bioihbjkbjnl/mcl2 huggingface dataset:
Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma
Condition: Allergic Asthma
MeSH terms: Asthma
Intervention: RhuMab-E25
Intervention description: three subcutaneous injections spaced 1 month apart; dose based on subject weight and baseline IgE level.
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      A single center pilot study to determine the protective effects of RhuMAB-E25 on airway
      physiology and biology in allergic asthmatics that undergo bronchoprovocation with
      methacholine.

      The primary study objective determines the protective impact of RhuMAB-E25 on airway
      inflammation as reflected in exhaled nitric oxide (NO) levels in allergic asthmatics.

      The secondary objective determines the protective effect of rhuMAB E25 against airway
      bronchoconstriction as reflected in the Provocative Concentration of methacholine to cause a
      20% fall in FEV1(PC20) with methacholine challenge testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be at least 18 years of age,

          -  Must have an FEV1 of > 70% of predicted,

          -  Must have evidence of bronchial hyperreactivity to methacholine as defined by a
             methacholine provocation causing a 20% or greater fall in FEV1 (PC20) < 8 mg/ml

          -  Use of inhaled steroid is permitted; however, no change in inhaled steroid dosage will
             be permitted over the duration of study

          -  Must have a normal platelet count,

          -  Must be willing to and competent to sign the consent form

        Exclusion Criteria:

          -  Subjects that do not have allergic asthma will be excluded.

          -  Subjects with ER visits or upper respiratory infections within the last six weeks will
             be excluded.

          -  Subjects with tobacco use within the past year or > 10 pack year history of tobacco
             use will be excluded.

          -  Subjects with serum IgE levels of less than 30 or greater than 700 Iu/mL will be
             excluded.

          -  Subjects that require oral steroid use will be excluded.

          -  Subjects who weigh < 30 kg or > 150 kg are excluded, and subjects with baseline IgE
             levels greater than 300 may be excluded, depending on weight

          -  Pregnant or nursing females will be excluded.
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Intervention: Valbenazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine
      (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for
      the treatment of adults with TD until valbenazine is anticipated to be available commercially
      or they complete 72 weeks of treatment. This study will allow enrollment of up to 150
      medically stable male and female participants with TD who previously participated in and
      completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402
             (Kinect 4) Phase 3 study.

          -  Participants of childbearing potential must agree to use hormonal or two forms of
             nonhormonal contraception (dual contraception) consistently throughout the study and
             until 30 days after the last dose of valbenazine.

          -  If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood
             disorder, or other conditions, be on stable doses.

          -  Be in general good health.

          -  Have adequate hearing, vision, and language skills to perform the procedures specified
             in the protocol.

        Exclusion Criteria:

          -  Have an active, clinically significant unstable medical condition within 1 month prior
             to screening.

          -  Have a known history of substance dependence, substance (drug) or alcohol abuse.

          -  Have a significant risk of suicidal or violent behavior.

          -  Have a known history of neuroleptic malignant syndrome.

          -  Have a known history of long QT syndrome or cardiac arrhythmia.

          -  Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).

          -  Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than valbenazine) during the study.

          -  Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

          -  Have an allergy, hypersensitivity, or intolerance to tetrabenazine.

          -  Are currently pregnant or breastfeeding.
Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Condition: Breast Cancer; Metastases
MeSH terms: Breast Neoplasms
Intervention: Ixabepilone + Capecitabine; Capecitabine
Intervention description: Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity
Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity; Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
Intervention MeSH terms: Capecitabine; Epothilones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 752.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Breast Cancer

Summary:

      The purpose of this clinical research study is to learn if BMS-247550 added to the approved
      therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth
      of the cancer in women with metastatic breast cancer who are resistant to taxane and received
      anthracycline chemotherapy. The safety of this treatment will also be studied.
    

Eligibility criteria:

        -  Patients must have received either 2 or 3 prior chemotherapy regimens including
             adjuvant or neoadjuvant therapy.

