bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Tazarotene Cream 0.1%; Tazorac®; Placebo
Intervention description: Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.; Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.; Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1110.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing
      Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a
      Vehicle Control in the Treatment of Acne Vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis
             of acne vulgaris.

          -  Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and
             ≤ 2 nodulocystic lesions at baseline on the face.

          -  Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as
             per the Investigator's Global Assessment.

        Exclusion Criteria:

          -  Female subjects who are pregnant, nursing or planning to become pregnant during study
             participation.

          -  Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of
             the study medication ingredients.

          -  Presence of any skin condition that would interfere with the diagnosis or assessment
             of acne vulgaris.
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
Condition: Impetigo
MeSH terms: Impetigo
Intervention: Ozenoxacin; Placebo
Intervention MeSH terms: Ozenoxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 412.0
Sex: All
Minimum age: 2 Months
Healthy volunteers: No

Summary:

      This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority
      clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical
      diagnosis of non-bullous or bullous impetigo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of bullous or non bullous impetigo. The patient has a total
             affected area comprised between 1-100 cm2 with surrounding erythema not extending more
             than 2 cm from the edge of any affected area. In case of multiple affected areas the
             total area will be the sum of each affected area and will not exceed 100 cm2.
             Additionally for patients < 12 years the total area will not exceed a maximum of 2% of
             the body surface area.

          -  Total Skin Infection Rating Scale (SIRS) score of at least 3, including pus/exudate
             score of at least 1

        Exclusion Criteria:

          -  Has a bacterial infection, which in the opinion of the investigator, could not be
             appropriately treated by a topical antibiotic.

          -  Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary
             temperature over 37.2 °C (99.0 °F)
Effects of Gastric Bypass on Blood Levels of Duloxetine
Condition: Bariatric Surgery
Intervention: Duloxetine
Intervention description: Single dose of 60 mg of duloxetine
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gastric Bypass; Duloxetine; Cymbalta; Pharmacokinetics

Summary:

      This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine
      between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control
      subjects matched for body mass index (BMI), age and gender.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between the ages of 18 and 60 years.

          -  Subjects must be of good general health by history and physical exam.

          -  Ten experimental subjects 9 to 15 months post bariatric surgery (Roux-en-Y procedure),
             no BMI requirement.

          -  Ten normal control subjects who have met the inclusion criteria and have not received
             bariatric surgery and who are matched to the surgery subjects according to body mass
             index, age and sex.

          -  Women of child bearing potential must be practicing an accepted method of birth
             control (barrier method or oral contraceptive) and have a negative pregnancy test at
             baseline.

          -  No contraindications to receiving a single capsule of 60 mg of duloxetine

        Exclusion Criteria:

          -  Allergy to duloxetine or any of its constituents.

          -  Candidates who are pregnant or nursing

          -  Candidates currently receiving any antidepressant.

          -  Candidates that are determined to be poor metabolizers for CYP2D6

          -  Subjects who smoke or use any nicotine products

          -  Candidates currently receiving a medication that interacts with duloxetine.

          -  Candidates experiencing clinically significant, unstable neurological, hepatic, renal
             or cardiovascular disease.

          -  Candidates experiencing or with a history of vomiting or diarrhea associated with
             bariatric surgery

          -  Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for
             schizophrenia, schizoaffective disorder, bipolar disorder.

          -  Candidates who have participated in an investigational drug study in past 30 days.

          -  Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or
             who have a history of drug/alcohol abuse or dependency.
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Condition: Gingivitis
MeSH terms: Gingivitis
Intervention: Glide dental floss
Intervention description: Glide waxed dental floss
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, controlled, examiner-blind, parallel group, four week clinical study
      comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing
      gingivitis.
    

Eligibility criteria:

        Inclusion Criteria:

        In order to be included in the study, each subject must:

          -  be at least 18 years of age;

          -  be physically able to floss their teeth;

          -  have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or
             extensively restored will not be included);

          -  have refrained from performing oral hygiene the morning of the Baseline visit;

          -  be in good general health;

          -  have interproximal MGI (Modified Gingival Index) score of >2.8.

        Exclusion Criteria:

        Subjects are excluded from study participation where there is evidence of:

          -  severe periodontal disease;

          -  discoloration or pigmentation in the gingival tissue;

          -  meaningful misalignment of front teeth;

          -  fixed facial orthodontic appliances;

          -  use of antibiotics within two weeks of the Baseline Visit and at any time during the
             study;

          -  any diseases or conditions that could be expected to interfere with the subject safely
             completing the study.
12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Asenapine; Placebo
Intervention description: Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.; Placebo fast dissolving SL tablets, BID
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 12-week study that will test the safety and efficacy of asenapine when used in
      addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I
      Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have bipolar I disorder, current episode manic or mixed

          -  Treated with lithium or valproic acid

        Exclusion Criteria:

          -  Have an unstable medical condition

          -  Clinically significant laboratory abnormality.

          -  Have a primary diagnosis other than bipolar I disorder.
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone; Lurasidone; Quetiapine XR; Placebo
Intervention description: Lurasidone 80 mg tablets; Lurasidone 4 40 mg tablets; Quetiapine XR 600mg; Matching Placebo to Lurasidone or Quetiapine
Intervention MeSH terms: Quetiapine Fumarate; Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 488.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Schizophrenia; SM-13496; Latuda; Lurasidone

Summary:

      Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This
      clinical study is designed to test the hypothesis that lurasidone is effective, tolerable,
      and safe as compared with quetiapine XR short term among acutely psychotic patients with
      chronic schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent and aged between 18 and 75 years of age.

          -  Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.

          -  Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate
             and reliable contraception for duration of study.

