bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid; Necrosis
Intervention: tofacitinib; tofacitinib; adalimumab; etanercept
Intervention description: Oral tablet, 5 mg BID; Oral tablet, 10 mg BID; Pre-filled syringe, 40 mg subcutaneous injection, every other week; Pre-filled syringe, 50 mg subcutaneous injection, every week
Intervention MeSH terms: Adalimumab; Etanercept; Tofacitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4372.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Post-marketing; Phase 4; Open-label; Safety Surveillance; CP690550; Xeljanz; oral treatment

Summary:

      This post-marketing study is designed to compare the safety of tofacitinib versus TNF
      inhibitor with respect to major cardiovascular adverse events and malignancies, excluding
      non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety
      events, including non-melanoma skin cancers, hepatic events, infections, and efficacy
      parameters will be collected and evaluated in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe rheumatoid arthritis

          -  Taking methotrexate without adequate control of symptoms

          -  Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure,
             high cholesterol levels, diabetes mellitus, history of heart attack, family history of
             coronary heart disease, extra-articular RA disease)

        Exclusion Criteria:

          -  Current or recent infection

          -  Clinically significant laboratory abnormalities

          -  Pregnancy
Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
Condition: Osteoarthritis, Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Intervention: Celecoxib; Celecoxib
Intervention description: 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily.
Placebo used as flare medication when directed.; 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily.
Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Intervention MeSH terms: Celecoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 875.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use

Summary:

      To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious
      than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee
      and hip.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has been diagnosed, according to American College of Rheumatology guidelines,
             with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory
             drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone
             telephone.

        Exclusion Criteria:

          -  Subject has had surgery on index joint.

          -  Subject has history of rheumatoid arthritis or fibromyalgia syndrome.

          -  Subject has active gastrointestinal or cardiovascular disease.
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: levocetirizine dihydrochloride; placebo
Intervention description: 5mg daily (oral tablet) for 14 days; 0mg (matching oral tablet)for 14 days
Intervention MeSH terms: Levocetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 596.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: levocetirizine; Xyzal; Seasonal Allergic Rhinitis; total symptom score; quality of life

Summary:

      The study objective is to investigate the efficacy of levocetirizine in reducing symptoms
      associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a history of SAR symptoms

          -  A positive skin prick test at least one grass allergen

          -  Moderate - severe SAR symptoms at baseline

          -  Women of childbearing potential must use a medically acceptable form of contraception

          -  80% compliance on run in study medication and 80% compliance on completing the diary

        Exclusion Criteria:

          -  The presence of any clinically significant comorbid disease which may interfere with
             the study assessments

          -  The presence of renal disease

          -  Pregnant or breastfeeding

          -  Subject is currently participating in another clinical trial

          -  Known hypersensitivity to piperazines or any of the excipients

          -  Intake of medications prohibited before the start of the trial

          -  Subjects who started or changed the dose of immunotherapy

          -  Rhinitis medicamentosa

          -  Subjects with a recent history (within the last 2 years) of drug or alcohol abuse.
Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy
Condition: Hysterectomy (MeSH nr: E04.950.300.399)
Intervention: Bupivacain; Morphine; Propofol; Propofol; Fentanyl; Rocuronbromid; Morphine
Intervention description: 5 mg/mL, 4 mL intrathecally as a single dos; 0.4 mg/mL; 0.5 mL intrathecally as a single dosage; 2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery; Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intubation maintenance dosage of 6-10 mg/kg/hour IV during the surgery; 100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.; 0.6 mg/kg body weight IV (intravenously) at induction of anesthesia. If additional muscle relaxation is needed during surgery 5-10 mg is injected IV. The drug is given only at induction of anesthesia and during surgery; 5 mg is given IV (intravenously) before end of surgery
Intervention MeSH terms: Fentanyl; Morphine; Bupivacaine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Hospitalization; Postoperative care; Quality of Life; Health economy; Anesthesia. Spinal; Anesthesia, General

Summary:

      The purpose of this study is to determine whether spinal anesthesia combined with intrathecal
      morphine in abdominal hysterectomy on benign gynecological indications gives better outcome
      concerning duration of hospital stay and postoperative patient comfort than general
      anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female between 18 and 60 years of age.

          -  Scheduled for abdominal hysterectomy - total or subtotal -on benign gynecological
             indication.

          -  At least one ovary planned to be preserved at the hysterectomy.

          -  Can understand and communicate in Swedish

          -  Accept participation after written and verbal information and after signed informed
             consent.

          -  Has supervision at home after discharge from hospital during the first couple of days
             and has access to a telephone.

        Exclusion Criteria:

          -  Contra-indications against spinal or general anesthesia or the standard dosage of the
             study drugs

          -  ASA classification ≥ Class 3

          -  Postmenopausal women without HRT (hormone replacement therapy).

          -  Suspected gynecological malignancy

          -  Previously undergone bilateral oophorectomy

          -  Substantial physically disabled so that a normal recovery with early physical
             mobilization can not be anticipated.

