bioihbjkbjnl/mcl2 huggingface dataset:
Covid-19 Associated Coagulopathy
Condition: COVID 19 Associated Coagulopathy
MeSH terms: COVID-19; Hemostatic Disorders; Blood Coagulation Disorders
Intervention: Intermediate dose thromboprophylaxis; Standard of Care thromboprophylaxis
Intervention description: 2) Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI<30kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).; Patients randomized to the standard of care arm will receive standard prophylactic dose enoxaparin (40 mg subcutaneously daily if BMI <30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30 kg/m2).
Intervention MeSH terms: Enoxaparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multi-center, randomized, open-label study comparing standard prophylactic dose enoxaparin (40 mg SC daily or 30 or 40 mg SC twice daily if BMI ≥30kg/m2; standard of care arm) versus intermediate-dose enoxaparin (1 mg/kg SC daily or 0.5 mg/kg SC twice daily if BMI≥30kg/m2; intervention arm) in hospitalized patients with laboratory-confirmed SARS-CoV-2 infection.
Masking: None (Open Label)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This prospective, randomized, open-label, multi-center interventional study is designed to
      compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the
      University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria
      score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care
      arm) or intermediate-dose LMWH (intervention arm).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Laboratory confirmed SARS-CoV-2 infection

          -  Age ≥18 years

          -  Requires hospital admission for further clinical management

          -  Modified ISTH Overt DIC score ≥ 3

        Exclusion Criteria:

          -  Indication for full therapeutic-dose anticoagulation

          -  Acute venous thromboembolism (deep vein thrombosis or pulmonary embolism) within prior
             3 months

          -  Acute cardiovascular event within prior 3 months

          -  Acute stroke (ischemic or hemorrhagic) within prior 3 months

          -  Active major bleeding

          -  Severe thrombocytopenia (<25,000/mm3)

          -  Increased risk of bleeding, as assessed by the investigator

          -  Acute or chronic renal insufficiency with Creatinine Clearance < 30 ml/min calculated
             by the modified Cockcroft and Gault formula

          -  Weight < 40 kg

          -  Known allergies to ingredients contained in enoxaparin, allergy to heparin products or
             history of heparin induced thrombocytopenia
Comparison of Insulin Therapy in Treating Post-Transplant Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Insulin, Isophane; insulin glargine
Intervention description: daily dosing based on fasting morning glucose levels; daily dose based on fasting morning glucose levels
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Subjects will be randomized to
Insulin glargine (Lantus) or
Insulin isophane (NPH)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post-transplant; diabetes mellitus; renal transplant; kidney transplant; lung transplant; heart transplant; insulin

Summary:

      To determine if the use of insulin isophane results in improved control of blood sugars
      compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart
      transplantation (NODAT).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be followed by the Inova Fairfax Hospital transplantation program for
             post-transplant care

          2. Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin
             hypoglycemic medication

          3. Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if
             it was required)

          4. Ability to read consent form and give consent in English.

        Exclusion Criteria:

          1. Use of insulin or non-insulin hypoglycemic medication before transplantation

          2. Cystic fibrosis patients

          3. Age < 18 years of age

          4. Pregnancy

          5. Non-English speaking subjects
Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Dexmedetomidine; Placebo Saline
Intervention description: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.; Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, prospective, double-blind , placebo-controlled trial examining the
      effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar
      spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects,
      over the age of 18, undergoing lumbar spinal fusion will be considered eligible for
      enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal
      saline infusion. They will be followed for approximately six weeks postoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults who will undergo lumbar spinal fusion, including surgeries extending into
             thoracic and sacral segments

          -  Subject is non-lactating and is either:

          -  Not of childbearing potential

          -  Of childbearing potential but is not pregnant at time of surgery as determined by
             pre-surgical pregnancy testing

          -  Subject is ASA physical status 1, 2, or 3.

        Exclusion Criteria:

          -  Subject is pregnant or breastfeeding

          -  Any subject whom the investigators deem unable to complete any/all research related
             tasks

          -  Subjects who are cognitively impaired (by history)

          -  Subject requires antipsychotic medications

          -  Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks
             prior to surgery

          -  Subject has known allergy to dexmedetomidine

          -  Subjects with impaired renal or hepatic function

          -  Subjects with advanced heart block

          -  Subjects with severe ventricular dysfunction
Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
Condition: Shoulder Pain; Rotator Cuff Tear
MeSH terms: Shoulder Pain; Rotator Cuff Injuries
Intervention: Liposomal bupivacaine; Bupivacaine 0.25%
Intervention description: liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc); 20 cc of bupivacaine 0.25%
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Exparel; Liposomal Bupivacaine; Arthroscopic Shoulder Surgery

Summary:

      The purpose of this study is to compare the quality and duration of pain relief after
      shoulder surgery provided by a single injection of liposomal bupivacaine versus standard
      bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized
      that the liposomal bupivacaine formulation will provide more effective pain relief than
      standard bupivacaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English speaking adults (age >17 years) of American Society of Anesthesiologists (ASA)
             I-III physical class scheduled for elective arthroscopic shoulder surgery will be
             eligible to participate regardless of race/ethnicity.

