bioihbjkbjnl/mcl2 huggingface dataset:
Cannabinoids for Pain Control During Medical Abortion
Condition: Medical Abortion; Pain
Intervention: Dronabinol 5mg Cap; Placebo
Intervention description: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain; Subjects randomized to placebo and ibuprofen 800mg for pain
Intervention MeSH terms: Dronabinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: Female
Minimum age: 21 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Medical Abortion; Pain; Cannabis

Summary:

      The objective of this study is to determine if a synthetic cannabis derivative, dronabinol,
      in addition to ibuprofen, decreases maximum pain scores compared to ibuprofen and placebo in
      women undergoing medical abortion. Results of this study will help providers counsel patients
      regarding cannabis use during medical abortion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 21 years or older

          -  Consented for elective medical abortion

          -  Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound

          -  Able and willing to receive text messages via phone

          -  English speaking

          -  Able and willing to give informed consent and agree to the study terms

          -  Have assistance at home; no motor vehicle use while taking study medications

        Exclusion Criteria:

          -  Desires to continue pregnancy or currently breastfeeding

          -  Lack of access to cell phone and texting capabilities

          -  Prior participation in this study

          -  Early pregnancy failure

          -  Contraindications to the study medications: Marinol or marijuana derivatives, sesame
             oil, Ibuprofen

          -  Contraindications to medical abortion with Mifepristone or Misoprostol

          -  History of methadone, buprenorphine or heroin use within the last year

          -  History of a seizure disorder

          -  Used marijuana 5 or more days in the last week

          -  History of any adverse effects associated with prior use of recreational or medical
             marijuana products, or sensitivity/allergy to Marinol.
Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
Condition: Renal Transplant
Intervention: Tacrolimus
Intervention description: See description in arm/group sections
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Renal Transplant; Tacrolimus; UNC; Phase IV

Summary:

      Objective: Investigate the direct correlation of CYP3A5 genotype with tacrolimus trough
      levels and clinical outcomes. The primary endpoint of this study is to evaluate the
      proportion of patients reaching target levels (8-10 ng/mL) on Day 3 and Day 7 after kidney
      transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All new kidney transplant recipients aged 18 to 65 years who are admitted at UNC-CH
             and provided informed consent will be included in this study.

        Exclusion Criteria:

        - Patients will be excluded from participating in the study to receive genotype-guided
        tacrolimus dosing if he/she meets any of the exclusion criteria described below.

          -  Recipients who did not consent to participate in the study.

          -  Highly sensitized patients (ie, pretransplant T or B cell flow crossmatch positive)

          -  Recipients of ABO incompatible kidney transplant

          -  Recipients with preformed donor-specific antibodies (DSA)

          -  Human Leukocyte Antigen (HLA) identical kidney transplant

          -  Recipients of non-kidney transplant

          -  Recipients of repeat transplant if they are on immunosuppression at the time of
             transplant

          -  Patients using medications that have known pharmacokinetic (PK) drug interaction with
             tacrolimus

          -  Patients in whom tacrolimus therapy is contraindicated
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial
Condition: PCOS; Depression; Vitamin D Deficiency; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Vitamin D Deficiency; Depression; Depressive Disorder
Intervention: Metformin; Vitamin D
Intervention description: Oral medication daily; Oral medication daily
Intervention MeSH terms: Vitamin D; Cholecalciferol; Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PCOS; Depression; Vitamin D; Insulin Resistance; Anxiety; Quality of life; Mood disorders

Summary:

      Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in
      improving symptoms of depressed mood in polycystic ovary syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria)

          -  Vitamin D insufficiency (serum Vitamin D <30 ng/mL)

          -  Insulin resistance

          -  Mild or greater severity of depression by Beck Depression Inventory-II

        Exclusion Criteria:

          -  Current metformin use

          -  Vitamin D supplementation of > 50,000 IU following confirmation of Vitamin D
             insufficiency

          -  Insulin-dependent diabetes mellitus

          -  Pregnancy or breastfeeding

          -  Untreated hypothyroidism

          -  Current active substance abuse

          -  Other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data
Neuromuscular Blockade During Transurethral Resection of Bladder Cancer
Condition: Neuromuscular Blockade
MeSH terms: Urinary Bladder Neoplasms
Intervention: Rocuronium; Sugammadex
Intervention description: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.; Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the
      mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia
      for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the
      use of sugammadex as a reversal agent may be associated with better endoscopic surgical
      condition and recovery profile compared with moderate NMB during TURB.

