bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Moderate to Severe Lateral Canthal Lines
Condition: Lateral Canthal Lines
Intervention: botulinum toxin; Placebo
Intervention description: neuromodulator; placebo
Intervention MeSH terms: Botulinum Toxins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to evaluate the efficacy and safety of a single dose of
      QM1114-DP compared to placebo for the treatment of moderate to severe LCL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 years of age or older.

          2. Moderate to severe LCL at maximum smile as assessed by the Investigator.

          3. Moderate to severe LCL at maximum smile as assessed by the subject.

        Exclusion Criteria:

          1. Previous use of any Botulinum toxin treatment in facial areas within 9 months prior to
             study treatment.

          2. Female who is pregnant, breast feeding, or intends to conceive a child during the
             study.

          3. Known allergy or hypersensitivity to any component of the investigational product
             (QM1114-DP) or any botulinum toxin serotype.
Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder
Condition: Chronic Motor or Vocal Tic Disorder; Tourette's Disorder
MeSH terms: Tics; Tic Disorders; Tourette Syndrome
Intervention: aripiprazole; placebo
Intervention description: Initial dose : 2mg, Maximum dose : 20mg; Initial dose: 2mg, Maximum dose:20mg
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Motor Tic disorder; Chronic Phonic Tic disorder; Tourette's disorder; Aripiprazole; Abilify; Children; Adolescent

Summary:

      The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in
      children and adolescents aged 6~18 years with chronic tic disorders or Tourette's disorder
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who can provide an assent form signed by themselves and informed consent form
             by their legal representatives prior to performing of any study procedures.

          2. Male or female children and adolescents aged 6 to 18 years

          3. Patients who are diagnosed with chronic tic disorders(Motor or Phonic) or Tourette's
             disorder according to DSM-IV(Diagnostic and Statistical Manual of Mental
             Disorders-Fourth Edition)(using K-SADS-PL-K (Kiddle-Schedule for Affective Disorders
             and Schizophrenia,Present and Lifetime Version-Korean version)) and require drug
             therapy.

          4. The total tic score of the K-YGTSS (Korean version of Yale Global Tic Severity
             Scale)is more than 22 at baseline

        Exclusion Criteria:

          1. Patients with secondary tic symptoms accompanied by Tardive tics, Huntington disease,
             neuroacanthocytosis, mental retardation, or autism

          2. Patients with IQ (Intelligence quotient) (assessed using KEDI-WISC (Korean educational
             Development Institute-Wechsler Intelligence Scale for children)) 70 and lower than 70

          3. Patients with a history of neuroleptic malignant syndrome

          4. Patients with antipsychotic or alcohol use disorder (abuse, dependence, and/or
             withdrawal) according to DSM-IV criteria for the past 3 months

          5. Patients with a history of allergy or hypersensitivity reaction to aripiprazole

          6. Patients with a history of resistance to treatment with antipsychotics

          7. Patients who have participated in another clinical study within 1 month prior to
             screening

          8. Patients who have previously taken aripiprazole or participated in a clinical study
             with aripiprazole
Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza virus vaccine; Comparator influenza vaccine
Intervention description: Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.; Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1893.0
Sex: All
Minimum age: 3 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza, Egg-Derived, Healthy Children, Healthy Adolescents, Healthy Adults, Safety, Immunogenicity, Trivalent, Inactivated, Vaccination

Summary:

      This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the
      2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in
      the EU and many other worldwide countries, according to the US FDA Draft Guidance for
      Industry "Clinical data needed to support the licensure of trivalent inactivated influenza
      vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and
      immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional
      influenza vaccine already licensed in US. The purpose of the control arm is primarily to
      provide a comparative assessment for safety, not immunogenicity or effectiveness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects 3 to 64 years of age

        Exclusion Criteria:

          -  Receipt of other investigational products within 3 months or other vacine within 1
             month;

          -  Allergy to eggs, egg products, or any other vaccine component;

          -  Laboratory confirmed influenza disease within 6 months;

