bioihbjkbjnl/mcl2 huggingface dataset:
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Condition: End Stage Renal Disease (ESRD)
MeSH terms: Kidney Failure, Chronic
Intervention: Mycophenolic Acid (Myfortic)
Intervention description: Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Kidney; Transplant; Corticosteroid; Myfortic

Summary:

      To determine the safety and efficacy of a new formulation of Myfortic in combination with
      tacrolimus and thymoglobulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 18 and 75 years of age.

          -  Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical
             living related donor renal transplant recipients.

        Exclusion Criteria:

          -  Patient previously received or is receiving an organ transplant other than kidney.

          -  Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.

          -  Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis
             B virus (HBV), or human immunodeficiency virus (HIV).

          -  Uncontrolled concomitant infection or other unstable medical condition.

          -  Patients that received an investigational drug in the 30 days prior to transplant.

          -  Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated
             mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.

          -  Receiving chronic steroid therapy at the time of transplant.

          -  History of malignancy in last 5 years.

          -  Pregnant or lactating.
Improving Driving in Young People With Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Buspirone
Intervention description: Buspirone is an atypical anxiolytic medication.
Intervention MeSH terms: Buspirone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 24 Years
Healthy volunteers: No
Keywords: Autism Spectrum Disorder; ASD; Anxiety

Summary:

      This study will examine the effects of treatment with the anti-anxiety medicine buspirone on
      driving performance (eye tracking) in individuals with high-functioning autism spectrum
      disorder (HF-ASD).

      The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as
      two Driving Simulation visits that will take place at Massachusetts Institute of Technology
      (MIT). Subjects will be given buspirone and asked to take the medication for the two days
      preceding the Driving Simulation Visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder

          -  Has a valid Driver's License

        Exclusion Criteria:

          -  Major sensorimotor handicaps (e.g. deafness, blindness)

          -  Individuals who have never held a valid driver's license

          -  Intellectual Deficiency (Verbal Comprehension Index < 80)

          -  Inadequate command of the English language

          -  Subjects with any clinically meaningful medical or psychiatric condition as determined
             by the investigator

          -  Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any
             reason

          -  Pregnant
Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
Condition: Chemotherapy-Induced Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Intervention: Pregabalin; Placebo
Intervention description: 150- 600 mg/day (double blind in divided doses); Placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pain; chemotherapy

Summary:

      Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral
      neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of cytological confirmed carcinoma of the Colon Stage III (Dukes C) or
             metastatic Colorectal Cancer (Dukes D)

          -  Independent of this protocol, the patient has decided to receive standard of care for
             the treatment of cancer with oxaliplatin combined with 5-fluorouracil/folinic acid
             (5-FU/FA) for a minimum of 9 cycles

        Exclusion Criteria:

          -  Presence of neuropathic pain or peripheral polyneuropathy or identified causes of
             painful paresthesia including radiotherapy-induced or malignant plexopathy, lumbar or
             cervical radiculopathy existing prior to baseline

          -  Any patients who are not suitable to be treated with either Oxaliplatin and/or 5-FU/FA
             or pregabalin according to the respective local labeling
Metformin in Insulin Resistant Left Ventricular (LV) Dysfunction (TAYSIDE Trial)
Condition: Congestive Heart Failure; Insulin Resistance
MeSH terms: Heart Failure; Insulin Resistance
Intervention: Metformin; Matched Placebo (Capsules)
Intervention description: Started at 500mg bd for 2 weeks. If well tolerated, increase to 1000mg bd for 14 weeks; Similar dosing regime as active comparator
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 25 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Heart Failure; Insulin Resistance; Metformin; Peak VO2

Summary:

      Will metformin improve exercise capacity in chronic heart failure patients who has insulin
      resistance (pre-diabetic- means before they become diabetic)?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 25-80 yrs with compensated CHF in NYHA functional I-III with evidence of
             insulin resistance [fasting insulin resistance index values of > 2.7 are said to have
             insulin resistance].

