bioihbjkbjnl/mcl2 huggingface dataset:
Comparing a Virtual vs. Face to Face Weight Management Program Using Phentermine for Patients With Overweight or Obesity
Condition: Obesity
MeSH terms: Obesity; Overweight
Intervention: Phentermine 37.5 Mg; Dietary program; Exercise program
Intervention description: Patients will receive 37.5 mg of phentermine daily for a 12 week duration; Patients will be able to select either the Mediterranean diet or the Ketogenic diet and will work with a dietician; Patients will be provided with a personalized exercise program
Intervention MeSH terms: Phentermine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Single-center, Parallel-group trial comparing the use of virtual visit for prescription of phentermine versus standard face-to-face visits for weight management
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will study the effects associated with the prescription of phentermine in a
      virtual setting, comparing with prescription of phentermine via a standard face-to-face visit
      for patients with obesity or overweight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years old

          -  Body mass index (BMI) greater than or equal to 27 with 1 or more comorbidities
             (hypertension, diabetes, sleep apnea, fatty liver disease, PCOS, dyslipidemia,
             congestive heart failure, osteoarthritis) OR a BMI or 30 or greater

          -  Able to log into an online platform or have a smartphone

          -  Willing to join a virtual weight management program

        Exclusion Criteria:

          -  Contraindication for use of phentermine

          -  Female who is pregnant, breast-feeding, or intends to become pregnant or is of
             child-bearing potential and not using adequate contraceptive methods

          -  Participation in another clinical trial within 30 days of screening

          -  Cardiovascular disease including uncontrolled hypertension or history of arrhythmias

          -  Treatment with any medication with the intention of weight loss within 180 days before
             screening

          -  Use of Topiramate within 180 days of screening

          -  Previous history of bariatric surgery or use of minimally invasive weight loss devices
The Effects of Dexmedetomidine and Remifentanil on Carotid Patients
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis
Intervention: Remifentanil; Dexmedetomidine
Intervention description: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical; Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Carotid Endarterectomy patients

Summary:

      We propose to test whether intraoperative administration of dexmedetomidine will reduce
      hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic
      requirements in patients undergoing carotid endarterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consenting adult patients (age >50 years) undergoing carotid endarterectomy with
             general anesthesia.

        Exclusion Criteria:

          -  Receiving another alpha 2-adrenoreceptor agonist;

          -  Contraindication to dexmedetomidine, including allergy;

          -  Current hepatic disease (liver function tests > twice upper limit of normal);

          -  Renal insufficiency, as defined by a creatinine > 2.0 mg/dL;

          -  Mentally impairment, including dementia or delirium;

          -  Heart block ;

          -  Sick sinus syndrome;

          -  Atrial fibrillation with a low ventricular response (< 50 bpm);

          -  Absolute or relative hypovolemia;

          -  Prior stroke;

          -  Severe left-ventricular dysfunction
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Condition: Diabetes, Type 1; Diabetes, Type 2; Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: Bacitracin; AmeriGel®; Vitamin C
Intervention description: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.; Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.; Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve
Intervention MeSH terms: Ascorbic Acid; Bacitracin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adult

Summary:

      The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic
      wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health
      Care Corp., Clearwater, FL) and Bacitracin, with and without vitamin C supplementation, will
      be done to evaluate impact on time to wound closure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years of age

          -  Diabetic (Type I and Type II)

          -  Ulceration of the foot at least one centimeter in width/length

          -  Ulceration at least 0.2 centimeters in depth

        Exclusion Criteria:

          -  Ulceration width/length > 7.5 centimeters

          -  Wound depth > 1.25 centimeters

          -  Purulent, excessive drainage and/or other signs of infection (i.e. erythema, edema,
             warmth)

          -  Inability to provide informed consent

          -  Inability to swallow pills (vitamin C supplement)

          -  Patients with concurrent renal problems

          -  Patients with medication contraindications to Vitamin C and/or topical wound dressings
Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)
Condition: Infertility
MeSH terms: Infertility
Intervention: Lipiodol UF; Saline
Intervention description: Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter; Up to 10cc of saline will be infused via intrauterine catheter
Intervention MeSH terms: Ethiodized Oil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      Performing fluoroscopic HSG with oil based contrast medium has been shown to increase
      pregnancy rates in a subfertile population. This is a pilot study to test the efficacy of as
      well as the tolerability and safety of using lipid based oil medium for sonographic based
      hysterosalpingography (Sono HSG) compared to water based contrast (i.e. normal saline) for
      women seeking fertility. The double blind study will randomize 56 women at the time of Sono
      HSG in a 1:1 ratio to receive through the SHG catheter either up to 10 cc of Lipiodol UF® or
      normal saline. The investigators will collect subjective pain experience and follow the
      subjects for 6 months after the test for pregnancy and collect all adverse events during and
      after the procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible for Sono HSG for fertility testing

