bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Certolizumab Pegol; Placebo
Intervention description: Active Substance: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 200 mg/mL
Route of Administration: Subcutaneous use; Active Substance: Placebo
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 0.9 % saline
Route of Administration: Subcutaneous use
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia; Psoriasis

Summary:

      The purpose of this study is to investigate the efficacy and safety of two dose levels of
      certolizumab pegol in adults with moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provided informed consent

          -  Adult men or women >= 18 years

          -  Chronic plaque psoriasis for at least 6 months

          -  Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and
             Physician's Global Assessments score >= 3

          -  Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Erythrodermic, guttate, generalized pustular form of psoriasis

          -  History of current, chronic, or recurrent infections of viral, bacterial, or fungal
             origin as described in the protocol

          -  Congestive heart failure

          -  History of a lymphoproliferative disorder including lymphoma or current signs and
             symptoms suggestive of lymphoproliferative disease

          -  Concurrent malignancy or a history of malignancy as described in the protocol

          -  History of, or suspected, demyelinating disease of the central nervous system (e.g.,
             multiple sclerosis or optic neuritis)

          -  Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the
             study or within 3 months following last dose of study drug. Male subjects who are
             planning a partner pregnancy during the study or within 10 weeks following the last
             dose

          -  Any other condition which, in the Investigator's judgment, would make the subject
             unsuitable for participation in the study

          -  Other protocol-defined exclusion criteria may apply
Phase III Cat-PAD Follow-on Study
Condition: Cat Allergy
Intervention: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]; Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]; Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 430.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in
      cat allergic subjects for up to five years after the start of administration of treatment.
      The study is an optional follow-up study to a phase III double-blind, placebo controlled,
      Cat-PAD study; no further investigational product is administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  previously completed clinical study CP007 [NCT01620762]

        Exclusion Criteria:

          -  started allergen therapy since completing CP007

          -  Institutionalised due to a legal or regulatory order
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab; Ustekinumab
Intervention description: 300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48; Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.
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: 1114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque psoriasis; secukinumab; ustekinumab; ain457; ain457a

Summary:

      Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe
      plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must give a written, signed and dated informed consent

          -  Chronic plaque-type psoriasis present for at least 6 months before randomization

          -  Moderate to severe plaque psoriasis as defined at randomization by:

               -  PASI score of ≥12 and

               -  Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and

               -  IGA mod 2011 ≥3 (based on a scale of 0-4)

          -  Candidate for systemic therapy, defined as having psoriasis inadequately controlled
             by:

               -  Topical treatment (including topical corticosteroids) and/or

               -  Phototherapy and/or

               -  Previous systemic therapy

        Exclusion Criteria:

          -  Forms of psoriasis other than plaque psoriasis

          -  Drug-induced psoriasis

          -  Ongoing use of prohibited treatments

          -  Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A
             or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23

          -  Use of any other investigational drugs within 5 half-lives of the investigational
             treatment before study drug initiation

          -  Pregnant or nursing (lactating) women

        Other protocol-defined inclusion/exclusion criteria may apply
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Evolocumab
Intervention description: subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5035.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: High Cholesterol; Treatment for high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia

Summary:

      The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and
      well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease
      (CVD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent before initiation of any study-specific
             activities/procedures

          -  Subject has completed FOURIER (Study 20110118) while still receiving assigned
             investigational product.

        Exclusion Criteria:

          -  Investigational product was permanently discontinued during FOURIER for any reason,
             including an adverse event or serious adverse event

          -  Subject is currently receiving treatment in another investigational device or drug
             study, or ended treatment on another investigational device or drug study(ies) within
             less than 4 weeks. Other investigational procedures while participating in this study
             are excluded

          -  Subject is not likely to be available to complete protocol-required study visits or
             procedures and/or to comply with required study procedures to the best of the
             subject's and investigator's knowledge

          -  Subject has a history or evidence of any other clinically significant disorder,
             condition, or disease that, in the opinion of the investigator or Amgen physician, if
             consulted, would pose a risk to subject safety or interfere with the study evaluation,
             procedures, or completion

          -  Subject has a known sensitivity to any of the active substances or excipients (eg,
             sodium acetate) to be administered during dosing

          -  Female subject is pregnant or breastfeeding or is planning to become pregnant or
             planning to breastfeed during treatment with evolocumab and within 15 weeks after the
             end of treatment with evolocumab

          -  Female subjects of childbearing potential who are not willing to use an acceptable
             method(s) of effective birth control during treatment with evolocumab and for an
             additional 15 weeks after the end of treatment with evolocumab are excluded
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: CT-P13; Remicade
Intervention description: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose; Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is to assess noninferiority in efficacy and to assess overall safety of CT P13
      compared to Remicade in patients with active Crohn's disease up to Week 54.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with active Crohn's disease and a Crohn's disease activity
             index score between 220 and 450 points

        Exclusion Criteria:

          -  Patient who has previously received a biological agent for the treatment of Crohn's
             disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of
             other disease.

          -  Patient who has allergies to any of the excipients of infliximab, any other murine
             and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.
18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 18F-fluciclovine PET CT
Intervention description: Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 221.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent
      prostate cancer after curative-intent primary therapy and negative or equivocal findings on
      standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine
      PET/CT. Site clinicians will manage study subjects per standard practices and will document
      any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants
      will be followed for up to 6 months, with clinical data collected for this study. An
      interdisciplinary panel will provide expert guidance to local readers on request. The final
      reporting of the PET/CT scan will be a single report by the local reader following any such
      discussion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of histologically confirmed adenocarcinoma of the prostate post
             curative-intent local treatment (radical prostatectomy, local radiotherapy,
             brachytherapy).

