bioihbjkbjnl/mcl2 huggingface dataset:
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Exantide with Dapagliflozin; Exentide; Dapagliflozin
Intervention description: 2 mg weekly suspension injection and 10 mg Dapagliflozin; 2 mg; 10 mg once daily Dapagliflozin
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 695.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Exenatide; Dapagliflozin; Diabetes medication; Treatment efficacy; Placebo; Metabolism; Cardiovascular metabolic

Summary:

      Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter,
      Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous
      administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD)
      compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes
      who have inadequate glycemic control on metformin.
    

Eligibility criteria:

        Inclusion criteria

          -  Has a diagnosis of T2DM.

          -  Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.

          -  Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to
             Screening.

        Exclusion criteria

          -  FPG ≥280 mg/dL (15.6 mmol/L).

          -  Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)

          -  Clinically significant abnormal free T4 values or patients needing initiation or
             adjustment of thyroid treatment according to the investigator.

          -  Abnormal thyroid stimulating hormone (TSH) value at Screening will be further
             evaluated by free T4.Patients with clinically significant abnormal free T4 values will
             be excluded.

          -  Known active proliferative retinopathy.

          -  History of, or currently have, acute or chronic pancreatitis, or have triglyceride
             concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1

          -  History or presence of inflammatory bowel disease or other severe GI diseases,
             particularly those which may impact gastric emptying, such as gastroparesis or pyloric
             stenosis.

          -  History of gastric bypass surgery or gastric banding surgery, or either procedure is
             planned during the time period of the study. Current use of gastric balloons is also
             excluded.
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Ingenol Mebutate; Vehicle
Intervention description: Vehicle gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 729.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for
      actinic keratosis applied to large treatment areas once daily for three consecutive days on
      face, scalp or chest.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs)
        non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged
        skin on either:

          -  The full face

          -  The full balding scalp

          -  A contiguous area of approximately 250 cm2 on the chest

        Exclusion Criteria:

          -  Location of the treatment area (full face, full balding scalp or chest) within 5 cm of
             an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC)
             or squamous cell carcinoma (SCC).

          -  Previously assigned treatment in this clinical trial or previously participated in a
             clinical trial in the LEO clinical programme on ingenol mebutate gel for larger
             treatment areas.

          -  Treatment with ingenol mebutate gel in the selected treatment area within the last 12
             months.

          -  Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous
             horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two
             previous occasions).
Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Condition: Adjunctive Treatment of Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Pimavanserin
Intervention description: Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
Intervention MeSH terms: Pimavanserin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the safety and tolerability of long-term pimavanserin treatment in subjects with
      major depressive disorder and inadequate response to antidepressant treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059

          2. May benefit from longer term therapy with open-label pimavanserin treatment

          3. If the subject is female, she must not be pregnant or breastfeeding. She must also be
             of nonchildbearing potential OR must agree to use acceptable methods of contraception

        Exclusion Criteria:

          1. Is determined to be inappropriate for the study

          2. Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal,
             hepatic, hematologic, or other medical or mental disorder, including cancer or
             malignancies that would affect the patient's ability to participate in the program

        Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to
        ensure that all criteria for study participation are met. Patients may be excluded from the
        study based on these assessments (and specifically, if it is determined that their baseline
        health and psychiatric condition do not meet all pre-specified entry criteria).
Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
Condition: Bacterial Infections; Skin Structures and Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Soft Tissue Infections
Intervention: Omadacycline; Linezolid
Intervention description: Injection for IV dosing; Tablets for oral dosing; Infusion solution for IV dosing; Tablets for oral dosing
Intervention MeSH terms: Linezolid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 655.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared
      to linezolid in the treatment of adults with acute bacterial skin and skin structure
      infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, ages 18 years or older who have signed the informed consent

          -  Has a qualifying skin and skin structure infection

          -  Female patients 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

        Exclusion Criteria:

          -  Infections where the outcome is strongly influenced by factors other than
             protocol-defined treatment and procedures, that require antibacterial treatment for
             greater than 14 days

          -  Evidence of significant immunological disease

          -  Severe sepsis or septic shock

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline or to
             linezolid

          -  Has received an investigational drug within past 30 days

          -  Women who are pregnant or nursing
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
Condition: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder
MeSH terms: Neuromyelitis Optica
Intervention: Eculizumab; Placebo
Intervention description: Induction Phase: 900 mg IV weekly for 4 weeks, followed by 1200 mg for the fifth dose; Maintenance Phase: 1200 mg IV every 2 weeks; Induction Phase: matching placebo (900 mg) IV weekly for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose; Maintenance Phase: matching placebo (1200 mg) IV every 2 weeks
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; Devic's disease, Transverse Myelitis; Optic Neuritis; relapse; eculizumab; soliris; NMO-IgG; CNS Autoimmune Disorders; Demyelinating Disorders; NMO; NMOSD

Summary:

      The objectives of this time-to-event study were to assess the efficacy and safety of
      eculizumab as compared with placebo in participants with neuromyelitis optica spectrum
      disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female participants ≥ 18 years old.

          2. Diagnosis of NMO or NMOSD.

          3. AQP4 antibody seropositive.

          4. Historical relapse of at least 2 relapses in the last 12 months or 3 relapses in the
             last 24 months with at least 1 relapse in the 12 months prior to the screening.

