bioihbjkbjnl/mcl2 huggingface dataset:
Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: On-Q Pain Pump
Intervention description: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      After Laparoscopic surgery most patients experience some form of mild to moderate pain. The
      current standard of care is to treat this pain with local anesthetics (numbing medication,
      that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic
      analgesics (medication injected into your vein to control pain such as morphine).

      Although this treatment improves pain symptoms it is not perfect. Firstly, complete pain
      control is rarely achieved and secondly, narcotics (such as morphine) often have many side
      effects including nausea, vomiting, sedation (sleepiness), constipation and abdominal upset.
      All of these issues make recovery less comfortable and delays return to full function (work,
      school and other activities of daily life).

      A new FDA approved device is now available that offers the benefits of long term anesthesia
      without the side effects of narcotics. It consists of a pump that continuously infuses local
      anesthesia into and around the surgical site. This pump is placed during your operation. You
      then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing
      medicine around your wounds for 2 days continuously.

      The purpose of this study is to see if this pump improves postoperative pain, decreases the
      need for narcotic pain medicine and allows people to return to their activities earlier.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing laparoscopic cholecystectomy or Lap-Band ASA III or less

        Exclusion Criteria:

          -  Patients who refuse consent

          -  Are converted from laparoscopy to open surgery

          -  Are allergic to bupivacaine

          -  Are unable to followup
Treatment Utility of Postpartum Antibiotics in Chorioamnionitis
Condition: The Primary Outcome of This Study Will be the Rate of Endometritis
MeSH terms: Endometritis; Chorioamnionitis
Intervention: Postpartum Antibiotics; No postpartum antibiotics
Intervention description: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting.; Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops.
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 80.0
Sex: Female
Minimum age: 14 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for
      pregnancies with treated chorioamnionitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of chorioamnionitis

          -  Undergoing cesarean section for delivery

        Exclusion Criteria:

          -  Multiple gestations,

          -  Allergy to beta-lactam antibiotics

          -  Patients with estimated creatinine clearance (ClCr) less than 70 mL/min

          -  Maternal fever explained by etiology other than chorioamnionitis

          -  Inability to comply with the study protocol.
Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Methadone; Buprenorphine/naloxone
Intervention description: 10-60 mg/day divided by 2-4 times a day for 6 months; 4-16 mg/day divided by 2-4 times a day for 6 months
Intervention MeSH terms: Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: chronic pain; opioid dependence; methadone; buprenorphine; substance use disorder

Summary:

      Chronic pain patients are treated with prescription opioids and many exhibit opioid
      addiction. Currently, there are no evidence-based guidelines to better manage patients with
      chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and
      methadone treatment in these patients. The investigators hypothesize that both buprenorphine
      and methadone treatment will reduce pain and addiction behaviors and increase functioning in
      these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. have a well-documented chronic pain disorder due to past back surgery,

          2. have a chronic back pain syndrome,

          3. have evidence of opioid addiction,

          4. prior attempt at abstinence-oriented treatment documented by the referring physician,

          5. be able to understand spoken and written English,

          6. reside in Erie or Niagara counties,

          7. have health insurance or other ability to pay for treatment with the approval from
             patient's primary physician;

          8. have no prior history of methadone or BUP/NLX maintenance treatment since the last
             surgery,

          9. not be a member of a vulnerable population, including prisoners

        Exclusion Criteria:

          1. homeless, or any patient without a "locator" (no means to participate in the follow-up
             data collection interviews by phone),

          2. inability to give consent,

          3. those with major co-occurring psychiatric disorders,

          4. EKG showing prolonged QT and/or previous cardiac issues,

          5. are taking a medication that is contraindicated with methadone,

          6. medically unstable,

          7. urine positive for cocaine at initial visit,

          8. pregnant women
Topical Steroid Formulation and Wet Wraps
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: 0.1% triamcinolone CREAM; 0.1% triamcinolone OINTMENT
Intervention description: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.; Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Wet Wraps; Topical Steroid

Summary:

      The purpose of this study is to

        1. Compare efficacy of 0.1% triamcinolone containing wet wrap as an ointment or as a cream
           formulation in patients with moderate to severe atopic dermatitis

        2. The relative patient/subject acceptance and adherence will also be compared between the
           two wet wrap types
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients between the ages of 3-17 experiencing a symmetric, bilateral flare of atopic
             dermatitis

          2. The flares must reach a certain threshold for inclusion based on the investigator's
             global assessment scale

        Exclusion Criteria:

