bioihbjkbjnl/mcl2 huggingface dataset:
LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye
Condition: Non Infectious Uveitis
MeSH terms: Uveitis
Intervention: DE-109 Intravitreal Injections; Sham Procedure; DE-109 Intravitreal Injections; DE-109 Intravitreal Injections (Open Label)
Intervention description: 440 ug of DE-109 Injectable Solution; The sham procedure mimics an intravitreal injection without penetrating the eye.; Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug); After double-masked treatment period (injections every 2 months), eligible subjects would enter the open-labeled period and had DE-109 440 ug injections every 2 months (Month 6, Month 8, and Month 10)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months
      in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS).

      There is a 6-month, single-arm, open-label period after completion of the 6-month double-
      masked, controlled period allows the evaluation of the efficacy and safety of intravitreal
      injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo
      or sham control.
    

Eligibility criteria:

        Inclusion Criteria:

        Non-Infectious Active Uveitis of the Posterior Segment

        Exclusion Criteria:

        Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected
        infectious uveitis
Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ponesimod; Placebo
Intervention description: One tablet of ponesimod 20 mg administered orally once daily in the morning from Day 15 to EOT. To reduce the first-dose effect of ponesimod, an uptitration scheme will be implemented from Day 1 to Day 14 (with dose strength increasing from 2 mg to 20 mg).; One tablet of matching placebo administered orally once daily in the morning
Intervention MeSH terms: Ponesimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod
      vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to initiation of any study-mandated procedure.

          -  Women of childbearing potential must have a negative pregnancy test and use reliable
             methods of contraception

          -  Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic
             Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple
             sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed
             relapses).

          -  Ongoing treatment with DMF for at least 6 months prior to screening

          -  Active disease after at least 3 months of DMF treatment

          -  Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).

        Exclusion Criteria:

          -  Lactating or pregnant women and women intending to become pregnant during the study.

          -  Presenting with a diagnosis of MS with progressive course from onset (i.e., primary
             progressive MS or progressive relapsing MS).

          -  Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS
             assessment.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             full participation in the study or compliance with the protocol.
Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: Standard fluid management; Goal directed fluid therapy with the Edwards EV1000 system
Intervention description: The patient will receive standard fluid management; This arm will have fluid therapy guided by the Edwards EV1000 system.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Perioperative Fluid Management; liver resection; 12-056

Summary:

      The purpose of this study is to help us learn what is the best amount of fluid to administer
      to patients during liver surgery. Patients will receive either an amount for this surgery
      based on weight, blood pressure, heart rate and urine output or an amount guided by a
      computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The
      FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on
      real time information like blood pressure, pulse and the ability of the heart and blood
      vessels to maintain normal vital signs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (18 years old or greater) who are able to provide informed consent.

          -  Patients who undergo an open, elective liver resection. Including those initially
             approached laparoscopically but converted to an open resection and those undergoing
             additional procedures.

        Exclusion Criteria:

          -  Active coronary disease.

          -  Patients with a history of coronary disease will be eligible if they have had a
             cardiac stress study showing no reversible ischemia and normal LV function within 3
             months of operation.

          -  Active symptomatic cerebrovascular disease.

          -  Active congestive heart failure and ejection fraction <35%.

          -  Active severe restrictive or obstructive pulmonary disease and resting SpO2 <90%.

          -  Active renal dysfunction (Cr >1.8)

          -  Abnormal coagulation parameters (INR > 1.8 not on Coumadin, or platelet count <
             100,000 per mcL)

          -  Presence of active infection including HIV

          -  Patients with active atrial fibrillation or flutter.

          -  Preoperative hypoalbuminemia (Albumin < 2g/dl).

          -  Female patients who are pregnant (female patients of child-bearing potential must have
             a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to
             surgery with a negative urine pregnancy test the morning of surgery).

          -  Presence of ascites.

