bioihbjkbjnl/mcl2 huggingface dataset:
Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Peramivir
Intervention MeSH terms: Peramivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute uncomplicated; Elderly

Summary:

      This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of
      600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza
      infection and in subjects with acute uncomplicated influenza infection at higher risk for
      influenza complications. All subjects will receive IV peramivir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at
             least one clinical sign or symptom consistent with acute influenza infection as listed
             below OR

          -  Clinical signs and symptoms consistent with acute influenza infection consisting of an
             oral temperature ≥ 100°F (37.8°C) with at least one respiratory symptom of at least
             moderate severity (cough or rhinitis) and at least one constitutional symptom of at
             least moderate severity (myalgia [aches and pains], headache, feverishness, or
             fatigue)

          -  Influenza symptom onset < 48 hours. However, due to historically delayed presentation
             for medical care in the adult population, approximately 20% of the elderly population
             may be enrolled with symptoms starting > 48-hours but ≤ 72-hours

        Exclusion Criteria:

          -  Women who plan to breast-feed for the first 48 hours after study drug administration

          -  Subjects requiring hospital admission to treat medical condition(s) which could
             represent complications of influenza.

          -  Recent worsening of any chronic medical condition consistent with complications of
             influenza

          -  Current evidence of a bacterial infection requiring antibiotic treatment
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Edema
Intervention: Brolucizumab; Aflibercept
Intervention description: Intravitreal injection; Intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 566.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema; intravitreal injection; brolucizumab; aflibercept; double-masked; Diabetic Macular Edema (DME); macular edema; diabetic retinopathy

Summary:

      The purpose of this study was to evaluate the efficacy and safety of brolucizumab in
      treatment of patients with visual impairment due to diabetic macular edema (DME).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent before any assessment

          -  Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening

          -  Medication for the management of diabetes stable within 3 months prior to
             randomization and is expected to remain stable during the course of the study

        Exclusion Criteria:

          -  Active proliferative diabetic retinopathy in the study eye

          -  Active intraocular or periocular infection or active intraocular inflammation in study
             eye

          -  Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25
             millimeters mercury (mmHg)

          -  Previous treatment with anti-VEGF drugs or investigational drugs in the study eye

          -  Stroke or myocardial infarction during the 6-month period prior to baseline

          -  Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value
             ≥100 mmHg

        Other protocol-specified inclusion/exclusion criteria may apply
US Phase III Study of APD421 in PONV
Condition: PONV
Intervention: APD421- Amisulpride for IV injection; Placebo
Intervention description: APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia; Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
Intervention MeSH terms: Amisulpride
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 364.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at
      moderate-to-high risk of PONV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥ 18 years of age

          -  Patients undergoing elective surgery (open or laparoscopic technique) under general
             anaesthesia, expected to last at least one hour from induction of anaesthesia to wound
             closure and expected to require at least one overnight stay in hospital

        Exclusion Criteria:

          -  Patients scheduled for outpatient/day case surgery

          -  Patients scheduled to undergo intra-thoracic, transplant or central nervous system
             surgery

          -  Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal
             or epidural) block

          -  Patients who are expected to remain ventilated for a period after surgery

          -  Patients who are expected to need a naso- or orogastric tube in situ after surgery is
             completed
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Baricitinib; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2877.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the long-term safety and any side effects of
      baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis
      study.

      The study provides 7 years of additional treatment with baricitinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the final active treatment in study JADV (NCT01710358), JADZ
             (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS
             (NCT02265705)

        Exclusion Criteria:

          -  Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI],
             unstable angina, unstable arterial hypertension, severe heart failure, or
             cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine,
             hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed
             during a previous baricitinib study that, in the opinion of the investigator, pose an
             unacceptable risk to the participant if investigational product continues to be
             administered

          -  Have a known hypersensitivity to baricitinib or any component of this investigational
             product

          -  Had investigational product permanently discontinued at any time during a previous
             baricitinib study

          -  Had temporary investigational product interruption at the final study visit of a
             previous baricitinib study and, in the opinion of the investigator, this poses an
             unacceptable risk for participation in the study

          -  Have any other condition that, in the opinion of the investigator, renders the
             participant unable to understand the nature, scope, and possible consequences of the
             study or precludes the participant from following and completing the protocol
A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Intervention: Sci-B-Vac-Lot B; Sci-B-Vac-Lot A; Engerix-B
Intervention description: Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml; Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml; Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind, three-arm, two-stage, randomized study
Masking: Single (Participant)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sci-B-Vac; Prophylactic vaccine; Hepatitis B vaccines; Phase 3; pre-S1; pre-S2; Surface antigen; 3-antigen

Summary:

      This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one
      site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two
      production lots of Sci-B-Vac vaccine produced at two different facilities (OLD facility (Lot
      A) and NEW facility (Lot B) with respect to anti-hepatitis B-Surface (HBs) response.
      Secondary efficacy analysis was performed to demonstrate non-inferiority of seroprotection of
      each lot of Sci-B-Vac vaccine when compared to Engerix-B vaccine
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy adults 18 to 45 years of age who were seronegative for HBsAg, anti-HBs,
        anti-Hepatitis B core antigen, HIV, and Hepatitis C Virus (HCV)

        Exclusion Criteria:

          -  Evidence of alcoholism or drug abuse, history of HIV, or HCV

          -  Blood transfusions within the three months prior to inclusion in the study

          -  Uncontrolled hypertension and other cardiovascular diseases

          -  Chronic/concurrent administration (>14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and
             topical steroids were permitted

