bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery
Condition: Neuromuscular Blockade; Postoperative Complications
MeSH terms: Postoperative Complications
Intervention: Succinylcholine; Cisatracurium
Intervention description: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.; Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
Intervention MeSH terms: Cisatracurium; Succinylcholine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Open label drug administration. Outcomes assessor and care providers are otherwise masked.
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Postoperative Pulmonary Complications; Residual Neuromuscular Blockade; Cardiac Surgical Procedures

Summary:

      The investigators will conduct a prospective, randomized trial to assess the impact of
      neuromuscular blockade on early (<72 hours post-ICU admission) postoperative respiratory
      complications in cardiac surgical patients. The study will compare continual neuromuscular
      blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for
      cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective cardiac surgery (CABG, valve replacement, CABG + valve) requiring
             cardiopulmonary bypass

        Exclusion Criteria:

          -  Emergency surgery

          -  Extremes of age

          -  Previous cardiac surgery

          -  Clinical contraindications to succinylcholine or cisatracurium

          -  Anticipated difficult tracheal intubation

          -  Preoperative mechanical ventilation

          -  Preoperative pharmacologic/mechanical hemodynamic support
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
Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy; Asthenia
Intervention: cervical interlaminar with lidocaine; cervical interlaminar with normal saline; Lidocaine; Triamcinolone Acetonide; Normal saline
Intervention description: Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.; Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline; 2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.; 2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.; 2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.
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: Single (Participant)
Masking description: Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section.
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: cervical epidural steroid injection; local anesthetic; upper extremity weakness

Summary:

      "Does low-does cervical epidural lidocaine cause transient weakness?"
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-80.

          2. Clinical diagnosis of cervical radicular pain.

          3. Magnetic resonance imaging pathology consistent with clinical symptoms/signs.

          4. Numerical Rating Scale (NRS) pain score of 4 or higher.

          5. Pain duration of more than 6 weeks despite trial of conservative therapy (medications,
             physical therapy, or chiropractic care).

          6. Patients who will undergo CESI for treatment of cervical radiculitis.

        Exclusion Criteria:

          1. Refusal to participate, provide consent, or provide communication and follow-up
             information for duration of the study.

          2. Inability to perform handgrip or arm strength testing.

          3. Contraindications to Cervical ESI (active infection, bleeding disorders, current
             anticoagulant or antiplatelet medication use, allergy to medications used for CIESI,
             and pregnancy).

          4. Current glucocorticoid use or ESI within past 6 months.

          5. Prior cervical spine surgery.

          6. Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular
             muscular disease.

          7. Patient request for or requirement of conscious sedation for the injection procedure.
Medication Abortion Via Pharmacy Dispensing
Condition: Pregnancy Related; Abortion Early
Intervention: Mifepristone; Training on mifepristone dispensing
Intervention description: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit; Pharmacists were offered a training on medication abortion and mifepristone dispensing
Intervention MeSH terms: Mifepristone
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective cohort
Masking: None (Open Label)
Enrollment: 326.0
Sex: Female
Minimum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: medication abortion; mifepristone

Summary:

      This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ®
      (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard
      clinical evaluation. Women participating in this study will obtain mifepristone and
      misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability,
      and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients,
      evaluate their clinical outcomes from electronic health records, and survey and interview
      pharmacists at study sites.
    

Eligibility criteria:

        Patient Inclusion Criteria:

          -  Women seeking medication abortion through 70 days gestation

          -  Eligible for Mifeprex® at a study clinical site

          -  English or Spanish speaking

          -  Willing and able to participate in the study, including willing to go to the study
             pharmacy to obtain mifepristone

        Patient Exclusion Criteria:

          -  Not pregnant

          -  Not seeking medication abortion

          -  Under the age of 15

          -  Contraindications for medication abortion

               -  All pharmacists providing services at one of the study pharmacies during the
                  study are eligible for the pharmacist survey and interview.
A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Leuprolide
Intervention description: Subcutaneous Injection
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leuprolide acetate; Prostate cancer

Summary:

      The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian
      prostate cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A patient for whom the physician has decided to initiate treatment with a Luteinizing
             Hormone Releasing Hormone (LHRH) agonist in standard clinical practice

          -  Biopsy-proven prostate adenocarcinoma

          -  Locally advanced prostate cancer with biochemical relapse radical prostatectomy and/or
             radiotherapy, OR hormonal treatment-naive advanced or metastatic prostate cancer
             patient who has not received chemotherapy and has no plans to undergo treatment with
             chemotherapy at study entry.

