bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
Condition: Pain
Intervention: Fentanyl; Fentanyl; Oxycodone/acetaminophen; oxycodone/acetaminophen
Intervention description: Fentanyl buccal tablet 100 mcg once; Fentanyl buccal tablet 200 mcg once; Oxycodone/acetaminophen 5/325 mg once; Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Fentanyl; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Fentanyl buccal tablet

Summary:

      The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia
      in comparison to standard analgesia, to determine if the FBT allows for faster achievement of
      "significant analgesia"
    

Eligibility criteria:

        Inclusion Criteria:

          -  pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin

          -  only if Emergency Department provider approves

          -  a negative pregnancy test is required for participation for women of childbearing age

        Exclusion Criteria:

          -  If treating provider determines intravenous analgesia is required

          -  allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently
             taking phenothiazines, CNS depressants (including alcohol), or if they have taken an
             monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in
             the past two weeks

          -  if patient has already been administered an opioid analgesic for their current injury

          -  patients on chronic opioids therapy or a history of opioid abuse

          -  breastfeeding mothers

          -  patients who plan to drive home after their emergency department visit

          -  history of phenylketonuria (due to phenylalanine in the formulation of the
             lansoprazole solutab)
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Risankizumab; Placebo solution for risankizumab
Intervention description: Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously; Placebo solution in prefilled syringes, self-administered subcutaneously
Intervention MeSH terms: 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: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Risankizumab; Psoriasis; Plaque Psoriasis

Summary:

      The primary objective of this study was to evaluate the safety and efficacy of risankizumab
      (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants
      with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the
             baseline visit.

          -  Participant meets following disease activity criteria:

          -  Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal
             to 10% body surface area (BSA) psoriasis involvement, static physician global
             assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity
             Index (PASI) greater than or equal to 12 at Screening and baseline visit.

          -  Candidate for systemic therapy as assessed by the investigator.

        Exclusion Criteria:

          -  Participant has history of active skin disease other than psoriasis that could
             interfere with the assessment of psoriasis.

          -  Participant has history of erythrodermic psoriasis, generalized or localized pustular
             psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset
             guttate psoriasis.

          -  Participant has previous exposure to risankizumab.
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
Condition: Hypercholesterolemia; Atherosclerotic Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Intervention: ETC-1002; Placebo
Intervention description: ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided); Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; cholesterol; heterozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease; ASCVD; HeFH; LDL

Summary:

      The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated
      versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is
      not adequately controlled by their current therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-C ≥ 70 mg/dL

          -  High cardiovascular risk (diagnosis of HeFH or ASCVD)

          -  Be on maximally tolerated lipid-modifying therapy

        Exclusion Criteria:

          -  Total fasting triglyceride ≥500 mg/dL

          -  Renal dysfunction or nephrotic syndrome or history of nephritis

          -  Body Mass Index (BMI) ≥50kg/m2

          -  Significant cardiovascular disease or cardiovascular event in the past 3 months
A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Tazarotene Cream 0.05%; TAZORAC® (tazarotene) Cream 0.05%; Placebo
Intervention description: Tazarotene Cream 0.05% to cover only the lesions with a thin film.; TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.; Placebo (vehicle of the test product) to cover only the lesions with a thin film.
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 855.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing
      Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a
      Vehicle Control in the Treatment of Stable Plaque Psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis,
             involving at least 2% and no more than 20% of the body surface area (BSA) (not
             including the scalp and intertriginous areas)

          -  Have a minimum plaque elevation at the target lesion site of at least moderate
             severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe
             lesion at baseline should be identified as the target lesion

          -  Have an Investigator's Global Assessment (IGA) of disease severity of at least
             moderate (score ≥ 3) as an overall assessment of all lesions to be treated.

        Exclusion Criteria:

          -  A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to
             use an acceptable form of birth control within the study participation period

          -  Have a current diagnosis of unstable forms of psoriasis in the treatment area,
             including pustular, guttate, exfoliative or erythrodermic psoriasis

          -  Have a history of psoriasis unresponsive to topical treatments
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Condition: Alagille Syndrome
MeSH terms: Alagille Syndrome; Syndrome
Intervention: Odevixibat; Placebo
Intervention description: Odevixibat is a small molecule and selective inhibitor of IBAT.; Placebo identical in appearance to experimental drug (odevixibat).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 52.0
Sex: All
Healthy volunteers: No
Keywords: ALGS; Alagille syndrome

Summary:

      Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and
      safety of odevixibat compared to placebo in Patients with Alagille Syndrome.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Genetically confirmed diagnosis of Alagille syndrome

          -  History of significant pruritus as measured by the Albireo Observer or Patient
             Reported Outcome instrument

          -  Elevated serum bile acid level

        Key Exclusion Criteria:

          -  History or ongoing presence of other types of liver disease (eg. biliary atresia,
             progressive familial intrahepatic cholestasis, hepatocellular carcinoma)

          -  History of liver transplant, or a liver transplant is planned within 6 months of
             randomization

          -  ALT >10× upper limit of normal (ULN) at screening

          -  Total bilirubin >15 × ULN at screening

          -  Patient suffers from uncontrolled, recalcitrant pruritic condition other than Alagille
             syndrome
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Intervention description: SAGE-217 hard gelatin capsules.; SAGE-217 matched placebo hard gelatin capsules.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 581.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study
      evaluating the efficacy of SAGE-217 in the treatment of adult participants with major
      depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant had a diagnosis of MDD with symptoms that had been present for at least a
             4-week period.

          2. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32
             and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at
             screening and Day 1 (prior to dosing).

