bioihbjkbjnl/mcl2 huggingface dataset:
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
Condition: Cardiac Amyloidosis
MeSH terms: Amyloidosis
Intervention: F-18 florbetapir
Intervention description: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: F-18 florbetapir; Amyvid; PET scan; Early detection

Summary:

      The investigators postulate that F-18 florbetapir will show improved detection of cardiac
      amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis

          2. Patients with a ratio of affected to unaffected free light chains >5 or free light
             chain difference of >50

        Exclusion Criteria:

          1. Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall
             thickness ≥ 13mm

          2. Contraindication to florbetapir or its components

          3. Refusal to participate in the study
Pharmacokinetics of Voriconazole in Obese Subjects
Condition: Healthy
Intervention: Voriconazole low dose; Voriconazole high dose
Intervention description: Voriconazole 400 mg po x 2 doses (loading dose)then 200 mg po twice daily x 7 doses; Voriconazole 400 mg po x 2 doses (loading dose)then 300 mg po twice daily x 7 doses
Intervention MeSH terms: Voriconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Voriconazole; Pharmacokinetics; Obese; Healthy Volunteer

Summary:

      Obese subjects may require a higher fixed oral maintenance dosing regimen of voriconazole
      compared to normal weight subjects to achieve comparable plasma exposures. The current study
      is designed to address this issue.
    

Eligibility criteria:

        Inclusion Criteria:

          1. males and females, 18 to 50 years of age;

          2. non-smoking or light-smoking (≤5 cigarettes per day) volunteers;

          3. BMI ≥ 35 kg/m2;

          4. female subjects of childbearing potential either surgically sterilized, using an
             effective method of contraception (diaphragm, cervical cap, condom) or agree to
             abstain from sex from time of prestudy screening, during entire study period and 1
             week following the study period.

        Exclusion Criteria:

          1. History of significant hypersensitivity reaction or intolerance to voriconazole,
             fluconazole,itraconazole, posaconazole, or ketoconazole ;

          2. history of significant clinical illness requiring pharmacological management;

          3. abnormal serum electrolyte or complete blood count requiring further clinical work-up;

          4. transaminases (AST or ALT) >2.5 x upper limit of normal;

          5. estimated creatinine clearance <50 mL/min (Cockcroft-Gault equation);

          6. positive urine pregnancy test (if female);

          7. abnormal electrocardiogram (ECG) as judged by study physician;

          8. unable to tolerate venipuncture and multiple blood draws;

          9. clinically significant abnormal physical examination defined as a physical finding
             requiring further clinical work-up.
Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren/Amlodipine; Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)
Intervention description: Amlodipine capsule (5 mg)
Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg); Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)
HCTZ capsule (12.5 mg, 25mg)
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 412.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; Aliskiren; Amlodipine; HCTZ; Systolic blood pressure; Diastolic blood pressure; Stage II; Combination

Summary:

      The purpose of the study is to compare the combination of aliskiren, amlodipine and
      Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in
      minority Stage 2 hypertensive patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are newly diagnosed or have a history of hypertension, who are eligible
             and able to participate in the study, and who give written informed consent before any
             assessment is performed.

          -  Men or women 18 years and older of minority background; self-identified.

          -  Patients with stage 2 hypertension defined as MSSBP ≥160 mmHg and <200 mmHg at Visit 5
             (randomization).

        Exclusion Criteria:

          -  Patients with MSDBP ≥110 mmHg and/or MSSBP ≥200 mmHg as measured by office cuff at any
             visit.

          -  Patients on 4 or more antihypertensive medications.

          -  Patients with uncontrolled hypertension (MSSBP >180 mmHg) taking more than 1
             antihypertensive medication at Visit 1.
Brain Effects of Opiate Agonist and Antagonist
Condition: Chronic Low-back Pain
MeSH terms: Low Back Pain
Intervention: Morphine
Intervention description: 30 mg oral tablet
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will look at the short-term effect of morphine on brain response to food.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants

          -  Patients in pain: suffering from persistent pain more days than not, 3/10 in intensity
             on a numerical rating scale, for at least 6 weeks or more.

