bioihbjkbjnl/mcl2 huggingface dataset:
A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, 5% and Permethrin Foam, 4% for the Treatment of Scabies
Condition: Scabies
MeSH terms: Scabies
Intervention: Permethrin Foam 4%; Permethrin Foam 5%; Vehicle Foam
Intervention description: Topical application, whole-body treatment; Topical application, whole-body treatment; Topical application, whole-body treatment
Intervention MeSH terms: Permethrin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: Sarcoptes; Scabiei; Scabies; ectoparasite; parasite; infestation; Renaissance

Summary:

      To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5%
      with that of vehicle in subjects with scabies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of active scabies infection.

          -  Subject is in good general health with normal appearing skin in noninfested areas.

          -  Females must be post-menopausal, surgically sterile or use an effective method of
             birth control with a negative pregnancy test (10 years of age and older) at study
             start.

        Exclusion Criteria:

          -  Subject is pregnant, lactating, or is planning to become pregnant during the study.

          -  Subject has used any ectoparasiticide within the three weeks prior to study start.

          -  Subject has signs of systemic infection or is receiving systemic therapy for an
             infectious disease.

          -  Subject has severe cutaneous bacterial or fungal infections requiring therapy or
             heavily crusted lesions consistent with Norwegian scabies.

          -  Subject is currently enrolled in an investigational drug or device study or has used
             an investigational drug or device within 30 days prior to study start.

          -  Subject whose close personal contacts will not comply with standard of care for fomite
             management.
A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)
Condition: Respiratory Distress Syndrome, Adult; Acute Lung Injury; Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Syndrome; Wounds and Injuries
Intervention: Fish oil (eicosapentaenoic acid and docosahexanoic acid)
Intervention description: Liquid fish oil 7.5cc enterally every 6 hours
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Respiratory distress syndrome, adult; Acute lung injury; Acute respiratory distress syndrome; ARDS, human; Fish oils; Fatty Acids, Omega-3; Docosahexaenoic Acids; Eicosapentaenoic Acid

Summary:

      The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids)
      given enterally is safe and effective in reducing lung and systemic inflammation seen in
      acute lung injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requiring positive-pressure mechanical ventilation

          -  ALI criteria: PaO2/FiO2 <300, bilateral infiltrates on chest radiograph, no left
             atrial hypertension

          -  Age > 17 years

        Exclusion Criteria:

          -  Expected ICU length of stay <48 hours

          -  Unable to undergo bronchoalveolar lavage at enrollment

          -  Unable to obtain enteral access

          -  Post-cardiac arrest with suspected significant anoxic brain injury

          -  Expected survival < 28 days

          -  Pregnant

          -  Platelet count < 30,000, active bleeding, or international normalized ratio (INR)>3.0

          -  History of ventricular tachycardia or fibrillation

          -  Receiving recombinant human activated protein C (rh-APC) for sepsis

          -  Acquired immune deficiency syndrome (AIDS) with CD4 count < 200

          -  Metastatic cancer

          -  History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant
SYL040012, Treatment for Open Angle Glaucoma
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: 1 drop of 0.375% SYL040012 (bamosiran); 1 drop of 0.750% SYL040012 (bamosiran); 1 drop of 1.125% SYL040012 (bamosiran); 1 drop of 1.5% SYL040012 (bamosiran); 1 drop of 0.5 % timolol maleate
Intervention MeSH terms: Timolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SYL040012; bamosiran; siRNA; RNAi; Glaucoma; Ocular hypertension

Summary:

      The purpose of this double-masked, randomized, controlled study is to assess the safety and
      ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops
      compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated
      intraocular pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients older than 18 years of either sex

          -  Good or fair general health as assessed by the investigator.

          -  Signed informed consent prior to any clinical trial-related procedures

          -  Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)

          -  Post-washout mean IOP above target range

          -  BCVA 1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200)

          -  Stable visual field

          -  Central corneal thickness 480-620 μm

          -  Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes

        Exclusion Criteria:

          -  Pregnant or breastfeeding females

          -  Females of childbearing potential not willing to use a medically acceptable
             contraceptive method

          -  Clinically significant systemic disease

          -  Changes of systemic medication that could have a substantial effect on IOP

          -  Known hypersensitivity to any component of the formulations

          -  Unable to comply with the clinical trial requirements

          -  Clinically significant abnormalities in laboratory tests

          -  Severe visual field defect

          -  Any secondary glaucoma

          -  Pseudoexfoliation or pigment dispersion component, history of angle closure or narrow
             angles.

