bioihbjkbjnl/mcl2 huggingface dataset:
Determine the Clinical Advantage of IV vs PO Acetaminophen
Condition: Inguinal Hernia
MeSH terms: Hernia, Inguinal
Intervention: Acetaminophen IV Soln; Oral Acetaminophen; Placebo Pills; Saline
Intervention description: 1000mg of IV acetaminophen; oral acetaminophen 975mg pills; placebo match to acetaminophen; Intravenous saline
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acetaminophen; Tylenol; Intravenous versus oral

Summary:

      There is limited research on the clinical outcome differences between intravenous (IV)
      acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen
      sometimes being almost 100 times the cost of PO acetaminophen, it is not only important
      fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The
      proposed research study is to determine the clinical advantages of IV vs PO acetaminophen
      during the post-operative recovery time for ambulatory surgery patients by analyzing
      differences in time to first opioid delivery, pain scores, and patient satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA scores I-III

          -  Ambulatory surgery patients

          -  Ages 18-75

          -  Surgeries requiring general anesthesia for hernia surgery

        Exclusion Criteria:

          -  Patients with contraindications to acetaminophen (history of end organ liver
             dysfunction)

          -  Known allergy to acetaminophen

          -  Emergency surgery

          -  Patients who were not fasted

          -  Patients who cannot tolerate PO

          -  Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen

          -  Pregnancy

          -  Weight less than 50kg

          -  Chronic daily narcotic use

          -  Patients who's anesthetic plan requires regional anesthesia

          -  Patient refusal to participate or do not have capacity to provide consent.
Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Weight Loss
Intervention: Promotora-led Intervention; Metformin Therapy; Usual Care
Intervention description: Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.; Participants in this group will receive metformin 850 mg bid for one year.; Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: Female
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The overarching goal of this project is to develop and test a behavioral intervention
      delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female gender

          -  Latino ethnicity

          -  Spanish fluency

          -  Age ≥20 years

          -  BMI ≥25 kg/m2

          -  And "increased risk of diabetes" (ADA Diabetes Risk Score ≥4 as determine by 7-item
             questionnaire and hemoglobin A1C ≥ 5.6%)

        Exclusion Criteria:

          -  Hemoglobin A1C ≥ 6.5%

          -  Current or planned pregnancy during the study period

          -  Chronic conditions that could affect potential participants' ability to participate
             (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily
             bronchodilator use, and severe psychiatric disease)

          -  Medical comorbidities that could influence weight loss or weight gain (thyroid
             disease, cancer, and HIV)

          -  Medications that could affect weight or glucose metabolism (thiazide diuretics,
             β-blockers, and systemic glucocorticoids).
Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Anti-hypertensive Medication -
Intervention description: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.
Dosing regimen either in the morning (between 06.00 and 11.00) or in the evening (between 18.00 and 23.00).
Intervention MeSH terms: Antihypertensive Agents; Calcium Channel Blockers; Angiotensin II; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Renin Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypertension

Summary:

      A randomised crossover trial of anti-hypertensive medication dosing regimen in effective
      blood pressure control.

      To investigate whether there is a difference in 24 hour blood pressure (BP) control when
      antihypertensive medications are taken in the morning compared with the evening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Caucasian patients aged 18-80 years;

          -  History of any grade of hypertension for at least 1 year, including at least 3 months
             of constant antihypertensive medication (consisting of ≥ 1 antihypertensive drugs,
             each administered in one dose daily), with reasonably controlled BP (≤150/90 mmHg and
             ≥ 115/75 mmHg on usual medication) based on previous clinic records, in the last 3
             months.

        Exclusion Criteria:

          -  BP levels > 150/90 mmHg or < 115/75 mmHg in the last 3 months.

          -  Postural hypotension, defined as symptoms resulting from a > 20 mm Hg drop of systolic
             BP or a > 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing
             from the sitting position.

          -  Known Extreme dippers at baseline (fall of mean night time SBP > 20% of mean day time
             SBP)

          -  Individuals with jobs which require night-time shift work.

          -  Pregnant women or those planning to become pregnant.
Adductor Canal Block for Medial Compartment Knee Arthroplasty
Condition: Postoperative Analgesia; Medial Unicompartmental Knee Arthroplasty
Intervention: Adductor canal block; Lumbar plexus block
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Partial knee replacement

Summary:

      This study will evaluate the affects of a single injection ultrasound-guided adductor canal
      block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee
      arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia
      provided by the adductor canal block with that provided by single injection lumbar plexus
      blockade. The working hypothesis is that the analgesia provided by the adductor canal block
      will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome
      will be a comparison of verbal numerical pain scores at rest and with movement over the first
      24 hours following nerve blockade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18-85

          -  Undergoing unilateral robotic-assisted (MAKOplasty) medial compartment knee
             arthroplasty at Wake Forest University Baptist Medical Center.

