bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients
Condition: Traumatic Injury; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism; Wounds and Injuries
Intervention: Enoxaparin 40 mg q12h; Enoxaparin 30 mg q8h
Intervention description: Patients receive enoxaparin 40 mg every 12 hours. Dose will be escalated to enoxaparin 50 mg every 12 hours if steady state trough concentration is still subtherapeutic.; Patients receive enoxaparin 30 mg every 8 hours.
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ
      between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed
      on enoxaparin 30 mg twice daily for VTE prophylaxis. Secondarily, this study will compare two
      enoxaparin dosing strategies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Multi-system trauma

          -  Anticipated length of stay of at least 72 hours

          -  At high risk (risk adjustment profile [RAP] >= 5) and initiated on enoxaparin 30 mg
             every 12 hours per VTE prophylaxis protocol

          -  No counterindication to trauma team VTE prophylaxis protocol (e.g., intracranial
             bleeding, incomplete spinal cord injury with hematoma within 24 hours post injury,
             ongoing hemorrhage, uncorrected coagulopathy, >= grade IV liver or spleen injury,
             intraocular injury)

        Exclusion Criteria:

          -  Renal dysfunction (creatinine clearance < 30 mL/min or on continuous renal replacement
             therapy)

          -  Weight < 50 kg or > 150 kg

          -  Platelet count < 50,000

          -  Allergy to heparin or low molecular weight heparin

          -  On therapeutic anticoagulation on admission or requiring it within 24 hours of
             admission

          -  Isolated intracranial hemorrhage

          -  Known hyperbilirubinemia (serum bilirubin > 6.6 mg/dL)

          -  Pregnancy

          -  Incarceration
Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines
Condition: Glabellar Lines
Intervention: botulinum toxin type A; botulinum toxin type A
Intervention description: 20 units (total dose) botulinum toxin type A injected into glabellar region on Day 0; 30 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of two different types of botulinum toxin
      type A for the treatment of glabellar frown lines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe glabellar frown lines

        Exclusion Criteria:

          -  Diagnosis of myasthenia gravis or Eaton Lambert syndrome

          -  Aesthetic treatment with botulinum toxin within 6 months or planned treatment with
             botulinum toxin for any reason during the study

          -  Prior filler treatments, surgeries, insertion procedures in/to the glabellar region

          -  Facial cosmetic procedures in the glabellar area within 6 months

          -  Bleeding disorders or use of anticoagulants within 10 days

          -  History of facial nerve palsy
A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]; ribavirin; ribavirin
Intervention description: 180 mcg sc weekly, 24 weeks; 180 mcg sc weekly, 16 weeks; 800 mg orally daily; 400 mg orally daily
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys
      (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with
      chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups
      receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two
      doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment
      is 16 or 24 weeks with a 24-week follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, 18-65 years of age

          -  Chronic hepatitis C, genotype 2 or 3

          -  Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)

          -  Abdominal sonography within 3 months prior to study start

        Exclusion Criteria:

          -  Previous interferon and/or pegylated interferon and ribavirin therapy

          -  Liver cirrhosis, class B or C (Child-Pugh)

          -  Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug

          -  History or evidence of medical condition associated with chronic liver disease other
             than chronic hepatitis C

          -  Decompensated liver disease

          -  Positive for HIV
Liposomal Bupivacaine After Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Intervention: Liposomal bupivacaine; Placebo
Intervention description: Liposomal bupivacaine solution (Exparel) for injection; Inert solution created to appear as liposomal bupivacaine (Exparel) for injection
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Liposomal bupivacaine, a long-acting form of bupivacaine, has been found to be effective for
      postoperative pain control after total knee, total hip and total shoulder arthroplasty. We
      are conducting a randomized, controlled trial to evaluate pain control after arthroscopic
      rotator cuff repair in ambulatory patients, comparing standard care in the control group,
      with standard care plus the addition of injection of liposomal bupivacaine in the
      experimental group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients up to age 65 years, undergoing elective, ambulatory, arthroscopic
             rotator cuff repair.

