bioihbjkbjnl/mcl2 huggingface dataset:
On Versus Off Pump Myocardial Revascularization Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Off-pump bypass surgery; On-pump bypass surgery
Intervention description: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally.; is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 411.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: off-pump; bypass; coronary artery surgery

Summary:

      Compare completeness and modality of revascularization, operative and postoperative results
      and 1 year clinical outcomes in unselected high risk patients referred for primary coronary
      artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery bypass
      graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pts candidate to a myocardial revascularization for any patter of coronary artery
             disease, ventricular dysfunction or any other co-morbidity

          -  EUROSCORE ≥ 6

          -  Pts who signed the Informed Consent

          -  Age ≥ 18 years

        Exclusion Criteria:

          -  Patients in cardiogenic shock requiring emergency surgery or preoperative intra-aortic
             balloon pump

          -  Patients requiring additional surgical procedures

          -  Porcelain Aorta

          -  Lack of informed consent
Varenicline Adjunctive Treatment in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Varenicline; Placebo
Intervention description: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks; Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Varenicline; Neurobiology; clinical trial; cognitive deficits; Schizophreniform Disorder

Summary:

      The principal aim of the project is to conduct an off-label adjunctive clinical trial
      evaluating varenicline as a treatment for core neurobiological and clinical deficits in
      schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-60

          -  DSM-IV Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform
             disorder

          -  Clinically stable with no change in antipsychotic medications and increase of daily
             dose for 4 weeks prior to enrollment

          -  Sufficient understanding of the study and risks (ESC score 10 or above)

        Exclusion Criteria:

          -  Major medical illness history including, but not limited to, history of heart attack,
             stroke, TIA (transient ischemic attack)

          -  History of organic brain disorders that may affect neurophysiological measurements,
             including seizure disorder, brain tumor, head injury with evidence of significant
             cognitive deterioration

          -  DSM-IV diagnosis of substance dependence within 6 months except nicotine and marijuana

          -  On nicotine replacement therapy (nicotine patch, gum, or nasal spray)

          -  Uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95)

          -  EKG of second or third degree atrioventricular (AV) block

          -  Renal insufficiency with estimated creatinine clearance <40 ml/min

          -  Women who have positive urine pregnancy tests

          -  Women who are pregnant, plan to become pregnant, or in breastfeeding
Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents
Condition: Dermatitis, Contact
MeSH terms: Dermatitis; Dermatitis, Contact
Intervention: T.R.U.E. Test
Intervention description: 48 hour application of 28 allergens and negative control
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: allergic; contact dermatitis; contact allergy; Type IV; Children; TRUE TEST

Summary:

      Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E.
      TEST allergens in children and adolescents ages 6-18.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms and history potentially consistent with allergic contact dermatitis based on
             symptoms and clinical history (i.e., subjects are visiting the clinic/physician to
             diagnose, treat or resolve this condition).

          -  Children and adolescents 6 to 18 years of age, and in general good health.

          -  Adolescent females 15 years of age or older (or with menarche) must consent to a urine
             pregnancy test; urine test results must be negative for study inclusion.

          -  Informed consent must be signed and understood by subject. If underage, informed
             consent must be signed and understood by parent or legal guardian, consistent with all
             institutional, local and national regulations.

        Exclusion Criteria:

          -  Topical corticosteroid treatment during the last 7 days on or near the test area.

          -  Systemic treatment with corticosteroids or other immunosuppressive during the last 7
             days.

          -  Subjects currently receiving (or received during the previous 3 weeks) other
             investigational drugs, treatments or devices, or participating in another clinical
             study.

          -  Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.

          -  Acute dermatitis outbreak or dermatitis on or near the test area on the back.

          -  Subjects unable to comply with activity restrictions (e.g., protecting test panels
             from excess moisture due to showering or vigorous activity).

          -  Subjects unable or unwilling to comply with multiple return visits.

          -  Female subjects 15 years of age (or with onset of menarche) and older unable to
             consent to a urine pregnancy test, or those with a positive pregnancy test.
Effect of Cequa™ in Subjects With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: CequaTM (Cyclosporine 0.09%) ophthalmic solution
Intervention description: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Intervention MeSH terms: Cyclosporine; Ophthalmic Solutions; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Keratoconjunctivitis Sicca; KCS; Dry eye

Summary:

      This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease,
      which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects with a history of bilateral dry eye disease for a period of at
             least 3 months.

