bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Steroid for the Postoperative Swelling After Orthognathic Surgery
Condition: Swelling
Intervention: Dexamethasone"low-dose"; Dexamethasone"high-dose"
Intervention description: 5mg; 15 mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: orthognathic surgery; steroid; swelling; 3-dimensional photogrammetry

Summary:

      Postoperative swelling is one of most common concerns to plastic and oromaxillary surgeons
      after orthognathic surgery. The purpose of this study is to develop a steroid regimen
      protocol for minimizing postoperative facial swelling after orthognathic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who receive LeFort I osteotomy of maxilla and bilateral sagittal split
             osteotomy of mandible

        Exclusion Criteria:

          -  patients with local or systemic diseases

          -  patients taking aspirin, steroid, nonsteroidal anti-inflammatory drugs, or having
             contraindications for steroids

          -  patients with history of psychosis

          -  patients with active or chronic infection

          -  patients with active or latent peptic ulcer
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Condition: Insulin Sensitivity; Cardiovascular Risk; Perimenopausal Disorder
MeSH terms: Insulin Resistance; Hypersensitivity
Intervention: Ortho Cyclen®
Intervention description: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)
Masking: None (Open Label)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oral contraceptive; birth control pill; women; healthy volunteer; insulin sensitivity; insulin resistance; cardiovascular risk factors; endothelial function; estrogen metabolism; racial difference; glucose intolerance

Summary:

      Birth control pills are the most commonly used method of birth control. The purpose of this
      research study is to examine whether birth control pills change heart disease risk and how
      the body handles blood sugar when given to different women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal, regular-cycling women 18-35 years

          -  Either African-American or Caucasian (African-American and Caucasian women will be
             BMI-matched)

          -  non-smoker.

        Exclusion Criteria:

          -  Diabetes

          -  Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric,
             infectious, and malignant disease

          -  Contraindications to oral contraceptive use (history of blood clots, heart attacks or
             stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer,
             migraine head-aches, major surgery within past 6 months, blood pressure >160/100 mmHg,
             pregnancy or lactation)

          -  Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic,
             anti-hypertensive or other vasoactive drugs within previous 3 months
Vitamin D Deficiency in Patients With Hypertension
Condition: Vitamin D Deficiency; Hypertension
MeSH terms: Hypertension; Vitamin D Deficiency
Intervention: Aliskiren; Cholecalciferol; Placebo
Intervention description: 150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks; 3000 I.U. once daily for 6 weeks; Placebo for two weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Vitamin D; Hypertension

Summary:

      This study will evaluate the effects of Vitamin D replacement and the effects of an approved
      medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who
      have low levels of vitamin D in their blood. The study will compare the effects of vitamin D
      or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women over 21 years of age with a history of Stage 1 or 2 hypertension (defined
             as a seated diastolic BP ≥ 90 mmHg and < 110 mmHg in the untreated state).

          -  Patients under treatment for hypertension must be willing and able to discontinue any
             previous antihypertensive medications for the duration of the study.

          -  25-hydroxyvitamin D levels < 30 ng/ml and > 12 ng/ml.

          -  Women of childbearing potential must be using a medically acceptable form of birth
             control for the duration of the trial, must have a negative serum pregnancy test at
             screening, and must have a negative urine pregnancy test within 7 days before
             initiating aliskiren therapy.

        Exclusion Criteria:

          -  Vitamin D levels < 12 ng/ml

          -  Known hypersensitivity or allergy to aliskiren

          -  Clinic blood pressure > 180/110 mmHg

          -  Known forms of secondary hypertension

          -  Chronic atrial fibrillation

          -  Uncontrolled or unstable cardiovascular diseases

          -  Shift or night workers

          -  Mid-arm circumference > 42 cm in diameter

          -  Current or recent (<1 year) alcohol or drug abuse

          -  Pregnant or lactating women
Predictors of Lorcaserin-Induced Weight Loss
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Intervention: Belviq; Placebo
Intervention description: Belviq is an oral drug; The placebo is made to mimic Belviq, but does not contain any active drug
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Overweight; Obesity; Weight Loss; Lorcaserin; Healthy Volunteers

Summary:

      This two-phase study aims to explore ways to predict who will respond well to the weight loss
      drug lorcaserin and to understand the mechanisms that develop which limit drug efficacy.
      Subjects will be recruited for a 5-week crossover study (phase 1) with lorcaserin and placebo
      followed by treatment with lorcaserin for 24 weeks (phase 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) 28-40

        Exclusion Criteria:

          -  Any clinically significant or relevant medical condition, including:

          -  Diabetes

          -  Uncontrolled Hypertension

          -  Heart disease

          -  Bleeding disorder

          -  Kidney or liver dysfunction

          -  Neurologic disease

          -  Psychiatric or eating disorders

          -  Pregnancy or breastfeeding

          -  Use of tobacco or opiates

          -  History of alcohol or drug abuse

          -  Recent weight change +/- 5%

          -  Medications that affect body weight
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV); Comparator Quadrivalent Influenza Virus Vaccine
Intervention description: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.; Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 402.0
Sex: All
Minimum age: 5 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent
      Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in
      children aged 5 years to less than 9 years. Comparison will be made to a licensed
      Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the
      2014/2015 influenza season in the US.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 5 to less than 9 years at the time of first study vaccination.

