bioihbjkbjnl/mcl2 huggingface dataset:
Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Lumacaftor; Ivacaftor
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the
      pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in
      subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic
      fibrosis transmembrane conductance regulator (CFTR) gene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF defined as: with 2 CF-causing mutations, chronic
             sinopulmonary disease or gastrointestinal/nutritional abnormalities

          -  Subjects who weigh ≥15 kg without shoes at Screening Visit

          -  Subjects who are homozygous for the F508del-CFTR mutation

          -  Subjects with percent predicted forced expiratory volume in 1 second (FEV1) of 70% to
             105% (inclusive) (Part A) or ≥40% (Part B) at Screening Visit where the predicted
             values are adjusted for age, sex, and height using the Wang equation

          -  Subjects with stable CF disease and who are willing to remain on stable CF medication
             regimen

          -  Able to swallow tablets

        Exclusion Criteria:

          -  History of any illness or condition that might confound the results of the study or
             pose an additional risk in administering study drug to the subject

          -  Acute respiratory infection, pulmonary exacerbation, or changes in therapy for
             pulmonary disease within 28 days before Day 1 of the study

          -  Abnormal liver function as defined in the protocol at Screening Visit

          -  Abnormal renal function as defined in the protocol at Screening Visit

          -  History of solid organ or hematological transplantation

          -  Ongoing participation in an investigational drug study or prior participation in an
             investigational drug study within 30 days prior of Screening Visit

          -  History or evidence of lens opacity or cataract at Screening Visit

          -  Colonization with organisms associated with a more rapid decline in pulmonary status
             at Screening Visit (Part A only)

          -  A standard 12-lead ECG demonstrating QTcF >450 msec at Screening Visit
Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)
Condition: Cervical Cancer; Genital Warts
MeSH terms: Warts; Condylomata Acuminata; Uterine Cervical Neoplasms
Intervention: V501; Comparator: Placebo; Human Papillomavirus (HPV) 16 Monovalent
Intervention description: Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.; a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.; HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5759.0
Sex: Female
Minimum age: 16 Years
Maximum age: 23 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of the study is to determine if GARDASIL (V501) with four components is
      able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial
      Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female with an intact uterus with lifetime history of 0-4 sexual partners

        Exclusion Criteria:

          -  Prior Human Papillomavirus (HPV) vaccination

          -  Prior abnormal paps

          -  History of genital warts
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Condition: Metastatic Breast Cancer; Locally Recurrent Breast Cancer
MeSH terms: Breast Neoplasms; Recurrence
Intervention: Eribulin; Balixafortide
Intervention description: Eribulin alone; Balixafortide + Eribulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 432.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to
      investigate the efficacy, safety and tolerability of intravenous balixafortide given with
      eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or
      Metastatic Breast Cancer.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed Breast cancer

          -  Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally
             recurrent breast cancer

          -  refractory to the most recent chemotherapy, documented by progression on or within six
             (6) months of therapy

          -  At least 14 days from the completion of any previous cancer therapy

          -  Adequate organ function

          -  Life expectancy of 3 months or more

          -  Willing and able to comply with the protocol and able to understand and willing to
             sign an informed consent

        Key Exclusion Criteria:

          -  Previously treated with eribulin

          -  Peripheral neuropathy Grade ≥3

          -  Receipt of prior CXCR4 therapy

          -  Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or
             sargramostim, or radiation therapy within 14 days prior to study Day 1

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to balixafortide or eribulin or other agents used in the study

          -  Breast feeding or pregnant

          -  Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias,
             known congenital long QT syndrome, QT interval corrected with Fridericia's formula
             (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently
             taking drugs at known risk of prolonging the QT interval or causing torsades de
             pointes
Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population
Condition: Periodontitis
MeSH terms: Periodontitis
Intervention: Triclosan/copolymer/fluoride; Fluoride
Intervention description: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.; Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride
      toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2
      diabetic population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of
             >200mg/dl.

          -  Minimum of 16 teeth

          -  Chronic periodontitis as indicated by periodontal probing depths >4mm on at least 6
             teeth

        Exclusion Criteria:

          -  Any condition requiring antibiotic cover for dental treatment

          -  Other serious illness
Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin aspart; liraglutide
Intervention description: Injected s.c. (under the skin) once daily. The doses will be individually adjusted; Injected s.c. (under the skin) once daily. The doses will be individually adjusted.; Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 413.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and North America. The aim of this trial is to compare the
      efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest
      meal to insulin degludec in subjects with type 2 diabetes.

      Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643
      (NCT01193309) trial will be randomised to receive treatment intensification while subjects
      with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to
      receive insulin degludec treatment. Subjects are to continue their pre-trial metformin
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. (Trial-related
             activities are any procedure that would not have been performed during normal
             management of the subject).

          -  The subject must have completed the end of treatment visit of NN1250-3643 with Insulin
             degludec once daily + metformin.

