bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
Condition: Pertrochanteric Fracture
Intervention: Marcaine, Duramorph , ketorolac; Bupivacaine (Marcaine); General Anesthetics
Intervention description: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.; 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.; Placebo group will only receive standard of care general anesthesia
Intervention MeSH terms: Ketorolac; Morphine; Bupivacaine; Anesthetics; Anesthetics, General
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the
      effects of surgical site injection on pain and narcotic utilization in participants who
      undergo surgery for lower extremity fractures. 200 participants with lower extremity
      fractures who are admitted for operative fixation will be included in the study. Participants
      will be randomized to receive either a pain cocktail injection around the fracture site and
      surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation
      progress, length of stay, narcotic utilization, and satisfaction scores will be performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric,
             and femoral shaft fracture

        Exclusion Criteria:

          -  Pregnant women

          -  Treatment with Arthroplasty

          -  Patients who receive a peripheral nerve block

          -  Patients who receive intra-op or post-op ketamine

          -  Patients with concomitant TBI or MR

          -  Polytrauma patients

          -  Pathologic Fractures

          -  Patients who live greater than 10 miles from NYU or who will not be followed by an NYU
             provider

          -  Patients with a contraindication to any of the medications on the study list due to
             other medical problems such as renal or liver disease or due to allergy/intolerance

          -  Patients with prior extremity weakness resulting from stroke or other neurological
             condition

          -  Prior or current history of narcotic use

          -  Patients with advanced dementia

          -  NYUMC Students, Residents, Faculty
Testosterone Patch's Effects on the Cardiovascular System and Libido
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Intervention: Intrinsa Transdermal testosterone patch
Intervention description: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hypoactive sexual desire disorder

Summary:

      The purpose of this study is to examine the effect of the testosterone patch, in addition to
      hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy postmenopausal women

          -  45 to 70 years of age

          -  on HRT and willing to continue the same HRT regimen for the next 6 months

          -  are in a stable relationship which was started at least 6 months ago

          -  continue on any concomitant medications without any change during the study

          -  give informed consent.

        Exclusion Criteria:

          -  have dyspareunia

          -  have received testosterone implants within the last 12 months or other androgen
             therapy within the last 6 months

          -  have received any medications which may interfere with the study (SSRI,
             anti-androgens, PDE5 inhibitors, DHEA, SERMS)

          -  have a significant psychiatric disorder

          -  have a history of breast cancer

          -  have diabetes, thromboembolic disorders, cardiovascular disease, any condition
             affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled
             hyperlipidaemia

          -  are on tibolone (due to its androgenic effect).
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Prednisolone Sodium Phosphate Ophthalmic Solution 1%; Tears Naturale II Ophthalmic Solution
Intervention description: One drop in each eye, four times/day for 8 days.; one drop in each eye, four times/ day (QID) for 8 days
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Pharmaceutical Solutions; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of the modified Conjunctival
      Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to
      treatment with a proven ocular anti-inflammatory medication,

      Prednisolone, assessed by the following measures:

        -  Ocular itching

        -  Conjunctival redness
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age & either sex, any race

          -  Willing and able to follow all instructions

          -  Positive history of ocular allergies

          -  Reproducible positive ocular allergic reaction induced by conjunctival allergen
             challenge

        Exclusion Criteria:

          -  Have planned surgery during trial period

          -  Female currently pregnant, planning a pregnancy or lactating

          -  Use of disallowed medications

          -  Have ocular infections, or ocular conditions that could affect study parameters