          1. Systemic infection or bacterial skin infections

          2. Eczema herpeticum

          3. Evidence of suppression of the Hypothalamic-Pituitary-Adrenal axis

          4. Non-English or Non-Spanish speaking
Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
Condition: Pulmonary Hypertension; Diastolic Heart Failure; Heart Failure With Preserved Ejection Fraction
MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Failure; Heart Failure, Diastolic
Intervention: Nebivolol
Intervention description: Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
Intervention MeSH terms: Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Heart failure with preserved ejection fraction (HFpEF), is one of the leading causes of
      pulmonary hypertension (PH). Despite the severity of this disease, no established treatments
      exist for this class of PH. Nebivolol is a drug used in high blood pressure and heart
      failure, but not used in patients with PH. Due to some additional properties it possesses,
      the investigators believe nebivolol will improve disease severity in patients with PH
      associated with HFpEF. The hypothesis of this research study is that nebivolol improves PH
      severity in patients with HFpEF, as measured by hemodynamic and clinical parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (≥ 18 years of age) with World Health Organization Group 2 Pulmonary
             Hypertension (Mean pulmonary artery pressure ≥ 25 mmHg and pulmonary capillary wedge
             pressure ≥ 15 mmHg)

          -  New York Heart Association class II-IV symptoms

          -  Left ventricular ejection fraction (LVEF) ≥ 45%

        Exclusion Criteria:

          -  Other causes of heart failure other than diastolic dysfunction, such as restrictive
             cardiomyopathy or infiltrative cardiomyopathy

          -  Women who are pregnant or nursing

          -  Liver cirrhosis,

          -  Primary valvular disease

          -  Acute coronary syndrome

          -  Causes of PH other than that of heart failure, such as: chronic thromboembolic PH,
             sickle-cell disease, or sarcoidosis

          -  Severe bradycardia or greater than 1st degree heart block

          -  Decompensated heart failure

          -  Current use of a third generation beta-blocker (nebivolol, carvedilol, or labetalol)
             or high dose of any beta-blockers (greater than 100 mg daily of metoprolol, or
             equivalent)
Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: adapalene gel, 0.3%; clindamycin/benzoyl peroxide gel
Intervention description: Applied once daily at bedtime; Applied once daily in the morning
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 12 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel
      0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel)
      applied in the morning, in Subjects with Acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects with a minimum of 20 inflammatory lesions on the face;

          2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and
             closed comedones) on the face, excluding the nose;

          3. Subject has a Global Severity Assessment

        Exclusion Criteria:

        1. Subjects with more than three nodulo-cystic lesions
Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: methotrexate; methotrexate
Intervention description: oral administration Escalating dose (15, 20, 25 mg); 25 mg oral administration
Intervention MeSH terms: Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis; MTX polyglutamates; clinical outcome

Summary:

      The primary objective is to determine whether erythrocyte polyglutamate levels are associated
      with objective clinical response in patients with rheumatoid arthritis after oral
      administration of low-dose methotrexate.The secondary aim of this study is to compare the
      efficacy and safety of standard dose methotrexate versus a higher starting dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MTX-naive

          -  Age > 18 years

          -  DAS-28 > 3.2

          -  American College of Rheumatology-criteria for RA

          -  Chest-X-ray

          -  Informed consent

          -  Prednisolon < 10 mg a day

        Exclusion Criteria:

          -  Pregnancy

          -  Lactation

          -  Renal and hepatic impairment

          -  Malignant diseases (last 5 years)

          -  Contraindications

          -  Human Immunodeficiency Virus (HIV), Hepatitis B and C
Ticagrelor China Pharmacokinetic/Pharmacodynamic Study
Condition: Stable Coronary Heart Disease (CHD)
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)
Intervention description: To determine the Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).
Intervention MeSH terms: Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      open label, single centre, randomised, Phase IV, pharmacokinetic, pharmacodynamic, and safety
      study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in Chinese
      patients with stable coronary heart disease
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of signed and dated written informed consent prior to any study specific
             procedures.

          2. Female or male Chinese (as defined by Chinese Regulatory) patients aged 18 years or
             older with suitable veins for cannulations or repeated venipunctures.

          3. Documented stable coronary heart disease (CHD) fulfilling all of the following, and
             taking 75-100 mg ASA daily treatment:

             Diagnosed stable angina pectoris per the guidance of Chinese Society of Cardiology
             published in 2007, patients with angina severity classified as I and II of Canadian
             Cardiovascular Society grading of angina pectoris.

          4. Female patients without pregnant potential

        Exclusion Criteria:

          1. Any indication for oral anticoagulant or dual antiplatelet treatment and chronic ASA
             with doses greater than 100 mg/day.

          2. Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow
             therapeutic index, or strong CYP3A inducers within 14 days preceding the first dose of
             study medication and during study treatment.

