bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Intervention: Pegylated-Interferon-lambda; Ribavirin; Daclatasvir
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective for this study is to evaluate the proportion of subjects who achieve
      SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects
      with Genotype(GT)-1b, -4 and GT-2, -3
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Severe hemophilia (defined as < 1% factor activity level)

          -  Infection with the hepatitis C virus (HCV) with underlying hemophilia

          -  Males 18 years of age and above

          -  Have not been previously treated with an interferon

        Exclusion Criteria:

          -  Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Chronic liver disease caused by any disease other than chronic HCV infection

          -  Presence of Bethesda inhibitor

          -  Current evidence of or history of portal hypertension
Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
Condition: Onychomycosis of Toenails
MeSH terms: Onychomycosis
Intervention: AN2690 Topical Solution, 5%; Solution Vehicle
Intervention description: AN2690 Topical Solution, 5%, applied once daily for 48 weeks; AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
Intervention MeSH terms: Tavaborole; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 604.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onychomycosis; nail fungus; toenail fungus; fungal nail; hyperkeratosis; nail infection; nail treatment; toenail infection; toenail treatment; foot dermatoses; fungal culture; onycholysis; podiatrist; podiatry; subungual; tinea unguium; antifungal; anti-fungal; dermatologist; dermatology; dermatophyte; distal subungual onychomycosis; yellow nail; thick nail; brittle nail; crumbling nail; discolored nail; weak nail

Summary:

      The purpose of this study is to determine whether AN2690 topical solution is a safe and
      effective treatment for onychomycosis of the toenail.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of distal subungual onychomycosis affecting at least one great
             toenail

          -  KOH positive at screening

          -  Willingness not to use any other products including nail polish applied to the
             toenails during the study

          -  Women of childbearing potential who are currently sexually active must agree to use
             contraception for the entire study period

        Exclusion Criteria:

          -  Concurrent or recent use of certain topical or systemic medications without a
             sufficient washout period

          -  History of any significant chronic fungal disease other than onychomycosis

          -  Significant confounding conditions as assessed by study doctor

          -  Participated in any other trial of an investigational drug or device within 30 days or
             participation in a research study concurrent with this study

          -  Pregnancy or lactation
A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Revefenacin; Placebo; Formoterol
Intervention description: Revefenacin is administered via a nebulizer.; Placebo version of Revefenacin is administered via a nebulizer.; Administered sequentially in both revefenacin and placebo arms using a nebulizer.
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled, parallel-group study. Each participant will receive treatment daily for a total of 42 days. One group will receive placebo and formoterol and one group will receive revefenacin and formoterol.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; Pulmonary Function; COPD; Performist

Summary:

      The primary objective of the study was to characterize the safety and tolerability of
      once-daily revefenacin inhalation solution when dosed sequentially with twice-daily
      formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of
      participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over
      21 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a male or female subject 40 years of age or older.

          -  Participant is willing and able to provide signed and dated written informed consent.

          -  Participant has a current or past cigarette smoking history (or equivalent for cigar
             or pipe smoking history) of at least 10 pack-years.

          -  Participant must be willing and able to attend study visits according to the visit
             schedule and adhere to all study assessments/procedures.

        Exclusion Criteria:

          -  Participant has a concurrent disease or condition that, in the opinion of the
             investigator, would interfere with study participation or confound the evaluation of
             safety, tolerability, or pharmacokinetics of the study drug.

          -  Participant has a history of reactions or hypersensitivity to inhaled or nebulized
             anticholinergics, short-acting beta-agonists and long-acting beta-agonists.

          -  Participant with clinically significant and uncontrolled hypertension,
             hypercholesterolemia or Type II diabetes mellitus, as assessed by the investigator.

          -  Participant is unwilling or unable to stop the use of prohibited medications during
             the washout (if required) and treatment period and follow-up period of the study.
Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: fesoterodine fumarate
Intervention description: 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
Intervention MeSH terms: Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To assess the long term safety, tolerability and efficacy of fesoterodine in patients with
      OAB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day
             and urinary urgency episodes >=1 per day.

        Exclusion Criteria:

          -  Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or
             to peanut or soya or any of the excipients.

          -  Patient has a known neurological disease influencing bladder function.

