bioihbjkbjnl/mcl2 huggingface dataset:
Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)
Condition: Juvenile Psoriatic Arthritis; Enthesitis-related Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Enthesopathy; Arthritis, Juvenile
Intervention: secukinumab; placebo
Intervention description: secukinumab is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.; Matched placebo to AIN457 for use in the double blind Treatment Period 2
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: JIA; JPsA; ERA; Secukinumab; ILAR; Arthritis

Summary:

      This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to
      investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic
      Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related
      Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period)
      consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a
      randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment
      Period 2
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic
             arthritis (JPsA) according to the International League of Associations for
             Rheumatology (ILAR) classification criteria of at least 6 months duration.

          2. Active disease (ERA or JPsA) defined as having both:

               -  at least 3 active joints

               -  at least 1 site of active enthesitis at baseline or documented by history.

          3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal
             anti-inflammatory drugs(NSAID)

          4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying
             antirheumatic drugs (DMARD)

          5. No concomitant use of second line agents such as disease-modifying and/or
             immunosuppressive drugs.

        Exclusion Criteria:

          1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.

          2. Patients who have ever received biologic immunomodulating agents

          3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA
             patients only).

          4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled
             uveitis.

        Other protocol-defined inclusion/exclusion criteria apply.
Safety and Efficacy of NT 201 (IncobotulinumtoxinA [Xeomin]) in the Treatment of Glabellar Frown Lines
Condition: Glabellar Lines
Intervention: IncobotulinumtoxinA (Xeomin) (20 units)
Intervention description: Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 801.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study objective was to investigate the safety and efficacy of incobotulinumtoxinA
      (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with
      moderate to severe glabellar frown lines at maximum frown who completed participation in one
      of the studies in this program, i.e. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or
      MRZ 60201-0741/1 were eligible to participate in this repeat-dose study.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants with 'moderate' or 'severe' glabellar frown lines at maximum frown at the
        beginning of each treatment cycle (as assessed by the investigator according to FWS) ,
        stable medical condition; Completion of one former study in the Merz NT 201 glabellar
        program

        Exclusion Criteria:

        Participants with preexisting neuromuscular diseases (e.g. myasthenia gravis, Lambert-Eaton
        syndrome) putting the participant at risk, History of Facial Nerve Palsy, Previous
        treatment with Botulinum Toxin in the glabellar area during the last 12 months, Previous
        treatment with biodegradable fillers or other procedures (e.g. chemical peeling, photo
        rejuvenation) in the glabellar area during the last 12 months, Previous insertion of
        permanent material in the glabellar area; Planned treatment with Botulinum toxin of any
        serotype in any body region during the study period, Any other planned facial aesthetic
        procedure in the glabellar area during the trial period; Any surgery in the glabellar area
        including surgical removal of the corrugator, procerus or depressor supercili muscles or a
        combination of these or scars in the glabellar area, Inability to substantially lessen
        glabellar frown lines even by physically spreading apart, Marked facial asymmetry or ptosis
        of eyelid and/or eyebrow; Any infection in the area of the injection sites.
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis
Intervention: Placebo; Relamorelin
Intervention description: Placebo injected subcutaneously twice daily.; Relamorelin 10 μg injected twice daily for 12 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of relamorelin compared to placebo in
      participants with diabetic gastroparesis. Participants will report daily severity scores of
      their diabetic gastroparesis symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 or Type 2 diabetes mellitus

          -  Meet the per protocol criteria of diabetic gastroparesis

          -  Compliance with diary

          -  Compliance with the per protocol study treatment dosing instructions

        Exclusion Criteria:

          -  Currently receiving nutrition intravenously, by nasogastric tube, or other feeding
             tube

          -  Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder
             at the time of Screening (Visit 1)

          -  Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity

          -  History of gastrointestinal disorders that may be similar to gastroparesis

          -  Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab
Intervention description: Administered by subcutaneous injection once a month
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 770.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to characterize the safety and tolerability of long-term
      administration of evolocumab in adults with known coronary artery disease and
      hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed week 80 of study 20120153 (NCT01813422).

