bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Ciclesonide
Intervention MeSH terms: Ciclesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Allergic rhinitis

Summary:

      The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™
      (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide
      HFA-metered-dose inhaler (MDI). The administration of the study medication will be as
      follows: three single doses, separated by a wash-out period. The study will provide further
      data on the safety and tolerability of ciclesonide.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Written informed consent and HIPAA

          -  Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a
             body weight >50 kg

          -  General good health

          -  Ability to use oral inhaler

        Main Exclusion Criteria:

          -  Pregnancy, breast feeding, intention to become pregnant during the course of the study
             or lack of safe contraception in pre-menopausal women

          -  Participation in any investigational drug trial within the 30 days before Screening
             Visit and thereafter

          -  History or current clinically relevant allergies or idiosyncrasy to drugs or food

          -  History of allergic reactions to any corticosteroids including ciclesonide or any
             excipients of the formulations

          -  Any contraindication to nasally administered corticosteroids

          -  History of a respiratory infection or disorder [including, but not limited to
             bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory
             syndrome (SARS)] within the 30 days before Screening Visit, or development of a
             respiratory infection during the Screening Period

          -  History or current evidence of any other relevant allergic, cardiovascular, pulmonary,
             hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological,
             psychiatric, or other disease within the last 2 years

          -  Non-vaccinated exposure to or active infection with, chickenpox or measles within the
             21 days preceding Screening Visit
Flu Vaccine Study in Neuromuscular Patients 2011
Condition: Duchenne Muscular Dystrophy; Spinal Muscular Atrophy; Congenital Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Atrophy; Muscular Atrophy, Spinal
Intervention: 2011-2012 seasonal flu vaccine Subcutaneous; 2011-2012 seasonal flu vaccine Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Participant, care provider, and investigator are not masked. The outcomes assessor (personnel determining the HI titers) is masked.
Enrollment: 22.0
Sex: All
Minimum age: 3 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: DMD; SMA; CMD; flu vaccine

Summary:

      The purpose of the study is to compare the immune response of two different injection methods
      (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among
      patients with neuromuscular conditions who have significant muscle degeneration. This
      research study hypothesizes that the subcutaneous route of vaccine administration, as
      compared to the intramuscular route, may confer at least comparable, or possibly better,
      immunogenicity. At least 30 individuals followed by the CCHMC Neuromuscular Comprehensive
      Care Center will be recruited to participate in this study lasting approximately one to two
      months with two clinic visits and one follow-up telephone call. Immunogenicity will be
      assessed by comparing hemagglutination inhibition (HI) antibody titers obtained pre- and
      post-vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-ambulatory;

          -  Quadriceps muscle strength of MRC (Medical Research Council Scale) grade 3 or below

          -  Any subject who is between 3 to 8 years of age must have received at least two doses
             of influenza vaccine last season or at least one dose tow or more years ago.

        Exclusion Criteria:

          -  Subject must not have a history of severe reactions following previous immunization
             with influenza vaccine.

          -  Subject must not have previously received a 2011-2012 influenza vaccine.

          -  Subject must not have a history of Guillain-Barre syndrome.

          -  Subject must not have received a live viral vaccine (i.e., MMR, varicella) within 28
             days prior to receipt of the study vaccine.

          -  Subject must not have any condition that the investigator believes would render
             vaccination unsafe or interfere with successful completion of the study.
Effects of Garlic Supplements on Opioids in Healthy Volunteers
Condition: Healthy, No Evidence of Disease
Intervention: garlic powder tablets; oxycodone
Intervention description: Each Garlicin tablet has a claimed allicin content of 3,200 microgram per tablet; Single administration of three 5-mg oxycodone tablets or a 15-mg dose
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy, No Evidence of Disease

Summary:

      RATIONALE: Garlic supplements may alter the pharmacokinetics of oxycodone, thereby affecting
      its effectiveness as an opioid analgesic for the relief of moderate or severe pain.

      PURPOSE: This randomized phase 4 trial is studying how garlic supplements may change the
      pharmacokinetics of oxycodone and its analgesic and side effects in healthy volunteers.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Healthy volunteer

          -  Body mass index 20-32

        EXCLUSION CRITERIA:

          -  Not pregnant

          -  No history of cardiopulmonary, liver, renal, endocrine, neurologic, or psychiatric
             disease

          -  No anemia

          -  No known adverse reactions to opioids, benzodiazepines, cardiac glycosides, or garlic
             supplements

          -  No known allergy or hypersensitivity to sulfur-containing food or drugs

          -  No significant gastrointestinal intolerance to lactose in dairy products

          -  No recent history of alcohol or substance abuse

          -  No history of or concurrent heavy daily consumption of allium vegetables (i.e.,
             garlic, shallots, leeks, and chives)

          -  No handicaps due to visual and hearing impairments

          -  No resting heart rate < 50 beats per minutes

          -  No abnormal cardiac rhythm by EKG

          -  No unusually sensitive response or resistance to pain stimulation (Cold Pressor Test)