          -  History of anaphylaxis (including shock) or any significant allergy or atopy
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
Condition: Urinary Bladder, Neurogenic
MeSH terms: Urinary Bladder, Neurogenic
Intervention: Fesoterodine PR 4 mg; Fesoterodine PR 8 mg; Fesoterodine PR 8 mg; Oxybutynin; Fesoterodine PR; Fesoterodine BIC 2 mg; Fesoterodine BIC 4 mg
Intervention description: Fesoterodine 4 mg tablet once daily for 24 weeks; Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.; Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.; Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation.; Fesoterodine 4 mg or 8 mg tablets once daily for 12 weeks after 12 weeks of oxybutinin. Those assigned to 8 mg will take 4 mg for the first week.; Fesoterodine BIC 2 mg tablet once daily for 24 weeks.; Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.
Intervention MeSH terms: Fesoterodine; Oxybutynin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: neurogenic detrusor overactivity; neurogenic bladder; neuropathic bladder; neurologic disease; fesoterodine

Summary:

      The objective of the study is to find out if the medicine fesoterodine is a useful treatment
      in children with bladder muscle overactivity caused by a neurological condition. Children
      will be aged 6 to 17 years old. This is done by finding out how well it works, what the body
      does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It
      will be compared with the medicine oxybutynin, which is already available for treating the
      condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 6 to 17 years old

          -  Subjects with stable neurological disease and neurogenic detrusor overactivity

          -  Subjects using clean intermittent catheterization may participate

        Exclusion Criteria:

          -  Concomitant medications which may increase the risk to subjects or confound study
             results

          -  Other medical conditions which may increase the risk to subjects or confound study
             results

          -  Contraindications to the use of fesoterodine or oxybutynin
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Synflorix; Prevenar; Infanrix hexa
Intervention description: 1 dose injected IM in the right thigh or deltoid.; 1 dose injected IM in the right thigh or deltoid.; 1 dose injected IM in the right thigh or deltoid.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 1200.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus pneumonia, pneumococcal conjugate vaccine

Summary:

      This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of
      GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of
      age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553.
      Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization
      course in study 105553 (NCT00307554). The immune response to a booster dose of GSK
      Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to
      subjects not primed with GSK Biologicals' vaccine but with Prevenar™.

      The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal
      conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children
      primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of
      children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal
      conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  a healthy male or female, 12 to 18 months of age at the time of vaccination, who
             received at least one dose of either pneumococcal conjugate vaccine or Prevenar™
             during study 105553 and with written informed consent obtained from the
             parent/guardian of the subject.

        Exclusion Criteria:

          -  use of any investigational or non-registered drug or vaccine other than the study
             vaccine within 30 days preceding the vaccination, or planned use during the entire
             study period (active phase and safety follow-up).

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting one month before vaccination up to Visit 2.

          -  Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since
             end of study 105553. Children with a history of seizures or neurological disease,
             allergic disease, immunosuppressive or immunodeficient condition.
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Baricitinib; Placebo
Intervention description: Administered orally.; Administered orally.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Polyarticular JIA; Oligoarthritis; Juvenile psoriatic arthritis (JPsA); Enthesitis-related juvenile idiopathic arthritis (ERA)

Summary:

      The reason for this study is to see if the study drug baricitinib given orally is safe and
      effective in participants with JIA from 2 years to less than 18 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have had a diagnosis of active JIA (polyarticular, extended
             oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including
             JPsA).

          -  Participants must have had an inadequate response to at least one conventional or
             biologic disease-modifying antirheumatic drug (DMARD).

        Exclusion Criteria:

          -  Participants must not have systemic JIA, with or without active systemic features.

          -  Participants must not have persistent oligoarticular arthritis.

          -  Participants must not have been previously treated with a Janus kinase (JAK)
             inhibitor.
A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: TEZ/IVA; IVA; Placebo; Placebo
Intervention description: Participants weighing <40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet.; Participants weighing <40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet.; Placebo matched to TEZ/IVA FDC; Placebo matched to IVA
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA)
      in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the
      F508del mutation (F/F) or heterozygous for F508del with an eligible residual function
      mutation (F/RF).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for F508del or heterozygous for F508del and an RF mutation (as defined in
             the protocol).

          -  Participants with ppFEV1 of ≥70 percentage points adjusted for age, sex, height.

          -  Participants with a screening LCI2.5 result ≥7.5.

          -  Participants who are able to swallow tablets.

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension.

          -  Colonization with organisms associated with a more rapid decline in pulmonary status.

          -  Solid organ or hematological transplantation.

        Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: RPC1063; Placebo
Intervention MeSH terms: Ozanimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1012.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether RPC1063 is effective in the treatment of
      Ulcerative Colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 to 75 years (at screening for Cohort 1 and 2)

          -  UC confirmed on endoscopy

          -  Moderately to severely active UC (May score 6-12)

          -  Currently receiving treatment with aminosalisylate, prednisone, or budesonide

          -  Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be
             stopped prior to randomization

        Exclusion Criteria:

          -  Have severe extensive colitis as evidence by:

          -  Physician judgment that the patient is likely to require colectomy or ileostomy within
             12 weeks of baseline.

          -  Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or
             bowel perforation.

          -  Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD
             or microscopic colitis, radiation colitis, or ischemic colitis

          -  Clinically relevant cardiovascular conditions or other relevant diseases that could
             impact the implementation or interpretation of the trial, or put the patient at risk

          -  History of uveitis or unknown macular edema

          -  Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG)
             measured during screening