          -  Prior treatment must have included both an anthracycline (i.e., doxorubicin or
             epirubicin) and a taxane (i.e., paclitaxel or docetaxel).

          -  Patients must have received a minimum cumulative dose of anthracycline or must be
             resistant to an anthracycline.

          -  Patients must be resistant to taxane therapy.

          -  Patients may not have any history of brain and/or leptomeningeal metastases.

          -  Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).

          -  Patients may have not have had prior treatment with an epothilone and/or capecitabine
             (i.e., Xeloda)
Efficacy of Lansoprazole in Chronic Post Nasal Drip
Condition: Larynx Disease
MeSH terms: Laryngeal Diseases
Intervention: Lansoprazole Tablet; PH and impedence testing; manometry; lansoprazole; placebo
Intervention description: 40 mg bid x 16 weeks; 24 hour ph monitoring; done prior to pH probe to measure length of esophagus; 40mg bid; one tablet bid
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether aggressive acid suppression with
      Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors
      of response based on clinical and physiologic parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Negative RAST inhalant allergy panel OR negative skin testing (Group A)

          -  Positive RAST or Positive skin testing AND insufficient response to all of the
             following: (Group B)

               -  Allergen avoidance

               -  Topical nasal steroids

               -  Allergy shots if indicated

               -  Antihistamines

               -  Negative CT sinuses (coronal)

               -  < 4mm of mucosal thickening and < 3 sinus sites

               -  Absence of air-fluid levels

               -  Negative anterior rhinoscopy

               -  Absence of pus, crusts on mucosal surfaces

        Exclusion Criteria:

          -  Age < 18

          -  Pregnancy, confirmed by urine pregnancy test at day of randomization

          -  Ciliary dyskinesia

          -  Immune deficiency

          -  Cystic fibrosis

          -  Diagnosis of acute sinusitis or chronic RS (AAO-HNS)

          -  Active use of topical decongestant

          -  Use of PPI within the last 30 days

          -  Previous fundoplication

          -  Uncontrolled thyroid disease

          -  Isolated chronic cough without the symptom of post nasal drip
Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: florbetapir F 18
Intervention description: No study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to test the relationship between measurements of brain amyloid using
      florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by
      histopathological assessment. The study will address the following specific aims:

        1. To expand the number of subjects included in the A07 (NCT00857415) trial correlation
           analysis (measuring the correlation between the global visual rating of brain amyloid
           plaque density on an independent blinded read of the florbetapir F 18 PET scan and the
           cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in
           the autopsy cohort).

        2. To determine the sensitivity and specificity of an independent blinded visual read
           assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded
           neuropathological assessment made at autopsy.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects are enrolled in this study if they:

          -  Met entrance criteria and were enrolled and imaged in trial 18F-AV-45-A07
             (NCT00857415)

          -  Gave informed consent for the 18F-AV-45-A07 (NCT00857415) study procedures and brain
             donation consistent with the legal requirements of the State in which they are
             enrolled and the State in which they die

          -  Consent to participate in the 18F-AV-45-A16 (NCT01447719) extension protocol, if
             required by the IRB

          -  Reconfirm their consent to a research brain autopsy, if required by the IRB.
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention description: Tablet, Flexible dosing up to 200 mg/day, twice daily.
The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 767.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures; Adjunctive treatment

Summary:

      This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and
      single arm study of brivaracetam (BRV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject completed the Treatment Period of N01358 or the evaluation period of N01258

          -  Male/female subject from 16 years or older. Subject under 18 years may only be
             included where legally permitted and ethically accepted

          -  Subject for whom the Investigator believes a reasonable benefit from the long term
             administration of BRV may be expected

          -  Female subject without childbearing potential (premenarcheal, postmenopausal for at
             least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are
             eligible

        Exclusion Criteria:

          -  Subject has developed hypersensitivity to any components of the investigational
             medicinal product (IMP) or comparative drugs as stated in this protocol during the
             course of the core studies