          -  Must be right handed

          -  No color blindness

          -  No history of learning disabilities or dyslexia

          -  Must be literate and proficient in English

          -  Must be a nonsmoker

          -  No concurrent medication except oral contraceptives

          -  No concurrent grapefruit or grapefruit juice

          -  No other concurrent over-the-counter herbal products or herbal tea
A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients
Condition: COPD
Intervention: Indacaterol and glycopyrronium (QVA149); Tiotropium
Intervention description: Capsules for inhalation delivered via SDDPI; Capsules for inhalation delivered via HandiHaler® device
Intervention MeSH terms: Glycopyrrolate; Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 379.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; open-label; QVA149; symptomatic; tiotropium

Summary:

      To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once
      daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15
      min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 50% of the predicted normal
             value and post-bronchodilator FEV1/FVC < 0.7 (COPD Grade 1 or 2 by severity of airflow
             limitation (GOLD 2015)

          -  Patients with CAT score ≥ 10 at Visit 0 and Visit 1.

          -  Patients who are on and have been on tiotropium monotherapy for the past 3 months.

          -  0 or 1 COPD exacerbation in the previous 12 months (not leading to hospital
             admission).

        Exclusion Criteria:

          -  Treatment with any inhaled corticosteroid (ICS) in the 3 months prior to Visit 1.

          -  COPD exacerbation between Visit 0 and 1.

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of respiratory infection within 4 weeks prior to Visit 0.

          -  Prior or current diagnosis of asthma.

          -  Presence of any contraindication, warning, precaution, hypersensitivity to LABA and
             LAMA

        Other protocol-defined inclusion/exclusion criteria may apply
PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin 10mg then Placebo Oral Tablet; Placebo Oral Tablet then Dapagliflozin 10mg
Intervention description: SGLT2 inhibitor - Dapagliflozin then Placebo; Placebo then SGLT2 inhibitor - Dapagliflozin
Intervention MeSH terms: Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Post renal transplant type 2 diabetes mellitus patients and non-diabetic mellitus patients after renal transplant with a control group of type 2 diabetes mellitus who have not undergone renal transplant
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose
      concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal
      denervation) or in subjects after renal sympathectomy (63) can add insight about the possible
      role of a neural arc which mediates the changes in plasma glucagon and/or insulin
      concentration in response to glucosuria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age = 18-70 years

          -  BMI = 18.5-40 kg/m2

          -  HbA1c ≥ 7.0% and ≤10.0% for type 2 diabetics

          -  males or females

          -  Must be at least 3 months post renal transplantation and be on a stable dose of
             prednisone (≤5 mg/day), tacrolimus, and mycophenolate mofetil

          -  Not taking any antidiabetic medications or who are treated with metformin,
             sulfonylurea, dipeptidyl peptidase 4 (DPP4) inhibitor, thiazolidinedione or some
             combination

          -  Must be in good general health as determined by physical exam, medical history, blood
             chemistries, CBC, TSH, T4, EKG and urinanalysis

        Exclusion Criteria:

          -  Subjects who are taking insulin or SGLT2 inhibitor are excluded

          -  Only subjects whose body weight has not been stable (± 3 lbs) over the preceding three
             months and/or who participate in an excessively heavy exercise program will be
             excluded.

          -  Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine
             >1.4 females or >1.5 males (and eGFR <45ml/min.1.73m2), or 24-hour urine albumin
             excretion > 300 mg will be excluded.
Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
Condition: Severe Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: Rifaximin
Intervention description: Rifaximin 550 MG BID
Intervention MeSH terms: Rifaximin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to characterize the steady state plasma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver
             cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically
             impaired subjects will have a MELD score of >25.

        Exclusion Criteria:

          -  Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients
             and/or vehicles used in the formulation, or any other clinically significant
             allergies.

          -  Subject has participated in an investigational drug or device study within 30 days
             prior to Day 1 (Baseline).

          -  Subject has any concurrent illness (other than liver cirrhosis), disability or
             circumstance that may affect the interpretation of clinical data, could cause
             noncompliance with treatment or visits or otherwise contraindicates participation in
             this study in the opinion of the investigator.
Prospective, Double Blind, Placebo Control, Bariatric IV Ace
Condition: Obesity
Intervention: intravenous acetaminophen; Placebo
Intervention description: administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia; Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bariatric; Post-operative nausea and vomiting; laparoscopic Sleeve gastrectomy; intravenous acetaminophen

Summary:

      The purpose of this study is to determine if the administration of acetaminophen given
      intravenously (through an IV) beginning during surgery and then for 3 additional doses during
      the first 24 hours post-operatively will reduce the length of time subjects undergoing
      elective sleeve gastrectomy spend in the hospital following this operation. Additional
      questions that may be answered include whether administration of the study medication leads
      to improvement in pain control, a reduction in post-operative nausea and vomiting, and an
      overall improvement in quality of recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old

