bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
Condition: Chalazion
MeSH terms: Chalazion
Intervention: SUN-131 1.5% TDS; Placebo TDS
Intervention description: SUN-131 1.5% TDS will be worn for 14 days; No active substance; Placebo TDS will be worn each day for 14 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 263.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5%
      TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The
      purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared
      with placebo TDS in the treatment of a chalazion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects aged ≥ 6 years of either sex and of any race

          2. Subjects with a diagnosis of a single chalazion

          3. Subjects with chalazion erythema score of ≥ 1

          4. Normal eyelid function without active signs of eye and eyelid infection in either eye.

          5. Must be willing and able to correctly apply and wear a transdermal patch to the eyelid

          6. Avoid wearing contact lenses in the study eye

        Exclusion Criteria:

          1. Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal
             surrounding lid tissue, associated loss of tissues).

          2. History of chalazion incision and curettage in study eyelid.

          3. Multiple chalazia in any one eyelid.

          4. Active ocular or eyelid infection Presence of hordeolum in any one eyelid.

          5. An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic
             dermatitis, etc.) where the study drug will be applied.

          6. Diagnosed with glaucoma in either eye.

          7. History of steroid-induced elevation of IOP.

          8. Female subjects who are pregnant or lactating.
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
Condition: Non Small Cell Lung Carcinoma NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Durvalumab +Tremelimumab; Paclitaxel + carboplatin; Gemcitabine + cisplatin; Gemcitabine + carboplatin; Pemetrexed + cisplatin; Pemetrexed + carboplatin
Intervention description: Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agent; Chemotherapy Agent
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Gemcitabine; Pemetrexed; Durvalumab; Tremelimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 953.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: NSCLC; PDL1; TMB; MEDI4736; Durvalumab; Tremelimumab; OS

Summary:

      This is a randomized, open-label, multi-center, global, Phase III study to determine the
      efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based
      SoC chemotherapy in the first-line treatment of patients with epidermal growth factor
      receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

        For inclusion in the study, patients should fulfill the following criteria:

          -  Aged at least 18 years

          -  Documented evidence of Stage IV NSCLC

          -  No activating EGFR mutation or ALK rearrangement

          -  No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC

          -  World Health Organization (WHO) Performance Status of 0 or 1

          -  No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to,
             other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, excluding therapeutic
             anticancer vaccines

        Exclusion Criteria:

        Patients should not enter the study if any of the following exclusion criteria are
        fulfilled:

          -  Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant

          -  Brain metastases or spinal cord compression unless the patient is stable
             (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for
             at least 14 days prior to start of study treatment.

          -  Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's
             disease, ulcerative colitis)
Safety and Efficacy of KPI-121 in Subjects With DED
Condition: Kerato Conjunctivitis Sicca
MeSH terms: Conjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Keratoconjunctivitis
Intervention: KPI-121 Ophthalmic Suspension; Vehicle
Intervention description: KPI-121 Ophthalmic Suspension; Vehicle for KPI-121 0.25% ophthalmic suspension
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 901.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%
      ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented
      clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2
      drops instilled in each eye four times daily (QID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a documented clinical diagnosis of dry eye disease in both eyes

        Exclusion Criteria:

          -  Known hypersensitivity or contraindication to the investigational product(s) or
             components

          -  History of glaucoma, IOP>21 mmHg at the screening or randomization visits, or being
             treated for glaucoma in either eye.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance; or have
             been exposed to an investigational drug within 30 days prior to screening.

          -  In the opinion of the Investigator or study coordinator, be unwilling or unable to
             comply with study protocol or unable to successfully instill eye drops.
MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)
Condition: Glabellar Lines; Lateral Canthal Lines
Intervention: MT10109L; Placebo
Intervention description: MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.; Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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

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.
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Intervention: Macitentan 10 mg; Placebo
Intervention description: film-coated tablet; oral use; film-coated tablet; oral use
Intervention MeSH terms: Macitentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on
      exercise capacity through cardiopulmonary exercise testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent/assent from the subject and/or a legal representative prior
             to initiation of any study-mandated procedures

          -  Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary
             connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery > 1 year before
             Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary
             connection

          -  New York Heart Association (NYHA) functional class (FC) II or III (assessed by the
             investigator using the Specific Activity Scale

          -  Women of childbearing potential must have a negative serum pregnancy test use reliable
             contraception

        Exclusion Criteria:

          -  Pattern of Fontan circulation severity

          -  Deterioration of the Fontan-palliated condition.

          -  Limitations to Cardiopulmonary exercise testing (CPET)

          -  Peak VO2 < 15 mL/kg/min.