          -  Severe medical, neurological, or psychiatric disorders, or laboratory values which may
             have an impact on the safety of the subject

          -  Poor compliance with the visit schedule or medication intake in the previous BRV study

          -  Planned participation in any other clinical study of another investigational drug or
             device during this study

          -  Pregnant or lactating woman

          -  Any medical condition which, in the Investigator's opinion, warrants exclusion

          -  Subject has a lifetime history of suicide attempt or has suicidal ideation in the past
             6 months
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Condition: Transplantation Infection
Intervention: Everolimus 0.25 and 0.75 mg tablets; Cyclosporine very low dose (150-300 ng/mL) microemulsion; Cyclosporine low dose (350-500 ng/mL) microemulsion
Intervention description: The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range. Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range.; The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.; The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.
Intervention MeSH terms: Cyclosporine; Everolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: immunosuppression; kidney transplantation; everolimus; safety

Summary:

      The purpose of this study was to allow the continuation of everolimus treatment in patients
      who have completed the core study (NCT00170885) and to collect long-term safety,
      tolerability, and efficacy data in a group of patients treated with the upper everolimus
      target levels plus very low dose cyclosporin in comparison with the standard everolimus
      target levels plus low dose cyclosporin in patients with renal transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with functioning graft who had completed the 6-month treatment period of core
             study

          -  Patients who were receiving treatment with either everolimus and cyclosporin at the
             end of the core study

          -  Patients who signed the informed consent of the present study extension

        Exclusion Criteria:

        - Women who were pregnant, lactating or who wished to became pregnant.

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B
Condition: Severe Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: rFIXFc
Intervention description: Administered as specified in the treatment arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Male
Healthy volunteers: No
Keywords: B-LONG; B-YOND; B-LONG Extension; rFIXFc; Severe Hemophilia B

Summary:

      The primary objective of the study is to evaluate the long-term safety of rFIXFc in
      participants with hemophilia B.

      The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention
      and treatment of bleeding episodes.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects who have completed studies 998HB102 (NCT01027364) or 9HB02PED (NCT01440946)
             or other studies with rFIXFc

          -  Ability to understand the purposes & risks of the study and provide signed and dated
             informed consent.

        Key Exclusion Criteria:

          -  High-titer inhibitor (>/=5.00 BU/mL)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
Condition: Exocrine Pancreatic Insufficiency; Steatorrhea; Malabsorption Syndromes; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Malabsorption Syndromes; Steatorrhea; Fibrosis
Intervention: Pancrease MT 10.5, or MT 21; Placebo for Pancrease MT 10.5 or MT 21
Intervention description: Pancrease MT capsules for maximum dose of 10,000 lipase units / Kg / day; Capsules with Pancrease MT excipients without the active enzymes
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 7 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Exocrine pancreatic insufficiency; Steatorrhea; Malabsorption syndromes; Cystic fibrosis; Pediatrics; Adult; Pancrelipase

Summary:

      The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT
      in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with
      clinical symptoms of exocrine pancreatic insufficiency (EPI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of CF documented by sweat chloride results (>60 mmol/L) and require
             pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI
             (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of excess
             fat in the feces

          -  Have documentation of an abnormal COA-fat and a fecal elastase result of <100
             micrograms fecal elastase/gram stool

          -  Must be on a stable diet and dose of pancreatic enzyme supplementation that has
             provided satisfactory symptom control for at least the past 1 month

        Exclusion Criteria:

          -  No extreme physical wasting with loss of weight and muscle mass

          -  No severe, acute, or chronic pulmonary disease unrelated to complications of CF

          -  No worsening of pulmonary disease in past 30 days

          -  No use of drugs known to affect blood uric acid concentrations (e.g., aspirin,
             diflunisal, allopurinol, probenecid, thiazide diuretics, phenylbutazone,
             sulfinpyrazone)

          -  No known congenital (present at birth) abnormalities of the gastrointestinal tract,
             heart, or liver

          -  No distal intestinal obstruction syndrome (DIOS)
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