bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: 1% Lidocaine; 0.25% Bupivacaine; Bupivacaine plus Lidocaine
Intervention description: 10 mL of 1% lidocaine; 10 mL of 0.25% bupivacaine; 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Intervention MeSH terms: Lidocaine; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 75.0
Sex: Female
Minimum age: 19 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Local anesthetic; Labor epidural

Summary:

      This study will compare and determine the most ideal local anesthetic (LA) solution to
      activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus
      lidocaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant patients over the age of 19 who are scheduled for an induction of labor and
             request an epidural are eligible for the study

        Exclusion Criteria:

          -  age <19

          -  allergy to the drug or drug class

          -  preexisting neuropathy

          -  history of back pain prior to pregnancy or history of back surgery

          -  history of chronic opioid use

          -  history of hypertension or hypertensive disorders of pregnancy

          -  congenital or acquired cardiac disease

          -  contraindication to epidural placement (patient refusal, severe coagulopathy,
             infection at site of epidural needle insertion, severe hypovolemia)
Study of Paliperidone ER in Adolescents and Young Adults With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Paliperidone ER
Intervention description: Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Autistic Disorder

Summary:

      This 8-week, prospective open-label study will investigate the effectiveness and tolerability
      of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er
      will be well tolerated and efficacious for reducing aggression, self-injury, and irritability
      in adolescents and young adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between ages of 12 and 21 years

          -  Tanner Sage III or IV (post-pubertal)

          -  Diagnostic and Statistical Manual Fourth Edition Text-Revised (DSM-IV-TR) diagnosis of
             autism

          -  Outpatient

          -  Ability to swallow pills

          -  Antipsychotic medication-free for at least 2 weeks

          -  Score of 4 or more on the Clinical Global Impressions Severity Scale

          -  Score of 18 or higher on the Aberrant Behavior Checklist Irritability Scale

          -  Mental age of 18 months or greater based on testing

          -  Subjects must be in good physical health

        Exclusion Criteria:

          -  Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise Specified (PDD
             NOS), Rett's Disorder, childhood disintegrative disorder, schizophrenia, bipolar
             disorder, Fragile X Syndrome, Tuberous Sclerosis

          -  A significant medical condition

          -  An active seizure disorder

          -  Females who are pregnant

          -  Evidence of a prior adequate trial of paliperidone ER

          -  History of neuroleptic malignant syndrome

          -  Hypersensitivity to paliperidone ER
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: PF-04965842 100 mg; PF-04965842 200 mg; Placebo
Intervention description: PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks; PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks; Placebo, administered as two tablets to be taken orally once daily for 12 weeks
Intervention MeSH terms: Abrocitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 387.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: atopic dermatitis; atopic eczema; eczema; JAK; janus kinase

Summary:

      B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with
      a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy
      and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily,
      will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients
      will have an option to enter a long-term extension study after completing 12 weeks of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older with a minimum body weight of 40 kg

          -  Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
             to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4)

          -  Recent history of inadequate response or inability to tolerate topical AD treatments
             or require systemic treatments for AD control

        Exclusion Criteria:

          -  Unwilling to discontinue current AD medications prior to the study or require
             treatment with prohibited medications during the study

          -  Prior treatment with JAK inhibitors

          -  Other active nonAD inflammatory skin diseases or conditions affecting skin

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q
             wave interval abnormalities, current or history of certain infections, cancer,
             lymphoproliferative disorders and other medical conditions at the discretion of the
             investigator

          -  Pregnant or breastfeeding women, or women of childbearing potential who are unwilling
             to use contraception
Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.
Condition: Myelofibrosis With High Molecular Risk Mutations
MeSH terms: Primary Myelofibrosis
Intervention: Ruxolitinib; Ruxolitinib Placebo
Intervention description: 5 mg tablet for oral use; 5 mg placebo tablet for oral use
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Early Myelofibrosis; high molecular risk mutations.; Ruxolitinib; INC424; High molecular risk mutations; HMR

Summary:

      Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive
      disease with increased risk of leukemic transformation and reduced overall survival. As there
      are no therapies currently established in the subset of high molecular risk patients with
      early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of MF with bone marrow fibrosis of at least Grade 1; irrespective
             of JAK2 mutational status

          -  Patients with at least one mutation in one of the five HMR genes (ASXL1, EZH2, SRSF2
             and IDH1/2)

          -  Patients with non-palpable spleen or spleen palpable ≤ 5 cm from the left costal
             margin to the point of greatest splenic protrusion

          -  Patients with MF-7 score of ≤ 15, with each individual symptom score of ≤ 3

        Exclusion Criteria:

          -  Patients with prior treatment with ruxolitinib or other JAK inhibitors.
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
Condition: Refractory Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461
Intervention description: samidorphan + buprenorphine administered sublingually
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No
Keywords: Alkermes; Major depressive disorder; Depression; ALKS 5461

Summary:

      This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive
      treatment for refractory MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed study ALK5461-217

          -  Be willing to abide by the contraception requirements as outlined in the study
             protocol

          -  Be willing and able to follow the study procedures and visits as outlined in the
             protocol

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Pregnant, planning to become pregnant, or breastfeeding

          -  A positive urine drug test for drugs of abuse

          -  Poses a current suicide risk

          -  Additional criteria may apply
The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Condition: Neonatal Abstinence Syndrome; Aromatherapy
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: lavender and chamomile essential oils
Intervention description: Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Maximum age: 2 Weeks
Healthy volunteers: No

Summary:

      Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms
      of Neonatal Abstinence Syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants greater than or equal to 36 weeks EGA

          -  Intrauterine opioid exposure

          -  Primary diagnosis of NAS

          -  Parental permission to participate

        Exclusion Criteria:

