bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab; Adalimumab
Intervention description: Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio; Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 853.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; secukinumab; adalimumab; monoclonal antibody; CASPAR

Summary:

      This was a randomized, double-blind, active controlled, multicenter, parallel-group study
      evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients
      with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or
      having inadequate response to conventional disease modifying anti-rheumatic drugs (also known
      as non-biologic DMARDs).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of PsA classified by CASPAR

          -  Rheumatoid factor and anti-CCP antibodies negative

          -  Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of >= 2cm
             diameter or nail changes consistent with psoriasis or documented history of plaque
             psoriasis

          -  Inadequate control of symptoms with NSAIDs

          -  Inadequate control of symptoms with a conventional DMARD.

        Key Exclusion Criteria:

          -  Pregnant or nursing women

          -  Evidence of ongoing infectious or malignant process

          -  Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis

          -  Subjects taking high potency opioid analgesics

          -  Ongoing use of prohibited psoriasis treatments/medications

          -  Previous treatment with any cell-depleting therapies including but not limited to
             anti-CD20 investigational agents.
An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine
Intervention description: Rotigotine transdermal patches:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
Optimal dosing:
The maximum rotigotine dose allowed is 16 mg/24 hours.
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: All
Minimum age: 31 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro®

Summary:

      The objective of this open-label extension is to assess the safety and tolerability of
      long-term treatment of rotigotine in subjects with idiopathic PD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed treatment in one of the SP824 (NCT00242008), SP825
             (NCT00243971), or SP826 (NCT00243945) trials

        Exclusion Criteria:

          -  Subjects who had an ongoing serious adverse event from the previous OLE trial that was
             assessed as related to study medication
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Daridorexant 25 mg; Daridorexant 50 mg; Placebo
Intervention description: Daridorexant will be administered as tablets, orally, once daily in the evening.; Daridorexant will be administered as tablets, orally, once daily in the evening.; Matching placebo will be administered as tablets, orally, once daily in the evening.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 930.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant)
      in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective
      and subjective sleep parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure;

          -  Male or female aged ≥ 18 years;

          -  Insomnia disorder according to DSM-5 criteria;

          -  Insomnia Severity Index score ≥ 15;

          -  Insufficient sleep quantity as collected subjectively in the sleep diary;

          -  Women of childbearing potential must have a negative and urine pregnancy test and use
             the contraception scheme up to at least 30 days after last study treatment intake.

        Exclusion Criteria:

          -  Body mass index below 18.5 or above 40.0 kg/m2;

          -  Any lifetime history of of related breathing disorder, periodic limb movement
             disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM)
             behavior disorder, narcolepsy, or apnea/ hypopnea;

          -  Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1
             month prior to Visit 3 and the subject agrees to continue this CBT throughout the
             study;

          -  Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;

          -  Acute or unstable psychiatric conditions diagnosed by the Mini International
             Neuropsychiatric Interview;

          -  Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;

          -  For female subjects: pregnant, lactating or planning to become pregnant during
             projected duration of the study;

          -  History or clinical evidence of any disease or medical condition or treatment, which
             may put the subject at risk of participation in the study or may interfere with the
             study assessments.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             the subject's full participation in the study or compliance with the protocol.
Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
Condition: Major Depression Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Adjunct brexpiprazole; ADT
Intervention description: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.; Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as
      adjunctive treatment in an elderly population with major depressive disorder and an
      inadequate response to antidepressant treatment
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  • The patient is a man or woman aged ≥65 yrs

               -  The patient has Major Depressive Disorder according to Diagnostic and Statistical
                  Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™).

               -  The patient has an inadequate response to at least one adequate antidepressant
                  treatment in the current Major Depressive Episode (MDE).

               -  The patient has had the current MDE for ≥8 weeks

               -  The patient is currently treated with a protocol specified ADT for at least 6
                  weeks

               -  The patient is judged to benefit from adjunctive treatment with brexpiprazole
                  according to the clinical opinion of the investigator.

               -  Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at
                  screening and baseline

               -  Clinical Global Impression - Severity (CGI-S) total score ≥3 at screening and
                  baseline

        Main Exclusion Criteria:

          -  • The patient has a clinically significant unstable illness

               -  The patient has newly diagnosed or unstable diabetes

               -  The patient has a Mini Mental State Exam (MMSE) score <24

               -  The patient has received Transcranial Magnetic Stimulation (TMS) and/or
                  electroconvulsive therapy (ECT) less than 6 months prior to the Screening.

               -  The patient, in the opinion of the investigator or based on Columbia-Suicide
                  Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at
                  significant risk of suicide

        Other protocol defined inclusion and exclusion criteria may apply
Kansas University DHA Outcome Study (KUDOS) Follow-Up
Condition: Pregnancy
Intervention: DHA; Placebo Capsule
Intervention description: 600 mg DHA capsule; 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 190.0
Sex: Female
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: DHA; childhood development

Summary:

      This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to
      follow-up with participants on the original study to determine if the effects of increasing
      DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at
             enrollment (date/ultrasound)

          -  Agree to consume study capsules from enrollment until delivery

          -  Agree to return to the study center for delivery

          -  BMI < 40

          -  No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted
             diseases, not HIV positive)

          -  Available by telephone

        Exclusion Criteria:

