bioihbjkbjnl/mcl2 huggingface dataset:
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
Condition: Cataract
MeSH terms: Cataract; Uveitis; Inflammation
Intervention: Loteprednol etabonate; Prednisolones acetate
Intervention description: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.; 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Intervention MeSH terms: Loteprednol Etabonate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 107.0
Sex: All
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Pediatric cataract

Summary:

      The objective of this study is to compare the efficacy and safety for the treatment of
      postoperative inflammation following ocular surgery for childhood cataract.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a candidate for routine, uncomplicated surgery for childhood cataract

        Exclusion Criteria:

          -  Subjects who have a severe/serious ocular condition, or any other unstable medical
             condition that, in the Investigator's opinion, may preclude study treatment or
             follow-up.

          -  Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure
             (IOP) lowering therapy in either eye or systemically.

          -  Subjects with a history of steroid-induced IOP elevation in either eye.

          -  Subjects who have known hypersensitivity or other contraindication to the study
             drug(s) or any components in the drug formulation.
A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ezetimibe; Comparator: placebo
Intervention MeSH terms: Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Primary Hypercholesterolemia

Summary:

      A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with
      primary hypercholesterolemia (high cholesterol) after eating a meal that is high in
      cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the
      cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a
      cholesterol-enriched test meal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible patients will be otherwise healthy men and women (if not on oral
             contraceptives or hormone replacement therapy) 18 through 70 years of age with
             moderately high cholesterol.

        Exclusion Criteria:

          -  Individuals on other lipid-lowering therapy (medicines that lower cholesterol)
             including statins (within 6 weeks) and fibrates (within 8 weeks) prior to
             administration of the study drug.
Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
Condition: Cataract
MeSH terms: Cataract
Intervention: modified light transmission intraocular lens; monofocal acrylic intraocular lens
Intervention description: violet visible light blocking acrylic intraocular lens; conventional hydrophobic acrylic intraocular lens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cataract; monofocal; intraocular lens; acrylic

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of a new
      investigational modified light transmission monofocal intraocular lens compared to a
      conventional intraocular lens (IOL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years of age or older

          -  Bilateral cataracts for which phacoemulsification extraction and posterior IOL
             implantation has been planned

          -  Visual potential in both eyes of 20/30 Snellen or better after cataract removal and
             IOL implantation

          -  Preoperative corneal astigmatism of 1.5 diopters or less

        Exclusion Criteria:

          -  Use of systemic or ocular medications that may affect vision

          -  Uncontrolled systemic or recurrent ocular disease

          -  Requiring an intraocular lens <15.0 or >26.0 diopters

          -  Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates

          -  History of ocular trauma or prior ocular surgery

          -  Known pathology that may affect visual acuity or visual field

          -  Corneal abnormalities

          -  Pupil abnormalities

          -  Capsule or zonular abnormalities
Long-term Extension Study of BEMA™ Fentanyl
Condition: Respiratory Depression
MeSH terms: Respiratory Insufficiency
Intervention: BEMA Fentanyl
Intervention description: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Pain; Ventilatory Response to Hypercapnia (VRH)

Summary:

      This study is designed to provide continued access to BEMA Fentanyl for those subjects who
      previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the
      treatment of their breakthrough cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. previously qualified for and participated in study FEN-202 for at least 2 weeks,

          2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and

          3. provide signed informed consent at screening prior to any study procedures.

        Exclusion Criteria:

          1. they have developed a new medical condition after initial enrollment in FEN-202 which,
             in the opinion of the investigator, would preclude safe and appropriate use of BEMA
             Fentanyl or participation in this study, or

          2. there is evidence of improper use of the study drug.
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: contact lens with ketotifen; contact lens
Intervention description: K-Lens (generic name not established) and Ketotifen combination drug-device product; Placebo contact lens
Intervention MeSH terms: Ketotifen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy normal, soft contact lens wearing volunteers

          -  normal ocular health

          -  contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or
             less in each eye

        Exclusion Criteria:

          -  active ocular infection

          -  history of ocular surgery

          -  use of topical ophthalmic preparations (including rewetting drops)