          -  Have previously received an influenza vaccination (3 to 8 years only);
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: terbinafine; Placebo; terbinafine; Placebo
Intervention description: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks; vehicle (placebo) applied once daily for 48 weeks; Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks; vehicle (placebo) applied once daily for 24 weeks
Intervention MeSH terms: Terbinafine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 518.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Toenail fungus; Onychomycosis; Nail fungus; Toenail fungal infection; Tinea unguium; Dermatophytes; Foot dermatoses

Summary:

      This study is designed to assess the efficacy, safety and tolerability of a topical
      formulation of terbinafine solution applied daily in patients with toenail fungus. This trial
      will study patients with mild to moderate toenail fungus disease of the big toenail and their
      responses to two treatment durations, 24 or 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and females 12 - 75 years of age

          -  Fungal toenail infection of one or both of the large (great) toenails

          -  The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and
             non-dermatophyte] are not allowed)

        Exclusion Criteria:

          -  Target foot must not have severe plantar (moccasin) tinea pedis that would require
             systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be
             treated with terbinifine prior to baseline or at any time during the trial. Other
             topical treatments for athlete's foot may be recommended at the discretion of the
             investigator.

          -  Subjects must not have abnormalities of the nail that could prevent a normal appearing
             nail if clearing of infection is achieved

          -  No administration of systemic antifungal medications within 6 months prior to
             screening visit

          -  No application of prescription topical antifungal medications for toenail fungus
             within 3 months or other commercially available topical medications for toenail fungus
             applied directly to the toenails within 1 month prior to screening visit

          -  No professional pedicures or application of any nail polish product or nail cosmetic
             to the toenails after the screening visit

          -  Known pregnancy or lactation at time of enrollment

        Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of Efficacy and Safety of SDN-037
Condition: Inflammation and Pain Associated With Ocular Surgery
MeSH terms: Inflammation
Intervention: SDN-037; Placebo
Intervention description: twice daily; twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle
      for the treatment of inflammation and pain associated with ocular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be at least 2 years of age on the date of assent or 18 years of age at the date of
             consent

          2. Be able and willing to follow study instructions and complete all required visits

          3. Females of childbearing potential must not be pregnant (as confirmed by a negative
             urine pregnancy test

          4. Able to self-instill the IP or have a caregiver available to instil all doses of the
             IP

        Exclusion Criteria:

          1. Any known allergy or hypersensitivity to difluprednate therapy

          2. An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation
             in the study eye

          3. Any active corneal pathology noted in the study eye

          4. Currently suffering from alcohol and/or drug abuse
Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis
Condition: Conjunctivitis; Keratitis; Blepharitis
MeSH terms: Conjunctivitis; Keratitis; Blepharitis
Intervention: Loteprednol and tobramycin; Tobramycin and dexamethasone
Intervention description: Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.; Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Intervention MeSH terms: Loteprednol Etabonate; Tobramycin; Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blepharokeratoconjunctivitis

Summary:

      This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and
      tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in
      the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a clinical diagnosis of BKC in at least one eye

          -  Subjects must be willing to discontinue contact lens use for the duration of the study

          -  Subjects who are able and willing to comply with all treatment and follow- up/study
             procedures.

        Exclusion Criteria:

          -  Subjects participating in any drug or device clinical investigation within 30 days
             prior to entry into this study and/or during the period of study participation.

          -  Subjects who have any uncontrolled systemic disease or debilitating disease.

          -  Subjects who have a known hypersensitivity to the study drugs or their components
             (including benzalkonium chloride) or contraindications to tobramycin or ocular
             corticosteroids.

          -  Subjects who use any topical or systemic ophthalmic medications listed as disallowed
             in the study protocol, within the specified time frame prior to Visit 1.

          -  Subjects who have a disease or conditions which the Investigator determines could
             interfere with the safety and efficacy evaluations of the study drug.