          -  Have moderate to severe dry eye

          -  Have used an investigational drug or device within 30 days of start of study

          -  Female that is currently pregnant, planning a pregnancy or lactating
UPMC OPTIMISE-C19 Trial, a COVID-19 Study
Condition: Covid19
MeSH terms: COVID-19
Intervention: Lilly Bamlanivimab; Regeneron Casirivimab + Imdevimab; Lilly Bamlanivimab + Etesevimab; Sotrovimab; Bebtelovimab
Intervention description: Administration of Lilly Bamlanivimab to COVID positive patients; Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients; Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients; Administration of Sotrovimab to COVID positive patients; Administration of Bebtelovimab to COVID positive patients
Intervention MeSH terms: Sotrovimab; Bamlanivimab; Casirivimab and imdevimab drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is an adaptive platform and as such is intended to study multiple interventions simultaneously, does not have a defined sample size, and is intended to move forward in perpetual fashion with domains and interventions being added and subtracted over time. For example, interventions will be added and subtracted depending on federal decisions regarding monoclonal antibodies, such as granting or revoking authorization for use.
Masking: None (Open Label)
Enrollment: 4571.0
Sex: All
Minimum age: 12 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: COVID; monoclonal antibodies

Summary:

      Multiple monoclonal antibodies (mABs) have been shown to reduce viral burden and improve
      clinical outcomes, have been granted FDA Emergency Use Authorization (EUA) for use in select
      populations, and are routinely used in the UPMC Health System, which has made expanded access
      a priority. However, the comparative effectiveness of these mABS is unknown. The National
      Academies of Sciences, Engineering, and Medicine has called for expanded access and clinical
      use of mABs, noting it is "critical to collect data and evaluate whether they are working as
      predicted". This pragmatic evaluation will determine the relative effects of the EUA-governed
      mABs versus each other. When U.S. government mAB policies change (e.g., FDA grants or revokes
      EUAs), UPMC Health System policies and the evaluated mABs will accordingly change.
    

Eligibility criteria:

        Inclusion Criteria:

          -  COVID-19 positive patients

          -  Eligible for mAB under FDA EUA

        Exclusion Criteria:

          -  Death is deemed to be imminent or inevitable

          -  Previous participation in this REMAP within the last 90 days
Using Saline for Myofascial Pain Syndromes (USAMPS)
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders
Intervention: Normal Saline; Lidocaine Hydrochloride; Triamcinolone acetonide
Intervention description: Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.; Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.; Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myofascial Pain Syndrome; trigger point injection

Summary:

      This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The
      purpose of this research study is to determine if there is a therapeutic difference between
      trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic +
      steroid) in treating MPS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus,
             iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the
             emergency department.

        Exclusion Criteria:

          -  Patients allergic to lidocaine and/or steroids.

          -  Pregnant women.

          -  Prisoners.

          -  Patients who are cognitively impaired and/or unable to consent for the study.

          -  Age < 18.

          -  Signs of localized infection or skin breakdown at the injection site.
Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large-Cell, Anaplastic
Intervention: Brentuximab vedotin
Intervention description: Brentuximab vedotin IV infusion
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma; Anaplastic Large-cell; Relapsed; Refractory; Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; monomethyl auristatin E; Drug Therapy; Immunotherapy; Hematologic Diseases

Summary:

      The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab
      vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall
      objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent
      chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride [hydroxydaunorubicin],
      vincristine sulfate [Oncovin], and prednisone [CHOP] or equivalent multiagent chemotherapy
      regimens with curative intent).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants age 18 years or older, with relapsed or refractory sALCL
             who have previously received at least 1 multiagent chemotherapy

          -  Bidimensional measurable disease

          -  An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Female participants who are postmenopausal for at least 1 year before the screening
             visit, surgically sterile, or agree to practice 2 effective methods of contraception,
             at the same time, from the time of signing the informed consent form through 30 days
             after the last dose of study drug, or agree to practice true abstinence

          -  Male participants who agree to practice effective barrier contraception during the
             entire study treatment period through 6 months after the last dose of study drug or
             agree to practice true abstinence

          -  Clinical laboratory values as specified in the study protocol

        Exclusion Criteria:

          -  Previous treatment with brentuximab vedotin.

          -  Previously received an allogeneic transplant.

          -  Participants with current diagnosis of primary cutaneous anaplastic large cell
             lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).