          -  Ability and willingness to adhere to the protocol including self measurement of plasma
             glucose according to the protocol

        Exclusion Criteria:

          -  Participated in NN1250-3643 and treated with insulin glargine

          -  Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g.
             exenatide, liraglutide)

          -  Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the
             upper limit of normal at end of treatment in NN1250-3643

          -  Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for
             males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for
             metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the
             Cockroft & Gault formula] at end of treatment in NN1250-3643.
Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: PF-04965842 100 mg; PF-04965842 200 mg; Placebo
Intervention description: PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks; PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks; Placebo, administered as two tablets to be taken orally once daily for 12 weeks
Intervention MeSH terms: Abrocitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 391.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: atopic dermatitis; atopic eczema; eczema; JAK; janus kinase

Summary:

      B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with
      a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy
      and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily,
      will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients
      will have an option to enter a long-term extension study after completing 12 weeks of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older with a minimum body weight of 40 kg

          -  Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
             to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS
             severity 4)

          -  Recent history of inadequate response or inability to tolerate topical AD treatments
             or require systemic treatments for AD control

        Exclusion Criteria:

          -  Unwilling to discontinue current AD medications prior to the study or require
             treatment with prohibited medications during the study

          -  Prior treatment with JAK inhibitors

          -  Other active nonAD inflammatory skin diseases or conditions affecting skin

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q
             wave interval abnormalities, current or history of certain infections, cancer,
             lymphoproliferative disorders and other medical conditions at the discretion of the
             investigator

          -  Pregnant or breastfeeding women, or women of childbearing potential who are unwilling
             to use contraception
A Trial to Reduce Pneumonia in Nursing Home Residents
Condition: Pneumonia; Lower Respiratory Tract Infection
MeSH terms: Infections; Pneumonia; Respiratory Tract Infections
Intervention: Enhanced Oral Care; Usual oral care
Intervention description: oral brushing plus oral chlorhexidine plus upright feeding positioning; Usual oral care and feeding positioning
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 834.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Pneumonia; Lower respiratory tract infection; Lower respiratory tract infection other than pneumonia

Summary:

      The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol
      in preventing pneumonia among nursing home residents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  long term care resident of nursing home

          -  residents age >65

          -  residents of nursing home for at least one month

          -  residents having at least one of two modifiable risk factors for pneumonia (i.e.,
             impaired oral hygiene, swallowing difficulty)

        Exclusion Criteria:

          -  residents housed in nursing home for short term rehabilitation

          -  residents who receive nourishment by tube feeding

          -  residents who have a life expectancy < 3 months

          -  residents who have been diagnosed with pneumonia within the previous 6 weeks

          -  residents who are currently using oral chlorhexidine

          -  residents who have previously been enrolled in the study

          -  residents, or their designated proxies, who are unwilling to give informed consent

          -  residents who have tracheostomy

          -  residents who are non-english speaking

          -  residents who the administrator leadership of the home felt were not appropriate for
             the study
Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene/ BPO gel with Lymecycline capsules; Adapalene/ BPO vehicle gel with Lymecycline capsules
Intervention description: Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning; Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Intervention MeSH terms: Lymecycline; Adapalene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 378.0
Sex: All
Minimum age: 12 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: acne vulgaris

Summary:

      Randomized, controlled, multi-center, double-blind, parallel-group comparison study in
      Subjects with moderate to severe acne vulgaris on the face.

      The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide
      (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl
      Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of
      moderate to severe acne vulgaris.

      The safety of the two treatment regimens will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female Subjects of any race, aged 12 to 35 years inclusive,

          2. Subjects with moderate to severe facial acne vulgaris (Investigator's Global
             Assessment score of 3 or 4),

        Exclusion Criteria:

          1. Subjects with more than 3 nodules or cysts on the face

          2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced
             acne, etc.),

          3. Subjects with a wash-out period for topical treatment on the face less than:
             Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other
             anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1
             week), Phototherapy devices for acne and cosmetic procedures (1 week)

          4. Subjects with a wash-out period for systemic treatment less than:Acne therapy
             containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne
             treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months),
             Spironolactone / Drospirenone (3 months)

          5. Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal
             (creatinine clearance greater than 60 ml/min) functions based on a blood sample,

          6. Subjects with known intolerance to lactose,
Bimatoprost in the Treatment of Eyelash Hypotrichosis
Condition: Idiopathic Eyelash Hypotrichosis
MeSH terms: Hypotrichosis
Intervention: bimatoprost formulation A solution; bimatoprost solution 0.03 %; vehicle of bimatoprost formulation A solution; vehicle of bimatoprost solution 0.03 %
Intervention description: Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.; Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.; Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.; Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 464.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost solution formulation A
      compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash
      hypotrichosis (inadequate eyelashes).
    

Eligibility criteria:

        Inclusion Criteria:

        -Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).

        Exclusion Criteria:

          -  Damage to eyelid area (scarring) that may prevent growth of eyelashes

          -  Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe
             dry eye)

          -  Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery,
             blepharoplasty) during the 3 months prior to screening

          -  Current eyelash implants of any kind

          -  Eyelash tint or dye application within 2 months of baseline

          -  Eyelash extensions application within 3 months of baseline

          -  Use of eyelash growth products within 6 months of baseline

          -  Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents,
             etc) within 6 months prior to baseline.