bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: IDP-121 Lotion; IDP-121 Vehicle Lotion
Intervention description: IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.; IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 820.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objective of this study was to evaluate the efficacy, safety, and tolerability of a once
      daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle
      Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an
      Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female at least 9 years of age and older.

          -  Written and verbal informed consent must be obtained. Participants less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if participant reaches age of consent during the study they
             should be re-consented at the next study visit).

          -  Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at
             the screening and baseline visit

        Key Exclusion Criteria:

          -  Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study.

          -  Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram-negative folliculitis.

          -  Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive.

          -  Participants with a facial beard or mustache that could interfere with the study
             assessments.
Evaluation of the Performance of Non-molded Soft Contact Lenses
Condition: Ametropia
MeSH terms: Refractive Errors
Intervention: Soft contact lens
Intervention description: Soft contact lens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the performance of the study soft lens for vision, comfort, physiology and lens
      surface properties.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, good health, age >17yrs, able to wear contact lenses as primary vision
             correction, able to see well and achieve good fit with study lens, has understood &
             signed consent form.

        Exclusion Criteria:

          -  Has active ocular disease, uses topical eye medication, wears gas permeable/silicone
             hydrogel /overnight wear contact lenses, is a participant in another clinical study,
             is deemed unsuitable for soft contact lens wear.
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab; Placebo; Permitted DMARDs
Intervention description: Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.; Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.; As prescribed. The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These DMARDs could be used alone or in combination, except for the combination of MTX and leflunomide, which was not allowed.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 619.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in
      combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in
      signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an
      inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either
      tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also
      received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on
      study treatment was 3-12 months and the target sample size was 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥18 years of age

          -  Active rheumatoid arthritis of >6 months duration

          -  Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline

        Exclusion Criteria:

          -  Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid
             arthritis

          -  Major surgery within 8 weeks prior to screening or planned within 6 months following
             randomization

          -  Unsuccessful treatment with a biologic agent, including an anti-TNF agent

          -  Previous treatment with tocilizumab
Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
Condition: Hot Flashes
MeSH terms: Hot Flashes
Intervention: Estradiol transdermal one 90 μL spray; Estradiol transdermal spray, two 90 μL sprays; Estradiol transdermal three 90 μL sprays; Placebo transdermal two 90 μL sprays; Placebo transdermal three 90 μL sprays; Placebo transdermal one 90 μL spray
Intervention description: Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator; Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator; Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator; Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator; Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator; Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 454.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Postmenopause; Hot Flashes; Estradiol; Polyestradiol phosphate; Estradiol valerate; Estradiol 3-benzoate; Estradiol 17 beta-cypionate; Estrogens; Hormones; Hormones, Hormone Substitutes; Hormone Antagonists

Summary:

      Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in
      postmenopausal women. This study will evaluate the safety and efficacy of Evamist.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post menopausal women,

          -  Ages 35 or older,

          -  Frequent moderate to severe hot flushes,

          -  Qualifying general medical health

        Exclusion Criteria:

          -  Disqualifying gynecological disorders,

          -  Disqualifying dermatological disorders,

          -  Disqualifying concurrent conditions
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
Condition: Cystic Fibrosis
MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis
Intervention: AZLI; Placebo to match AZLI; Tobramycin inhalation solution
Intervention description: Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily combined with diluent administered using an eFlow nebulizer; Placebo to match AZLI 3 times daily combined with diluent administered using an eFlow nebulizer; Tobramycin inhalation solution (TIS) 300 mg 2 times daily using a PARI® LC Plus nebulizer and DeVilbiss Pulmo-Aide® air compressor
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen
      with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in
      adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa
      (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be
      eligible for randomization in the comparative phase if they have not received non-study oral
      antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between
      Visits 2 and 3, have not developed a condition requiring hospitalization or other change in
      clinical status which, in the opinion of the investigator would preclude their ability to
      continue in the study, and have demonstrated at least 50% TIS compliance. Participants
      enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each
      cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28
      days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF

          -  Presence of PA in 2 lower respiratory tract cultures in the 12 months prior to
             screening

          -  Forced expiratory volume (FEV)1 ≥ 25 and ≤ 75% predicted

          -  History of 1 hospitalization or 1 course of IV antibiotics for an acute respiratory
             exacerbation in the 12 months prior to screening

        Exclusion Criteria:

          -  Concurrent use of oral, IV or inhaled antibiotics at enrollment

          -  Concurrent hospitalization at enrollment

          -  History of local or systemic hypersensitivity to monobactams or aminoglycoside
             antibiotics or history of aminoglycoside antibiotic associated toxicity
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
Condition: Allergy
MeSH terms: Conjunctivitis
Intervention: 300 IR grass pollen allergen extract tablet; Placebo tablet
Intervention description: One sublingual tablet daily during 4 months before pollen season and during pollen season; One sublingual tablet daily during 4 months before pollen season and during pollen season
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 278.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Sublingual immunotherapy; Grass pollen tablet; Allergic rhinoconjunctivitis

Summary:

      A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens
      compared with placebo for reduction of symptoms and rescue medication usage in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients aged 5 to 17 years.

          -  Written consent / assent.

          -  Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen
             seasons.

          -  Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at
             least Class 2).

          -  Total symptom score on the Retrospective RTSS during the previous pollen season of
             greater than or equal to 12.

        Exclusion Criteria:

          -  Patients who have received any desensitisation treatment for grass pollen.
Safety and Efficacy Study of a Eye Drop for Eye Allergy
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: alcaftadine; Placebo
Intervention description: 0.25% Ophthalmic Solution, one drop in each eye at each of two visits.; Vehicle without active, one drop in each eye at each of two visits.
Intervention MeSH terms: Alcaftadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 10 years of age

          -  positive history of ocular allergies

          -  positive skin test reaction to allergens.

