bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Trial of Web-Delivered Acceptance Therapy for Smoking Cessation (WebQuit)
Condition: Smoking
Study type: Interventional

Summary: 
      The goal of this study is to determine whether the ACT website provides higher quit rates
      than a current standard smoking cessation website.
    


Intervention name(s): ACT; CBT
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Acceptance & Commitment Therapy; Cognitive Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance
Condition: Acute Phase Response; Insulin Resistance
MeSH terms: Insulin Resistance; Acute-Phase Reaction
Study type: Interventional

Summary: 
      Prolonged fasting may increase the organic response to trauma. Carbohydrate-based drinks have
      been tested and they may reduce insulin resistance. No study so far has aimed to examine the
      possible benefits of whey protein drink in the composition of preoperative drinks.
    

Detailed description: 
      The patients will be randomized into two groups: the carbohydrate-protein group (CHO-P) and
      the control group (CO). The patients will reeive a specific drink to their group on the
      evening prior to surgery and three hours before the operation. The CHO-P group will receive
      474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14%
      whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55%
      sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil) and the CO group will
      receive the same volume of water.

      Outcome measures On the day of the surgery and on the first postoperative day blood samples
      will be collected for glucose, insulin, triglycerides, albumin, pre-albumin, CRP, and
      α-1-acid glycoprotein (α-1-GA) assays. HOMA-IR will be calculated
    

Intervention name(s): whey protein plus carbohydrate drink
Intervention type(s): Dietary Supplement
Intervention description(s): The CHO-P group received 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil)
Other intervention name(s): Resource® Breeze - Nestlé, São Paulo, Brasil
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: preoperative fasting; insulin resistance; carbohydrates; whey protein; inflammatory response
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)
Condition: Infections; Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of safety and effectiveness of ceftaroline fosamil in children with
      Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.
    

Detailed description: 
      To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in
      pediatric subjects ages 2 months to < 18 years who are initially hospitalized with
      Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to
      methicillin-resistant Staphylococcus aureus (MRSA)
    

Intervention name(s): Ceftaroline fosamil; IV Ceftriaxone and Vancomycin
Intervention type(s): Drug; Drug
Intervention description(s): Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour)
Subjects < 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour)
Optional Oral Switch:
PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
PO clindamycin 13 mg/kg/dose
PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h; IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND
IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes.
Optional Oral Switch:
PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
PO clindamycin 13 mg/kg/dose
PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
Other intervention name(s): Teflaro; PPI-0903; TAK-599; TAK599; PPI0903
Intervention MeSH terms: Vancomycin; Ceftriaxone; Ceftaroline fosamil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infections; Pediatrics; Teflaro; Ceftriaxone; cephalosporin; Vancomycin; Clindamycin; Amoxicillin Clavulanate; Linezolid; MRSA; pneumonia
Biomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will
      respond to treatment.

      PURPOSE: This research study is studying biomarkers in tissue samples from patients with
      breast cancer treated with bevacizumab.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To demonstrate that vascular endothelial growth factor-A (VEGFA) haplotypes that are
           associated with an increased VEGFA expression will predict superior outcome for patients
           with metastatic breast cancer receiving bevacizumab in ECOG-E2100 (but not for the
           control arm).

        -  To demonstrate that candidate single nucleotide polymorphisms (SNPs) will further
           improve the predictive capacity of outcome (efficacy and toxicity) in patients enrolled
           in ECOG-E2100.

        -  To demonstrate that tumor VEGFA amplification or borderline amplification (estimated 14%
           frequency) will predict superior outcome for patients with metastatic breast cancer
           receiving bevacizumab on ECOG-E2100 whereas those with VEGFA deletion (estimated 11%
           frequency) will predict inferior outcome.

        -  To demonstrate that VEGFA amplification/deletion will not predict outcome in the control
           arm of ECOG-E2100.

      Secondary

        -  To demonstrate that tumor VEGFA amplification will predict increased protein expression
           as ascertained by IHC.

        -  To demonstrate that a combined algorithm calculated from tumor-specific variability
           (VEGFA amplification/deletion) and host-specific variability (SNPs) will optimally
           predict outcome (efficacy) with bevacizumab in patients enrolled on ECOG-E2100.

      OUTLINE: This is a multicenter study.

      Previously collected tumor-derived DNA is analyzed for VEGFA amplification/deletion and
      haplotype as biomarkers for outcome after bevacizumab treatment. Gene expression,
      polymorphism, protein expression analysis, and IHC are performed on the samples.
    