          -  IOP ≥ 35 mm Hg in any eye

          -  Previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser
             trabeculoplasty) and refractive surgery

          -  Any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6
             months prior to Baseline

          -  Evidence of ocular infection, inflammation, clinically significant blepharitis or
             conjunctivitis at baseline (Visit 0), or a history of herpes simplex keratitis

          -  Clinically significant ocular disease
A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Intervention: ATR-101
Intervention description: 125-1000 mg twice per week
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single treatment arm with up to 5 planned dosing periods with escalating doses. Subjects were dosed with each dose level for 2 weeks, followed by 2 weeks of matching placebo (subjects blinded).
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ATR-101; classic congenital adrenal hyperplasia; 21-hydroxylase deficiency; CAH

Summary:

      This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and
      efficacy of orally administered ATR-101 in subjects with classic congenital adrenal
      hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to
      6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of
      5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based
             on: Documented genetic mutation in the CYP21A2 enzyme consistent with a diagnosis of
             classic CAH, or historical documentation of elevated 17-hydroxyprogesterone

          -  Biochemical marker of disease status of 17-hydroxyprogesterone ≥ 4 times the upper
             limit of normal

          -  Chronic glucocorticoid replacement therapy for at least 6 consecutive months

          -  Stable glucocorticoid and mineralocorticoid regimen for at least 1 month

        Exclusion Criteria:

          -  Non-classic CAH

          -  Other causes of adrenal insufficiency

          -  Surgery within the previous 3 months prior to screening or planned surgery during
             study participation

          -  History of active cancer requiring medical or surgical therapy within the past 6
             months
A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen
Condition: Rhinitis; Allergic; Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Placebo drops; Placebo tablets matching to levocetirizine; Placebo tablets matching to cetirizine; Levocetirizine drops; Levocetirizine tablets; Cetirizine drops; Cetirizine tablets
Intervention description: Pharmaceutical form: Drops for oral administration
Route of administration: Oral use; Pharmaceutical form: Tablets for oral administration
Route of administration: Oral use; Pharmaceutical form: Tablets for oral administration
Route of administration: Oral use; Pharmaceutical form: Drops for oral administration
Concentration: 5 mg/ml
Route of administration: Oral use; Pharmaceutical form: Tablets for oral administration
Concentration: 5 mg
Route of administration: Oral use; Pharmaceutical form: Drops for oral administration
Concentration: 10 mg/ml
Route of administration: Oral use; Pharmaceutical form: Tablets for oral administration
Concentration: 10 mg
Route of administration: Oral use
Intervention MeSH terms: Cetirizine; Levocetirizine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 551.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Levocetirizine; Xyzal; Rhinitis; Allergic; Seasonal; Ragweed

Summary:

      The purpose of the study is to assess the efficacy comparability of cetirizine and
      levocetirizine, by comparing the effects of single intake of the two drugs to placebo in
      reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects
      exposed to ragweed pollen in an Environmental Exposure Unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subject of non-childbearing potential or of childbearing potential agreeing not
             to become pregnant during the study.

          -  Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years

          -  Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as
             defined by protocol

        Exclusion Criteria:

          -  Any clinically significant condition that might interfere with the treatment
             evaluation, both for efficacy and safety

          -  Have used forbidden concomitant medications as defined by the protocol
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17
Condition: Vaccines; Meningococcal Vaccines
Intervention: rLP2086 and Gardasil; rLP2086; Gardasil
Intervention description: Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.; Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.; Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2499.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; rLP2086; Gardasil; HPV; meningitis B; N. meningitidis serogroup B; adolescents; single-blind; Meningococcal Vaccines

Summary:

      This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil
      (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be
      randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection
      being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and
      saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent
      children between the ages of 11 and 17 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects from 11 to 17 years old at the time of they start the study.

          -  Subject must be healthy which will be determined by obtaining subject's medical
             history, receiving a physical examination and by judgment of the investigator.

