bioihbjkbjnl/mcl2 huggingface dataset:
Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole
Condition: Schizophrenia; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Schizophrenia
Intervention: Stayers; Switchers
Intervention description: Participants remain on their current antipsychotic.; Subjects are randomized to switch to aripiprazole from their current antipsychotic.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Schizophrenia; Obesity; Hyperglycemia; Dyslipidemia; Type 2 Diabetes Mellitus

Summary:

      This proposal aims to use well-validated methodologies such as dual energy x-ray
      absorptiometry (DEXA), frequently sampled oral glucose tolerance tests (fsOGTTs), and
      hyperinsulinemic euglycemic clamps to characterize the metabolic effects of 12 weeks of
      aripiprazole treatment following chronic pretreatment with olanzapine, quetiapine,
      risperidone or ziprasidone.

      We hypothesize that switching to aripiprazole treatment will induce improvements in total
      body adiposity, inflammation (e.g., high sensitivity C-reactive protein [hsCRP]), glucose
      metabolism (e.g., insulin sensitivity) and lipid metabolism (e.g., fasting plasma
      triglyceride), in comparison to chronic pretreatment with olanzapine, risperidone and
      quetiapine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets DSM-IV criteria for Schizophrenia

          -  18-60 years of age or older

          -  Able to give informed consent

          -  Treated with olanzapine, quetiapine, risperidone or ziprasidone for greater than or
             equal to 3 months prior to enrollment

        Exclusion Criteria:

          -  pregnant or breastfeeding women will be excluded

          -  Meets DSM-IV criteria for substance abuse or dependence within past 6 months

          -  involuntary legal status (as per Missouri law)

          -  any serious medical disorder that may confound assessment of symptoms

          -  subjects taking prescription medications except psychotropic meds

          -  meets DSM-IV criteria for Mental Retardation (mild or worse)

          -  Subjects taking tricyclic antidepressants or mood stabilizers
Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
Condition: Immunosuppression
Intervention: Tacrolimus; combination therapy
Intervention description: tacrolimus; MMF
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: immunosuppression; steroid withdrawal; rejection; coronary disease; cytomegalovirus infection

Summary:

      This was a study to compare less intense immunosuppression with a more traditional approach.
      The hypothesis was that less immunosuppression will provide similar protection against
      rejection than typical 2-3 drug therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (at least 18 years old)

          -  Undergoing a first heart transplant (no heart/kidney transplants), who receive their
             transplant at one of the study sites

          -  Specifically INCLUDED are patients on ventricular assist devices, and allosensitized
             recipients

        Exclusion Criteria:

          -  Age less than 18

          -  Inability to provide proper informed consent

          -  Combined organ transplantation

          -  Re-Transplantation
Effect of Topical Application of Iodex® Balm on Local Surface Temperature
Condition: Pain
Intervention: IODEX® balm; Placebo balm
Intervention description: 2 ± 0.2 g of test balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications.; 2 ± 0.2 g of placebo balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications.
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 35 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The rationale of this study is to map out changes in temperature distribution brought about
      by topical application of our test product, and use this physiological phenomenon to
      visualize the onset of action involved in overall mechanism of action of the product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants suffering from chronic osteoarthritis of knee joint (as per American
             College of Rheumatology criteria) for > 3 months

          -  Participants in good general and mental health with no clinically significant and
             relevant abnormalities of medical history or physical examination

        Exclusion Criteria:

          -  Women of child bearing potential, pregnant and lactating women

          -  Intolerance/hypersensitivity to study material/ingredient

          -  Recent history of alcohol or drug abuse

          -  Participants receiving topical non-steroidal antiinflammatory drugs (NSAIDs), other
             topical analgesics/counterirritants/mineral oils, or other medication, which might
             interfere with study results

          -  Participants having psoriasis/active atopic dermatitis/eczema/skin infected
             lesions/burn/wound at the site of application
Assess the Blood-Oxygen-Level-Dependent (BOLD) Signal Changes in the Brain by Paracetamol as Measured by Functional Magnetic Resonance Imaging (fMRI) in Subjects With Osteoarthritis (OA)
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Paracetamol; Placebo
Intervention description: 665 mg sustained release paracetamol caplets; Placebo caplets
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: osteoarthritis; pain; paracetamol; Blood-Oxygen-Level-Dependent functional magnetic resonance imaging

Summary:

      Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA
      knee following treatment with four consecutive doses (at 8 hour intervals) on giving
      sustained released paracetamol treatment or placebo will be compared. The fMRI and pain
      assessments will occur approximately 2-5 hours after taking the final dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of osteoarthritis of at least one knee for 3 months

          -  Male or female at least 45 years of age

          -  Score a minimum of 4 out of 10 on the numerical pain rating and a maximum of 8 at
             screening

