bioihbjkbjnl/mcl2 huggingface dataset:
Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
Condition: Pain
Intervention: Bupivacaine; Hydromorphone; Fentanyl
Intervention description: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter; Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).; Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.
Intervention MeSH terms: Fentanyl; Hydromorphone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Postoperative analgesia following spine surgery is difficult to manage. Current treatment
      modalities rely heavily on opioid analgesics with all of the inherent limitations and side
      effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple
      different drugs and techniques to control pain after surgery), there is no consensus
      regarding which components of this multimodal therapy provide optimal analgesia. This
      prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion
      Surgery at Zale Lipshy University Hospital. The primary objective is to determine the
      comparative efficacy of epidural analgesia, as compared with intravenous (IV)
      patient-controlled analgesia (PCA), on post-operative analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects aged 18 years or older

          -  Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels

        Exclusion Criteria:

          -  Baseline cognitive deficits sufficient to make objective pain self-assessments
             unreliable in the estimation of the Study Investigators.

          -  Immunocompromised subject

          -  Coagulopathy

          -  Severe liver and renal dysfunction

          -  Preoperative neurological deficits

          -  The dura damage during surgery

          -  Inability to follow directions or comprehend the English language.

          -  Females who are pregnant as determined by positive pregnancy test on or before the day
             of surgery.

          -  Prisoners.

          -  Patient refusal to provide informed consent.

          -  Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine) or opioid
             (fentanyl) allergy if patient assigned epidural analgesia.

          -  Hydromorphone allergy if patient assigned IV PCA
Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department
Condition: Hypertensive Urgency
MeSH terms: Emergencies
Intervention: nicardipine intravenous; Labetalol
Intervention description: nicardipine intravenous 5 mg/hour titrated every 5 minutes by 2.5 mg/hour until target systolic blood pressure range (TSBPR) is reached or maximum dose of 15 mg/hour is achieved.Following achievement of target systolic blood pressure range the infusion rate should be decreased to 3 mg/hour; Labetalol: bolus therapy to start at 20 mg intravenous injection over 2 minutes, may repeat 20mg, 40mg or 80mg injections every 10 minutes until target systolic blood pressure range(TSBPR)is reached or a maximum of 300 mg is injected.
Intervention MeSH terms: Labetalol; Nicardipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertension; emergency department; Nicardipine; Labetalol; hypertensive emergency; hypertensive urgency

Summary:

      The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol
      administered intravenously for the management of hypertension in the emergency department
      setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Systolic blood pressure ≥180 mm Hg on 2 consecutive readings(10 minutes
             apart)presenting in the emergency department (ED)

        Exclusion Criteria:

          -  Use of any investigational drug within 1 month prior to emergency department (ED)

          -  Pregnant or breast-feeding females

          -  Contraindications or allergy to beta-blockers and calcium channel blockers (see FDA
             approved labeling for nicardipine intravenous and labetalol)

          -  Subjects with decompensated congestive heart failure (CHF) or with a known left
             ventricular ejection fraction (LVEF) <35%

          -  History of stroke within 30 days

          -  Known liver failure

          -  Suspected myocardial infarction

          -  Suspected aortic dissection

          -  Suspected cocaine overdose

          -  Concurrently receiving other intravenous (I.V.) hypertensive medications
Post Market Clinical Follow-up Study
Condition: Hip or Knee Surgery
Intervention: Mepilex border post. op; Mepilex border post op
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: hip; knee

Summary:

      The overall rationale for this study is to evaluate the clinical performance potential for
      Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less
      dressing change due to high absorption capacity. This study is a part of Post Market Clinical
      Follow-Up (PMCF).
    

Eligibility criteria:

        Inclusion Criteria

          1. Age 45 years

          2. Have an expected total length of stay of 4 or more days

          3. Undergoing elective primary arthroplasty of the hip or knee

          4. Undergoing hip surgery with a standard access

          5. Give their written informed consent to participate

        Exclusion Criteria

          1. Dressing size does not fit the incision area

          2. Known allergy hypersensitivity to any of the components of the dressing

          3. Multi-trauma

          4. Undergoing arthroplasty due to tumour

          5. Fractures

          6. Wound at the surgical site prior to surgery

          7. Neurological deficit of operated side

          8. Subject has documented skin disease at time of enrolment, as judged by the
             investigator

          9. Previously enrolled in the present investigation

         10. Subject included in other ongoing investigation at present, as judged by the
             investigator.
Smoking Tobacco and Drinking Study
Condition: Smoking; Heavy Episodic Drinking
Intervention: Tobacco Status Project Intervention; Tobacco Status Project + Alcohol Intervention; nicotine patch
Intervention description: 90 days of Facebook messaging, weekly live sessions targeting tobacco use; 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use; 14-day supply of nicotine patch
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tobacco; Cigarettes; Alcohol; Cessation; Intervention; Young adults; Internet; Social media