        Exclusion Criteria:

          -  Subjects will not be eligible for this trial if they report a history of an allergy to
             a local anesthetic, baseline neurological deficit, a medical condition that would make
             it difficult to assess sensory distribution or communicate with the staff, a recent
             history (< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a
             preexisting coagulation disorder.
Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients
Condition: Nephrotoxicity
Intervention: Belatacept
Intervention MeSH terms: Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pancreas transplantation; immunosuppression; belatacept

Summary:

      Kidney damage is a major complication of current antirejection medicines used in
      transplantation. An increasing number of brittle diabetics are successfully receiving a
      pancreas transplant. One of the challenges following pancreas transplant is that a patient
      can develop kidney damage from one of their antirejection medicines, tacrolimus. The
      objective of this study is to substitute a new antirejection medicine which does not cause
      kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus
      related kidney damage to slow the progression of kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pancreas transplant alone recipients

          -  EBV IgG positive

          -  Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy

          -  Maintained on a regimen of tacrolimus, sirolimus, mycophenolate

        Exclusion Criteria:

          -  EBV IgG negative

          -  Not maintained on an immunosuppression regimen that contains tacrolimus

          -  Unable or unwilling to give informed consent

          -  Active infection

          -  History of malignancy post transplant

          -  Glomerular filtration rate < 15 mL/min
Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
Condition: Idiopathic Focal Segmental Glomerulosclerosis
MeSH terms: Proteinuria; Glomerulosclerosis, Focal Segmental
Intervention: Acthar Gel
Intervention description: Acthar Gel 80 U/mL solution for subcutaneous injection
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FSGS; primary FSGS; idiopathic FSGS

Summary:

      Focal segmental glomerulosclerosis (FSGS) is a condition that harms the kidney "filters" that
      remove waste from the blood. Proteins are supposed to stay in the blood. Damaged "filters"
      let protein get into the kidney.

      FSGS is a serious condition that can lead to kidney failure. The only treatment for kidney
      failure is dialysis or kidney transplant.

      Proteinuria means too much protein came through the kidneys into the urine.

      If the doctor cannot figure out what is causing the problem, it is primary (idiopathic) FSGS.
      This kind of FSGS is very hard to treat.

      This study will test Acthar in patients with this condition who have not responded to other
      treatments. It primarily investigates how well the therapy is tolerated by the patients and
      how well they respond to this treatment.
    

Eligibility criteria:

        Inclusion Criteria

        Potential participants must meet the following summary criteria for inclusion in the study:

          -  Is male or non-pregnant, non-lactating female

          -  Has primary FSGS, is nephrotic and did not achieve at least partial proteinuria
             response with prior therapy

          -  Has been treated with an angiotensin converting enzyme inhibitor or receptor blocker
             (or have documented intolerance), for at least 4 weeks before screening

          -  Has blood pressure no higher than 150/90 mmHg

          -  Meets all other inclusion criteria detailed in the protocol

        Exclusion Criteria

        Potential participants will not be eligible for the the study if they meet the following
        summary criteria:

          -  Has hepatitis B or C, tuberculosis, or other contraindication listed on the United
             States (US) Prescribing Information for Acthar

          -  Has Type 1 or Type 2 diabetes mellitus or any clinically significant infection

          -  Has received specific treatments at exclusionary time points per protocol

          -  Has been involved in a therapeutic drug/device trial (other than for FSGS) within 4
             weeks before screening

          -  Meets any other exclusion criteria detailed in the protocol

          -  Has any other condition that might, per protocol or in the opinion of the
             investigator, compromise:

               1. the safety and well-being of the participant or their offspring

               2. the safety of study staff

               3. analysis of results
Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy
Condition: Shoulder Arthroscopy; Pain
Intervention: IV Saline; IV Dexamethasone 4mg; IV Dexamethasone 6mg; IV Dexamethasone 8mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks.
      However, these studies only used fixed doses of IV dexamethasone at relatively high doses,
      which could potentially lead to increased glucose levels, delayed wound healing, and
      unintended side effects. There remains a paucity of research on the effective dose range of
      IV dexamethasone for the prolongation of supraclavicular blocks. The optimal dosage of IV
      dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular
      blocks in shoulder surgery has yet to be delineated.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients undergoing shoulder arthroscopy under regional anesthesia