          5. Expanded Disability Status Scale score ≤ 7.

          6. If a participant entered the study receiving immunosuppressive therapy (IST) for
             relapse prevention, the participant must have been on a stable maintenance dose of
             IST(s), as defined by the treating physician, prior to Screening and must have
             remained on that dose for the duration of the study, unless the participant
             experienced a relapse.

          7. Female participants of childbearing potential were to have a negative pregnancy test
             (serum human chorionic gonadotropin). Participants were required to practice an
             effective, reliable, and medically approved contraceptive regimen during the study and
             for up to 5 months following discontinuation of treatment.

        Key Exclusion Criteria:

          1. Use of rituximab within 3 months prior to Screening.

          2. Use of mitoxantrone within 3 months prior to Screening.

          3. Use of intravenous immunoglobulin within 3 weeks prior to Screening.
A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo-matching Rapastinel
Intervention description: Rapastinel pre-filled syringes for IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1304.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams
      (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive
      treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in
      participants with Major Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Screening

          -  Have no more than partial response (< 50% improvement) to ongoing treatment with a
             protocol-allowed antidepressant

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Screening

          -  Lifetime history of meeting DSM-5 criteria for:

          -  Schizophrenia spectrum or other psychotic disorder

          -  Bipolar or related disorder

          -  Major neurocognitive disorder

          -  Neurodevelopmental disorder of greater than mild severity or of a severity that
             impacts the participant's ability to consent, follow study directions, or otherwise
             safely participate in the study

          -  Dissociative disorder

          -  Posttraumatic stress disorder

          -  MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator.
A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1
Condition: Primary Hyperoxaluria; Primary Hyperoxaluria Type 1 (PH1)
MeSH terms: Hyperoxaluria, Primary
Intervention: Lumasiran
Intervention description: Lumasiran will be administered by subcutaneous (SC) injection.
Intervention MeSH terms: Lumasiran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 0 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: PH1; Primary Hyperoxaluria; Hyperoxaluria; RNAi Therapeutic; siRNA; AGT

Summary:

      The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and
      pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary
      hyperoxaluria type 1 (PH1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has genetic confirmation of primary hyperoxaluria type 1 (PH1)

          -  Meets urinary oxalate excretion requirements

          -  If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90
             days

        Exclusion Criteria:

          -  If <12 months old at screening, has an abnormally high serum creatinine

          -  If ≥12 months old at screening, has an estimated glomerular filtration rate (GFR) of
             ≤45 mL/min/1.73m^2

          -  Clinical evidence of systemic oxalosis

          -  History of kidney or liver transplant
Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation
Condition: Invasive Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Eucerin; Mometasone Furoate 0.1%
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Status post mastectomy; plan to receive PMRT; Topical; steroid cream; emollient skin care; Eucerin; Mometasone Furoate 0.1%

Summary:

      The purpose of this study is to find out if the effect of mometasone furoate is any different
      from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing
      the skin from peeling, or reducing the amount of irritation the patient reports during
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC

          -  Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary
             lymph node dissection) to receive PMRT

          -  ECOG Performance Status of 0 or 1

        Exclusion Criteria:

          -  Male

          -  Patients with clinical evidence of gross disease

          -  Patients who are pregnant or breastfeeding

          -  Prior radiation therapy to the ipsilateral chest wall or thorax

          -  Patients requiring a chest wall boost

          -  Concurrent chemotherapy (biologic agents are allowed)

          -  Psychiatric illness that would prevent the patient from giving informed consent

          -  Inability or unwillingness to comply with skin care instructions and follow-up

          -  Allergy to either Eucerin or MF

          -  Residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at
             intended site of study drug application at the time of the start of RT

          -  Medical condition such as uncontrolled infection (including HIV), uncontrolled
             diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other
             collagen vascular diseases)

          -  Treatment with palliative or pre-operative radiation
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Condition: HIV-1 Infection
Intervention: DTG; F/TAF; B/F/TAF; DTG Placebo; F/TAF Placebo; B/F/TAF Placebo
Intervention description: 50 mg tablets administered orally, once daily; 200/25 mg tablets administered orally, once daily; 50/200/25 milligrams (mg) FDC tablets administered orally, once daily; Tablets administered orally, once daily; Tablets administered orally, once daily; Tablets administered orally, once daily
Intervention MeSH terms: Dolutegravir; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 657.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      This primary objective of this study is to evaluate the efficacy of a fixed dose combination
      (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus
      dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1
      infected, antiretroviral treatment-naive adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral
             agent following a diagnosis of HIV-1 infection) except the use for pre-exposure
             prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to
             screening

          -  Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at
             screening

          -  Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL per minute (min)
             (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula

        Key Exclusion Criteria:

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening

          -  Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance

          -  Females who are pregnant (as confirmed by positive serum pregnancy test)

          -  Females who are breastfeeding

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Lubiprostone; Placebo
Intervention description: Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID); Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as
      compared to matching placebo, when administered orally to subjects with chronic idiopathic
      constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of
      fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically-confirmed diagnosis of chronic idiopathic constipation

          -  Willing to discontinue use of prescribed or over-the-counter (OTC) medication that
             affects gastrointestinal motility during the study

          -  Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific
             reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors

        Exclusion Criteria:

          -  Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or
             defecation.

          -  Medical/surgical condition that might interfere with the absorption, distribution,
             metabolism, or excretion of the study medication.