          -  BMI > 45 or <17
CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Convalescent plasma
Intervention description: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 940.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Convalescent plasma; Transfusion; SARS-CoV-2; Passive immunization

Summary:

      There is currently no treatment available for COVID-19, the acute respiratory illness caused
      by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19
      that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA
      approved the use of convalescent plasma under the emergency investigational new drug (eIND)
      category. Randomized trials are needed to determine the efficacy and safety of COVID-19
      convalescent plasma for acute COVID-19 infection.

      The objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19
      convalescent plasma to adult patients admitted to hospital with COVID-19 infection at
      decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19.

      It is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma
      early in their clinical course will reduce the risk of death, and that other outcomes will be
      improved including risk of intubation, and length of ICU and hospital stay.

      This pan-Canadian clinical trial has the potential to improve patient outcomes and reduce the
      burden on health care resources including reducing the need for ICU beds and ventilators.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥16 years old (>18 years of age in the United States)

          -  Admitted to hospital with confirmed COVID-19 respiratory illness

          -  Receiving supplemental oxygen

          -  500 mL of ABO compatible convalescent plasma is available

        Exclusion Criteria:

          -  Onset of respiratory symptoms >12 days prior to randomization

          -  Intubated or plan in place for intubation

          -  Plasma is contraindicated (e.g. history of anaphylaxis from transfusion)

          -  Decision in place for no active treatment
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Pimecrolimus Cream, 1%; Placebo Cream; Pimecrolimus Cream, 1%
Intervention MeSH terms: Pimecrolimus; Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 654.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No

Summary:

      To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of
      reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate
      Atopic Dermatitis.

      To establish superiority of each active treatment over the placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-immuno compromised male or female aged 8 years and older

          -  Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)

          -  Failed to respond adequately to other topical prescription treatments for AD, or for
             whom those treatments are not advisable.

          -  A diagnosis of AD for at least 3 months

          -  An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at
             baseline (score of 2 or 3)

          -  Affected area of AD involvement at least 5% body surface area (BSA)

          -  Treated with a bland emollient for at least 7 days

        Exclusion Criteria:

          -  Females who are pregnant, breast feeding, or who wish to become pregnant during the
             study period

          -  Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g.,
             clinically infected atopic dermatitis, impetigo).

          -  Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline,
             which would interfere with evaluations

          -  History or presence of confounding skin conditions, e.g., psoriasis, rosacea,
             erythroderma, ichthyosis, or scabies.

          -  History or presence of Netherton's Syndrome, immunological deficiencies or diseases,
             HIV, diabetes, malignancy, serious active or recurrent infection, clinically
             significant severe renal insufficiency or severe hepatic disorders

          -  Concurrent disease or treatment likely to interfere with the study treatment or
             evaluations

          -  Known allergy or hypersensitivity to pimecrolimus or any other component of the drug
             products

          -  Not willing to minimize or avoid natural and artificial sunlight exposure during
             treatment
Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: Flutamide; Leuprolide Acetate
Intervention description: 10.8 mg intramuscularly once every 3 months for 12 months; 50 mg tablet orally daily for 12 months
Intervention MeSH terms: Leuprolide; Goserelin; Flutamide; Bicalutamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: Male
Healthy volunteers: No
Keywords: stage I prostate cancer; stage II prostate cancer

Summary:

      RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy
      using leuprolide and flutamide may fight prostate cancer by reducing the production of
      testosterone. It is not yet known whether receiving leuprolide and flutamide is more
      effective than receiving no further therapy.

      PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in
      treating patients who have stage I or stage II prostate cancer that is at high risk of
      recurrence and who have already undergone surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging

          2. Radical prostatectomy and bilateral lymph node dissection performed

          3. Pathologic assessment of surgical specimens by MDACC pathologist

          4. High risk of clinical or biochemical failure post prostatectomy (must fulfill one of
             the following criteria): pathology; a) Gleason grade sum score greater than or equal
             to 8, b) Seminal vesicle involvement, c) Extraprostatic extension with positive
             surgical margins and Gleason greater than or equal to 7

