bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Placebo (for alirocumab); Ezetimibe; Placebo (for ezetimibe); Lipid Modifying Therapy (LMT)
Intervention description: 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.; 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.; One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.; One capsule once daily orally at approximately the same time of the day with or without food.; Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
Intervention MeSH terms: Ezetimibe; Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 720.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9
      (proprotein convertase subtilisin/kexin type 9).

      Primary Objective of the study:

      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as
      add-on therapy to stable maximally tolerated daily statin therapy in comparison with
      ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high
      cardiovascular (CV) risk.

      Secondary Objectives:

        -  To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time
           points

        -  To evaluate the effect of alirocumab on other lipid parameters

        -  To evaluate the safety and tolerability of alirocumab
    

Eligibility criteria:

        Inclusion criteria:

        Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD
        risk equivalents who were not adequately controlled with a maximally tolerated daily dose
        of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

        Exclusion criteria:

          -  Age < 18 or legal age of adulthood, whichever was greater

          -  Participants without established CHD or CHD risk equivalents

          -  LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented
             cardiovascular disease

          -  LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented CV
             disease

          -  Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L)

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: CSL's Influenza Virus Vaccine (Afluria); Influenza Virus Vaccine (Fluzone)
Intervention description: 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines; 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1474.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the immunogenicity and safety profile of CSL
      Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus
      Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18
             years at the time of the first study vaccination.

          -  For participants aged ≥ 6 months to < 9 years, born after a normal gestation period
             (between 36 and 42 weeks).

          -  Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically
             sterile) must be abstinent or be willing to use a medically accepted contraceptive
             regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also
             return a negative urine pregnancy test at enrollment.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs,
             chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
Study of Paliperidone ER in Adolescents and Young Adults With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Paliperidone ER
Intervention description: Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Autistic Disorder

Summary:

      This 8-week, prospective open-label study will investigate the effectiveness and tolerability
      of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er
      will be well tolerated and efficacious for reducing aggression, self-injury, and irritability
      in adolescents and young adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between ages of 12 and 21 years

          -  Tanner Sage III or IV (post-pubertal)

          -  Diagnostic and Statistical Manual Fourth Edition Text-Revised (DSM-IV-TR) diagnosis of
             autism

          -  Outpatient

          -  Ability to swallow pills

          -  Antipsychotic medication-free for at least 2 weeks

          -  Score of 4 or more on the Clinical Global Impressions Severity Scale

          -  Score of 18 or higher on the Aberrant Behavior Checklist Irritability Scale

          -  Mental age of 18 months or greater based on testing

          -  Subjects must be in good physical health

        Exclusion Criteria:

          -  Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise Specified (PDD
             NOS), Rett's Disorder, childhood disintegrative disorder, schizophrenia, bipolar
             disorder, Fragile X Syndrome, Tuberous Sclerosis

          -  A significant medical condition

          -  An active seizure disorder

          -  Females who are pregnant

          -  Evidence of a prior adequate trial of paliperidone ER

          -  History of neuroleptic malignant syndrome

          -  Hypersensitivity to paliperidone ER
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Condition: Menopause; Osteoporosis
MeSH terms: Osteoporosis
Intervention: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg; bazedoxifene 20 mg/ conjugated estrogens 0.625 mg; bazedoxifene 20 mg; conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg; Placebo
Intervention description: One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.; One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.; One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.; One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.; One capsule, placebo (over-encapsulated), once a day for one year.
Intervention MeSH terms: Bazedoxifene; Medroxyprogesterone Acetate; Medroxyprogesterone; Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1886.0
Sex: Female
Minimum age: 40 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Postmenopausal Women; Bazedoxifene/Conjugated Estrogens

Summary:

      The purpose of this research study is to evaluate the safety and effectiveness of this
      investigational drug for the treatment of menopausal symptoms while protecting the
      endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject
      participation will last approximately 14.5 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for
             menopausal symptoms

          -  At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with
             follicle-stimulating hormone (FSH) levels > 40 mIU/mL

          -  Intact Uterus

        Exclusion Criteria:

          -  Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator
             (SERM) containing drug products within 8 weeks before screening

          -  A history or active presence of clinically important medical disease: eg.
             cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast
             cancer, etc.
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Plecanatide
Intervention MeSH terms: Plecanatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2370.0
Sex: All
Minimum age: 18 Years
Maximum age: 81 Years
Healthy volunteers: No
Keywords: Plecantaide; Chronic Idiopathic Constipation; Chronic; Idiopathic; Constipation; Synergy; CIC; CIC study; CIC OLE; CIC OLE study; OLE; OLE CIC; OLE CIC3; Open label; Open label study; Long term; Long term study; Extension; Extension study

Summary:

      This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in
      patients with Chronic Idiopathic Constipation (CIC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient completed a previous double-blind plecanatide study and was compliant with the
             study requirements.

          -  Patient is in good health without unstable acute illness or exacerbation of an
             unstable chronic illness or chronic disease that may affect study assessments,
             particularly if there has been a significant change to health status since the
             previous plecanatide study.

        Exclusion Criteria:

          -  Patient has had major surgery including laparoscopic procedures requiring general
             anesthesia within 60 days of Day 1.