          2. Aged of at least 18 years.

          3. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in
             an individual zone ≥2 as per National Eye Institute Grading Scale.

          4. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using
             visual analogue scale.

          5. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the
             Screening/Baseline visit

        Exclusion Criteria:

          1. Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less
             than 3 months prior to the Screening/Baseline visit.

          2. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.

          3. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either
             eye.

          4. Subjects who had already Use initiated any systemic or topical ocular medication.
Tissue Sealant Use in LASIK Enhancement Surgery
Condition: Epithelial Ingrowth
Intervention: Tissue sealant
Intervention description: Application of tissue sealant on eyes undergoing LASIK enhancement
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 21 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LASIK, Ingrowth, Tissue sealant

Summary:

      The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent
      epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects age 21 and older

          -  Subjects with healthy eyes

          -  Subjects who have previously undergone LASIK surgery

          -  Subjects with residual refractive error.

        Exclusion Criteria:

          -  Subjects under the age of 21.

          -  Subjects with excessively thin corneas.

          -  Subjects with topographic evidence of keratoconus.

          -  Subjects with ectatic eye disorders.

          -  Subjects with autoimmune diseases.

          -  Subjects who are pregnant or nursing.
Comparison of Wound Bed Establishment in Facial Burns
Condition: Burns
MeSH terms: Burns
Intervention: Enzymatic agent; Bacitracin
Intervention description: Enzymatic agent
Intervention MeSH terms: Bacitracin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Participants received both the test drug and the standard of care, one on each side of the face.
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Facial; Partial thickness

Summary:

      Forty percent of patients admitted to the contributing regional burn unit over a five month
      period received facial burns (n=14). The purpose of this study is to examine if the time
      until a granulation bed is well established can be decreased be using an enzymatic agent,
      when compared to a second standard ointment, for patients with partial-thickness facial
      burns. The current study will use a prospective, experimental study design in which each
      individual will be their own matched control. That is, each individual will receive both the
      experimental ointment (one-side of the face) and the standard ointment (other-side of the
      face). Outcomes measured will be the benefits (e.g., decreased in the time until granulation
      bed establishment) one ointment achieves in partial-thickness facial burns when compared to a
      second ointment. Exploratory analyses will examine the relationships among demographic
      variables, granulation bed establishment time, pain, anxiety, itching, and scarring. That is,
      testing whether the time until granulation establishment may be associated with an
      individual's demographic variables, treatment type, pain, anxiety, itching levels, and
      scarring. Significance for all analysis will be at the 0.05 level. The investigators
      hypothesize that promoting rapid granulation bed establishment will decrease hospital length
      of stays, costs, risk of infection, and possibly associated appearance changes. The results
      from the current study will provide preliminary findings for a future, more sophisticated
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients (over the age of 18 years) admitted to the burn unit with a minimum of 1%
             partial-thickness burns each side of the face.

        Exclusion Criteria:

          -  patients with superficial or full-thickness facial burns;

          -  patients receiving facial grafts; patients with burns from chemical or contact
             sources;

          -  patients with wound infection;

          -  any patients starting treatment 24 hours after burn injury;

          -  patients with known sensitivity to either standard treatment; and

          -  any women by history who are pregnant or breast feeding.
Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin
Condition: Anticoagulants and Bleeding Disorders; Surgery; Regional Anesthesia Morbidity
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Intervention: Enoxaparin; Enoxaparin
Intervention description: The intervention is the implementation of a 36-hour time period from the last dose of treatment dose Enoxaparin to the blood sampling for anti-Xa testing.; This is the historical control arm. 24 hours removed from their last dose (time period from the last dose of treatment dose Enoxaparin to the blood sampling for anti-Xa testing)
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After consenting to the study, patients will be randomized to one of two groups.
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: enoxaparin; thromboembolism; coagulation; factor Xa

Summary:

      The main objective of this study is to determine the time interval following the last
      treatment dose of enoxaparin at which the amount of anti-Xa level activity is reliably less
      than 0.2 international unit per milliliter (IU/mL) in patients presenting for elective
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        Eligible patients need:

          -  to be on treatment dose (1mg/kg twice daily or 1.5mg/kg daily) enoxaparin at the time
             of presentation for elective surgery

          -  and must be able to accurately report the timing of their last dose and the
             administered dosage.

          -  Patients must also be between the ages of 18-100 years of age

          -  and must be able to give written consent to participate.

