bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene
Condition: Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Alirocumab; Placebo
Intervention description: SC injection in the abdomen; SC injection in the abdomen
Intervention MeSH terms: Alirocumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the pharmacodynamic (PD) effect of alirocumab
      on serum low density lipoprotein cholesterol (LDL-C) during 14 weeks of subcutaneous (SC)
      administered alirocumab in patients with autosomal dominant hypercholesterolemia (ADH) and
      gain-of-function mutation (GOFm) in 1 or both alleles of the proprotein convertase
      subtilisin/kexin type 9 (PCSK9) gene or with loss-of-function mutation (LOFm) in 1 or more
      alleles of the apolipoprotein (ApoB) gene.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria include, but are not limited to the following:

          1. Between the ages of 18 and 70 years, inclusive

          2. A history of molecularly confirmed PCSK9 GOFm for cohort 1 and a history of
             molecularly confirmed PCSK9 GOFm or ApoB LOFm

          3. Plasma LDL-Cholesterol levels ≥70 mg/dL at the screening visit on a lipid-lowering
             therapy (LLT) regimen stable for at least 28 days

        Exclusion Criteria:

        Exclusion criteria include, but are not limited to the following:

          1. Serum triglycerides >350 mg/dL at the screening visit

          2. Known to be positive for human immunodeficiency virus (HIV), hepatitis B virus, or
             hepatitis C virus

          3. Pregnant or breast-feeding women.

          4. Sexually active man or woman of childbearing potential who is unwilling to practice
             adequate contraception during the study
MDD POC Study GSK372475 Subjects Depressive Disease
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: GSK372475; Paroxetine; Placebo
Intervention description: GSK372475 1.0-1.5 mg/day; Paroxetine 20-30 mg/day; Placebo to Match
Intervention MeSH terms: Paroxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 492.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: MDD; flexible-dose; Major Depressive Disorder; paroxetine; GSK372475

Summary:

      To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the
      treatment of outpatients subjects with major depressive disorder to exhibit decreased
      pleasure, interest and energy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR
             criteria)

          -  Duration of current episode is at least 12 weeks duration and less than 2 years

          -  Symptoms of decreased energy, pleasure, and interest

          -  Female subjects who agree to use acceptable methods of birth control throughout the
             study

        Exclusion criteria:

          -  Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic
             attacks that could interfere with their ability to complete the trial

          -  Symptoms of MDE better accounted for by another diagnosis

          -  Diagnosis of panic disorder / attacks, generalised anxiety, borderline or antisocial
             personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of
             screening), bipolar disorder, schizophrenia or any other psychotic disorder(s).

          -  Started psychotherapy within 3 months prior to the Screening

          -  Received electroconvulsive therapy or transcranial magnetic stimulation within 6
             months prior to screening

          -  Received psychoactive drugs within 4 weeks of randomization

          -  Positive urine drug screen or positive blood alcohol

          -  Suicidal risk or has had any previous suicide attempt, a family history of suicide
             attempt

          -  Positive pregnancy test

          -  History of seizure disorder, myocardial infarction (< 1yr), or unstable medical
             condition

          -  Failed to respond to an adequate course of pharmacotherapy of at least 2 different
             antidepressants
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Neladenoson bialanate (BAY1067197); Placebo
Intervention description: 5 mg orally once daily for 20 weeks; 10 mg orally once daily for 20 weeks; 20 mg orally once daily for 20 weeks; 30 mg orally once daily for 20 weeks; 40 mg orally once daily for 20 weeks; Orally once daily for 20 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 427.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Heart Failure; Heart Failure with Reduced Ejection Fraction

Summary:

      The objective of the study is to find the optimal dose of once daily oral neladenoson
      bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with
      reduced ejection fraction (HFrEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 18 years and older

          -  Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class
             II-IV, LVEF ≤ 35% and elevated NT-proBNP

        Exclusion Criteria:

          -  Acute de-novo heart failure

          -  Requirement of any intravenous (IV) treatments following 48 hours prior to
             randomization

          -  Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation,
             mechanical ventilation, or any ventricular assist device)