Summary:

      This trial will test the efficacy of a 3-month intervention on Facebook targeting tobacco use
      and heavy episodic drinking against a 3-month Facebook intervention targeting tobacco use.
      Both groups will be offered a nicotine patch starter kit. The primary outcome is verified
      7-day point prevalence abstinence from smoking at 3, 6, and 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  read English

          -  between 18 and 25 years of age

          -  indicate they use Facebook "most" (≥ 4) days per week

          -  have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette
             per day on 4 or more days of the week

          -  have had at least one heavy drinking episode (5+ for men, 4+ for women) in the past
             month.

        Exclusion Criteria:

          -  do not read English

          -  are not between 18 and 25 years of age

          -  indicate they do not use Facebook "most" (≥ 4) days per week

          -  have not smoked ≥100 cigarettes in their lives and currently smoke at least 1
             cigarette per day on 4 or more days of the week

          -  have not had at least one heavy drinking episode (5+ for men, 4+ for women) in the
             past month.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Adefovir; Entecavir; Placebo; peginterferon alfa-2a [Pegasys]
Intervention description: From week -4 to week 2; From week -4 to week 2; From week -4 to week 2; 180 micrograms sc weekly, from week 1-48
Intervention MeSH terms: Peginterferon alfa-2a; Entecavir; Adefovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with
      Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be
      randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4
      to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or
      3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment
      will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study
      treatment is 1 year, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-65 years of age;

          -  HBeAg+ve for >=3 months;

          -  positive serum HBV DNA within 3 months prior to entry;

          -  patients with chronic hepatitis B, either naive to HBV treatment, or not
             responded/relapsed to nucleoside analogues;

          -  >=3 months treatment-free interval from nucleotide analogues.

        Exclusion Criteria:

          -  evidence of decompensated liver disease;

          -  history or other evidence of a medical condition associated with chronic liver disease
             othr than viral hepatitis;

          -  co-infection with active hepatitis A,C or D, or HIV.
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG
Condition: Obesity
MeSH terms: Emergencies
Intervention: Levonorgestrel-based emergency contraception 1.5 mg; Levonorgestrel-based emergency contraception 3.0mg
Intervention description: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC; Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Body weight; Emergency contraception; Levonogestrel; Ulipristal acetate

Summary:

      Obese women are significantly more likely than their normal BMI counterparts to experience
      failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence
      for testing a dose escalation strategy in an effort to provide improved efficacy from
      orally-dosed emergency contraceptives in obese women. The overall project will be focused on
      both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but
      this protocol registration is for the LNG aspect of the study procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally health women

          -  Aged 18-35 years old

          -  Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a
             progesterone level of 3ng/ml or greater.

          -  Subjects must have a BMI of >30 kg/m2 and weigh at least 80 kg or more.

        Exclusion Criteria:

          -  Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian
             Syndrome

          -  Impaired liver or renal function

          -  Actively seeking or involved in a weight loss program (must be weight stable)
             pregnancy, breastfeeding, or seeking pregnancy

          -  Recent (within last 8 weeks) use of hormonal contraception

          -  Current use of drugs that interfere with metabolism of sex steroids

          -  Smokers.
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
Condition: Hemangioma
MeSH terms: Hemangioma
Intervention: Prednisolone; Propranolol
Intervention description: 2mg/kg/day for 16weeks; 2mg/kg/day for 16weeks
Intervention MeSH terms: Prednisolone; Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 34.0
Sex: All
Maximum age: 9 Months
Healthy volunteers: No
Keywords: Hemangioma; Propranolol; prednisolone; steroid

Summary:

      The purpose of this study is to determine the safety and efficiency of Propranolol as an
      initial treatment for pediatric hemangioma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hemangioma patient ( 0 ~ 9 months old)

