bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: placebo for risankizumab IV; risankizumab SC; risankizumab IV
Intervention description: placebo for risankizumab administered as intravenous (IV) infusion.; risankizumab administered by subcutaneous (SC) injection; risankizumab administered as intravenous (IV) infusion.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 618.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ABBV-066; BI 655066

Summary:

      The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus
      placebo during induction therapy in participants with moderately to severely active CD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to
             local regulations, at the Baseline Visit. Where locally permissible, participants 16
             to < 18 years of age who meet the definition of Tanner stage 5 for development at the
             Baseline Visit.

          -  Confirmed diagnosis of CD for at least 3 months prior to Baseline.

          -  Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.

          -  Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
             abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).

          -  Demonstrated intolerance or inadequate response to biologic therapy for CD.

          -  If female, participant must meet the contraception recommendations.

        Exclusion Criteria:

          -  Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

          -  Participants with unstable doses of concomitant Crohn's disease therapy.

          -  Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab,
             certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab
             within 12 weeks prior to Baseline), or any investigational biologic or other agent or
             procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is
             longer.

          -  Prior exposure to p19 inhibitors (e.g., risankizumab).

          -  Complications of Crohn's disease.

          -  Having an ostomy or ileoanal pouch.

          -  Known active Coronavirus Disease 2019 (COVID-19) infection.
Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)
Condition: Metastatic Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Ibrutinib; Gemcitabine; Nab-paclitaxel
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 430.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with
      nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic
      pancreatic adenocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.

          2. Stage IV disease diagnosed within 6 weeks of randomization

          3. Adequate hematologic function:

               -  Absolute neutrophil count (ANC) ≥1.5 x 109/L

               -  Platelet count ≥100 x 109/L

               -  Hemoglobin ≥9 g/dL

          4. Adequate hepatic and renal function defined as:

               -  AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x
                  ULN without liver metastases

               -  Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present

               -  Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of
                  non-hepatic origin, such as hemolysis)

               -  Estimated Creatinine Clearance ≥30 mL/min

          5. PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN

          6. KPS ≥70.

          7. Eastern Cooperative Oncology Group (ECOG) 0-1

        Exclusion Criteria:

          1. Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or
             cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.

          2. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma

          3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in
             case of clinical suspicion of central nervous system involvement).

          4. Major surgery within 4 weeks of first dose of study drug.

          5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

          6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: tapinarof cream, 1%
Intervention description: Intermittent use of Tapinarof cream, 1%, applied once daily according to PGA score
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Subjects in this study completed treatment with tapinarof or vehicle in 1 of 2 parent Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). The study will consist of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period.
Masking: None (Open Label)
Enrollment: 763.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Tapinarof; plaque psoriasis,; adult; phase 3; topical; open-label; efficacy; safety; psoriasis; long-term; therapeutic aryl hydrocarbon receptor modulating agent

Summary:

      This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of
      topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed
      treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study
      DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety
      follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed the 12-week treatment period in 1 of the 2 parent studies (Study
             DMVT-505-3001 or Study DMVT-505-3002);

          2. Male and female subjects

          3. Females of child bearing potential and male subjects who are engaging in sexual
             activity that could lead to pregnancy agree to follow the specified contraceptive
             guidance while on the study, and for at least 4 weeks after the last exposure to study
             treatment

          4. Capable of giving written informed consent

        Exclusion Criteria:

          1. Used a prohibited concomitant product or procedure to treat psoriasis during parent
             study

          2. Had a serious adverse event (SAE) that was potentially related to treatment or
             experienced an adverse event (AE) that led to permanent discontinuation of treatment
             in the parent study

          3. History of or ongoing serious illness or medical, physical, or psychiatric
             condition(s) that, in the Investigator's opinion, may interfere with the subject's
             completion of the study

          4. Known hypersensitivity to tapinarof
Optimizing Tobacco Dependence Treatment in the Emergency Department
Condition: Tobacco Use Disorder
MeSH terms: Emergencies; Tobacco Use Disorder
Intervention: Brief Negotiated Interview (BNI); Nicotine replacement therapy (NRT); CT Smokers Quitline (QL); SmokefreeText (Text)
Intervention description: Brief motivational interview on smoking behavior; 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.; Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.; Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Enrollment: 1056.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators propose an innovative full-factorial design in a cohort of 1056 adult
      smokers in an urban emergency department (ED), to test the efficacy of four key intervention
      components: motivational interviewing, medication, quitline referral, and texting. At the
      trial's completion, a mixed-methods approach will be used to identify the components that
      were efficacious within the proposed cost constraint, along with feasibility and
      acceptability to providers and subjects. The investigators will then assemble an intervention
      that maximizes efficacy, given a cost-effectiveness constraint and findings from a
      qualitative analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  have smoked >= 100 cigarettes lifetime

          -  describe themselves as every or some day smokers

          -  smoke at least 5 cigarettes/day

          -  own a cellphone with texting capability

          -  are able to give written informed consent

        Exclusion Criteria:

          -  Inability to read or understand English

          -  currently receiving formal tobacco dependence treatment

          -  life-threatening or unstable medical, surgical, or psychobehavioral condition

          -  unable to provide at least one collateral contact

          -  live out-of-state

          -  leaving the ED against medical advice

          -  pregnant (self-report or urine testing), nursing, or trying to conceive.
A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC.; Administered SC.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache; treatment-resistant; treatment resistant

Summary:

      The purpose of this study is to assess the safety and efficacy of galcanezumab in people with
      treatment-resistant episodic or chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of migraine or chronic migraine.

