bioihbjkbjnl/mcl2 huggingface dataset:
Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
Condition: Type 2 Diabetes Mellitus; Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: iobitridol; gadoterate meglumine
Intervention description: Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.; Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 351.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study aimed to prospectively investigate the prevalence of myocardial scar on
      Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients
      with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery
      disease on Cardiac Computed Tomography Angiography (CCTA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with onset of type 2 diabetes occurred at age 30 years or older

          -  Patient between the ages of 50 and 75 years at enrolment time

          -  Patient with at least two identified cardiac risk factors who will undergo a CMR and a
             CCTA examinations to evaluate his/her coronary and cardiac status

        Exclusion Criteria:

          -  Patient with angina pectoris or chest discomfort

          -  Patient with stress test or invasive coronary angiography within the prior 3 years

          -  Patient with history of myocardial infarction, overt non compensated heart failure, or
             coronary revascularization

          -  Patient with hemodynamic instability.

          -  Patient with a contraindication or intolerance to Beta-Blocker administration
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Albuminuria
MeSH terms: Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Canagliflozin, 100 mg; Canagliflozin, 300 mg
Intervention description: One placebo capsule taken orally (by mouth) once daily for 156 weeks; One 100 mg capsule taken orally (by mouth) once daily; One 300 mg capsule taken orally (by mouth) once daily
Intervention MeSH terms: Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5813.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Albuminuria; Canagliflozin; Cardiovascular outcomes; Type 2 Diabetes Mellitus; T2DM; JNJ-28431754; Antihyperglycemic Agent

Summary:

      The purpose of this study is to assess the effect of canagliflozin compared to placebo on
      progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard
      care but with inadequate glycemic control and at elevated risk of cardiovascular events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of type 2 diabetes mellitus

          -  Must have inadequate diabetes control (as defined by glycosylated hemoglobin level
             >=7.0% to <=10.5% at screening)

          -  Greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or
             >= 50 yrs old with high risk of CV events

          -  Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy,
             or combination AHA therapy with any approved agent for the control of blood glucose
             levels.

        Exclusion Criteria

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell
             transplantation, or diabetes secondary to pancreatitis or pancreatectomy

          -  History of one or more severe hypoglycemic episode within 6 months before screening

          -  History of hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Ongoing, inadequately controlled thyroid disorder

          -  Renal disease that required treatment with immunosuppressive therapy or a history of
             chronic dialysis or renal transplant

          -  Myocardial infarction, unstable angina, revascularization procedure, or
             cerebrovascular accident within 3 months before screening.
Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
Condition: Contact Lens Discomfort; Dry Eye
MeSH terms: Dry Eye Syndromes
Intervention: Systane Complete
Intervention description: Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group will be randomized Systane Complete, and one group will be randomized to no treatment.
Masking: Double (Participant, Investigator)
Masking description: The patients who are randomized to Systane Complete will be masked to the brand of the artificial tears.
There will be a masked examiner who does not know the subject's study group.
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Artificial Tears; Systane Complete; Contact Lens Discomfort; Dry Eye; Daily Disposable Contact Lenses

Summary:

      Clinicians commonly use artificial tears off label for treating contact lens (CL) discomfort
      and the dry eye associated with CLs because new artificial tear formulations have the
      potential to outperform the available CL rewetting drops. While off-label, McDonald et al.
      have previously shown that using a common artificial tear, Systane Ultra, before and after CL
      use is an effective means for treating daily disposable CL wears who have CL discomfort.
      Recently, a new formulation of artificial tears, Systane Complete, was released to the
      market. Systane Complete is a unique formulation that has combined elements from both Systane
      Ultra (indicated for aqueous deficient dry eye) and Systane Balance (indicated for
      evaporative dry eye) to create an artificial tear with an indication for aqueous deficient,
      evaporative, and mixed (both aqueous deficient and evaporative) dry eye. Thus, the goal of
      this study is to determine in a randomized clinical trial if Systane Complete is able to
      effectively improve the symptoms of patients who have CL discomfort.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self-reported contact lens discomfort

