bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-118 Lotion
Intervention description: IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 555.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the long-term safety of IDP-118 lotion.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a Body
             Surface Area (BSA) of at least 3 percent (%), but no more than 12%. The face, scalp,
             palms, soles, axillae and intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigators
             Global Assessment (IGA) score of 3 or 4 (The face, scalp, palms, soles, axillae and
             intertriginous areas are to be excluded in this assessment).

        Key Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             Investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently
             participating in another clinical study with an investigational drug or device.
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CT-P43; Stelara
Intervention description: 45mg or 90mg dose subcutaneous administration; 45mg or 90mg dose subcutaneous administration
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 509.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is a randomized, active-controlled, double-blind, phase 3 study to compare the
      efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.

        Exclusion Criteria:

          -  Patients diagnosed with forms of psoriasis other than plaque-type.

          -  Patients previously received ustekinumab or a biosimilar of ustekinumab.

          -  Patient who has allergies to the active substance or any of the excipients of
             ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin
             products or natural rubber and latex.
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Condition: Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Acute Coronary Syndrome; Atherosclerosis
Intervention: Alirocumab; Placebo; LMT
Intervention description: Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.; Placebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.; Statins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other LMT as clinically indicated.
Intervention MeSH terms: Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18924.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV)
      events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial
      infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring
      hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to
      52 weeks prior to randomization and were treated with evidence-based medical and dietary
      management of dyslipidemia.

      Secondary Objectives:

        -  To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD
           event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic
           stroke, CHD deaths, CV deaths, all cause mortality).

        -  To evaluate the safety and tolerability of alirocumab.

        -  To evaluate the effect of alirocumab on lipid parameters.
    

Eligibility criteria:

        Inclusion criteria :

        Recently (< 52 weeks) hospitalized for ACS.

        Exclusion criteria:

          -  Age < 40 years.

          -  ACS event occurring more than 52 weeks prior to randomization visit.

          -  LDL-C likely to be <70 mg/dL (<1.81 mmo/L), and apolipoprotein B (ApoB) <80 mg/dL
             (<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) <100 mg/dL (<2.59
             mmol/L) with evidence-based medical and dietary management of dyslipidemia.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
Condition: Eczema
MeSH terms: Eczema
Intervention: alitretinoin; Placebo
Intervention description: Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks; Patients receive matching placebo for up to 24 weeks
Intervention MeSH terms: Alitretinoin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: retinoid treatment; fingertip dermatitis; hyperkeratotic hand eczema; vesicular hand eczema; pompholyx

Summary:

      The purpose of this study is to investigate the safety and efficacy of alitretinoin in the
      treatment of severe chronic hand eczema that does not respond to treatment with potent
      topical steroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all types of chronic hand eczema, lasting for at least 6 months since initial
             diagnosis

          -  rated as severe by the physician

          -  unresponsive to highly potent topical corticosteroids, such as clobetasol

        Exclusion Criteria:

          -  patients whose disease is adequately controlled by standard non-medicated therapy,
             including potent topical steroids, skin moisturizers, and avoidance of allergens and
             irritants

          -  patients with known allergens and irritants, who have not made a reasonable effort to
             avoid the substances

          -  patients with psoriasis lesions

          -  active fungal, bacterial or viral infections of the hands

          -  female patients who are pregnant or breastfeeding

          -  female patients of childbearing potential who cannot use or will not commit to use two
             effective methods of contraception
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
Condition: Diabetes Mellitus, Non-Insulin-Dependent; High Risk for Cardiovascular Event
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin 10 mg; Placebo tablet
Intervention description: Oral dose (od); Oral dose (od)
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17190.0
Sex: All
Minimum age: 40 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Phase IIIb; T2DM; cardiovascular events

Summary:

      This study is being carried out to determine the effect of dapagliflozin on cardiovacular
      outcomes when added to current background therapy in patients with type 2 diabetes with
      either established cardiovacular disease or cardiovascular risk factors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Female or male aged ≥40 years

          -  Diagnosed with Type 2 Diabetes

          -  High Risk for Cardiovascular events

        Exclusion Criteria:

          -  Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of
             radiation therapy to the lower abdomen or pelvis at any time

          -  Chronic cystitis and/or recurrent urinary tract infections

          -  Pregnant or breast-feeding patients
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Lebrikizumab
Intervention description: Subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Eczema; Dermatitis; Dermatitis, Atopic; Skin Diseases

Summary:

      This is an open-label, single arm study of 52 weeks duration. The study will assess the
      safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40
      kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).

          2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has
             been present for ≥1 year before the screening visit.

          3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.

          4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit

          5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.

          6. History of inadequate response to treatment with topical medications; or determination
             that topical treatments are otherwise medically inadvisable.

