bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain
Condition: Postoperative Delirium; Postoperative Pain; Opioid Use; Hospital Length of Stay
MeSH terms: Delirium; Emergence Delirium
Intervention: Gabapentin
Intervention description: This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 750.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: gabapentin; pain; surgery; delirium; cognitive decline

Summary:

      This will be a double blind, placebo-controlled study of patients ≥65 years of age undergoing
      surgery of the spine, hips and knees replacement at the University of California, San
      Francisco (UCSF) Medical Center. Intraoperative anesthetic and postoperative pain management
      will be standardized. Patients will be randomized to receive either placebo or gabapentin
      preoperatively, and continued postoperatively until discharge. Intraoperative anesthetic and
      other postoperative pain management strategies will be standardized. Postoperative delirium
      will be measured using structured interviews. Cognitive function will be measured using a
      battery of neurocognitive tests pre- and post-operatively. Using an intention to treat
      strategy, we, the researchers at UCSF, will compare the incidence of postoperative delirium
      and cognitive dysfunction, the amount of postoperative pain, and narcotic requirements
      between the two groups. The primary outcome will be postoperative delirium. Secondary
      outcomes will be postoperative pain and opioids use, and length of hospital stay, and
      cognitive dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥65 years of age undergoing surgery involving the spine, hip or knee
             replacement.

          -  English speaking.

          -  Anticipated to stay in the hospital for at least 48 hours.

        Exclusion Criteria:

          -  Patients who take gabapentin preoperatively, or have known sensitivity to the drug, or
             those unable to be randomized to receive gabapentin.

          -  Subjects who are unable to provide informed consent.

          -  Patients with a history of narcotic tolerance.

          -  Patients with planned two stage spinal procedures (anterior-posterior spinal fusion to
             be done on two separate days).
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
Condition: Cystic Fibrosis; Advanced Lung Disease
MeSH terms: Cystic Fibrosis; Lung Diseases; Fibrosis
Intervention: Lumacaftor; Ivacaftor
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination
      therapy in subjects 12 years and older with CF and advanced lung disease and who are
      homozygous for the F508del CFTR mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del-CFTR mutation; historical genotype must be documented in
             the participant's source documents.

          -  Percent predicted FEV1 <40 of adjusted for age, sex, and height at Screening

        Exclusion Criteria:

          -  Participant currently receiving invasive mechanical ventilation.

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             participant

          -  Any clinically significant laboratory abnormalities at screening that would interfere
             with the study assessments or pose an undue risk for the subject

          -  A 12-lead electrocardiograms (ECG) demonstrating QTcF >450 msec at Screening

          -  History of solid organ or hematological transplantation

          -  History of alcohol or drug abuse in the past year

          -  Ongoing or prior participation in an investigational drug study (including studies
             investigating lumacaftor and/or ivacaftor) within 30 days of screening.

          -  Use of strong inhibitors, moderate inducers, or strong inducers of CYP3A

          -  Pregnant and nursing females: Females of childbearing potential must have a negative
             pregnancy test at Screening and Day 1.

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements

          -  Use of beta blockers or the equivalent at Screening.
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
Condition: Mild Persistent Asthma
MeSH terms: Asthma
Intervention: methacholine chloride; placebo ProAir HFA; ProAir HFA; Lupin albuterol HFA MDI; placebo Lupin albuterol HFA MDI
Intervention MeSH terms: Albuterol; Procaterol; Methacholine Chloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test
      product to the reference product, using bronchoprovocation (methacholine challenge testing)
      in adult patients with stable mild asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and non-pregnant female subjects (18-65 years of age)

          -  Stable mild asthmatics based on National Asthma Education and Prevention Program
             (NAEPP) guidelines.

          -  Forced Expiratory Volume in 1 second ( FEV1) ≥ 80% of predicted. Airway responsiveness
             to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.

          -  Nonsmokers for at least 1 year prior to the study and a maximum smoking history of
             five pack-years (the equivalent of one pack per day for five years).