          -  Patient who indicates that once the study is completed, he expects having access to
             androgen deprivation therapy (ADT), either medical or surgical, within the local
             healthcare system (either through public/ private health insurance or out of pocket
             payment).

        Exclusion Criteria:

          -  Patient with castrate resistant prostate cancer

          -  Patient who previously underwent bilateral orchiectomy

          -  Patient who has received prior treatment with LHRH analogues

          -  Prior or concomitant treatment with systemic chemotherapy. A patient where there is a
             likelihood to receive systemic chemotherapy should not be enrolled

          -  Life expectancy of < 1 year due to comorbidities

          -  Participation in another interventional clinical trial within one month prior to study
             entry or during the duration of the study

          -  Patient who plans to receive intermittent ADT at the time of study entry

          -  Patient receiving non-palliative radiotherapy within 3 months prior to study entry

          -  Patient receiving adjuvant ADT in combination with definitive radiotherapy

          -  Patient with metastatic hormonal treatment-naive prostate cancer, for whom
             chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated.

          -  Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist
             analogs or any of the components of ELIGARD®

          -  Patient with any contraindication for ELIGARD® use based on local prescribing
             information
Alternate Day Versus Daily Oral Iron Therapy in Adolescents
Condition: Iron Deficiency Anemia; Heavy Menstrual Bleeding; Abnormal Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Menorrhagia; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Hemorrhage
Intervention: Ferrous sulfate
Intervention description: Alternate day dosing of ferrous sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Minimum age: 9 Years
Maximum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Iron deficiency anemia affects over half of girls and young women with heavy periods and is
      the most common cause of anemia worldwide. Most girls with heavy periods who also have iron
      deficiency anemia are prescribed iron to take by mouth every day by their doctor. There are
      some studies showing that taking iron every other day may actually help the iron be absorbed
      into the bloodstream better. This study is trying to compare how taking iron every other day
      compares to taking iron daily for treatment of anemia.

      The goal of this clinical research study is to learn which of the two methods of care will be
      the best way for girls and young women with iron deficiency anemia to take iron
      supplementation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 9 years or greater and less than age 22 years

          2. Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score
             >100

          3. Iron deficiency anemia, defined as both hemoglobin <12 g/dL and ferritin <15 ng/mL
             within 7 days of enrollment.

        Exclusion Criteria:

          1. non-uterine cause of vaginal bleeding

          2. pregnancy

          3. chronic kidney disease

          4. serology confirmed celiac disease

          5. active gastrointestinal blood loss

          6. active malignancy

          7. inability to follow-up at Texas Children's Hospital

          8. receipt of intravenous iron within 30 days prior to enrollment

          9. allergy or known inability to tolerate oral iron
Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Oxytocin; Saline
Intervention description: 10 IU oxytocin (Pitocin) for intramuscular injection; 1.5 ml preservative free saline for intramuscular injection
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blinded crossover treatment with oxytocin and placebo (saline)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Participant, Investigator and outcomes assessor will be blinded. Research Pharmacist will prepare the study medication administration and hold the randomization.
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study proposes to evaluate the effects that a dose of oxytocin given by intramuscular
      (IM) injection (into the muscle) will have on an area of skin that has been exposed to
      ultraviolet (UV) light. The area of skin exposed to UV light will have a mild sun burn
      feeling.