          -  In good general health

          -  Willing and capable of complying with the study procedures

          -  At least one patent tube and no endometrial pathology on Sono HSG

          -  Ready to undergo infertility treatment immediately after the test

          -  Not planning on IVF therapy in the next 6 mos

        Exclusion Criteria:

          -  Known tubal or endometrial (polyp, submucous fibroid, etc.) pathology

          -  At high risk for tubal disease due to history of Pelvic Inflammatory Disease

          -  Known hypersensitivity to Lipiodol UF®or known allergy to iodine containing contrast
             media or shellfish

          -  Endometrial pathology on Sono HSG requiring further evaluation (as per the performing
             physician)

          -  Bilateral tubal occlusion on Sono HSG

          -  Unable to tolerate potential pain associated with the study.

          -  Requiring IVF due to severe male factor, known pelvic adhesions, etc.

          -  Couples with decreased male factor fertility rate (i.e., low sperm count or motility,
             i.e. less than 5 million/mL concentration on semen analysis
Immune Monitoring to Facilitate Belatacept Monotherapy
Condition: Kidney Transplant Rejection; Immunosuppression
Intervention: Allosure; Immunosuppression reduction; Trugraf
Intervention description: Monthly monitoring of dd-cfDNA levels in blood; Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results; Monthly monitoring of Trugraf result
Intervention MeSH terms: Sirolimus; Prednisone; Everolimus; Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Prospective single-center, single-arm pilot study
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      -  To determine the utility of novel blood-based immune monitoring tools (Allosure and
           Trugraf) to facilitate belatacept monotherapy.

        -  To determine the percent of belatacept-treated renal transplant patients that can be
           safely converted to belatacept monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age minimum 18 years

          -  Written informed consent

          -  Single kidney transplant recipient (i.e. no combined organ transplants)

          -  Treated with de novo belatacept since transplantation (i.e. no previous use of
             calcineurin inhibitor or mTOR inhibitor for the current transplant)

          -  At least 1 year after transplantation or after initiation of belatacept

          -  Stable renal function (eGFR > 40 ml/min continuously during previous 6 months)

          -  Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA
             < 1%; for Trugraf this corresponds to "TX" signature)

          -  No history of BK viremia in current allograft

        Exclusion Criteria:

          -  History of biopsy-proven acute rejection

          -  Presence of donor-specific antibodies (at any MFI)

          -  Spot urine protein/creatinine ratio > 0.5 g/g
Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
Condition: Tourniquet Hypertension; Intraoperative Hypertension; Total Ankle Arthroplasty; Ankle Fusion
MeSH terms: Hypertension
Intervention: Mepivacaine; Perifemoral Injection of Local Anesthetic; Saline
Intervention description: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.; An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.; An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
Intervention MeSH terms: Anesthetics; Mepivacaine; Anesthetics, Local
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Perifemoral; Tourniquet; Mepivacaine; Tourniquet Hypertension

Summary:

      The purpose of this prospective randomized double-blind study is to determine if the novel
      technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral
      artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet
      time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be
      randomized 1:1 to receive either local anesthetic or saline, which will be injected
      superomedially to the femoral artery in an attempt to block sympathetic afferents and
      decrease tourniquet associated hypertension intraoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients that will be included in the study are English speaking 18-75 year old ASA 1-3
        patients undergoing total ankle arthroplasty.

        Exclusion Criteria:

          1. ASA 4 or 5

          2. Diagnosis of chronic pain

          3. Daily chronic opioid use (over 3 months of continuous opioid use).

          4. Inability to communicate pain scores or need for analgesia.

          5. Infection at the site of block placement

          6. Age under 18 years old or greater than 75 years old

          7. Pregnant women (as determined by standard of care day-of surgery urine bHCG)

          8. Intolerance/allergy to local anesthetics

          9. Weight <50 kg

         10. Suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

         11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the investigator, may interfere with study assessments or compliance.