          3. Increased bleeding risk.

          4. Contraindication or other reason that ASA or ticagrelor should not be administered

          5. Patients that are scheduled for revascularization (eg, PCI, CABG) during the study
             period
Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel
Condition: Contraception
Intervention: Placebo Control (Placebo Herb); St. John's Wort; Levonorgestrel
Intervention description: Placebo herb three times daily (ground cellulose) for 4-6 weeks; St. John's Wort (Hypericum perforatum) orally or 4-6 weeks; Levonorgestrel in a single oral dose
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 36.0
Sex: Female
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menstruation; Complementary Therapies; Pharmacokinetics; Hypericum; St. John's wort; Levonorgestrel; Women

Summary:

      This study will determine the effects of St. John's wort, a common herbal remedy, on
      metabolism of the female contraceptive hormone levonorgestrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) between 20 and 25

          -  Regular menstrual cycles for at least 3 months prior to study entry

        Exclusion Criteria:

          -  Current use of foods, herbs, vitamins, over-the-counter supplements, or any
             medications that could alter pharmacokinetics of other drugs

          -  Medical contraindications to the use of contraceptives
Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL)
Condition: Hypertriglyceridemia in Type 4 Hyperlipidemia; Non Diabetic Subjects With Normoglycemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias; Hypertriglyceridemia
Intervention: Rosiglitazone; Placebo (Rosiglitazone); Placebo (Fenofibrate); Fenofibrate
Intervention description: Rosiglitazone 8mg daily for 12 weeks; Placebo (Rosiglitazone) 8mg daily for 12 weeks; Placebo (Fenofibrate) 145 mg daily for 12 weeks; Fenofibrate 145 mg daily for 12 weeks
Intervention MeSH terms: Rosiglitazone; Fenofibrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Type 4 hyperlipidemia; Rosiglitazone; Fenofibrate

Summary:

      The design of the study will be randomized, double blind trial, which will examine the
      effects of Rosiglitazone on the fasting triglycerides (TG), high-density lipoprotein (HDL),
      low-density lipoprotein (LDL), and plasma concentrations of apolipoproteins A-I, A-II, and
      C-III as compared to Fenofibrate and placebo. This study will also assess the synergistic
      effect of Rosiglitazone and Fenofibrate on the same parameters. Data from this study will
      help clarify whether Rosiglitazone favorably impacts plasma lipid and lipoprotein
      concentrations through improving insulin sensitivity and glycemic control, or by directly
      influencing the synthesis of the apolipoproteins that are responsible for very-low-density
      lipoprotein (VLDL) and HDL metabolism.
    

Eligibility criteria:

        Inclusion criteria:

          1. Fasting plasma glucose <100 mg/dl

          2. Fasting LDL <160 mg/dl and Triglyceride <400 mg/dl.

        Exclusion criteria:

          1. Congestive heart failure

          2. Evidence of renal impairment (serum creatinine> 1.4mg/dL)

          3. Liver disease (ALT and/or AST above the upper level of normal)

          4. Known diabetes mellitus or impaired fasting glucose (fasting glucose ≥ 100mg/dL)

          5. LDL of ≥160mg/dL and/or triglycerides of ≥400mg/dL

          6. Pregnant or breast feeding women

          7. Prior history of an acute coronary syndrome, myocardial infarction or
             revascularization procedures in the past

          8. Life-threatening disease with a survival prognosis <3 years

          9. Inability to take rosiglitazone and/or fenofibrate

         10. Already on statin therapy or have been on statin therapy in the last 3 months
A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications
Condition: Diagnostic Imaging
Intervention: Xenetix; Visipaque
Intervention description: 300 mg of iodine/ml; 270 mg of iodine/ml
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 1 Year
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Multislice computed tomography (MSCT)indications

Summary:

      This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric
      indications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child aged 1 year or above and 16 years or under

          -  Patients with normal renal function (creatinine clearance > 60 ml/min/1.73 m2)

          -  Patient requiring MSCT with contrast medium injection for diagnosis

          -  Patient who has a blood sample planned in the 24 hours preceding the MSCT scan

          -  Female patient with childbearing potential must have effective contraception
             (contraceptive pill or intrauterine device), be surgically sterilized or blood beta
             human chorionic gonadotropin (ßHCG) will be tested prior to product injection.

          -  Parent(s) of the patient (and child with sufficient intellectual maturity) provided
             his/her/their written informed consent for their child to participate in the trial.

          -  Patient with national health insurance

        Exclusion Criteria:

          -  Patients who have received diuretic or biguanide treatment during the 48 hours
             preceding the MSCT scan.

          -  Patient with known allergy to iodinated contrast agent.

          -  Patient treated with nephrotoxic drugs within one week before first blood sample

          -  Patients planned to either undergo surgery or receive chemotherapy within 72 hours
             post injection (ie: before the blood test 72 hours post injection)

          -  Patient received or planned to receive an iodinated contrast agent during 48 hours
             preceding the MSCT scan.

          -  Breast feeding patient.

          -  Pregnant patient.

          -  Patient already included in this trial

          -  Patient included in another clinical trial involving an investigational drug.

          -  Patients whose degree of cooperation is incompatible with carrying out the study