bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Intervention: NPC-01; IKH-01; Placebo
Intervention description: Norethisterone 1mg, Ethinyl estradiol 0.02mg; Norethisterone 1mg, Ethinyl estradiol 0.035mg; Placebo for NPC-01
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 215.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether NPC-01 is effective in the treatment of
      dysmenorrhea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  dysmenorrhea

        Exclusion Criteria:

          -  severe hepatopathy

          -  pregnant woman
Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
Condition: Lymphoblastic Leukemia, Acute
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Prednisone, Dexamethasone, Vincristine, Daunorubicin; Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase; Methotrexate, Cyclophosphamide, Cytarabine, Etoposide; Mercaptopurine, Imatinib; chemotherapy, intrathecal chemotherapy; steroid therapy, hematopoietic stem cell transplantation
Intervention description: See Detailed Description sections for details on treatment interventions.; See Detailed Description sections for details on treatment interventions.; See Detailed Description sections for details on treatment interventions.; See Detailed Description sections for details on treatment interventions.; See Detailed Description sections for details on treatment interventions.; See Detailed Description sections for details on treatment interventions.
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisone; Cyclophosphamide; Doxorubicin; Methotrexate; Etoposide; Vincristine; Daunorubicin; Asparaginase; Mercaptopurine; Pegaspargase
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 501.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia

Summary:

      The primary objective is to estimate the overall event-free survival of children at least one
      year of age at diagnosis who are treated with risk-directed therapy and to monitor the
      molecular remission induction rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of non-B-cell ALL by immunophenotyping, as determined by the reactivity
             pattern to a panel of monoclonal antibodies with flow cytometry as well as morphology
             and cytochemical staining.

          -  Age range: 1 to 18 years (inclusive).

        Exclusion Criteria:

        • Previously treated with chemotherapy for one week or longer.
Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
Condition: Dry Eye Disease (DED)
MeSH terms: Dry Eye Syndromes; Eye Diseases
Intervention: NOV03
Intervention description: 100% Perfluorohexyloctane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this trial are to evaluate the safety and tolerability of
      perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry
      Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction).

      Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during
      long-term use in subjects with DED associated with MGD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed ICF (Informed Consent Form)

          -  Subject-reported history of Drye Eye Disease (DED) in both eyes

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Women who are pregnant, nursing or planning pregnancy

          -  Unwillingness to submit a blood pregnancy test at screening and the last visit (or
             early termination visit) if of childbearing potential, or unwillingness to use
             acceptable means of birth control

          -  Clinically significant slit-lamp findings or abnormal lid anatomy at screening

          -  Ocular/peri-ocular malignancy

          -  History of herpetic keratitis

          -  Active ocular allergies or ocular allergies that are expected to be active during the
             study

          -  Ongoing ocular or systemic infection

          -  Wear contact lenses within 1 month prior to screening or anticipated use of contact
             lenses during the study

          -  Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have
             planned ocular and/or lid surgeries over the study period

          -  Presence of uncontrolled systemic diseases

          -  Presence of known allergy and/or sensitivity to the study drug or saline components

          -  Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears
             or topical anti-glaucoma medication within 2 months prior to screening
Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease
Condition: Dry Eye Syndromes; Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Intervention: KPI-121 0.25% Ophthalmic Suspension; Vehicle of KPI-121 0.25% Ophthalmic Suspension
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 909.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ocular Discomfort; Pain; Corticosteroid; Hyperemia; Dry Eye

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.
Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement
Condition: Pain, Perioperative
Intervention: Placebo; Pregabalin
Intervention description: Placebo as an adjunct to standard of care; 75 mg BD for 14 days
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: perioperative; pregabalin; total hip replacement; post-operative pain

Summary:

      The purpose of this study is the investigate if pregabalin started a day before surgery and
      continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and
      post-operative anxiety and sleep disturbances.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is undergoing a routine (i.e., expected to be uncomplicated) total primary
             or secondary hip replacement surgery performed under a standardized regimen of spinal
             anesthesia, and is expected to experience moderate to severe post-surgical pain in the
             absence of post-operative analgesia

        Exclusion Criteria:

          -  The patient is undergoing a revision to a previous hip replacement procedure, hip
             replacement procedure further to a road traffic accident with multiple injuries, or a
             procedure expected to last longer than 4 hours

          -  The patient has a history of uncontrolled chronic disease or a concurrent clinically
             significant illness or medical condition, which in the Investigator's opinion, would
             contraindicate study participation or confound interpretation of the results
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
Condition: Chronic HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF
Intervention description: 90/400 mg FDC tablet administered orally once daily without regard to food
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 384.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in
      treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C
      virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other
             approved or experimental HCV-specific direct-acting antiviral agent; OR HCV
             treatment-experienced with medical records that include sufficient detail of prior
             IFN-based treatment to allow for categorization of prior response as either
             intolerant, non-responder, or experienced viral breakthrough or relapse.

