bioihbjkbjnl/mcl2 huggingface dataset:
Assessing Maternal Post-partum Pain With Suppositories
Condition: Pain
Intervention: Belladonna and opioid suppository; Glycerin Suppository
Intervention description: Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery; A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
Intervention MeSH terms: Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to receive either a belladonna and opioid suppository or a glycerin suppository (placebo) every eight hours after delivery during the first 24 hours after delivery using a 1:1 allocation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Belladonna; Opium; Suppository

Summary:

      This trial will evaluate whether the routine use of belladonna/opium (B&O) suppositories
      improve patients' self-reported pain control in the first 24-hours after delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Anticipated Vaginal or Cesarean delivery at Gottlieb Medical Center or Loyola
             University Medical Center

          -  > 34 weeks gestation at time of delivery

          -  > 18 years old

          -  No known allergy to belladonna, opium, or vegetable oil suppositories

          -  Able to consent and complete study documents

        Exclusion Criteria:

          -  Chronic pain condition or on narcotic medication prior to admission

          -  Contraindications to B&O suppositories, including patients with glaucoma, severe
             hepatic, or renal disease; bronchial asthma; narcotic idiosyncrasies; respiratory
             depression; convulsive disorders; acute alcoholism; delirium tremens; history of
             hypersensitivity to any component of product.
Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
Condition: Spondylarthropathies, Enthesitis
MeSH terms: Enthesopathy; Spondylarthropathies
Intervention: Etanercept; Placebo
Intervention description: 50 mg injection once weekly; placebo
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Refractory Heel Enthesitis in Spondylarthropathy; Spondylarthropathy; Refractory Heel Enthesitis

Summary:

      To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and
      refractory heel enthesitis.
    

Eligibility criteria:

        Inclusion criteria

          -  Spondylarthropathy

          -  Heel enthesitis refractory to standard treatment

          -  Between 18 and 70 years of age

          -  The patient global assessment of the disease activity (measured by a 100 mm VAS) must
             be >40 in the last 48 hours

        Exclusion criteria

          -  Use of > 1 local steroid injection within 2 weeks of screening

          -  Prior exposure to any TNF-inhibitor, including etanercept

          -  Dose of NSAIDs changed within two weeks of study drug evaluation
Addition of Excimer Laser to Treatment With Acitretin Tablets for Psoriasis of the Palms and Soles
Condition: Psoriasis, Skin or Nails
MeSH terms: Psoriasis
Intervention: Excimer laser; Acitretin
Intervention description: twice weekly treatments with the excimer laser for a total of 8 weeks.; 17.5mg/d
Intervention MeSH terms: Acitretin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; palmoplantar; acitretin; retinoids; laser treatment

Summary:

      Psoriasis is a common skin disease that can affect 1-3% of the population. For more severe
      psoriasis, oral medication such as acitretin is sometimes given. While acitretin may be
      sufficient for treatment of some patients, psoriasis of the palms and soles is particularly
      challenging to treat, and may not respond to acitretin alone.

      In this study, the focus is on patients who have psoriasis of the palms and soles, and are
      currently taking acitretin. The aim is to initially recruit 10 patients and offer them
      treatment with a laser, the excimer laser, to one palm and one sole. Patients will receive
      laser treatment twice weekly for a total of 8 weeks, while also taking their acitretin
      tablet. If the side treated with the excimer laser shows greater improvement compared to the
      other side, the second part of the study will be conducted.

      In this second part, another 15 patients will be included. These patients will receive twice
      weekly treatments with the excimer laser to one both palms and/or soles, for a total of 8
      weeks. The aim is to prove that the addition of excimer laser to treatment with acitretin
      will lead to greater improvement of psoriasis on palms and soles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject at least 18 years of age

          -  Diagnosis of psoriasis, with palmoplantar involvement

          -  Initiated on oral acitretin for treatment of their psoriasis by their physician

        Exclusion Criteria:

          -  Subjects less than 18 years old

          -  Subjects with any skin disease, disease state, or physical condition that would impair
             evaluation of the skin

          -  Additional systemic therapy for psoriasis in last 4 weeks

          -  Additional topical or photo-therapy in last 2 weeks

          -  Usage of any additional therapy except for emollients and keratolytic agents (5%
             salicylic acid ointment or 30% urea cream)

          -  Pre-existent or current cutaneous malignancy affecting the palms and/or soles

          -  History of photosensitive disorders

          -  Ingestion of drugs reported to cause photosensitivity reactions

          -  Presence of erythroderma or generalized pustular psoriasis

          -  Concomitant use of sunlamps
Treatment Study of Vitamin D Deficiency in Adolescents
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: Vitamin D3
Intervention description: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 13 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adolescents; minority

Summary:

      To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU
      weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of
      vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly
      Hispanic and black adolescents with vitamin D deficiency [25(OH)D level <20 ng/ml] by
      assessing change in 25(OH)D levels before and after 8 weeks of treatment.