        Exclusion Criteria:

          1. Participation in a prior lebrikizumab clinical study.

          2. Treatment with the following prior to the baseline visit:

               1. An investigational drug within 8 weeks or within 5 half-lives (if known),
                  whichever is longer.

               2. Dupilumab within 8 weeks.

               3. B-cell-depleting biologics, including to rituximab, within 6 months.

               4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.

          3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
             planned during the study.

          4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.

          5. Evidence of active acute or chronic hepatitis

          6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
             screening.

          7. History of malignancy, including mycosis fungoides, within 5 years before the
             screening visit, except completely treated in situ carcinoma of the cervix, completely
             treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

          8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study.
An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
Condition: Brain Neoplasms
MeSH terms: Glioblastoma; Brain Neoplasms
Intervention: Nivolumab; Temozolomide; Radiotherapy; Nivolumab Placebo
Intervention MeSH terms: Nivolumab; Temozolomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 716.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated
      (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus
      radiation therapy. They will be compared to patients receiving nivolumab in addition to
      temozolomide plus radiation therapy.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Males and Females, age ≥ 18 years old

          -  Newly diagnosed brain cancer or tumor called glioblastoma or GBM

          -  Karnofsky performance status of ≥ 70 (able to take care of self)

          -  Substantial recovery from surgery resection

          -  Tumor test result shows MGMT methylated or indeterminate tumor subtype

        Exclusion Criteria:

          -  Biopsy-only of GBM with less than 20% of tumor removed

          -  Prior treatment for GBM (other than surgical resection)

          -  Any known tumor outside of the brain

          -  Recurrent or secondary GBM

          -  Active known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: Volanesorsen; Placebo
Intervention description: 300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.; Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26
      weeks in participants with Hypertriglyceridemia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Body mass index (BMI) ≤ 45 kg/m2

          2. Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.

          3. If on statin or fibrate, participants must be on stable, labeled dose for at least 3
             months prior to screening. Participants not receiving these drugs within 4 weeks prior
             to screening are also eligible.

        Exclusion Criteria:

          1. Type 1 diabetes mellitus

          2. Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥
             9.0% at Screening

          3. Acute pancreatitis within 3 months of screening

          4. Acute Coronary Syndrome within 6 months of screening

          5. Major surgery within 3 months of screening

          6. Prior exposure to ISIS 304801

          7. Have any other conditions in the opinion of the investigator which could interfere
             with the participant participating in or completing the study
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Condition: Asthma
MeSH terms: Asthma
Intervention: QAW039; QAW039; Placebo
Intervention description: QAW039 150 mg once daily; QAW039 450 mg once daily; Placebo once daily
Intervention MeSH terms: Indoleacetic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 877.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; QAW039

Summary:

      This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to
      placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care
      (SoC) asthma therapy (GINA 2016) in the following two populations:

        -  patient with inadequately controlled severe asthma and high eosinophil counts
           (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)

        -  patients with inadequately controlled severe asthma (overall study population)
           Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent.

          -  Male and female patients aged ≥12 years.

          -  A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.

          -  Evidence of airway reversibility or airway hyper- reactivity.

          -  FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for
             patients aged 12 to <18 years

          -  An ACQ score ≥1.5

          -  A history of 2 or more asthma exacerbations within the 12 months prior to entering the
             study.

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of study entry, or within 30
             days, whichever is longer.

          -  Subjects who have participated in another trial of QAW039.

          -  A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).

          -  History of malignancy with the exception of local basal cell carcinoma of the skin.

          -  Pregnant or nursing (lactating) women.

          -  Serious co-morbidities.

          -  Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or
             >2 mg of pitavastatin.
ARTEMIS Peanut Allergy In Children
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101 powder provided in capsules & sachets; Placebo powder provided in capsules & sachets
Intervention description: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol; Study product formulated to contain only inactive ingredients for use as defined in the protocol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; ARTEMIS; Allergy

Summary:

      The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral
      immunotherapy (OIT) in peanut-allergic children.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 4 to 17 years, inclusive

          -  Clinical history of allergy to peanuts

          -  Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L

          -  Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg

          -  Written informed consent from the subject's parent/guardian

          -  Written assent from the subject as appropriate (per local regulatory requirements)

          -  Use of effective birth control by sexually active female subjects of childbearing
             potential

        Key Exclusion Criteria:

          -  History of cardiovascular disease, including uncontrolled or inadequately controlled
             hypertension

          -  History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma
             (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control

          -  History of severe or life threatening episode of anaphylaxis or anaphylactic shock
             within 60 days of screening

          -  History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal
             disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),
             symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology

          -  History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic
             idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold
             urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema

          -  Any other condition that, in the opinion of the Investigator, precludes participation
             for reasons of safety