bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA; Placebo (matched to ELX/TEZ/IVA); Placebo (matched to IVA)
Intervention description: Fixed-dose combination tablet for oral administration qd in the morning.; Tablet for oral administration qd in the evening.; Placebo matched to ELX/TEZ/IVA for oral administration once daily (qd) in the morning.; Placebo matched to IVA for oral administration qd in the evening.
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: 121.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) /
      ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic
      fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF
      genotypes).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Heterozygous for the F508del mutation (F/MF)

          -  Forced expiratory volume in 1 second (FEV1) value greater than equal to(≥) 70%

        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
A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease
Condition: End Stage Renal Failure on Dialysis
MeSH terms: Kidney Failure, Chronic
Intervention: Hemodialysis; Patiromer Oral Product
Intervention description: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.; Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hemodialysis; Kidney Disease; Kidney Function

Summary:

      The optimal frequency of hemodialysis treatments in patients with incident end-stage kidney
      disease in not known. This pilot trial will randomize patients with incident end-stage kidney
      disease due to chronic kidney disease progression to two different regimens of hemodialysis:
      i) twice-weekly hemodialysis for six weeks with adjuvant pharmacologic medications followed
      by thrice-weekly hemodialysis, or ii) thrice-weekly hemodialysis. The study will test
      feasibility of stepwise hemodialysis, and the effects of the two regimens of hemodialysis on
      residual kidney function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Incident ESKD from CKD progression (including a failing renal transplant)

          -  Are deemed to require dialysis initiation by the treating nephrologist

          -  Have elected HD for renal replacement therapy (RRT)

        Exclusion Criteria:

          -  Have urine output <500ml per day

          -  Have ESKD as a result of severe acute kidney injury (AKI) (stage 3 AKI defined by
             Acute Kidney Injury Network [AKIN]) criteria)

          -  Abrupt decline in kidney function preceding HD therapy initiation (i.e., if eGFR was
             ≥30 mL/min/1.73 m2 3 months prior to the initiation of dialysis therapy)

          -  Are scheduled to undergo transplantation from a live donor within the next 6 months

          -  Have an active diagnosis of hepatorenal syndrome

          -  Have a significant malignancy that is likely to impact survival

          -  Have a medical condition that would jeopardize the safety of the subject.
Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
Condition: Malocclusion
MeSH terms: Malocclusion
Intervention: OrthoAccel Device; Sham Device
Intervention description: The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.; Inactive sham device that is held in the mouth for 20 minutes.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Orthodontic; Extraction; Device; Space Closure; Orthodontic malocclusion

Summary:

      To gather data indicating whether or not the OrthoAccel device speeds tooth movement in
      people who use orthodontics (braces).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Permanent dentition between the ages of 12 and 40

          -  Minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior
             teeth from canine to canine or by distal movement of the canines

          -  Good oral hygiene and compliance

        Exclusion Criteria:

          -  Any compromised medical or dental condition

          -  Patient currently involved in any other study

          -  Lives significantly outside San Antonio, TX

          -  use of bisphosphonates

          -  pregnant females
A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Emicizumab
Intervention description: Emicizumab will be administered as per the schedule specified in the respective arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the
      efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially
      once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This
      study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W)
      and once every 4 weeks (Q4W) regimens in pediatric participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children less than (<) 12 years of age, with allowance for participants 12 to 17 years
             of age who weigh <40 kilograms (kg) (Cohort A only); and participants <2 years of age
             will be allowed to participate only after the protocol-defined interim data review
             criteria are met (Cohort A only)

          -  Diagnosis of congenital hemophilia A of any severity and documented history of
             high-titer inhibitor (that is [i.e.], greater than or equal to [>/=] 5 bethesda units
             [BU])

          -  Requires treatment with bypassing agents

          -  Adequate hematologic, hepatic, and renal function

        Exclusion Criteria:

          -  Inherited or acquired bleeding disorder other than hemophilia A

          -  Ongoing (or planning to receive during the study) immune tolerance induction (ITI)
             therapy or prophylaxis treatment with FVIII

          -  Previous (in the past 12 months) or current treatment for thromboembolic disease or
             signs of thromboembolic disease

          -  Other disease that may increase risk of bleeding or thrombosis

          -  History of clinically significant hypersensitivity associated with monoclonal antibody
             therapy or components of the emicizumab injection

