bioihbjkbjnl/mcl2 huggingface dataset:
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
Condition: Liver Transplantation
Intervention: Mycophenolate mofetil; CNI (50%); CNI (≥75%)
Intervention description: 1.5 to 2.0 g daily PO BID; 50% reduction from BL; ≥75% reduction from BL
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of switching to CellCept combined with
      different regimens of reduced calcineurin inhibitors (CNI) in patients with liver
      transplants. Patients currently receiving CNI treatment will be randomized into one of 2
      groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or
      2) CellCept 2.0g/day po bid + >=75% reduction of CNI from baseline. The anticipated time on
      study treatment is 1 year, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  single organ recipients of liver allograft;

          -  CNI-based immunosuppressive regimen prior to study entry and regimen adjustment;

          -  >=6 months post-transplant, with renal dysfunction (serum creatinine 140-300micromol/L
             at entry);

          -  negative pregnancy test for women of childbearing potential; contraception must be
             taken before beginning study drug therapy and until 6 weeks after last dose of study
             medication.

        Exclusion Criteria:

          -  treatment with CellCept or any other product which delivers mycophenolic acid within
             the 3 months prior to the recent switch to CellCept relevant for enrollment;

          -  known contraindications to CNI, corticosteroids or CellCept.
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections
Intervention: Bezlotoxumab
Intervention description: Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group compared to concurrent and historical control groups
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: clostridium difficile; diarrhea

Summary:

      This study will examine whether the human monoclonal antibody, bezlotoxumab administered
      AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent
      antibiotic therapy, will eliminate the high risk of C. diff relapse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  C diff diagnosed within 90 days

          -  Receipt of high-risk antibiotics for C diff (e.g. Beta-lactams, carbapenems) in an
             inpatient setting

          -  Age 60 years and older

        Exclusion Criteria:

          -  Receipt of current C.diff active antibiotics (oral vancomycin, fidaxomycin,
             metronidazole, tigecycline/ doxycycline, nitazoxanide, rifamycin) within 72hrs.

          -  Not Expected to survive 8 weeks

          -  Prior or planned fecal microbiota transplant or Bezlotoxumab use

          -  Congestive heart failure (a potential risk of Bezlotoxumab)
Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence
Condition: Hypotrichosis
MeSH terms: Hypotrichosis
Intervention: bimatoprost ophthalmic solution 0.03%; bimatoprost vehicle solution
Intervention description: One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.; One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine patient satisfaction with LATISSE® treatment for
      increasing eyelash prominence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have inadequate eyelashes

          -  Never used prescription eyelash growth products

        Exclusion Criteria:

          -  No visible eyelashes

          -  Permanent eyeliner or eyelash implants

          -  Semi-permanent eyelash tint, dye, or extensions within 3 months

          -  Over-the-counter eyelash growth products within 6 months

          -  Any disease, infection or abnormality of the eye or area around the eye

          -  Eye surgery within 3 months, or the anticipated need for eye surgery during the study

          -  Unable or unwilling to keep contact lenses out during drug application and for 30
             minutes after application
Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
Condition: Primary Total Hip and Knee Arthroplasty
Intervention: Arixtra; Pneumatic compression stockings; Aspirin
Intervention description: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
Intervention MeSH terms: Aspirin; Fondaparinux
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hip, Knee, Arthroplasty, venous thromboembolic events, blood loss

Summary:

      This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to
      detect changes in coagulability following elective total knee and hip arthroplasty. Patients
      will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:

        1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325
           mg for 5 weeks, or

        2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc.,
           Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women age ≥ 18 years old

          2. Total knee or total hip arthroplasty planned in the 60 days following study enrollment

        Exclusion Criteria:

          1. Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and
             all other non-mentioned anticoagulants) on admission

          2. History of bleeding diathesis

          3. Known active malignancy

          4. Prothrombin time >1.5 x control

          5. Platelet count < 100,000/mm3, hematocrit < 30%, creatinine clearance <30 mL/min

          6. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic
             hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis

          7. Major surgery within past 3 months of enrollment

          8. Patients requiring bilateral arthroplasty

          9. Body weight <50 kg (venous thromboembolism prophylaxis only)

         10. Unable to return to site for follow-up visit
A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Enfuvirtide; Highly active antiretroviral treatment (HAART)
Intervention description: 90 mg subcutaneous injection twice a day; An oral HAART regimen of 3-5 antiretrovirals was chosen by the physician and patient, based on the patient's prior treatment history and genotypic antiretroviral resistance testing.
Intervention MeSH terms: Anti-Retroviral Agents; Enfuvirtide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with
      HAART alone in achieving and maintaining viral load suppression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected adults >=18 years of age;

          -  currently on antiretroviral (ARV) therapy;

          -  previously treated with 2 or 3 different antiretroviral classes;

          -  HIV-1 Ribonucleic acid (RNA) >=1,000 copies/mL;

          -  Cluster differentiation antigen four (CD4) lymphocyte count >=200 cells/mm^3;

          -  females of childbearing potential must be willing to use a reliable form of effective
             barrier contraception for the duration of the study and for 30 days after the last
             dose of study drug.

        Exclusion Criteria:

          -  history of prior use of enfuvirtide or T-1249;

          -  women who are pregnant, breastfeeding or planning to become pregnant during the study;

          -  active, untreated opportunistic infection;

          -  patients on treatment interruption, or patients interrupting ARV therapy within 4
             weeks of screening or during the screening period for reasons either than toxicity
             management.
Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
Condition: Cancer
MeSH terms: Pneumonia
Intervention: 1,25 (OH)2 D3; Inspiratory isometric resistance training; Oral Placebo; Sham Inspiratory Isometric Resistance Training; Threshold Inspiratory Muscle Trainer (IMT)
Intervention description: 0.25 micrograms, taken daily for eight weeks, orally; A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax).; Placebo will be created to mimic the appearance of the study drug; A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax.; A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
Intervention MeSH terms: Calcitriol; Dihydroxycholecalciferols
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia

Summary:

      This research is intended to begin to explore the impact of inspiratory muscle resistance
      exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients
      (subjects).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of cancer

          -  Renal and hepatic function (creatinine </= 2 x the institutional upper limit of
             normal; bilirubin </= 2 x the institutional upper limit of normal)

          -  No contraindication to receive either of the planned interventions of inspiratory
             resistance training or 1,25(OH)2D3 in the opinion of the healthcare provider

          -  No difficulties with swallowing oral medications in the opinion of the enrolling
             physician

        Exclusion Criteria:

          -  Patient is taking calcium or Vitamin D supplements and is unwilling to stop for 8
             weeks

          -  Severe chronic obstructive pulmonary disease (oxygen dependent or patient self-reports
             unable to walk one block without difficulty)

          -  Calcium or phosphorus level above the institutional upper limit of normal
Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty
Condition: Femoral Neck Fractures
MeSH terms: Femoral Neck Fractures
Intervention: Tranexamic Acid; Placebo (saline)
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Hip Hemiarthroplasty; Tranexamic Acid; Topical; Blood Transfusion

Summary:

      This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1
      gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion
      following hip hemiarthroplasty surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture

        Exclusion Criteria:

          -  History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism,
             history of thrombophilia, history of chronic renal failure

          -  Patients with coronary ischemia (active or within the past calendar year), patients
             who have suffered a myocardial infarction, undergone percutaneous coronary
             intervention, undergone coronary artery bypass grafting, or undergone any
             revascularization procedure within the past calendar year

          -  Patients with active subarachnoid hemorrhage, acquired defective color vision,
             patients who sustained a pathologic fracture (fracture through a neoplastic lesion),
             or patients who are pregnant

          -  Patients with a known allergy to tranexamic acid

          -  Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma
CUTE (Chronic Urticaria Treatment Evaluation)
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Levocetirizine; Desloratadine
Intervention description: 5mg oral capsules, once daily, 4 week duration; 5mg oral capsules, once daily, 4 week duration
Intervention MeSH terms: Levocetirizine; Desloratadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 886.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Idiopathic Urticaria; CUTE Levocetirizine Xyzal®

Summary:

      A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in
      patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus
      severity score over the first week of treatment
    

Eligibility criteria:

        Inclusion Criteria:

        - At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6
        weeks during the last 3 months without an identifiable cause

        - At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of
        CIU, both in terms of symptoms and severity.