          -  Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12

          -  Daily disposable contact lens wearer

          -  Best-corrected visual acuity of 20/30 or better

        Exclusion Criteria:

          -  All other contact lens types (e.g., currently wearing two week or monthly replacement
             contact lenses or hard contact lenses)

          -  Non-compliant daily disposable contact lens wearers (must regularly replace contact
             lenses daily)

          -  Systemic health conditions known to alter tear film physiology

          -  History of ocular surgery within the past 12 months

          -  History of severe ocular trauma, active ocular infection, or inflammation

          -  Currently using Accutane or eye medications

          -  Pregnant or breast feeding
Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Intervention: Colgate Cavity Protection toothpaste; Colgate Total toothpaste; Parodontax toothpaste
Intervention description: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.; 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste; 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
Intervention MeSH terms: Listerine; Sodium Fluoride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this randomized, single center, parallel clinical research study is to
      evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste,
      Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and
      dental plaque in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects, ages 18-70, inclusive.

          2. Availability for the six-month duration ofthe clinical research study.

          3. Good general health.

          4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).

          5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and
             Silness Gingival Index.

          6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein
             Plaque Index (Turesky Modification).

          7. Signed Informed Consent Form.

        Exclusion Criteria:

          1. Presence of orthodontic bands.

          2. Presence of partial removable dentures.

          3. Tumor(s) of the soft or hard tissues of the oral cavity.

          4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss
             of periodontal attachment or alveolar bone).

          5. Five or more carious lesions requiring immediate restorative treatment.

          6. Antibiotic use any time during the one month prior to entry into the study.

          7. Participation in any other clinical study or test panel within the one month prior to
             entry into the study.

          8. Dental prophylaxis during the past two weeks prior to baseline examinations.

          9. History of allergies to oral care/personal care consumer products or their
             ingredients.

         10. On any prescription medicines that might interfere with the study outcome.

         11. An existing medical condition which prohibits eating or drinking for periods up to 4
             hours.

         12. History of alcohol or drug abuse.

         13. Pregnant or lactating subjects.
Methylphenidate for Attention Problems After Pediatric TBI
Condition: Traumatic Brain Injury; TBI; ADHD
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Intervention: Methylphenidate; Placebo
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: TBI; traumatic brain injury; ADHD; methylphenidate; Concerta; attention problems

Summary:

      Traumatic Brain Injury (TBI) - methylphenidate treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between ages of 6-17

          -  Sustained Moderate to Severe TBI

          -  TBI occurred at least 6 months prior to beginning the study

          -  TBI occurred no earlier than 5 years of age

          -  Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or
             hyperactivity scale

        Exclusion Criteria:

          -  History of developmental disability or mental retardation

          -  Current active participation in ADHD-related behavioral intervention

          -  History of psychiatric condition requiring an inpatient admission in past 12 months

          -  Actively taking medications with a contraindication to Concerta that cannot be
             discontinued

          -  Current use of stimulant medication or ADHD specific medications that cannot be
             discontinued

          -  Non-blunt head injury

          -  Family history of arrhythmia

          -  Pregnancy
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
Condition: Osteoarthritis; Hip Arthropathy; Shoulder Arthropathy
MeSH terms: Joint Diseases
Intervention: Tranexamic acid (TXA); Normal saline
Intervention description: 1.5g of TXA in 100ml normal saline solution
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tranexamic acid (TXA)

Summary:

      The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in
      decreasing blood loss following both shoulder arthroplasty and primary total hip
      arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system
      within the body. The investigators hypothesize that topical application of TXA prior to
      closure reduces postoperative bleeding as measured by absolute changes in postoperative
      hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic
      acid may reduce the need for transfusions, the rates of hematomas, infections, and length of
      hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Shoulders: All adult patients over the age of 18 scheduled for a primary total
             arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion
             in the study.

        Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty
        will be eligible for inclusion in the study.