          -  Known infection with human immunodeficiency virus (HIV) or hepatitis B or C virus

          -  Use of systemic immunomodulators at enrollment or planned use during the study period

          -  Planned surgery (excluding minor procedures such as tooth extraction or incision and
             drainage) during the study

          -  Inability (or unwillingness by caregiver) to receive (allow receipt of) blood or blood
             products (or any standard-of-care treatment for a life-threatening condition)

          -  Participants who are at high risk for thrombotic microangiopathy (TMA) (e.g., have a
             previous medical or family history of TMA), in the investigator's judgement
Implantable Cardioverter-Defibrillator Use in the VA System
Condition: Cardiomyopathies
MeSH terms: Cardiomyopathies
Intervention: Clinical Reminder
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Despite being a proven life-saving intervention in appropriately selected individuals,
      multiple studies continue to demonstrate low implantation of defibrillators in potential
      candidates. Based upon prior research, a major barrier to low utilization is low referral of
      potential candidates by healthcare providers. In this study, via brief clinical reminder
      placed in the electronic medical record, we ask healthcare providers who have not referred
      potential candidates for defibrillator the reasons for this decision and provide them with
      the tools for referral if appropriate.
    

Eligibility criteria:

        Inclusion Criteria:Meeting published criteria for receipt of an implantable cardioverter
        defibrillator Exclusion Criteria:provider is not affiliated with the VA health care system
Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Rosuvastatin; Ezetimibe; Placebo
Intervention description: Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.; Rosuvastatin over-encapsulated tablets orally.; Ezetimibe over-encapsulated tablets orally.; Placebo for alirocumab and ezetimibe.
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe; Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab
      (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia
      at high cardiovascular (CV) risk.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with LDL-C greater than or equal to 70 mg/dL at the screening visit and who
             are not adequately controlled with a stable daily dose of rosuvastatin, with or
             without other LMT.

             OR

          2. Patients with screening LDL-C greater than or equal to 100 mg/dL who are not
             adequately controlled with a stable daily dose of rosuvastatin before the screening
             visit, with or without other LMT.

        Exclusion Criteria:

          1. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented
             cardiovascular disease (CVD)

          2. LDL-C less than 100 mg/dL at the screening visit in patients without history of
             documented coronary heart disease (CHD) or non-CHD CVD, but with other risk factors

          3. Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping)

          4. Recent (within 3 months prior to the screening visit) myocardial infarction (MI),
             unstable angina leading to hospitalization, percutaneous coronary intervention (PCI),
             coronary bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke,
             transient ischemic attack, carotid revascularization, endovascular procedure or
             surgical intervention for peripheral vascular disease

          5. Newly diagnosed (within 3 months prior to randomization visit) or poorly controlled
             diabetes

          6. Presence of any clinically significant uncontrolled endocrine disease known to
             influence serum lipids or lipoproteins

        (The inclusion/ exclusion criteria provided above is not intended to contain all
        considerations relevant to a patient's potential participation in this clinical trial).
Phase 3 Study of OTO-201 in Acute Otitis Externa
Condition: Acute Otitis Externa; Swimmer's Ear
MeSH terms: Otitis; Otitis Externa
Intervention: 12 mg ciprofloxacin; Sham Control
Intervention description: Single administration of OTO-201; Simulated, single adminstration
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 262.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study
      in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a
      single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external
      auditory canal of the affected ear(s).
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female age 6 months or older

          -  Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa

          -  Subject or subject's caregiver is willing to comply with the protocol and attend all
             study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has tympanic membrane perforation

          -  Subject has eczematoid otitis externa

          -  Subject has diabetes mellitus
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Intervention: OTO-201; Sham
Intervention description: Single, intratympanic injection; Simulated single, intratympanic injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 266.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: otitis media; otorrhea; middle ear effusion; tympanostomy tubes

Summary:

      The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201
      in the treatment of pediatric subjects with bilateral middle ear effusion who require
      tympanostomy tube placement.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 17 years, inclusive

          -  Subject has a clinical diagnosis of bilateral middle ear effusion requiring
             tympanostomy tube placement

          -  Subject's caregiver is willing to comply with the protocol and attend all study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has a history of prior ear or mastoid surgery, not including myringotomy or
             myringotomy with tympanostomy tube placement