          -  Written informed consent.

        Exclusion Criteria:

          -  Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper
             respiratory tract infection, lower respiratory tract, viral bronchitis and/or
             sinobronchitis) within six weeks preceding the screening visit.

          -  History of seasonal asthma exacerbations, in which case the patient should be studied
             outside of the relevant allergen season.

          -  History of cystic fibrosis, bronchiectasis or other respiratory diseases.

          -  History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, or
             chronic condition that could put the safety of the patient at risk during the study or
             affect the efficacy and safety analyses during the study.

          -  Treatment in an emergency room, urgent care center, or hospitalization for acute
             asthmatic symptoms within the past 6 months or need for daily oral corticosteroids
             within past 3 months.

          -  Known intolerance or hypersensitivity to any component of the albuterol metered dose
             inhaler (MDI).
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 668.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese
      Infants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male or female infants ≥2 months to ≤6 months at the time of consent.

          -  Healthy infants determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis)

          -  Major known congenital malformation or serious chronic disorder.

          -  History of microbiologically proven invasive disease caused by S pneumoniae.

          -  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 and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.
A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC as add-on to the pre-trial background medication.; Administered SC as add-on to the pre-trial background medication.
Intervention MeSH terms: Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 475.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glucose-dependent insulinotropic polypeptide (GIP); glucagon-like peptide-1 (GLP-1); GIP/GLP-1 dual receptor agonist; T2DM

Summary:

      The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide
      to placebo in participants with type 2 diabetes that are already on insulin glargine, with or
      without metformin. Participants will administer tirzepatide or placebo along with their
      previous glucose lowering medications. The study will last approximately 47 weeks and may
      include about 23 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with
             insulin glargine (U100), once daily with or without metformin ≥3 months prior to
             screening visit.

          -  Have HbA1c between ≥7.0% and ≤10.5%.

          -  Have a stable weight (± 5%) for at least 3 months before screening.

          -  Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus.

          -  Have had chronic or acute pancreatitis any time prior to study entry.

          -  Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative
             diabetic retinopathy requiring acute treatment.

          -  Have disorders associated with slowed emptying of the stomach, or have had any stomach
             surgeries for the purpose of weight loss.

          -  Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants
             on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than
             the country-specific threshold for using the protocol-required dose of metformin per
             local label)]

          -  Have had a heart attack, stroke, or hospitalization for congestive heart failure in
             the past 2 months.

          -  Have a personal or family history of medullary thyroid carcinoma or personal history
             of multiple endocrine neoplasia syndrome type 2.

          -  Have been taking weight loss drugs, including over-the-counter medications during the
             last 3 months.
Bexagliflozin Efficacy and Safety Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Bexagliflozin; Placebo
Intervention description: 20 mg, tablet; 20 mg tablet to match active comparator
Intervention MeSH terms: Bexagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1700.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the effect of bexagliflozin in lowering
      hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased
      risk of cardiovascular adverse events.

      The data from this study will be combined with the data from other bexagliflozin studies in a
      meta-analysis of CV safety outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of T2DM

          -  Subjects who have had a stable treatment regimen for T2DM for the past 3 months

          -  Subjects who present with at least one of the following 3 histories:

        Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure
        Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently
        smoking, reduced kidney function, or cholesterol problems

        Exclusion Criteria:

          -  Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young

          -  History of genitourinary tract infections

          -  Evidence of abnormal liver function

          -  History of MI, stroke or hospitalization for heart failure in the past 3 months

          -  Prior kidney transplant or evidence of kidney problems

          -  Prior or planned pace maker implantation

          -  Pregnant or nursing
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: icatibant
Intervention description: Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg
Intervention MeSH terms: Icatibant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Efficacy; Hereditary angioedema; HAE; Pediatric; Children; Pharmacokinetics; Safety; Firazyr; icatibant

Summary:

      HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the
      Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single
      subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with
      Hereditary Angioedema (HAE) during an initial acute attack.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Two through <18 years of age at the time of first HAE attack.