        Exclusion Criteria:

          1. Participant had active psychosis.

          2. Participant had attempted suicide associated with the current episode of MDD.

          3. Participant had a medical history of bipolar disorder, schizophrenia, and/or
             schizoaffective disorder.
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Cohort 1: Lubiprostone Capsule, Fasted; Cohort 1: Lubiprostone Sprinkle Formulation, Fasted; Cohort 2: Lubiprostone Sprinkle Formulation, Fed; Cohort 2: Lubiprostone Sprinkle Formulation, Fasted
Intervention description: Lubiprostone soft gelatin capsule administered under fasted conditions; Lubiprostone sprinkle formulation administered under fasted conditions; Lubiprostone sprinkle formulation administered under fed conditions; Lubiprostone sprinkle formulation administered under fasted conditions
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle
      formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is male or female, between 18 and 55 years of age, inclusive.

          -  Has a 12-lead electrocardiogram (ECG) within normal limits and is in good health based
             upon review of medical history, physical examination results, vital signs (within
             normal range), and normal laboratory profile for both blood and urine.

        Exclusion Criteria:

          -  Has an active or recent history of alcoholism or drug addiction (within 1 year prior)

          -  Is a smoker or has a recent history of smoking (within 6 months)

          -  Routinely consumes food known to alter drug metabolism (i.e., grapefruit juice,
             coffee, tea, cola, chocolate, cocoa, or other caffeine or methyl-xanthine containing
             foods or beverages) and/or cannot refrain from these items

          -  Has donated blood within 3 months

          -  Has a medical/surgical condition that might interfere with the absorption,
             distribution, metabolism, or excretion of the study medication.
Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 0.3% OPA-15406; 1% OPA-15406; Placebos
Intervention description: Twice daily; Twice daily; Twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 251.0
Sex: All
Minimum age: 2 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406
      ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for
      4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary
      endpoint in pediatric patients with Atopic Dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AD based on the Japanese Dermatological Association's criteria

          -  Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of
             body surface area (BSA, excluding scalp) at the screening and baseline examinations

          -  IGA score of 2 or 3 at the screening and baseline examinations

        Exclusion Criteria:

          -  Subjects who have an AD or contact dermatitis flare-up defined as a rapid
             intensification of AD, within 28 days prior to the baseline examination
Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
Condition: Parkinson's Disease; Helicobacter Infections; Motor Fluctuations
MeSH terms: Helicobacter Infections; Parkinson Disease
Intervention: clartihromycin, amoxicillin, and omeprazole; placebo
Intervention description: clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days; placebo therapy
Intervention MeSH terms: Amoxicillin; Omeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: Male
Healthy volunteers: No
Keywords: Parkinson's disease; levodopa; Helicobacter pylori

Summary:

      The purpose of this study is to determine whether treatment of H. pylori (an infection of the
      stomach) improves treatment effectiveness in patients with Parkinson's disease and motor
      fluctuations.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adults diagnosed with idiopathic Parkinson's disease, Hoehn & Yahr stage 2-4 in the
             "off" state, with no other concomitant neurologic diseases.

          -  Stable (≥30 days) Parkinson's disease therapy, with demonstrable medication efficacy,
             but with wearing off phenomenon present between levodopa doses (average off time ≥3
             hours off time/day).

          -  Levodopa therapy required; Any formulation (e.g. Sinemet, Sinemet CR, Stalevo) is
             acceptable. Parkinson's disease treatment may also include any of the following
             medications or classes: non-ergot dopamine agonists, COMT inhibitors, MAO-B
             inhibitors, amantadine, anticholinergics.

          -  Positive for H. pylori IgG Ab by serum ELISA (before inclusion in randomized treatment
             arms).

        Exclusion criteria:

          -  Current abdominal pain, unexplained nausea/vomiting, or gastrointestinal bleeding.

          -  History of gastric cancer, peptic ulcer, duodenal ulcer, or other gastric or duodenal
             lesions.

          -  History of previous gastric surgery.

          -  History of previous brain surgery for Parkinson's disease.

          -  Family history of gastric cancer.

          -  Prior treatment for H. pylori+ status.

          -  Recent use (previous 4 weeks) of proton-pump inhibitor, amoxicillin, or
             clarithromycin.

          -  Allergy or sensitivity to penicillin, amoxicillin, clarithromycin, or omeprazole.

          -  Use of drugs affecting gastric motility (e.g. domperidone, metoclopramide).

          -  Inability to tolerate or participate in testing in the morning in an "off" state.

          -  Inability to communicate effectively with study personnel in English.

          -  Pregnancy.
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
Condition: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: dimethyl fumarate
Intervention description: Initial oral dose for 7 days with maintenance dose thereafter
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Tecfidera; DMF; dimethyl fumarate

Summary:

      The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset
      counts during the first year of treatment in subjects with relapsing-remitting multiple
      sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute
      lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects of childbearing potential (including female subjects who are post-menopausal
             for less than 1 year) must practice effective contraception during the study and be
             willing and able to continue contraception for 30 days after their last dose of study
             treatment.

          -  Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria
             (2010) [Polman 2011]

        Key Exclusion Criteria:

          -  History of or positive test result at Screening for:

          -  human immunodeficiency virus

          -  hepatitis C virus antibody

          -  hepatitis B infection

          -  Drug or alcohol abuse within 1 year prior to Screening.

          -  Prior treatment with any of the following:

          -  cladribine

          -  mitoxantrone

          -  total lymphoid irradiation

          -  alemtuzumab

          -  T-cell or T-cell receptor vaccination

          -  any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab

          -  Treatment with any of the following medications or procedures within 6 months prior to
             Baseline (Day 1):

          -  DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40
             subjects (out of 200) with prior DMF exposure

          -  cyclosporine

          -  azathioprine

          -  methotrexate

          -  mycophenolate mofetil

          -  intravenous (IV) Ig

          -  plasmapheresis or cytapheresis

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply