bioihbjkbjnl/mcl2 huggingface dataset:
BOTOX® in the Treatment of Crow's Feet Lines in Japan
Condition: Lateral Canthus Rhytides; Crow's Feet Lines
Intervention: botulinum toxin Type A (24 U); botulinum toxin Type A (12 U); Normal Saline
Intervention description: 24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.; 12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.; Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared
      to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).
    

Eligibility criteria:

        Inclusion Criteria:

        -Moderate to severe Crow's Feet Lines

        Exclusion Criteria:

          -  Current or previous botulinum toxin treatment of any serotype

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis

          -  Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial
             peels, or topical retinoid therapy or hormone cream within 3 months

          -  Laser treatment or phototherapy of the face for medical purposes, blepharoplasty,
             brow-lift or related procedure, periorbital permanent make-up, or oral retinoid
             therapy within one year

          -  Medium-depth or deep facial peels within 5 years

          -  Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift,
             periorbital treatment with fillers, implantation or transplantation)
Emergency Contraception Actual Use Study
Condition: Emergency Contraception
MeSH terms: Emergencies
Intervention: DR-104
Intervention description: One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.
Intervention MeSH terms: Levonorgestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: Female
Minimum age: 11 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a non-comparative case series study to assess the ability of females 11-16 years of
      age, inclusive, who are requesting emergency contraception (EC) to use the study product,
      DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and 11-16 years of age, inclusive

          -  Subject must be requesting emergency contraception for her own use (not for use by
             another person) and for current (not future) use

          -  Subject can read and understand English, according to her own judgment

          -  Others as dictated by FDA-approved protocol
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: S5G4T-1; S5G4T-2
Intervention description: Once a day topical cream; Once a day topical cream
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 372.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: papulopustular rosacea

Summary:

      To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once
      daily for 12 weeks in participants with papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must sign an Institutional Review Board (IRB) approved written informed
             consent for this study.

          2. Male and female 18 years of age and older.

          3. Participants must have clinical diagnosis of moderate to severe rosacea.

          4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules
             and/or pustules) including those present on the nose.

          5. Have 2 nodules or less.

        Exclusion Criteria:

          1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of
             their study participation or were found to have positive pregnancy test at Baseline or
             screening visits.

          2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).

          3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or
             keratitis) of sufficient severity to require topical or systemic antibiotics.
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: TC-5214; Placebo
Intervention description: Tablet, oral, twice daily for 8 weeks; Tablet, oral, twice daily for 8 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2409.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression; Safety; add-on therapy

Summary:

      The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like
      medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
      together with another antidepressant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures.

          -  The patient must have a clinical diagnosis of major depressive disorder (MDD) with
             inadequate response to no more than one antidepressant.

          -  Outpatient status at enrollment and randomization.

        Exclusion Criteria:

          -  Patients with a lifetime history of bipolar disorder, psychotic disorder or
             post-traumatic stress disorder.

          -  Patients with a history of suicide attempts in the past year and/or seen by the
             investigator as having a significant history of risk of suicide or homicide.

          -  History of renal insufficiency or impairment or conditions that could affect
             absorption or metabolism of investigational product.
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Adapalene BPO Gel standard daily overnight application; Adapalene-BPO 3-hour daily application before bedtime; Adapalene-BPO Gel every other day application; Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Intervention description: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week; Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks; Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks; Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
Intervention MeSH terms: Adapalene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 12 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Acne

Summary:

      The purpose of this study is to compare the tolerability of 3 treatment regimens containing
      Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5%
      Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The
      efficacy of the four treatment regimens will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Subjects of any race, aged 12 to 35 years inclusive

          -  Subjects with mild or moderate facial acne vulgaris

          -  Subjects with skin phototype I to IV

        Exclusion Criteria:

          -  Subjects with more than 1 nodules or cysts on the face,

          -  Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced
             acne, etc.)
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Condition: Alagille Syndrome
MeSH terms: Alagille Syndrome; Syndrome
Intervention: Odevixibat; Placebo
Intervention description: Odevixibat is a small molecule and selective inhibitor of IBAT.; Placebo identical in appearance to experimental drug (odevixibat).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 52.0
Sex: All
Healthy volunteers: No
Keywords: ALGS; Alagille syndrome

Summary:

      Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and
      safety of odevixibat compared to placebo in Patients with Alagille Syndrome.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Genetically confirmed diagnosis of Alagille syndrome

          -  History of significant pruritus as measured by the Albireo Observer or Patient
             Reported Outcome instrument

          -  Elevated serum bile acid level

        Key Exclusion Criteria:

          -  History or ongoing presence of other types of liver disease (eg. biliary atresia,
             progressive familial intrahepatic cholestasis, hepatocellular carcinoma)

          -  History of liver transplant, or a liver transplant is planned within 6 months of
             randomization

          -  ALT >10× upper limit of normal (ULN) at screening

          -  Total bilirubin >15 × ULN at screening

          -  Patient suffers from uncontrolled, recalcitrant pruritic condition other than Alagille
             syndrome
MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: Methoxy polyethylene glycol-epoetin beta
Intervention description: Mircera will be administered intravenously every 4 weeks for a total of 52 weeks. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and
      tolerability of once-monthly intravenous administration of Mircera in hemodialysis
      participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin
      alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting
      dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating
      agent [ESA] dose administered on Week -1). Subsequent doses will be adjusted to maintain
      hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter
      [g/dL] for Switzerland and 10 to 12 g/dL for Austria).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than or equal to (≥) 18 years of age