        Exclusion Criteria:

          -  Did not complete investigational product in the 20120153 parent study

          -  Have an unstable medical condition, in the judgment of the investigator

          -  Known sensitivity to any of the products to be administered during dosing

          -  Currently enrolled in another investigational device or drug study (excluding
             evolocumab (AMG 145) parent study), or less than 30 days since ending another
             investigational device or drug study(s),or receiving other investigational agent(s)
MSB11022 in Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis; Plaque Type Psoriasis; Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: MSB11022; Humira®
Intervention description: Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.; Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 443.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adalimumab; MSB11022; Psoriasis; Phase III

Summary:

      The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022
      and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants greater than or equal to (>=) 18 years old with a clinical
             diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and
             Severity Index [PASI] score >=12, Physician Global Assessment [PGA] score >=3, and
             >=10% of body surface area affected at Screening and Baseline [Day 1 of Week 1]) who
             have a history of receipt of or are candidates for systemic therapy or phototherapy
             for active plaque-type psoriasis despite topical therapy

          -  Participants must not have received more than 1 biologic therapy

          -  Other protocol-defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participants was excluded if they have erythrodermic, pustular, guttate, or
             medication-induced forms of psoriasis or other active skin diseases/infections that
             may interfere with the evaluation of plaque psoriasis

          -  Participants must not have received adalimumab or an investigational or licensed
             biosimilar of adalimumab; topical therapies for the treatment of psoriasis or
             ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP)
             administration or plan to take such treatment during the trial; or psoralen combined
             with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis
             within 4 weeks prior to IMP administration

          -  Participants was excluded if they have a history of an ongoing, chronic, or recurrent
             infectious disease (except for latent tuberculosis [TB]); history of active TB; or a
             history of hypersensitivity to any component of the IMP formulation, comparable drugs,
             or latex

          -  Other protocol-defined exclusion criteria could apply
Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Condition: Generalized Pustular Psoriasis (GPP); Adalimumab; Japanese
MeSH terms: Psoriasis
Intervention: Adalimumab
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 15 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: efficacy; safety

Summary:

      The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of
      adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not
      have an adequate response to their currently approved treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of generalized pustular psoriasis

          -  Total skin score of at least 3 and erythema with pustules (skin score of at least 1)
             at baseline in the Japan Dermatology Association (JDA) severity index of Generalized
             Pustular Psoriasis (GPP) in GPP Medical Care Guideline 2014 in Japan

          -  Inadequate response to, or intolerance to, or contraindication to the currently
             approved GPP treatment (excluding infliximab)

          -  Infliximab secondary failure, or intolerant to infliximab

        Exclusion Criteria:

          -  Erythrodermic psoriasis, guttate psoriasis or sub-corneal pustular dermatosis at
             Screening

          -  Drug-induced GPP

          -  Cannot stop ongoing use of prohibited GPP treatments

          -  Total JDA severity index of GPP of 14 or more in GPP Medical Care Guideline 2014 in
             Japan
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
Condition: Congenital Hyperinsulinism
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hyperinsulinism
Intervention: Dasiglucagon; Standard of Care
Intervention description: Glucagon analog; Standard of care according to site and/or country
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 3 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The objective of the trial is to evaluate the efficacy and safety of dasiglucagon
      administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established and documented diagnosis of CHI based on standard of care

          -  Experiencing ≥3 events of hypoglycemia per week (plasma glucose [PG] <70 mg/dL [<3.9
             mmol/L]) according to the investigator's evaluation

          -  Previously undergone near-total pancreatectomy or being treated with a non-surgical
             approach, having been evaluated as not eligible for pancreatic surgery

          -  If somatostatin analogues or sirolimus are used, the therapy should be well
             established as judged by the investigator, especially when considering their
             biological half-life

        Exclusion Criteria:

          -  Previous administration of dasiglucagon

          -  Known or suspected allergy to the trial drug or related products

          -  Previous participation (randomization) in this trial

          -  Circulatory instability requiring supportive medication or presence of
             pheochromocytoma

          -  Requires exogenous insulin

          -  Body weight of <4 kg (8.8 lbs.)