               -  Prepubertal and pubertal/postpubertal subjects experiencing and acute cutaneous,
                  abdominal, or laryngeal HAE attack treated with icatibant as part of this study.

               -  Pubertal/postpubertal subjects with HAE who are treated with icatibant, but not
                  during an attack.

          2. Documented diagnosis of HAE Type I or II.

          3. Informed consent (and subject assent as appropriate) signed by the subject's
             parent(s)or legal guardian(s).

        Exclusion Criteria:

          1. Diagnosis of angioedema other than HAE.

          2. Participation in another clinical trial that involves the use of any investigational
             product (drug or device)within 30 days prior to study enrollment or at any time during
             the study.

          3. Any known factor/disease that might interfere with the treatment compliance, study
             conduct,or result interpretation.

          4. Congenital or acquired cardiac anomalies that interfere significantly with cardiac
             function.

          5. Treatment with ACE inhibitors within 7 days prior to treatment.

          6. Use of hormonal contraception within the 90 days prior to treatment.

          7. Androgen use (eg, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone)
             within the 90 days prior to treatment.

          8. Pregnancy or breastfeeding.

          9. A physical condition that interferes with pubertal status determination.
Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Intervention: BAF312; Placebo
Intervention description: 0.25, 0.5, 1, and 2 mg film-coated tablets; Film-coated tablets
Intervention MeSH terms: Siponimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1653.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Secondary Progressive Multiple Sclerosis

Summary:

      Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment
      duration in patients with secondary progressive multiple sclerosis (Core Part) followed by
      extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability
      and efficacy (Extension Part).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior history of relapsing remitting MS

          -  SPMS defined as progressive increase of disability over at least 6 months

          -  EDSS score of 3.0 to 6.5

          -  No relapse of corticosteroid treatment within 3 months

        Exclusion Criteria:

          -  Women of child bearing potential must use reliable forms of contraception.

          -  Diagnosis of Macular edema during screening period

          -  Any medically unstable condition determined by investigator.

          -  Unable to undergo MRI scans

          -  Hypersensitivity to any study drugs or drugs of similar class Other protocol defined
             inclusion/exclusion may apply.
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)
Condition: Agglutinin Disease, Cold
MeSH terms: Anemia, Hemolytic, Autoimmune
Intervention: BIVV009
Intervention description: Sutimlimab was administered as intravenous (IV) infusion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of Part A was to determine whether sutimlimab administration resulted in a
      greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb)
      levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during
      treatment in participants with primary cold agglutinin disease (CAD) who had a recent history
      of blood transfusion. The purpose of Part B was to evaluate the long-term safety and
      tolerability of sutimlimab in participants with CAD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight of >= 39 kg at screening.

          -  Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic
             hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific
             DAT strongly positive for C3d; d) Cold agglutinin titer >= 64 at 4 degree celsius; e)
             Immunoglobulin G (IgG) DAT less than or equal to (<=) 1+, and f) No overt malignant
             disease.

          -  History of at least one documented blood transfusion within 6 months of enrollment.

          -  Hemoglobin level <= 10.0 g/dL.

          -  Bilirubin level above the normal reference range, including participants with
             Gilbert's Syndrome.

        Exclusion Criteria:

          -  Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active
             hematologic malignancy.

          -  Clinically relevant infection of any kind within the month preceding enrollment (e.g.,
             active hepatitis C, pneumonia).

          -  Clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with
             anti-nuclear antibodies at Screening. Anti-nuclear antibodies of long-standing
             duration without associated clinical symptoms adjudicated on a case-by-case basis
             during the Confirmatory Review of Patient Eligibility.

          -  Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C
             virus antibody) prior to or at Screening.

          -  Positive human immunodeficiency virus (HIV) antibody at screening.

          -  Treatment with rituximab monotherapy within 3 months or rituximab combination
             therapies (e.g., with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within
             6 months prior to enrollment.