bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Oxymorphone ER
Intervention description: Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.
Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications
Intervention MeSH terms: Oxymorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Opioid tolerant; Pediatric; Male 6-17 years of age; Female 6-17 years of age; Pain; Non malignant; Malignant

Summary:

      Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the
      Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every
      12 hours. Dosing adjustments will be based on the review of the subject's pain scores.
      Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain
      medication (as needed). Titration Period will end when the fixed dose of study medication is
      tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the
      open-label 3-month maintenance period on the fixed dose of study medication established
      during the Titration Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a
             strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45
             mg/daily (qd) oral morphine equivalent)

          -  Weigh at least 50 kg

          -  Expected to continue to require a strong opioid for pain relief for at least 4 weeks
             and up to 4 months.

        Exclusion Criteria:

          -  Have a life expectancy <4 weeks

          -  Plan to undergo a surgical procedure within 3 days of study entry or during the
             Titration Period

          -  Have dysphagia or difficulty swallowing whole tablets

          -  Have a previous exposure to oxymorphone

          -  Have an ileostomy
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder
Condition: CDKL5 Deficiency Disorder
Intervention: ganaxolone; Placebo
Intervention description: active drug; inactive
Intervention MeSH terms: Pregnanolone; Ganaxolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The double-blind phase will randomize subjects to adjunctive ganaxolone or placebo at a 1:1 ratio to standard of care
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 2 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: refractory seizures; genetic pediatric encephalopathies; epilepsy in children; seizure disorder

Summary:

      A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone
      therapy compared to placebo for the treatment of seizures in children and young adults with
      genetically confirmed CDKL5 gene mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genetically confirmed CDKL5 gene mutation, seizure onset by 1 year of age and lack of
             independent ambulation by 2 years of age

          -  Failure to control seizures despite 2 or more anti-seizure medications

          -  At least 16 seizures per 28 days of primary seizure types

          -  On a stable regimen of 0-4 anti-seizure medications (Vagus nerve stimulator, ketogenic
             diet, and modified Atkins diet do not count towards this limit)

          -  Additional Inclusion Criteria apply and can be discussed with study team

        Exclusion Criteria:

          -  Previous exposure to ganaxolone

          -  West Syndrome with hypsarrhythmia pattern on EEG or seizures predominantly of
             Infantile Spasms type

          -  Use of adrenocorticotropic hormone (ACTH), prednisone or other glucocorticoid or use
             of moderate or strong inducers or inhibitors of CYP3A4/5/7 are prohibited

          -  Use of tetrahydrocannabinol (THC) or cannabidiol (CBD) is prohibited during the
             double-blind phase, unless patient has a prescription of Epidiolex®

          -  Exposure to any other investigational drug within 30 days or fewer than 5 half-lives
             prior to screening

          -  Plasma allopregnanolone-sulfate (Allo-S) levels greater than or equal to 6.0 ng/ml at
             screening visit

          -  Additional Exclusion Criteria apply and can be discussed with study team
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
Condition: Urinary Bladder, Neurogenic
MeSH terms: Urinary Bladder, Neurogenic; Urinary Bladder, Overactive
Intervention: Fesoterodine PR 4 mg; Fesoterodine PR 8 mg; Fesoterodine BIC 2 mg; Fesoterodine BIC 4 mg
Intervention description: Fesoterodine 4 mg tablet once daily for 28 or 40 weeks; Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks; Fesoterodine BIC 2 mg tablet once daily for 28 weeks; Fesoterodine BIC 4 mg tablet once daily for 28 weeks
Intervention MeSH terms: Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: neurogenic detrusor overactivity; fesoterodine; Japan

Summary:

      The purpose of this study is to investigate the safety and tolerability of fesoterodine
      following once daily long-term treatment in Japanese pediatric neurogenic detrusor
      overactivity (NDO) subjects.
    

