |
| TAVR in aortic valve disease<br> | Device: transcatheter heart valve<br>* patients with severe aortic valve disease underwent transcatheter heart valve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death during follow-up | all-cause death during 5-year follow-up | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac death during follow-up | Cardiac death during 5-year follow-up | 5 years |
Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?

Study Overview
=================
Brief Summary
-----------------
The malaise of the infant represents a polymorphic pathology in its clinical presentation. Due to the young age of the patients concerned and the parental anxiety generated, hospital management is necessary, for clinical and paraclinical evaluation and monitoring. The practice of complementary examinations is guided by personal and family history, and the precise description of the discomfort as well as clinical examination of the child and assessment of his vital parameters. However, in view of the particular terrain represented by infants under one year of age, a number of tests are carried out systematically, and therefore empirically, because they are not guided by the clinic. These various tests can be invasive, anxiety-provoking for parents and generate a significant additional cost during hospital management. An evaluation of the indication and interest of these tests is necessary in order to propose a homogeneous clinical and paraclinical management of the discomfort of the infant, in particular of discomforts of type BRUE (Brief Resolved Unexplained Events), as described in the 2016 American Academy of Pediatrics (AAP) recommendations.

Official Title
-----------------
Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?

Conditions
-----------------
Brief Resolved Unexplained Events (BRUE)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant less than one year old Admitted to the paediatric emergencies of the CHRU of Nancy between 11/01/2019 and 04/30/2020 for discomfort Exclusion Criteria: Child over one year old Reasons for consultation in paediatric emergencies other than malaise;

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 365 Days

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 |
| --- | --- | --- |
| Measurement of the proportion of BRUE-type discomfort among infants hospitalized for discomfort between 11/01/2019 and 04/30/2020 |  | From 11/01/2019 to 04/30/2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Assessment of the number of additional tests performed, their nature and the results found - Assessment of the child's orientation following consultation in paediatric emergencies (return home / hospitalization) - Epidemiological analysis |  | From 11/01/2019 au 04/30/2020 |