bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound Guided Octreotide LAR Injection in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Octreotide LAR 30 MG Injection
Intervention description: Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.
Intervention MeSH terms: Octreotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acromegaly; Octreotide LAR; Ultrasound guidance

Summary:

      Approximately half of patients with acromegaly do not respond to treatment with somatostatin
      receptor ligands such as octreotide LAR. This may be due to inadequate drug delivery if the
      standard of care regular injection is inaccurately delivered in the intramuscular (IM)
      compartment. Ultrasound guidance of IM injections may improve accuracy of placement of IM
      injections and increase drug levels, thereby improving efficacy of octreotide LAR for the
      treatment of acromegaly. The purpose of this study is to determine whether octreotide LAR
      drug levels differ if given by ultrasound-guided IM injection or by regular IM injection in
      patients with acromegaly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active acromegaly based on evidence of a pituitary tumor

          -  Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of
             growth hormone (GH) < 1 ng/mL during an oral glucose tolerance test

          -  Previous treatment with a stable dose of octreotide LAR for at least 3 months

          -  No previous treatment with a stable dose of octreotide LAR for at least 3 months after
             receiving 3 months of octreotide LAR during a run-in phase prior to any other
             study-related activity

        Exclusion Criteria:

          -  Uncontrolled diabetes mellitus

          -  Pregnant or breast feeding

          -  Current gallstones

          -  History of hepatic disease, except patients with < 3 X ULN LFTs indicative of hepatic
             steatosis

          -  Past or current history of cancer, except for basal cell carcinoma or in situ cancer
             of the cervix

          -  History of glucocorticoid therapy within the past 6 months, current treatment with any
             chemotherapeutic agents or exogenous GH therapy

          -  History of investigational drugs administered or received within 30 days of study
             entry

          -  Known hypersensitivity to octreotide LAR

          -  Any other concomitant illnesses or therapy that would interfere with evaluation of
             efficacy or safety or increase the risk for study interruption or discontinuation in
             the opinion of the investigator or sponsor
Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study
Condition: Vitamin D Deficiency; Nutritional Deficiency
MeSH terms: Vitamin D Deficiency; Malnutrition
Intervention: High dose Cholecalciferol; Cholecalciferol
Intervention description: Mothers in experimental group will receive 6,000 IU of vitamin D in addition to their prenatal vitamin, daily for 3 months. Infants in this group will receive placebo vitamin D drops; Mothers in placebo control group will receive 600 IU of vitamin D in the form of their prenatal vitamin along with placebo vitamin D. Infants of the mothers in this group will receive standard 400 IU of vitamin D
Intervention MeSH terms: Cholecalciferol; Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 0 Days
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Vitamin D

Summary:

      The overall goal of this study is to assess maternal vitamin D status along with diet, and
      milk composition, and in turn, to evaluate if infant vitamin D status can be improved with
      increased maternal supplementation and diet education. The central hypothesis is that by
      maximizing maternal vitamin D status in breastfed, preterm infants (<35 weeks), there will be
      an increase infant 25(OH)D status at 1,2, and 3 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with documentation of fully breastfeeding who present within one month of
             delivery, who are 18-45 years old and in good general health will be eligible for
             participation.

          -  Infants <35 weeks corrected gestational age at birth

        Exclusion Criteria:

          -  NO DMI/DMII, HTN, or parathyroid disease IF thyroid issues, currently euthyroid

          -  Multiple gestations

          -  No liver disease

          -  No major congenital abnormalities

          -  No kidney disease

          -  No inborn errors of metabolism

          -  No parathyroid disease

          -  No disorders of calcium metabolism

          -  No antiepileptics

          -  No steroids

          -  No congenital heart disease

          -  No severe illness at birth deemed incompatible with survival
Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Condition: Pain; Fever
MeSH terms: Fever
Intervention: Ibuprofen
Intervention description: Ibuprofen, 10 mg/kg
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Multi-center, Open-label
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: No
Keywords: Pediatric (Birth to less than 6 months of age); Pain; Fever

Summary:

      The primary objective of this study is to evaluate the pharmacokinetic profile of a single
      dose of intravenous ibuprofen administered over approximately ten (10) minutes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a hospitalized male or female subject between birth (> 37 weeks gestational age)
             and < six (6) months of age.

          -  Have a clinical indication of pain or fever.

          -  Have written informed consent provided by legal parent, guardian, or authorized agent
             prior to participation in the study or performance of any study-only related
             procedures.

        Exclusion Criteria:

          -  Have inadequate intravenous access.

          -  Have an uncorrected ductus dependent congenital heart disease.

          -  Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory
             drug or aspirin.

          -  Have a current history of uncorrected hypovolemia or acute renal disease.

          -  Have a current history of acute liver disease.

          -  Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to
             dosing. Have received another investigational drug within the past 30 days.