Intervention name(s): DNA analysis; gene expression analysis; polymorphism analysis; protein expression analysis; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E2100 from whom samples were submitted for research
      
Keywords: male breast cancer; stage IV breast cancer; recurrent breast cancer
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
Condition: A/Vietnam/H5N1 Influenza Virus
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to assess the usability of long-term stored H5N1 antigen
      and adjuvant. The study is designed to assist in stockpile management by assessing the
      safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine
      when administered with or without MF59® adjuvant.
    

Detailed description: 
      This study is a randomized, double-blinded, Phase 2 study to assess the safety and
      immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1
      virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and
      nonpregnant females, aged 18 to 49 years, inclusive. This study is designed to assist in
      stockpile management and will assess the usability of long-term stored H5N1 antigen (ie,
      stored >10 years) and adjuvant (ie, stored >5 years).
    

Intervention name(s): 7.5 mcg H5N1 (stored as monobulk); 15 mcg H5N1 (stored as monobulk); 90 mcg H5N1 (stored as monobulk); 90 mcg H5N1 (stored in vials); MF59; MF59 (stored as monobulk)
Intervention type(s): Biological; Biological; Biological; Biological; Other; Other
Intervention MeSH terms: MF59 oil emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension; Ayerza Syndrome; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of Iloprost in subjects
      that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).
    

Detailed description: 
      This is a randomized, placebo-controlled study in subjects with Pulmonary Arterial
      Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and
      bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to
      study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and
      will continue conventional therapy and bosentan. At the end of the double-blind phase study,
      open label Iloprost will be provided.
    

Intervention name(s): Iloprost or placebo
Intervention type(s): Drug
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: STEP; PAH; iloprost; inhalation; prostacyclin
Glucagon Efficiency After High and Low Carbohydrate Diet
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      No studies have investigated if the dietary composition of carbohydrate influences the
      glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further,
      the recommended diet composition to patients with type 1 diabetes has not been thoroughly
      validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due
      to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon
      can be used as an add-on to intensive insulin treatment, these aspects need to be elucidated.
      The purpose of this study is to determine, whether diet composition of carbohydrate affects
      the glycogen stores in the liver and affects the glucose response of glucagon during
      hypoglycaemia.

      HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of
      low-dose glucagon is not associated with diet carbohydrate content.

      AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet
      influence the glycaemic response of low-dose glucagon in patients with insulin pump treated
      type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks
      differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose
      excursions.

      DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After
      participants have given an informed consent, they will go through four steps: 1) screening
      visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study
      visit and 4) second meal intervention for one week finalizing with another study visit.
    


Intervention name(s): High carbohydrate intake; Low carbohydrate intake
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Carbohydrate intake < 50 gram; Carbohydrate intake > 250 gram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: glucagon; Carbohydrate diet
Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to understand the effects of everolimus on tacrolimus
      pharmacokinetics (pk) in patients receiving de novo kidney transplants.
    

Detailed description: 
      Multidrug immunosuppression regimens have synergistic effects which allow the use of lower
      doses of individual agents. These regimens generally include calcineurin inhibitors (CNIs:
      cyclosporine or tacrolimus), mammalian target of rapamycin (mTOR) inhibitors (everolimus or
      sirolimus), and corticosteroids. CNIs and mTOR inhibitors are substrates for cytochrome P450
      3A4 (CYP3A4) and P-glycoprotein (P-gp); in addition, cyclosporine is a inhibitor of CYP3A4
      and P-gp. Therefore, concomitant administration of those drugs may alter their serum levels.

      It is remained to be evaluated whether the pharmacokinetics or clinical efficacy of
      tacrolimus will be affected when the regimens contain everolimus in clinical practice and the
      effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs. Mycophenolate
      mofetil (MMF) has no effect on pharmacokinetics of tacrolimus; therefore, MMF is used as a
      control to understand the effects of everolimus on pharmacokinetics of tacrolimus in patients
      receiving de novo kidney transplants. The effect of ABCB1、CYP3A4、CYP3A5、POR genetic
      polymorphism on the two Drugs was also assessed.
    

Intervention name(s): Everolimus; Mycophenolate mofetil; Tacrolimus; Methylprednisolone; Prednisolone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Everolimus: 1 mg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 3-8 ng/mL; Mycophenolate mofetil: 10-15 mg/kg orally every 12 hours from post-operation day 1 (decrease 50% dose if white blood cell < 4000/mcL); Tacrolimus: 0.05-0.075 mg/kg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 8-12 ng/mL; Methylprednisolone: 50 mg iv every 6 hours on post-operation day 1, 40 mg iv every 6 hours on post-operation day 2, 30 mg iv every 6 hours on post-operation day 3, 20 mg iv every 6 hours on post-operation day 4, 20 mg iv every 8 hours on post-operation day 5, 20 mg iv every 12 hours on post-operation day 6, 20 mg iv on post-operation day 7; Prednisolone: 20 mg orally once a day from post-operation day 8 to post-operation week 4, then titrated gradually
Other intervention name(s): Certican; CellCept; Prograf; Solu-Medrol; Predonine
Intervention MeSH terms: Mycophenolic Acid; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Everolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tacrolimus, everolimus, pharmacokinetics, drug interaction
The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin
Condition: Metabolism; Insulin Resistance; Hypopituitarism
MeSH terms: Hypopituitarism; Insulin Resistance
Study type: Interventional

