bioihbjkbjnl/mcl2 huggingface dataset:
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: BIBW 2992; trastuzumab; vinorelbine; vinorelbine
Intervention description: patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management; patients receive trastuzumab 2mg/kg intravenously every week; patients receive vinorelbine 25mg/m² intravenously every week; patients receive vinorelbine 25mg/m² intravenously every week
Intervention MeSH terms: Trastuzumab; Vinorelbine; Afatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 508.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v.
      chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who
      failed one prior trastuzumab (Herceptin®) treatment
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed diagnosis of HER2-overexpression breast cancer

          -  Stage IV metastatic disease

          -  Must have progressed on one prior trastuzumab treatment

          -  no more than one prior trastuzumab based therapy regimen (either adjuvant or
             first-line)

          -  Must have received anthracycline and/or taxane based chemotherapy for adjuvant
             treatment of breast cancer or first-line treatment of metastatic breast cancer

          -  Must have (archived) tumour tissue sample available for central re-assessment of
             HER2-status

          -  At least one measurable lesion according to RECIST 1.1.

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .

        Exclusion criteria:

          -  Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor
             Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab

          -  Prior treatment with vinorelbine

          -  Known pre-existing interstitial lung disease

          -  Active brain metastases

          -  History or presence of clinically relevant cardiovascular abnormalities such as
             uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable
             angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to
             randomisation.

          -  Cardiac left ventricular function with resting ejection fraction of less than 50%.

          -  Patients unable to comply with the protocol.

          -  Any contraindications for therapy with vinorelbine or trastuzumab.

          -  Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.

          -  Use of any investigational drug within 4 weeks of randomisation.

          -  Inadequate hepatic, renal and haematologic organ function
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: SAGE-217 15/20 mg Oral Solution; Placebo; SAGE 217 30 mg Capsules
Intervention description: SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).; SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.; SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Postpartum Care

Summary:

      The primary purpose of this study was to determine if treatment with SAGE-217 reduces
      depressive symptoms in participants with severe postpartum depression (PPD) compared to
      placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for
      Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of
      SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign
      measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the
      Columbia Suicide Severity Rating Scale (C-SSRS).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant either must have ceased lactating at screening or, if still lactating or
             actively breastfeeding at screening, must agree to temporarily cease giving breast
             milk to her infant(s)

          -  Participant has had a Major Depressive Episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by the
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders (DSM)-5 Axis I Disorders (SCID-I)

          -  Participant was <=six months postpartum.

        Key Exclusion Criteria:

          -  Active psychosis

          -  Attempted suicide associated with current episode of postpartum depression

          -  Medical history of seizures

          -  Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

        Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion
        criteria might apply.
Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-120 Gel; IDp-120 Vehicle Gel
Intervention description: IDP-120 Gel, once-daily application; IDP-120 Vehicle Gel, once-daily application
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
Enrollment: 608.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120
      Vehicle Gel
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older;

          2. Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit);

          3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
             Severity Score (EGSS) assessment at the baseline visit;

          4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20 but no more than 50;

          5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
             less than 25 but no more than 100;

          6. Subjects with two or fewer facial nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study;

          2. Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis,
             eczema;

          3. Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive;

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments;

          5. Subjects with more than two (2) facial nodules;

          6. Evidence or history of cosmetic-related acne
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BGF MDI 320/14.4/9.6 μg; GFF MDI 14.4/9.6 μg; BFF MDI 320/9.6 μg
Intervention description: Budesonide, Glycopyrronium, and Formoterol Fumarate; Glycopyrronium and Formoterol Fumarate; Budesonide and Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-Blind
Enrollment: 627.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with
      Moderate to Very Severe Chronic Obstructive Pulmonary Disease
    

Eligibility criteria:

        Inclusion Criteria:

        Given their signed written informed consent to participate. Must have agreed to participate
        in and complete the lead-in Study PT010006.(NCT02497001)

        Exclusion Criteria:

        Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil
        dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are
        scheduled to undergo cataract surgery
Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS; Placebo
Intervention description: topical product; topical product
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 373.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III
      Clinical Study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp,
             defined by an Investigator's Global Assessment (IGA) score of at least 2 at
             baseline/randomization

        Exclusion Criteria:

          -  Patients whose scalp psoriasis necessitates systemic or other concomitant topical
             therapies during the study (concomitant treatment of body psoriasis with over the
             counter topical products including emollients, is allowed).

          -  Patient has a scalp skin condition that would interfere with the diagnosis or
             assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema,
             cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse,
             pustular or erythrodermic psoriasis)

          -  Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the
             treatment areas that could interfere with the rating of efficacy parameters, including
             planned extensive exposure to sunlight during the study.

          -  History of psoriasis unresponsive to topical treatments.

          -  Current immunosuppression or history of organ transplant.

          -  Patients who have a history of or current diagnosis of glaucoma.

          -  Patients who have had surgery on the eyes or eyelids within 1 month before baseline or
             plan to have eye or eyelid surgery during the study.