      This study was designed to compare patients with deep neuromuscular blockade (NMB) with
      moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical
      condition and postoperative recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged more than 18 years

          -  American Society of Anesthesiologists (ASA) physical status I and II

          -  scheduled to undergo elective Transurethral resection of the bladder tumor (TURB)

        Exclusion Criteria:

          -  history of neuromuscular, renal, or hepatic disease

          -  a body mass index (BMI) of < 18.5 or > C 30.0 kg/m2

          -  treatment with drugs known to interfere with neuromuscular function
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Eslicarbazepine; Carbamazepine
Intervention description: Healthy adults will be titrated onto Eslicarbazepine Acetate (800mg daily) . After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.; Healthy adults will be titrated onto Carbamazepine (400 mg bid). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.
Intervention MeSH terms: Carbamazepine; Eslicarbazepine acetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Eslicarbazepine; Carbamazepine; cognition

Summary:

      Double-blind, randomized, two period crossover comparison of the cognitive and behavioral
      effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adults between the ages of 18 and 55 years old.

          2. Male or female

        Exclusion Criteria:

          1. Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic,
             neurologic, psychiatric, or renal disease or pregnancy.

          2. Presence or history of drug or alcohol abuse.

          3. The use of concomitant medications, which are known to affect ESL or Carbamazepine or
             the use of any concomitant medications that may alter cognitive function (see Section
             VII.E for a partial list).

          4. Use of oral contraceptive hormones or other medications that could be affected by ESL
             or Carbamazepine.

          5. Prior adverse reaction to or prior hypersensitivity to either study medication or to
             related compounds.

          6. Prior participation in studies involving anticonvulsant medications.

          7. Subjects who have received any investigational drug within the previous thirty days.

          8. Subjects with IQ < 70 as determined by the Peabody Picture Vocabulary Test.

          9. Presence of HLA B*1502 in subjects of Asian descent; this will be obtained at
             screening in subjects of Asian descent.
The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine
Condition: Headache
MeSH terms: Headache
Intervention: Prochlorperazine; Ketamine; Diphenhydramine; Ondansetron; Normal Saline
Intervention description: prochlorperazine 10 mg IV; Ketamine 0.3 mg/kg IV; Diphenhydromine 25 mg IV; Ondansetron 4 mg IV; Normal Saline 500 cc IV Bolus
Intervention MeSH terms: Diphenhydramine; Promethazine; Ketamine; Ondansetron; Prochlorperazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind Randomized Clinical Control Trial
Masking: Double (Participant, Care Provider)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Headache, Migraine

Summary:

      This study compares the efficacy of low dose Ketamine versus Compazine for the control of
      headache in patients presenting to the Emergency Department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 65 years

          -  Temperature < 100.4° F

          -  Diastolic Blood Pressure <104 mm Hg

          -  Normal neurological exam and mormal mental status

        Exclusion Criteria:

          -  Pregnant or breastfeeding.

          -  Meningeal signs are present

          -  Acute angle closure glaucoma is suspected.

          -  Head trauma within the previous two weeks

          -  Lumbar puncture within the previous two weeks

          -  Thunderclap onset of the headache

          -  Weight more than 150 kg or less than 40 kg.

          -  Known allergy to one of the study drugs.

          -  History of schizophrenia or bipolar disorder.

          -  History of intracranial hypertension.

          -  Is a prisoner

          -  Patient declined informed consent

          -  Non-English speaking patient.

          -  Attending provider excludes patient
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
Condition: Single Ventricle Heart Disease After Fontan Surgery
MeSH terms: Heart Diseases; Univentricular Heart
Intervention: Cardiac catheterization
Intervention description: All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 3 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Single ventricle; Fontan; Sildenafil; Pressure-Volume Loops

Summary:

      The study will investigate the cardiovascular effects of sildenafil on patients with Fontan
      circulation. Recent studies suggest that sildenafil may improve exercise in patients with
      Fontan circulation. However, why this occurs is not known. The study will used specialized
      catheters to measure pressure and volume. The measure of pressure and volume leads to more
      detailed analysis of heart function. Patients will receive either sugar pill or sildenafil
      prior to catheterization. It is believed that sildenafil will improve relaxation and
      contraction of the heart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of a congenital heart defect that leads to single ventricle physiology