        Exclusion Criteria:

          -  allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy
             within 5 days of surgery, history of seizures, renal failure (creatine clearance
             <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or
             pulmonary embolism), significant cardiac history (myocardial infarction, angina,
             stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females
             and < 12g/dl in males).
Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
Condition: Forehead Rhytides; Forehead Wrinkles
Intervention: Botulinum toxin type A; 2.5% lidocaine/2.5% prilocaine; petrolatum ointment
Intervention description: Botulinum toxin type A will be administered to both sides; 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead; petrolatum ointment will be applied to one side of the forehead
Intervention MeSH terms: Lidocaine; Prilocaine; Petrolatum; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner.
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rhytides; Forehead Wrinkles

Summary:

      The purpose of this study is to determine whether there is a difference in clinical effect,
      duration of effect, level of discomfort and patient satisfaction in patients receiving
      topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to
      Botulinum Toxin Type A administration for the treatment of forehead rhytides.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 65 years of age

          -  Presence of horizontal forehead rhytides

          -  Good eyebrow excursion (greater than or equal to 5 mm)

          -  Able to understand and sign an informed consent form that has been approved by the
             Committee for the Protection of Human Subjects

        Exclusion Criteria:

          -  Previous injection of botulinum toxin in the intended treatment area for the study
             within the last 4 months

          -  Known allergy to botulinum toxin

          -  Known history of sensitivity to local anesthetics of the amide type

          -  Existing disorder of neuromuscular transmission

          -  Usage of medication with effect on neuromuscular function

          -  Women of childbearing potential (who are not postmenopausal for at least 1 year or
             surgically sterile), who are pregnant or nursing or intend to become pregnant during
             the time of the study

          -  Significant brow asymmetry (> 5mm)

          -  Unable to follow-up for the duration of the study (16 weeks)
Immunologic Response to FluMist vs. Flucelvax
Condition: Influenza, Human; Immune Response
MeSH terms: Influenza, Human
Intervention: FluMist live attenuated influenza vaccine; Flucelvax inactivated influenza vaccine
Intervention description: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.; Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 465.0
Sex: All
Minimum age: 4 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate immunologic response to different types of influenza
      vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized
      controlled trial (RCT), that will assess immune response in about 440 participants (about 220
      per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine
      given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza
      vaccine).
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 4-21 years;

          -  has prior vaccination history available (which can be determined based either on
             medical record review or through state registry review);

          -  plans to receive the current seasonal influenza vaccination at one of the recruiting
             sites

        Exclusion Criteria:

          -  unable or unwilling to completed required study activities, including informed
             consent, randomization to vaccine, and bloodwork;

          -  has already received influenza vaccine for the current season;

          -  has a known immunocompromising condition or is on an immunosuppressing medication
             (e.g., high dose steroids >10 days);

          -  is known to be pregnant;

          -  has a history of severe allergy to eggs or to influenza vaccine or any of its
             components
Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
Condition: Plaque Psoriasis
MeSH terms: Psoriasis; Erythema Multiforme
Intervention: Clobex Spray
Intervention MeSH terms: Clobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the utility of a technological based rating scale for
      assessing improvement in plaque psoriasis with Clobex spray treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 years of age or older.

          -  Subjects with a board certified dermatologist clinical diagnosis of active moderate to
             severe psoriasis lesions affecting up to 20% of the body surface area at the baseline
             visit, and in the opinion of the investigator, is otherwise a good candidate for
             treatment with clobetasol propionate 0.05% spray.

          -  Subjects with a target lesion of at least 1 cm x 1 cm

          -  Subjects who agree to be photographed at each visit

        Exclusion Criteria:

          -  Subjects with any condition or presentation that may, in the opinion of the
             investigator, may put the subject at risk, may confound study results, or may
             interfere with participation in the study.

          -  Subjects with any known allergies to any of the ingredients listed on the test article
             label or surgical ink.

          -  Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast
             feed during the course of the trial.

          -  Subjects that are relatives of the investigator, or are themselves or a relative of
             any study staff or any Galderma employee.

          -  Subjects who have participated in an investigational study within 30 days of
             enrollment; participated in biologic investigational studies within 90 days of
             enrollment, or subjects planning to participate in any other interventional clinical
             research study while enrolled in this trial.