        Exclusion Criteria:

          -  If female, is pregnant, lactating, or breast feeding

          -  Has secondary cause of knee arthritis

          -  Lower extremity surgery in the last 6 months

          -  Prior injury in the last twelve months to the index knee

          -  Used any analgesics (NSAIDs, COX2 inhibitor, etc) within 5 half lives of study start

          -  Recently used oral or injected glucocorticoids
Osteoarthritis Shoulder Injection Study
Condition: Glenohumeral Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Triamcinolone
Intervention description: Ultrasound guided glenohumeral shoulder joint injection
Intervention MeSH terms: Triamcinolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ultrasound guided injection

Summary:

      The purpose of this study is to determine the most effective intraarticular steroid dose for
      the treatment of glenohumeral osteoarthritis. The investigators aim to randomize patients
      into low, medium, and high dose groups of injectable corticosteroids as these doses are
      typically used in the standard of care for our patients. To date there has been no study to
      evaluate which dose is most efficient with the fewest side effects for glenohumeral
      osteoarthritis. The investigators objective will be to provide ultrasound guided
      intraarticular glenohumeral injections of these randomized concentrations and to evaluate
      pain and function before and following injection with the Shoulder Pain and Disability Index
      (SPADI). The investigators hypothesize that the low dose steroid will provide equivalent
      improvement of the pain and function to the medium and high doses, while minimizing side
      effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An X-ray within a year with Radiographic evidence of OA

          -  18 years of age or older

          -  Clinical diagnosis established due to symptoms that will include pain attributed to
             glenohumeral osteoarthritis, pain with range of motion, and/or functional limitations
             longer than 3 months.

        Exclusion Criteria:

          -  Previous guided steroid injection of the glenohumeral joint within 3 months

          -  Previous diagnosis of inflammatory arthritis, rotator cuff tear, or immunocompromised

          -  Previous shoulder surgery

          -  Allergy to steroid or lidocaine

          -  A Kellgren and Lawrence classification of 1 or less on radiograph

          -  Non-English Speaking

          -  Inability to provide informed consent
Dapagliflozin Effects on Epicardial Fat
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Metformin; Placebo
Intervention description: 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.; 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL; Placebo pill taken once daily to mimic Dapagliflozin
Intervention MeSH terms: Metformin; Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: epicardial fat; diabetes; dapagliflozin

Summary:

      The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on
      the fat of the heart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes, as defined by ADA criteria

          -  HbA1c < 8% measured at least 1 week prior to the study

          -  BMI ≥27 kg/m2

          -  Pre-treatment with Metformin as monotherapy

          -  Age > 18 and < 65 years old

          -  Normal and stable hemodynamic status

        Exclusion Criteria:

          -  Known contra-indications to Farxiga, in accordance with risks and safety information
             included in the latest updated Prescribing Information

          -  Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria

          -  Insulin dependent or treated type 2 diabetes

          -  Current use of other SGLT2 inhibitors, Glucagon Like Peptide -1 (GLP- 1) analogs or
             Dipeptidyl Peptidase 4 (DPP4) inhibitors

          -  Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2

          -  Signs or symptoms of hypovolemia

          -  Patients with poor glycemic control (HbA1c ≥ 8%) will be excluded to maximize
             long-term patient retention without need

          -  History of diabetes ketoacidosis

          -  Patients with active bladder cancer or with a prior history of bladder cancer

          -  Acute or chronic infective, including genital mycotic infections

          -  Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart
             failure

          -  Clinical or laboratory evidences of chronic active liver diseases

          -  Acute or chronic infective diseases

          -  Cancer or chemotherapy

          -  Current use of systemic corticosteroids or in the 3 months prior this study

          -  Known or suspected allergy to Dapagliflozin, excipients, or related products

          -  Pregnant, breast-feeding or the intention of becoming pregnant

          -  Females of childbearing potential who are not using adequate contraceptive methods
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2; Hypogonadism
Intervention: androgel; androgel 10g; placebo
Intervention description: androgel 5g; androgel 10g; placebo
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 49.0
Sex: Male
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: DM type 2; Hypogonadism; Testosterone; AndroGel

Summary:

      This is to study the effect of replacing testosterone on different inflammatory cells in type
      2 diabetics with low testosterone levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males with age 35-75 years inclusive.

          -  Evidence of hypogonadism: low free testosterone.

          -  Type 2 Diabetes

          -  People on stable doses of cholesterol lowering medications, blood pressure medications
             and multi-vitamins are allowed.

          -  If currently on testosterone replacement,testosterone treatment will be held for 8
             weeks.

          -  BP under control even if on medication.