      To compare the effects of vitamin D repletion [25(OH)D level >20 ng/mL] on selected
      musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black
      adolescents with vitamin D deficiency [25(OH)D level < 20 ng/mL].

      Hypothesis 1: Increase in vitamin D level will be associated with improvement in
      musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist
      circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 13-20

        Exclusion Criteria:

          -  currently receiving treatment for hypovitaminosis D

          -  hepatic or renal disease

          -  metabolic rickets

          -  inability to complete the questionnaire
Chewed Versus Integral Pill of Ticagrelor
Condition: Percutaneous Coronary Intervention
Intervention: Ticagrelor; Ticagrelor
Intervention description: Chewed; Integral
Intervention MeSH terms: Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Ticagrelor; Stent

Summary:

      Hypothesis The primary question the investigators propose to answer is whether all patients
      undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed
      ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as
      compared to integral pill form 1 hour after drug administration.
    

Eligibility criteria:

        Inclusion Criteria:

        • All patients presenting to the cardiac catheterization lab for percutaneous coronary
        intervention.

        Exclusion Criteria:

          -  Age <18 years or Age >89 years

          -  Known coagulopathy, bleeding diathesis, or active bleeding

          -  History of recent gastrointestinal or genitourinary bleed within 2 months

          -  Known chronic therapy with clopidogrel, prasugrel, or ticagrelor

          -  Major surgery within last 6 weeks

          -  History of intracranial bleed or intracranial neoplasm

          -  Suspected aortic dissection

          -  Severe hemodynamic instability, cardiogenic shock

          -  Life expectancy <1 year

          -  Known severe liver or renal disease

          -  Known HIV treatment

          -  Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any
             use during the procedure

          -  Any use of Cangrelor during or after the procedure

          -  Hemoglobin <10 g/dL, platelet (PLT) <100x10^9/L

          -  Pregnancy

          -  Known allergy to study medication
Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine.
Condition: Chronic Migraine, Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Preserved saline in reconstitution of Botox
Intervention description: The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Migraine; Onabotulinumtoxin A; Botox; Reconstitution; Saline

Summary:

      A growing body of literature on the cosmetic use of OnabotulinumtoxinA has suggested that the
      use of preserved saline exerts a local anesthetic effect, and reduces the procedure
      discomfort when used in reconstitution in lieu of preservative-free saline. However, this has
      never been studied in chronic migraine.

      While reducing discomfort is a desirable target in all procedures, it has a special
      importance in the use of OnabotulinumtoxinA for chronic migraine due to the numerous
      injection locations each session (31 sites) and the ubiquity of scalp tenderness in this
      population. In addition, the pain during procedure is a known migraine trigger for many of
      these patients.

      We hypothesize that preserved saline (known as bacteriostatic saline) produces lower
      procedure-related discomfort when used as a dissolving solution for OnabotulinumtoxinA in
      individuals with chronic migraine as opposed to using preservative-free saline.

      In addition, we hypothesize that reduction of procedure-relate pain during the injections
      will also result in reduced migraine/headache attacks in the week immediately following the
      procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with diagnosis of chronic migraine receiving FDA-approved treatment with
             OnabotulinumtoxinA injection as per standard protocol. Standard protocol consists of
             31 injection sites, with total dose ranging from 155 u to 195u.

        Exclusion Criteria:

          -  Subjects whom OnabotulinumtoxinA injections deviate from standard protocol for any
             reason, such as head/neck infection, head deformity, recent surgery…etc.
A Study of Tadalafil After Radical Prostatectomy
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Tadalafil; Placebo
Intervention description: Administered by mouth for 9 months; Administered by mouth, daily or on demand for 9 months
Intervention MeSH terms: Tadalafil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 583.0
Sex: Male
Minimum age: 18 Years
Maximum age: 67 Years
Healthy volunteers: No
Keywords: Erectile Dysfunction; Radical Prostatectomy

Summary:

      The study will include patients with localized prostate cancer who experience erectile
      dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be
      randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on
      demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for
      9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for
      recovery of unassisted erectile function (without medication). An open-label extension for
      three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day.
      Further objectives are to evaluate the treatment satisfaction of the respective therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for
             organ-confined, non-metastatic prostate cancer

          -  have a normal preoperative erectile function score of more or equal to 22 at
             screening(as evaluated by International Index of Erectile Function - Erectile Function
             domain (IIEF-EF))

          -  develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve
             and/or maintain an erection sufficient to permit satisfactory sexual intercourse)
             after surgery

          -  have an interest in resuming sexual activity as soon as possible after surgery and
             anticipate having the same adult female sexual partner during the study

          -  agree not to use any other treatment for ED, including herbal and over-the-counter
             (OTC) medications, during the study

