bioihbjkbjnl/mcl2 huggingface dataset:
3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Finasteride; Placebo
Intervention description: Finasteride 5mg every day by mouth for 3 months; Placebo every day by mouth for 3 months
Intervention MeSH terms: Finasteride
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 383.0
Sex: Male
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Finasteride; Placebo; Prostate cancer; Prostate Specific Antigen (PSA); Men at intermediate risk of prostate cancer; Men scheduled for prostate biopsy

Summary:

      The investigators will propose a novel method to improve prostate cancer screening with PSA,
      using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia
      (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will
      also examine three additional promising tests that may further improve diagnosis of prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention
             Trial (PCPT) prostate cancer risk calculator.
             (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months
             prior to study entry. A description of the frequency of these individuals in the
             population is provided in Specific Aim 2

          2. Patient has been recommended to undergo and plans to have a prostate biopsy.

          3. Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo
             treatment.

          4. No allergy to finasteride or other five alpha reductase inhibitors.

          5. Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month
             treatment period.

          6. Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for
             this age range.)

        Exclusion Criteria:

          1. Risk of cancer greater than 60% or less than 20%.

          2. Prior history of prostate cancer.

          3. Prior treatment with finasteride or dutasteride in the past 6 months

          4. Younger than age 55.
Azithromycin - Ivermectin Mass Drug Administration for Skin Disease
Condition: Scabies; Yaws; Impetigo
MeSH terms: Scabies; Impetigo
Intervention: Ivermectin; Azithromycin; Permethrin
Intervention description: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.; Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.; Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
Intervention MeSH terms: Azithromycin; Ivermectin; Permethrin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1291.0
Sex: All
Healthy volunteers: No

Summary:

      This is an open-label prospective community intervention trial to assess the impact of
      community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws
      bacterial skin infections.

      Communities will be randomised to receive standard treatment for both yaws and scabies either
      in parallel (site 1) or in sequence (site 2).

      Treatment of yaws:

      Single dose of Azithromycin (30mg/kg, max 2G).

      Treatment of scabies:

      Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a
      contraindication to Ivermectin (WT<15kg, pregnant or breastfeeding women) given in 2 doses
      7-14 days apart.

      Investigators will complete a clinical and microbiological assessment of bacterial skin
      disease at baseline and at 12 months to assess the impact of treatment on the prevalence of
      bacterial infection and the emergence of antimicrobial resistance.

      Primary Outcome

        1. Difference in the change in prevalence of impetigo between baseline and 12- months
           between the parallel and the sequential treatment arms.

           Secondary Outcomes

        2. Change in the proportion of swab samples from which S. pyogenes is cultured between
           baseline and follow-up in the two arms

        3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured
           in the two arms
    

Eligibility criteria:

        Inclusion Criteria:

          -  All community members are able to be included in the study.

        Exclusion Criteria:

          -  Allergy to any of the components of the allocated drug regimen
CNS Sarcoidosis and Acthar Gel
Condition: CNS Sarcoidosis
MeSH terms: Sarcoidosis
Intervention: H.P. Acthar Gel
Intervention description: 80 IU subcutaneously daily for 10 days then followed by 80 IU subcutaneously three times per week through Month 12
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to see if treatment with H.P. Acthar® Gel will result in the
      improvement and long-term stabilization of clinical and radiographic abnormalities that occur
      in patients with CNS sarcoidosis. In addition, it will also look at whether treatment will be
      also associated with improvement in measures of quality of life. The treatment of CNS
      sarcoidosis involves the use of either corticosteroids such as prednisone or potent
      immunosuppressive agents such as methotrexate, both which can induce severe long term side
      effects. The adverse effects of steroids may be avoided by treatment with adrenocorticotropic
      hormone (ACTH), which is available for patient use as H.P. Acthar® Gel. The efficacies of
      H.P. Acthar® Gel in the treatment of CNS sarcoidosis and the impact on quality of life have
      not been previously studied. In addition, little is known regarding the expression of immune
      markers in CNS sarcoidosis and the association of such markers with disease activity and
      response to treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A highly probable diagnosis of sarcoidosis, as determined using the World Association
             for Sarcoidosis and Other Granulomatous Disorders (WASOG) Sarcoidosis Organ Assessment
             Instrument (Judson et al., 2014), with involvement not limited to the central nervous
             system.