          -  History of migraine headaches at least 1 year prior to screening, with onset prior to
             age 50.

          -  History of at least 4 migraine headache days and at, with at least 1 headache-free day
             per month on average within the past 3 months.

          -  Have documentation of 2 to 4 migraine preventive medication category failures due to
             inadequate efficacy or tolerability, in the past 10 years.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to galcanezumab or another calcitonin gene-related
             peptide (CGRP) antibody.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine).

          -  Pregnant or nursing.
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Intervention description: Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks; Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; Etrasimod; APD334; UC

Summary:

      The purpose of this study is to determine whether oral etrasimod is a safe and effective
      treatment in adult Japanese participants with moderately to severely active ulcerative
      colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will
      continue with the same blinded treatment assigned in Study APD334-302 for a total treatment
      duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).
    

Eligibility criteria:

        Inclusion Criteria:

        Participants with moderately to severely active ulcerative colitis (UC) are eligible to
        enroll into this study if they fulfill all of the following:

          -  Must have completed the Week 12 visit of Study APD334-302

          -  Ability to provide written informed consent or assent (parent or legal guardian must
             provide consent for a participant < 20 years of age or as required per local
             regulations who has assented to participate in the study) and to be compliant with the
             schedule of protocol assessments. Enrollment of participants < 20 years should be
             conducted only if acceptable according to local laws and regulations.

          -  Both men and women subjects agree to use a highly effective method of birth control if
             the possibility of conception exists

        Exclusion Criteria:

        Participants who meet any of the following exclusion criteria will not be eligible for
        enrollment into the study:

          -  If the Investigator considers the participant to be unsuitable for any reason to
             participate in the study

          -  Participants requiring partial or total colectomy during the APD334-302 study

          -  Participants requiring treatment with prohibited concomitant medications
Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
Condition: Asthma
MeSH terms: Inflammation
Intervention: Benralizumab; Placebo
Intervention description: Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive; Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive
Intervention MeSH terms: Benralizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: asthma

Summary:

      This is a randomized, double-blind, parallel group, placebo-controlled study designed to
      evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4
      weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an
      inhaled allergen.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures

          2. Female or male aged 18 to 65 years, inclusively, at the time of enrolment.

          3. General good health

          4. Mild, stable, allergic asthma and asthma therapy limited to inhaled, short-acting beta
             2 agonists (not more than twice weekly)

          5. Positive skin-prick test to at least one common aeroallergen

        Exclusion Criteria:

          1. Current lung disease other than mild allergic asthma

          2. Any history or symptoms of disease, including, but not limited to, cardiovascular,
             neurologic, autoimmune or haematologic

          3. Any clinically significant abnormal findings in laboratory test results in complete
             blood count, coagulation, chemistry panel and urinalysis at enrolment and during
             screening period

          4. History of anaphylaxis to any biologic therapy or vaccine
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: FF; Placebo
Intervention description: fluticasone furoate 110 μg nasal spray; placebo nasal spray
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 301.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: GW685698X; perennial allergic rhinitis; allergic rhinitis

Summary:

      The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg
      once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent
      subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of perennial allergic rhinitis (PAR).

          -  Must comply with study procedures and be literate.

        Exclusion Criteria:

          -  Significant concomitant medical conditions.

          -  Use of corticosteroids.

          -  Use of allergy and other identified medications during the study.

          -  Current tobacco use or tobacco use within the past year.

          -  Exposure to an investigational study drug within the past 12 months.

          -  Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.
Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer
Condition: Carcinoma, Squamous Cell of Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; Cisplatin/Carboplatin; 5-fluorouracil
Intervention description: Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m^2) on Day 1 and a subsequent dose of 250 mg/m^2 on Day 8 and Day 15 of each 21-day treatment cycle.; Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.; Participants received 5-fluorouracil (FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.
Intervention MeSH terms: Carboplatin; Fluorouracil; Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial aimed to assess efficacy and safety of cetuximab when given in combination with
      chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or
      metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of SCCHN

          -  Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment

          -  Presence of at least 1 measurable lesion according to RECIST Version 1.1

          -  Signed written informed consent before any trial-related activities are carried out

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Other protocol-defined inclusion criteria could apply

        Exclusion Criteria:

          -  Prior systemic chemotherapy, except if given as part of multimodal treatment for
             locally advanced disease, that was completed within 6 months before randomization

          -  Surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before
             trial entry

          -  Previous treatment with monoclonal antibody or signal transduction inhibitors
             targeting epidermal growth factor receptor

          -  Nasopharyngeal carcinoma

          -  Known central nervous system metastasis and/or leptomeningeal disease

          -  Medical or psychological condition that would not permit the participant to complete
             the trial or sign informed consent

          -  Legal incapacity or limited legal capacity

          -  Other protocol-defined exclusion criteria could apply