          -  Be otherwise unsuitable for the study, in the opinion of the Investigator.
Patiromer With or Without Food for the Treatment of Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Intervention: patiromer
Intervention description: 8.4 g/day starting dose, administered orally
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of Hyperkalemia; Hyperkalemia; Potassium; Chronic Kidney Disease

Summary:

      The purpose of this study is to evaluate the efficacy and safety of patiromer administered
      once daily (QD) when given with food compared to without food (experimental treatment group)
      for the treatment of hyperkalemia (high potassium in the blood).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Potassium concentration > 5.0 mEq/L from two blood draws at Screening

          -  Stable RAASi medication, if taking

          -  Medications taken on a chronic basis are given once daily or twice daily

          -  Informed consent given

        Key Exclusion Criteria:

          -  Expected need for dialysis

          -  Major organ transplant

          -  History of conditions associated with pseudohyperkalemia

          -  History of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or
             severe gastrointestinal disorders or major gastrointestinal surgery

          -  Cancer or unstable medical condition
Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Greenlight XPS Laser; BiVAP Saline Vaporization of the prostate
Intervention description: Treatment of BPH with Greenlight XPS laser; treatment of BPH with BiVAP Saline Vaporization
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: enlarged prostate

Summary:

      This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus
      BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic
      Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up
      visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male over the age of 18 years

          -  present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical
             intervention

          -  subjects must read, understand and sign the Informed Consent

          -  AUA ≥ 15

          -  Qmax < 15mL/sec

          -  Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months

          -  Prostate volume ≥ 30g

        Exclusion Criteria:

          -  PVR > 300ml

          -  Current urine retention

          -  Previous surgical or invasive treatments (TURP, TUMT, TUNA)

          -  PSA ≥ 4 (must have negative biopsy within last 12 months)

          -  Neurogenic bladder

          -  Obstruction due to urethral stricture

          -  Any disorder or condition of the subject that the investigator believes will counter
             indicate their inclusion in the study
Alternative Sedation During Bronchoscopy
Condition: Sedation
Intervention: Dexmedetomidine load; Ketamine load; Midazolam load; Fentanyl load; Dexmedetomidine maintenance; Ketamine maintenance; Midazolam demand; Fentanyl demand; Benadryl demand
Intervention description: Dexmedetomidine 1 µg/kg prior to bronchoscopy; Ketamine 30 mg bolus prior to bronchoscopy; 2 mg bolus prior to bronchoscopy; 50 µg bolus prior to bronchoscopy; 0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average); 8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average); 0.5 mg demand bolus at discretion of pulmonologist; 12.5 µg demand bolus at discretion of pulmonologist; 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Intervention MeSH terms: Diphenhydramine; Midazolam; Fentanyl; Dexmedetomidine; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: bronchoscopy

Summary:

      This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the
      use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in
      less respiratory depression while providing better compliance with the procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults over the age of 18 scheduled for elective flexible bronchoscopy in the
             endoscopy suite or OR of HUP

        Exclusion Criteria:

          -  History of inability to complete bronchoscopy attributable to inadequate sedation

          -  Requiring more than 2 LPM supplemental oxygen to maintain SaO2 > 90%

          -  History of allergy to study medications

          -  Pregnancy

          -  A history of psychosis

          -  Any condition deemed likely by the pulmonologist or anesthesiologist to pose a
             significant risk due to elevation of blood pressure, including cerebral/aortic
             aneurysm, and or ischemic cardiovascular disease

          -  Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist

          -  A diagnosis of significant renal or hepatic impairment
Use of Tranexamic Acid in Reduction Mammoplasty
Condition: Hematoma Postoperative; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism; Hematoma
Intervention: Tranexamic acid; Placebo (topical saline)
Intervention description: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.; The untreated breast will receive topical saline.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Each patient undergoing routine bilateral breast reduction randomized to receive the study drug in either the right or left breast
Masking: Double (Participant, Care Provider)
Masking description: The patient and the surgical team will be blinded to which breast has received the study drug
Enrollment: 98.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: breast reduction mammoplasty; hematoma; tranexamic acid

Summary:

      Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic
      surgery. However, postoperative hematoma is one of the most common complications following
      BRM. Hematoma-related complications include unplanned surgery, need for blood transfusion,
      wound healing issues, and unfavorable surgical outcomes.

      Tranexamic acid has emerged in the literature as a promising agent that reduces perioperative
      blood loss and need for transfusion. However, despite its consistently reported efficacy, low
      cost, and favorable safety profile, tranexamic acid remains underutilized in plastic surgery.