         12. Current or historical evidence of any clinically significant disease or condition
             that, in the opinion of the investigator, may increase the risk of surgery or
             complicate the subject's postoperative course
Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Syntocinon (Oxytocin); Placebo (Physiological water (solution of sodium chloride (NaCl) in water))
Intervention description: Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray; Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Oxytocin; Autism Spectrum Disorders

Summary:

      The current trial aims to explore the neural and behavioral effects of oxytocin in autism
      spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and
      supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of
      complex social behaviors. Initial studies showed that intranasal administration of oxytocin
      can have a positive effect on social functioning in ASD.

      However, future studies are necessary to explore whether and how oxytocin effects neural
      processes in the brain underlying these behavioral improvements. This trial will not only
      measure behavioral enhancements, but will specifically focus on elucidating the associated
      neurophysiological changes by guiding the administration of oxytocin with regular
      neurophysiological assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Autism Spectrum Disorder, Asperger Syndrome or Autism

          -  Male

          -  Age between 18 and 40 years old

        Exclusion Criteria:

          -  Associated neuro(psycho)logical disorder (i.e. epilepsy, concussion, stroke)

          -  Eye sight worse than + or - 7

          -  Genetic syndrome

          -  Color blindness

          -  Any contraindication to neuroimaging research as assessed with the MRI screening list:

        MRI contraindications:

        pacemaker, implanted defibrillator, ear implant / a cochlear implant, insulin or implanted
        pump, a neurostimulator or VP shunt, any metallic object in the eyes (metallic fragments)
Methadone Versus Morphine for Orthopedic Surgery Patients
Condition: Fracture; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Methadone; Morphine
Intervention description: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation; Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Surgery, Orthopedic; Pain, Postoperative

Summary:

      The investigators propose to compare analgesia by methadone and ketamine with a combination
      of morphine and ketamine in orthopedic surgery patients with moderate to severe pain. The
      investigators hypothesize that when given with ketamine before surgical incision, methadone
      is more effective than morphine in reducing postoperative morphine consumption and reducing
      pain during movement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I-III

          -  Ages 18-65 years

          -  Presenting for lower extremity orthopedic surgery involving fracture of long bones at
             University of Louisville Hospital

          -  Surgery expected to last more than one hour

          -  Patient expected to have moderate to severe post-operative pain

          -  Patient refused regional anesthesia or has a contraindication to regional anesthesia

        Exclusion Criteria:

          -  Any known contraindications to methadone including hypothyroidism, Addison's disease,
             prostatic hypertrophy, or urethral stricture.

          -  Difficulty or inability to understand the study or protocol

          -  Known renal or hepatic dysfunction

          -  BMI> 35

          -  Known respiratory or cardiovascular problems, such as obstructive sleep apnea or
             oxygen saturation of less than 92% on room air

          -  Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme
             systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates,
             dexamethasone, and macrolide antibiotics.

          -  Pregnancy

          -  Taking preoperative opioids for more than 2 weeks before the surgery
Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty
Condition: Osteoarthritis; Acetaminophen; Arthroplasty, Hip Replacement
MeSH terms: Osteoarthritis
Intervention: Intravenous acetaminophen; Oral acetaminophen
Intervention description: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.; Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 56 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if intravenous acetaminophen is superior to oral
      acetaminophen when used as part of a multimodal pathway for primary total hip arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for elective, primary total hip replacement for osteoarthritis

          -  American Society of Anesthesiologists (ASA) Physical Classification I-III

          -  Weight 50 kg or greater

          -  Body mass index 18-40 kg/m2

        Exclusion Criteria:

          -  Inability to consent to study

          -  Inability to speak English

          -  Pregnancy

          -  Weight <50 kg

          -  Revision hip replacement or emergency surgery

          -  Contraindications to spinal anesthesia: coagulopathy or bleeding diathesis, local
             infection, allergy to local anesthetics

          -  Allergies/intolerances/contraindications to any of the multimodal agents:
             acetaminophen, pregabalin, celecoxib, ketamine, or dexamethasone

          -  Chronic pain from a separate source other than operative hip

          -  Daily opioid equivalent use of 30 mg of morphine or greater at time of consent

          -  History of heart failure

          -  History of drug or alcohol abuse

          -  Rheumatoid arthritis

          -  Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion
             of the investigator, may interfere with the study assessments

          -  Chronic malnutrition, renal or liver impairment

          -  Hypersensitivity to acetaminophen or any of its excipients