bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SQ; Administered SQ
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in
      participants with plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque psoriasis for at least 6 months prior to enrollment

          -  At least 10% BSA of psoriasis at screening and at enrollment

          -  sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment

          -  Candidates for phototherapy and/or systemic therapy

          -  Participant must agree to use reliable method of birth control during the study; women
             must continue using birth control for at least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis

          -  History of drug-induced psoriasis

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to enrollment and during the study

          -  Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4
             weeks; or had topical psoriasis treatment within the previous 2 weeks prior to
             enrollment

          -  Concurrent or recent use of any biologic agent

          -  Have participated in any study with ixekizumab

          -  Received a live vaccination within 12 weeks prior to enrollment

          -  Serious disorder or illness other than psoriasis

          -  Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis

          -  Major surgery within 8 weeks of baseline, or will require surgery during the study

          -  Breastfeeding or nursing (lactating) women
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: 700 µg Dexamethasone; 350 µg Dexamethasone; Sham Injection
Intervention description: 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.; 350 µg Dexamethasone intravitreal implant administered on Day 0.; Sham injection on Day 0.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone
      for the treatment of macular edema associated with retinal vein occlusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older with macular edema resulting from retinal vein occlusion

          -  Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or
             worse)

          -  Visual acuity in other eye no worse than 20/200

        Exclusion Criteria:

          -  Known anticipated need for ocular surgery within next 12 months

          -  History of glaucoma or current high eye pressure requiring more than 1 medication

          -  Diabetic retinopathy

          -  Uncontrolled systemic disease

          -  Known steroid-responder

          -  Use of systemic steroids

          -  Use of warfarin/heparin
A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors
Condition: Carcinoma, Islet Cell; Carcinoma, Pancreas
MeSH terms: Carcinoma; Adenoma, Islet Cell; Carcinoma, Islet Cell
Intervention: sunitinib malate; Placebo
Intervention description: sunitinib malate oral starting dose 37.5 mg daily (continuous dosing).
Dose may be decreased to 25 mg daily in case of adverse events.
It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment.
Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination.; Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.
Intervention MeSH terms: Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study randomized patients with advanced pancreatic islet cell tumors to receive either
      sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib
      daily, those randomized to placebo received a tablet that looked similar but had no active
      drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or
      placebo. Patients were followed to determine the status and size of their tumors, survival,
      quality of life and safety of the drug.

      The study was designed to detect a 50% improvement in median PFS[Progression Free Survival]
      with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130
      events had occurred, and the final analysis was to be conducted when 260 events had occurred.

      Study A6181111 was stopped early during the enrollment period because of a clear and
      clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended
      by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and
      the actual number of PFS events recorded was 81 PFS events. The decision to terminate the
      study was not based on safety concerns related to sunitinib administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Well-differentiated advanced/metastatic pancreatic islet cell tumor

          -  Tumor has shown progression within the past year.

        Exclusion Criteria:

          -  Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or
             investigational anticancer agent other than somatostatin analogues

          -  Prior treatment with any tyrosine kinase inhibitors or anti-VEGF[Vascular endothelial
             growth factor] angiogenic inhibitors.

          -  Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted
Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
Condition: Epilepsy; Partial Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Levetiracetam; Carbamazepine
Intervention description: Immediate release film-coated tablets at strengths of 250 mg and 500 mg.
Up-titration Period (Week 1 to Week 3): Levetiracetam (LEV) 250 mg twice daily (bid)
Stabilization Period and Evaluation Period (Week 3 to Week 30): LEV 500 mg bid
Down-titration Period (Week 30 up to Week 33); Immediate release tablets at a strength of 200 mg.
Up-titration Period (Week 1 to Week 3): Carbamazepine- Immediate Release (CBZ-IR) 200 mg once daily (qd)
Stabilization Period and Evaluation Period (Week 3 to Week 30): CBZ-IR 200 mg bid
Down-titration Period (Week 30 up to Week 33)
Intervention MeSH terms: Carbamazepine; Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 436.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Levetiracetam; Keppra; Monotherapy; China; Epilepsy; Partial-onset Seizures

