bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Intervention: Sestamibi
Intervention description: Sestamibi
Intervention MeSH terms: Technetium Tc 99m Sestamibi
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 445.0
Sex: All
Minimum age: 4 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging
      (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of
      developing cardiac events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females between 4 and 16

          -  Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of
             incomplete KD, including evidence of coronary artery disease as determined by their
             physician.

          -  Be able to exercise adequately to achieve 85% age predicted maximum heart rate

        Exclusion Criteria:

          -  Terminal illness where expected survival is < 6 months
A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis; Psoriatic Arthritis
MeSH terms: Arthritis, Psoriatic; Psoriasis
Intervention: Bimekizumab; Placebo
Intervention description: Bimekizumab will be provided at pre-specified time intervals.; Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 435.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; PSO; Psoriasis

Summary:

      Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of
      subjects with moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age

          -  Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit

          -  Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
             >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

          -  Subject is a candidate for systemic PSO therapy and/or phototherapy

          -  Female subject of child bearing potential must be willing to use highly effective
             method of contraception

        Exclusion Criteria:

          -  Subject has an active infection (except common cold), a recent serious infection, or a
             history of opportunistic, recurrent, or chronic infections

          -  Subject has concurrent acute or chronic viral hepatitis B or C or human
             immunodeficiency virus (HIV) infection

          -  Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB
             infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

          -  Subject has any other condition, including medical or psychiatric, which, in the
             Investigator's judgment, would make the subject unsuitable for inclusion in the study

          -  Presence of active suicidal ideation or positive suicide behavior

          -  Presence of moderately severe major depression or severe major depression

          -  Subject has any active malignancy or history of malignancy within 5 years prior to the
             Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
             carcinoma, or in situ cervical cancer
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Tritanrix™-HepB; Rotarix™; Zilbrix™; Triple Antigen™; Engerix™-B; Placebo
Intervention description: GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.; GSK Biologicals' live attenuated human rotavirus vaccine; GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine; Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.; GSK Biologicals' hepatitis B vaccine; Placebo for the Rotarix™ vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 308.0
Sex: All
Minimum age: 3 Weeks
Maximum age: 4 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Pertussis; Prophylaxis; Hepatitis B diseases; Tetanus

Summary:

      To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant
      administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody
      response to the diphtheria antigen after a three-dose primary vaccination course.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects who the investigator believes that their parent/guardian can and will comply
             with the requirements of the protocol.

          -  Administration of one dose of hepatitis B vaccine at birth.

          -  A male or female between, and including, 11 and 17 weeks of age at the time of the
             first DTPw vaccination.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days before the first vaccine dose or planned administration during the
             study period with the exception of oral polio vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination (no laboratory testing is required)

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.
Ultravist: Safety and Efficacy in Computed Tomography of Head and Body
Condition: Computed Tomography; Diagnostic Imaging
Intervention: Iopromide 370 mg I/mL; Iopromide 300 mg I/mL
Intervention description: Iopromide (Ultravist 370 mg I/mL) administered intravenously; Iopromide (Ultravist 300 mg I/mL) administered intravenously
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 435.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ultravist 370; CECT; CT Scan

Summary:

      This is a research study involving the use of a contrast agent called Ultravist Injection.
      Ultravist, the study drug, is used to improve the pictures obtained using computed tomography
      (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case
      of this study, it will be injected into a vein in the patient's arm; from there, it travels
      through the blood stream and to the areas to be examined. CT scans will then be taken of the
      patient's head and/or body as ordered by his/her physician.

      Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When
      Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast
      Enhanced Computed Tomography (CECT) of the Head and/or Body
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the
             head or body.

        Exclusion Criteria:

          -  Patients that are less than 18 years old and do not have a clinical indication for a
             contrast-enhanced CT of the head or body.
MK0476 Study in Adult Patients With Acute Asthma (0476-322)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium; Comparator: Placebo
Intervention description: 7 mg or 14 mg single injection; Placebo single injection
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 225.0
Sex: All
Minimum age: 15 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study evaluates the efficacy and safety of MK0476 intravenous administration in adult
      patients with acute asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult Patients With Acute Asthma Attacks

        Exclusion Criteria:

          -  Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary
             Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)

          -  Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years

          -  Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or
             Other Severe Disease
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461; Placebo
Intervention description: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant); Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major depressive disorder (MDD); depression; Alkermes; ALKS 5461; samidorphan

Summary:

      This study will evaluate the efficacy and safety of ALKS 5461.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a BMI of 18.0 to 40.0 kg/m2, inclusive

          -  Agree to use an acceptable method of contraception for the duration of the study

          -  Have an MDD primary diagnosis

          -  Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the
             current Major Depressive Episode (MDE)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Have a current primary Axis-I disorder other than MDD

          -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days

          -  Have received electroconvulsive therapy treatment within the last 2 years or received
             more than one course of electroconvulsive treatment during their lifetime