          -  does not require the initiation of adjuvant therapy for prostate cancer

        Exclusion Criteria:

          -  history of ED

          -  have received previous or current treatment with tadalafil or any other
             Phosphodiesterase Type 5 (PDE5) inhibitor

          -  have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer

          -  have a history of prostatic surgery or prostatic physical treatments

          -  have a history of diabetes mellitus

          -  have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose
             malabsorption

          -  have clinically significant renal insufficiency as determined by the investigator
Prophylactic Ephedrine and Combined Spinal Epidurals for Labor
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Ephedrine; Placebo
Intervention description: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea; Patients received normal saline (placebo) administered immediately after combined spinal epidural (CSE) placement
Intervention MeSH terms: Ephedrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 710.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Combined spinal epidural analgesia, labor, fetal bradycardia

Summary:

      The combined spinal epidural (CSE) technique has become increasingly popular for labor pain
      because of its rapid onset and superior first stage analgesia. However, increased risk for
      early profound fetal bradycardia (EPFB) following CSE continues to be a concern. Various
      factors are implicated in the etiology of EPFB but the cause is unknown. Ephedrine
      administration prior to CSE analgesia may help reduce the risk of EPFB, but to date, nobody
      has studied the impact of a single dose of intravenous (IV) ephedrine given at the time of
      CSE administration during labor. The purpose of this study is to measure the incidence of
      EPFB after combined spinal epidural analgesia using standard definitions. The incidence of
      EPFB will be compared between patients who receive prophylactic ephedrine or placebo at the
      time of CSE placement.
    

Eligibility criteria:

        Inclusion criteria:

          -  Ability to speak and understand English

          -  Term (37-42 weeks' gestation)

          -  Cephalic presentation

          -  Singleton pregnancy

          -  ASA 3 or less

          -  No pregnancy-induced hypertension

          -  No chronic hypertension

          -  BMI <40

          -  No evidence of pre-epidural fetal heart rate abnormality

          -  No IUGR or low AFI. ASA 1-3 women who request epidural analgesia Informed consent
             signed upon admission to L&D

        Exclusion Criteria:

          -  ASA 4 women, BMI > 39

          -  Contraindication to epidural analgesia

          -  Twin pregnancy

          -  Preterm labor

          -  Severe preeclampsia

          -  Decision to perform CS prior to epidural insertion

          -  Unable to read or speak English

          -  Unable or unwilling to sign the IFC
Dexamethasone for Post-cesarean Delivery Pain
Condition: Pain, Postoperative; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting
Intervention: Dexamethasone; Placebo
Intervention description: Dexamethasone 8 mg IV (as a one time dose); Sodium Chloride 0.9% -5 ml
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anesthesia; Cesarean Section; Pain, Postoperative; Postoperative Nausea and Vomiting; Dexamethasone; Injections, Spinal; morphine

Summary:

      The purpose of this study is to compare post-cesarean section consumption of pain medication
      between two groups of patients undergoing scheduled cesarean section at term gestation who
      receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo
      at 24 hours after surgery. The hypothesis is that a single perioperative dose of
      dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in
      women having cesarean delivery under spinal anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiology (ASA) class 1, 2 and 3

          -  Gestational age > 37 weeks

          -  scheduled for elective cesarean delivery

          -  spinal or combined spinal epidural anesthesia

          -  18 years or older

          -  speak English

        Exclusion Criteria:

          -  BMI > 45 kg/m2

          -  Diabetes Mellitus (Type 1, 2 and gestational)

          -  mild or severe preeclampsia

          -  history of intravenous drug or opioid abuse

          -  previous history of chronic pain syndrome

          -  history of opioid use in the past week

          -  receipt of an antiemetic within 24 h prior to surgery

          -  Non-English speaking
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
Condition: Sickle Cell Anemia Crisis
MeSH terms: Anemia, Sickle Cell
Intervention: Acetaminophen; Normal saline
Intervention description: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen; Normal saline volume equivalent
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 4 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sickle cell; acetaminophen in pain crises; opioid-sparing

Summary:

      The purpose of this study is to determine whether IV acetaminophen can decrease the need for
      subsequent opioid administration in the acute management of sickle cell crisis pain in the
      pediatric emergency room.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient age 4-16 years with sickle cell disease who presents the Pediatric ER with
             acute sickle cell pain crisis with a pain of 6/10 or higher

        Exclusion Criteria:

          -  Patient with fever (38C or 100.4F)

          -  Patient less than age 4 years

          -  Patient greater than age 16 years

          -  Patient with hypersensitivity/allergy to either morphine, NSAIDs, or acetaminophen

          -  Patient received acetaminophen within the past 4 hours

          -  Patient with known liver disease or renal disease

          -  Patient not requiring IV morphine (pain score 5/10 or less)

          -  Patient enrolled in the study within the past 72 hours