bioihbjkbjnl/mcl2 huggingface dataset:
Early Sodium Intake in Preterm Newborns
Condition: Hyponatremia; Premature
MeSH terms: Hyponatremia
Intervention: Sodium < 1mEq/kg/day; Sodium 5mEq/kg/day
Intervention description: Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1; Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 52.0
Sex: All
Maximum age: 24 Hours
Healthy volunteers: No
Keywords: Preterm infant; Sodium; Hyponatremia

Summary:

      Hyponatremia is a common complication among preterm infants, renal losses of sodium
      contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact
      in newborns outcome. There is controversy about the time of initiation and the requirements
      of sodium in premature infants. Hypothesis: early (24 hours of life) sodium supplementation
      (5mEq/kg/day) prevents the develop of hyponatremia in preterm infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Preterm infants <35 Weeks gestation

        Exclusion Criteria:

          -  Urinary malformations

          -  Congenital abdominal wall defect

          -  Intestinal atresia / obstruction

          -  Congenital heart defect
Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Condition: Total Knee Arthroplasty
MeSH terms: Acute Pain
Intervention: Placebo; Duloxetine 60mg
Intervention description: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.; Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 25 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      We are investigating the impact of duloxetine ("Cymbalta"), a serotonin and norepinephrine
      reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the
      investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores
      2 weeks after TKA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with osteoarthritis scheduled for primary tricompartmental total knee
             arthroplasty with a participating surgeon

          -  Age 25 to 75 years

          -  Planned use of regional anesthesia

          -  Ability to follow study protocol

          -  English speaking (primary outcome obtained via telephone call and secondary outcomes
             include questionnaires validated in English only)

          -  Patients planning on being discharged home or to a rehabilitation center that has
             agreed to participate

        Exclusion Criteria:

          -  Concurrent use of duloxetine or other SNRIs, MAOIs, Tricyclic antidepressants,
             triptans (sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan,
             almotriptan, frovatriptan), lithium, buspirone, St. John's Wort

          -  Hepatic insufficiency

          -  Renal insufficiency

          -  Patients younger than 25 years old and older than 75

          -  Patients intending to receive general anesthesia

          -  Allergy or intolerance to one of the study medications

          -  Patients with an ASA of IV

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (taking opioids for longer than 3 months)

          -  Patients with major prior ipsilateral open knee surgery
The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Condition: Chronic Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Intervention: Allopurinol; Placebo
Intervention description: lactose placebo pill
Intervention MeSH terms: Allopurinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: allopurinol

Summary:

      Subjects will undergo a placebo and allopurinol phase to better understand the effects of the
      reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  self-identified as Asian/European ancestry

          -  generally healthy with approved lab values for CBC,HFP,RFP, and uric acid

          -  Subjects with the ABCG2 genotype, homozygous, heterozygous or homozygous for the major
             allele of rs2231142 will be recruited

        Exclusion Criteria:

          -  vascular disease

          -  renal impairment

          -  medications/supplements that affect uric acid levels

          -  pregnant or lactating women

          -  prior history of allergic reaction to allopurinol or testing positive for HLA-B*5801
             allele

          -  risk of urinary or gastric retention or narrow-angle glaucoma

          -  impaired hepatic function

          -  evidence of anemia

          -  evidence or diagnosis of congestive heart failure

          -  smokers

          -  subjects with a mutation other than rs2231142 in the ABCG2 genotype

          -  subjects taking hormonal contraceptives or other hormonal medications

          -  evidence of recreational drug use as determined by questionnaire
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.
HPV Vaccination Study in Postpartum Women
Condition: HPV; Immunization; Human Papilloma Virus
MeSH terms: Papilloma
Intervention: Gardasil9
Intervention description: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: Female
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Papilloma Virus; HPV; Immunization

Summary:

      The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the
      United States (U.S.) and is responsible for a wide range of conditions, including cancers
      within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that
      HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical
      cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum
      care at Johns Hopkins University. The investigators will measure the immunogenicity and
      acceptability of the vaccine in the postpartum setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants biologically born as females between the ages of 15 through 45 who have
             delivered a live born baby within the past 72 hours.