          -  The subject's parent or guardian to provide written informed consent and be willing
             and able to adhere to all protocol requirements.

          -  In good health, as determined by medical history and a targeted physical examination
             (if warranted).

        Exclusion Criteria:

          -  Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to
             eggs or any components of the study vaccines.

          -  Clinical signs of significant active infection or an elevated oral temperature at
             study entry.

          -  A clinically significant medical or psychiatric condition.

          -  A history of seizures or febrile convulsions or Guillain-Barré syndrome.

          -  Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months
             preceding study entry.

          -  Vaccination with a licensed vaccine within 14 days preceding study entry, or planning
             to be vaccinated with another licensed vaccine before the study exit evaluation.

          -  Currently receiving systemic glucocorticoid therapy (excluding intra-articular,
             topical or inhaled preparations) or have received such therapy within the 3 months
             preceding study entry.

          -  Currently receiving immunoglobulins and/or any blood products or have received such
             treatment within the 3 months preceding the administration of the study vaccine.

          -  Currently receiving treatment with warfarin or other anticoagulants.
Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema
Condition: Diabetic Retinopathy
MeSH terms: Diabetic Retinopathy
Intervention: ranibizumab 0.5 mg
Intervention description: intravitreal injection
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic macular edema; Visual impairment

Summary:

      The purpose of this study was to demonstrate that the change of best corrected visual acuity
      (BCVA) was comparable in patients treated with ranibizumab at the discretion of the
      investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c)
             ≤ 12.0%

          -  Patients with visual impairment due to DME in at least one eye

          -  BCVA ≥ 24 and ≤ 78 letters in the study eye

        Exclusion Criteria:

          -  Active intraocular inflammation

          -  Any active infection in either eye at the

          -  Structural damage within 0.5 disc diameter of the center of the macula in the study
             eye

          -  Uncontrolled glaucoma in either eye at screening

        Other protocol-defined inclusion/exclusion criteria may apply.
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
Condition: Hepatitis B, Chronic; Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: adefovir dipivoxil 10mg
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adefovir Dipivoxil(Hepsera); Chronic Hepatitis B (CHB)

Summary:

      This is an open label, single-arm, multi-centre extension study for Korean patients with
      chronic hepatitis B and compensated liver disease who have completed one-year adefovir
      dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of
      long term (up to 3 years) adefovir dipivoxil 10mg therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject has completed ADF103814 and continues with adefovir dipivoxil treatment via
        prescription without interruption prior enrolment in this extension study.

        Availability and willingness of subject to provide written informed consent.

        Exclusion Criteria:

        Use of immunosuppressive therapy requiring use of more than 5mg of prednisolone(or
        equivalent) per day, immunomodulatory therapy (including interferon or thymosin) or
        systemic cytotoxic agents during the study.

        Previous or current lamivudine or antiviral therapy Clinical signs of decompensated liver
        disease as indicated by the protocol Inadequate haematological function defined by the
        protocol - Documented evidence of active liver disease due to other causes Hepatocellular
        carcinoma as evidenced by the protocol Any serious or active medical or psychiatric
        illnesses other than hepatitis B which, in the opinion of the investigator, would interfere
        with patient treatment, assessment or compliance with the protocol. This would include any
        uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic,
        digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency
        disorders or cancer.

        Active alcohol or drug abuse or history of alcohol or drug abuse considered by the
        investigator to be sufficient to hinder compliance with treatment, participation in the
        study or interpretation of results.

        Planned for liver transplantation Therapy with nephrotoxic drugs or competitors of renal
        excretion can be expected during the course of the study.