        Exclusion Criteria:

          -  Pregnancy, coagulopathy, allergy to bupivacaine, renal failure, hepatic insufficiency,
             and/or inappropriate candidate for usual therapy (specifically, if unable to receive
             the usual preoperative interscalene nerve block: preexisting nerve injury on side of
             surgery, refusal of nerve block, infection at site of nerve block).
Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital
Condition: Diabetes
Intervention: Glargine insulin
Intervention description: 20-180 units per day
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 22 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes

Summary:

      In this study the investigators would like to test the hypothesis that in diabetic patients
      discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected
      Glargine in terms of diabetes control, compliance, and patient satisfaction and preference.
      The investigators will test this hypothesis in a randomized, crossover trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients with type 1 and 2 diabetes discharged from the hospital with
             recommendations to take Glargine

        Exclusion Criteria:

          -  Patients unwilling to participate and patients incapable of complying with the study
             regimen, such as patients with alcohol and drug addiction problems and patients with
             severe mental illness
Ultrasound Guided Distal Peripheral Nerve Blocks and Postoperative Pain.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Levobupivacaine
Intervention description: In dPNBs group, we performed ultrasound guided dPNBs on radial and median nerves using low concentration and low volume of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve). Using low concentrations of levobupivacaine on target nerves could achieve a prolonged sensitive block in the surgical area without motor block of the hand.
Intervention MeSH terms: Anesthetics; Levobupivacaine; Anesthetics, Local
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ultrasound guided distal peripheral nerve blocks

Summary:

      The aim of this clinical trial is to determinate if distal ultrasound guided peripheral nerve
      blocks on target nerves (radial and median nerve blocks at the elbow), using low volume and
      low concentration of long acting local anesthetic provide better postoperative pain control
      compare with systemic analgesia alone after thumb resection arthroplasty (TRA) due to a
      prolonged selective sensitive block on the tissue trauma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age more than 18 years.

          -  Ambulatory TRA.

          -  Free acceptance to participate in the study, with informed consent signed by patient,
             guardian or family member.

        Exclusion Criteria:

          -  Age less than 18 years

          -  Pregnancy.

          -  Inability to provide informed consent.

          -  Allergy to amide local anesthetics/NSAIDs

          -  Preexisting chronic pain treated with opioids.

          -  Neuropathy involving the extremity undergoing surgery or neurological-cognitive
             deficits that may interfere in the assessement.

          -  Contraindications to dPNBs
Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers
Condition: Peptic Ulcer Hemorrhage
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Intervention: omeprazole sodium IV; Rabeprazole
Intervention description: Intravenous Omeprazole (brand name: Losec® injection 40 mg) 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.; Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
Intervention MeSH terms: Omeprazole; Rabeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: peptic ulcer bleeding; rabeprazole; proton pump inhibitor

Summary:

      This study is conducted to compare and evaluate the effect of administering a high-dose
      intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent
      bleeding after the endoscopic treatment of bleeding peptic ulcers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on
             hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active
             bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI
             endoscopy performed within 24 hours after the hospitalization

          -  patients who achieved primary hemostasis with endoscopic hemostasis procedure via
             upper GI endoscopy

        Exclusion Criteria:

          -  Patients who refuse endoscopic procedure

          -  Patients with complications from gastric ulcer that require operative treatment prior
             to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer
             perforation)

          -  Pregnancy

          -  Patients with serious concurrent diseases such as malignant tumors or end-stage
             diseases

          -  History of previous gastrectomy or vagotomy

          -  Known hypersensitivity to proton pump inhibitors

          -  Elderly patients

          -  Epilepsy
Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia
Condition: Idiopathic Scoliosis; Spondylolisthesis
MeSH terms: Scoliosis; Spondylolisthesis; Hyperalgesia
Intervention: Ketamine; Normal Saline
Intervention description: ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h; Normal saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: opioid tolerance; hyperalgesia; scoliosis; pupillometry

Summary:

      The purpose of this study is to:

      1. Establish whether ketamine can decrease opioid consumption and modulate the onset of
      opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years
      to 18 years, undergoing posterior spinal fusion and instrumentation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is 10 to 18 years of age

          2. The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3
             (see appendix I)

          3. The subject is scheduled for elective posterior spinal fusion and instrumentation.

          4. The subject's parent/legally authorized guardian has given written informed consent to
             participate

        Exclusion Criteria:

          1. The subject has a history or a family (parent or sibling) history of malignant
             hyperthermia

          2. The subject is pregnant or nursing.

          3. The subject has known significant renal disorders determined by medical history,
             physical examination or laboratory tests