      The investigators propose a prospective, double-blinded randomized controlled study of the
      efficacy of tranexamic acid in reducing hematoma development in patients undergoing reduction
      mammoplasty. The investigators hope to contribute to the growing body of literature
      supporting tranexamic acid to reduce unwanted surgical bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Being over the age of 18

          -  Undergoing bilateral reduction mammoplasty at the Hutchinson Metro Center of
             Montefiore Medical Center, Bronx, New York

        Exclusion Criteria:

          -  Oncologic breast reduction

          -  Unilateral breast reduction

          -  History of thromboembolic disease

          -  History of bleeding diatheses

          -  History of stroke

          -  History of seizure disorder

          -  Currently pregnant

          -  Severe comorbidity (defined as American Society of Anesthesiologists (ASA) fitness
             grade IV or above)
The Effects of Dexmedetomidine Dose on Motor Evoked Potentials
Condition: Spinal Fusion
Intervention: Dexmedetomidine
Intervention description: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Masking description: The anesthesiologist administering anesthetic agents will have knowledge of their doses. The technologist performing motor evoked potential testing and other participants will not.
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: motor evoked potentials

Summary:

      This a parallel group, two-arm, randomized superiority trial that will compare the effect of
      two different doses of dexmedetomidine on motor evoked potentials during spine surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing multi-level posterior spine fusions requiring motor evoked
             potential monitoring

        Exclusion Criteria:

          -  Allergy to dexmedetomidine, propofol

          -  Conditions knows to make recording of motor evoked potentials difficult, including
             poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or
             previous surgery during which motor evoked potentials were difficult to obtain

          -  Hepatic disease
Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients
Condition: Systemic Fungal Infections
MeSH terms: Mycoses
Intervention: Posaconazole
Intervention description: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.
Intervention MeSH terms: Posaconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to try to find out how critically ill patients receiving the
      anti fungal medication, posaconazole, process it in their body. Investigators would like to
      study if the recommended doses of posaconazole achieve adequate concentrations in the
      patients blood to treat fungal infections.The disease process in critically ill patients can
      profoundly influence the concentration of anti fungal medication in the blood. The process by
      which a drug travels through the body in blood, how it is broken down and removed by the body
      is called pharmacokinetics (PK).

      This information is important to know because if antifungal levels are low in the blood, the
      fungal infection has an opportunity to become resistant to the antifungal medication which
      can lead to the medication being less effective against the fungal infection potentially
      exposing future patients with infection to a limited range of effective antifungals.

      Investigators can measure the PK by taking blood samples at specific times after the anti
      fungal medication is given.

      This study will enroll 8 patients who are admitted to the intensive care unit and are being
      treated with an antifungal medication for a fungal infection. Patients will be consented and
      given a single dose of posaconazole and serial blood samples will be collected just prior to
      the dose and at 15, 45,75 minutes during the infusion and at 3, 5, 8, 12, 18, 24, 30 36 and
      48 hours . Information about the patients stay in the ICU will also be collected including
      blood pressure, temperature, blood test results.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years

          -  Admission for ICU care

          -  The presence of suspected or confirmed fungal infection requiring systemic antifungal
             therapy

          -  Presence of central venous access for drug administration

        Exclusion Criteria:

          -  Age < 18 years

          -  Pregnancy

          -  Prescription of drugs that are known to interact with posaconazole

          -  Oral posaconazole use within the last two week prior to enrolment

          -  Documented history of drug reaction to the triazole antifungal medications
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis
Condition: Saphenous Vein Graft Disease
MeSH terms: Thrombosis
Intervention: Aspirin; Ticagrelor
Intervention MeSH terms: Aspirin; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Saphenous vein graft disease; Coronary artery bypass graft surgery; Antiplatelet therapy; Coronary artery disease; Secondary prevention; Graft patency

Summary:

      Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude
      in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including
      recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While
      aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts
      continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin
      and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more
      pronounced platelet inhibition, and may substantially improve graft patency following CABG
      compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on
      saphenous vein graft patency following CABG. In this context, the investigators seek to
      compare vein graft patency between patients randomized to receive aspirin therapy, the
      current standard of care, or ticagrelor treatment, starting in the early postoperative
      period, and continuing for 2 years after CABG.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures

          2. Female and/or male patients aged 18-90 years

          3. Patients undergoing first-time CABG with at least 1 saphenous vein graft, irrespective
             of concurrent valve surgery

        Exclusion Criteria:

          1. Inability to provide informed consent

          2. Pregnancy or seeking pregnancy

          3. Patients undergoing redo-CABG

          4. Serum creatinine >1.8 mg/dL (need for contrast with CT coronary angiogram)

          5. Hypersensitivity or allergy to aspirin or ticagrelor

          6. Anticipated need for postoperative anticoagulation with coumadin, dabigatran or
             rivaroxaban (mechanical valve, chronic atrial fibrillation, DVT/PE)

          7. History of gastrointestinal hemorrhage

          8. Active pathological bleeding

          9. History of intracranial hemorrhage

         10. Severe hepatic impairment

         11. Current or anticipated use of strong CYP3A4 inhibitors (e.g. ketoconazole,
             clarithromycin, nefazadone, ritonavir, and atazanavir)