          -  Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy
             for organ confined disease defined as :

          -  Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second
             confirmatory level of >0.2 ng/mL

          -  Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir

          -  Negative or equivocal findings on standard-of-care imaging for restaging of disease in
             the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT;
             and either CT or MRI of the pelvis (or the abdomen and pelvis).

          -  Being considered for salvage therapy

          -  Any non-surgical local treatment such as previous cryotherapy, external beam
             radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.

          -  Previous brachytherapy treatment will have occurred at least 2 years in the past

          -  Ability to understand and the willingness to sign a written informed consent.

        Exclusion Criteria:

          -  Ongoing treatment with any systemic therapy intended for the treatment of prostate
             cancer (e.g., antiandrogen or LHRH agonist or antagonist)

          -  Androgen deprivation therapy (ADT) in the past 3 months

          -  History of bilateral orchidectomy

          -  Inability to tolerate 18F-fluciclovine PET/CT
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks
Condition: Bronchospasm; Bronchiolitis; Bronchospasm; Bronchitis
MeSH terms: Bronchiolitis; Bronchitis; Bronchial Spasm; Respiratory Sounds
Intervention: Biological vaccine
Intervention description: daily spray (2 puff of 100 µL) for six months
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 12 Months
Maximum age: 36 Months
Healthy volunteers: No
Keywords: Vaccine; Bronchospasm

Summary:

      The study will be conducted in two hospitals of the same geographic area. It will be included
      children <3-years-old with recurrent wheezing attacks, confirmed by the review of the medical
      records, in the previous 12 months or a shorter time for those younger than one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects whose parents /legal representative have given written informed consent.

          -  Both gender

          -  Subject up to 36 months of age.

          -  Subjects with recurrent bronchospasms (wheezing attacks); 3 or more exacerbations in
             the last 12 months

        Exclusion Criteria:

          -  Subjects whose parents/legal representative have not given written informed consent.

          -  Subjects out of aged range

          -  Subjects with malignancies or chemotherapy treatment

          -  Subjects included in another clinical trial in the last 12 months.

          -  Subject in immunosuppressive or immunostimulatory treatment

          -  Subjects who have received iv gamma globulin in the past 12 months.

          -  Subjects diagnosed with candidiasis or fungal recurrent infections.

          -  Subjects diagnosed with malabsorption syndrome

          -  Subjects with clinical allergy to common aeroallergens in the geographical area.

          -  Subjects with hepatitis virus infections, HIV and tuberculosis
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: SPIL1033; Placebo
Intervention description: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.; 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: SPIL1033; type 2 diabetes mellitus

Summary:

      SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in
      reducing blood glucose levels. The purpose of study is to establish safety and efficacy of
      SPIL1033
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects 20 years of age and older.

          -  Established clinical diagnosis of type 2 diabetes mellitus treated with diet and
             exercise or anti-diabetic agents as monotherapy or combination therapy.

          -  Weight stable: their weight should not have varied more than 10% of screening visit
             weight, within 6 months prior to screening visit.

          -  Women of child bearing potential practicing an acceptable method of birth control as
             judged by the investigator(s); with a negative urine pregnancy test.

          -  Willing to participate and give written informed consent.

        Exclusion Criteria:

          -  Previous exposure to exenatide (anti-exenatide antibodies at screening) or a
             glucagon-like peptide (GLP-1) analogue.

          -  Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine,
             rimonabant, or similar over-the-counter medications) within 3 months of screening.

          -  Received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of trial entry.

          -  Severe renal impairment (creatinine clearance <30 ml/min) or end stage renal disease.
A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; Ocrelizumab; Placebo
Intervention description: Oral repeating dose; Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Methotrexate; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 613.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FILM; RA; anti-CD20; CD20

Summary:

      This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in
      combination with methotrexate in patients with active rheumatoid arthritis who are naive to
      methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or
      ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be
      administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5
      mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and
      the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age ≥ 18

          -  Rheumatoid arthritis for 3 months-5 years

          -  Naive to methotrexate

          -  If receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior to
             baseline

        Exclusion criteria:

          -  Rheumatic autoimmune disease or inflammatory joint disease other than RA

          -  Prior receipt of any biologic therapy for RA

          -  Concurrent treatment with any DMARD
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 3831; Olanzapine
Intervention description: Daily dosing; Daily dosing
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 561.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Olanzapine; Weight

Summary:

      This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects
      with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and
             Visit 2

          -  Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia

          -  Subject is appropriate for outpatient treatment; has no hospitalizations for acute
             exacerbations of schizophrenia within 6 months before Visit 1

          -  Subject has maintained a stable body weight (change </= 5%) for at least 3 months
             prior to Visit 1 based on self-report

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Subject has any of the following psychiatric conditions per DSM-5 criteria:

          -  Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current,
             untreated or unstable major depressive disorder

          -  Clinically significant cognitive difficulties present within the past 2 years that
             could interfere with participation in the study

          -  Drug-induced or toxic psychosis

          -  Any other psychiatric condition that could interfere with participation in the study

          -  Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the
             investigator

          -  Subject has inflammatory bowel disease or any other gastrointestinal disorder
             associated with weight loss, anorexia nervosa, or binge eating disorder

          -  Additional criteria may apply