        Exclusion Criteria:

          -  Pregnancy

          -  Severe allergic reaction to vaccine components

          -  Prior receipt of an HPV vaccine dose

          -  Fetal demise or stillbirth

          -  Allergy to latex or yeast

          -  Moderate or severe acute illness (deemed by the investigator to exclude)

          -  Immunosuppression (e.g., HIV, solid organ transplant).
S. Aureus Screening and Decolonization
Condition: Wound Infection Due to Staphylococcus Aureus; MRSA Infection of Postoperative Wound
MeSH terms: Infections; Communicable Diseases; Wound Infection; Wounds and Injuries
Intervention: antiseptic bundle; standard of care
Intervention description: Chlorhexidine gluconate liquid soap for bathing daily.
Chlorhexidine gluconate mouthrinse to use twice daily.
Nasal mupirocin to apply twice daily.; Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.
Intervention MeSH terms: Anti-Infective Agents, Local
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Staphylococcus aureus infection; Decolonization; Surgical site infection

Summary:

      Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity
      and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year
      over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such
      infections double the length of hospitalization and risk of dying, and increase U.S. health
      care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by
      either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers
      of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA
      SSI. A potential prevention approach is routine pre-operative screening of patients, followed
      by decolonization of identified SA carriers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patient who are 18 years and older, able to give informed consent and willing to
             complete the study decolonization protocol.

          -  Surgery must be scheduled 2 weeks in the future to allow completion of the study
             protocol prior to the scheduled operation.

          -  Patients will be admitted from home the day of the surgery or have the surgery done on
             an outpatient basis.

        Exclusion Criteria:

          -  Currently on antibiotic therapy, allergy to mupirocin or CHG.
Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
Condition: Bradycardia; Arrhythmias
MeSH terms: Bradycardia
Intervention: Atropine
Intervention description: intravenous atropine affect on heart rate
Intervention MeSH terms: Atropine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: This is a single arm study where a dose of atropine was administered and the ECG recorded.
Masking: None (Open Label)
Masking description: Observer of ECG rhythm strips was unaware of the study hypothesis, the study drug administered, the dose given and the arrhythmias sought. Your statement that masking a single outcome implies a multi-arm study precludes a panoramic perspective of clinical research study designs and scenarios in which assessors may be effectively blinded.
Enrollment: 60.0
Sex: All
Minimum age: 1 Day
Maximum age: 2 Years
Healthy volunteers: No
Keywords: Atropine; bradycardia; tachycardia

Summary:

      An infants heart rate is very important because it ensures that blood is pumped to all organs
      in the body. Heart rate may decrease during anesthesia and surgery, and this is why the
      anesthesiologist will often give a medication to prevent this from happening. The most common
      drug for this purpose is called atropine. The dose of most drugs given to babies is based
      upon the baby's weight, but some believe that the dose of atropine should not be less than
      0.1mg. However there is no evidence to support this minimum dose. A larger dose of atropine
      may cause a very fast heart rate instead. Anesthesiologists routinely dose the atropine based
      upon the baby's weight without regard for a minimum dose.

      The purpose of the present study is to measure the heart rate after doses of atropine in
      neonates and infants who receive less than 0.1 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age : 0-2 years old

          2. Weight : less than the 95th percentile for age and height ( no more than 15kg )

          3. ASA classification : I-II

          4. Meets the hospital and department of anesthesiology guidelines with respect to
             peri-operative care

        Exclusion Criteria:

          1. History of heart disease

          2. Any condition predisposing to arrhythmia

          3. Any medication known to influence the heart rate

          4. Child taking anti-cholinergic medication routinely

          5. The use of succinylcholine anticipated (will cause bradycardia)

          6. Rapid sequence intubation is required (due to aspiration risk)

          7. Known difficult airway (may be difficult to bag mask ventilate)
Opioid Free Management After Ureteroscopy
Condition: Kidney Stone
MeSH terms: Kidney Calculi
Intervention: Norco 5milligram-325milligram Tablet; Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED
Intervention description: Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later.; Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later.
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blinded
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ureteroscopy; Opioid; Non-Opioid; Stent Placement; Nephrolithiasis

Summary:

      The purpose of this research study is to compare how well two medications work to control
      post-operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ureteroscopy performed for renal stones

