bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
Condition: Uncomplicated Bacterial Cystitis
MeSH terms: Cystitis
Intervention: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days; ciprofloxacin 250 mg BID x 3 days
Intervention MeSH terms: Ciprofloxacin; Nitrofurantoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of
      nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  pre-menopausal females

          -  ages 18-45 years old

          -  symptoms of a UTI (dysuria, frequency, urgency)

        Exclusion Criteria:

          -  Onset of symptoms >7 days prior to the ED visit

          -  Non-English speaking

          -  Symptoms of pyelonephritis

          -  Diabetic

          -  Indications of sepsis

          -  Immunocompromised

          -  Currently using prophylactic antimicrobials

          -  Medications that could interfere with study drug

          -  Pregnant

          -  Lactating

          -  History of kidney or liver disease

          -  Vaginal symptoms

          -  Presence of a urinary catheter

          -  Treatment for UBC <2 weeks prior to ED visit

          -  Known allergy to study drug

          -  Unavailable for follow-up
Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C
Condition: Chronic Kidney Disease; Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Viekira Pak ± ribavirin; Mavyret
Intervention description: 12 weeks treatment with AbbVie Viekira Pak ± ribavirin; 8 or 12 weeks treatment with AbbVie Mavyret
Intervention MeSH terms: Ribavirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This a single-arm study. Initially, Viekira Pak was available through Abbvie. However, once Mavyret became available, it supplanted Viekira Pak as the study medication.
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CKD; HCV

Summary:

      Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for
      adults with chronic kidney disease and hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥ 18 year of age

          2. HCV genotype 1 ≥ 1000 IU/mL

          3. 6. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi
             equation

        Exclusion Criteria:

          1. Pregnant or lactating females

          2. Uncontrolled depression or psychiatric disease

          3. History or presence of any form of cancer within 3 years of enrollment

          4. Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of
             rituximab, steroids or plasmapheresis.

          5. Uncontrolled cardiovascular or pulmonary disease

          6. Experiencing symptoms attributed to uremia

          7. Anticipated need to begin renal replacement therapy in the next 6 months

          8. History of kidney transplant
Lessons on Urethral Lidocaine in Urodynamics
Condition: Urethra Issue; Pelvic Organ Prolapse; Urinary Incontinence; Vaginal Vault Prolapse; Cystocele; Uterine Prolapse; Vaginal Prolapse; Pelvic Floor Disorders
MeSH terms: Urinary Incontinence; Pelvic Floor Disorders; Cystocele; Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Intervention: Water-Based Vaginal Lubricant; lidocaine topical
Intervention description: 5cc water based jelly applied intraurethral; 5cc 2% lidocaine jelly applied intraurethral
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 63.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts
      sensation during filling (i.e., a change of more than 25% of first sensation, first desire to
      void, strong desire to void, or maximum cystometric capacity) and determine whether the use
      of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics,
      and voiding metrics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients

          -  >18 years of age

          -  Already scheduled (or being scheduled) for UDS to assess urinary incontinence

          -  Able to speak and read in English

        Exclusion Criteria:

          -  Diagnosis of pelvic pain, interstitial cystitis, or bladder pain syndrome

          -  Known neurogenic disease impacting voiding/ continence (e.g., Parkinson disease,
             multiple sclerosis, myasthenia gravis, recent stroke)

          -  Active UTI

          -  Pelvic organ prolapse that is unable to be easily reduced

          -  Pregnancy or breastfeeding

          -  Allergy or hypersensitivity to lidocaine or local anesthetics
Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Ioversol 320 mgI/mL; Iodixanol 320 mgI/mL
Intervention description: 125 mL of Ioversol administered in the vein; 125 mL of Iodixanol administered in the vein
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal; Kidney; Contrast Induced Nephropathy

Summary:

      The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in
      subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed
      tomography.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18 years of age or older

          -  Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125
             mL)

          -  Subjects have an abnormal screening SCr that results in a calculated eGFR of < 60
             mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have
             been excluded

          -  Subjects have stable reduced renal function which is defined as an abnormal screening
             SCr measurement with a < 15% difference from the oldest historical SCr measurement
             obtained within the proceeding 1 week to 12 weeks

          -  Subjects must provide written consent and agree to abide by the site and study
             requirements

        Exclusion Criteria:

          -  Subjects previously entered into this study

          -  Subjects on dialysis

          -  Subjects received any investigational drug within 30 days of contrast administration
             or participated in an investigational study within 30 days prior to study enrollment