          -  Mentally or severly psychic disabled
Increasing Naloxone Access for Persons Who Use Opioids
Condition: Naloxone
Intervention: Opioid Overdose Education with Naloxone Distribution; Opioid Overdose Education
Intervention description: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with a naloxone kit.; Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with information on where they can obtain a naloxone kit.
Intervention MeSH terms: Analgesics, Opioid; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid overdose; Naloxone distribution; Narcan; Online training

Summary:

      Deaths relating to opioid overdose have rapidly increased over the past two decades. Due to
      the serious public health concern of the opioid epidemic, federal agencies recommend
      employing various harm reduction interventions. The implementation of Opioid Overdose
      Education and Naloxone Distribution (OEND) programs is effective in reducing opioid overdose
      mortality, yet these programs do not reach many high-risk individuals. Traditionally, OEND
      program venues are found in large, urban medical centers, drug treatment facilities, and
      needle exchange programs. Identifying unreached, high-risk individuals and providing training
      and naloxone kits through online recruitment could significantly expand access to this
      life-saving intervention. The primary goal of the current proposed project is to examine the
      acceptability and feasibility of online recruitment, online opioid overdose and naloxone
      administration education, and postal distribution of naloxone kits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Current or past six months illicit use of opioids

          -  Electronic device access for online survey completion

          -  Willing to provide email address to receive survey link and compensation

          -  Able to read and speak English

          -  Willing to provide their contact information and that of two friends/family members

          -  Permanent address for mailing of naloxone kit

          -  Does not currently have a naloxone kit in possession

        Exclusion Criteria:

          -  Contraindication for naloxone (known severe allergic reaction)

          -  Cognitive impairment or unstable psychiatric condition that interferes with the
             informed consent process
Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
Condition: Pulmonary Infections
MeSH terms: Infections; Communicable Diseases
Intervention: Dornase alfa; Placebo
Intervention description: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation; No therapy will be given to placebo arm
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 7 Days
Maximum age: 4 Months
Healthy volunteers: No
Keywords: ventilator associated pulmonary infections

Summary:

      To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator
      associated pulmonary infections. Dornase alfa has been effective in the treatment of
      pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The bacteria
      causing pulmonary infections in cystic fibrosis patients is similar to those infecting
      preterm infants. The investigators expect that dornase alfa therapy will improve recovery
      from ventilator associated pulmonary infections in preterm infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  infants less than 38 weeks gestation and over 7 days of age

          -  infants with a ventilator associated pulmonary infection, defined as intubated infants
             who have moderate to heavy White Blood Cells (WBCs) on tracheal aspirate, organisms on
             tracheal aspirate gram stain, a positive endotracheal tube culture, a chest x-ray with
             infiltrate, consolidation or atelectasis, an increase in oxygen (FiO2) requirement and
             whom the clinical team decides to treat with systemic antibiotic therapy

        Exclusion Criteria:

          -  Extremely ill infants not expected to survive

          -  Critically ill infants requiring high frequency ventilation

          -  Infants with congenital pneumonia

          -  Infants with congenital malformations of the respiratory system (e.g. Congenital
             diaphragmatic hernia, cystic adenomatoid malformation or tracheo-esophageal fistula)
             Cyanotic congenital heart disease, chromosomal abnormalities and infants with a
             positive newborn screen for cystic fibrosis
The Effects of Dexmedetomidine on the Heart Beat During Elective Surgery in Children
Condition: Myocardial Repolarization; Healthy
Intervention: Dexmedetomidine; Saline
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 3 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: changes in myocardial repolarization in healthy children

Summary:

      Dexmedetomidine is a sedative drug that is commonly used to improve calmness and reduce pain
      in children waking up after surgery. Some of the side effects of dexmedetomidine, such as a
      potential change in how the heart muscles contract and changes in blood sugar and potassium
      levels, are poorly understood. The current study aims to examine these changes directly in
      healthy children undergoing elective surgery by measuring the heart beats (with an
      electrocardiogram) and blood sugar and potassium at specific times before and after
      dexmedetomidine is given. The investigators aim to establish a better understanding of this
      drug's safety profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA Physical Status I-II

          -  Age 3 to 10yrs

          -  Elective surgical procedure requiring general anesthesia

          -  Use of dexmedetomidine acceptable to the staff anesthesiologist

          -  Un-premedicated

          -  Ability to read and understand English (parent/legal guardian(s) and child)

        Exclusion Criteria:

          -  Long QT syndrome (LQTS)

