bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Adalimumab; Placebo
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 952.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis

Summary:

      To evaluate safety and efficacy of two adalimumab dosing regimens for induction and
      maintenance (standard and higher dosing) in achieving clinical remission in subjects with
      moderately to severely active ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy
             during Screening period.

          -  Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite
             concurrent or prior treatment with a full and adequate course, in the opinion of the
             Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is
             confirmed by central reader.

        Exclusion Criteria:

          -  Subject with Crohn's disease (CD) or indeterminate colitis (IC).

          -  Current diagnosis of fulminant colitis and/or toxic megacolon.

          -  Subjects with disease limited to the rectum (ulcerative proctitis) during the
             screening endoscopy.

          -  Chronic recurring infections or active tuberculosis (TB).
Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
Condition: Heart Disease
MeSH terms: Heart Diseases
Intervention: sulphur hexafluoride lipid-type A microspheres
Intervention description: Ultrasound imaging contrast agent
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV
      EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the
      study in pediatric subjects represented those utilized in routine clinical practice in
      adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide Written informed consent from parent(s) or legal guardian

          -  Provide assent when required according to local regulations

          -  Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for
             congenital heart disease

          -  Undergone a previous transthoracic echocardiogram within one month prior to enrollment
             resulting in suboptimal left ventricular endocardial border defined as ≥ 2 contiguous
             segments in any given view that cannot be visualized.

        Exclusion Criteria:

          -  Children < 9 years of age

          -  Previously enrolled in the study

          -  Administered any other contrast agent either intravascularly or orally within 48 hours
             of Lumason administration

          -  Known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated
             saline study performed before administration of Lumason)

          -  Known hypersensitivity to one or more of the ingredients of the investigational
             product

          -  Received an investigational compound within 30 days before enrolling into this study

          -  Pregnant or lactating female

          -  Determined by investigator to be unsuitable for the study
Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
Condition: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
Intervention: Denosumab; Placebo for risendronate; Risendronate; Placebo for denosumab
Intervention description: Administered by subcutaneous injection once every 6 months; Administered orally once a day; Administered orally once a day; Administered by subcutaneous injection once every 6 months
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 795.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density

Summary:

      This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with
      glucocorticoid-induced osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Men and women 18 years of age or older who have been taking glucocorticoid treatment. Men
        and women who are less than 50 years of age must have had a fracture as an adult to be
        eligible. Men and women who are 50 years of age or older who have been taking
        glucocorticoids must meet protocol-specific BMD criteria.

        Exclusion Criteria:

        Use of agents affecting bone metabolism, use of more than one biologic agent for
        inflammatory disease, history of bone disease (except osteoporosis), low vitamin D level
        (one can enter the trial after vitamin D levels are corrected), abnormalities of blood
        calcium, an underactive or overactive thyroid condition that is not treated and stable,
        Addison's disease, any abnormality of the parathyroid glands (the glands that control blood
        calcium), currently pregnant or planning a pregnancy, currently breast feeding, and other
        criteria may apply.
PreHospital Air Medical Plasma Trial
Condition: Hemmorhagic Shock During Air Medical Transport
MeSH terms: Shock
Intervention: infusion of 2 units of plasma
Intervention description: infusion of 2 units of plasma
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 523.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: hemmorhagic shock, plasma, air medical transport, randomized, multicenter

Summary:

      To determine the effect of the prehospital infusion during air transport of 2 units of AB
      plasma on 30 day mortality in patients with hemorrhagic shock as compared to conventional
      care.
    

Eligibility criteria:

        Inclusion Criteria: Hemorrhagic shock not responsive to crystalloid infusion -

        Exclusion Criteria: Isolated Fall, Cervical cord injury, prisoner, pregnant patient,
        traumatic arrest

        -
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Condition: Epilepsy, Benign Neonatal
MeSH terms: Seizures; Epilepsy, Benign Neonatal
Intervention: Phenobarbital Sodium Injection
Intervention description: The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose.
Intervention MeSH terms: Phenobarbital
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 34 Weeks
Maximum age: 44 Weeks
Healthy volunteers: No
Keywords: Neonatal Seizures; Phenobarbital; Anticonvulsants

Summary:

      This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of
      the administration of phenobarbital sodium injection in neonates who have suffered from
      electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse
      effects, including death, placebo-controlled studies are not appropriate for this population.
      This study is designed to show intravenous phenobarbital is effective at preventing
      subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower
      dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female neonates with a gestational age of ≥ 34 - ≤44 weeks admitted into the
             NICU with a high probability of developing seizures (e.g., HIE, stroke, intracerebral
             hemorrhage, central nervous system infection)

          -  Parental informed consent (in-person or remote consent)

          -  Undergoing continuous video electroencephalogram (cvEEG) monitoring

          -  Has evidence of electrographic seizure burden of at least 30 seconds/h

        Exclusion Criteria:

          -  Received anticonvulsant treatment, including phenobarbital, prior to randomization
             (with exception of lorazepam administered for sedation > 24 hours before enrollment)

          -  Strong suspicion or confirmed diagnosis of brain malformation, inborn error of
             metabolism genetic syndrome, or major congenial malformation prior to randomization

          -  Seizures responding to correction of hypoglycemia, hypocalcemia or any other metabolic
             disorder

          -  Death appears to be imminent as assessed by the NICU attending physician

          -  Is currently enrolled in another study assessing the same and/or similar
             primary/secondary endpoints with/without drug treatment.
Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
Condition: Moderate to Severe Convexity of Submental Fat; Safety; Efficacy
Intervention: ATX-101; Placebo
Intervention description: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Phosphate buffered saline placebo for injection
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 65 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objectives of this study are to explore the safety and efficacy of subcutaneous
      injections of Deoxycholic Acid relative to placebo, in the submental area of participants who
      are 65 to 75 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 65 to 75 years of age