          -  Subjects have undergone a procedure using iodinated or gadolinium contrast agent
             within 7 days prior to contrast administration, or is scheduled to receive additional
             doses of contrast agents during the 48-72 hour post-study contrast administration

          -  Subjects in acute renal failure or have one or more known causes of acute renal
             failure

          -  Subjects have known or suspected unstable renal function

          -  Subjects scheduled for a surgical intervention or other procedure within 72 hours
             after the contrast administration

          -  Subjects taking NSAIDs (with the exception of ASA) and/or any type of diuretics who
             cannot discontinue these drugs post contrast administration and hold all subsequent
             doses until the 48-72 hour post contrast SCr has been drawn

          -  Subjects taking aminoglycosides

          -  Subjects known to have an organ transplantation

          -  Subjects have severe congestive heart failure (Class III-IV)
Clopidogrel Versus Ticagrelor in Type-2 Diabetes
Condition: Coronary Artery Disease; Diabetes Mellitus
MeSH terms: Coronary Artery Disease
Intervention: Ticagrelor; Clopidogrel; Standard medical therapy
Intervention description: Ticagrelor 90 mg twice daily; Clopidogrel 150 mg once daily; Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Healthy volunteers: No

Summary:

      CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study
      evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and
      platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with
      percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes mellitus

          -  stable coronary disease

          -  coronary revascularization with PCI at least 1 month prior to recruitment

        Exclusion Criteria:

          -  acute coronary syndrome

          -  platelet count <70x109/l

          -  active bleeding or bleeding diathesis

          -  history of intracranial bleeding

          -  gastrointestinal bleeding <6 months

          -  cerebrovascular accident <3 months

          -  history of malignancy

          -  concomitant need for oral anticoagulant therapy

          -  severe liver disease or chronic renal failure (glomerular filtration rate <30 ml/min
             /1.73m2)
Success of External Cephalic Version Study
Condition: External Cephalic Version
Intervention: Bupivacaine; Terbutaline
Intervention description: intrathecal bupivacaine 7.5 mg; 0.25 mg Terbutaline subcutaneously
Intervention MeSH terms: Bupivacaine; Terbutaline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: External Cephalic Version; neuraxial analgesia

Summary:

      The purpose of this study is to determine the best way to optimize the success of external
      cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is
      recommended because it may decrease the risk of needing a cesarean section for abnormal
      presentation. While the study team knows that this procedure can be effective, the study team
      still has some un-answered questions as to the best way to perform this procedure to increase
      the chance of success. Many prior studies have shown that using spinal anesthesia (a shot of
      medication placed in your back to numb and relax the abdomen) can increase the success rate
      of a version. This ultimately has led to the finding that using this anesthesia can decrease
      the rate of cesarean section. However, there have been only a small number of studies
      assessing the success rate if spinal anesthesia is used only in the event that without it
      fails. Therefore the study team is going to compare patients who receive spinal anesthesia
      with those who only receive spinal anesthesia if the procedure to turn the baby (ECV) fails
      without it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients included are those with singleton pregnancies of at least 37 weeks gestation
             in nonvertex presentation with no contraindication for a vaginal delivery.

          -  Membranes must be intact with a minimum of a 2x2 pocket and Category 1 non-stress
             test.

        Exclusion Criteria:

          -  All patients with a contraindication for a vaginal delivery will be excluded from the
             study.

          -  Patients with gross fetal anomalies or uterine malformations.

          -  Patients with contraindications to neuraxial anesthesia or allergies to any of the
             study medications will also be excluded.
Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Autoimmune Diseases
Intervention: Rituximab Infusion
Intervention description: Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion.
Intervention MeSH terms: Rituximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rapid Infusion Rituximab

Summary:

      The purpose of this study is to evaluate the impact of rapid infusion rituximab on the
      incidence of infusion-related reactions in patients with Autoimmune Diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autoimmune patient at Wake Forest Baptist Health that is eligible for rituximab
             therapy

          -  Tolerate the standard infusion rituximab with ≤ grade 2 hypersensitivity reaction

          -  Consent to participate in the rapid infusion study

          -  Age ≥ 18 years ≤ 80 years

        Exclusion Criteria:

          -  Tolerate the standard infusion rituximab with ≥ grade 3 hypersensitivity reaction

          -  Neurocognitive impairment (i.e. dementia, Alzheimers, et al)
Pain Management in Response to Exparel vs. Standard Bupivicaine
Condition: Pain
Intervention: Liposomal Bupivicaine; 0.25% standard bupivicaine
Intervention description: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.; standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Exparel; Thoracoscopy; Bupivicaine; Liposomal

Summary:

      This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on
      decreasing the amount of consumed pain medications.