          -  Have attempted suicide within the past 2 years

          -  Have a positive test for drugs of abuse

          -  Are pregnant, planning to become pregnant, or breastfeeding

          -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
             antagonists (eg, naltrexone, naloxone)

          -  Have had a significant blood loss or blood donation within 60 days

          -  Additional criteria may apply
PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Apremilast 20mg; Apremilast 30mg; Placebo
Intervention description: Apremilast 20 mg twice daily, orally; Apremilast 30 mg twice daily, orally
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 505.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Psoriasis; Arthritis; inflammation; skin condition; inflammatory cells; apremilast; CC-10004; phosphodiesterase type 4

Summary:

      The purpose of this study is to determine whether apremilast is safe and effective in the
      treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.

      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and
      swollen joints, pain, physical function) in treated patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, aged ≥ 18 years at time of consent.

          -  Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration.

          -  Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria for PsA at
             time of screening.

          -  Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)

          -  May not have axial involvement alone

          -  Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine

          -  Have ≥ 3 swollen AND ≥ 3 tender joints.

          -  Males & Females must use contraception

          -  Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.

          -  Have at least one ≥2 cm psoriasis lesion

        Exclusion Criteria:

          -  Pregnant or breast feeding.

          -  History of allergy to any component of the investigational product Hepatitis B surface
             antigen and/or Hepatitis C antibody positive at screening.

          -  Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF)
             blocker
Study for the Treatment of Crohn's Disease With Adacolumn
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adacolumn; Sham
Intervention description: Ten apheresis sessions:
One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9).; Sham, ten apheresis sessions within 9 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn
      Apheresis System as a treatment for the signs and symptoms of Crohn's disease.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Moderate to severe Crohn's disease

          -  Adequate peripheral venous access

          -  Agree to participate in the required follow-up visits

          -  Able to complete a diary

          -  Signed written informed consent document and authorization for use of protected health
             information

        Key Exclusion Criteria:

          -  Extremely severe Crohn's disease

          -  Known obstructive symptoms within the past 3 months

          -  Presence of toxic megacolon

          -  Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks

          -  Total colectomy, ileostomy, stoma or 100 cm of resected small bowel

          -  Requiring in-patient hospitalization

          -  A history of allergic reaction to heparin or heparin-induced thrombocytopenia

          -  A history of hypersensitivity reaction associated with an apheresis procedure or
             intolerance of apheresis procedures

          -  A history of severe cardiovascular or peripheral arterial diseases

          -  A history of cerebral vascular diseases

          -  Liver diseases

          -  Renal insufficiency

          -  Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other
             than apheresis treatment

          -  Any hypercoagulable disorder

          -  Known infection with Hepatitis B or C, or HIV

          -  Severe anemia

          -  Leukopenia or granulocytopenia

          -  Evidence of current systemic infection

          -  Malignancy

          -  Pregnant, lactating or planning to become pregnant during the course of the
             investigational study

          -  Used within the last 30 days, an investigational drug, biologic or device or 5
             half-lives, if known, for any investigational drug or biologic
HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone furoate/Vilanterol Inhalation Powder; Fluticasone propionate/salmeterol Inhalation Powder; Placebo (1); Placebo (2)
Intervention description: Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks; Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks; Inhalation powder inhaled orally once daily for 24 weeks; Inhalation powder inhaled orally twice daily for 24 weeks
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 810.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Salmeterol; fluticasone furoate; Vilanterol; fluticasone propionate; GW642444

Summary:

      The purpose of the study is to compare the efficacy and safety of fluticasone
      furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone
      propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of
      age and older with persistent bronchial asthma over a 24-week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of asthma

          -  Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4
             inhalations of albuterol

          -  FEV1 of 40-85% predicted normal

          -  Currently using inhaled corticosteroid therapy

        Exclusion Criteria:

          -  History of life-threatening asthma within previous 5 years (requiring intubation
             and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)

          -  Respiratory infection or oral candidiasis

          -  Asthma exacerbation requiring oral corticosteroids or that resulted in overnight
             hospitalisation requiring additional asthma treatment

          -  Uncontrolled disease or clinical abnormality

          -  Allergies

          -  Taking another investigational medication or prohibited medication

          -  Night shift workers

          -  Current smokers or subjects with smoking history of at least 10 pack years
Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Intervention: AZD1222; Placebo
Intervention description: AZD1222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.; Commercially available 0.9% (n/V) saline for injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double Blind: two or more parties are unaware of the intervention assignment.
Enrollment: 32450.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19 Vaccine

Summary:

      The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the
      prevention of COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Increased risk of SARS-CoV-2 infection

          -  Medically stable

        Exclusion Criteria:

          -  confirmed or suspected immunosuppressive or immunodeficient state

          -  significant disease, disorder, or finding

          -  Prior or concomitant vaccine therapy for COVID-19