Summary:

      To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine
      Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese
      population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset
      Seizures (POS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is of Chinese origin and ≥ 16 years of age

          -  Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked
             Partial-Onset Seizures (POS)

          -  Subject has experienced at least 2 unprovoked seizures in the year preceding
             randomization, of which at least 1 unprovoked seizure occurred in the 3 months
             preceding randomization

          -  Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT)
             scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of
             Epilepsy with POS

        Exclusion Criteria:

          -  Subject tests positive for human leukocyte antigen major histocompatibility complex,
             class I,B (HLA-B)* 1502 allele

          -  Subject has a history or presence of seizures of other types than Partial-Onset
             Seizures (POS)

          -  Subject has only experienced type IA nonmotor seizures

          -  Subject has a history or presence of seizures occurring only in clustered patterns

          -  Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of
             Idiopathic Generalized Epilepsy prior to randomization

          -  Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or
             other nonepileptic ictal events that could be confused with seizures

          -  Subject has a history of Status Epilepticus
Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: thymectomy plus prednisone; prednisone alone
Intervention description: The thymectomy will be performed as soon as possible after randomization.; Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.
Intervention MeSH terms: Prednisone; Prednisolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: myasthenia gravis; thymectomy; prednisone; corticosteroid; extended transsternal thymectomy; ETTX; MG; thymus; thymoma

Summary:

      The purpose of this trial is to determine if thymectomy combined with prednisone therapy is
      more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female MG patients age greater than 18 and less than 65 years

          -  Onset of generalized MG within the last 5 years

          -  Positive serum anti-acetylcholine receptor binding antibodies (muscle acetylcholine
             receptors, AchRAb =/> 1.00 nmol/L. AchRAb levels of 0.50-0.99 nmol/L will be
             acceptable if there is another confirmatory test for MG, including single-fiber
             electromyography (EMG), repetitive nerve stimulation, or unequivocal edrophonium
             testing.)

          -  MGFA class II-IV at entry, using the MG Foundation of America (MGFA) classification,
             while receiving optimal anti-cholinesterase treatment with or without oral prednisone

        Exclusion Criteria:

          -  Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would
             not require the use of corticosteroids

          -  Myasthenic weakness requiring intubation (MGFA Class IV) in the prior month

          -  Immunosuppressive therapy other than corticosteroids in the preceding year

          -  Medically unfit for thymectomy

          -  Chest CT evidence of thymoma.

          -  Pregnancy or lactation; contraindications to the use of corticosteroids, unless
             postmenopausal or surgically sterile. Women considering becoming pregnant during the
             period of the study are to be excluded.

          -  A serious concurrent medical, neurological or psychiatric condition that would
             interfere with thymectomy or subsequent clinical assessments

          -  Current alternate day dose of prednisone > than 1.5 mg/kg or 100 mg or the equivalent
             daily doses (> 0.75 mg/kg or 50 mg).

          -  Participation in another experimental clinical trial

          -  History of alcohol or drug abuse within the 2 years prior to randomization.
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
Condition: Painful Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Intervention: Lacosamide
Intervention description: 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 621.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lacosamide

Summary:

      SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial
      is to assess safety and tolerability of long-term exposure of lacosamide (previously referred
      to as SPM 927) in subjects with painful distal diabetic neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the
             investigator's opinion, might benefit from long-term administration of SP746
             (NCT00546351). Exception: subjects who prematurely discontinued

          -  SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to
             intolerability to trial medication (after Visit 5but prior to entering the Maintenance
             Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with
             the medical monitor

        Exclusion Criteria:

          -  Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a
             QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743
             (NCT00238524) or SP874 (NCT00350103)

          -  Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥3
             times the upper limit of the normal range (ULN) with total bilirubin ≥2 times ULN or
             transaminases (AST and/or ALT) ≥5 times ULN

          -  Subject has a clinically relevant medical condition that, in the opinion of the
             investigator, jeopardizes or compromises the subject's ability to participate in this
             trial