          -  Known cerebral/meningeal disease including signs or symptoms of progressive multifocal
             leukoencephalopathy (PML)

          -  Female participants who are lactating and breastfeeding or pregnant

          -  Known human immunodeficiency virus (HIV) positive

          -  Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C
             infection
BPO vs Hibiclens Soap for Surgical Preparation
Condition: Propionibacterium Acnes
Intervention: Benzoyl Peroxide 10% Bar; Chlorhexidine Gluconate
Intervention description: Patients will wash with Benzoyl Peroxide 10% Bar; Patients will wash with Chlorhexidine Gluconate
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical
      preparation. The objective is to determine whether benzoyl peroxide soap, commonly available
      in drug stores for over-the-counter acne treatment, is as or more effective than the standard
      surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of
      Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty
      (joint replacement).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects

          -  Subjects scheduled for elective shoulder arthroplasty at the University of Washington
             Medical Center

          -  Subjects between ages 18-89

        Exclusion Criteria:

          -  Subjects who self-report very sensitive skin

          -  Subjects who are sensitive to benzoyl peroxide

          -  Subjects who are allergic to chlorhexidine

          -  Subjects who had recent prior use of antibiotics (or expect to use them prior to
             surgery)

          -  Subjects who had recent use of acne treatment

          -  Subjects who are not fluent in English.
Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: dapsone gel
Intervention description: Dapsone (ACZONE) 7.5% gel topically once daily.
Intervention MeSH terms: Dapsone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 9 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of
      ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with
      acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

        -Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions
        (noninflammatory and/or inflammatory).

        Exclusion Criteria:

          -  Has uncontrolled systemic disease(s)

          -  Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne,
             drug-induced acne)

          -  Has used topical dapsone within 1 month prior to the screening

          -  Has used oral dapsone within 2 months prior to screening.
Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU
Condition: Deep Sedation; Ventilators, Mechanical; Critical Illness
MeSH terms: Delirium; Critical Illness
Intervention: Midazolam; Propofol; Dexmedetomidine
Intervention description: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.; IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.; IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Intervention MeSH terms: Midazolam; Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ventilators, Mechanical; Intensive Care Units; Deep Sedation

Summary:

      This study aims to examine the use of protocol directed sedation using the Duke PAD protocol
      with the current sedation medications of propofol or dexmedetomidine compared to the PAD
      protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial
      step toward understanding the best management of sedation in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients admitted to the Duke CICU, who require intubation and sedation for
             mechanical ventilation that is expected to be >24 hours in duration will be included,
             unless they meet the specified exclusion criteria.

          -  Patients intubated within one hour prior to care transition to the CICU will also be
             screened for inclusion.

        Exclusion Criteria:

          -  Exclusion criteria include patients following resuscitation from cardiac arrest who
             are treated on the cooling protocol

          -  patients who have suffered a neurologic event (seizure, stroke) or who have baseline
             dementia, both of which could limit delirium assessment

          -  patients with child class B and C liver disease

          -  patients with known allergy to study medications.
High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department
Condition: Abdominal Pain; Renal Colic
MeSH terms: Emergencies; Abdominal Pain; Renal Colic
Intervention: Lidocaine Iv; HYDROmorphone Injection
Intervention description: 2 mg/kg over 5 minutes; 1 mg over 5 minutes
Intervention MeSH terms: Lidocaine; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: lidocaine; hydromorphone; abdominal pain

Summary:

      Intravenous lidocaine will be given at a dose of 2 mg/kg intravenously to patients in the
      emergency department with a diagnosis of acute abdominal pain. Its efficacy will be compared
      to 1 mg of intravenous hydromorphone, with a primary endpoint of mean improvement of pain at
      90 minutes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be a patient in the emergency department (ED)

          -  Must have acute abdominal pain, defined as abdominal or flank pain of a duration of 7
             days or less

          -  Predicted treatment must include the use of an intravenous opiate

        Exclusion Criteria:

          -  Cardiac conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, PR
             interval <0.12s or > 0.2s)

          -  Known renal (CKD >2) or liver disease (Childs-Pugh B or greater)

          -  Hemodynamically instability, defined by the attending physician

          -  Pregnant or breastfeeding

          -  Have a known allergy to either medication

          -  Used of prescription or illicit opioids within the previous week

          -  Patients with a chronic pain disorder, defined as use of any analgesic medication on
             more days than not during the four weeks preceding the acute episode of pain