bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: HL036 Ophthalmic Solution; Placebo
Intervention description: HL036 Ophthalmic Solution; Placebo vehicle solution
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 637.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study was to compare the safety and efficacy of 0.25% HL036 Ophthalmic
      Solutions to placebo for the treatment of the signs and symptoms of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a patient-reported history of dry eye for at least 6 months prior to Visit 1

          -  Be willing and able to comply with all study procedures

          -  Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2

        Exclusion Criteria:

          -  Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1

          -  Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses
             during the study

          -  Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the
             last 12 months

          -  Have any previous experience using HL036
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: ALD403; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 898.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess ALD403 in the prevention of migraine headache in
      frequent episodic migraineurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)

          -  History of migraine ≥ 12 months with

               -  ≤ 14 headache days of which at least 4 have to be migraine days (migraine days
                  count as headache days) in each 28 day period in the 3 months prior to screening

               -  During the 28 days following the screening visit, the subject experiences ≤ 14
                  headache days of which at least 4 have to be migraine days (migraine days count
                  as headache days) as recorded in the eDiary

          -  No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons
             requiring injections in the head, face, or neck 4 months prior to screening and during
             the 28 day period prior to randomization

          -  Headache eDiary was completed on at least 25 of the 28 days prior to randomization

        Exclusion Criteria:

          -  Confounding pain syndromes, e.g. fibromyalgia, complex regional pain syndrome or any
             pain syndrome that requires regular analgesia

          -  Psychiatric conditions that are uncontrolled and untreated, including conditions that
             are not controlled for a minimum of 6 months prior to screening

          -  History or diagnosis of complicated migraine (ICHD- II, 2004 Section 1), chronic
             tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
             daily persistent headache, migraine with brainstem aura, sporadic and familial
             hemiplegic migraine

          -  Unable to differentiate migraine from other headaches

          -  Have any clinically significant concurrent medical condition

          -  Receipt of any monoclonal antibody treatment within 6 months of screening (within or
             outside a clinical trial)

          -  Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Condition: Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Alirocumab; Placebo (for alirocumab); Lipid Modifying Therapy (LMT)
Intervention description: Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).; Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).; Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 486.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PCSK9

Summary:

      Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9
      (proprotein convertase subtilisin/kexin type 9).

      Primary Objective of the study:

      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels
      after 24 weeks of treatment in comparison with placebo.

      Secondary Objectives:

        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time
           points

        -  To evaluate the effects of alirocumab on other lipid parameters

        -  To evaluate the safety and tolerability of alirocumab
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with heterozygous familial hypercholesterolemia who were not adequately
             controlled with their lipid-modifying therapy

        Exclusion criteria:

          -  Age < 18 years or legal age of adulthood, whichever is greater

          -  LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease

          -  LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease

          -  Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)

          -  Known history of homozygous familial hypercholesterolemia

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165; Placebo; Apremilast
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Apremilast; Deucravacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 666.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the experimental medication BMS-986165 compared
      to placebo and a currently available treatment in participants with moderate to severe plaque
      psoriasis.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Plaque psoriasis for at least 6 months

          -  Moderate to severe disease

          -  Candidate for phototherapy or systemic therapy

        Exclusion Criteria:

          -  Other forms of psoriasis

          -  History of recent infection

          -  Prior exposure to BMS-986165 or active comparator

        Other protocol defined inclusion/exclusion criteria apply
Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging
Condition: Myocardial Infarction; Death, Sudden, Cardiac
MeSH terms: Myocardial Infarction; Death, Sudden, Cardiac; Infarction; Death, Sudden
Intervention: Omega-3 Fatty Acids (Fish Oil Supplements); Placebo
Intervention description: 4 grams of omega-3 fatty acids taken orally once per day for 6 months; Placebo tablets taken orally once per day for 6 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 358.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Heart Attack; Sudden Cardiac Death; Peri-infarct Zone; Omega-3 Fatty Acids; Biological Markers; Cytogenetic Analysis; Cardiac Arrest

Summary:

      Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the
      body. This study will evaluate a new MRI technique in people who have recently had a heart
      attack. Researchers will also examine the effect of fish oil supplementation on heart health
      in study participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Experienced a heart attack in the 2 to 4 weeks before study entry

          -  Lives in the greater Boston area or adjacent regions (within a 50-mile radius of
             Boston)

        Exclusion Criteria:

          -  Unable to undergo an MRI because of metallic implants (e.g., pacemakers, an
             implantable cardioverter defibrillator [AICD]) at time of study entry

          -  Active cancer or any other terminal illness with an expected survival rate of less
             than 6 months after study entry

          -  Significant kidney dysfunction with a glomerular filtration rate (GFR) of less than 60
             mL/min in the 2 weeks before study entry

          -  Inability to follow study procedures

          -  Pregnant

          -  Hemodynamic instability

          -  Urgent clinical need for a pacemaker or AICD

          -  Inaccessibility of medical records
Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botulinum toxin type A; Placebo
Intervention description: Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only; Up to 2mL
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL
      dilution compared with placebo for the treatment of Cervical Dystonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary diagnosis of Cervical Dystonia at least 9 months since onset and either
             previously untreated with botulinum toxin or currently treated with Botox at a total
             dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last
             injection cycle, and having had a satisfactory treatment response in the principal
             investigator's judgment during the last two sequential Botox treatment cycles.