          -  Must give written informed consent for anesthesia including subarachnoid blockade and
             peripheral nerve blockade of both the lumbar plexus and adductor canal.

          -  Must consent to the performance of a sham block at the site to which they are not
             randomized.

          -  Must also be reliable to give accurate verbal pain scores postoperatively.

        Exclusion Criteria:

          -  Contraindication to adductor canal blockade or lumbar plexus blockade (including
             significant coagulation abnormalities)

          -  History of opioid addiction or current chronic pain therapy for pain other than at the
             surgical site that is being treated with high-dose opioids (extended release opioids
             or > 40mg oxycodone equivalents per day)

          -  Allergy to study medications

          -  Failure to adequately place either the adductor canal or lumbar plexus blocks.

          -  Patients who decline or have a contraindication to subarachnoid blockade will also be
             excluded from the study.

          -  Pregnancy.
Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics
Condition: Pain; Fever; Hepatotoxicity
Intervention: Acetaminophen
Intervention description: 2 x 500 mg by mouth once
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Although acetaminophen is the most commonly used nonprescription drug in the USA, little is
      known regarding the influence of genes and race/ethnicity on acetaminophen disposition. The
      investigators long-term goal is to understand the causes of differences in acetaminophen
      disposition between people that are the result of genetic variation and ethnicity and may
      predispose individuals to a higher risk of acetaminophen hepatotoxicity. The aim of this
      particular study is to measure the rate of elimination of acetaminophen via the 3 main
      pathways (glucuronidation, sulfation and oxidation) in self-identified White-Americans
      (n=100) and African-Americans (n=100). These rates will then be correlated with selected
      genetic polymorphisms in genes encoding enzymes involved in acetaminophen metabolism. Two
      main hypotheses will be tested: 1. African-Americans eliminate acetaminophen more rapidly by
      glucuronidation than do White-Americans. 2. Elimination via glucuronidation, sulfation, and
      oxidation in subjects will be significantly correlated with the presence of polymorphisms in
      the UGT1A6, SULT1A1, and CYP2E1 genes, respectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  self-declared white/Caucasian

          -  self-declared African-American

          -  active

          -  ambulatory

          -  no evidence of medical disease

        Exclusion Criteria:

          -  alcohol use of 3 or more drinks per day

          -  HIV or hepatitis (B or C) infection

          -  isoniazid

          -  disulfiram

          -  phenobarbital

          -  phenytoin

          -  carbamazepine

          -  rifampicin

          -  valproic acid

          -  probenecid

          -  St. John's Wort
Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)
Condition: Osteoporotic Fractures; Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Fractures, Bone; Osteoporotic Fractures
Intervention: Zoledronic acid; vitamin D; calcium; Saline
Intervention description: Annual intravenous 5.0 mg; 800 IU daily; approximately 1200 mg (dietary and supplement); Annual intravenous saline placebo
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 310.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Bone loss; Frail Geriatric Women; Nursing Home Patients; Long-term Care Patients; Osteoporosis; Osteoporotic Fractures

Summary:

      The goal of this study is to perform the first fracture reduction clinical trial with a
      potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term
      care population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women age ≥65 years including those using assistive devices to maximize
             generalizability if they:

               1. Reside in long-term care (LTC);

               2. Have:

                    -  osteoporosis by axial bone density (spine, hip or forearm bone mineral
                       density (BMD) T-score ≤ -2.5 SD); or

                    -  a previous adult fragility fracture of the spine or hip; or,

                    -  would be treated based on FRAX National Osteoporosis Foundation (NOF)
                       treatment thresholds of a 10 year risk of ≥ 20% for a major osteoporotic
                       fracture or ≥ 3% for hip fracture using femoral neck BMD.

        Exclusion Criteria:

          -  Men because osteoporosis is less common in men and our initial ZEST 1 study only
             included women.

          -  Institutionalized women with subacute illnesses surviving or discharged in < 3 years.

          -  Women currently on bisphosphonate, denosumab, or teriparatide therapy or who have been
             on a bisphosphonate for greater than 1 year during the previous 2 years because
             bisphosphonates are long acting.

          -  Patients with a calculated creatinine clearance < 35 ml/min or who have a
             contraindication for bisphosphonates (allergy, hypocalcemia).
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa
Condition: Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis
MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis
Intervention: TIS or TIP
Intervention description: 300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis, Pseudomonas aeruginosa, Lung Clearance Index, Multiple Breath Washout, Inhaled Tobramycin, Inhaled Antibiotics.

