bioihbjkbjnl/mcl2 huggingface dataset:
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
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects
Condition: Pharmacokinetics; Cytochrome P-450 CYP2D6; CYP3A4 Protein, Human
Intervention: Aripiprazole; Aripiprazole + desvenlafaxine succinate sustained release
Intervention description: Period 1-Aripiprazole 5mg on study day 1.; Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.
Intervention MeSH terms: Aripiprazole; Desvenlafaxine Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetic; safety and tolerability; genetic testing; CYP 2D6 and CYP 3A4

Summary:

      The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine
      Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy
      adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine
      SR and Aripiprazole when coadministered to healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between the ages of 18 and 55 years

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)

          -  Nonsmoker or smoker of fewer than 5 cigarettes per day as determined by history

          -  An informed consent document signed and dated by the subject

        Exclusion Criteria:

          -  History of significant blood, kidney, endocrine, lung, gastrointestinal, heart, liver,
             psychiatric, neurologic, or allergic disease

          -  History of seizure disorder

          -  Presence or history of glaucoma or increased intraocular pressure

          -  Allergy to or unable to tolerate aripiprazole, desvenlafaxine, or venlafaxine

          -  History of substance abuse within 1 year of study

          -  A positive urine drug screen

          -  Treatment with an investigational drug within 30 days

          -  Consumption of grapefruit or grapefruit related citrus fruits

          -  12 lead ECG demonstrating QTc >450 msec at screening

          -  Pregnant or nursing females

          -  Use of prescription or nonprescription drugs and dietary supplements

          -  History of sensitivity to heparin or heparin induced thrombocytopenia

          -  Severe acute or chronic medical or psychiatric condition or laboratory abnormality
Acetazolamide Challenge With Perfusion in the Prediction of Cerebral Vasospasm
Condition: Subarachnoid Hemorrhage, Aneurysmal; Vasospasm, Cerebral
MeSH terms: Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hemorrhage
Intervention: Acetazolamide
Intervention description: 1 g acetazolamide through a peripheral IV line
Intervention MeSH terms: Acetazolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acetazolamide challenge; cerebral vasospasm; aneurysmal subarachnoid hemorrhage

Summary:

      The investigators propose a technique using cone beam CT perfusion (CBCTP) imaging with an
      acetazolamide challenge as a potential diagnostic tool to detect a defect in cerebral
      autoregulation at a time when it has not yet caused clinically apparent signs or symptoms. 30
      participants will be enrolled at the University of Wisconsin - Madison and can expect to be
      on study for about 2 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with aneurysmal subarachnoid hemorrhage presenting to our institution within
             24 hours of symptom onset

          -  Adults, 18 years of age or older

          -  Women of childbearing potential must not be pregnant (negative urine pregnancy test)

        Exclusion Criteria:

          -  Contraindication to acetazolamide (i.e. sulfonamide allergy, renal or liver failure)

          -  Contraindication to contrast media (Allergy or abnormal serum Cr and/or GFR based on
             current UW guidelines for IV contrast)

          -  Renal insufficiency, history of renal failure or renal transplant

          -  Hunt and Hess grade 1 and 5 (Attached protocol provides details on the grading scale.
             Grade 1 have lowest yield for vasospasm and Grade 5 are by definition critically ill
             and unstable patients)

          -  Critically ill patients who are unstable and who cannot undergo scans within the
             proposed timeline i.e. within 24 hours of the onset of their symptoms.
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence, Stress
Intervention: Pubovaginal sling procedure
Intervention description: The procedure involves placing a band of sling material directly under the bladder neck (ie, proximal urethra) or mid-urethra, which acts as a physical support to prevent bladder neck and urethral descent during physical activity. The sling also may augment the resting urethral closure pressure with increases in intra-abdominal pressure.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: Female
Healthy volunteers: No
Keywords: OAB; Urinary Bladder, Overactive; Overactive Bladder Syndrome; VESIcare; Urgency; Nocturia; Frequency; Urge Urinary Incontinence; UUI; Pubovaginal Sling; PVS; Incontinence

Summary:

      Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by
      strenuous events such as child birth. A common purported side effect of PVS is urgency, the
      feeling of a compelling need to void with little warning. Other overactive bladder (OAB)
      adverse effects that some claim to develop post-op include further leakage (incontinence),
      frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however,
      suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be
      alleviated by said procedure. It is our aim to investigate this relationship in our clinic.