        Exclusion Criteria:

          -  Any DSM diagnosis

          -  diabetes

          -  food allergies

          -  lactose intolerance

          -  participants seeking to quit smoking or to lose weight

          -  participants on any psychotropic medication including opiate based analgesics (e.g.
             oxycodone, methadone, suboxone)

          -  pregnant or nursing women

          -  pacemaker or other implanted electrical devices

          -  Participants with a past history of head trauma or seizures

          -  Any past history of illegal drug or alcohol misuse

          -  Participants who cannot undergo an MRI scan.
Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Intervention: Quantitative POC TSH Kit; Qualitative POC TSH Kit; Third generation TSH Kit
Intervention description: A drop (approximately 30 microliter [mcL]) of blood will be taken from subject's fingertip to test TSH quantitatively by using the quantitative POC TSH test kit according to the product specification on Day 1 to Day 5.; A drop (approximately 30 mcL) of blood will be taken from subject's fingertip to test TSH qualitatively by using the qualitative POC TSH test kit according to the product specification on Day 1 to Day 5.; One milliliter (mL) of subject's venous blood will be taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit on Day 1 to Day 5.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 283.0
Sex: All
Healthy volunteers: No
Keywords: Hypothyroidism; Third generation TSH kit; Quantitative POC TSH kit; Qualitative POC TSH kit

Summary:

      This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled
      subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and
      the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at
      the same time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suspected hypothyroidism subject

          -  Willing to comply with the trial protocol

          -  Signed informed consent document

        Exclusion Criteria:

          -  Menstrual period, bleeding hemorrhoids, hematuria

          -  Drinking or taking aspirin within 48 hours

          -  Subjects with partially or completely restricted consciousness and behavioral ability,
             who do not have independent decision-making ability.

          -  Subjects who are unwilling or unable to complete the trial

          -  Subjects who do not sign informed consent form
24-hour IOP-lowering Effect of Brimonidine 0.1%
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: brimonidine 0.1% (Alphagan® P)
Intervention description: Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in
      patients with glaucoma or ocular hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with open-angle glaucoma or ocular hypertension

        Exclusion Criteria:

          -  allergy to brimonidine

          -  inability to complete 24 hour stay for monitoring
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy
Condition: Dexamethasone; Glucocorticoids; Mastectomy; Breast Cancer; Pain, Postoperative; Nausea and Vomiting, Postoperative; Steroid; Systemic Inflammatory Response Syndrome; Postoperative Complications
MeSH terms: Vomiting; Pain, Postoperative; Postoperative Complications; Systemic Inflammatory Response Syndrome; Postoperative Nausea and Vomiting
Intervention: Dexamethasone
Intervention description: pre-operative intravenous administration
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the effect of a single preoperative high-dose steroid
      injection on complications in the immediate postoperative phase after breast cancer surgery,
      with removal of the breast (mastectomy). Primary outcome is the proportion patients who
      require transfer to the post anaesthesia care unit (PACU) and the proportion that can be
      transferred directly to the ward. Secondary outcomes are organospecific complications in the
      postanesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first
      14 days and readmissions the first 30 days after surgery.

      The investigators hypothesize that the frequency of transfer to the PACU and organospecific
      complications will be lower among patients receiving high dose dexamethasone. The
      investigators hypothesize, that there will be no difference in wound infections, seroma or
      readmissions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  planned unilateral mastectomy with or without axillary dissection or sentinel node in
             the study period

          -  informed signed consent

        Exclusion Criteria:

          -  Chronic/ongoing use of glucocorticoids (except inhalation therapy)

          -  ongoing use of immunosuppressive therapy

          -  insulin dependent diabetes

          -  pregnancy/breastfeeding

          -  allergies toward study medication, or medication in a standard treatment

          -  contralateral surgery (lumpectomy/mastectomy) at time of mastectomy

          -  surgery cannot be performed
Below Knee DVT Study
Condition: Deep Vein Thrombosis (DVT); Blood Clots
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Low Dose Enoxaparin; High Dose Enoxaparin
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lovenox; enoxaparin; DVT

Summary:

      Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis
      or DVT), which can lead to death if those clots break off and migrate to the lungs. We know
      that if there is a blood clot in the large leg veins near the hips and in the thighs,
      treating these patients with high-doses of blood thinners reduces the risk of these deaths.