        History of hypersensitivity to nucleoside and/or nucleotide analogues. Inability to comply
        with study requirements as determined by the study investigator.
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Intervention: Placebo; Rifaximin
Intervention description: Placebo, oral, 0 mg BID, 6 months of treatment; Rifaximin, oral, 550 mg BID, 6 months treatment
Intervention MeSH terms: Rifaximin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatic Encephalopathy; Liver Failure; Hepatic Insufficiency; Liver Diseases; Brain Diseases; Rifaximin; Cirrhosis

Summary:

      The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with
      severe hepatic impairment and Hepatic Encephalopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-breast feeding female ≥ 18 years old

          -  In remission from demonstrated overt HE

          -  Had ≥1 episode of overt HE associated with liver disease within the last 6 months

          -  MELD score of ≥ 19

          -  Has a close family member or other personal contact who is familiar with the subject's
             HE, can provide continuing oversight to the subject and is willing to be available to
             the subject during the conduct of the trial

        Exclusion Criteria:

          -  HIV

          -  History of tuberculosis infection

          -  Chronic respiratory insufficiency

          -  Current infection and receiving antibiotics

          -  Renal insufficiency requiring dialysis

          -  Active spontaneous bacterial peritonitis infection

          -  Intestinal obstruction or has inflammatory bowel disease

          -  Active malignancy within the last 5 years

          -  Current GI bleeding or has had a GI hemorrhage within past 3 months

          -  Anemia
Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
Condition: Heart Disease
MeSH terms: Heart Diseases
Intervention: Implantable Defibrillator; Implantable Defibrillator
Intervention description: Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia; number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Implantable Cardiac Defibrillator; therapies reduction; Shocks; Quality of Life

Summary:

      To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered
      for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a
      consequence of self-termination and better arrhythmia discrimination due to a greater number
      of R-R intervals necessary to detect ventricular events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC /
             ESC guidelines.

          -  Previous implant of a Medtronic device including "ATP During Charging" feature for 15
             days at the maximum.

        Exclusion Criteria:

          -  ICD replacements and upgrading.

          -  Brugada Syndrome, Long QT and HCM patients

          -  Ventricular tachyarrhythmia associated with reversible cause.

          -  Other electrical implantable devices (Neurostimulators, etc.).

          -  Subject's life expectancy less than 1 year.

          -  Subject on heart transplant list which is expected in less than 1 year.

          -  Subject is <18 years of age, or the subject is under a minimum age that is required as
             defined by local law

          -  Women who are pregnant or women of childbearing potential who are not on a reliable
             form of birth control.

          -  Unwillingness or inability to provide written informed consent.

          -  Enrolment in, or intention to participate in, another clinical trial.

          -  Inaccessibility to come to the study center for the follow-up visits.

          -  Mechanical tricuspid valve.
Effect of Nebulized Bronchodilators on Heart Rate
Condition: COPD; Sepsis; Shock
Intervention: Levalbuterol; Albuterol
Intervention description: inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg; Nebulized albuterol 2.5mg
Intervention MeSH terms: Albuterol; Ipratropium
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tachycardia; tachyarrhythmias; bronchodilator therapy; Critically ill patients

Summary:

      The purpose of the study is to determine adverse events rates of nebulized albuterol versus
      levalbuterol among adult critically ill patients and determine if a differential exists in
      adverse events between the two drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults who required inhaled bronchodilator therapy in the form of short acting beta
             adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6
             hours for respiratory functions

        Exclusion Criteria:

          -  Known allergy or sensitivity to study medications

          -  Baseline heart rate was greater than 110 beats per minute
Spinal Cord Stimulation for Painful Diabetic Neuropathy
Condition: Diabetic Neuropathy; Pain; Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: Precision Spinal Cord Stimulation
Intervention description: Stimulation on throughout the study once device is implanted
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Implantable stimulation device; Neuropathy

Summary:

      The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals
      who suffer from painful diabetic peripheral neuropathy. Patients invited to participate in
      this study will be eligible for SCS therapy, and will have already selected therapy with the
      Advanced Bionics Precision system independent of possible inclusion in this study. The
      device, accessories, and procedures associated with device placement and the indications for
      use are all consistent with the current and approved product labeling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have chronic neuropathic pain in at least one limb with a score of at least 3 using
             the Michigan Neuropathy Screening Instrument (MNSI) secondary to Type 1 or Type 2
             diabetes

          -  Have chronic neuropathic pain for at least 12 months

          -  Be 18 years of age or older

          -  Be refractory to pain medication including gabapentin or the use of pain medication is
             contraindicated or not tolerated because of side effects or other medical condition

          -  Be an appropriate candidate for SCS therapy and have already decided to use the
             Precision system

          -  Be willing and able to comply with all study related procedures and visits

          -  Be capable of reading and understanding patient information materials and giving
             written informed consent

        Exclusion Criteria:

          -  Are a smoker

          -  Have any other chronic pain condition likely to confound evaluation of study endpoints

          -  Have any significant medical condition that is likely to interfere with study
             procedures or likely to confound evaluation of study endpoints such as peripheral
             vascular disease or neurological disorders unrelated to diabetic neuropathy