bioihbjkbjnl/mcl2 huggingface dataset:
Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      It is well known that the hormone insulin lowers blood glucose in part by acting directly on
      the liver and reducing hepatic glucose production. Animal studies have shown that the hormone
      insulin can act on the brain to indirectly lower glucose production by the liver. It has
      previously been shown that a nasal spray can deliver insulin directly to the brain without
      affecting circulating insulin concentration in humans. Intranasal spray of insulin suppressed
      hepatic glucose production in lean subjects. It is unknown whether this effects is blunted in
      subjects with insulin resistance.
    

Detailed description: 
      Each study participant will be admitted to hospital the evening prior to the study. Following
      admission each study participant will be provided with a standardized dinner. At 7am (t=0)
      the next day we will begin a primed, constant intravenous infusion d2 glucose (a stable
      isotope of glucose, the enrichment of which can be measured by gas chromatography mass
      spectrometry, allowing us to calculate endogenous glucose production rates) and continue this
      for 8 hours. At the same time (7am) a pancreatic clamp will be started as described above for
      8 hours. Blood samples will be analysed with a glucometer for instant blood glucose readings
      At 9 am (+120 minutes) intranasal placebo or insulin will be administered. The insulin
      (Humalog Lispro 100 IU/ml, Eli Lily, Canada) and placebo (diluent) will be transferred to a
      metered nasal device (Pharmasystems, Ontario #063636 802721, Item 10271) immediately prior to
      use. This device dispenses 0.1ml (10 IU) per puff. 4 x 0.1 ml puffs/vials (2 per nostril)
      will be administered at rate of 2 (one in each nostril) every 60 seconds. Blood will be drawn
      at t=0, 30, 60, 120 and every 10 minutes thereafter for 6 hours. In order to match peripheral
      lispro concentrations between study visits, a small dose of Humalog (lispro) insulin will be
      administered intravenously at 9am, during the placebo arm of the study. Based on the
      pharmacokinetics of Humalog lispro (personal communication from Eli Lilly), we propose to
      administer 0.005 IU/kg over 30 minutes. 20% dextrose will be administered to maintain
      euglycemia as necessary. Insulin, glucagon, and glucose isotopic enrichment will be measured.
      The enrichment data and glucose infusion will be used to calculate steady state glucose
      production.
    

Intervention name(s): Intranasal insulin; Intranasal placebo
Intervention type(s): Drug; Drug
Intervention description(s): Humalog lispro 40 IU intranasally; Diluent intranasally
Other intervention name(s): Insulin; Placebo
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients
Condition: Sepsis
MeSH terms: Sepsis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study hypothesis is to measure how the drug doripenem is cleared from the body of
      critically ill trauma patients. The investigators will measure blood drug concentrations and
      calculate how much the drug distributes in the body and how fast it is removed from the body.
      There is little information on how drugs are cleared in critically ill patients and the wrong
      dose of a drug could make it ineffective. The investigators will use this information to
      predict the most reasonable dose to treat infections effectively in these patients.
    

Detailed description: 
      Understanding the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of an antibiotic
      can provide insight into developing appropriate dosing regimens. It is even more imperative
      at the present time to maximize PK/PD parameters since there are no new novel antimicrobial
      agents to treat resistant gram-negative infections. This approach allows us to achieve
      superior PD parameters and treat bacteria that would have been resistant to standard dosing
      due to higher minimum inhibitory concentrations (MICs).

      Doripenem exhibits time-dependent bactericidal activity and the pharmacodynamic parameter
      predicting clinical and bacteriologic outcomes is the percentage of the dosing interval that
      free drug concentrations remain above the minimum inhibitory concentration (T > MIC) of the
      infecting pathogen Sepsis is known to influence drug pharmacokinetics and pharmacodynamics as
      a result of changes in hemodynamics, capillary permeability, third spacing, acid-base status,
      serum proteins, and organ function. Moreover, trauma patients tend to be younger with fewer
      comorbidities. They are hypermetabolic and are often given aggressive fluid resuscitation
      resulting in increased renal clearance of drugs and a larger volume of distribution. As a
      consequence of these differences in PK parameters, the calculated PD parameters will likely
      differ resulting in sub-optimal T> MIC. For time-dependent antibacterial agents such as
      doripenem, the T > MIC is one of the most important pharmacodynamic parameters in predicting
      clinical efficacy, therefore it is imperative to evaluate the PK parameters in this
      particular population.
    

Intervention name(s): Doripenem
Intervention type(s): Drug
Intervention description(s): Doripenem 1 gm administered over 4 hours X 3 doses
Intervention MeSH terms: Doripenem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics; Doripenem; Trauma; sepsis; Trauma patients with sepsis
Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)
Condition: Obesity
MeSH terms: Obesity; Metabolic Diseases
Study type: Interventional

Summary: 
      60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients
      with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type
      2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients
      and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal
      pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose
      oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio
      urinary excretion. Intestinal and colonic biopsies will be also provided for studying
      permeability. For only patients, samples from the gastric resection will be provided for
      analysing the enteric nervous system and motricity.
    