          -  Subject is a pregnant or nursing female, or is of childbearing potential and is not
             surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of
             contraception
Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ataluren
Intervention description: Ataluren will be provided as a vanilla-flavored powder to be mixed with water or milk.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This is an open-label extension study for participants who completed a Phase 3,
      placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis
      (nmCF) not receiving chronic inhaled aminoglycosides.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of study treatment (placebo or active) in the previous Phase 3,
             double-blind study protocol (Protocol PTC124-GD-021-CF)

          -  Evidence of signed and dated informed consent/assent document(s) indicating that the
             participant (and/or the participant's parent/legal guardian) has been informed of all
             pertinent aspects of the trial.

        Exclusion Criteria:

          -  Known hypersensitivity to any of the ingredients or excipients of the study drug.

          -  Ongoing participation in any other therapeutic clinical trial.
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: AN2728 Topical Ointment, 2%; Matching vehicle control
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 764.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: atopic dermatitis

Summary:

      The purpose of this study is to investigate the safety and efficacy of AN2728 Topical
      Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic
      dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 2 years and older

          -  Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of
             Hanifin and Rajka

          -  Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)

          -  Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1

          -  All female subjects of childbearing potential must use acceptable methods of
             contraception from the Screening Visit continuously until 30 days after stopping study
             drug

        Exclusion Criteria:

          -  As determined by the study doctor, a medical history that may interfere with study
             objectives

          -  Unstable AD or any consistent requirement for high potency topical corticosteroids

          -  History of use of biologic therapy (including intravenous immunoglobulin)

          -  Recent or anticipated concomitant use of systemic or topical therapies that might
             alter the course of AD

          -  Recent or current participation in another research study

          -  Females who are breastfeeding, pregnant, or with plans to get pregnant during the
             participation in the study

          -  Participation in a previous AN2728 clinical trial
Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Condition: Pain
Intervention: Buprenorphine; Placebo
Intervention description: Buprenorphine sublingual spray delivered via single 100 μL spray; Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 322.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Post-Surgical Pain; Bunionectomy

Summary:

      The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine
      Sublingual (under the tongue) Spray compared with placebo in participants with postoperative
      pain after bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets protocol-specified criteria for qualification and contraception

          -  Willing and able to remain confined in the study unit for the entire duration of each
             treatment period and comply with restrictions related food, drink and medications

          -  Voluntarily consents to participate and provides written informed consent prior to any
             protocol-specific procedures

        Exclusion Criteria:

          -  History or current use of over-the-counter medications, dietary supplements, or drugs
             (including nicotine and alcohol) outside protocol-specified parameters

          -  Signs, symptoms or history of any condition that, per protocol or in the opinion of
             the investigator, might compromise:

               1. the safety or well-being of the participant or study staff;

               2. the safety or well-being of the participant's offspring (such as through
                  pregnancy or breast-feeding);

               3. the analysis of results
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
Condition: Hepatitis C Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Intervention: ABT-493/ABT-530
Intervention description: Tablet; ABT-493 coformulated with ABT-530
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV Genotype 1; HCV Genotype 4; HCV Genotype 2; Cirrhotic; Interferon-Free; Compensated Cirrhosis; HCV Genotype 5; Hepatitis C; HCV Genotype 6

Summary:

      The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following
      12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5
      or 6 infection and compensated cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or
             6 (GT1,2,4,5,6) infection

          -  Chronic HCV infection

          -  Subject must be HCV treatment-naïve or have failed prior HCV treatment

          -  Subject must have documented compensated cirrhosis and no current or past clinical
             evidence of decompensated liver disease

        Exclusion Criteria:

          -  Positive test result at screening for Hepatitis B surface antigen or anti-human
             immunodeficiency virus (anti-HIV) antibody

          -  HCV genotype performed during screening indicating co-infection with more than 1 HCV
             genotype

          -  Consideration by the investigator, for any reason, that the subject is an unsuitable
             candidate to receive ABT-493/ABT-530