bioihbjkbjnl/mcl2 huggingface dataset:
Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Axial Spondyloarthritis; Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis
Intervention: Etanercept
Intervention description: 50 mg subcutaneous, once weekly, 24 weeks
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: non-radiographic axial spondyloarthritis

Summary:

      The purpose of this study is to study the benefits and risks of etanercept withdrawal in
      patients who have achieved a significant clinical response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of axial SpA duration of symptoms >3 months and <5 years back pain with a
             less than favorable response to NSAIDs

        Exclusion Criteria:

          -  radiological sacroiliitis previous treatment with TNF inhibitor, biologic,
             immunosuppressive
Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients
Condition: Pediatrics; Anesthesia; Vasospasm
Intervention: Papaverine; Heparin; Rescue papaverine, as needed
Intervention description: 0.12 mg/mL papaverine administered as soon as the arterial catheter is placed and secured, and 0.12 mg/mL papaverine administered one hour after initial dose; 2 units/mL heparin administered as soon as the arterial catheter is placed and secured, and 2 units/mL heparin administered one hour after initial dose; If the arterial catheter spasm/patency or waveform does not improve 10 minutes after the second papaverine plus heparin or heparin only dose, then the anesthesiology care team will consider treating clinically with 0.3 mg of papaverine.
Intervention MeSH terms: Heparin; Papaverine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Heparin; Papaverine

Summary:

      The purpose of this study is to compare intraoperative papaverine plus heparin to heparin
      alone for prevention of arterial spasm and maintenance of patency of peripheral arterial
      catheters during surgery in pediatric patients. The hypothesis is that periodic,
      intraoperative small-volume boluses of diluted papaverine plus heparin in peripheral arterial
      catheters of pediatric patients will prevent arterial spasm and help maintain patency of
      arterial catheters during general anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

        - All patients age 0-17 years who would require elective placements of arterial catheters
        based on patients clinical complexity (ex. congenital heart disease) or based on the type
        of surgery (ex. open heart surgery).

        Exclusion Criteria:

          -  Patients with a history of significant liver dysfunction.

          -  Patients undergoing liver transplants.

          -  Patients with Grade 2 or more of intraventricular hemorrhage.

          -  All preterm patients with a gestational age less than 37 weeks at the time of surgery.
Levofloxacin Pharmacokinetics (PK) in the Severely Obese
Condition: Obesity; Critical Illness
MeSH terms: Critical Illness
Intervention: Levofloxacin 750 mg IV
Intervention description: PK in obesity
Intervention MeSH terms: Levofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obesity is known to affect the concentrations of certain medications in the body.
      Levofloxacin is a commonly used antibiotic. Based on what the investigators know about
      levofloxacin and how it moves through the body, obesity may affect levofloxacin
      concentrations. This study aims to show the effect of obesity on levofloxacin concentrations.

      The hypothesis is as follows: A 750 mg intravenous (IV) dose of levofloxacin administered to
      severely obese, critically ill patients will yield serum concentrations that are likely to be
      therapeutic.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 55 years of age

          2. Body mass index > 35 kg/m2

          3. Has been prescribed levofloxacin, but the medication has not yet been administered
             (hospitalized cohort only)

        Exclusion Criteria:

          1. Hypersensitivity to fluoroquinolones

          2. Creatinine clearance < 50 ml/min

          3. Administration of levofloxacin within the previous 7 days

          4. Pregnant or lactating females

          5. Participation in another investigational protocol within the past 30 days
ACL Repair and Multimodal Analgesia
Condition: Pain
Intervention: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine; placebo pills and injectables
Intervention description: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane; receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds
Intervention MeSH terms: Acetaminophen; Ketamine; Gabapentin; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effectiveness of an aggressive multimodal regimen versus
      standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for
      patients having surgery in our outpatient surgicenter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of orthopedic surgeons on the study team scheduled for ACL repair using
             hamstring graft from the same leg will be considered for inclusion in this study.
             Other inclusion criteria are as follows:

               -  American Society of Anesthesiologists (ASA) physical status 1-3

               -  BMI of < 40 kg/m2

               -  Consents to general anesthesia and pre-operative femoral nerve block for case

        Exclusion Criteria:

          -  Any contraindication to a femoral nerve block

          -  Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine,
             acetaminophen, hydromorphone, oxycodone

          -  Peripheral or central nervous system disease

          -  Renal or hepatic impairment

          -  History of opioid dependence or current regular narcotic use

          -  Significant psychiatric disease

          -  Pregnancy or lactation (by verbal report)

          -  Seizure Disorder

          -  History of post-operative nausea and vomiting

          -  Latex allergy

          -  Clinically significant cardiac or pulmonary disease
The OBstetric Lidocaine Patch (OBLido) Trial
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Transdermal Lidocaine Patch; Transdermal Hydrocolloid Placebo Patch
Intervention description: Transdermal Lidocaine Patch; hydrocolloid placebo patches
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, single blind, randomized controlled trial
Masking: Single (Participant)
Enrollment: 66.0
Sex: Female
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: lidocaine; patch

Summary:

      This study will be a single-center, single blind, randomized controlled trial. The study will
      be conducted at UnityPoint-Health Meriter Hospital under investigators from the University of
      Wisconsin-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean
      delivery at UnityPoint-Health Meriter will be eligible.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Maternal age greater than or equal to 18

          -  Prepregnancy body mass index greater than or equal to 30 kg/m2 or ≥35 kg/m2 at
             delivery if no prepregnancy/ early pregnancy weight available

          -  Singleton or multifetal pregnancy

          -  Able to receive neuraxial analgesia

          -  Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery with adequate
             time to consider and consent to the study

          -  Gestational age greater or equal to 32 weeks

        Exclusion Criteria:

          -  Known hypersensitivity to lidocaine or colloid patch (defined as a history of a
             reaction or allergy to lidocaine (injectable, intravenous, or transdermal) or
             hydrocolloid patch reported by patient or documented in the medical record) or patient
             report

          -  Contraindication to regional analgesia

          -  Positive urine drug screen at admission to the hospital, if ordered for clinical
             purposes.

          -  Current opioid use or opioid use disorder per patient report or documented in the
             medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery)

          -  Chronic opioid use or opioid use disorder, either patient reported or documented in
             the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined
             as opioid use on most days for >3 months

          -  Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative
             pain control measures, possible prolonged intubation)

          -  Planned vertical midline incision

          -  Presence of renal dysfunction precluding the use of NSAIDs

          -  Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy

          -  Coagulopathy

          -  Planned discharge from the hospital less than 24 hours postpartum
Tranexamic Acid Dosing for Total Joint Arthroplasty
Condition: Arthropathy of Hip; Arthropathy of Knee
MeSH terms: Joint Diseases
Intervention: Tranexamic Acid
Intervention description: Comparison of 3 different doses of the drug
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tranexamic Acid; Total Joint Arthroplasty; Intraoperative Blood Loss

Summary:

      The purpose of this study is to determine the effect of increasing doses of tranexamic acid
      (TXA) on limiting blood loss during total knee and total hip arthroplasty as defined by a
      change in hemoglobin from pre-operative baseline to the first post-operative day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing primary unilateral total knee arthroplasty or primary unilateral
             total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/
             New York Presbyterian Hospital.

        Exclusion Criteria:

          -  Non-English speaking.

          -  Patient refusal to participate.

          -  Weight exceeding 100kg.

          -  Baseline hemoglobin of less than 10.

          -  Repeat, revision, or bilateral surgery.

          -  Known sensitivity or allergy to Tranexamic Acid.

          -  Active intra-vascular clotting.

          -  History of coagulopathy or congenital thrombophilia.

          -  Thromboembolic event in the 12 months prior to enrollment.

          -  Percutaneous coronary intervention requiring a drug eluting stent in the 12 months
             prior to enrollment.

          -  History of anticoagulant medication use unless stopped prior to surgery as recommended
             by and in accordance with the American Society of Regional Anesthesia Guidelines.

          -  Use of a general anesthetic in the current anesthetic.

          -  Blood transfusion for a hemoglobin value which deviates from the study's transfusion
             protocol.
Effect of Gabapentin on Orthopedic Pain
Condition: Degenerative Arthritis and Postoperative Pain
MeSH terms: Osteoarthritis; Pain, Postoperative
Intervention: Placebo; Gapabentin
Intervention description: Normal Saline; 400mg orally at 9pm day of surgery and the first evening post operatively.
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: orthopedic pain

Summary:

      This study is being done to determine if a drug called gabapentin helps in the postoperative
      management of patients undergoing hip and knee operations. The investigators wish to
      determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a
      patient's pain and improve sleep, the patient will be better able to participate in their
      physical therapy. Gabapentin has already been shown to lessen postoperative pain when given
      before surgery. In healthy patients, it has also been shown to improve certain aspects of
      sleep. We hope to identify the effect of the drug, when given after surgery, on patients'
      pain and sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing a hip arthroplasty, total knee arthroplasty, hip fracture repair American
             Society of Anesthesiologist rating I-III as determined by your anesthesiologist

        Exclusion Criteria:

          -  Pregnancy and breast feeding

               -  An allergy to any of the drugs to be used in the study (midazolam, Celecoxib,
                  gabapentin, hydromorphone, bupivacaine)

               -  History of a sleep disorder (Obstructive sleep apnea or daytime somnolence)

               -  History of taking chronic narcotic pain medications or gabapentin

               -  History of rheumatoid arthritis, a psychiatric disorder, or diabetes with
                  impaired renal function

               -  History of alcohol or illicit drug abuse.

               -  History of a kidney or liver problem.

               -  Inability or unwilling to use patient-controlled analgesia.

               -  Unable to meet the criteria for removal of the endotracheal tube in the Operating
                  Room

               -  History of asthma, hives or an allergic type reaction following an aspirin or
                  other NSAIDS drug such as Ibuprofen.