Intervention name(s): Digestive functions investigations
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Patients eligible for bariatric surgery (BMI>40kg/m2)
US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
Condition: Acellular Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      New immunization recommendations in the US include vaccination of adolescents against
      pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the
      Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced
      Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate
      vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the
      same office visit if vaccination with both vaccines is indicated. Therefore, this study is
      designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix
      co-administered with Menactra as compared to the administration of either vaccine alone in
      healthy adolescents 11 - 18 years of age.
    

Detailed description: 
      A phase IV, randomized, partially blinded multicenter study to evaluate the safety and
      immunogenicity of a booster vaccination with GlaxoSmithKline's tetanus toxoid, reduced
      diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap Boostrix®] co-administered
      intramuscularly with Aventis-Pasteur's meningococcal (serogroups A, C, Y and W-135)
      polysaccharide diphtheria toxoid conjugate vaccine (Menactra™) as compared to the
      administration of either vaccine alone in healthy adolescents 11-18 years of age.
      "Experimental design: Prospective, randomized, controlled multicenter study with three
      groups:

      Group 1: Boostrix + Menactra on Day 0, blood samples at Month 0 and Month 1 Group 2: Boostrix
      on Day 0, Menactra at Month 1, blood samples at Month 0, Month 1, and Month 2 Group 3:
      Menactra on Day 0, Boostrix at Month 1, blood samples at Month 0, Month 1 and Month 2
      Treatment allocation: randomized 1:1:1 Type of study: self-contained Duration of the study:
      Approximately one month for each subject in Group 1 and approximately two months for each
      subject in the Group 2 and Group 3."
    

Intervention name(s): Boostrix®; Menactra™
Intervention type(s): Biological; Biological
Intervention description(s): GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.; Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: tetanus; pertussis; Prophylaxis; meningococcus; diptheria
Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects
      of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult
      Subjects
    


Intervention name(s): EDP-938; EDP-938; Cyclosporine; Prednisone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1); Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2); Subjects will receive one dose of cyclosporine on Day 5; Subjects will receive prednisone once daily from Day 5 to Day 14
Intervention MeSH terms: Cyclosporine; Prednisone; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 2-Part Single Group study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug drug interaction study
Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
Condition: Low-Risk Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine if trans-rectal microwave ablation of the index
      tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using
      MRI-transrectal ultrasound image registration.
    

Detailed description: 
      In men with low-risk prostate cancer, European and American guidelines recommend either
      active surveillance or whole-gland treatments, with significant induced morbidity and burden
      on quality of life. Focal treatments of the index tumor are currently under investigation to
      decrease morbidity while proposing active treatment.

      The purpose of this study is to determine the feasibility, precision and safety of a novel
      ablation treatment using microwaves, delivered transrectally under real-time guidance with
      MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate
      MRI and characterized with targeted biopsies using MRI-transrectal ultrasound image
      registration. It will then be ablated with microwaves using the same transrectal approach and
      guidance system (KOELIS).
    

Intervention name(s): Microwave trans rectal focal treatment
Intervention type(s): Device
Intervention description(s): Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration
Other intervention name(s): Microwave thermal ablation system called TATO (Biomedical)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; prostate; PSA; biopsies; microwave trans rectal focal treatment
Trial of Antimicrobial Restraint in Presumed Pneumonia
Condition: Healthcare-Associated Pneumonia; Sepsis
MeSH terms: Pneumonia; Healthcare-Associated Pneumonia
Study type: Interventional

Summary: 
      The objective of this cluster-randomized crossover study is to determine the effect of
      delaying antimicrobial initiation until objective microbiologic data is obtained in patients
      with presumed ICU-acquired pneumonia without septic shock.
    

Detailed description: 
      This study will involve 8 centers is to determine the effect of delaying antimicrobial
      initiation until objective microbiologic data is obtained in patients with presumed
      ICU-acquired pneumonia without septic shock. The study team will compare two sequential
      4-month periods in each unit, one 'aggressive' antimicrobial initiation period and one
      'conservative' antimicrobial initiation period.

      This study will serve the following specific aims:

      Specific Aim 1: To determine feasibility of a larger multicenter study of the same design as
      well as assess protocol adherence across multiple centers.

      Specific Aim 2: Prospectively determine the all-cause, in-hospital mortality for all patients
      with suspected pneumonia who were treated under either an aggressive or conservative
      antimicrobial initiation protocol.

      Specific Aim 3: Prospectively determine antimicrobial initiation rates, total days of
      antimicrobial administration, hospital and ICU length of stay, and ventilator-free alive days
      for patients treated under each protocol.

      Specific Aim 4: To survey physicians that participated in the study to assess their feelings
      about the study including level of comfort starting antimicrobials aggressively, level of
      comfort withholding antimicrobials until definitive evidence of infection, perceived protocol
      adherence, perceived importance of the study, and willingness to participate in other studies
      of its kind (to be performed after closure of the clinical portion of the study).
    