        Exclusion Criteria:

          -  Coronary event or procedure in previous past 4 wks.

          -  High PSA

          -  H/O prostate cancer

          -  Hepatic or renal disease

          -  Participation in any other concurrent clinical trial

          -  Any other life- threatening , non cardiac disease.

          -  Uncontrolled BP

          -  Congestive heart failure

          -  High hemoglobin

          -  Use of investigational agent or therapeutic regimen within 30 days of study.
Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Bydureon; Placebo
Intervention description: Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.; Placebo
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared
      with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin > or = to
             1500mg/day as monotherapy for at least 8 weeks

          -  Hemoglobin A1c (HbA1c) 7% to 10% at screening

          -  Body mass index (BMI) < or = to 45 kg/m2

        Exclusion Criteria:

          -  History of taking antihyperglycemic therapy other than metformin or metformin extended
             release (XR) during the 8 weeks prior to screening

          -  History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12
             weeks prior to screening

          -  History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or
             during the study

          -  History of prescription or over the counter weight loss medication during 3 months
             prior to screening

          -  Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist
             during 6 months prior to screening
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
Condition: Renal Transplanted Recipients
Intervention: Everolimus (RAD001); Cyclosporine (Calcineurin Inhibitor (CNI)); Methylprednisone/prednisone; Mycophenolate sodium (MPA)
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Prednisone; Everolimus; Cyclosporins; Calcineurin Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Renal transplantation; everolimus; Immunosuppressants

Summary:

      The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation
      versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure
      cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium
      (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will
      be compared to a third control group, who will receive treatment consisting of cyclosporine
      micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.
    

Eligibility criteria:

        Inclusion criteria

          1. Males and females aged 18-65 years inclusive.

          2. First time recipients of cadaveric, living unrelated or living related donor kidney
             transplants.

          3. Patients who are willing and able to participate in the study and from whom written
             informed consent has been obtained.

        Exclusion criteria

          1. Patients who are recipients of multiple organ transplants, including more than one
             kidney, kidney and pancreas, or previous transplant with any organ other than kidney.

          2. Patients at high immunological risk of graft loss, indicated by peak PRA >50% or loss
             of a previous renal allograft within the first 6 months of transplantation due to
             acute rejection.

          3. Patients who have received an investigational drug within 4 weeks prior to the
             screening visit.

          4. Presence of any severe allergy or hypersensitivity to drugs similar to everolimus
             (e.g. antibiotics such as Clindamycin)

        Other protocol-defined inclusion/exclusion criteria may applied
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
Condition: Kidney Calculi; Urologic Diseases; Benign Prostatic Hypertrophy
MeSH terms: Urologic Diseases; Prostatic Hyperplasia; Kidney Calculi; Nephrolithiasis; Hypertrophy; Calculi
Intervention: Tranexamic acid
Intervention description: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Male
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      This study is designed to assess if there is a significant difference in same day discharge
      rates after Holmium Laser Enucleation of the Prostate (HoLEP). The investigators attempt to
      perform HoLEP as a same-day discharge (SDD) procedure, but at Northwestern Memorial, the SDD
      rate is currently approximately 60%. The limiting factor in SDD is hematuria. Tranexamic acid
      (TXA) is a clot promoting drug that is commonly used by orthopedic, cardiac and obstetric
      surgeons to prevent bleeding. The primary outcome will be to assess if there is a difference
      in SDD rates in those who receive TXA vs. those who do not.

      Secondary outcomes will assess bleeding complications (defined as unplanned ED visit/clinic
      visit/procedure/admission related to bleeding, clot retention, clot evacuation, need for
      perioperative transfusion) between participants who receive TXA vs. those do not. The study
      will also assess differences in perioperative complications associated with TXA including but
      not limited to: deep venous thrombosis, pulmonary embolism, cerebrovascular events, between
      the groups. The study will also assess for the duration of postoperative hematuria between
      groups as well as differences in operative times between the groups.

      The investigators anticipate that there may be up to a 25% increase in SDD rates in those who
      receive TXA vs. those who do not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males 18-89 undergoing HoLEP

          -  Willing to sign the Informed Consent Form

          -  Able to read, understand, and complete patient questionnaires, pain texts, and
             medication diary

        Exclusion Criteria:

          -  Allergy or hypersensitivity to TXA, history of acute venous or arterial thrombosis,
             intrinsic risk for thrombosis or thromboembolism, history of thromboembolic disease,
             hereditary thrombophilia, use of hormonal agents

          -  Patients having any additional simultaneous procedure other than a HoLEP
             (cystolitholapaxy allowed).

          -  Anticipated need for perineal urethrostomy at the time of HoLEP

          -  Patient not undergoing catheter removal and voiding trial at Northwestern Memorial
             Hospital