bioihbjkbjnl/mcl2 huggingface dataset:
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
Condition: Anesthesia
Intervention: Fospropofol disodium, propofol; Fospropofol disodium, propofol; Fospropofol disodium, propofol
Intervention description: Two Treatment Periods: fospropofol disodium 6.5 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 0.65 mg/kg IV bolus, or propofol injectable emulsion 0.65 mg/kg IV bolus followed by fospropofol disodium 6.5 mg/kg IV bolus.; Two Treatment Periods: fospropofol disodium 10.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.0 mg/kg IV bolus, or propofol injectable emulsion 1.0 mg/kg IV bolus followed by fospropofol disodium 10.0 mg/kg IV bolus.; Two Treatment Periods: fospropofol disodium 15.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.5 mg/kg IV bolus, or propofol injectable emulsion 1.5 mg/kg IV bolus followed by fospropofol disodium 15.0 mg/kg IV bolus.
Intervention MeSH terms: Propofol; Fospropofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of
      fospropofol disodium in comparison to propofol. In addition, the study will compare the
      maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.
    

Eligibility criteria:

        Inclusion

          -  Males or females greater than or equal to 18 or less than or equal to 45 years old

          -  Non-smokers for at least 18 months prior to Screening

          -  Body Mass Index (BMI) less than or equal to 30 Exclusion

          -  Subjects having a past or current medical history of any respiratory illness including
             asthma

          -  Subjects currently taking any medications (birth control will be allowed if the
             subject has been taking it for at least 12 weeks prior to dosing and during the entire
             study), including over-the-counter (OTC) medication, within 14 days of Screening

          -  Subjects with a known or suspected history of drug or alcohol misuse within 6 months
             prior to Screening, or who have a positive urine drug test at Screening and pre-dose
             at Visit 2 and Visit 3

          -  Subjectw who are allergic to eggs, egg products, soybeans, or soy products

          -  Subjects with a positive pregnancy test at Screening or breastfeeding

          -  Subjects who are unwilling or unable to abide by the requirements of the study

          -  Subjects who have any condition that would make him/her, in the opinion of the
             investigator, unsuitable for the study or who, in the opinion of the investigator, are
             not likely to complete the study for any reason
Bupropion for Smoking Cessation During Pregnancy
Condition: Pregnancy Related; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Bupropion SR; Smoking Cessation Counseling; Placebo
Intervention description: Bupropion SR 150 mg tablet; 35-min counseling by trained research nurse; Matching Bupropion SR placebo tablet
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregnancy; Tobacco use disorder; Smoking cessation; Bupropion SR; Zyban

Summary:

      This is a prospective, double-blind placebo-controlled randomized pilot trial of the
      preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for
      smoking cessation during pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days

          -  13-30 weeks gestation

          -  ≥18 years of age

          -  able to speak English or Spanish

          -  intent to carry pregnancy to term

          -  stable residence

        Exclusion Criteria:

          -  current illicit drug or alcohol abuse or dependence

          -  twins or other multiple gestation

          -  treatment for psychiatric disorder within the last 6 months

          -  unstable medical problems (eg, hypertension (BP>140/90), preeclampsia, threatened
             abortion, hyperemesis gravidarum)

          -  known congenital abnormality

          -  seizure disorder

          -  use of psychotropic medication

          -  use of medication known to lower the seizure threshold

          -  anorexia/bulimia

          -  a personal history of closed head trauma with > 30 minutes of loss of consciousness or
             amnesia or resulting in skull fracture or subdural hematoma/brain contusion

          -  use of any other smoking cessation treatment in the past 30 days

          -  current enrollment in methadone treatment program

          -  prior pregnancy with preeclampsia diagnosis

          -  chronic hypertension (past history or current diagnosis)
The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis
Condition: Type 2 Diabetes
Intervention: Liraglutide; Placebo
Intervention MeSH terms: Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the mechanisms underlying the effect of incretin therapy on
      lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of
      liraglutide on hepatic de novo lipogenesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with type 2 diabetes treated with a lifestyle or metformin (any dose)

          -  waist circumference > 88 cm in women and > 92 cm in men

          -  BMI 27-40 kg/m2

          -  triglycerides between 1.0 - 4.0 mmol/L

          -  LDL < 4.5 mmol/l

        Exclusion Criteria:

