bioihbjkbjnl/mcl2 huggingface dataset:
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Bepotastine besilate
Intervention description: Two TAU-284 5mg tablets will be taken orally twice a day
Intervention MeSH terms: Bepotastine besilate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 7 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: TAU-284; Bepotastine besilate; Histamine H1 receptor antagonists; children

Summary:

      The objective of this study is to evaluate the long-term safety and efficacy of TAU-284
      (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks
      administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged between 7 and 15 years

          -  Patients who have received a diagnosis of perennial allergic rhinitis according to the
             diagnostic criteria

          -  Patients with a mean total score for the three major nasal symptoms [sneezing,
             rhinorrhea, and nasal congestion] of at least 3 on the basis of symptoms recorded in
             the nasal allergy diary during the observation period etc.

        Exclusion Criteria:

          -  Patients with vasomotor rhinitis or eosinophilic rhinitis

          -  Patients who have concurrent nasal disease that may affect the efficacy of TAU-284

          -  Patients with a history of any of the nasal surgical procedures

          -  Patients with current or previous history of drug allergy

          -  Patients who concurrently have renal function abnormalities that may cause safety
             problems etc.
Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus
Condition: Vulvar Lichen Sclerosus
MeSH terms: Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
Intervention: Fractionated Carbon Dioxide Laser; Clobetasol Propionate 0.05% ointment
Intervention description: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart.; Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment.
Intervention MeSH terms: Clobetasol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vulva; Lichen Sclerosus; Fractionated Carbon Dioxide Laser; Mona Lisa Laser; Clobetasol Propionate; Vulvodynia

Summary:

      This study is being done to compare the effects, good and bad, of fractionated CO2 laser
      treatment and clobetasol propionate .05% ointment on vulvar lichen sclerosus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven symptomatic vulvar lichen sclerosus

          -  Ability to understand the study, accept randomization and logistically follow-up with
             scheduled visits

          -  English Speaking

        Exclusion Criteria:

          -  Known vulvar malignancy

          -  Pregnancy or planning pregnancy or less than 3 months postpartum

          -  Premenopausal

          -  Current or prior diagnosis of any gynecologic malignancy

          -  Previous pelvic radiation therapy

          -  Allergy to topical steroid

          -  Active Urinary Tract Infection (UTI), vulvar infection (candida, herpes, bacterial
             vaginosis, trichomoniasis or other infection)

          -  Pelvic organ prolapse > than Stage 2

          -  Treatment with systemic immunomodulators, topical calcineurin inhibitors (tacrolimus,
             pimecrolimus), or vaginal hormonal or vulvar topical steroid use within 2 months of
             enrollment

          -  History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)

          -  IUD (Intrauterine Device)

          -  Skindex-29 overall score <21, below mildly impaired health related quality of life
             threshold
Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; NVA237; QAB149; Placebo
Intervention description: QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily; NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily; QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily; Placebo capsules provided in blister packs for inhalation via SDDPI, once daily
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 193.0
Sex: All
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; QVA149; QAB149; NVA237; indacaterol; glycopyrronium bromide

Summary:

      The study assessed the safety and efficacy of the fixed combination product QVA149 versus the
      component products QAB149 and NVA237, administered concurrently, in patients that have
      moderate to severe chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged ≥ 40 yrs

          -  Smoking history of at least 10 pack years

          -  Diagnosis of COPD (moderate to severe as classified by the Global Initiative for
             Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010)

          -  Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and
             post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

        Exclusion Criteria:

          -  Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular co-morbid conditions

          -  Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

          -  Patients in the active phase of a supervised pulmonary rehabilitation program

          -  Patients contraindicated for inhaled anticholinergic agents and β2 agonists

        Other protocol-defined inclusion/exclusion criteria may apply
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED)
Condition: Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: dorzolamide hydrochloride (+) timolol maleate; Comparator: timolol maleate; Comparator: dorzolamide hydrochloride
Intervention description: Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week; timolol maleate 0.5%, 8-week; dorzolamide hydrochloride 1%, 8-week
Intervention MeSH terms: Timolol; Dorzolamide; Maleic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 474.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%)
      with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in
      patients with glaucoma and ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with glaucoma and ocular hypertension

        Exclusion Criteria:

          -  History of ocular surgery within 3 months

          -  Administration contradiction to timolol and dorzolamide
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Intervention: Buprenorphine transdermal patch; Buprenorphine transdermal patch; Buprenorphine transdermal patch
Intervention description: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.; Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.; Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Low back pain; Opioid; Transdermal

Summary:

      The purpose of the extension phase is to evaluate the long-term safety and tolerability of
      buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h
      and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on
      adequate pain relief and tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who completed all visits of the double-blind phase on study drug, and
             subjects who discontinued study drug due to lack of therapeutic effect in the
             double-blind phase but completed all visits of the double-blind phase off study drug
             are eligible to enroll in the extension phase.