      As a prospective member of this study, you will be asked to complete five surveys. The first
      survey will be administered prior to your pubovaginal sling. This will be used to establish
      your baseline experience of OAB. Over the course of the next year, you will be asked to
      complete the four remaining surveys at regularly scheduled check-ups.
    

Eligibility criteria:

        Inclusion Criteria.

          -  Post-pubovaginal sling patient.

          -  Complete agreement and signing of Informed Consent Form.

        Exclusion Criteria.

          -  Currently taking antimuscarinics or α1 blockers.

          -  Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle
             glaucoma.
Sub-dissociative Dose Ketamine Dosing Study
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Ketamine
Intervention description: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All study investigators, patients and clinicians except the clinical pharmacist will be blinded to the study treatment allocation. Treatment will be prepared and blinded by the ED clinical pharmacist.
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate
      to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to
      Ketamine administered at 0.3 mg/kg, with fewer adverse effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ages 18-59

          -  Weight 45 - 115 kg

          -  Acute abdominal, flank, back, musculoskeletal pain, or a headache

          -  Onset of pain within 7 days

          -  Pain score of 5 or more

          -  Requiring intravenous analgesia

          -  Hasn't been enrolled in this study previously

        Exclusion Criteria:

          -  Pregnancy

          -  Breast-feeding

          -  Altered mental status rendering the patient unable to consent to the study

          -  Allergy to ketamine

          -  Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or
             >150 beats/minute, and respiration rate <10 or >30 breaths/minute)

          -  History of acute head or eye injury, seizure, intracranial hypertension

          -  Chronic pain

          -  Renal or hepatic insufficiency

          -  Known alcohol or drug use disorder

          -  Currently under influence of alcohol/opiates

          -  Acute psychiatric illness
A Randomised Cross-over Study With Two 1-piece Urostomy Bags.
Condition: Urostomy
Intervention: SenSura Uro; Hollister
Intervention description: The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.; The comparator product is CE-marked and non-sterile and produced for urostomy operated. It is a flat one-piece urostomy product, Hollister Moderma Flex Urostomy beige, Cut-to-Fit Bag, flat adhesive.
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: urostomy, 1-piece, cross-over, randomised, preference

Summary:

      Background Urostomy is a surgical procedure that detours or diverts urine away form a
      diseased or defective bladder. The bladder can be removed and the urine is passed out of the
      body through an opening (stoma) in the stomach. People with urostomy will not be able to
      start and stop urine coming out through the stoma, so a urostomy bag will be fitted to
      collect the urine as it comes out.

      A urostomy bag consists of an adhesive, which is attached to the skin around the stoma and a
      bag connected to the adhesive to collect the urine.

      It is very important the standard is high on these products; otherwise the user
      (urostomy-patient) will experience lots of problems with the skin around the stoma.
    

Eligibility criteria:

        Inclusion Criteria:

        In order to be enrolled in the clinical investigation, the subject must:

          -  Be at least 18 years old,

          -  Be mentally and physically capable of signing the written consent form

          -  Be able to fill in the Case Report Form (questionnaire)

          -  Have an urostomy with a size between 15-55 mm.

          -  Have had the urostomy for 3 months or more,

          -  Use a 1-piece bag normally.

          -  Be able to handle the bag themselves (application and removal)

          -  Be willing to use Coloplast SenSura 1-piece bag

          -  Be willing to use Hollisters Moderma Flex, 1-piece bag

        Exclusion Criteria:

        In order to be enrolled in the clinical investigation, the subjects must not:

          -  Be a convex base plate user (i.e. a bowl-shaped adhesive which pushes the stoma
             forward)

          -  Need to use an ostomy belt

          -  Be currently suffering from any dermatologiacal problems, needing special treatment,
             in the peristomal area (investigator will evaluate skin according to a newly developed
             ostomy skin tool from Coloplast A/S)

          -  Being treated with chemo- or radiation therapy,

          -  Be hospitalized during study enrollment, or have a hospitalization or significant
             surgery planned during the 4-week study period, or

          -  Be pregnant or breast-feeding.
Cilostazol After Lower Extremity Arterial Revascularization Trial
Condition: Peripheral Arterial Disease; Claudication (Finding)
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
Intervention: Cilostazol
Intervention description: 100 mg twice daily for 90 days
Intervention MeSH terms: Cilostazol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: leg pain; claudication

Summary:

      Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm
      (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the
      treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to
      collect quality of life data on patients undergoing peripheral revascularization in order to
      determine the sample size required to adequately power a trial of Cilostazol versus usual
      care without Cilostazol and its effect on quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 35 years of age

          -  Atherosclerotic peripheral arterial disease

          -  Able to provide informed consent

          -  Lower extremity open or endovascular revascularization.