      Patients will be randomly selected to received either Exparel or standard bupivicaine
      injection during surgery. Patients will be followed up to assess pain levels using a visual
      pain scale, and to assess how much pain medication was consumed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients over 18 years of age

          -  Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

        Exclusion Criteria:

          -  Previous ipsilateral thoracic surgery

          -  Need for operative pleurectomy or pleurodesis

          -  Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs
             (NSAIDs), sedatives, or hypnotics

          -  Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or
             acetaminophen

          -  Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)

          -  Renal dysfunction (eGFR < 60ml/min/1.73m2)

          -  History of peptic ulcerative disease

          -  Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen
             supplementation

          -  Inability to consent

          -  Pregnancy

          -  Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy

          -  Patient is discharged from the hospital with a chest tube in place

          -  Patient fails to comply with post-operative instructions
Spinal Cord Stimulation (SCS) Dosing Study
Condition: Back Pain; Leg Pain
MeSH terms: Back Pain
Intervention: Spinal Cord Stimulation
Intervention description: Programming
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      This study characterized the effects of amplitude on subject satisfaction and pain relief in
      subjects being treated by SCS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 22 years of age or older

          2. Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month

          3. Has approproate SCS settings

          4. Willing and able to provide signed and dated informed consent

          5. Capable of comprehending and consenting in English

          6. Capable of getting into the supine and sitting positions

          7. Willing and able to comply with all study procedures and visits

          8. On stable (no change in dose, route, or frequency) prescribed pain medications

        Exclusion Criteria:

          1. Implanted with leads for peripheral nerve stimulation or an implantable intrathecal
             drug delivery system

          2. Had a pain-related surgery in the previous 1 month of enrollment or the intent to
             undergo surgery during the period of the study

          3. Implanted with quadripolar lead

          4. Currently enrolled or planning to enroll in a potentially confounding clinical study
             during the course of the study

          5. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable
             form of birth control during the study

          6. Has untreated major psychiatric comorbidity

          7. Has serious drug-related behavioral issues

          8. Has unresolved major issues of secondary gain
Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
Condition: Post-operative Urinary Retention
MeSH terms: Urinary Retention
Intervention: Tamsulosin; Placebo
Intervention description: Active drug; Lactose-filled capsules identical to active drug
Intervention MeSH terms: Tamsulosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 610.0
Sex: Male
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to
      tamsulosin versus a placebo.
    

Eligibility criteria:

        Inclusion Criteria

          -  Male patient age 50 - 85 years

          -  Undergoing elective spine surgery at least 5 days after enrollment

          -  Preop visit done at office practice

        Exclusion Criteria:

          -  Currently on tamsulosin or other alpha-adrenergic blocking drug

          -  Allergy to tamsulosin

          -  Allergy to lactose

          -  Serious or life-threatening allergy to sulfa drugs

          -  Emergent procedure

          -  History of spinal trauma, spinal infection or spinal cord tumor

          -  Pre-existing indwelling urinary catheter

          -  History of orthostatic hypotension or current orthostatic hypotension

          -  History of prostate, urethral or bladder surgery

          -  Renal failure

          -  Non-English speaking

          -  Unable to provide informed consent
Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline
Condition: Acne
Intervention: Minocycline
Intervention description: Oral extended release minocycline
Intervention MeSH terms: Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 14 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the skin and plasma concentrations of
      minocycline in subjects undergoing treatment of acne vulgaris with oral extended release
      minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Otherwise healthy male and female subjects 14 to 40 years of age

          -  Moderate to severe inflammatory facial acne vulgaris (EGSA score of 3-5)

          -  Subjects not using oral or topical antibiotic products for at least 30 days prior to
             study entry and willing to refrain from use of oral and topical antibiotics for the
             duration of study participation

          -  Subjects not currently using and willing to refrain from use of other topical acne
             products for the duration of study participation

        Exclusion Criteria:

          -  Mild, non-inflammatory or nodular acne vulgaris

          -  Have current or previous skin cancer

          -  Have a history of skin disease or presence of skin condition the PI believes would
             interfere with the study

          -  Females who report that they are pregnant, planning a pregnancy during the study
             period or breastfeeding

          -  Have conditions or factors that the PI believes may affect the response of the skin or
             the interpretation of the results

          -  Participation in any clinical study within the previous 30 days or plan concurrent
             participation in other studies