          -  pregnancy or lactation
Ivermectin for Severe COVID-19 Management
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Ivermectin
Intervention description: Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under "Good Manufacturing Practices" (GMP) certification conditions.
Intervention MeSH terms: Azithromycin; Hydroxychloroquine; Ivermectin; Favipiravir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients who were hospitalised with a pre-diagnosis of severe COVID-19 pneumonia and thereafter diagnosis of COVID-19 was also confirmed microbiologically with polymerase chain reaction (PCR) positivity in respiratory tract samples were included into the study. They were randomized to the study and control group, respectively. Single numbered patients were accepted as study group and double numbered patients as control group
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ivermectin; SARS-CoV-2; Treatment

Summary:

      In this multicenter study; it was aimed to investigate the effectiveness and safety of
      ivermectin use in the treatment of patients with severe COVID-19 pneumonia that have no
      mutations which alter ivermectin metabolism and cause side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who were hospitalised with a pre-diagnosis of "severe COVID-19 pneumonia" and
             thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR
             positivity in respiratory tract samples were included into the study. They were
             randomized to the study and control group, respectively.

        Patients with at least one of the criteria below were accepted as patients with severe
        COVID-19 pneumonia;

          1. Presence of tachypnea ≥ 30/minute, SpO2 level < 90% in room air, PaO2/FiO2 <300 in
             oxygen receiving patient

          2. Presence of specific radiological finding for COVID-19 in lung tomography (bilateral
             lobular, peripherally located, diffuse patchy ground glass opacities)

          3. Mechanical ventilation requirement

          4. Acute organ dysfunction findings; patients with SOFA (sepsis-related organ failure
             assessment) score >2

        Exclusion Criteria:

          -  Patients with the following characteristics were excluded from the study.

               1. Pediatric patients; <18 years of old

               2. Patients with chronic liver or kidney disease

               3. Pregnant women

               4. Patients with known ivermectin allergy
Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo; Metformin
Intervention description: Oral tablet, once daily for 24 weeks; oral tablet, once daily for 24 weeks; oral tablet, once daily for 24 weeks
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 570.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DPP-4 inhibitors; HbA1c; Incretins

Summary:

      Saxagliptin is a new investigational medication being developed for treatment of type 2
      diabetes. This study is designed to evaluate the efficacy and safety in adult patients who
      have inadequate glycaemic control when treated with metformin in addition to diet and
      exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Type 2 diabetes

          -  Treatment with metformin at a stable dose >1500 mg/day

          -  HbA1c ≥ 7.0% and ≤10.0%

        Exclusion Criteria:

          -  Insulin therapy within one year of enrolment (with the exception of insulin therapy
             during a hospitalization or use in gestational diabetes)

          -  Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma
Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: BMS-936558 (Nivolumab); Placebo matching BMS-936558 (Nivolumab); Dacarbazine; Placebo matching Dacarbazine
Intervention MeSH terms: Nivolumab; Dacarbazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the clinical benefit, as measured by overall
      survival, of nivolumab with that of. dacarbazine in patients with previously untreated,
      unresectable, or metastatic melanoma
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women ≥18 years of age

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

          -  Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as
             per the staging system of the American Joint Committee on Cancer

          -  Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1

          -  Tumor tissue from an unresectable or metastatic site of disease must be provided for
             biomarker analyses

          -  Known BRAF wild-type, as per regionally acceptable V600 mutational status testing.
             BRAF mutant patients and those with indeterminate or unknown BRAF status are not
             permitted to randomize

        Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases

          -  Ocular melanoma

          -  Any active, known, or suspected autoimmune disease
Patient-Reported Outcome Of Facial Erythema (PROOF)
Condition: Rosacea; Erythema
MeSH terms: Rosacea; Erythema
Intervention: Brimonidine tartrate was applied cutaneously once daily for 8 days.; Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of
      patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The
      feedback of patients receiving the active drug will be compared to the feedback of patients
      receiving the placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects age of 18 years or older