Summary: 
      This study will investigate the non-growth-hormone-dependent metabolic effects of the hormone
      Ghrelin in growth hormone deficient subjects by examining the insulin tolerance as well as
      signal proteins in fat and muscle biopsies.
    

Detailed description: 
      Ghrelin is a relatively 'new' hormone that is produced in the stomach and to a lesser extend
      in the hypothalamus of the brain. The actions of ghrelin are diverse and includes stimulation
      of the appetite center of the brain and the release of growth hormone. We have for the first
      time shown that ghrelin also stimulates the metabolism of fatty acids and induces insulin
      resistance in skeletal muscle. These effects have we confirmed in growth hormone deficient
      subjects on a stabile substitution treatment with growth hormone and hydrocortisone. With
      these subjects we can investigate the effects of ghrelin that are independent of growth
      hormone. The present study is a continuation of these findings, as we wish to investigate
      whether the insulin resistance effect of ghrelin is dependent of the concomitant metabolism
      of fatty acids. This is possible by administration of the niacin acid antagonist Acipimox,
      that blocks the fatty acid metabolism reversibly. We have applied this experimental principle
      in other settings with success.

      Knowledge of the effects of ghrelin in general can in shot-sight as well as in long-sight
      have great importance for the understanding of growth disorders from overweight and type 2
      diabetes to malnutrition and eating disorders.
    

Intervention name(s): Acipimox; Ghrelin; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day; Ghrelin infusion 4.2 ng/kg/min throughout the investigation day; placebo tablets or saline infusion
Other intervention name(s): Tablet Olbetam 250 mg; Placebo tablets; Saline infusion
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: ghrelin; metabolism; type 2 diabetes; insulin resistance
Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10
      mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical
      status, adverse events and laboratory investigations and assess relative safety and tolerance
      under fasting conditions
    

Detailed description: 
      An open-label randomized, single dose, two way crossover oral bioequivalence study to compare
      Amlodipine Besylate/Benazepril Hydrochloride 10 mg/40 mg capsules (Dr. Reddy's Laboratories
      Ltd.,) with Lotrel® capsules Novartis Pharmaceuticals Corporation in healthy human subjects
      under fasting conditions.
    

Intervention name(s): Amlodipine Besylate/Benazepril HCl
Intervention type(s): Drug
Intervention description(s): Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules
Other intervention name(s): Lotrel
Intervention MeSH terms: Amlodipine; Benazepril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Ketorolac Versus Opioid for Pain After Endoscopy
Condition: Kidney Calculi; Ureteral Calculi
MeSH terms: Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      A double blind randomized controlled trial designed to compare pain control and safety with
      ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy
      for treatment of urinary stones. Patients are followed for five days after their surgery as
      they record their pain scores, medication utilization, and stent related symptoms.
    

Detailed description: 
      Pain is the leading cause for unplanned emergency department visits and readmissions after
      ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current
      opioid epidemic. The investigators conducted a double-blinded, randomized controlled trial
      (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs)
      to opiates for postoperative pain control in patients undergoing URS for urolithiasis.

      Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as
      needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study
      outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes
      included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire
      (USSQ) scores.
    

Intervention name(s): Oxycodone; Ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg of oxycodone taken by mouth every 6 hours for 5 days; 10 mg of ketorolac taken by mouth every 6 hours for 5 days
Other intervention name(s): Toradol
Intervention MeSH terms: Ketorolac; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)
Condition: Healthy
Study type: Interventional

Summary: 
      This is an open-label study. A total of approximately 60 subjects will be randomly assigned
      to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe
      or a heat patch (30 subjects) alone. The study will consist of 2 visits.
    


Intervention name(s): Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell); Temperature Probe
Intervention type(s): Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: temperature profile; air activated 3-cell patch; adhesion
Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a
      new investigational drug being developed for treatment of tuberculosis. If single doses are
      safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy
      volunteers and patients with pulmonary tuberculosis.
    


Intervention name(s): SQ109
Intervention type(s): Drug
Intervention description(s): Single oral dose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SQ109; Tuberculosis