          -  Documented Left ventricular systolic dysfunction or LV ejection fraction < 35%

        Exclusion Criteria:

          -  Elderly patients (aged >80 yrs);

          -  Patients with decompensated CHF (NYHA functional class IV and /or signs of
             decompensated CHF);

          -  Renal dysfunction (serum creatinine > 160 mmol/L);

          -  Patients who are unable to exercise including patients that will be excluded for
             reasons of safety or potential effects on exercise performance. Therefore, patients
             with angina or other cardiac or pulmonary symptoms potentially limiting exercise
             performance will be excluded.

          -  Systolic blood pressure >190 mmHg at rest or >250 mmHg with exercise or diastolic
             blood pressure >95 mmHg at rest or >105 mmHg with exercise will also be a reason for
             exclusion;

          -  Patients with underlying disease likely to limit life span and/or increase risk of
             interventions will be excluded i.e., cancer; cardiovascular disease .i.e.,
             uncontrolled hypertension: SBP>180 mmHg or DBP, recent stroke, any severe chronic
             disease (including renal and hepatic disease).
Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries
Condition: Postpartum Sepsis; Postpartum Endometritis; Postpartum Fever
MeSH terms: Sepsis; Puerperal Infection; Endometritis
Intervention: Azithromycin; Azithromycin and amoxicillin; Placebo
Intervention description: Azithromycin tablet; azithromycin and amoxicillin; Placebo tablet
Intervention MeSH terms: Amoxicillin; Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 756.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon,
      Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or
      prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of
      azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal
      infectious outcomes and perinatal outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal
             delivery with

               1. Prolonged membrane rupture (≥8 hours) or

               2. Prolonged labor (≥18 hours).

        Exclusion Criteria:

          -  Clinical chorioamnionitis or any other active bacterial infection (e.g.
             pyelonephritis, pneumonia, abscess) at time of randomization: because standard
             antibiotic therapy for these conditions may confound trial intervention.

          -  Allergy to azithromycin or amoxicillin

          -  Plan for cesarean delivery prior to enrollment

          -  Fetal demise or major congenital anomaly: Major congenital anomalies may confound
             assessment of neonatal outcomes and every attempt will be made up front to exclude
             them from randomization. However, some unrecognized fetal anomalies may inevitably be
             randomized. These will not be excluded post-randomization from the primary (maternal
             outcome) analysis; they will be taken into consideration in the secondary analyses of
             neonatal outcomes.
A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira® Vaccine in Healthy Volunteers
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: CSL Influenza Vaccine
Intervention description: The study vaccine (CSL Influenza Vaccine) is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2012/2013 influenza season). The vaccine will be administered by intramuscular or subcutaneous injection.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to assess the immune (antibody) response and safety of the 2012/2013
      formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or
      older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 years or older at the time of vaccination.

          -  Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically
             sterile) must be abstinent or be willing to use a medically accepted contraceptive
             regimen for the duration of the study. Females of child-bearing potential must return
             a negative urine pregnancy test result prior to vaccination with the vaccine.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to
             eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the
             vaccine.

          -  Clinical signs of an active infection.

          -  A clinically significant medical condition.

          -  Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months
             preceding study entry.

          -  Females who are pregnant or lactating.
Study of EXPAREL in Patients Undergoing Breast Augmentation
Condition: Mammoplasty; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Instillation - EXPAREL; Infiltration - EXPAREL
Intervention description: Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.; IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Mammoplasty; Postoperative pain; Analgesia

Summary:

      This is a Phase 4, prospective, open-label, non-randomized, sequential study with two
      treatment groups differing only in the technique used for EXPAREL administration
      (instillation or infiltration).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female, 18-75 years of age inclusive.

          -  American Society of Anesthesiologists (ASA) physical status 1-3.

          -  Undergoing bilateral augmentation mammoplasty without any concurrent surgical
             procedure(s).

          -  Physically and mentally able to participate in the study and complete all study
             assessments.

          -  Able to give fully informed consent to participate in this study after demonstrating a
             good understanding of the risks and benefits of the study components.