          -  Patient has a complication of lower urinary tract pathology potentially responsible
             for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic
             organ prolapse.
Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
Condition: Anti- VGF Inhibitor; Diabetic Macular Edema; Diabetic Retinopathy
MeSH terms: Macular Edema; Diabetic Retinopathy; Edema
Intervention: pegaptanib sodium
Intervention description: Upon enrollment, all subjects will be treated in the study eye with pegaptanib sodium 0.3 mg at the investigators' discretion based on visual acuity assessment up to a maximum of 48 weeks. The minimum dosing interval between injections will be at least 6 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pegaptanib sodium; diabetic macular edema

Summary:

      This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular
      edema. The hypothesis is that pegaptanib is safe and efficacious in patients with diabetic
      macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

          -  Subjects with documented clinical diagnosis of diabetic macular edema (DME) with
             proliferative or non proliferative diabetic retinopathy.

          -  Subjects, who according to the clinical assessment of the investigator, may benefit
             from anti-VEGF therapy including those subjects who were participating in the A5751013
             study and who, in the investigator's opinion, may benefit from continued pegaptanib
             sodium therapy.

        Exclusion Criteria:

          -  Eyes with prior scatter (panretinal) photocoagulation within 4 months prior to
             baseline or anticipated scatter (panretinal) photocoagulation within the next 6
             months.

          -  Presence of any abnormality that is likely to confound assessment of visual acuity
             improvement in eyes in which macular edema resolves, or improves, such as
             non-perfusion for >1 disc area involving the foveal avascular zone (FAZ - involving 2
             or more quadrants centered around the foveal avascular zone), epiretinal membrane
             associated with signs of contraction and/or significant opacification (i.e. striae
             within 1 disc diameter of the foveal center), or presence of chorioretinal atrophy
             involving the center of the macula.

          -  Vitreomacular traction determined clinically and/or by optical coherence tomography
             (OCT), which, in the investigator's opinion, contributes to the macular edema (or
             causes associated foveal detachment), and would preclude improvement with pegaptanib
             sodium.

          -  Any other cause of macular edema such as vitreous extension, or entrapment to anterior
             segment wound, or any retinal vein occlusion involving the macula.
LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Condition: Cataract; Pain; Ocular Inflammation
MeSH terms: Cataract; Inflammation
Intervention: Loteprednol Etabonate Ophthalmic Gel dosed TID; Loteprednol Etabonate Ophthalmic Gel dosed BID; Vehicle Gel
Intervention description: Gel; Gel; Gel
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of
      Ocular Inflammation and Pain Following Cataract Surgery.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and with
             the capacity to provide voluntary informed consent.

          2. Be able to read, understand, and provide written informed consent on the Institutional
             Review Board (IRB)/Ethics Committee (EC) approved ICF and provide Health Insurance
             Portability and Accountability Act (HIPAA) authorization.

          3. Be willing and able to comply with all treatment and follow-up/study procedures.

          4. Be a candidate for routine, uncomplicated cataract surgery (phaco-emulsification with
             posterior chamber intraocular lens [IOL] implantation, not combined with any other
             surgery).

          5. In the Investigator's opinion, have potential postoperative pin-holed Snellen visual
             acuity (VA) of at least 20/200 in the study eye at Visit 1 (Screening) and at least
             20/200 in the fellow eye.

        Key Exclusion Criteria:

          1. Have a severe/serious ocular condition or history/presence of chronic generalized
             systemic disease that the Investigator feels might increase the risk to the subject or
             confound the result(s) of the study.

          2. Be a female subject who is pregnant or breastfeeding.

          3. Be monocular (fellow eye is nonfunctional or fellow eye's pinhole vision is worse than
             Snellen 20/200).

          4. Have had ocular surgery (including laser surgery) in the study eye within 3 months or
             in the fellow eye within 2 weeks prior to Visit 1 (Screening).
Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo
Intervention description: 5mg, oral tablet, once daily for 24 weeks; oral tablet, once daily for 24 weeks
Intervention MeSH terms: Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 568.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DPP-4 inhibitors; HBA1c; Incretins

Summary:

      Saxagliptin is a new investigational medication being developed for treatment of type 2
      diabetes. This study is designed to evaluate the efficacy and safety in adult patients with
      inadequate glycaemic control with diet and exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Type 2 diabetes