          5. Radical prostatectomy performed within 90 days of enrollment and serum PSA level <
             0.1ng/ml

          6. Written informed consent

        Exclusion Criteria:

          1. Any evidence of metastatic disease confirmed prior to enrollment

          2. Inability to confirm pathologic risk factors or inadequate prostatectomy (see item
             4.1.5).

          3. Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer

          4. Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to
             enrollment in study

          5. Elevation of liver function tests 2x normal

          6. Contraindication to the use of LH-RH agonists or antiandrogens

          7. Active secondary malignancy (other than squamous or basal cell skin cancer) within
             five years prior to enrollment in study

          8. Any concomitant medical condition that would make it undesirable for the 7patient to
             participate in the trial or jeopardize compliance with the protocol
Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Intervention: thyroid hormone and folinic acid
Intervention description: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
Intervention MeSH terms: Leucovorin; Folic Acid; Hormones; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Months
Healthy volunteers: No
Keywords: Down syndrome; Young children; Psychomotor development; Thyroid hormone; Folinic acid; Psychometric tests; GMDS; Griffiths; Genetic factors; Biochemical factors

Summary:

      Evaluation of the following in very young children with Down syndrome:

        -  the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically
           and by ultrasensitive thyreostimulating hormone (TSH) assay),

        -  the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,

        -  any interaction between these two treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation
             trisomy 21

          -  patient having undergone a cardiac ultrasound not demonstrating any severe heart
             disease

          -  patient aged 6 to 18 months at inclusion

        Exclusion Criteria:

          -  congenital hypothyroidism

          -  hypothyroidism demonstrated by laboratory tests (TSH > 7mUI/l)

          -  presenting or having presented hyperthyroidism

          -  presenting or having presented leukaemia

          -  presenting or having presented West syndrome or any other form of epilepsy or unstable
             neurological disease

          -  presenting or having presented signs of central nervous system distress: stroke,
             postoperative hypoxia, meningitis)

          -  presenting severe heart disease on cardiac ultrasound, with haemodynamic effects

          -  presenting non-controlled cardiac arrhythmia

          -  Apgar < 7 to 5 min at birth

          -  Gestational age < 231 days (33 gestation weeks)
PALISADE Follow-on Study (ARC004)
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101
Intervention description: AR101 powder provided in capsules & sachets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 388.0
Sex: All
Minimum age: 4 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Allergy; Peanut-Allergic Children; Peanut-Allergic Adults; Desensitization; PALISADE

Summary:

      The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101
      through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed
      the ARC003 study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completion of the ARC003 study

          -  Written informed consent and/or assent from subjects/guardians as appropriate

          -  Use of effective birth control by sexually active female subjects of child-bearing
             potential

        Key Exclusion Criteria:

          -  Early discontinuation from the ARC003 study

          -  Meets any longitudinally applicable ARC003 study exclusion criteria

          -  (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or
             mild symptoms in the ARC003 study Exit DBPCFC

          -  Any other condition that, in the opinion of the Investigator, precludes participation
             for reasons of safety
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Saline; Influenza vaccine
Intervention description: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Normal saline for injection; Seasonal inactivated influenza vaccine (SIIV)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1796.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the
      same visit or separately
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants ≥65 years of age at the time of consent

          -  Adults determined by clinical assessment, including medical history and clinical
             judgment, to be eligible for the study, including adults with preexisting stable
             disease

          -  Adults who have no history of ever receiving a pneumococcal vaccine, or have a history
             of receiving a licensed pneumococcal vaccination ≥6 months prior to first study
             vaccination.

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis)

          -  Previous vaccination with any investigational pneumococcal vaccine, or planned receipt
             of any licensed or investigational pneumococcal vaccine through study participation.

          -  Vaccination with any influenza or pneumococcal vaccine <6 months before
             investigational product administration, or planned receipt of any licensed or
             investigational non-study influenza vaccine during study participation.

             -- Serious chronic disorder, that in the investigator's opinion would make the
             participant inappropriate for entry into the study

          -  Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results