          -  Less than 16 or greater than 35 years of age

          -  BMI < 40

          -  Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV
             positive

          -  Expecting multiple infants

          -  Diabetes or gestational diabetes at baseline

          -  Elevated blood pressure due to any cause

          -  Not planning to return to the study center for delivery

          -  Gestational age at baseline < 8 weeks or >20 weeks

          -  Unable or unwilling to agree to consume capsules until delivery

          -  Unable to provide informed consent in English
Methotrexate - Inadequate Response Device Sub-Study
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept combination product (ACP)
Intervention description: Abatacept Solution, Subcutaneous, 125 mg/device, Weekly, 3 months
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and acceptability of a device used in
      place of traditional syringes for abatacept self-injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, ages ≥ 18

          -  Participants who are considered methotrexate inadequate responders (MTX-IR)

          -  10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint
             count)

          -  Participants were to have been enrolled in the main MTX-IR study and been treated with
             open label abatacept for at least 3 months in the long term period

        Exclusion Criteria:

          -  Participants who failed one or multiple anti-tumor necrosis factor (TNF) therapies

          -  Participants who meet diagnostic criteria for any other rheumatic disease (e.g., lupus
             erythematosus)

          -  Participants with active vasculitis of a major organ system (except for subcutaneous
             rheumatoid nodules)

          -  Participants with severe chronic or recurrent bacterial infections

          -  Participants who have received treatment with rituximab
Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
Condition: Bipolar Mania; Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Placebo; Ziprasidone Oral Capsule
Intervention description: Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.; Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 584.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue
      to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or
      mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

        Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth
        Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)

        Exclusion Criteria:

        Ultra rapid cyclers and subjects with significant cardiovascular disease including history
        of QT prolongation and/or congenital long QT syndrome
Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Intervention: inotuzumab ozogamicin; rituximab; rituximab; cyclophosphamide; vincristine; prednisone/prednisolone; mitoxantrone; fludarabine; dexamethasone
Intervention description: IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.; IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.; intravenous rituximab at a dose of 375 mg/m2 on day 1; intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1; intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1; oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5; mitoxantrone 10 mg/m2 intravenous on day 2; fludarabine 25 mg/m2 intravenous on days 2 through 4; oral dexamethasone 20 mg/day on days 1-5
Intervention MeSH terms: Dexamethasone; Prednisone; Prednisolone; Cyclophosphamide; Rituximab; Fludarabine; Vincristine; Mitoxantrone; Inotuzumab Ozogamicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given
      with rituximab compared to a defined investigator's choice therapy. Subjects will be
      randomized to one of these two arms of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who have
             received 1 or 2 prior regimens, at least 1 of which should have contained
             administration of rituximab (either as a single agent or in combination).

          -  Age 18 years or older.

          -  ECOG performance status <= 2.

          -  ANC >= 1.5 x 10^9/L (1500/mL) and platelets >= 75 x 10^9/L (75,000/mL), serum
             creatinine <= 1.5 x ULN and urine protein to creatinine ratio of <= 0.5, total
             bilirubin <= 1.5 x ULN, AST and ALT <= 2.5 x ULN.

          -  At least 1 measurable disease lesion that is >= 1.5 cm x 1.5 cm by CT or MRI, in an
             area of no prior radiation therapy, or documented progression in an area that was
             previously irradiated.

        Exclusion Criteria:

          -  Subjects with clinical evidence of transformation to a more aggressive subtype of
             lymphoma or grade 3b follicular lymphoma.

          -  Subjects whose disease is rituximab refractory, meaning that they did not have a CR or
             PR, or that they experienced disease progression within 6 months from the initiation
             of the rituximab or rituximab containing treatment regimen administered immediately
             preceding study enrollment.
Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Clindamycin 1% Gel; Placebo
Intervention description: Topical gel; Topical Placebo gel
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1125.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study,
      designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the
      marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.
    

Eligibility criteria:

        IInclusion Criteria:

          -  Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical
             diagnosis of acne vulgaris.

          -  Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25
             non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions
             (nodules and cysts) and have an IGA score of 2, 3 or 4.

        Exclusion Criteria:

          -  Subject has more than 2 facial nodular lesions; any nodules present will be documented
             but not included in the inflammatory lesion count for analysis.

          -  Subject has active cystic acne.

          -  Subject has acne conglobata.

          -  Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that
             would interfere with the diagnosis or assessment of acne.
A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Desloratadine 5 mg; Placebo
Intervention description: Desloratadine 5 mg tablets; Matching placebo to desloratadine 5 mg tablets
Intervention MeSH terms: Desloratadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 608.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Rhinitis; Allergic Rhinitis; Nose Diseases; Respiratory Tract Diseases; Immune System Diseases; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents

Summary:

      This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese
      participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine
      is superior to placebo after 2 weeks of treatment with regard to change from baseline in
      Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with perennial allergic rhinitis

          -  Outpatient.

        Exclusion Criteria:

          -  Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper
             respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.)

          -  Coexisting infections or systemic mycosis for which there are no effective antibiotics

          -  Asthma complication under treatment

          -  Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed

          -  Vasomotor rhinitis or eosinophilic rhinitis

          -  Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic
             rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the
             evaluation of the efficacy of the study drug

          -  History of hypersensitivity to antihistamines or study drug

          -  Currently receiving treatment with another investigational drug or has received an
             investigational drug in the past 3 months

          -  Has started specific desensitization therapy or nonspecific allassotherapy
             (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90
             days (3 months) before the day of obtaining informed consent

          -  Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting
             diseases and whose general condition is poor

          -  History of malignancy or clinically important hematological disorder

          -  History of severe drug allergy (e.g., anaphylactoid reaction).