          -  Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency
             virus (HIV) infection.

          -  Patient has taken a protocol-prohibited drug without the appropriate washout period.
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: SEL; Placebo to match SEL 6 mg; Placebo to match SEL 18 mg
Intervention description: Tablets administered orally once daily; Tablets administered orally once daily; Tablets administered orally once daily
Intervention MeSH terms: Selonsertib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 808.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can
      cause fibrosis regression and reduce progression to cirrhosis and associated complications in
      adults with NASH and bridging (F3) fibrosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH
             Clinical Research Network (CRN) classification in the opinion of the central reader

          -  Has the following laboratory parameters at the screening visit:

               -  Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)

               -  Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the
                  Cockcroft-Gault equation

               -  Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is
                  unable to be resulted)

               -  Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's
                  syndrome or hemolytic anemia is present)

        Key Exclusion Criteria:

          -  Prior history of decompensated liver disease including clinical ascites, hepatic
             encephalopathy (HE), or variceal bleeding

          -  Child-Pugh (CP) score > 6, as determined at screening, unless due to therapeutic
             anti-coagulation

          -  Model for End-stage Liver Disease (MELD) score > 12, as determined at screening,
             unless due to therapeutic anti-coagulation

          -  Other causes of liver disease including, but not limited to, alcoholic liver disease,
             hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson
             disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history
             and/ or centralized review of liver histology.

          -  History of liver transplantation

          -  Current or history of hepatocellular carcinoma (HCC)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Teduglutide
Intervention description: 0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of an investigational
      treatment (teduglutide) in Japanese patients with PN-dependent SBS. This study will also look
      at how teduglutide moves through the body (pharmacokinetics).
    

Eligibility criteria:

        This study has 3 stages, consisting of an optimization/stabilization period (Stage 1), a
        24-week treatment period in which all patients will receive teduglutide (Stage 2), and a
        long-term extension (Stage 3).

        During the long-term extension (Stage 3), patients will continue to receive teduglutide for
        up to an additional 24 months or until teduglutide is commercially available, whichever
        comes earlier.
Long Term Safety Assessment of SER120 in Patients With Nocturia
Condition: Nocturia
MeSH terms: Nocturia
Intervention: SER120
Intervention description: once a day treatment of nocturia
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: decrease in the number of nocturic episodes for patients with nocturia

Summary:

      The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies

          -  Willing to provide consent for the study

        Exclusion Criteria:

          -  Incontinence

          -  Diabetes Insipidus, Diabetes Mellitus

          -  CHF

          -  Renal Insufficiency

          -  Significant medical history which make participation unacceptable
A Study of Oral Contraception Under Simulated OTC Conditions
Condition: Contraception
Intervention: Norgestrel 0.075 mg tablets
Intervention description: All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 16 weeks.
Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet.
Intervention MeSH terms: Norgestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Daily birth control

Summary:

      This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a
      progestin only pill for contraception, in a manner consistent with the OTC package directions
      in an Over-the-Counter (OTC)-like setting.
    

Eligibility criteria:

        Inclusion Criteria:

        -Women who are willing purchase (in the pharmacies) or be provided (in the clinics) oral
        contraception for their own use for the purposes of the study

        Exclusion Criteria:

          -  Cannot read, speak and understand English

          -  Cannot see well enough to read information on the label
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab; Disease-modifying anti-rheumatic drugs; Non-steroidal anti-inflammatory drugs; Oral corticosteroids
Intervention description: For participants weighing > 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.; Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.; Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.; Oral corticosteroids (≤ 10 mg/day) were permitted during the study.
Intervention MeSH terms: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2067.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm study evaluated the long-term efficacy and safety of tocilizumab in
      participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche
      protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol
      WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in
      combination with standard anti-rheumatic treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed participation in 1 of the core studies in adult rheumatoid
             arthritis.

        Exclusion Criteria:

          -  Treatment with any investigational agent since the last administration of study drug
             in the core studies.

          -  Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last
             administration of study drug in the core studies.

          -  Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or
             any biologic since the last administration of study drug in the core studies.

          -  Immunization with a live/attenuated vaccine since the last administration of study
             drug in the core studies.

          -  Previous treatment with any cell-depleting therapies, including investigational
             agents.

          -  Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to
             baseline in this study.
Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: montelukast sodium; Comparator: loratadine; Comparator: placebo
Intervention description: montelukast 10 mg tablet orally once daily in the morning for 4 weeks; loratadine 10 mg tablet orally once daily in the morning for 4 weeks; placebo tablet orally once daily in the morning for 4 weeks
Intervention MeSH terms: Loratadine; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1079.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning,
      versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the
      study as an active control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a history of seasonal allergic rhinitis that worsens during the study
             season

          -  Patient is a nonsmoker

          -  Patient is in good health physical and mental health

        Exclusion Criteria:

          -  Patient is hospitalized

          -  Patient is a woman who is < 8 weeks postpartum or is breastfeeding

          -  Patient plans to move or vacation away during the study

          -  Patient has had any major surgery with in past 4 weeks

          -  Patient is a current or past abuser of alcohol or illicit drugs