Intervention name(s): antimicrobial initiation
Intervention type(s): Other
Intervention description(s): antimicrobial initiation based on protocol assignment.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a pragmatic, before-and-after, cluster-randomized, protocol crossover study.
Masking: None (Open Label)
Primary purpose: Treatment
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
Condition: Diarrhea; Gastroenteritis
MeSH terms: Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus
      vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2
      months and 4 months). In this interventional, open-label study, infants 2 through 5 weeks of
      age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and 4
      month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to
      the standard recommended schedule (2, 4, and 6 months of age). Sera will be obtained from
      subjects one month following the final dose of vaccine and will be assayed for anti-rotavirus
      IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4 and P[8]
      serotypes. Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers (GMTs) will
      be compared between children receiving pentavalent rotavirus vaccine (RV5) according to the
      alternate dosing schedule versus the standard recommended schedule. Likewise, post dose 3 G2,
      G3, G4 and P[8] SNA and serum rotavirus IgA GMTs will be compared between children receiving
      RV5 according to the alternate dosing schedule and the standard recommended schedule. The
      safety and tolerability of RV5 in children receiving vaccine according to the alternate
      dosing schedule will be described.
    


Intervention name(s): RV5 (Pentavalent Rotavirus Vaccine)
Intervention type(s): Biological
Other intervention name(s): RotaTeq
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gastroenteritis; Diarrhea; Rotavirus; Vaccine; Dehydration
Study on the Effects of Epicatechin and Quercetin Supplementation on Vascular Function and Blood Pressure (FLAVO)
Condition: Hypertension; Endothelial Dysfunction
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Flavonoid-rich foods such as tea and cocoa have been identified as having a blood
      pressure-lowering effect. Part of this effect is thought to be due to the flavonoid content
      of these foods although it is currently unknown which flavonoids play a role. Epicatechin is
      one the major flavonoids in cocoa while quercetin is largely found in tea.

      During this study the investigators plan to investigate the effects of pure epicatechin and
      quercetin supplementation on vascular function and blood pressure in untreated
      (prehypertensive) subjects by way of a three-armed double-blind crossover intervention.
      Participants will sequentially consume supplements containing quercetin, epicatechin or
      placebo for a period of 4 weeks. Before and after this 4 week period, measurements of
      vascular function and blood pressure will be taken.

      The investigators hypothesize that the supplementation of epicatechin and quercetin will
      improve vascular function and blood pressure.
    

Detailed description: 
      By means of a three-armed double-blind crossover intervention, the effects of pure flavonoid
      supplementation will be investigated. The products under investigation will be epicatechin
      and quercetin-3-glucoside. Subjects will be asked to consume either 160mg of
      quercetin-3-glucoside, 100mg of epicatechin or a placebo capsule for a period of 4 weeks.
      Measurements of vascular function and blood pressure will be taken before and after each
      4-week intervention period. A 4-week washout period will be planned between each
      intervention.

      Measurements of vascular function will include flow-mediated dilation, pulse wave analysis,
      pulse wave velocity and vasomotion as well as biomarkers of inflammation and vascular
      function.
    

Intervention name(s): Epicatechin; Quercetin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will be asked to consume supplements containing 100mg of epicatechin daily; Subjects will be asked to consume 160mg of quercetin-3-glucoside daily; Subjects will be asked to consume capsules containing placebo (cellulose) daily
Intervention MeSH terms: Quercetin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Flavonoids; Quercetin; Epicatechin; Vascular function; Blood pressure; Endothelial function
A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the effects of the medication doxazosin on sleep in men and women with
      PTSD. Sleep will be measured objectively at home using a portable sleep recorder and wrist
      actigraphy.
    

Detailed description: 
      This pilot study will assess the effects of doxazosin on objective measures of sleep in PTSD
      subjects using home ambulatory polysomnography. Twenty (20) men and women with chronic PTSD
      will be enrolled at the San Francisco Veterans Affairs Medical Center. After initial
      screening, subjects will complete 1 week of baseline assessments including 2 nights of home
      ambulatory polysomnography. They will then participate in a 2-week flexible-dose titration of
      doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose
      treatment ending with 2 nights of home polysomnography. Subjective and rater-based
      assessments will be conducted at baseline and at set intervals during and at the end of
      treatment. Wrist actigraphy measurements will also be made at baseline and at end of
      treatment as an economical, fairly valid and unobtrusive measure of sleep duration. We
      hypothesize that doxazosin will be associated with an increase in total sleep time (TST) and
      a decrease in wake time after sleep onset (WASO). We hypothesize that doxazosin will also be
      associated with clinical gains with respect to nightmares, subjective sleep quality,
      non-sleep PTSD symptoms, depression symptoms, and quality of life.
    

Intervention name(s): Doxazosin XL
Intervention type(s): Drug
Intervention description(s): Subjects will participate in a 2 week flexible-dose titration of doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose treatment.
Other intervention name(s): Cardura XL
Intervention MeSH terms: Doxazosin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Posttramatic Stress Disorder; Post-traumatic Stress Disorder; PTSD; Doxazosin; Nightmares; Sleep Disturbance