          -  A clinical diagnosis of facial rosacea

          -  A Patient Self-Assessment score of 4 (severe) at Baseline prior to the study drug
             application

          -  A Clinician's Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at
             Baseline prior to the study drug application

        Exclusion Criteria:

          -  More than 5 facial inflammatory lesions (papules or pustules) of rosacea

          -  Any uncontrolled chronic or serious disease or medical condition that may either
             interfere with the interpretation of the clinical trial results, or put the subject at
             significant risk if the subject participates in the clinical trial as judged by the
             investigator

          -  Known or suspected allergies or sensitivities to any component of the study drugs,
             including the active ingredient brimonidine tartrate (see Investigator's Brochure)

          -  Female who is pregnant or lactating
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Condition: Spinal Fractures; Osteoporosis
MeSH terms: Osteoporosis; Spinal Fractures
Intervention: Percutaneous vertebroplasty; Sham vertebroplasty
Intervention description: Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture; Participants, following local anesthesia with lidocaine and bupivacaine, were given verbal and physical cues such as pressure on the back, but the needle was not placed.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Vertebroplasty; Crushed Vertebrae; Back Pain; Structurally Unstable Vertebrae; polymethylmethacrylate; INVEST; PMMA; RDQ

Summary:

      Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the
      spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of
      fractures due to osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed osteoporosis or osteopenia by a referring physician and/or medical history
             and physical exam OR osteopenia on plain film

          -  Vertebral compression fracture in vertebrae T4 through L5, of less than 1 year old

          -  Pain not responsive to standard medical therapy

          -  Current rating for pain intensity of at least 3 on a scale of 0 to 10

        Exclusion Criteria:

          -  Evidence or suspicion of malignant tumor or spinal canal compromise

          -  Concomitant hip fracture

          -  Local or systemic infection

          -  Uncorrectable bleeding diatheses

          -  Surgery within the previous 60 days

          -  Lack of access to telephone

          -  Inability to communicate in English

          -  Dementia

          -  Pregnancy

          -  Abnormal renal function or anticipated venography

          -  Conscious sedation is contraindicated for subject
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
Condition: Systemic Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Canakinumab
Intervention description: canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection and administered at 4mg/kg every 4 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 2 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: ACZ885; canakinumab; Juvenile Rheumatoid arthritis (JRA) chronic; systemic inflammatory disorder; painful joints; inflammation of the synovial membrane; auto-immune rheumatoid disease; reactive rheumatoid arthritis; Systemic Juvenile Rheumatoid arthritis (SJRA); Japanese patients

Summary:

      This was a phase III study designed to provide efficacy and safety data for canakinumab
      administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in
      Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA)
      data at Week 28 and 48 from this study supported a registration submission of canakinumab in
      the indication of SJIA in Japan.
    

Eligibility criteria:

        Inclusion Criteria

        - Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR)
        definition (Petty, et al. 2004) that must have occurred at least 3 months prior to
        enrollment with an onset of disease < 16 years of age: Arthritis in one or more joints,
        with or preceded by fever of at least 2 weeks duration that is documented to be
        daily/quotidian for at least 3 days and accompanied by one or more of the following: Rash
        due to SJIA, lymphadenopathy, Hepatomegaly/Splenomegaly, Serositis

          -  Active disease at the time of baseline defined as follows:

          -  At least 2 joints with active arthritis

          -  Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day
             during the screening epoch and within 1 week before first canakinumab dose

          -  C-Reactive Protein (CRP) > 30 mg/L(3 mg/dL) (normal range < 10 mg/L(1 mg/dL))

          -  Negative TB screen (Chest X-ray and T-SPOT test)

        Exclusion Criteria:

          -  With active or recurrent bacterial, fungal or viral infection at the time of
             enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV)
             infection, Hepatitis B and Hepatitis C infection. Patients with resolved/previous
             hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or
             anti-HBc antibody).

          -  With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions
             which in the opinion of the investigator immunocompromises the patient and /or places
             the patient at unacceptable risk for participation.

          -  With neutropenia (absolute neutrophil count < 1500/mm3) at screening.