          -  Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic
             dilated cardiomyopathy
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
Condition: Schizophrenia; Alcohol Use Disorder
MeSH terms: Alcoholism; Schizophrenia; Alcohol Drinking
Intervention: Samidorphan + olanzapine (ALKS 3831); Placebo + olanzapine
Intervention description: Oral tablet, taken once daily; Oral tablet, taken once daily
Intervention MeSH terms: Olanzapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alkermes; Schizophrenia; Alcohol Use Disorder; ALKS 3831

Summary:

      This double-blind, randomized study will evaluate the efficacy, safety and tolerability of
      ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a BMI between 18.0 and 40.0 kg/m2, inclusive

          -  Has a diagnosis of schizophrenia

          -  Has a diagnosis of alcohol use disorder (AUD)

          -  Has experienced an acute exacerbation of schizophrenia within the past 6 months

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Is pregnant or breastfeeding

          -  Had first lifetime psychotic episode less than 1 year before screening or has
             experienced only a single lifetime psychotic episode

          -  Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine

          -  Has current or pending legal charges with the potential for incarceration

          -  Has a positive drug screen for opiates

          -  Additional criteria may apply
Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
Condition: Bone Pain
Intervention: Loratadine; Placebo
Intervention description: 10 mg in a capsule; Administered via capsule
Intervention MeSH terms: Loratadine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 12 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Granulocyte-colony stimulating factor

Summary:

      G-CSF causes a release of histamine that may be a cause of chronic bone pain. Loratadine
      targets histamine, and so may be effective in reducing bone pain.The researchers plan to
      prospectively assess the effectiveness of loratadine for chronic bone pain in patients with
      chronic G-CSF use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of neutropenia

          -  Granulocyte-colony stimulating factor (G-CSF) use for at least 3 months at least 4
             times per month

          -  Mean bone pain of at least a 2/10 as assessed by questions 3-6 of the Brief Pain
             Inventory (BPI)

        Exclusion Criteria:

          -  Other sources of chronic pain

          -  Previously tried loratadine for 7 consecutive days or more for bone pain

          -  Allergy to loratadine

          -  Chronic daily usage of antihistamine without an acceptable alternative
             non-antihistamine medication
AXS-05 Phase II Trial on Smoking Behavior
Condition: Smoking Cessation; Smoking, Cigarette; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: AXS-05; Bupropion SR
Intervention description: Dextromethorphan Immediate Release + Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.; Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.
Intervention MeSH terms: Dextromethorphan; Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to either take AXS-05 or BUP SR in parallel for the duration of the study.
Masking: Double (Participant, Care Provider)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking cessation; Nicotine dependence; Bupropion; DXM; Nicotine addiction; Cigarette smoking; Dextromethorphan

Summary:

      This research study is designed with the purpose of evaluating a new drug, combination
      Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Age 18 years or above

          2. Daily smoker using 10 or more cigarettes per day

          3. Willing to be smoke-free for 7 days

          4. Is able to provide written informed consent (in English) to participate in the study
             and able to understand the procedures and study requirements.

          5. Is willing to voluntarily sign and date an informed consent form that is approved by
             an institutional review board before the conduct of any study procedure.

        Key Exclusion Criteria:

          1. Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline,
             bupropion)

          2. Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless
             tobacco)

          3. Not pregnant or breastfeeding

          4. Contraindication to the use of bupropion.

          5. Additional criteria may apply.
IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
Condition: Acute Pyelonephritis
MeSH terms: Pyelonephritis
Intervention: Omadacycline; Levofloxacin; Omadacycline
Intervention description: po tablets; iv solution/po tablets; iv solution
Intervention MeSH terms: Levofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or
      iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of
      female adults with acute pyelonephritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants, age 18-65 years who have signed the informed consent form

          -  Must have a qualifying acute pyelonephritis

          -  Participants must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

          -  Must be able to comply with all of the requirements of the study

        Exclusion Criteria:

          -  Males

          -  Symptoms of acute pyelonephritis present for longer 7 days prior to randomization

          -  Infections that require antibacterial treatment for greater than 14 days

          -  Evidence of suspected non-renal source of infections, vaginitis, or sexually
             transmitted infection

          -  Evidence of significant immunological disease

          -  Evidence of liver impairment or disease

          -  Evidence of unstable cardiac disease

          -  Severe renal disease or requirement for dialysis

          -  Evidence of septic shock

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline or to
             levofloxacin