               -  History of stroke or heart attack or thrombotic event within the past 3 months

               -  Lactose intolerance

               -  History of cardiac surgery
The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood
Condition: Perimenopausal Disorder; Stress, Emotional
Intervention: Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release; Placebo Patch; Progesterone Capsule; Placebo Oral Capsule
Intervention description: Transdermal Estradiol worn daily for 16 weeks (patch changed every 7 days).; Matching placebo patches to be worn every day for 16 weeks (patch changed every 7 days).; Micronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week; Matching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week.
Intervention MeSH terms: Estradiol; Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: Female
Minimum age: 45 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: perimenopause; menopause transition; estrogen; stress; mood

Summary:

      Women in the menopause transition ('perimenopause') are exposed to extreme hormone
      variability, tend to experience a unique set of severe stressors (e.g., divorce, death of
      loved ones), and are also at substantially elevated risk to suffer from mood and anxiety
      disorders. The purpose of this research is to understand the mechanisms by which variability
      in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest
      and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal
      manipulation, this research will determine the degree to which the E2 variability (or E2
      levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it
      does so by affecting biological responses to stress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Perimenopausal (either early perimenopause, defined as menstrual cycle length 7+ days
             longer or shorter than usual; or the late perimenopause, defined as ≥2 skipped cycles
             and an interval of amenorrhea ≥60 days but within one year of the last menstrual
             period)

          -  45 to 60 years of age

          -  must be medically healthy

        Exclusion Criteria:

          -  a history of cardiovascular disease (CVD) including coronary artery disease,
             arteriosclerosis, heart attack, or stroke

          -  Type I or II diabetes

          -  personal history of thrombotic events

          -  personal or family history suggesting elevated risk for E2-related cancer

          -  currently experiencing migraine headaches with aura
Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery
Condition: Hypoglycemia; Evidence of Previous Gastric Surgery
MeSH terms: Hypoglycemia
Intervention: Pramlintide
Intervention description: See description above (arm description).
Intervention MeSH terms: Pramlintide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants in this study were asked to complete 4 study visits.
Arm/Phase 1: Baseline: Study V1 was a screening visit. Participants kept a 3-day log of food intake, blood glucose (8 per day), as well as any hypoglycemic symptoms. At V2, a baseline mixed meal tolerance test (MMTT) was performed. Glucose, hormonal responses, and satiety were assessed. Glucose and symptom logs were reviewed.
Arm / Phase 2: Pramlintide treatment Pramlintide was prescribed at the end of visit 2 (following MMTT), with instructions for titration from minimal to maximal dose (15 to 120 µg). During treatment, the participants kept a record of all hypoglycemic symptoms and blood glucose measurements at those times.
Study visit 3 occurred at week 4 of treatment and focused on evaluation of symptoms and side effects. Participants again completed a food and glucose diary for 3 days. During study visit 4 (week 8 of treatment), participants underwent a repeat MMTT.
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypoglycemia; Gastric bypass surgery

Summary:

      The purpose of this study is to determine whether pramlintide (Symlin) will help to reduce
      the frequency and severity of hypoglycemia in individuals who have had gastric bypass
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  severe hypoglycemic episodes post-gastric bypass surgery

          -  normal fasting glucose

          -  age 21 to 65

          -  hypoglycemia must not have responded to dietary intervention (low glycemic index,
             controlled carbohydrate portions) and a trial of acarbose therapy at the maximally
             tolerated dose

        Exclusion Criteria:

          -  Hypoglycemia in the fasting state (greater than 12 hours fast)

          -  History of preoperative diabetes mellitus

          -  Use of medications that affect gastrointestinal motility (e.g., cisapride,
             metoclopramide)

          -  Impaired renal function (creatinine clearance < 20 ml/min or on dialysis

          -  Hepatic disease (defined as liver enzymes > 2 times upper normal limit for alanine
             transaminase (ALT) and aspartate aminotransferase (AST))

          -  Blood donation for 2 months prior to the study.

          -  Severe hypoglycemic unawareness, as defined by inability to recognize adrenergic or
             neuroglycopenic symptoms of hypoglycemia despite detailed education
Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.
Condition: Retinal Vein Occlusion; Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Macular Edema; Retinal Vein Occlusion
Intervention: Ranibizumab Intravitreal injections
Intervention description: Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody
      fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic
      macular edema (DME), retinal vein occlusion and age-related macular degeneration.

      Currently, there is limited epidemiologic information in Chile regarding the incidence of DME
      and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy
      of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and
      functional improvement following this treatment and to increase the local experience
      regarding the use of anti-VEGF in the treatment of diabetic macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of macular edema due to diabetes (confirmed by fundus photography, and/or
             fluorescein angiography, and/or OCT) in at least one eye.

          2. Vision impairment due to DME (BCVA ETDRS letter score at 4 meters between 20 and 70
             letters (6/12 - 3/60 at Snellen chart).

        Exclusion Criteria:

          1. Laser photocoagulation in the study eye for the last 3 months.

          2. Any history of any intraocular surgery in the study eye within the past 3 months.

          3. Blood pressure >160/100 mmHg.

          4. Proliferative Diabetic Retinopathy.

        Any other protocol inclusion/exclusion criteria that may apply.