          -  Able and agrees to remain off prior antipsychotic medication for the duration of
             study.

          -  Good physical health on the basis of medical history, physical examination, and
             laboratory screening.

          -  Willing and able to comply with the protocol, including the inpatient requirements and
             outpatient visits.

        Exclusion Criteria:

          -  Considered by the investigator to be at imminent risk of suicide or injury to self,
             others, or property.

          -  Any chronic organic disease of the CNS (other than schizophrenia).

          -  Used investigational compound within 30 days.

          -  Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence
             within the last 6 months.
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Intervention: Placebo; Prasterone (DHEA)
Intervention MeSH terms: Dehydroepiandrosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 558.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vulvovaginal atrophy (VVA); Vaginal atrophy; Atrophic vaginitis; prasterone; DHEA; Intrarosa

Summary:

      The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on
      symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects
      exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.
    

Eligibility criteria:

        Inclusion Criteria:

        Main criteria:

          -  Postmenopausal women (hysterectomized or not)

          -  Women between 40 and 80 years of age

          -  Women having ≤5% of superficial cells on vaginal smear at baseline

          -  Women having a vaginal pH above 5 at baseline

          -  Women who have self-identified moderate or severe symptom(s) of vaginal atrophy

          -  Willing to participate in the study and sign an informed consent

        Exclusion Criteria:

        Main criteria:

          -  Previous enrollment in EndoCeutics studies performed with intravaginal DHEA

          -  Previous diagnosis of cancer, except skin cancer (non melanoma)

          -  Clinically significant metabolic or endocrine disease (including diabetes mellitus)
             not controlled by medication

          -  The administration of any investigational drug within 30 days of screening visit

          -  Clinically significant abnormal serum biochemistry, urinalysis or hematology
Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine
Condition: Hypertension
MeSH terms: Hypertension
Intervention: placebo; telmisartan + HCTZ; telmisartan + HCTZ; amlodipine
Intervention description: placebo matching amlodipine capsule; FDC tablet; FDC tablet; capsule
Intervention MeSH terms: Amlodipine; Telmisartan; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 132.0
Sex: All
Minimum age: 20 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This is a multi-centre, randomised, double-blind, active-controlled, parallel-group
      comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +
      hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+
      hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the
      end of the double-blind period in essential hypertensive patients who fail to respond
      adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.

      Patients are assigned to one of the two groups after a 6-week open-label run-in period taking
      T80/H12.5 mg.

      In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide
      12.5 mg will be evaluated in a 52-week extension period.

      In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg
      group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5
      mg group change to the T80/A5/H12.5 mg therapy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs
             and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean
             seated systolic blood pressure (SBP) must be =<200 mmHg

          2. Able to stop all current antihypertensive drugs (other than study medication) from
             Visit 1b through the end of the trial without risk to the patient based on the
             investigator's opinion

          3. Age 20 years or older

        Exclusion criteria:

          1. Patients with known or suspected secondary hypertension

          2. Patients with clinically relevant cardiac arrhythmia

          3. Congestive heart failure with New York Heart Association (NYHA) functional class
             III-IV

          4. Patients with recent cardiovascular events

          5. Patients with recent stroke events

          6. Patients with a history of sudden deterioration of renal function with angiotensin II
             receptor blockers or angiotensin converting enzyme inhibitors; or patients with
             post-renal transplant or post-nephrectomy

          7. Patients with hepatic and/or renal dysfunction

          8. Pre-menopausal women who are nursing or pregnant
Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Intervention: NPSP558
Intervention description: All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Hypoparathyroidism, rhPTH[1-84], NPSP558

Summary:

      Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults
      with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and
      vitamin D supplements.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study

          2. With regard to female patients: women who are postmenopausal or willing to use two
             medically acceptable methods of contraception for the duration of the study with
             pregnancy testing conducted at every scheduled office visit

          3. Total serum calcium ≤ ULN based on local laboratory results prior to randomization

          4. Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to
             randomization

        Main Exclusion Criteria:

          1. Any disease or condition that, in the opinion of the investigator, has a high
             probability of precluding the patient from completing the study or being able to
             appropriately comply with study requirements

          2. Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of
             participation in the REPLACE trial

          3. Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral
             bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride

          4. Pregnant or lactating women

          5. Any condition that would, in the investigator's opinion in consultation with the
             sponsor, preclude the safe use of PTH

          6. Use of any experimental drug other than NPSP558 within 3 months of baseline.
A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Condition: Inadequately Controlled Asthma
MeSH terms: Asthma
Intervention: Tralokinumab open-label
Intervention description: Subcutaneous injection; fixed dose; 300 mg
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 28.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: open-label study; tralokinumab; subcutaneous; inadequately controlled asthma; asthma; medium to high-dose of inhaled corticosteroid; long-acting β2-agonist

Summary:

      A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese
      Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus
      Long-Acting β2-Agonist
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12 - 75 yrs

          2. Documented physician-diagnosed asthma

          3. Documented treatment with inhaled corticosteroid (ICS) at a total daily dose
             corresponding to ≥500 µg fluticasone propionate dry powder formulation equivalents and
             a long-acting beta-2 agonist (LABA)

          4. Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of ≥40% of
             their Predicted Normal Value (PNV)

          5. Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5

        Exclusion Criteria:

          1. Pulmonary disease other than asthma

          2. History of anaphylaxis following any biologic therapy

          3. Hepatitis B, C or HIV

          4. Pregnant of breastfeeding

          5. History or cancer

          6. Current tobacco smoking or a history or tobacco smoking for ≥10 pack-years

          7. Previous receipt of tralokinumab