        Exclusion Criteria:

          -  General anesthesia

          -  Contraindication to regional anesthesia

          -  Pre-existing neuropathy in the surgical limb

          -  Diabetes Mellitus

          -  History of postoperative nausea and vomiting &/ or motion sickness

          -  Procedures involving biceps tenotomy

          -  Peri-articular cocktail injections given intraoperatively to augment pain relief

          -  Chronic pain (daily opioid and/or gabapentinoid use for 6 weeks)

          -  Open surgical procedures

          -  Corticosteroid injection within 1 month

          -  Patients on systemic oral or IV steroid therapy within 6 months
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
Condition: Granulomatosis With Polyangiitis; Microscopic Polyangiitis
MeSH terms: Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Vasculitis; Systemic Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Intervention: Glucocorticoids; Rituximab
Intervention description: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.
Prednisone will be tapered over 8 weeks as follows:
60mg for 2 weeks
40mg for 2 weeks
30mg for 1 week
20mg for 1 week
10mg for 1 week
5mg for 1 week; Rituximab will be administered in four weekly doses at 375mg/m2
Intervention MeSH terms: Prednisone; Rituximab; Glucocorticoids
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to test whether an 8-week course of glucocorticoids,
      combined with rituximab, is effective in treating ANCA-associated vasculitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ages 18-85 years old

          -  Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus
             Conference

          -  New diagnosis or disease flare with a Birmingham Vasculitis Activity Score/Wegener's
             granulomatosis (BVAS/WG) of > 3

        Exclusion Criteria:

          -  Renal disease in patients with PR3-ANCA as defined by any of the following:

          -  Urinary red blood cell casts

          -  Biopsy-proven glomerulonephritis

          -  Increase in serum creatinine of >30% over baseline

          -  Severe renal disease in patients with MPO-ANCA as defined by both of the following:

          -  Urinary red blood cell casts or biopsy-proven glomerulonephritis

          -  Estimated glomerular filtration rate < 30 ml/min/1.73m2

          -  Diffuse alveolar hemorrhage requiring ventilatory support

          -  GC treatment for longer than 14 days prior to enrollment unless patient has been on a
             stable maintenance dose of prednisone at the time of the flare

          -  Daily oral cyclophosphamide within 1 month prior to enrollment

          -  Completed a remission induction course of cyclophosphamide or rituximab within 4
             months of enrollment

          -  Hepatitis B infection

          -  HIV infection

          -  History of anti-GBM disease

          -  Other uncontrolled disease, including drug and alcohol abuse, that may interfere with
             the study

          -  Pregnancy or breastfeeding

          -  History of severe allergic reactions to human or chimeric monoclonal antibodies
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
Condition: Oocyte Retrieval; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Fentanyl; Acetaminophen; Oxycodone
Intervention description: 0.5, 1 mcg/kg; Single + Oxycodone; With Acetaminophen
Intervention MeSH terms: Acetaminophen; Fentanyl; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Assessment of immediate and delayed postoperative pain
Masking: None (Open Label)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: assisted reproduction; postoperative pain; opioid

Summary:

      The central objective of this study will be to evaluate the relationship between estrogen
      levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) I to III health status (moderate systemic
             disease),

          -  Age between 18 and 50 yrs

          -  Undergoing oocyte retrieval with intravenous general anesthesia.

        Exclusion Criteria:

          -  Refuse or withdraw their consent

          -  Fail to adequately respond to IVF stimulations medications, and thus are not eligible
             for oocyte retrieval.
Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
Condition: Stem Cell Transplant Complications; Delirium
MeSH terms: Delirium
Intervention: Haldol
Intervention MeSH terms: Haloperidol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This research study proposes to conduct an open label, feasibility study administering
      prophylactic oral haldol to patients undergoing a hematopoietic stem cell transplant (HSCT).

      The study will address the following research aims: 1) To demonstrate the feasibility of
      enrolling HSCT patients in a prophylactic medication trial, 2) To determine the tolerability
      of oral haldol in HSCT patients and 2) To compare rates of delirium in HSCT patients who
      receive prophylactic haldol with an untreated historical control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant must undergo an autologous or allogeneic bone marrow or stem cell
             transplant

          -  The participant is 18 years of age or older

          -  The participant provides written consent

        Exclusion Criteria:

          -  The participant has a QTc of >450 msec at the time of enrollment

          -  The participant used any antipsychotic medications within the last 30 days

          -  The participant has any significant allergies or past intolerance to Haloperidol

          -  The participant has a history of major neurological, metabolic, psychiatric, or
             cardiovascular disease, cerebrovascular event, or substance abuse

          -  The participant has a history of mental retardation or learning disability that, at
             the discretion of the investigator, could affect their ability to complete study
             assessments.