          -  BMI > 30

          -  Undergoing Elective Sleeve Gastrectomy

          -  Able to consent

        Exclusion Criteria:

          -  Allergy/ Hypersensitive to acetaminophen or formulation incipients

          -  Allergy/Hypersensitive to aprepitant, ondasteron (serotonin type 3 receptor
             antagonists), dexamethasone

          -  Allergy to Propofol or formulation incipients (egg albumin, soy lecithin)

          -  Diagnosis or positive family history of malignant hyperthermia

          -  Abnormal LFTs (AST and ALT) >2x local upper limits of normal

          -  Renal impairment (creatinine clearance (CrCl) ≤ 30mL/min adjusted for obesity))

          -  Pregnancy

          -  Alcohol consumption > 3 drinks/day

          -  Requires awake intubation

          -  Unable to provide consent
Nexplanon and Combined Oral Contraceptive (COC) Combined Use Study
Condition: Contraception
Intervention: Etonogestrel contraceptive implant
Intervention description: Place nexplanon
Intervention MeSH terms: Contraceptive Agents; Etonogestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oral contraceptive; contraceptive implant; contraception; adherence; adverse event

Summary:

      Women currently using or starting a combined oral contraceptive will be offered study
      enrollment. Study subjects will have a Nexplanon placed and followed for 6 months to evaluate
      if they continue the COC, continue the implant, or both, and to assess adverse events and
      bleeding patterns.
    

Eligibility criteria:

        Inclusion:

          -  Women being seen in a UC Davis medical office or who contact our research office.

          -  Potential participants must be women currently COCs or intending to initiate COCs at
             the time of the office visit.

        Exclusion:

          -  Women who have contraindications to using a COC or a contraceptive implant (Category 3
             or 4 in the CDC Medical Eligibility Criteria) will be excluded.

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Prisoners
The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: lidocaine; ethyl chloride; Kenalog
Intervention description: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection; topical spray; used with lidocaine in shoulder injection
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Lidocaine; Ethyl Chloride
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: 70 Years
Healthy volunteers: No
Keywords: subacromial injection; rotator cuff disease; steroid injection

Summary:

      The specific aim of this prospective study is to determine whether local anesthetics prior to
      subacromial steroid injections reduce pain and consequently if they are cost-effective in the
      treatment for shoulder pathology.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18 to 70 years old

          -  Shoulder pain lasting at least 4 weeks

          -  Inability to use arm with restriction of movement and loss of full function.

          -  Able to understand study and provide voluntary, written informed consent

        Exclusion Criteria:

          -  Less than 18 or greater than 70 years old

          -  Contraindications of previous injections and previous shoulder surgery

          -  Unable to understand consent form (in the opinion of the PI)

          -  Non-English speaking individuals

          -  Medication contradictions to lidocaine, corticosteroids
Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis (Diagnosis); Allergic Rhinosinusitis; Chronic Eosinophilic Rhinosinusitis
MeSH terms: Sinusitis; Rhinitis, Allergic
Intervention: Mometasone Furoate Nasal Irrigation; Mometasone Nasal Spray
Intervention description: Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.; Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mometasone irrigation, mometasone spray, chronic rhinosinusitis

Summary:

      Chronic rhinosinusitis (CRS) affects up to 12.5% of the US population and has a significant
      disease burden. The recommended medical management of CRS includes large-volume, low-pressure
      saline lavage, systemic antibiotics, and intranasal corticosteroids (INCS). While the
      efficacy and safety of INCS are well-established for the long-term management of CRS,
      penetration of INCS beyond the nasal vestibule and into the paranasal sinuses is limited. The
      aim of this study is to evaluate the effectiveness of mometasone furoate large-volume,
      low-pressure nasal irrigation for surgery-naive CRS patients.
    

Eligibility criteria:

        Inclusion Criteria:

        12-weeks or longer of two or more of the following signs and symptom consistent with CRS:

          -  mucopurulent drainage(anterior, posterior, or both)

          -  nasal obstruction (congestion)

          -  facial pain-pressure-fullness

          -  and decreased sense of smell

        AND inflammation documented by one or more of the following findings:

          -  purulent mucus or edema in the middle meatus or ethmoid region

          -  radiographic imaging showing inflammation of the paranasal sinuses.

        Exclusion Criteria:

          -  inability to speak or understand English

          -  nasal polyps

          -  history of nasal or sinus surgery

          -  comorbid mucociliary conditions

          -  dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma
             and chronic obstructive pulmonary disease

          -  history of oral or systematic antibiotic use in the past 2 weeks

          -  history of allergy to MF or other topical steroids

          -  pregnant or breastfeeding

          -  participants with a baseline SNOT-22 score of 9 or less will be excluded due to
             inability to achieve a minimally clinically improved difference pre- and
             post-intervention.