        Exclusion Criteria:

          -  Known CHF (class III/IV)

          -  Allergic reaction to phosphodiasterase inhibitors

          -  Intracranial bleeding within 3 months or active bleeding peptic ulcer disease

          -  Traumatic vascular injuries requiring revascularization

          -  Pregnant or breast feeding women or women who plan to get pregnant over the study
             period

          -  Planned ipsilateral major amputation within 30 days of index procedure

          -  Moderate to severe hepatic impairment.
BK Treatment Study
Condition: BK Viremia
MeSH terms: Viremia
Intervention: levofloxacin; placebo
Intervention description: 500 mg tablet, daily, 30 days; no dose, tablet, daily, 30 days
Intervention MeSH terms: Levofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BK viremia; kidney transplantation; BK viremia in kidney transplant recipients

Summary:

      Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients
      with persistent viremia (BK virus found in blood) will impair progress to BK virus induced
      kidney damage by significantly decreasing or eliminating BK virus in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Living and cadaveric kidney transplant recipients over the age of 18 years with BK
             viremia

        Exclusion Criteria:

          -  Female patients of childbearing age who are pregnant or in whom adequate contraception
             cannot be maintained.

          -  Patients with active infections, history of malignancy/Posttransplant
             Lymphoproliferative Disease (PTLD) serologic positivity to HIV.

          -  Patients with evidence of urinary tract obstruction causing allograft dysfunction,
             unless corrected by time of enrollment.

          -  Patients with clinical or morphological evidence of recurrence of primary disease.

          -  Patients with a history of allergic reaction to quinolone antibiotics.

          -  Patients with history of prolong QT interval

          -  Patients with recurrent hypoglycemic episodes

          -  Patients with history of myasthenia gravis

          -  Patients taking Thioridazine
Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
Condition: Hip Arthroplasty
Intervention: Extended Release Epidural Morphine (EREM); Placebo
Intervention description: A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline; A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hip resurfacing; hip arthroplasty

Summary:

      At Wake Forest University, the investigators have been using Extended Release Epidural
      Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having
      gynecologic surgeries and hip arthroplasties.

      Hypothesis:

      In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in
      conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in
      increasing proportion of patients who meet discharge criteria within 24 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A primary unilateral Birmingham hip arthroplasty

          -  Men and women 18-65 years

        Exclusion Criteria:

          -  Refusal of regional anesthesia

          -  Laboratory evidence of coagulopathy (platelet count less than 100,000 cells/microliter
             of blood, prothrombin time greater than 12.1 seconds, partial thromboplastin time
             greater than 30 seconds, or international normalized ratio of greater than 1.5)

          -  Allergy to morphine

          -  Obstructive sleep apnea

          -  Body mass index (BMI) greater than 40 kg/m2

          -  Pregnant or lactating

          -  Severe renal or hepatic disease
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Condition: Pervasive Development Disorders
MeSH terms: Hyperkinesis; Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: placebo; extended-release guanfacine
Intervention description: Administered for up to 8 weeks.; 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
Intervention MeSH terms: Guanfacine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 5 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: Pervasive Developmental Disorders; PDD; PDD-NOS; Autistic Disorder; Autism; Asperger's Disorder; Hyperactivity; Attention Deficit Hyperactivity Disorder; ADHD; Medication; Drug; Guanfacine; Intuniv; Placebo; Methylphenidate

Summary:

      The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself
      or in combination with methylphenidate (also known as Ritalin) is helpful for treating
      hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PDD (PDD-NOS, Asperger's Disorder, Autistic Disorder)

          -  Hyperactivity

          -  Between ages 5 years 0 months and 13 years 11 months.

          -  Weight >/= 15 kg (33 lb)

          -  A mental age of at least 18 months

        Exclusion Criteria:

          -  Prior failed treatment with an adequate trial of guanfacine in the last 2 years

          -  Concurrent treatment with another psychoactive medication