          -  Subjects having ocular surgery (including laser surgery) in either eye within the past
             three months.
Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen
Condition: Kidney Transplantation
Intervention: Everolimus; Myfortic; Sandimmun Optoral; Simulect®
Intervention description: Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen; 1 tablet containing 180 mg or 360 mg
Dosing schedule:
Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day); 1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level; Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Basiliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 802.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Everolimus; mycophenolate; CNI-free; kidney transplantation

Summary:

      The purpose of this study is to compare renal function of immunosuppressive regimens with
      different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low
      dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.
    

Eligibility criteria:

        Inclusion criteria

          -  Males or females, aged 18 - 70 years

          -  Recipients of de novo cadaveric, living unrelated or living related kidney transplants

          -  Females capable of becoming pregnant must have a negative serum pregnancy test within
             7 days prior to or at screening, and are required to practice an approved method of
             birth control for the duration of the study and for a period of 6 weeks following
             discontinuation of study medication, even where there has been a history of
             infertility.

          -  Patients who are willing and able to participate in the study and from whom written
             informed consent has been obtained.

        Exclusion criteria

          -  More than one previous renal transplantation

          -  Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any
             other organ, different from kidney

          -  Patients receiving a kidney from a non-heart beating donor

          -  Donor age: < 5 years or > 70 years

          -  Graft loss due to immunological reasons in the first year after transplantation (in
             case of secondary transplantation)

          -  Other protocol-defined inclusion/exclusion criteria may apply
ARTEMIS Peanut Allergy In Children
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101 powder provided in capsules & sachets; Placebo powder provided in capsules & sachets
Intervention description: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol; Study product formulated to contain only inactive ingredients for use as defined in the protocol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; ARTEMIS; Allergy

Summary:

      The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral
      immunotherapy (OIT) in peanut-allergic children.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 4 to 17 years, inclusive

          -  Clinical history of allergy to peanuts

          -  Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L

          -  Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg

          -  Written informed consent from the subject's parent/guardian

          -  Written assent from the subject as appropriate (per local regulatory requirements)

          -  Use of effective birth control by sexually active female subjects of childbearing
             potential

        Key Exclusion Criteria:

          -  History of cardiovascular disease, including uncontrolled or inadequately controlled
             hypertension

          -  History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma
             (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control

          -  History of severe or life threatening episode of anaphylaxis or anaphylactic shock
             within 60 days of screening

          -  History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal
             disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),
             symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology

          -  History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic
             idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold
             urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema

          -  Any other condition that, in the opinion of the Investigator, precludes participation
             for reasons of safety
Tanezumab and Nerve Function In Arthritis Patients
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: tanezumab; tanezumab; Placebo
Intervention description: 5 mg dose Intravenously every 8 weeks for duration of study; 10 mg dose Intravenously every 8 weeks for duration of study; Placebo, Intravenously, every 8 weeks for duration of study
Intervention MeSH terms: Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted
      in sensory nerves.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI less or equal to 39 kg/m2

          -  Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies

          -  Willing to comply with study visit schedule and study requirements, including, for
             women of child-bearing potential or male patients with female partners of
             child-bearing potential, the use of 2 forms of birth control, one of which is a
             barrier method.

          -  Patients must consent in writing to participate in the study.

        Exclusion Criteria:

          -  Untreated, uncontrolled diseases,

          -  Unwilling or unable to discontinue the use of prohibited medications, including other
             pain medications, during the screening period and during the study,

          -  Significant cardiac disease within the past 6 months

          -  Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis,
             stroke) or signs of neuropathy at screening

          -  Known bleeding disorder or anticoagulation therapy

          -  Planned surgery during the study period

          -  History of alcoholism or drug abuse in the past 2 years

          -  Unable to use acetaminophen

          -  Use of a biologic (including live vaccines, with the exception of Flumist) within the
             past 3 months

          -  Allergic reaction to a biologic or an antibody in the past

          -  Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test

          -  Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.

          -  Medical condition that may interfere with study endpoints or safety of the subject as
             determined by the investigator.