          -  Has received an investigational drug within the past 30 days

          -  Participants who are pregnant or nursing

          -  Unable or unwilling to comply with the protocol requirements
Dose Range Study of CD5789 in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD5789 25 µg/g cream; CD5789 50 µg/g cream; CD5789 100 µg/g cream; Tazarotene 0.1% gel; Vehicle cream
Intervention description: CD5789 25 µg/g cream applied once daily; CD5789 50 µg/g cream applied once daily; CD5789 100 µg/g cream applied once daily; Tazarotene 0.1% gel applied once daily; Vehicle cream applied once daily
Intervention MeSH terms: Tazarotene; Trifarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Minimum age: 12 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      To assess the efficacy and safety of different concentrations of CD5789 cream in participants
      with acne vulgaris for the purpose of dose identification.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participant, 12 to 35 years old with the following characteristics:

          -  Facial acne severity grade of the following:

               -  Stratum 1: IGA score of 3 or 4

               -  Stratum 2: IGA score of 4

               -  Stratum 3: IGA score of 3 or 4

          -  A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the
             following strata:

               -  Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a
                  maximum of one nodule on the face.

               -  Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.

               -  Stratum 3: Participants of Japanese origin with at least 20 inflammatory lesions
                  and up to four nodules on the face.

                    -  Note: Participants of Japanese origin will not be included in Stratum 1 or
                       Stratum 2. Japanese origin is defined as all four grandparents were born in
                       Japan.

        Exclusion Criteria:

          -  The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary
             acne form (chloracne, drug-induced acne, etc.)

          -  Any uncontrolled or serious disease, or any medical or surgical condition, that may
             either interfere with the interpretation of the clinical trial results and/or put the
             participant at significant risk (according to the Investigator's judgment) if the
             participant participates in the clinical trial.

          -  Known or suspected allergies or sensitivities to any components of any of the study
             drugs.

          -  Current participation in any other clinical trial of a drug or device OR past
             participation within the 30 days prior to the Baseline visit.
X-82 to Treat Age-related Macular Degeneration
Condition: Age-Related Macular Degeneration (AMD); Macular Degeneration; Exudative Age-related Macular Degeneration; AMD; Macular Degeneration, Age-related, 10; Eye Diseases; Retinal Degeneration; Retinal Diseases
MeSH terms: Macular Degeneration; Eye Diseases; Retinal Diseases; Retinal Degeneration
Intervention: X-82; Anti-VEGF; Placebo
Intervention MeSH terms: Ranibizumab; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Vascular Endothelial Growth Factor (VEGF); Platelet Derived Growth Factor (PDGF); AMD

Summary:

      The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of
      vision loss due to wet AMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in
             one or both eyes for at least 6 months prior to joining the study and has required at
             least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater
             than 6 weeks for the past two injections in the eye that is selected to be the study
             eye.

          -  Must have demonstrated a reduction in macular fluid or macular thickness in the study
             eye 14 days following an anti-VEGF injection at Screening Visit 1

          -  Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25
             letters (20/320) or better in both eyes

        Exclusion Criteria:

          -  Previous vitrectomy to the study eye within 30 days of Screening Visit 1

          -  Choroidal neovascularization (CNV) due to causes other than AMD

          -  Proliferative diabetic retinopathy in either eye
Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; PF-06651600
Intervention description: 200mg pill every day (QD) for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in
      seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate
      (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF
      biologic).
    

Eligibility criteria:

        Inclusion Criteria

          -  Subjects between the ages of 18 and 75 years, inclusive

          -  Must have moderate-to-severe, active Rheumatoid Arthritis

          -  Must have had an inadequate response to Methotrexate

          -  Subjects may have received one approved TNF inhibiting biologic agent that was
             inadequately effective and/or not tolerated

        Exclusion Criteria

          -  Subjects with any acute or chronic infections or infection history

          -  Have acute or active chronic dermatological disorders prior to study start

          -  Any major illness/condition(s) or evidence of an unstable clinical condition that in
             the judgment of the investigator would make the subject inappropriate for entry into
             this study

          -  Known immunodeficiency disorder or a first degree relative with hereditary
             immunodeficiency

          -  Any live (attenuated) vaccines or current routine household contact with anyone who
             has received live (attenuated) vaccine