          -  Type 1 diabetes

          -  Apo E2/2 phenotype

          -  ALT/AST > 3x ULN

          -  GFR < 60 ml/min, clinically significant TSH outside normal range

          -  Lipid-lowering drugs other than statins within 6 months

          -  Current treatment with pioglitazone, insulin, sulphonylureas, gliptins, glinides,
             SGLT-2 inhibitors or thiazide diuretics (at a dose of > 25 mg / day)

          -  Blood pressure > 160 mmHg systolic and/or > 105 diastolic

          -  History of pancreatitis or stomach / other major bleeding, thyroid neoplasia,
             persistent hypothyroidism or persistent hyperthyroidism

          -  Any medical condition that puts the patient in the risk of dehydration

          -  Concurrent medical condition that may interfere with the interpretation of efficacy
             and safety data during the study.

          -  Females of childbearing potential who are not using adequate contraceptive methods

          -  Subjects who have experienced side-effects previously from GLP-1 agonists

          -  Non-compliance or withdrawal of consent

          -  Any information or clinical event described in liraglutide SPC that is a
             contraindication for the use of liraglutide
Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Intervention: Endotracheal intubation; Laryngeal mask airway; remifentanil
Intervention description: additional premedication in the endotracheal intubation/INSURE arm
Intervention MeSH terms: Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 2 Hours
Maximum age: 48 Hours
Healthy volunteers: No
Keywords: surfactant

Summary:

      In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via
      nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be
      randomized to standard delivery of surfactant via and endotracheal tube airway (inserted
      after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via
      laryngeal mask airway (LMA). The intent is to remove the airways and return babies to
      non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate
      of failure of initial surfactant therapy. Standardized failure criteria are reached: a)
      early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal
      intubation and mechanical ventilation) or, b) late, if the baby requires ventilation,
      retreatment with surfactant within 8 hours or more than 2 doses of surfactant.

      The objective of this protocol is to reduce the need for endotracheal intubation and
      mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by
      instilling surfactant though an LMA, while achieving comparable efficacy of surfactant
      treatment.

      The hypothesis is that surfactant treatment through an LMA will decrease the proportion of
      babies with RDS who require mechanical ventilation or subsequent intubation, when compared to
      standard surfactant treatment following endotracheal intubation with sedation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild-to-moderate RDS;

          -  Postnatal age 2 to 48 hours;

          -  Gestational age 27 0/7 to 36 6/7 weeks;

          -  Treated with nasal CPAP modalities ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at
             least 2 hours to maintain SpO2 90-95%;

          -  Informed consent

        Exclusion Criteria:

          -  Weight < 800 g;

          -  Airway anomalies;

          -  Pulmonary air leaks;

          -  Craniofacial or cardiothoracic malformations
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
Condition: Chronic Kidney Diseases; Hyperkalemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia
Intervention: Patiromer; Research Diet Menu
Intervention description: Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.; During the study, participants will be asked to consume only the foods provided in the research diet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic kidney disease, stages 3B-4

Summary:

      The purpose of this proof-of-concept controlled-feeding study is to determine whether
      patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum
      potassium concentrations in chronic kidney disease (CKD) patients who are transitioned to a
      plant-rich diet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stages 3B-4 CKD (estimated glomerular filtration rate (eGFR) of 15-44 mL/min/1.73m2,
             not treated with dialysis)

          -  No prior treatment with patiromer

          -  Mild hyperkalemia (potassium 5.1 to <6.5 mEq/L) on one of the last two blood tests

          -  No prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 mEq/L) in the past 6
             months

          -  Deemed appropriate for the intervention by the patient's nephrologist, considering the
             patient's prognosis, cognition and pending treatments (e.g., dialysis)

        Exclusion Criteria:

          -  Change in medications that alter potassium homeostasis (e.g., RAAS inhibitors,
             diuretics, β-blockers) in the last month

          -  Diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major GI surgery,
             short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic
             diarrhea)

          -  Dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to
             study diets (excludes dietary restrictions on high-potassium foods)