Eligibility criteria:

        Inclusion Criteria:

        •Subjects who completed 24 week treatment and all visit procedures in the precedent Study
        A0221047

        Exclusion Criteria:

          -  Subjects who had major protocol violation (as determined by the Sponsor) in Study
             A0221047

          -  Concomitant medications which may increase the risk to subjects or confound study
             results

          -  Other medical conditions which may increase the risk to subjects or confound study
             results
Lubiprostone for Children With Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Intervention: Lubiprostone
Intervention description: 12 or 24 mcg soft capsules for oral administration
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 419.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study is for children with constipation.

      Children who completed 3 months of treatment in the earlier study (NCT02042183):

        -  were invited to participate

        -  will receive lubiprostone for 9 more months

        -  will see if lubiprostone safely relieves their constipation if taken for a whole year
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed the 3-month placebo-controlled study (NCT02042183)

          -  Will continue to abstain from taking concomitant medication (prescribed or
             over-the-counter) that affects gastrointestinal motility

        Exclusion Criteria:

          -  Has untreated faecal impaction at the time of rolling over into study

          -  Has significant change in medical status, newly diagnosed and uncontrolled
             cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other
             systemic disease

          -  Has demonstrated non-compliance with study protocol during the 3-month
             placebo-controlled study (NCT02042183)
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Pomalidomide; Bortezomib; Dexamethasone
Intervention description: Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.; Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.; Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
Intervention MeSH terms: Thalidomide; Dexamethasone; Bortezomib; Pomalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 559.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Pomalidomide

Summary:

      The purpose of this study is to compare the efficacy of the combination of pomalidomide,
      bortezomib and low dose dexamethasone to the combination of bortezomib and low dose
      dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also
      assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is
      compared to the combination of bortezomib and low dose dexamethasone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be ≥ 18 years at the time of signing informed consent.

          -  Must have documented diagnosis of multiple myeloma and have measureable disease by
             serum and urine protein electrophoresis.

          -  Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.

          -  Must have documented disease progression during or after their last anti-myeloma
             therapy.

          -  All subjects must have received prior treatment with a lenalidomide containing regimen
             for at least 2 consecutive cycles.

        Exclusion Criteria:

          -  Documented progressive disease during therapy or within 60 days of the last dose of a
             bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.

          -  Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to
             randomization.

          -  Non-secretory multiple myeloma.

          -  Subjects with severe renal impairment requiring dialysis.

          -  Previous therapy with pomalidomide.
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ublituximab; Ibrutinib
Intervention description: Administered as an IV infusion; Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody,
      to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall
      response rate (ORR = CR [complete response] + PR [partial response]) in previously treated
      Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of
      the participants will receive ublituximab in combination with ibrutinib, while the other half
      will receive ibrutinib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment

          -  At least one high-risk cytogenetic feature defined by the presence of 17p deletion,
             11q deletion and/or p53 mutation

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

        Exclusion Criteria:

          -  Any major surgery, chemotherapy or immunotherapy within the last 21 days

          -  Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus
             (HIV) infection

          -  Autologous hematologic stem cell transplant within 3 months of study entry. Prior
             Allogeneic hematologic stem cell transplant is excluded

          -  Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's
             transformation)

          -  Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's
             tyrosine kinase (BTK)
BOTOX® Treatment in Pediatric Lower Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: botulinum toxin Type A; Normal Saline (Placebo)
Intervention description: Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.; Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 384.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in
      pediatric patients with lower limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum weight of 10 kg/22 lb

          -  Cerebral palsy with dynamic muscle contracture /spasticity of the ankle

        Exclusion Criteria:

          -  Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
             sclerosis, or mitochondrial disease

          -  Uncontrolled epilepsy

          -  Botulinum Toxin therapy of any serotype for any condition within the last 6 months

          -  History of surgical intervention of the lower study leg or planned surgery of any limb
             during the study

          -  Previous casting of the study limb for spasticity within 6 months or with a dynamic
             splint within 3 months, or planned casting or dynamic splinting for spasticity of the
             study limb or affected upper limb during the study
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
Condition: Non Small Cell Lung Carcinoma NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Durvalumab (MEDI4736); Paclitaxel + carboplatin; Gemcitabine + cisplatin; Gemcitabine + carboplatin; Pemetrexed + cisplatin; Pemetrexed + carboplatin
Intervention description: Anti-PD-L1 monoclonal Antibody monotherapy; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agent; Chemotherapy Agent
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Gemcitabine; Pemetrexed; Durvalumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 669.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: NSCLC; PD-L1; Durvalumab (MEDI4736); OS