          -  Subject has a history of sensorineural hearing loss

          -  Subject has a history of chronic or recurrent bacterial infections other than otitis
             media that likely will require treatment with antibiotics during the course of the
             study
Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
Condition: Eczema
MeSH terms: Eczema
Intervention: alitretinoin; Placebo
Intervention description: Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks; Patients receive matching placebo for up to 24 weeks
Intervention MeSH terms: Alitretinoin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: retinoid treatment; fingertip dermatitis; hyperkeratotic hand eczema; vesicular hand eczema; pompholyx

Summary:

      The purpose of this study is to investigate the safety and efficacy of alitretinoin in the
      treatment of severe chronic hand eczema that does not respond to treatment with potent
      topical steroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all types of chronic hand eczema, lasting for at least 6 months since initial
             diagnosis

          -  rated as severe by the physician

          -  unresponsive to highly potent topical corticosteroids, such as clobetasol

        Exclusion Criteria:

          -  patients whose disease is adequately controlled by standard non-medicated therapy,
             including potent topical steroids, skin moisturizers, and avoidance of allergens and
             irritants

          -  patients with known allergens and irritants, who have not made a reasonable effort to
             avoid the substances

          -  patients with psoriasis lesions

          -  active fungal, bacterial or viral infections of the hands

          -  female patients who are pregnant or breastfeeding

          -  female patients of childbearing potential who cannot use or will not commit to use two
             effective methods of contraception
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Fluocinolone Acetonide
Intervention description: 0.2 μg/day
Intervention MeSH terms: Fluocinolone Acetonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Healthy volunteers: No

Summary:

      This study will assess the safety and utility of the new inserter for the administration of
      ILUVIEN in subjects with diabetic macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects who previously participated in the FAME studies and subjects with chronic DME
             considered insufficiently responsive to available therapies.

          2. In the judgment of the Investigator, the subject will benefit from treatment with
             ILUVIEN.

          3. Ability and willingness to comply with the treatment and follow up procedures.

          4. Ability to understand and sign the Informed Consent Form. No expectation that subject
             will be moving out of the area of the clinical center to an area not covered by
             another clinical center during the next 12 months.

        Exclusion Criteria:

          1. Pregnant, lactating females or females of childbearing potential (unless using
             reliable contraception, i.e. double barrier, surgical sterilization, oral
             contraceptives, Norplant, intrauterine device (IUD)

          2. Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual
             field changes at screening in the study eye

          3. Retinal or choroidal neovascularization due to ocular conditions other than diabetic
             retinopathy (e.g., presumed ocular histoplasmosis, high myopia (spherical equivalent >
             8 diopters), macular degeneration)

          4. Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any
             history of a potentially recurrent infection which could be activated by treatment
             with a steroid, (e.g., ocular herpes simplex virus)

          5. Known or suspected hypersensitivity to any of the ingredients of the investigational
             product or to other corticosteroids

          6. History of uncontrolled IOP elevation with steroid use that did not respond to topical
             therapy or IOP-lowering procedure

          7. History or presence of any disease or condition (malignancy) that in the
             investigator's opinion would preclude study treatment or follow-up

          8. Any lens opacity which significantly impairs vision, in the opinion of the
             investigator.

          9. Peripheral retinal detachment in prospective area of insertion

         10. Participation in another clinical trial within 12 weeks before the screening visit or
             during the study
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo identical to BI 1356 5mg; Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg; BI 1356; Glimepiride
Intervention description: Placebo tablet once daily; Placebo tablets once daily; 5mg, once daily in the morning for 104 weeks; 1mg or 2mg or 3mg or 4mg in the morning for 104 weeks
Intervention MeSH terms: Glimepiride; Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1560.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the efficacy, safety and tolerability of
      BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to
      preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient
      glycaemic control
    

Eligibility criteria:

        Inclusion criteria:

          1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously
             treated with metformin alone or with metformin and one other oral antidiabetic drug

          2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with
             metformin and one other oral antidiabetic drug

          3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone

          4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

        Exclusion criteria:

          1. Myocardial infarction, stroke or transient ischemic attack (TIA)

          2. Impaired hepatic function

          3. Renal failure or renal impairment

          4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening

          5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within
             3 months prior to screening