          -  Age over 18 years

          -  Two kidneys

        Exclusion Criteria:

          -  Solitary Kidney

          -  Poor kidney function (GFR<30)

          -  Allergy to either Ibuprofen or Norco

          -  Pelvic Kidney
Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)
Condition: Diabetic Ketoacidosis
MeSH terms: Ketosis; Acidosis; Diabetic Ketoacidosis
Intervention: insulin glargine+ glulisine; NPH + Regular insulin
Intervention description: Daily insulin glargine + glulisine before meals; Split-mixed NPH + Regular insulin twice daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetic ketoacidosis; insulin therapy; DKA

Summary:

      The study is a multicenter, randomized controlled trial to compare the safety and efficacy of
      insulin analogs and human insulins both during acute intravenous treatment and during the
      transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients admitted to Grady Memorial Hospital who meet diagnosis criteria of DKA
             and who are willing to participate in the study protocol will be considered candidates
             for inclusion into the study.

          -  Diagnostic Criteria for DKA: Blood glucose > 250 mg/dL, arterial or venous phenol
             hydroxylase (pH) < 7.3, serum bicarbonate < 18 milliequivalent/L, and moderate to
             severe ketonemia (acetoacetate ≥ 1:4 or βeta-hydroxybutyrate > 3 mmol).

        Exclusion Criteria:

          -  Hemodynamic instability (MAP < 50 or patients requiring pressor)

          -  Significant identifiable medical or surgical illness, including but not limited to:
             acute myocardial infarction, congestive heart failure; respiratory failure requiring
             mechanical ventilation; acute or chronic renal insufficiency (serum creatinine > 3.0
             mg/dl); end stage liver failure, and cirrhosis.

          -  Patients with dementia or persistent altered mental status that would prevent
             collection of consent form and reliable information.

          -  Pregnancy
Intraoperative Glucose Control in Liver Transplant
Condition: Liver Transplant
Intervention: insulin
Intervention description: bolus or infusion 80 to 110 mg/dl
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: liver; transplant; blood sugar

Summary:

      The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict
      glycemic control to improve survival and infection rates following liver transplantation in a
      randomized, prospective trial.Primary objective: To determine if strict intraoperative blood
      glucose control, when compared to standard intraoperative glycemic control, improves 1-year
      recipient survival and decreases surgical complications, including infections, following
      liver transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥ 18 years old undergoing liver transplantation

          -  Patients willing and capable of giving written informed consent for study
             participation

        Exclusion Criteria:

          -  Multi-organ transplant recipients

          -  Patients receiving a liver incompatible with A, B or O blood types

          -  HIV infected patients

          -  Recipients of an organ from an HIV+ donor

          -  Patients with severe coexisting disease or presenting with any unstable medical
             condition which could affect the study objectives

          -  Patients with a co-existing alcoholic disease who have not been abstinent for at least
             6 month immediately prior to transplantation and are not expected to be able to remain
             abstinent after transplantation

          -  Patients who are unlikely to comply with the study requirements or unable to give
             informed consent

          -  Use of other investigational drugs at the time of enrollment, or within 30 days or 5
             half-lives of enrollment, whichever is longer or if such therapy is to be instituted
             posttransplantation

          -  Patients transplanted for hepatocellular carcinoma exceeding 3 nodules or with nodule
             diameter larger than 5 cm

          -  History of malignancy of any organ system, treated or untreated, within the past 5
             years whether or not there is evidence of local recurrence or metastases, with the
             exception of localized basal cell carcinoma of the skin

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadatropin (hCG) laboratory test (> 5 milli-International
             units (mIU/ml)
Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital
Condition: Diabetes
Intervention: Glargine insulin
Intervention description: 20-180 units per day
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 22 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes

Summary:

      In this study the investigators would like to test the hypothesis that in diabetic patients
      discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected
      Glargine in terms of diabetes control, compliance, and patient satisfaction and preference.
      The investigators will test this hypothesis in a randomized, crossover trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients with type 1 and 2 diabetes discharged from the hospital with
             recommendations to take Glargine

        Exclusion Criteria:

          -  Patients unwilling to participate and patients incapable of complying with the study
             regimen, such as patients with alcohol and drug addiction problems and patients with
             severe mental illness