          4. The subject has a known or suspected allergy to morphine, remifentanil or ketamine

          5. The subject is an ASA classification of 4 or greater (See Appendix I)

          6. The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)

          7. The subject is unable to self-administer morphine using patient-controlled analgesia
             (PCA) pump

          8. The subject had a recent opioid exposure (within 1 month of surgery)

          9. The subject is obese (body mass index >30kg/m2)

         10. The subject is planned for elective postoperative ventilation

         11. The subject has a known ocular disease not permitting pupillometric examination

         12. The subject has used any investigation products in the past 30 days
Hypertonic Saline for Acute Bronchiolitis
Condition: Bronchiolitis, Viral; Saline Solution, Hypertonic
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Intervention: Nebulized 3% saline; Nebulized 0.9% Normal Saline
Intervention description: 4 mL of nebulized 3% saline once; 4 mL of 0.9% nebulized normal saline once
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 2 Months
Maximum age: 23 Months
Healthy volunteers: No
Keywords: Bronchiolitis; Hypertonic Saline

Summary:

      The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS)
      improves respiratory distress in children 2-23 months presenting to the emergency department
      (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with
      a trial of nebulized albuterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 8 weeks through 23 months

          -  First episode of wheezing associated with respiratory distress and upper respiratory
             tract infection.

          -  Respiratory Distress Assessment Instrument (RDAI) rating of ≥4 and ≤15 after initial
             albuterol nebulization per standard care

          -  Pediatric Emergency Medicine (PEM) physician does not plan additional bronchodilator
             therapy within the hour after initial assessment.

          -  Parental/guardian permission (informed consent)

        Exclusion Criteria:

          -  Subjects with prior history of wheezing or asthma or who have received bronchodilator
             therapy prior to the current illness

          -  Chronic lung or heart disease

          -  Critically ill infants requiring immediate airway stabilization

          -  Non-English speaking parent/guardian

          -  Inability to take nebulized medications
An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: duloxetine
Intervention description: 30mg oral duloxetine per day for one week, titrated up to 60mg per day at day 8, concluded by a one week taper period of 4 days of 30mg pills at the conclusion of the study, followed by 3 days on no medication (4+3 days=1 week), concluded with a post-taper follow-up appointment with a study physician.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: IBS; irritable bowel syndrome; irritable bowel

Summary:

      We hypothesize that duloxetine treatment will be associated with improvement in symptoms of
      IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder.

      During this 12-week, open-label, outpatient study, male and female subjects between the ages
      of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be
      treated with open-label duloxetine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years of age

          -  Subjects must have been diagnosed with irritable bowel syndrome by a physician

          -  Subjects must have had gastrointestinal symptoms for 2 or more days per week for > 6
             months

        Exclusion Criteria:

          -  Lifetime history of bipolar disorder, psychotic disorder, or obsessive-compulsive
             disorder

          -  Current (within past 6 months) diagnosis of major depressive disorder or substance
             abuse disorder

          -  Active suicidal/homicidal ideation

          -  Pregnant women or women of child-bearing potential not using an approved methods of
             contraception

          -  Individuals with an unstable medical condition that in the opinion of the investigator
             would interfere with the interpretation of symptoms
A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]; vinorelbine
Intervention description: 150 mg, orally once a day for up to 6 cycles of 21 days each; 60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles
Intervention MeSH terms: Erlotinib Hydrochloride; Vinorelbine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in
      chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be
      randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and
      8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study
      treatment is until disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >=70 years of age

          -  Non-small cell lung cancer

          -  Naive to prior chemotherapy or specific immunotherapy

          -  Presence of at least 1 measurable lesion

        Exclusion Criteria:

          -  Active non-controlled infection or disease

          -  CNS metastases

          -  Any other malignancies (other than adequately treated basal cell cancer of skin, or in
             situ cancer of the cervix)
Effect of Perioperative i.v. Low-dose S(+) Ketamine
Condition: Hemorrhoids; Pain
MeSH terms: Hemorrhoids
Intervention: S (+) Ketamine; Placebo
Intervention description: 0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery; isotonic saline
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hemorrhoids; hemorrhoidectomy; S (+) ketamine; pain

Summary:

      The purpose of this study is to determine whether the use of perioperative intravenous S (+)
      ketamine reduces the amount and degree of postoperative pain.

      Furthermore the purpose of this study is to determine whether the use of perioperative
      intravenous S (+) ketamine effects cognitive function in the early postoperative period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of disc prolapse

          -  Age 18+

          -  ASA (American Society in Anesthesiology) I-II

          -  written consent

        Exclusion Criteria:

          -  Age < 18

          -  ASA > II

          -  liver failure

          -  renal failure

          -  heart failure

          -  glaucoma

          -  pregnancy