      It is unclear if treating blood clots in the calf with high doses of blood thinners is better
      than using low doses. In this study, after being diagnosed with a blood clot in the calf,
      patients will be treated with either low dose or high dose enoxaparin (Lovenox), a blood
      thinner. We will then see if low dose blood thinner has similar results as high dose blood
      thinner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over the age of 18 admitted to a trauma or general surgery service will be
             eligible

          -  Patients diagnosed with an isolated distal DVT

          -  Able to obtain informed consent

        Exclusion Criteria:

          -  Patients with a previous diagnosis of hypercoagulability

          -  Patients on chronic anticoagulation

          -  Patients with a history of heparin induced thrombocytopenia

          -  Patients have preexisting contraindications to anticoagulation

          -  Patients in renal failure requiring adjusted enoxaparin dosing

          -  Pregnant patients
Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Febuxostat; Placebo
Intervention MeSH terms: Febuxostat
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: uric acid; febuxostat; hypertension; intra-renal renin-angiotensin system; renal plasma flow; angiotensin II

Summary:

      In this study the investigators will recruit hypertensive subjects with higher than average
      uric acid levels to test the effect of lowering uric acid with febuxostat on several measures
      as listed below. This will be a randomized, double-blind, placebo-controlled, parallel group
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate hypertension. For purposes of this study, the investigators define
             mild to moderate hypertension as being on no more than 1-2 antihypertensive
             medications and blood pressure &lt;140 mm Hg systolic and &lt;90 mm Hg diastolic based
             on mean seated blood pressure at the screening visit in our clinic. For these visits,
             the investigators measure blood pressure using a Dinamap automatic oscillometric cuff
             while subjects are seated quietly. The subjects are left in a quiet room without
             speaking for 5 minutes initially. The Dinamap is started and the technician leaves the
             room and 3 blood pressures are obtained at intervals of 2 minutes. The investigators
             use the mean of last 2 blood pressures for classification purposes. This is the
             approach the investigators have used in several multicenter studies including HyperGEN
             and the NHLBI Family Heart Study.

          -  Age 18 to 60.

          -  Uric acid =5.8 mg/dl. This was the mean uric acid among hypertensives in our prior
             study.11 As renal plasma flow response to Ang II infusion decreased linearly with
             higher uric acid, the investigators felt that using higher than average uric acid will
             provide greater power.

        Exclusion Criteria:

          -  Severe or poorly controlled hypertension (treated blood pressure &gt;160 mm Hg
             systolic or &gt;100 mm Hg diastolic).

          -  Diabetes (type 1 or type 2).

          -  Estimated GFR &lt;60 ml/min.

          -  Persons unable stop all medications (including antihypertensives) other than stable
             doses of thyroxine or estrogen for at least 2 weeks.

          -  Secondary hypertension.

          -  Prior history of clinically diagnosed coronary artery disease or congestive heart
             failure.

          -  Taking uric acid lowering medication within 1 month of screening visit.
The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy
Condition: Pain
MeSH terms: Pain, Postoperative
Intervention: Acetaminophen; Placebo
Intervention description: Acetaminophen 1 g intravenous given at the beginning and end of surgery.; Placebo to match acetaminophen given at the beginning and end of surgery.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients selected for this study were being treated for Moyamoya disease and required two operations, scheduled 1-2 weeks apart. With random assignment, patients were administered 1 gram of intravenous acetaminophen at the beginning and end of surgery, and placebo during the other operation.
Masking: Double (Participant, Care Provider)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine the efficacy of IV acetaminophen when administered
      to neurosurgical patients at the beginning and end of their surgery. If the result is
      improved pain control with less opioid consumption postoperatively, then those patients may
      also experience less opioid related side effects such as nausea/vomiting, pruritus, and
      sedation. While numerous other studies have failed to show a benefit of IV acetaminophen
      after neurosurgical procedures, we are studying the administration of 1 g in two doses over
      the course of the operation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral
             external-carotid to internal-carotid bypass surgery to be done in two stages.

        Exclusion Criteria:

          -  Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone
             not able to provide informed consent.
Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Cystoscopic Fluid containing Neosporin G. U. Irrigant; Cystoscopy; Cystoscopic Fluid/Placebo
Intervention description: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL; Diagnostic cystoscopy performed during pelvic floor surgery; Normal saline cystoscopic fluid
Intervention MeSH terms: Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 242.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective
      gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative
      antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic
      medical therapies have been utilized to attempt to decrease this rate with little
      improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease
      postoperative UTIs. The investigators have designed a prospective randomized controlled study
      to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative
      urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult women at least 18 years of age

          -  Elective Female Pelvic Medicine and Reconstructive Surgery or Gynecologic Minimally
             Invasive surgeries including hysterectomy, suburethral sling, and pelvic organ
             prolapse repair that require cystoscopy.

        Exclusion Criteria:

          -  Surgeries that include: intradetrusor Botox, vaginal mesh excision, and fistula repair

          -  Pregnancy

          -  History of nephrolithiasis

          -  Allergy to study medications

          -  Congenital urogenital anomaly

          -  Neurogenic bladder