          -  No treatment before

          -  10 ~ 20 % volume increase in 2 ~ 4 weeks

          -  Hemangioma that caused organ function

          -  Hemangioma that will cause aesthetic problem

        Exclusion Criteria:

          -  Cardiovascular disease (impossible to use propranolol)

          -  Drug adverse reaction or allergy history (propranolol, steroid)

          -  Bradycardia, Atrioventricular block, atrial block

          -  Cardiogenic Shock

          -  Right heart failure (pulmonary hypertension)

          -  Congestive heart failure

          -  Hypotension

          -  Peripheral nerve disease (moderate)

          -  Angina

          -  Hormone deficiency patient

          -  Pulmonary disease (asthma)

          -  diabetic ketoacidosis

          -  laser treatment history
Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis
Condition: Moderate to Severe Psoriasis
MeSH terms: Psoriasis
Intervention: Etanercept; Etanercept + Acitretin; Acitretin
Intervention description: Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks; Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks; Acitretin at a dose of 10mg BID for 24 weeks
Intervention MeSH terms: Etanercept; Acitretin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Etanercept; Acitretin; Psoriasis

Summary:

      To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a
      maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice
      Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active, moderate to severe psoriasis defined by the following criteria: Clinically
             stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.

          -  In the opinion of the investigator, failure, intolerance, contraindication or not a
             candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus
             ultraviolet A radiation (PUVA) therapy.

          -  Negative urine pregnancy test before the first dose of study drug in all female
             patients

        Exclusion Criteria:

          -  Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere
             with evaluations of the effect of study medication on psoriasis.

          -  Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout,
             systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or
             associated syndromes.

          -  Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab
             (Raptiva®) and alefacept (Amevive®) is also prohibited.
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Celecoxib; Naproxen
Intervention description: Celecoxib 50 mg or 100 mg PO BID for 6 weeks; Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
Intervention MeSH terms: Celecoxib; Naproxen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis

Summary:

      This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib
      (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic
      Arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Polyarticular (both rheumatoid factor positive and rheumatoid factor
             negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the
             International League of Associations for Rheumatology (ILAR) criteria for Juvenile
             Idiopathic Arthritis (JIA)

          -  Subjects with Systemic JIA with active arthritis in at least 1 joint but without
             active systemic features are eligible

          -  ≥2 years of age and <18 years of age prior to the Baseline visit

          -  Body weight ≥10 kg at the Baseline visit

          -  Candidate for chronic NSAID therapy in the Investigator's judgment

        Exclusion Criteria:

          -  Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis
             types of JIA

          -  Active systemic features over the prior 12 weeks in children with systemic Juvenile
             Idiopathic Arthritis (JIA)

          -  Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated
             arthritis should be excluded

          -  Subjects with active Systemic JIA should not be enrolled
Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Condition: Pain; Fever
MeSH terms: Fever
Intervention: Ibuprofen
Intervention description: Ibuprofen, 10 mg/kg
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Multi-center, Open-label
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: No
Keywords: Pediatric (Birth to less than 6 months of age); Pain; Fever

Summary:

      The primary objective of this study is to evaluate the pharmacokinetic profile of a single
      dose of intravenous ibuprofen administered over approximately ten (10) minutes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a hospitalized male or female subject between birth (> 37 weeks gestational age)
             and < six (6) months of age.

          -  Have a clinical indication of pain or fever.

          -  Have written informed consent provided by legal parent, guardian, or authorized agent
             prior to participation in the study or performance of any study-only related
             procedures.

        Exclusion Criteria:

          -  Have inadequate intravenous access.

          -  Have an uncorrected ductus dependent congenital heart disease.

          -  Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory
             drug or aspirin.

          -  Have a current history of uncorrected hypovolemia or acute renal disease.

          -  Have a current history of acute liver disease.

          -  Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to
             dosing. Have received another investigational drug within the past 30 days.

          -  Be otherwise unsuitable for the study, in the opinion of the Investigator.
Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Quetiapine Immediate Release; Quetiapine Extended Release
Intervention description: Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day; Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: inpatient; bipolar depression; quetiapine; Seroquel IR; Seroquel XR; safety; tolerability

Summary:

      The purpose of the study is to compare the sedation profile one hour after dose
      administration between Seroquel IR and Seroquel XR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed

          -  Outpatient status as enrollment

        Exclusion Criteria:

          -  Other than bipolar disorder under study, patients must not have another current, major
             disorder that is symptomatic or has required treatment within 6 months of enrollment.