          -  Any known factor or disease that may interfere with treatment compliance or full
             participation in the study
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-123 Lotion; IDP-123 Vehicle Lotion
Intervention description: Tazarotene 0.045% Lotion; Vehicle Lotion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 813.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123
      Vehicle Lotion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older;

          2. Written and verbal informed consent must be obtained. Subjects 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 subject reaches age of consent during the study they should
             be re-consented at the next study visit);

          3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
             Severity assessment at the baseline visit;

          4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20 but no more than 50;

          5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
             less than 25 but no more than 100;

          6. Subjects with two or fewer nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study;

          2. 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, dermatitis,
             eczema;

          3. 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;

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments;

          5. Subjects with more than two (2) facial nodules;

          6. Evidence or history of cosmetic-related acne
Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis
Condition: Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis
MeSH terms: Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Uveitis, Anterior
Intervention: 4 mg CLS-TA Suprachoriodal Injection
Intervention description: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uveitis; UME; Posterior Uveitis; Anterior Uveitis; Intermediate Uveitis; Panuveitis; Non-infectious Uveitis; Triamcinolone; Choroid; Choroidal Injection; Suprachoroidal; Microneedle; Microinjection; Triamcinolone acetonide

Summary:

      This open-label study is designed to evaluate the safety of suprachoroidally administered
      triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis
      with and without macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate
             and posterior)

          -  ETDRS BCVA score of ≥ 5 letters read in the study eye

        Exclusion Criteria:

          -  Any active ocular disease or infection in the study eye other than uveitis

          -  Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; patients
             with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering
             medications.

          -  Any uncontrolled systemic disease that, in the opinion of the Investigator, would
             preclude participation in the study

          -  Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or
             periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX
             implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years
             prior to baseline.
The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)
Condition: Amyloidosis
MeSH terms: Amyloidosis
Intervention: Patisiran
Intervention description: Patisiran was administered IV.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All the participants received only patisiran but divided into 3 arm groups based on administration in the parent study (placebo or patisiran in 003 [NCT01961921] or 004 [NCT01960348] studies).
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic; FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis

Summary:

      The purpose of this study is to evaluate the safety and efficacy of long-term dosing with
      ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed a patisiran study (i.e., completed the last efficacy visit in the
             parent study) and, in the opinion of the investigator, tolerated study drug

          -  Be willing and able to comply with the protocol-required visit schedule and visit
             requirements and provide written informed consent

        Exclusion Criteria:

          -  Any new or uncontrolled condition that could make the participant unsuitable for
             participation
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: CINRYZE 500; CINRYZE 1000
Intervention description: 500 Units of CINRYZE administered by IV injection; 1000 Units of CINRYZE administered by IV injection
Intervention MeSH terms: Complement C1 Inhibitor Protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Pediatric; C1 inhibitor; HAE; Cinryze; C1 INH; Prevention

Summary:

      Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units
      and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent
      angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).

      Secondary Objectives - To assess the safety and tolerability, characterize the
      pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose
      levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type I or Type II HAE.

          -  History of angioedema attacks.

        Exclusion Criteria:

          -  History of bleeding or clotting abnormality.

          -  Diagnosis of acquired angioedema or known to have C1 INH antibodies.

          -  History of allergic reaction to C1 esterase inhibitor or other blood products.

          -  Receipt of any experimental agents other than those required for prevention or
             treatment of angioedema attacks within 30 days prior to screening.
Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate
Condition: Osteoporosis; Hypomagnesemia
MeSH terms: Osteoporosis
Intervention: EffCaMgCit; Placebo
Intervention description: Each sachet of EffCaMgCit will contain 19 meq or 380 mg calcium, 10 meq (122 mg) magnesium, and 50 meq total citrate.; Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate. Placebo will be added to 6 oz water for 1-2 minutes, to be dissolved/suspended before swallowing. The placebo will contain 400 units of vitamin D.
Intervention MeSH terms: Magnesium citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: To provide adequate blinding, each medication sachet will be labelled with the study name, IRB number, principal investigator's name, expiration date and identification number of the study subject. Labels will be applied to the appropriate medication sachets once the subject has been randomized and assigned to a treatment group. Labelling of the sachets will be done by personnel who are not engaged in patient care.
Enrollment: 62.0
Sex: All
Minimum age: 21 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bone mineral density

Summary:

      Proton pump inhibitors (PPIs) are widely used for the control of gastric ulcer-gastritis,
      erosive esophagitis (gastroesophageal reflux disease), peptic ulcer disease (duodenal ulcer),
      and heartburn. Despite their efficacy, their use has been implicated in possibly causing
      fragility fractures (osteoporosis), hypomagnesemia (magnesium deficiency) and increased risk
      of chronic kidney disease (CKD). The current trial represents the investigators' ongoing
      effort to discern whether these complications could be averted by effervescent calcium
      magnesium citrate (EffCaMgCit).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have taken PPI (omeprazole or equivalent ≥ 20 mg/day, ≥ three times per week, for
             at least 2 months)

          -  Expected to continue at a similar dosage

          -  Stage 1 hypertension (with systolic blood pressure <140 and diastolic <90)

          -  controlled diabetes mellitus Type II with HbA1C less than 7%

        Exclusion Criteria:

          -  end-stage renal failure on dialysis

          -  hypercalcemia

          -  hypophosphatemia (serum P < 2.5 mg/dL)

          -  hypertension stage 2 or higher

          -  diabetes Type II with HbA1C ≥ 7%

          -  treatment with adrenocorticosteroids, diuretics, non-steroidal anti-inflammatory
             agents

          -  regular dose of magnesium supplements, bisphosphonate, teriparatide, denosumab or
             selective estrogen receptor modulators.

        Inclusion/exclusion of other drugs or conditions will be considered on an individual basis.