          -  For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry
             if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with
             any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥
             500 milliseconds (msec) would be discontinued from the extension phase

        Exclusion Criteria:

          -  Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with a
             every (q) 24 hours (h) or q12h drug] or transdermal fentanyl during the extension
             phase should be discontinued from the study.
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bevacizumab [Avastin]; Chemotherapy
Intervention description: 10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks; Standard chemotherapy (doublets not allowed)
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 494.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label, parallel-group study will assess the efficacy and s afety of
      Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second-
      and third-line therapy in patients with locally recurrent o r metastatic breast cancer
      progressing after first-line therapy with Avastin and chemotherapy. Patients will be
      randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks
      intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study
      treatment is until third-line disease progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients, >/= 18 years of age

          -  Histologically confirmed HER2-negative breast cancer

          -  Disease progression during or following first-line treatment with Avastin and
             chemotherapy for locally recurrent or metastatic breast cancer

          -  Avastin treatment in first-line setting must have been a minimum of 4 cycles (15
             mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy

          -  ECOG performance status 0-2

          -  At least 28 days since prior radiation therapy or surgery and recovery from treatment

        Exclusion Criteria:

          -  Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin
             for first-line treatment

          -  Active malignancy other than superficial basal cell and superficial squamous cell
             carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5
             years

          -  Inadequate renal function

          -  Clinically relevant cardio-vascular disease

          -  Known CNS disease except for treated brain metastases

          -  Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75
             mg/day)

          -  Pregnant or lactating women
REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: REGN3918
Intervention description: Subcutaneous (SC) every week (QW) over the treatment period
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH

Summary:

      The primary objective of the study is to evaluate the long-term safety, tolerability, and
      effect on intravascular hemolysis of REGN3918 in patients with paroxysmal nocturnal
      hemoglobinuria (PNH).

      The secondary objectives of the study are:

        -  To evaluate the long-term effect of REGN3918 on intravascular hemolysis

        -  To assess the concentrations of total REGN3918 in serum

        -  To evaluate the occurrence of the immunogenicity of REGN3918
    

Eligibility criteria:

        Key Inclusion Criteria:

        • Patients with PNH who have completed, without discontinuation, study treatment in one of
        the parent studies in which they participated (either R3918-PNH-1852 [NCT03946748] or
        R3918-PNH-1853)

        Key Exclusion Criteria:

          -  Significant protocol deviation(s) in the parent study based on the investigator's
             judgment and to the extent that these would (if continued) impact the study objectives
             and/or safety of the patient (for example, repetitive non-compliance with dosing by
             the patient)

          -  Any new condition or worsening of an existing condition which, in the opinion of the
             investigator, would make the patient unsuitable for enrollment or could interfere with
             the patient participating in or completing the study

        NOTE: Other protocol defined exclusion criteria apply
Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
Condition: cUTI
MeSH terms: Urinary Tract Infections
Intervention: Eravacycline; Levofloxacin
Intervention MeSH terms: Levofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Except for the responsible study site pharmacist or designee and separate unblinded clinical research associates to monitor drug supply and adherence to study drug blinding and randomization procedures, all study staff and participants were blinded to treatment assignment.
Enrollment: 908.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to
      assess the efficacy and safety of eravacycline compared with levofloxacin in participants
      with complicated urinary tract infections (cUTI).
    

Eligibility criteria:

        Inclusion Criteria:

        1. Male and female participants with either:

        a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total
        population), OR b. cUTI with at least 1 of the following conditions associated with a risk
        for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately
        100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial
        obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v.
        Azotemia of renal origin (not congestive heart failure or volume related) such that the
        serum blood urea nitrogen (BUN) is elevated (>20 mg/deciliters) AND the serum BUN:
        creatinine ratio is <15 vi. Surgically modified or abnormal urinary tract anatomy (such as,
        bladder diverticula, redundant urine collection system) EXCEPT surgery within the last
        month

        Exclusion Criteria:

        1. Concurrent use of non-study antibacterial drug therapy that would have a potential
        effect on outcome evaluations in participants with cUTI, including:

          1. Participants with a history of a levofloxacin-resistant urinary tract infection

          2. Likely to receive ongoing antibacterial drug prophylaxis prior to the late
             Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)
Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
Condition: Chronic Pain; Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Intervention: Buprenorphine; Placebo
Intervention description: transdermal system 10 and 20 applied for 7-day wear; transdermal system (placebo) applied for 7-day wear
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 567.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic pain,; OA of the knee,; opioid,; transdermal

Summary:

      The objective of this study is to determine the analgesic efficacy and safety of
      Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve
      subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The
      double-blind treatment intervention duration is 12 weeks, during which time supplemental
      analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and
      acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to
      all subjects in addition to study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting
             several hours daily) as their predominant pain condition,

          -  clinical diagnosis of OA of the knee 1 year or longer,

          -  subjects treated within the 14 days prior to screening with nonopioid therapy only, or
             with therapy including opioids at a dose of < 5 mg oxycodone (or equivalent) per day,

          -  subjects whose OA knee pain is not adequately controlled with nonopioid analgesic
             medication and who the investigator feels are appropriate candidates for
             around-the-clock opioid therapy.

        Exclusion Criteria:

          -  subjects who have had arthroscopy on either knee or hip within 6 months of entering
             the study or open surgery on either knee or hip within 9 months of entering the study,

          -  subjects who are allergic to buprenorphine or who have a history of allergies to other
             opioids,

          -  subjects who have allergies or other contraindications to transdermal delivery systems
             or patch adhesives.

        Other protocol-specific inclusion/exclusion criteria may apply.
A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed dose combination (FDC) tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on
      cough and physical activity using wearable technology in CF participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Forced expiratory volume in 1 second (FEV1) value ≥30% and ≤90% predicted

          -  Heterozygous for CF transmembrane conductance regulator gene (CFTR) F508del mutation
             and a minimal function mutation (F/MF genotypes)

        Key Exclusion Criteria:

          -  Clinically significant liver cirrhosis

          -  Solid organ or hematological transplantation

          -  Non-ambulatory status

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

        Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed dose combination granules for oral administration.; Granules for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and
      efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination therapy in
      CF subjects 2 through 5 years of age.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for the F508del mutation or heterozygous for F508del and a minimal function
             (MF) mutation (F/F or F/MF genotypes)

        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