          -  TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

        Exclusion Criteria:

          -  In apparent remission from Cervical Dystonia

          -  Diagnosis of pure retrocollis or pure anterocollis

          -  For non-naïve subjects, previous poor response to either of the last two Botox
             treatments

          -  Known requirement of <100U or >200U of Botox injected into the neck muscles
12-Week Study of Plecanatide for CIC (The CIC3 Study)
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Plecanatide; Placebo; Bisacodyl
Intervention description: Plecanatide tablets QD for 12 weeks; Matching placebo tablets QD for 12 weeks; Rescue medication
Intervention MeSH terms: Bisacodyl; Plecanatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1394.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: CIC; Constipation; Chronic Constipation; Synergy; Plecanatide

Summary:

      The purpose of this study is to confirm that the investigational medication, plecanatide, is
      safe and effective in treating chronic idiopathic constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18-80, inclusive

          -  Meets modified Rome III criteria for functional chronic idiopathic constipation for at
             least 3 months with symptom onset for at least 6 months

          -  Completed a colonoscopy in accordance with AGA colon cancer screening guidelines (5
             years), with no clinically significant findings

          -  Willing to maintain a stable diet during the study

        Exclusion Criteria:

          -  Loose stool (mushy) or watery (Bristol score 6 or 7) stool in the absence of any
             laxative or prohibited medicine for > 25% of BMs during the 3 months prior to
             screening visit OR during the 14 day pre-treatment assessment

          -  Active peptic ulcer disease, diabetes or hypertension not adequately treated or not
             stable

          -  History of cathartic colon, laxative, enema abuse, or ischemic colitis

          -  Fecal impaction within 3 months of screening

          -  Patient has had /has any: diseases or conditions associated with constipation (GI or
             CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor
             dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal
             fissures or any disease or condition that can affect GI motility or defecation or can
             be associated with abdominal pain

          -  Unexplained and clinically significant "alarm symptoms" including lower GI bleeding,
             iron-deficiency anemia, weight loss or systemic signs of infection or colitis

          -  Major surgery, stroke or MI within 60 days of screening

          -  Participated in a previous plecanatide clinical trial
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: BIIB031 (rFVIIIFc); FVIII (PK subgroup only)
Intervention description: Vials of rFVIIIFc were combined as needed, based on the actual labeled potency to achieve the participant's calculated dose. Partial vial use was allowed, in order to achieve the calculated dose.; Baseline prestudy FVIII dosing in participants who enter the PK subgroup. Vials of prestudy FVIII were combined as needed, based on the nominal labeled potency (e.g., 250 IU, 500 IU, and 1000 IU), to achieve the participant's calculated dose.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Male
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the safety of Recombinant Coagulation
      Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with
      hemophilia A. Secondary objectives of this study in this study population are as follows: to
      evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to
      evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc
      consumption for prevention and treatment of bleeding episodes.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Severe hemophilia A defined as <1 IU/dL (<1%) endogenous FVIII

          -  Male <12 years of age and weight ≥13 kg

          -  History of at least 50 documented prior exposure days to FVIII

          -  No current, or history of, inhibitor development to FVIII

        Key Exclusion Criteria:

          -  Other coagulation disorders in addition to Hemophilia A

          -  History of anaphylaxis associated with any FVIII or IV immunoglobulin administration

        NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Intervention: Mepolizumab
Intervention description: 100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 347.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: extension study; Severe refractory asthma; safety; SB-240563; mepolizumab; eosinophils

Summary:

      This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab
      administered subcutaneously (SC) in addition to standard of care in subjects who participated
      in the MEA112997 study. At each clinic visit, adverse events will be assessed and
      exacerbations will also be reviewed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent.

          -  MEA112997 Study Participation: Received at least 2 doses of double-blind
             investigational product during the MEA112997 trial.

          -  MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have
             had a positive risk: benefit ratio.

          -  Currently being treated with a controller medication and the subject has been on a
             controller medication for the past 12 weeks.

          -  Male or Eligible Female Subjects. To be eligible for entry into the study, females of
             childbearing potential must commit to consistent and correct use of an acceptable
             method of birth control for the duration of the trial and for 4 months after the last
             study drug administration.

        Exclusion Criteria:

          -  Hypersensitivity related to mepolizumab.

          -  Clinically significant change in health status since completing participation in the
             MEA112997 trial.

          -  A current malignancy or previous history of cancer in remission for less than 12
             months prior to screening.

          -  For those subjects who had a SAE in MEA112997 that was assessed as possibly related to
             mepolizumab by the investigator.

          -  Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they
             plan to become pregnant during the time of study participation.

          -  Screening ECG which has a clinically significant abnormality.

          -  Received Xolair (omalizumab) within the past 130 days.

          -  Participated in a clinical trial within the past 30 days or have received
             investigational medication within five terminal half-lives of Screen Visit, whichever
             is longer.

          -  Current smokers.
Exparel Use in Adductor Canal Block After Total Knee Arthroplasty
Condition: Arthritis Knee; Pain, Postoperative; Opioid Use
MeSH terms: Pain, Postoperative
Intervention: Exparel; Ropivacaine
Intervention description: Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine; Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
Intervention MeSH terms: Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Exparel; adductor; knee; arthroplasty; opioid

Summary:

      Exparel has been shown to have better pain control compared to previously used infiltration
      agents, including bupivacaine, while having a minor side effect profile. The purpose of this
      study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal
      Blocks for peri-operative pain control following a total knee arthroplasty (TKA) procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients were eligible for inclusion if they were undergoing unilateral primary TKA
             for a diagnosis of knee osteoarthritis and were not undergoing any additional
             concomitant procedures were.

        Exclusion Criteria:

          -  Patients were not eligible for our study if they were undergoing revision TKA, if they
             were undergoing bilateral TKA or concomitant procedures, or if they had an active
             infection.