          -  Cardiac disease or rhythm abnormalities

          -  Family history of LQTS or abnormal cardiac conduction

          -  Currently taking medications known to prolong QT

          -  Currently taking medications known to predispose to hypokalemia

          -  Known hypersensitivity to dexmedetomidine or other study medication

          -  Weight < 5th centile or > 95th centile for age

          -  Previously diagnosed hypokalemia

          -  Impaired renal or liver function

          -  Pre-operative anxiety requiring sedatives or opioids

          -  Refusal to participate
Impact of Quadratus Lumborum Block on Recovery Profile After Ventral Hernia Repair
Condition: Pain, Postoperative; Opioid Use
MeSH terms: Hernia; Pain, Postoperative; Hernia, Ventral
Intervention: Quadratus Lumborum Block; Standard Medical Management
Intervention description: 30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will be injected on both sides of the mid-abdomen posterior to the mid-axillary line.; Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Masking description: The participant is blinded to the treatment.
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hernia, Ventral; Pain, Postoperative; Opioid Use; Pain

Summary:

      Ventral hernia repair may be associated with significant postoperative pain. Pain is
      typically managed with intravenous (IV) and oral medications that come with their own risks,
      such as nausea, constipation, sedation, respiratory depression, increased bleeding, and/or
      kidney or liver dysfunction. The quadratus lumborum peripheral nerve block has been shown to
      produce anesthesia of the anterior abdominal wall in the T7 to L1 distribution. This study
      aims to evaluate if the addition of the quadratus lumborum peripheral nerve block (QLB) can
      improve pain scores, decrease the need for IV and oral pain medications, and/or speed the
      patients' return to normal activity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is scheduled for elective laparoscopic ventral hernia repair;

          2. The subject is ≥ 18 years and ≤ 80 years;

          3. The patient agrees to receive a quadratus lumborum block

          4. American Society of Anesthesiologists class 1-3.

        Exclusion Criteria:

          1. Subject is < 18 years of age or >80 years of age;

          2. Subject is non-English speaking;

          3. Subject is known or believed to be pregnant;

          4. Subject is a prisoner;

          5. Subject has impaired decision-making capacity per discretion of the Investigator;

          6. Significant renal, cardiac or hepatic disease per discretion of the investigator;

          7. American Society of Anesthesiologists class 4-5;

          8. Known hypersensitivity and/or allergies to local anesthetics;

          9. Chronic opioid use (daily or almost daily use of opioids for > 3 months at any point
             in their lives).

         10. Repair of a recurrent ventral hernia

         11. Repair of multiple ventral hernias

         12. Unobtainable sonographic views

         13. Lacking health insurance
Non-cancer Pain and Cognitive Impairment: A Disabling Relationship
Condition: Arthritis; Pain; Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Intervention: long acting oxycodone; extra strength acetaminophen
Intervention description: 10mg twice daily; 1,000 mg twice daily
Intervention MeSH terms: Acetaminophen; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Pain; Analgesia; Cognitive impairment; Randomized controlled trial; Physical function

Summary:

      To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older
      persons with no and mild to moderate cognitive impairment and persistent moderate or higher
      intensity non-cancer lower extremity arthritis pain; and Describe the association of change
      in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and
      brief physical performance measure) and to determine if cognitive status modifies this
      relationship.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age over 65

          2. Pain at least 3 months duration

          3. Pain greater in lower extremity than other anatomical site with ambulation

          4. Pain self-report of moderate intensity of higher on an average day

          5. Community-dwelling

          6. Ambulatory

          7. Physician states participants have decision-making capacity to enroll into the trial

          8. Participants with cognitive impairment have a reliable caregiver

          9. Inadequate pain relief from NSAIDS and/or acetaminophen in the past

        Exclusion Criteria:

          1. Current cancer requiring chemotherapy

          2. History of addiction to opioids or other controlled substance

          3. Consumes more than 2 alcoholic drinks a day

          4. Severe balance disturbance

          5. Intra-articular steroid injection in the past 6 weeks
Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
Condition: Diabetes; Pre-hypertension; Hypertension
MeSH terms: Hypertension; Prehypertension
Intervention: aliskiren 300 mg once daily; Placebo/sugar pill
Intervention description: aliskiren 300 mg daily; Sugar pill/placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 19 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: aliskiren; endothelial function; hypertension

Summary:

      The study will evaluate the effects of the direct renin inhibitor, aliskiren, on
      flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic
      patients with pre-hypertension or Stage 1 hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  prehypertension or Stage 1 hypertension

        Exclusion Criteria:

          -  Type 1 diabetes

          -  Stage 2 hypertension

          -  CKD

          -  recent MI, revascularization, CVA or TIA
The Use of Belladonna and Opium Suppository in the Treatment of Postoperative Stent Pain
Condition: Nephrolithiasis
MeSH terms: Nephrolithiasis; Kidney Calculi
Intervention: Belladonna and Opium; Placebo suppository
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ureteral stent pain; nephrolithiasis; kidney stone

Summary:

      The purpose of this study is to determine if preemptive B&O suppository placement will
      decrease post-operative pain in patients undergoing ureteral stent placement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who will receive ureteroscopy with concurrent placement of a ureteral stent.

        Exclusion Criteria:

          -  age < 18,

          -  neurologic deficits of any kind

          -  non-English speaking patients.