        Exclusion Criteria:

          -  known allergy, contraindication, or sensitivities to the use of any of the study
             medication(s) or their components

          -  ocular surgical intervention within three (3) months prior to visit 1 or during the
             study

          -  known history of retinal detachment, diabetic retinopathy, or progressive retinal
             disease, or glaucoma

          -  any other significant illness
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Methylene Blue MMX®; Placebo
Intervention description: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
Intervention MeSH terms: Methylene Blue
Phase: Phase 3
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1249.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluation of the histologically proven adenoma and carcinoma detection rate in patients
      undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with
      200 mg of Methylene Blue MMX® tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, aged between 50 and 75.

          -  Outpatients scheduled for screening or surveillance colonoscopy for polyps or
             colorectal cancer )

          -  Able to comprehend the full nature and purpose of the study, including possible risks
             and side effects.

          -  Able to co-operate with the investigator and to comply with the requirements of the
             entire study.

          -  Signed written informed consent prior to inclusion in the study.

        Exclusion Criteria:

          -  Patients at high risk of colorectal cancer e.g. ulcerative colitis

          -  Previous medical history of, or suspected hypersensitivity to, the Methylene Blue
             and/or formulations' ingredients.

          -  Previous medical history of, or suspected hypersensitivity to, the PEG based bowel
             cleansing preparation and/or bowel cleansing formulations' ingredients.

          -  Previous medical history of gastrointestinal obstruction or perforation, toxic
             megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or
             IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Condition: Vitamin A Deficiency; Maternal Mortality; Infant Mortality
MeSH terms: Night Blindness; Maternal Death; Vitamin A Deficiency; Infant Death
Intervention: Vitamin A or Beta-Carotene Supplements
Intervention description: weekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy
Intervention MeSH terms: Vitamin A; Beta Carotene; Carotenoids
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 59666.0
Sex: Female
Minimum age: 15 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Maternal mortality; Infant mortality; Vitamin A; Beta-carotene; Micronutrients; Bangladesh; Neonatal mortality

Summary:

      The purpose of this trial is to determine whether providing women with a weekly oral
      supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a
      recommended intake from early pregnancy through three months postpartum, can reduce the risk
      of maternal mortality, fetal loss, or infant mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Married women of reproductive age

          -  First pregnancy during time period of trial

        Exclusion Criteria:

          -  Premenarchial girls

          -  Married women with a previous pregnancy enrolled into the trial

          -  Previously married women who have moved into the study area

          -  Single women (never married, widowers)

          -  Women who are sterilized (or whose husbands are sterilized)

          -  Menopausal women
38 Week Extension Study to CAIN457C2303
Condition: Uveitis
MeSH terms: Uveitis
Intervention: AIN457; AIN457; Placebo AIN457
Intervention description: 300mg every 4 weeks; 300mg every 2 weeks; Placebo to AIN457
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: uveitis

Summary:

      A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled
      study to assess the difference in the rate of recurrent exacerbations in Behçet's patients
      with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care
      immunosuppressive therapy
    

Eligibility criteria:

        Inclusion Criteria:

        -

        Exclusion Criteria:

        -
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone; Sham
Intervention description: 350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.; Sham posterior segment drug delivery system-needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 554.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone
      for the treatment of diabetic macular edema.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 years of age or older with diabetic macular edema;

          -  Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or
             worse);

          -  Visual acuity in other eye no worse than 20/200

        Key Exclusion Criteria:

          -  Known anticipated need for ocular surgery within next 12 months;

          -  History of glaucoma or current high eye pressure requiring more than 1 medication;

          -  Uncontrolled systemic disease;

          -  Known steroid-responder;

          -  Use of systemic steroids;

          -  Use of Warfarin/Heparin
A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
Condition: Primary Hyperoxaluria Type 1; Primary Hyperoxaluria
MeSH terms: Hyperoxaluria, Primary
Intervention: Lumasiran
Intervention description: Lumasiran will be administered by subcutaneous (SC) injection.
Intervention MeSH terms: Lumasiran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Healthy volunteers: No
Keywords: PH1; Primary Hyperoxaluria; Hyperoxaluria; RNAi Therapeutic; siRNA; AGT; Systemic Oxalosis

Summary:

      The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and
      pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1
      (PH1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has documented diagnosis of primary hyperoxaluria type 1 (PH1)

          -  Estimated glomerular filtration rate (eGFR) ≤45 mL/min/1.73 m^2 for patients ≥12
             months of age (<12 months of age, must have serum creatinine considered elevated for
             age)

          -  Meets plasma oxalate level requirements

          -  If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90
             days

          -  If on dialysis, may be on hemodialysis therapy only and must have been on a stable
             regimen for at least 4 weeks

        Exclusion Criteria:

          -  Hemodialysis/peritoneal dialysis combination therapy or peritoneal dialysis alone

          -  Diagnosis of conditions other than PH1 contributing to renal insufficiency

          -  History of liver transplant

          -  History of kidney transplant and currently receiving immunosuppressants
Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
Condition: Thromboembolism
MeSH terms: Thromboembolism; Hip Fractures
Intervention: Fondaparinux
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Xa factor; VTE; MOSLL; pentasaccharide

Summary:

      This study is requested by PMDA to confirm the efficacy and the safety for HFS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing hip fracture surgery within 10 days following the time of fracture
             of the hip (proximal femur) (or following the time of fracture estimated from trauma).

        Exclusion Criteria:

          -  Active, clinically significant bleeding (excluding drainage).