Summary:

      The purpose of the study was to evaluate lung clearance index (LCI) by a standardized
      procedure in a well characterized study setting and to assess feasibility of LCI as a more
      sensitive method than forced expiratory volume at 1 second (FEV1) to measure effectiveness of
      antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF

          -  Patients with elevated LCI of ≥ 7.5 at screening

          -  Patients with FEV1 of ≥ 50% predicted at screening

          -  Use of inhaled Tobramycin in a 28 days on / off regimen in the past 3 months before
             screening

          -  chronic lung Infection with Pseudomonas aeruginosa

        Exclusion Criteria:

          -  Patients who are regularly receiving more than one class of inhaled anti-pseudomonal
             antibiotic

          -  Patients who have used oral or intravenous anti-pseudomonal antibiotics within 28 days
             prior to on-phase of study drug

          -  Pregnant or nursing (lactating) women

          -  Change in dose, formulation or strength of the study drug in the past treatment cycle
             before screening

          -  History of hearing loss or chronic tinnitus

          -  Infection with Burkholderia cenocepacia complex

        Other protocol-defined inclusion/exclusion criteria may apply
Effects of Ranolazine and Exercise on Daily Physical Activity Trial
Condition: Chronic Stable Angina
MeSH terms: Angina, Stable
Intervention: Ranolazine; Aerobic Exercise; Placebo
Intervention description: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day; Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test); Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day
Intervention MeSH terms: Ranolazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Healthy volunteers: No

Summary:

      The primary objective is to assess whether the increased angina threshold on ranolazine and
      subsequent higher training intensity will result in improved exercise tolerance and oxygen
      consumption; and greater than that observed with exercise training on placebo. The study team
      anticipates the chronic exercise improvements with ranolazine will be incrementally higher
      than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key
      secondary objectives include the acute ranolazine and chronic exercise plus ranolazine
      effects on total daily energy expenditure (TDEE) and angina-related quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented CAD diagnosis

          -  Stable angina ≥ 3 months

        Exclusion Criteria:

          -  Class III or IV heart failure

          -  Myocardial Infarction or coronary revascularization procedure within 2 months

          -  QT interval > 500ms or prescribed medication known to prolong the QTc interval

          -  Contraindicated Medications

          -  Metformin dose > 1700mg/day

          -  Class Ia, Ic and III anti-arrhythmics

          -  CYP3A inhibitors

          -  Simvastatin >20mg/day

          -  Severe renal disease (< 30ml/min creatinine clearance)

          -  Currently on dialysis

          -  Lack of transportation to the exercise and testing facilities

          -  Implanted pacemaker that is not rate responsive
Nebulized Sub-dissociative Dose Ketamine for Treating Pain
Condition: Pain
Intervention: Ketamine 0.75 mg/kg; Ketamine 1.0 mg/kg; Ketamine 1.5 mg/kg
Intervention description: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg; Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg; Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      The investigators previous research study comparing the efficacy of intravenous ketamine to
      morphine showed ketamine to provide equivalent relief of moderate to severe acute pain in
      emergency department patients. A second study by the investigators showed that increasing the
      time of administration of the ketamine, from a push injection to a drip infusion, will
      minimize the adverse effects experienced by recipients of ketamine.

      The investigators now aim to see if nebulized subdissociative-dose ketamine administered as a
      single agent in a dose of 1.5 mg/kg via Breath-Actuated Nebulizers (BAN) over 5-15 minutes
      will provide a better pain relief in comparison to 1 mg/kg and 0.75 mg/kg doses or if the
      lower doses are equally as effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 and older

          -  acute and chronic abdominal, flank, back, musculoskeletal pain, and traumatic pain as
             well as cancer pain

          -  initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating
             scale.

        Exclusion Criteria:

          -  altered mental status,

          -  allergy to ketamine,

          -  weight greater than 150 kg,

          -  unstable vital signs (systolic blood pressure <90 or>180 mm Hg,

          -  pulse rate <50 or >150 beats/min,

          -  respiration rate <10 or >30 breaths/min)

          -  alcohol or drug abuse

          -  inability to provide consent

          -  psychiatric illness (schizophrenia),

          -  recent (4 hours before) opioid use.
Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Thrombosis
Intervention: Optison echocardiography contrast agent
Intervention description: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Atrial fibrillation; stroke; TEE; Left atrial thrombus

Summary:

      The investigators intend to determine if using Optison echocardiography contrast increases
      sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal
      echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo
      contrast.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 18 years old

          -  Cognitively sound and able to provide informed consent

          -  Indicated for TEE as a standard clinical procedure for evaluation of cardiac health
             status.

        Exclusion Criteria:

          -  Contraindicated for Optison administration

          -  Known right-to-left or bi-directional cardiac shunts

          -  Hypersensitivity to perflutren, blood, blood products or albumen

          -  Women who are pregnant

          -  Removal of Left Atrial Appendage

          -  Not able to provide informed consent