          -  Chronic renal anemia

          -  Hemoglobin concentration in country-specific target range (Switzerland: 11 to 13 g/dL;
             Austria: 10 to 12 g/dL)

          -  Regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months

          -  Continuous intravenous or subcutaneous maintenance ESA treatment during previous 2
             months

        Exclusion Criteria:

          -  Transfusion of red blood cells during previous 2 months

          -  Significant acute or chronic bleeding, such as overt gastrointestinal bleeding

          -  Active malignant disease (except non-melanoma skin cancer)
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
Condition: Opioid-Induced Bowel Dysfunction
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Opioid-Induced Constipation
Intervention: Lubiprostone 24
Intervention description: 24 mcg capsules for oral administration
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 439.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone
      administration in participants with opioid-induced bowel dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428

          -  Will continue to be treated consistently for chronic, non-cancer-related pain with any
             full agonist opiate and will continue opiate therapy for the duration of the study

          -  Willing to continue to abstain from use of disallowed medications as defined per
             protocol

        Exclusion Criteria:

          -  Has newly diagnosed impaired renal function identified at the Screening Visit [i.e.,
             serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]

          -  Has experienced an unexplained and/or clinically significant weight loss defined as >
             5% within 90 days prior to Screening Visit.

          -  Has plans to participate in another trial with an investigational drug or device
             during the course of the extension study
Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix™; Fluzone
Intervention description: Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.; Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 3327.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fluarix; Influenza

Summary:

      The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms
      of the immune response elicited and safety with a six month follow-up after first
      vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment
      Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female child age 6 months to < 18 years at the time of the vaccination;
             children who may or may not have had previous administration of influenza vaccine in a
             previous season are acceptable.

          -  Subjects having a parent/guardian who the investigator believes can and will comply
             with the requirements of the protocol should be enrolled in the study.

          -  Written informed consent obtained from the subject's parent/guardian; assent obtained
             in subjects > 10 years.

          -  Female subjects of childbearing potential must agree to take a pregnancy test.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine, other than the
             study vaccine) within 30 days preceding the administration of the study vaccine, or
             planned use during the study period. Routine, registered childhood vaccinations are
             not an exclusion.

          -  History of hypersensitivity to any vaccine.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine.

          -  Acute disease at the time of enrollment.

          -  History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated
             influenza virus vaccine.

          -  Pregnant or lactating female.

          -  Receipt of an influenza vaccine outside of this study, during current (2006-07) flu
             season.
MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
Condition: Lateral Canthal Lines; Glabellar Lines
Intervention: MT10109L; Placebo
Intervention description: MT10109L will be injected into either the LCL, or both the LCL and GL.; Placebo will be injected into either the GL, or both the LCL and GL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines
      (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with
      moderate to severe LCL and GL.
    

Eligibility criteria:

        Inclusion Criteria:

        -Female participants must not be pregnant or planning to get pregnant and willing to
        minimize the risk of inducing pregnancy for the duration of the clinical study and
        follow-up period.

        Exclusion Criteria:

          -  Known immunization or hypersensitivity to any botulinum toxin serotype.

          -  Any medical condition that may put the participant at increased risk with exposure to
             MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic
             lateral sclerosis, or any other condition that might interfere with neuromuscular
             function.

          -  History of facial nerve palsy.

          -  Any uncontrolled systemic disease.

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study intervention).

          -  Anticipated need for surgery or overnight hospitalization during the study.

          -  Prior exposure to botulinum toxin of any serotype for any reason.

          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,
             Gore-Tex®), and/or autologous fat transplantation.

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study.

          -  Females who are pregnant, nursing, or planning a pregnancy during the study.

          -  Participants who plan for an extended absence away from the immediate area of the
             study site that would preclude them from returning for all protocol-specified study
             visits.
The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
Condition: Neonatal Abstinence Syndrome; Aromatherapy
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: lavender and chamomile essential oils
Intervention description: Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Maximum age: 2 Weeks
Healthy volunteers: No

Summary:

      Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms
      of Neonatal Abstinence Syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants greater than or equal to 36 weeks EGA

          -  Intrauterine opioid exposure

          -  Primary diagnosis of NAS

          -  Parental permission to participate

        Exclusion Criteria:

          -  Infants less than 36 weeks EGA

          -  Major congenital anomalies

          -  Latrogenic drug withdrawal

          -  Diagnosis of infection or respiratory distress

          -  Prior initiation of opioid replacement therapy

          -  Non-English speaking

          -  Infants with respiratory conditions
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: FF; Placebo
Intervention description: fluticasone furoate 110 μg nasal spray; placebo nasal spray
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 301.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: GW685698X; perennial allergic rhinitis; allergic rhinitis

Summary:

      The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg
      once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent
      subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of perennial allergic rhinitis (PAR).

          -  Must comply with study procedures and be literate.

        Exclusion Criteria:

          -  Significant concomitant medical conditions.

          -  Use of corticosteroids.

          -  Use of allergy and other identified medications during the study.

          -  Current tobacco use or tobacco use within the past year.

          -  Exposure to an investigational study drug within the past 12 months.

          -  Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.