          -  Previously performed Fontan surgery

        Exclusion Criteria:

          -  The use of phosphodiesterase type 5 (PDE5) inhibitors at the time of catheterization
             of within 1 month of catheterization

               -  Unstable arrhythmia at the time of catheterization

               -  History of unstable arrhythmia within 2 months of catheterization

               -  Venous, arterial or cardiac malformation that precludes the proper placement of a
                  microconductance catheter

               -  Allergy to sildenafil or previous significant adverse reaction to sildenafil
                  (e.g. hypotension)
Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain
Condition: Injections, Intravenous
Intervention: Lidocaine injection flushed; Lidocaine injection tourniquet
Intervention description: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.; Intravenous lidocaine: tourniquet
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, controlled trial of two methods of administering lidocaine prior to propofol injection
Masking: Single (Participant)
Masking description: The participant is not told which group they are randomized to. However, a tourniquet is applied in the experimental group, thus some subjects may reason that they are in the experimental group. The study coordinator is aware which group the subject is in.
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Propofol; lidocaine; pain

Summary:

      Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection
      of propofol to reduce the amount of pain during propofol injection. The investigators want to
      study if giving the lidocaine through the IV while the forearm on the same limb has a
      tourniquet applied to it to prevent "washing out" of the lidocaine prior to propofol
      injection helps reduce propofol injection pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any subject at North Carolina Baptist Hospital scheduled for a procedure in which they
             will receive propofol for sedation or anesthesia and will not be receiving any other
             medications prior to the propofol injection.

          -  Cases must be schedule to have a duration less than 60 minutes.

        Exclusion Criteria:

          -  Subjects are excluded if they cannot verbalize a rating of pain

          -  Subjects are excluded if they require intravenous medications prior to the study
             period
RCT Superior Hypogastric Block During LH
Condition: Hysterectomy
Intervention: Bupivacaine Hydrochloride 0.25% Injection Solution
Intervention description: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Patients will be blinded to the treatment arm; however, the surgeon will know if a patient has been randomized to receive the block during the hysterectomy.
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Laparoscopy; Superior hypogastric plexus block

Summary:

      The goal of this study is to assess the efficacy of a superior hypogastric plexus block
      (SHPB) for pain relief following a laparoscopic hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over age 18

          -  English Speaking

          -  Able to provide informed consent

          -  Undergoing laparoscopic hysterectomy for benign indications

        Exclusion Criteria:

          -  Planned laparotomy incision

          -  Planned procedure that requires dissection of the presacral space

          -  Allergy to block medication (s)

          -  Known or suspected malignancy

          -  Non-English speaker
Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution
Condition: Surgical Preparation of the Vagina
Intervention: Povidone-Iodine; 4% Chlorhexidine Gluconate
Intervention description: Patients will receive povidone iodine for the surgical preparation of the vagina.; Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
Masking: Single (Participant)
Masking description: Patients will be randomized to the control or intervention and not be told which antiseptic they received for the surgical preparation of the vagina.
Enrollment: 134.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4%
      isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical
      preparations of the vagina. Patients will be randomized to either control (povidone iodine)
      or experimental (chlorhexidine gluconate), and then be given a short survey prior to and
      immediately after surgery, and again 24-48 hours via phone asking them about the presence and
      severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or
      burning with urination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Undergoing hysteroscopy

          2. Gynecologic dilation & curettage

          3. Endometrial ablation

          4. Essure without concomitant laparoscopy

        Exclusion Criteria:

          1. Pregnant

          2. Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or
             anaphylaxis to chlorhexidine gluconate or povidone iodine.
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Intervention: Tacrolimus
Intervention description: dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary Nephrotic syndrome

Summary:

      To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the
      investigators designed this prospective study. The investigators will enroll 100 children
      with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated
      with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level
      between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies
      will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs,
      multivitamins and lipid-lowering agents.

      Follow-up is every second week for the first 4 weeks, then monthly. After initiation of
      tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Frequent relapse nephrotic syndrome

          -  steroid resistance nephrotic syndrome

        Exclusion Criteria:

          -  secondary nephrotic syndrome

          -  estimated glomerular filtration rate < 60 mL/min/1.73m2

          -  with active hepatitis