          -  Patients with active infection (including but not limited to bacterial, fungal and
             viral infection) and/or open wounds on the entire head and neck area.
A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
Condition: Plaque Type Psorisis
MeSH terms: Psoriasis
Intervention: Secukinumab
Intervention description: Secukinumab was supplied as 150 mg solution in pre-filled syringe for subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Arms represent stratification of Cw6 positive and Cw6 negative patients
Masking: None (Open Label)
Enrollment: 434.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the differences in the efficacy and safety of secukinumab between
      Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must have been able to understand and communicate with the investigator and to
             comply with the requirements of the study and must have given a written, signed and
             dated informed consent before any study related activity was performed.

          2. Men or women at least 18 years of age at time of screening.

          3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months
             (including concomitant psoriatic arthritis as per the Classification Criteria for
             Psoriatic Arthritis criteria [CASPAR]).

          4. Moderate to severe psoriasis as defined at enrollment by:

               -  PASI score ≥ 10 or

               -  PASI score > 5 but < 10 and DLQI ≥10

          5. Patients that are candidates for systemic therapy, whether treatment naïve or after
             failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA)
             or to an anti-TNFα (or is intolerant and/or has a contraindication to these).

        Exclusion criteria

          1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
             guttate psoriasis).

          2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.

          3. Anti-TNFα therapy within timelines depending on drug half-life.

          4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17
             or the IL-17 receptor.

          5. Previous exposure to ustekinumab or any other biologic drug for the treatment of
             psoriasis that was not anti-TNFα therapy.

          6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during
             screening.

          7. Ongoing use of corticosteroid topical treatments or UV therapy.
Anxiolytic and Analgesic Effects of Melatonin
Condition: Anxiety
Intervention: Melatonin; Placebo
Intervention description: Gelatin capsules; Placebo capsules
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: Female
Healthy volunteers: No
Keywords: Melatonin; Surgery; Pharmacokinetic; Anxiolytic

Summary:

      The study's main objective is to investigate melatonin's anxiolytic and sleep-regulating
      effects in patients undergoing surgery. Moreover, the investigators intend to investigate the
      pharmacokinetic parameters of melatonin in this patient population.
    

Eligibility criteria:

        Inclusion Criteria part one:

          -  Patients who are candidates for breast surgery.

          -  BMI between 18 and 30

          -  Visible veins in the elbow region

          -  Fertile women use anti-contraception and have performed a negative pregnancy test

        Exclusion Criteria part one:

          -  Patients, who use daily opioids, benzodiazepines or melatonin

          -  Patients diagnosed with a psychiatric disorder (defined as in medical treatment)

          -  Patients with severe physical disease (ASA 3-4)

          -  Patients with previous or ongoing alcohol or drug abuse

          -  Patients with liver disease (defined as in medical treatment)

          -  Patients diagnosed sleep disturbances

          -  Patients who are unable to cooperate according to the protocol

          -  Patients with allergy to melatonin

        Inclusion Criteria part two:

        - Male patients who are candidates for inguinal or umbilical hernia reapir

        Exclusion Criteria part two:

          -  Patients, who use daily opioids, benzodiazepines or melatonin

          -  Patients diagnosed with a psychiatric disorder (defined as in medical treatment)

          -  Patients with severe physical disease (ASA 3-4)

          -  Patients with previous or ongoing alcohol or drug abuse

          -  Patients with liver disease (defined as in medical treatment)

          -  Patients diagnosed sleep disturbances

          -  Patients who are unable to cooperate according to the protocol

          -  Patients with allergy to melatonin

        Withdrawal- and drop-out criteria part 2:

          -  Patients can withdraw at any time during trial

          -  Complications during surgery occur that lead to:

               1. Immediate reoperation

               2. Hospitalization to intensive care unit

          -  If it is considered in the best interest of the patients physical- and psychological
             health to withdraw from the trial
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Nivolumab; Topotecan; Amrubicin
Intervention MeSH terms: Nivolumab; Topotecan; Amrubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 569.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy
      in subjects with relapsed SCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed small cell lung cancer (SCLC)

          -  Subjects with either limited or extensive disease stage at the initial diagnosis

          -  Must have recurrence or progression after platinum-based first-line chemotherapy or
             chemoradiation therapy for the treatment of limited or extensive disease stage SCLC

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion Criteria:

          -  Untreated or symptomatic central nervous system (CNS) metastases

          -  Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4
             antibody

          -  Inadequate hematologic or hepatic function
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Placebo; SM-13496; SM-13496
Intervention description: Placebo comparator; SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6; SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 525.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients
      with Bipolar I Depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who were fully informed of and understand the objectives, procedures, and
             possible benefits and risks of the study and who provided written voluntary consent to
             participate in the study.

          -  Outpatients aged 18 through 74 years at the time of consent

          -  Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode
             depressed (≥ 4 weeks and less than 12 months) without psychotic features.

        Exclusion Criteria:

          -  Patients with imminent risk of suicide or injury to self, others, or property.

          -  Patients who had been hospitalized because of a manic or mixed episode within 60 days
             prior to screening.

          -  Patients who are otherwise considered ineligible for the study by the investigator.