Summary:

      This is a randomized, open-label, multi-center Phase III study to determine the efficacy and
      safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of
      advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic
      lymphoma kinase (ALK) wild-type and with PD-L1 high expression (PEARL)
    

Eligibility criteria:

        Inclusion Criteria

          -  Aged at least 18 years

          -  Documented evidence of Stage IV NSCLC

          -  No sensitizing EGFR mutation and ALK rearrangement

          -  PD-L1 high expression

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Prior chemotherapy or any other systemic therapy for advanced NSCLC

          -  Prior exposure to immune-mediated therapy, including, but not limited to, other
             anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1
             (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies,
             excluding therapeutic anticancer vaccines

          -  Brain metastases or spinal cord compression unless the patient is stable and off
             steroids for at least 14 days prior to start of study treatment

          -  Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant

          -  Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or
             Crohn's disease]
An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes
Condition: Epilepsy; Dravet Syndrome; Lennox-Gastaut Syndrome
MeSH terms: Epilepsies, Myoclonic; Lennox Gastaut Syndrome; Syndrome
Intervention: GWP42003-P
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 681.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Cannabidiol; CBD; GWP42003-P; GWPCARE5

Summary:

      To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children
      and adults with Dravet or Lennox-Gastaut syndromes.
    

Eligibility criteria:

        Key Inclusion Criteria:

        • Participant has completed the treatment phase of their Core Studies: GWEP1332A
        [NCT02091206], GWEP1332B [NCT02091375], GWEP1424 [NCT02224703], GWEP1414 [NCT02224560],
        GWEP1424 [NCT02224703], and GWEP1423 [NCT02224690].

        Key Exclusion Criteria:

          -  Participant is currently using or has in the past used recreational or medicinal
             cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3
             months prior to study entry other than the investigational medicinal product (IMP)
             received during the Core Study and are unwilling to abstain for the duration for the
             study.

          -  Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the
             Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.

          -  Participant has been part of a clinical trial involving an IMP during the inter-study
             period.

          -  Female participant is of child bearing potential or male participant's partner is of
             child bearing potential, unless willing to ensure that they or their partner use
             highly effective contraception, for example, hormonal contraceptives, intrauterine
             devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or
             sexual abstinence, during the study and for 3 months thereafter (however, a male
             condom should not be used in conjunction with a female condom).

          -  Participant has significantly impaired hepatic function at the 'End of Treatment'
             visit of their Core Study or at Visit 1 if re-assessed: i) Alanine aminotransferase
             (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN); ii) ALT or
             AST >3 × ULN and (total bilirubin [TBL] >2 × ULN or international normalized ratio
             [INR] >1.5); iii) ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting,
             right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%). This
             criterion must be confirmed prior to entering the study.
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Human cl rhFVIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Male
Healthy volunteers: No
Keywords: Previously untreated patients

Summary:

      Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated
      patients with severe Hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients

          -  Severe Hemophilia A (FVIII:C <1%)

          -  No previous treatment with FVIII concentrates or other blood products containing FVIII

        Exclusion Criteria:

          -  Diagnosis with a coagulation disorder other than Hemophilia A

          -  Severe liver or kidney disease

          -  Concomitant treatment with any systemic immunosuppressive drug
Emergency Treatment of Coral Snake Envenomation With Antivenom
Condition: Coral Snake Bite; Toxic Effect of Coral Snake Venom
MeSH terms: Emergencies; Snake Bites
Intervention: Snake (Micrurus) North American immune F(ab')2 Equine
Intervention description: 5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Healthy volunteers: No
Keywords: Envenomation; Coral Snake; Antivenom; Micrurus fulvius

Summary:

      The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and
      death from the bite of a coral snake.

      Funding Source - FDA OOPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of any age. Presenting for emergency treatment of coral snake bite.

        Exclusion Criteria:

          -  Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.