          -  Genotype 1 HCV at screening

          -  HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

        Key Exclusion Criteria:

          -  Pregnant or nursing female

          -  Chronic liver disease of a non-HCV etiology

          -  Current or prior history of any clinically-significant illness (other than HCV)

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
Condition: Diabetic Nephropathy; Type 2 Diabetes Mellitus; Proteinuria
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Proteinuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: olmesartan medoxomil; Placebo Tablets
Intervention description: Tablets 10, 20, or 40 mg; Matching placebo tablets
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 577.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: angiotensin II type I receptor blockers; diabetic nephropathy; end-stage renal disease; renal failure; type 2 diabetes; olmesartan medoxomil

Summary:

      The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus
      placebo on the progression of diabetic renal disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes

          -  albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning urinalysis

          -  serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in
             men

        Exclusion Criteria:

          -  type 1 diabetes

          -  non-diabetic nephropathy

          -  history of myocardial infarction

          -  history of cardiac bypass grafting within 3 months

          -  history of percutaneous coronary intervention (PCI) within 6 months

          -  history of carotid artery or peripheral artery revascularization within 6 months

          -  stroke or transient ischemic attack (TIA) within 1 year

          -  unstable angina pectoris

          -  heart failure of NYHA functional classes III or IV

          -  rapid progression of kidney disease within 3 months

          -  severe orthostatic hypotension

          -  serum potassium level =<3.5 mEq(mmol)/L or =>5.5 mEq(mmol)L

          -  history of rapid elevation of the serum creatinine level after starting treatment with
             AII receptor antagonists or ACE inhibitors

          -  poor glycemic control: HbA1c level =>11%

          -  history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within
             3 months
Reverse Shoulder Prosthesis Study
Condition: Rotator Cuff Arthropathy; Failed Total Shoulder; Failed Hemi-arthroplasty
MeSH terms: Joint Diseases
Intervention: Reverse Shoulder Prosthesis; Reverse Shoulder Prosthesis
Intervention description: For subjects with rotator cuff arthropathy and no previous shoulder device implanted.; For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 516.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this clinical study is to evaluate the safety and efficacy of the Encore
      Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to
      clinical results published in literature for rotator cuff arthropathy and salvage procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with
             irreparable rotator cuff

          -  Evidence of upward displacement of the humeral head with respect to the glenoid

          -  Loss of glenohumeral joint space

          -  Functional deltoid muscle

          -  Patient is likely to be available for evaluation for the duration of the study

          -  Visual Analog Pain Scale 5 or greater

        Exclusion Criteria:

          -  Non functional deltoid muscle

          -  Active sepsis

          -  Excessive glenoid bone loss

          -  Pregnancy

          -  Neurological abnormalities, which could hinder patient's ability or willingness to
             follow study procedures. For example, any that may restrict physical activities such
             as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.

          -  Mental conditions that may interfere with ability to give an informed consent or
             willingness to fulfill the study requirements (i.e., severe mental retardation such
             that the patient cannot understand the informed consent process, global dementia,
             prior strokes that interfere with the patient's cognitive abilities, senile dementia,
             and Alzheimer's Disease.

          -  Prisoners

          -  Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle
             deficiencies, refusal to modify postoperative physical activities, skeletal
             immaturity).

          -  Known metal allergy (i.e., jewelry).

          -  Visual Analog Pain Scale <5.
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Peramivir; Oseltamivir
Intervention MeSH terms: Oseltamivir; Peramivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 0 Days
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of
      IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of
      pediatric subjects with acute uncomplicated influenza.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Clinical signs and symptoms consistent with acute influenza infection consisting of an
             oral temperature ≥ 100°F (37.8°C) or rectal temperature ≥ 101.3ºF (≥ 38.5ºC) with at
             least one respiratory symptom (cough or rhinitis) OR Positive influenza determined by
             PCR or Rapid Antigen Test

          2. Onset of symptoms no more than 72 hours before presentation for screening for subjects
             < 2 years old.

        Key Exclusion Criteria:

          1. Pregnant or breast-feeding females

          2. Development of symptoms while hospitalized

          3. Presence of a chronic disease or illness that may indicate increased risk for
             influenza-related complications

          4. Presence of immunocompromised status
A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab Pegol
Intervention description: Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; CDP870; Certolizumab Pegol; Cimzia

Summary:

      An open ended study in which patients who completed the preceding double-blind study
      NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid
      Arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients must have either failed to achieve an American College of Rheumatology 20 %
        (ACR20) response at Weeks 12 and 14 in C87050 [NCT00160602], or must have completed the
        entire Week 24 assessment of C87050 [NCT00160602] trial.

        Exclusion Criteria:

          -  A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or
             Ankylosing Spondylitis)

          -  A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia)
             that in the Investigator's opinion is symptomatic enough to interfere with evaluation
             of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis
             (RA)

          -  Any concomitant biological therapy

          -  Any experimental therapy, within or outside a clinical
Confirmatory Study of OPC-12759 Ophthalmic Solution
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: OPC-12759; Placebo
Intervention description: Instillation, 4 times/day for 4 weeks
Intervention MeSH terms: Rebamipide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 209.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective
      compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a
      reference drug.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Out patient

          2. Subjective complaint of dry eye that has been present for minimum 20 months

          3. Ocular discomfort severity is moderate to severe

          4. Corneal - conjunctival damage is moderate to severe

          5. Unanesthetized Schirmer's test score of 5mm/5minutes or less

          6. Best corrected visual acuity of 0.2 or better in both eyes

        Exclusion Criteria:

          1. Presence of anterior segment disease or disorder other than that associated with dry
             eye

          2. Ocular hypertension patient or glaucoma patient with ophthalmic solution

          3. Anticipated use of any topically-instilled ocular medications or patients who cannot
             discontinue the use during the study

          4. Anticipated use of contact lens during the study

          5. Patient with punctal plug

          6. Any history of ocular surgery within 12 months

          7. Female patients who are pregnant,possibly pregnant or breast feeding

          8. Known hypersensitivity to any component of the study drug or procedural medications

          9. Receipt of any investigational product within 4 months.