          -  Documented HbA1c ≥7% subsequent to near-total pancreatectomy and within 6 months prior
             to screening

          -  Known or suspected presence of significant central nervous system disease/injury such
             that in the investigator's opinion will affect trial participation

          -  Use of systemic corticosteroids, e.g., hydrocortisone >20 mg/m2 body surface area or
             equivalent in the 5 days before screening

          -  Use of anti-inflammatory biological agents, or other immune modulating agents in the 3
             months prior to screening

          -  Any clinically significant abnormality identified on echocardiogram that in the
             opinion of the investigator would affect the patient's ability to participate in the
             trial

          -  Any recognized clotting or bleeding disorders

          -  Has participated in an interventional clinical trial (investigational or marketed
             product) within 3 months of screening or 5 half-lives of the drug under investigation
             (whichever comes first), or plans to participate in another clinical trial.
Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer
Condition: Oropharynx Cancer
MeSH terms: Oropharyngeal Neoplasms
Intervention: Gabapentin; Placebo Oral Capsule
Intervention description: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures; Placebo
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Strategies to minimize and mitigate external beam radiation therapy related mucositis and
      pain during the treatment of head and neck cancer remain limited. The investigators
      hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance
      on opioid medication, and improve the quality of life for these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients being treated with combination chemotherapy and radiation therapy daily for
             locally advanced (stage III-IV) squamous cell carcinoma of the oropharynx.

          -  Age ≥ 18.

          -  ECOG performance status ≤ 1.

          -  Patients must provide study specific informed consent prior to study entry and be able
             to fill out toxicity and quality of life related questionnaires.

        Exclusion Criteria:

          -  Patients may not be receiving gabapentin, any other investigational agents, or other
             anticonvulsants.

          -  Patients with metastatic disease are excluded from this clinical trial.

          -  Patient with allergies or hypersensitivity to gabapentin.

          -  Patients receiving surgery as part of their definitive management.

          -  Patients who have received prior chemotherapy or radiation therapy.

          -  Patients unable to complete the required forms; however, verbal completion is adequate
             if recorded on the form daily.

          -  Uncontrolled serious illness including, but not limited to, ongoing or serious active
             infection requiring IV antibiotics for over 30 days, symptomatic congestive heart
             failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable
             atrial fibrillation, or psychiatric illness/social situations that would limit
             compliance with study requirements.
Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botulinum toxin type A
Intervention description: Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 516.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dysport, Cervical Dystonia

Summary:

      The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most
      frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly
      laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be
      assigned to one of the two basic types of cervical dystonia, either predominantly rotational
      torticollis or predominantly laterocollis on the basis of clinical examination. This will
      determine which therapy is to be administered, using the clearly defined, structured
      injection protocols.
    

Eligibility criteria:

        Inclusion Criteria:

          -  De novo patients with cervical dystonia

          -  Outpatient

          -  Patients to be of age 18 years or older

          -  Written informed consent to participate in the study

        Exclusion Criteria:

          -  Pre-treatment of cervical dystonia with botulinum toxin

          -  Pre-treatment with botulinum toxin for any indication other than cervical dystonia
             within the past 12 months

          -  Pure retro- or antecollis

          -  Neurological or other diseases which may affect head and neck motor function or
             neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy,
             motor neurone diseases, Bekhterev's disease
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Bimekizumab
Intervention description: Study participants will receive bimekizumab at pre-specified time points.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; PsA; Auto-Injector; Bimekizumab

Summary:

      The purpose of the study is to evaluate for each self-injecting device presentation the
      ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject
      bimekizumab at study start and 4 weeks after training in self-injection technique using the
      bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject fulfills all inclusion criteria for the PA0012 [NCT04009499] study

          -  Subject is considered reliable and capable of adhering to the DV0004 protocol (eg,
             able to understand and complete questionnaires, able to use investigational
             self-injecting device presentations according to the instructions for use (IFU), and
             able to adhere to the visit schedule) according to the judgment of the Investigator

          -  Subject is willing to self-inject

        Exclusion Criteria:

        -Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study
        exclusion criteria are met