      Sensory testing will be performed on the area of UV burn. The area will be evaluated for
      sensitivity in 3 methods: touch, vibratory
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female > 18 and < 60 years of age,

          -  Body Mass Index (BMI) <40

          -  Generally in good health as determined by the Principal Investigator based on prior
             medical history

          -  Normal blood pressure and resting heart rate without medication

        Exclusion Criteria:

          -  Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®

          -  Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the
             Principal Investigator, would place the subject at increased risk

          -  Women who are pregnant (positive result for serum pregnancy test at screening visit),
             women who are currently nursing or lactating, women that have been pregnant within 2
             years.

          -  Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain
             medications on a daily basis.
Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
Condition: Osteoarthritis of the Glenohumeral Joint
MeSH terms: Osteoarthritis
Intervention: intraarticular corticosteroid injections (IACSI); corticosteroid injections; Ultrasound
Intervention description: ultrasound-guided IACSI will be administered; Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder; ultrasound-guided IACSI
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This study will examine the effectiveness of a single cortisone injection in patients with
      shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors
      to help predict how a patient with shoulder osteoarthritis will respond to a cortisone
      injection utilizing ultrasound guidance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will
             be recruited from the patient population seeking treatment at the Orthopaedics Sports
             Medicine Institute.

          -  those who have failed previous treatment including over-the-counter analgesics and
             activity modification

          -  have elected to receive a medically-indicated, ultrasound-guided IACSI in the
             shoulder.

        Exclusion Criteria:

          -  Patients will be excluded from the study for any of the following reasons:

          -  Post traumatic osteoarthritis

          -  Inflammatory osteoarthritis

          -  Imaging confirmed rotator cuff tear

          -  Prior ipsilateral shoulder surgery

          -  Memory loss or inability to complete study measures

          -  History of allergy to injection medications

          -  Diabetic patients with patient-reported fasting blood glucose >200

          -  Prior injection in the ipsilateral shoulder within three months
PEP uP Protocol in Surgical Patients
Condition: Critically Ill
MeSH terms: Critical Illness
Intervention: PEP uP Protocol; Metoclopramide
Intervention description: Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.; Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked.
Intervention MeSH terms: Metoclopramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: feeding protocol; enteral nutrition protocol; critically ill; surgical ICU; enteral nutrition; nutrition therapy

Summary:

      The main objective of this project is to asses for safety, feasibility and effectiveness of
      an aggressive feeding protocol, PEP uP (Enhanced Protein-Energy Provision via the Enteral
      Route Feeding Protocol) in increasing protein and energy delivery to critically ill surgical
      patients. Our hypothesis is that an aggressive feeding protocol, PEP uP will be safe,
      acceptable, and effectively increase protein and energy delivery to critically ill surgical
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  ICU admission within past 48 hours

          -  Initiation of tube feeds currently planned by the surgical ICU (SICU) team and primary
             surgical team

          -  Admitted by a surgical service to the SICU (not a medical ICU or neurology patient)

          -  Expected to remain mechanically ventilated for > 24 h and expected to require ICU care
             for > 72 h after screening

        Exclusion Criteria:

          -  Pregnancy

          -  Attending surgeon preference (they must agree to feeding their patient according to
             the protocol in either arm using the goal rate determined by the SICU team and the
             nutritionist)

          -  Contraindication to enteral nutrition (bowel obstruction, bowel discontinuity,
             proximal enterocutaneous fistula, and short gut syndrome)

          -  Do not resuscitate (DNR) status or goals of care that specify limitations in medical
             therapies

          -  Death expected within 24 hours
Evaluation of Skin Affix in the Emergency Room
Condition: Wounds
MeSH terms: Emergencies
Intervention: Skin Affix
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: SkinAffix

Summary:

      Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than 5 years of age

          -  Requires the use of a surgical skin adhesive

          -  Informed consent signed

        Exclusion Criteria:

          -  Sensitivity to topical adhesive products or formaldehyde

          -  Hx keloid formation, hypotension, diabetes, blood clotting disorders

          -  Wound infections

          -  mucosal surfaces or skin exposed to body fluids