        Exclusion Criteria:

        - Any condition that would interfere with the evaluation of the therapeutic response.
Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Systolic Murmurs
Intervention: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Dextrose
Intervention description: Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.
Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.; Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.
Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary artery systolic pressure (PASP); Pulmonary Vascular Resistance (PVR); Right Heart Catheterization; Pulmonary hemodynamics

Summary:

      The design of this study is to conduct a comprehensive safety evaluation of the pulmonary
      hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac
      catheterization for clinical reasons.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be already scheduled for left and/or right heart catheterization for clinical
             reasons.

          -  Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess
             pulmonary hemodynamics by catheterization, as determined by the investigator.

          -  Women of childbearing potential must be using adequate birth control and have a
             negative pregnancy test.

        Exclusion Criteria:

          -  History of right-to-left, bi-directional, or transient right-to-left cardiac shunts or
             diagnosed by color flow Doppler echocardiography during screening.

          -  Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.

          -  Female subjects who are nursing mothers.
Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?
Condition: Larynx Disease; Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Laryngopharyngeal Reflux; Laryngeal Diseases
Intervention: Prevacid; Esophageal and Laryngeal Biopsies
Intervention description: 30 mg bid for 3 months; repeat egd with biopsy after Prevacid 30 mg bid for 3 months
Intervention MeSH terms: Lansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if tissue changes are predictor of clinical response
      to therapy.

      The hypothesis is that the patients who have laryngeal signs and symptoms related to acid
      reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of
      response to therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        GERD

          -  Documented erosive esophagitis:

               -  Patients will be newly diagnosed with esophageal erosion at initial visit via EGD

               -  Patients with non-erosive esophagitis who have been responsive to PPI

        LPR

          -  Diagnosed via Head & Neck Institute endoscopists:

               -  pts with chronic (> 3-months) history of hoarseness, throat clearing, sore- or
                  burning throat and globus

               -  Documentation of LPR using Larynx/Pharynx exam.

        This group is commonly evaluated at the Vanderbilt Voice Center.

        Exclusion Criteria:

          -  Age < 18yrs

          -  Pregnancy

          -  Patients with contra-indications for EGD

          -  Patients on corticosteroids

          -  Active smokers

          -  Patients with a history of regular (> 2 /day) alcohol use.

          -  Use of antacid (PPI, H2RB) within last 30 days

          -  Use of any/all medications affecting gastrointestinal motility

          -  Known history of: Barrett's esophagus, Peptic stricture, Pyloric stenosis, Gastric
             resection

          -  Patients unable to give informed consent

          -  Patients unable to comply with follow-up

          -  Patients with known contraindication to lansoprazole.

          -  Contraindications to biopsy: Taking anticoagulants other than aspirin (Coumadin,
             Plavix) or allergic to the local anesthetics.
Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Liposomal Bupivacaine; 0.5% Bupivacaine HCL
Intervention description: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL; 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Total Shoulder Arthroplasty (TSA); Interscalene Nerve Block (ISB)

Summary:

      This is a phase IV , randomized, single-blind, single-center study comparing patient related
      outcomes such as postoperative pain and opioid usage for patients who receive ISB 's
      containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine
      HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid
      utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5%
      bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to
      understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene
      block after TSA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing total shoulder arthroplasty;

          -  Patients who consent to be randomized.

        Exclusion Criteria:

          -  Patients younger than 18 and older than 75;

          -  Patients with a history of chronic pain that have used opioids for pain management for
             3 months or longer;

          -  Patients who are allergic to oxycodone;

          -  Patients who are unable to speak English;

          -  Patients with diagnosed or self---reported cognitive dysfunction;

          -  Patients with a history of neurologic disorder that can interfere with pain sensation;

          -  Patients with a history of drug or recorded alcohol abuse;

          -  Patients who are unable to understand or follow instructions;

          -  Patients with severe liver disease, renal insufficiency, congestive heart failure,
             and/or significant heart disease;

          -  Patients with an allergy or contraindication to any of the medications used in the
             study, or patients with a contraindication to any study procedures;

          -  Patients with BMI over 40;

          -  Any patient that the investigators feel cannot comply with all study related
             procedures;

          -  NYU Langone Health students, residents, faculty or staff members