        Exclusion Criteria:

          -  History of hypersensitivity or idiosyncratic reactions to amide-type local
             anesthetics.

          -  Any subject whose anatomy or surgical procedure might, in the opinion of the
             Investigator, preclude the potential successful local administration of EXPAREL.

          -  Subjects currently pregnant or who may become pregnant during the course of the study.

          -  Any subject who in the opinion of the Investigator might be harmed or be a poor
             candidate for participation in the study.

          -  Subjects who have received any investigational drug within 30 days prior to study drug
             administration, or planned administration of another investigational product or
             procedure during their participation in this study.
PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Intervention: 0.25 mg alprazolam; 1.0 mg alprazolam; placebo
Intervention description: 0.25 mg alprazolam PO (liquid) to be administered 1 hour prior to fMRI scan
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.; 1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.; Placebo (liquid) to be administered 1 hour prior to fMRI scan
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
Intervention MeSH terms: Alprazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: functional magnetic resonance imaging; fMRI; alprazolam; anxiety disorders

Summary:

      The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy
      controls to examine the acute effects of certain anxiolytic medications on brain function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, or female (not pregnant or intending to become pregnant during the study)

          -  Between the ages of 18-30.

          -  In good general health.

          -  No specific contraindications to the drug being administered

        Exclusion Criteria:

          -  Subjects with a history of DSM-IV depressive disorder, psychotic disorder, anxiety
             disorder

          -  Subjects who meet criteria for substance abuse or dependence within the last 6 months

          -  Subjects with an positive urine screen for illicit drugs

          -  having clinically significant abnormal laboratory, ECG or physical examination
             findings not resolved by the baseline visit

          -  Patients who have taken psychotropic drugs or antidepressants (including monoamine
             oxidase inhibitors, MAOI's) within the last year

          -  subject is left-handed.

          -  The subject suffers from claustrophobia, or phobia for injections or blood.

          -  Magnetic Resonance Imaging related exclusion criteria: cardiac pacemaker, metal
             fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal
             worker/welder; history of eye surgery/eyes washed out because of metal,
             aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid,
             heart valve replacement, subjects who are in the first trimester of pregnancy,
             subjects with an I.U.D. (birth control device), a shunt (ventricular or spinal),
             electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit).
Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Condition: Cataract; Aphakia
MeSH terms: Cataract; Aphakia
Intervention: Coaxial Micro-Incision Cataract Surgery; Coaxial Small Incision Cataract Surgery
Intervention description: 1.8 mm coaxial micro incision; 2.75 mm coaxial incision
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 36.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Ocular Surgery; Intraocular Lens

Summary:

      The objective of this study is to test the hypothesis that the time to reach a stable
      refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision
      compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision
      Enhancement System.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL)
             implantation for the correction of aphakia.

          -  Subject's ocular media must be clear except for the presence of the cataract in both
             eyes.

        Exclusion Criteria:

          -  Subject with any disease, which, in the Investigator's opinion, might interfere with
             the conduct of the study.
Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size
Condition: STEMI - ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: Cangrelor
Intervention description: Cangrelor 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion prior to PCI will be given. It will be continued for ≥ 2 hours or for the duration of the procedure, whichever is longer.
Intervention MeSH terms: Cangrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in
      patients with ST-elevation myocardial infarction randomized to receive cangrelor during their
      percutaneous coronary intervention and compares them to patients randomized to not receive
      cangrelor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with an acute STEMI with the University of Kentucky as the institution of
             presentation with plans for PCI

          -  English-speaking

        Exclusion Criteria:

          -  Pregnant patients

          -  Prisoners

          -  Patients who are unable to provide his/her own consent

          -  Patients with a prior history of myocardial infarction

          -  Patients who have received thrombolytics

          -  Patients on systemic anticoagulation

          -  Patients who are hemodynamically unstable with evidence of shock

          -  Patients who are mechanically intubated

          -  Patients with devices not MRI compatible

          -  Patients with chronic kidney disease, glomerular filtration rate less than 30

          -  Patients who are already on dual antiplatelet therapy