          -  Pregnant (females) or planning to become pregnant (males and females) during the study
Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines
Condition: Glabellar Frown Lines
Intervention: botulinum toxin Type A; normal saline (placebo)
Intervention description: botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.; Normal saline (placebo) injected into the glabellar region on Day 0.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in
      glabellar rhytides (frown lines) using a new treatment satisfaction measure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe glabellar wrinkles (frown lines)

        Exclusion Criteria:

          -  Previous treatment with botulinum toxin therapy of any serotype

          -  Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or
             superficial peels within 3 months

          -  Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g.,
             trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or
             permanent make-up within 6 months

          -  Mid-facial or periorbital treatment with non-permanent soft tissue fillers

          -  Subjects planning a facial cosmetic procedure or visible scars

          -  Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial
             lift, brow lift, eyelid lift or eyebrow surgery)

          -  Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

          -  History of facial nerve palsy

          -  A planned extended absence during the study
GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms
Condition: Aortic Aneurysm, Abdominal
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Intervention: GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
Intervention description: Implant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated
      Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic
      aneurysms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter

          2. Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification
             criteria per Instructions for Use

          3. Access vessel able to receive 18 French introducer sheath

          4. Life expectancy > 2 years

          5. Appropriate candidate for endovascular repair

          6. Ability to comply with protocol requirements including follow-up

          7. 21 years of age or older, male or infertile female**

        Exclusion Criteria:

          1. Mycotic or ruptured aneurysm

          2. Participating in another investigational device or drug study within one year

          3. Documented history of drug abuse within six months

          4. Myocardial infarction or cerebral vascular accident within six weeks

          5. Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to
             pulmonary function

          6. Iliac anatomy that would require occlusion of both internal iliac arteries

          7. Planned occlusion or reimplantation of significant mesenteric or renal arteries

          8. Planned concomitant surgical procedure or previous major surgery within 30 days

          9. Previous prosthesis placement in the aorta or iliac arteries

         10. Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)
An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections
Condition: Pulmonary Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Lung Diseases, Fungal
Intervention: Itraconazole
Intervention description: Itraconazole 200 milligram (mg) intravenous injection will be given twice daily for first 2 days, 200 mg once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily will be given for 2 to 4 weeks.
Intervention MeSH terms: Itraconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Invasive Pulmonary Fungal Infection; Itraconazole

Summary:

      The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential
      therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal
      infections ([IPFI]; lung diseases caused by fungal infection).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Probable or proven invasive pulmonary infectious participants (IPFI) - Hospitalized
             participants (at least hospitalized treatment and observation could be ensured during
             the intravenous injection period) - The participants (or legal representatives) have
             signed the informed consent forms.

        Exclusion Criteria:

          -  Currently taking taboo drugs, such as terfenadine, astemizole, cisapride and HMG CoA
             reductase inhibitors (for example simvastatin, lovastatin, oral or intravenous
             midazolam or triazolam) - History of allergy or intolerance to imidazoles or pyrrole
             drugs (for example fluconazole, itraconazole, ketoconazole, miconazole, clotrimazole)
             - Pregnant and breast feeding women, or women of child bearing age not taking
             effective contraception measures - Participants with pure oral, urinary tract, and
             vaginal candidiasis (yeast infection) - Participants with fungal meningitis
             (inflammation of the meninges), active liver disease, renal insufficiency with the
             serum creatinine clearance rate less than 30 milliliter per minute (ml/min), and
             current abnormal cardiac function such as congestive heart failure (condition in which
             the heart is unable to pump out sufficient blood to meet the metabolic need of the
             body), or participants with history of congestive heart failure
Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management
Condition: Acute Respiratory Distress
Intervention: CMAC videolaryngoscope; Direct Laryngoscopy
Intervention description: patients are intubated using the CMAC video laryngoscope; Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: endotracheal intubation; direct laryngoscopy; video laryngoscopy

Summary:

      Randomized controlled trial of intubation using the C-MAC video laryngoscope versus standard
      laryngoscopy. Patients who are going to be intubated using standard laryngoscopy will be
      randomized to have their first intubation attempt done using either standard laryngoscopy or
      the C-MAC video laryngoscope. Subsequent attempts will be at the discretion of the treating
      physician.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (age >17) requiring emergent endotracheal intubation in the Emergency
             Department using direct laryngoscopy

        Exclusion Criteria:

          -  Physician intends to intubate with a device other than a direct laryngoscope