          -  Stable Body Weight

          -  Dissatisfaction with the submental area expressed by participants

          -  Acceptable volume of submental fat graded by clinician

          -  BMI of ≤40.0 kg/m^2

          -  Signed informed consent (ICF)

          -  SMF rating of 2 or 3 by clinician and patient

        Exclusion Criteria:

          -  No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic
             agents)

          -  Absence of clinically significant health problems

          -  Anatomical features for which reduction in SMF may result in aesthetically
             unacceptable outcome, judged by clinician

          -  History of trauma associated with the chin or neck areas that in the judgment of the
             investigator may affect evaluation of safety or efficacy

          -  Body mass index of ≥40.0 kg/m^2
OTC Mouthpiece for Snoring
Condition: Snoring
MeSH terms: Snoring
Intervention: Zyppah Anti-snoring Appliance
Intervention description: Use of an OTC mouth guard at night to prevent snoring
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Patient serves as their own control
Masking: Double (Care Provider, Investigator)
Masking description: The data is compiled and analyzed by an outside, independent organization
Enrollment: 604.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Online patient registration to participate in clinical trial to test OTC mouthpiece that
      controls position of the tongue to reduce snoring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over 18 years of age

          -  Living in the United States

          -  Signing the Informed Consent Form

        Exclusion Criteria:

          -  Missing teeth (as the device won't be properly fitted)

          -  Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD,
             or a similar condition

          -  Poor dental health, such as severe gum disease, loose teeth, an abscess, mouth sores,
             or bleeding gums

          -  A dental implant placed within the last three months

          -  Diagnosed with a Temporomandibular joint condition (TMJ)

          -  Actively experiencing any mouth or jaw pain, including clenching of the teeth,
             grinding, or any other physical injury to the jaw or teeth

          -  Full dentures

          -  Braces

          -  Diagnosis of sleep apnea

          -  Less than 18 years of age
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Dapagliflozin; Placebo
Intervention description: 10 mg or 5 mg tablets given once daily, per oral use.; Placebo matching dapagliflozin 10 mg or 5 mg
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4304.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease (CKD); Cardiovascular Events (CV); Phase III outcome trial

Summary:

      The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and
      cardiovascular mortality in patients with chronic kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent prior to any study specific procedures

          -  Female or male aged ≥18 years at the time of consent

          -  eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1

          -  Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and
             ≤5000 mg/g at visit 1

          -  Stable, and for the patient maximum tolerated labelled daily dose, treatment with
             ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,

        Exclusion Criteria:

          -  Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis
             or ANCA-associated vasculitis

          -  Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for
             primary or secondary renal disease within 6 months prior to enrolment

          -  History of organ transplantation

          -  Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or
             previous intolerance of an SGLT2 inhibitor

          -  Type 1 diabetes mellitus

          -  New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of
             enrolment

          -  MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to
             enrolment
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Condition: Oral Mucositis
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Intervention: GC4419 90mg; Placebo
Intervention description: 60 minute IV infusion; 60 minute IV infusion
Intervention MeSH terms: Manganese; Avasopasem manganese
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: 455.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oral Mucositis; Superoxide Dismutase Mimetic; Cisplatin; Intensity-Modulated Radiation Therapy; Chemoradiation; OM; IMRT; Head and Neck Cancer; Squamous Cell Carcinoma; SCC; Oral Cavity; Oropharnyx; Mouth Sores; avasopasem mangenese

Summary:

      The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese)
      administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of
      radiation induced oral mucositis in patients who have been diagnosed with locally advanced,
      non-metastatic squamous cell carcinoma of the head and neck.
    

Eligibility criteria:

        Inclusion Criteria:

          -  squamous cell carcinoma of the head and neck

          -  treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy
             with a cumulative radiation dose of 60-72 Gy

          -  Treatment plan to receive standard cisplatin monotherapy

          -  Age 18 years or older

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Adequate hematologic, renal and liver function

          -  Negative serum pregnancy test

          -  Use of effective contraception

        Exclusion Criteria:

          -  Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands

          -  Metastatic disease

          -  Prior radiotherapy to the region of the study cancer or adjacent anatomical

          -  Prior induction chemotherapy

          -  Receiving any approved or investigational anti-cancer agent other than those provided
             for in this study

          -  Concurrent participation in another interventional clinical study

          -  Inability to eat soft solid food at baseline

          -  Malignant tumors other than HNC within the last 5 years

          -  Active infectious disease excluding oral candidiasis

          -  Presence of oral mucositis at baseline

          -  Known history of HIV or active hepatitis B/C

          -  Female patients who are pregnant or breastfeeding

          -  Known allergies or intolerance to cisplatin and similar platinum-containing compounds

          -  Requirement for concurrent treatment with nitrates or other drugs that may create a
             risk for a precipitous decrease in blood pressure
Study of DU-176b Aged 80 Years or Older
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Du-176b; placebo
Intervention description: DU-176b orally administered at a dose of 15 mg once daily.; Placebo orally administered once daily.
Intervention MeSH terms: Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 984.0
Sex: All
Minimum age: 80 Years
Healthy volunteers: No
Keywords: anticoagulants; DU-176b; edoxaban; factor Xa; oral; prevention; atrial fibrillation

Summary:

      The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with
      non-valvular NVAF aged 80 years or older who are ineligible for available oral
      anticoagulation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are
             ineligible for available oral anticoagulation therapy

        Exclusion Criteria:

          -  Patients with active bleeding

          -  Patients who have poorly controlled hypertension

          -  Patients who have liver dysfunction accompanied with disorder of blood coagulation
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.