          -  Patients should be drug naïve ie, not received medical treatment for diabetes,

          -  HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

        Exclusion Criteria:

          -  Insulin therapy within one year of enrolment (with the exception of insulin therapy
             during a hospitalization or use in gestational diabetes),

          -  Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma
Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Intervention: PS Group; NCPAP Group; ISX Group
Intervention description: Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.; Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.; Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
Intervention MeSH terms: Pulmonary Surfactants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 648.0
Sex: All
Minimum age: 26 Weeks
Maximum age: 29 Weeks
Healthy volunteers: No
Keywords: Prematurity; respiratory distress syndrome; surfactant; nasal continuous positive airway pressure

Summary:

      The best mode of delivery room stabilization for premature infants at high risk for
      respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct
      methods of post-delivery stabilization and subsequent early respiratory care on chronic lung
      disease and survival in premature infants at high risk for respiratory distress syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

        Infants likely to be delivered to women presenting to a participating Vermont Oxford
        Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks
        will be eligible for inclusion. Specific inclusion criteria that must be met prior to
        randomization include:

          1. Imminent delivery

          2. No potentially life-threatening congenital anomaly or genetic syndrome

          3. No known lung maturity

          4. Antenatal steroid status known

          5. Written, informed consent obtained (on admission or prior to delivery).

        Exclusion Criteria:

          1. Stillborn (Apgar score of 0 at one minute of age)

          2. Noted to have a potentially life-threatening congenital anomaly or genetic syndrome
             noted immediately after delivery.
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Condition: Benign Prostatic Hypertrophy
MeSH terms: Prostatic Hyperplasia; Hypertrophy
Intervention: Cetrorelix Pamoate
Intervention description: Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
Intervention MeSH terms: Cetrorelix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 528.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Cetrorelix; BPH

Summary:

      Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human
      males over the age of 50 which increases in prevalence with age and 40% of males reported
      moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this
      study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate.

      For this study, study medication (Cetrorelix pamoate) is administered by injection in the
      buttocks (Intramuscular).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Benign Prostatic Hyperplasia, based on medical history

          -  Voiding symptoms

          -  Uroflow (max) 5-15mL/sec

        Exclusion Criteria:

          -  Urgent need for prostate surgery

          -  History of allergic reaction to peptide

          -  Major organ dysfunction

          -  Prior surgical treatment of the prostate or bladder

          -  Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or
             botulinum toxin type a (Botox) within the last 6 months prior to trial medication at
             Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial
             medication at Week 0

          -  Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus
             or documented neurologic disorder, urethral stricture disease or history of pelvic
             radiation therapy

          -  History of acute obstructive, infectious, or neurological disorders of the
             genitourinary tract within the last 3 months
Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
Condition: Recurrent Nasopharynx Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Recurrence
Intervention: Etoposide phosphate; Carboplatin; Ifosfamide; Autologous Stem Cell Transplantation
Intervention description: Etoposide is one of three drugs used in the high-dose conditioning phase; Carboplatin is one of the drugs used in the high-dose conditioning phase.; Ifosfamide is one of the drugs used in the high-dose conditioning phase; Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
Intervention MeSH terms: Carboplatin; Etoposide; Ifosfamide; Etoposide phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Recurrent nasopharynx carcinoma

Summary:

      This is a pilot study to evaluate the response rates for patients undergoing high dose
      conditioning chemotherapy using Etoposide, Carboplatin and Ifosfamide followed by autologous
      stem cell transplantation for the treatment of recurrent Nasopharyngeal Cancer (NPC) in
      children, adolescents, and young adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Imaging and tissue diagnosis of recurrent or progressive nasopharyngeal carcinoma

          -  Documentation of previous treatment including conventional chemotherapy and/or
             radiation therapy as clinically appropriate

          -  Ages 2 to 30 years of age

          -  Negative serum pregnancy test if applicable

          -  Calculated creatinine clearance of greater than 60 mL/minute, serum creatinine of less
             than 12o micromoles/L, total bilirubin less than 2 mg/dL and aspartate
             aminotransferase (AST) must be less than twice the upper limit of normal

        Exclusion Criteria:

          -  Unsuitable candidate for autologous transplantation due to comorbidities or
             intractable psychosocial issues

          -  Pregnancy

          -  Breast-feeding women