        Exclusion Criteria:

          -  Previous vaccination with any meningococcal serogroup B vaccine.

          -  Previous vaccination with any HPV vaccine.

          -  Contraindication to vaccination with Gardasil or any HPV vaccine.
A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
Condition: Hemostasis; Oral Contraceptive
Intervention: desogestrel/ethinyl estradiol and ethinyl estradiol; desogestrel/ethinyl estradiol
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Desogestrel; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 293.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception; Hemostasis; Blood Coagulation

Summary:

      This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive
      compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy
      women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal, non-pregnant, non-lactating women age 18-40 years old

          -  Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²

          -  Regular spontaneous menstrual cycle

          -  Others as dictated by FDA-approved protocol

        Exclusion Criteria:

          -  Any condition which contraindicates the use of combination oral contraceptives

          -  Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial
             thromboembolic disease within one year of screening

          -  Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders;
             thrombogenetic valvulopathies or rhythm disorders

          -  Others as dictated by FDA-approved protocol
Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients
Condition: Exercise Induced Asthma
MeSH terms: Asthma; Asthma, Exercise-Induced
Intervention: budesonide; terbutaline; budesonide/formoterol
Intervention description: 400 yg x 1; 0.4 mg as-needed; 160/4.5 yg as-needed
Intervention MeSH terms: Budesonide; Terbutaline; Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Exercise induced asthma; Mild intermittent asthma; Exercise induced bronchoconstriction

Summary:

      1. The primary objective of this study is:

             -  To evaluate the magnitude of the protective effect of the combination of budesonide
                and formoterol on an as-needed basis compared to the use of terbutaline as-needed
                on exercise induced bronchoconstriction in adults and adolescents with mild
                intermittent asthma

        2. The secondary objectives of this study are:

             -  To evaluate the magnitude of the protective effect of the combination of budesonide
                and formoterol as-needed compared to regular once daily use of budesonide plus
                terbutaline as-needed on exercise induced bronchoconstriction in adults and
                adolescents with mild intermittent asthma

             -  To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and
                regular use of budesonide + terbutaline as-needed as terms of adverse event
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of exercise induced asthma

          -  Maximum 4 asthmatic episodes per week requiring use of reliever medication

        Exclusion Criteria:

          -  No previous treatment with inhaled oral corticosteroids during the last month before
             randomisation

          -  Suspected poor capability to follow instructions, ie to exercise 3-4 times a week
Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice
Condition: Caries
Intervention: Calcium sodium phosphosilicate; Sodium monoflurophosphate; Placebo
Intervention description: CSP high percentage weight by weight; 500 to 1500 parts per million (ppm) of fluoride; No CSP and no fluoride
Intervention MeSH terms: Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In situ study to compare treatment effect on enamel remineralization potential, measured by
      surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will
      explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice
      containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only
      dentifrice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Wears a removable bilateral mandibular partial denture that has good stability and
             support, with sufficient room on each side in the posterior buccal flange area to
             accommodate two enamel specimens [required dimensions 12 x 7 millimeters (mm)].
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab emtansine [Kadcyla]
Intervention description: Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.
Intervention MeSH terms: Trastuzumab; Ado-Trastuzumab Emtansine; Maytansine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Healthy volunteers: No
Keywords: Trastuzumab emtansine; MBC; Breast cancer; HER2-positive breast cancer; HER2

Summary:

      This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab
      emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal
      growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form.

          -  Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer
             (MBC); tissue (slides or blocks) available for HER2 confirmation.

          -  History of progression on HER2-directed therapy for the treatment of HER2-positive
             breast cancer.

          -  At least 1, and no more than 3, chemotherapy regimens for MBC.

          -  Granulocyte count ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL.

          -  Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine
             aminotransferase (ALT), and alkaline phosphatase ≤ 2.5x the upper limit of normal
             (ULN).

          -  Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

        Exclusion Criteria:

          -  Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy
             for the treatment of breast cancer within 2 weeks of the first study treatment.

          -  Prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent.

          -  History of significant cardiac disease, unstable angina, congestive heart failure
             (CHF), myocardial infarction, or ventricular arrythmia requiring medication.