        Exclusion Criteria:

          -  Patients with severe renal insufficiency (creatinine clearance <30ml/min) will be
             excluded from the study, as the elimination of enoxaparin is known to be affected in
             this patient population.

          -  Pregnant patients will also be excluded, as the elimination and metabolism of
             enoxaparin is known to be altered in this patient population, and dose adjustments are
             recommended if treatment dose enoxaparin is used during pregnancy.

          -  Patients who are receiving enoxaparin as a bridge from another anti-Xa inhibiting
             medication will be excluded as this could unpredictably affect the results of anti-Xa
             testing. These medications include: Apixaban, Edoxaban, Fondaparinux, and Xarelto.
Enamel Remineralization Potential of Dentifrices in Situ
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: NaF; SnF; NaMFP
Intervention description: Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.; Fluoride toothpaste containing stannous fluoride (1100 ppmF); Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Enamel remineralization; Fluoride; caries

Summary:

      This study will use an oral in-situ caries model to study remineralization of enamel due to
      the action of different combinations of fluoride salts delivered from dentifrices.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Good general health with (in the opinion of the investigator) no clinically
             significant and relevant abnormalities of medical or oral health.

          -  No current active caries or periodontal disease that may compromise the study or
             health of the subject.

          -  All restorations in a good state of repair

          -  Currently wearing a removable mandibular partial denture with sufficient room in the
             posterior buccal flange area to accomodate two enamel specimens required dimensions 12
             x 7 mm.

          -  Willing to have their denture modified to accomodate enamel test specimens

          -  Willing and capable of wearing removable mandibular partial dentures 24 hours per day
             during the treatment periods.

          -  Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate
             greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate
             greater than or equal to 0.8 mL/minute.

        Exclusion Criteria:

          -  Individuals currently taking antibiotics, or who have taken antibiotics within 30 days
             prior to the first treatment visit.

          -  Current active caries or periodontal disease that may compromise the study or health
             of the subject.
RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
Condition: Contraception
Intervention: Copper IUD; Levonorgestrel IUD
Intervention description: Randomization to copper/Paragard IUD for emergency contraception; Randomization to Levonorgestrel/Mirena IUD for emergency contraception
Intervention MeSH terms: Copper; Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 711.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Emergency contraception; Levonorgestrel IUD; Copper IUD

Summary:

      This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the
      most effective method of emergency contraception vs. the levonorgestrel IUD, the most
      preferred IUD which has never been tested as an emergency contraceptive. This research has
      the potential to increase use of highly effective contraception in a high-risk population and
      lower the persistently elevated rate of U.S. unintended pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females between 18-35 years old

          -  In need of EC (had unprotected intercourse within 120 hours - 5 days)

          -  Desire to prevent pregnancy for 1 year

          -  Fluent in English and/or Spanish

          -  Have a regular menstrual cycle (21-35 days)

          -  Know their last menstrual period (+/-3 days)

          -  Be willing to comply with the study requirements

          -  Desire to initiate an IUD

          -  Negative urine pregnancy test

        Exclusion Criteria:

          -  Current pregnancy

          -  Breastfeeding

          -  Intrauterine infection within the past three months

          -  Sterilization

          -  Already have an IUD or contraception implant (Nexplanon) in place

          -  Vaginal bleeding of unknown etiology

          -  Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully
             treated at least 7 days prior to study entry)

          -  Known abnormalities of the uterus that distort the uterine cavity

          -  Allergy to copper

          -  Use of oral Emergency Contraception in the preceeding 5 days
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Condition: Femoral Fractures
MeSH terms: Hemorrhage; Fractures, Bone; Femoral Fractures
Intervention: Tranexamic Acid plus standard of care; Standard of care
Intervention description: Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + Standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss); Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Tranexamic Acid; Blood Loss; Long Bone Fracture Surgery

Summary:

      Tranexamic acid has been shown to reduce postoperative blood losses and transfusion
      requirements in a number of types of surgery. Most trials in orthopedic surgery have been
      conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the
      effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture
      surgery, primarily fracture shaft of femur.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient undergoing surgery for fracture shaft of femur

        Exclusion Criteria:

          -  Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia

          -  Patients with known coagulopathy

          -  Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit <24%)

          -  Patients with documented DVT or PE at screening or in past three months

          -  Patients having known hypersensitivity to tranexamic acid or any other constituent of
             the product

          -  Patients with any associated major illness (e.g., severe cardiac or respiratory
             disease)

          -  Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein
             thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or
             completed within last week