          -  Infants less than 36 weeks EGA

          -  Major congenital anomalies

          -  Latrogenic drug withdrawal

          -  Diagnosis of infection or respiratory distress

          -  Prior initiation of opioid replacement therapy

          -  Non-English speaking

          -  Infants with respiratory conditions
A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-445/TEZ/IVA; TEZ/IVA; IVA; Placebo; Placebo
Intervention description: Participants received VX-445/TEZ/IVA orally once daily in the morning.; Participants received TEZ/IVA orally once daily in the morning.; Participants received IVA orally once daily in the evening.; Participants received placebo matched to VX-445/TEZ/IVA orally once daily in the morning.; Participants received placebo matched TEZ/IVA orally once daily in the morning.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor
      (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the
      F508del mutation (F/F)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for the F508del mutation (F/F)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; BKM120; BKM120 matching placebo
Intervention description: Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter); BKM120 100 mg once daily; BKM120 matching placebo, once daily
Intervention MeSH terms: Fulvestrant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1147.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Hormone receptor positive; HER2-negative; Metastatic; Locally advanced; PI3K; Fulvestrant; Refractory; Aromatase inhibitor

Summary:

      This study was a multi-center, randomized, double-blind, placebo controlled Phase III study
      to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus
      fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive
      (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally
      advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase
      inhibitor (AI) treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Locally advanced or metastatic breast cancer

          -  HER2-negative and hormone receptor-positive status (common breast cancer
             classification tests)

          -  Postmenopausal woman

          -  A tumor sample must be shipped to a Novartis designated laboratory for identification
             of biomarkers (PI3K activation status)

          -  Progression or recurrence of breast cancer while on or after aromatase inhibitor
             treatment

          -  Measurable disease or non measurable disease bone lesions in the absence of measurable
             disease as per RECIST 1.1

          -  Adequate bone marrow and organ function defined by laboratory values

        Key Exclusion Criteria:

          -  Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant

          -  More than one prior chemotherapy line for metastatic disease

          -  Symptomatic brain metastases

          -  Increasing or chronic treatment (> 5 days) with corticosteroids or another
             immunosuppressive agent

          -  Active heart (cardiac) disease as defined in the protocol

          -  Certain scores on an anxiety and depression mood questionnaires
Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
Condition: PONV
Intervention: APD421; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic
      in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting
      (PONV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥ 18 years of age

          -  Patients undergoing elective surgery (open or laparoscopic technique) under general
             anaesthesia, expected to last at least one hour from induction of anaesthesia to wound
             closure

          -  Patients with at least 3 "Apfel" risk factors for PONV

        Exclusion Criteria:

          -  Patients scheduled to undergo transplant surgery

          -  Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal
             or epidural) block

          -  Patients who are expected to remain ventilated for a period after surgery

          -  Patients who are expected to need a naso- or orogastric tube in situ after surgery is
             completed
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
Condition: Geographic Atrophy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Lampalizumab
Intervention description: Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 994.0
Sex: All
Healthy volunteers: No

Summary:

      This multicenter open-label extension study is designed to evaluate the safety and
      tolerability of lampalizumab intravitreal injections in participants with GA secondary to
      age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176
      (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the
      parent studies who received investigational lampalizumab, as well as lampalizumab-naive
      participants exposed to sham comparator. All participants will receive open-label
      lampalizumab in the present study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with
             completion of treatment and the Week 96 visit

          -  Agreement to remain abstinent or use a reliable form of contraception among all men
             and among women of child-bearing potential

        Exclusion Criteria:

          -  Concurrent ocular conditions that contraindicate use of lampalizumab or might affect
             interpretation of study results or that might increase the risk of treatment
             complications

          -  Concurrent disease, metabolic dysfunction, or physical or laboratory finding that
             contraindicates use of lampalizumab or might affect interpretation of study results or
             that might increase the risk of treatment complications

          -  Increased risk of infection

          -  Pregnancy or lactation
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Epratuzumab; Epratuzumab
Intervention description: 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles; 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
Intervention MeSH terms: Epratuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus; Monoclonal antibody; B-Cell immunotherapy; Epratuzumab

Summary:

      The primary objective of the study is assess the safety and tolerability of long-term
      epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010
             (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to
             lack of efficacy and would, in the opinion of the investigator, continue to benefit
             from continued epratuzumab treatment

          -  Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881),
             and would, in the opinion of the investigator, continue to benefit from continued
             epratuzumab treatment

          -  Women of childbearing potential must agree to use an acceptable method of birth
             control

        Exclusion Criteria:

          -  Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric
             element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease

          -  Subjects with active, severe SLE disease activity which involves the renal system

          -  Subjects with concurrent relevant medical conditions like defined chronic infections
             or high risk of new significant infections

          -  Substance abuse or dependence

          -  History of malignant cancer

          -  Subjects with any other condition which, in the investigator's judgment, would make
             the subject unsuitable for inclusion
GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GP2013 - A Proposed biosimilar rituximab; Originator rituximab - Rituxan ® or MabThera ®
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study objective is to identify potential safety risks of the transition from US-licensed
      Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to
      continuous treatment with the originator product in terms of general safety and
      immunogenicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis (RA) according to ACR 2010 criteria

          -  Completed one full treatment course with either Rituxan® or MabThera®

          -  Eligible for a further treatment course with Rituxan® or MabThera®- Currently treated
             with methotrexate

        Exclusion Criteria:

          -  RA functional status class IV (ACR 1991 revised criteria)

          -  Systemic manifestation of RA

          -  Positive serology for hepatitis B or hepatitis C infection

          -  Active systemic infection

          -  History of cancer

          -  Known severely immunocompromised state

        Other protocol-defined inclusion/exclusion criteria may apply