          -  At the time of enrollment, a history of clinical deterioration based on the
             development of new symptoms or worsening previously present symptoms with confirmation
             by clinical examination and objective clinical testing.

          -  If on steroids, on a stable dose of the medication for at least 3 months.

        Exclusion Criteria:
The Effect of Tamsulosin on Postoperative Urinary Retention
Condition: Urinary Retention
MeSH terms: Urinary Retention
Intervention: Tamsulosin; Placebo
Intervention description: Oral drug: 10 days of 0.4 mg of oral Tamsulosin; Oral drug: 10 days of identical-appearing placebo
Intervention MeSH terms: Tamsulosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: Female
Minimum age: 21 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Postoperative care; Urinary tract infection; Female pelvic reconstructive surgery; Enhanced recovery after surgery; Tamsulosin; Flomax

Summary:

      This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to
      prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing
      same-day discharge with an enhanced recovery after surgery protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage II or greater pelvic organ prolapse in > 1 vaginal compartment

          -  Plan for multicompartment native tissue vaginal repair (which would include any
             combination of uterosacral ligament suspension, sacrospinous ligament suspension,
             cystocele and/or rectocele repair, with or without hysterectomy and with or without
             concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and
             reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health

          -  Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day
             hospital discharge

          -  Willing to remain compliant with Investigation Product (IP)

        Exclusion Criteria:

          -  Intraoperative complication necessitating prolonged bladder drainage or placement of a
             vaginal pack x 24 hours (patients would exit study after randomization and will be
             excluded from the per-protocol analysis)

          -  Patients whose surgical plan would necessitate a voiding trial on postop day >0

          -  Less than 21 years of age

          -  Unable to understand English

          -  Patients who are scheduled to undergo combined colorectal procedures such as
             rectopexy, sphincteroplasty

          -  Patient with known allergy to Tamsulosin or sulfa drugs

          -  Patients with upcoming cataract surgery

          -  Patient with orthostatic hypotension

          -  History of postvoid residual (PVR>150) prior to surgery with prolapse reduction

          -  Patients with hypertension on alpha-blockers

          -  Single compartment prolapse repair (anterior or posterior repair only)

          -  Use of mesh for prolapse repair

          -  High tone pelvic floor dysfunction
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
Condition: Hiv
Intervention: TDF-FTC; Counselling on PrEP in antenatal and postnatal care
Intervention description: We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.; Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Open label cohort study
Masking: None (Open Label)
Enrollment: 200.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pre-exposure prophylaxis; PrEP; pregnancy; prevention of mother to child transmission; PMTCT

Summary:

      The overarching goal of this proposal is to evaluate the feasibility and acceptability of
      integrating PrEP into antenatal and postnatal care, to describe the cascade in women
      initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP
      cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1)
      Evaluate the feasibility and acceptability of integrating PrEP into antenatal and
      postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and
      adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate
      attrition and associated factors across the PrEP cascade.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal
             care protocol in this setting), confirmed with a 4th generation antigen HIV test at
             study enrollment

          2. No previous exposure triple-drug antiretroviral therapy

          3. Age 18 years or older

          4. Lives within 20 kilometers of a clinic

          5. Without psychiatric or medical contraindications to PrEP use

          6. Able to provide informed consent for research

        Exclusion Criteria:

        Failure to meet any of the inclusion criteria
Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Condition: Nail Diseases; Nail Abnormality
MeSH terms: Nail Diseases; Nails, Malformed
Intervention: Hydrocodone 5Mg/Acetaminophen 325Mg Tab; Acetaminophen 1000mg; Ibuprofen 400 mg
Intervention description: 5 mg/325 mg tablet; 1000 mg tablet; 400 mg tablet
Intervention MeSH terms: Acetaminophen; Ibuprofen; Hydrocodone
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: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: nail diseases; nail biopsy; nail procedure; pain management

Summary:

      The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone
      for nail-procedure associated pain management. The investigators hypothesize that ropivacaine
      with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for
      managing pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing fingernail or toenail, excision, or shave biopsy

          -  Must understand and voluntarily sign an informed consent form

          -  Must be male or female and aged 18-95 years at time of consent

          -  Must be able to adhere to the study visit schedule and other protocol requirements

        Exclusion Criteria:

          -  Subject is unable to provide written informed consent for any reason

          -  Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy

          -  Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any
             other chronic pain

          -  Subject has a history of opioid or alcohol use disorder

          -  Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency
             or a history of kidney disease, or has underlying liver disease

          -  Subject has a history of severe constipation

          -  Subject is sensitive or allergic to any of the elements included in this study

          -  Subject is unable to complete the required pain dairy

          -  Subject is pregnant, planning pregnancy, or nursing
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
Condition: HIV, Pediatric
Intervention: Atazanavir; Ritonavir
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to collect safety clinical data in HIV-infected pediatric
      patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are
      receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse
      transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed HIV-1 infection diagnosed by protocol criteria

          -  Male or female children, ≥ 6 years to <17 years 6 months of age at the time of first
             treatment

          -  Antiretroviral-naïve or treatment-experienced participants with a detectable viral
             load

          -  Antiretroviral-naïve participants must have genotypic sensitivity at screening to
             atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which
             have been approved for pediatric use and dosed per local country label

          -  Antiretroviral-experienced participants must have documented genotypic and phenotypic
             sensitivity at screening to atazanavir (fold change in susceptibility <2.2) and at
             least 2 NRTIs, which have been approved for pediatric use and dosed per local country
             label.

        Exclusion Criteria:

          -  Experienced participants who received atazanavir with or without ritonavir at any time
             prior to study enrollment

          -  Antiretroviral-naive or -experienced HIV-1 infected patients with contraindication to
             study medications

          -  Documented cardiac conduction abnormality, significant cardiac dysfunction, or a
             history syncope

          -  Family history of QTc interval syndrome, Brugada syndrome, right ventricular
             dysplasia, or a corrected QTc interval of >440 ms at screening

          -  One of the following cardiac rhythm abnormalities documented on the screening
             electrocardiogram:

               1. First degree atrioventricular (AV) block, as defined by protocol

               2. Type I second degree AV block while awake, type II second degree AV block at any
                  time, complete AV block at any time, or age-adjusted heart rate <2nd percentile

          -  Coinfection with either hepatitis B or C virus
Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Intervention: Protocol for rocuronium neuromuscular block
Intervention description: The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neostigmine; sugammadex; rocuronium; neuromuscular blocking agents

Summary:

      This is an estimation study, prospectively evaluating the incidence of postoperative residual
      neuromuscular blockade (PRNB) when a best practice protocol is implemented for a cohort of
      abdominal surgery and orthopedic surgery patients. The protocol is developed within the
      constraint of subjective monitoring, quantitative monitoring is not used, and use of
      rocuronium for paralysis and either neostigmine or sugammadex for reversal. The primary
      outcome is the incidence of PRNB on arrival to the post-anesthesia care unit, defined as a
      train-of-four ration <0.9.
    

Eligibility criteria:

        Inclusion Criteria: Adult 18 years old or older, Will undergo open or laparoscopic
        abdominal surgery or orthopedic surgery expected to last <6 hours at Harborview or Univ of
        Wash Med Ctr, Have American Society of Anesthesiologists physical status I-III, scheduled
        to have general anesthesia with at least 1 dose of nondepolarizing neuromuscular blocking
        drug for endotracheal intubation or intraoperative neuromuscular blockade.

        -

        Exclusion Criteria: Allergy to neuromuscular blocking drugs, patients with neuromuscular
        disease (myasthenia gravis or muscular dystrophy), pregnant or lactating women, non-English
        speaking.

        -
PIEB vs CEI for Labor Analgesia: An MLAC Study
Condition: Pregnancy
Intervention: Bupivacaine; Sufentanil
Intervention description: Continuous or bolus administration; Continuous or bolus administration
Intervention MeSH terms: Sufentanil; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine
      the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous
      Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB
      efficacy advantage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I & II, Nulliparous and Multiparous, Spontaneous/Induced/Augmented Labor, Early
             active labor (cervix <5 cm (if known)), Pain (VPS) > 3, 18-45 years of age

        Exclusion Criteria:

          -  <37 weeks gestation, H/o Cesarean Section, Multiple Gestation, Pre-eclampsia,
             Narcotics within 3 hours prior to labor epidural placement, Chronic Pain (as defined
             by chronic opiate consumption), Women who are participating in another study that will
             impact protocol