bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707
Condition: Pharmacokinetics of ASP1707
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects receive a single oral dose of radioactive ASP1707 on Day 1. Blood, plasma, urine and
      feces samples are collected for analysis of 14C-radioactivity and ASP1707. Metabolites are
      collected until at least 144 hours after dosing.
    

Detailed description: 
      Subjects are admitted to the clinic on Day -1 and receive a single oral dose of 14C-labeled
      ASP1707 on Day 1. They remain in the clinic for 6 days and are discharged on Day 7 if
      sufficient recovery of administered radioactivity is achieved, or the total excretion (urine
      + feces) per 24 hours is less than 1% of the administered dose during 2 consecutive 24-hour
      intervals. If these conditions are not met, the residential period may be prolonged for a
      maximum of 3 days. If after this time one of the conditions is still not met, subjects are
      requested to continue collecting their urine and/or feces at home for another 2 days. If
      after these additional 2 days one of the conditions is still not met, the condition of
      recovery of radioactivity is disregarded. Therefore only the total excretion condition is to
      be met by collecting 24-hour intervals for urine and feces once a week for up to 2 weeks. If
      the excretion condition is still not met after this time, no further samples are collected
      and the subject is discharged from the study.
    

Intervention name(s): 14C-labeled ASP1707
Intervention type(s): Drug
Intervention description(s): oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy subjects; Excretion; 14C-labeled ASP1707
Effect of Angiotensin Receptor Blockade on Insulin Resistance and Adipose Tissue Cytokines in Type 2 Diabetes
Condition: Insulin Resistance; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The study aims to investigate the effect of acute angiotensin receptor blockade on insulin
      action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose
      tissue in insulin-resistant subjects with type 2 diabetes and healthy controls.

      Hypothesis: Changes in adipocytokine concentrations and/or expressions and different
      reactions to acute in vivo induced hyperinsulinemia and angiotensin receptor blockade will be
      found in patients with type 2 diabetes compared to healthy subjects. A significant
      relationships between insulin sensitivity and selected adipokines and intracellular fat
      content and high energy phosphates in soleus muscle will be documented in healthy
      individuals, while no significant relation will be found in patients with type 2 diabetes.
    

Detailed description: 
      10-15 patients with type 2 diabetes and 10-15 healthy control subjects will be examined on an
      outpatient basis. The following examination will be carried out in each subject after 12 hrs
      fasting:

        -  Oral glucose tolerance test (75 g of glucose) (in healthy subjects to confirm the normal
           tolerance of glucose).

        -  Evaluation of insulin secretion after 1 mg of glucagon i.v.

        -  Hyperinsulinaemic (75 milly-international unit(mIU)/l) euglycemic clamp study lasting 4
           hours combined with indirect calorimetry and biopsy of subcutaneous adipose tissue.

        -  Hyperinsulinemic (75 mIU/l) euglycemic clamp study lasting 4 hours combined with
           indirect calorimetry after losartan 100 mg given in the evening and in the morning
           before the study.

        -  Proton and phosphorus magnetic resonance spectroscopy.

      Before (0 min), at 30 min and in the end of studies c) and d) the blood samples will be taken
      and biopsies of subcutaneous abdominal adipose tissue will be done.
    

Intervention name(s): Hyperinsulinaemia; Losartan; Saline
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp; Acute administration of losartan 200mg total prior to clamp; Infusion of Saline as a volume control intervention
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Adipose tissue; Adipokines
Molecular Imaging of Brain Inflammation in Depressive Disorders
Condition: Depressive Disorder, Major; Positron-Emission Tomography
MeSH terms: Infectious Encephalitis; Encephalitis; Inflammation; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      In a number of neuropsychiatric disorders such as depression, both brain inflammation and
      glutamate mediated excitotoxicity (cell death through over-activated stimulation) are
      suspected to play a key role. It is difficult, if not impossible, to determine the potential
      destructiveness of the inflammatory response seen in disease states by studying the brain's
      inflammatory cells (microglia) activity in isolation. The investigators are proposing to
      develop the means to concurrently study inflammatory response (i.e., microglial activity) and
      its potentially devastating consequence (i.e., glutamate excitotoxicity) across the entire
      brain in order to establish the importance of inflammation. In this study the investigators
      propose a phased clinical study whereby the early-phase involves the development of our
      capacity to study inflammation-mediated damage to brain cells, followed by a feasibility
      study in patients with clinical depression that tests whether concurrent inflammation and
      glutamate excess could be measured in key brain regions associated with a depressed mood
      state.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  Able to pass MRI screening form (reviewed by a MRI technician)

          -  diagnosed with depression or healthy control participants with no present mental
             health disorder

          -  Good general health with no diseases expected to interfere with the study

          -  Subject is not pregnant, lactating, or of childbearing potential (must be practising
             effective form of birth control)

          -  Patient and healthy controls must not have an infection or an autoimmune disorder or
             persistent inflammation.
      
Biospecimen description: 
      Blood drawn and analyzed
PACMAN - PAcing for CardioMyopathies, a EuropeAN Study
Condition: Heart Failure
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the benefit of biventricular pacing in patients
      with heart failure who were receiving optimal pharmacological therapy, and who were either
      with or without an ICD indication
    

Detailed description: 
      Heart Failure is a syndrome that affects millions of patients in Europe with over half a
      million new cases reported annually. Drug therapy had been the conventional treatment of
      choice until the emergence of cardiac resynchronization therapy (CRT) where biventricular
      pacing can be delivered to the heart through a pacemaker or implantable cardioverter
      defibrillator. This study was designed to assess the effect of CRT on patients optimized on
      conventional heart failure medication including diuretics, beta blockers and ACE inhibitors.
      The effect of CRT was evaluated by comparison of 6 minute walk performance, Quality of Life
      and NHYA class after 6 months with CRT therapy either programmed ON or OFF. In addition,
      evaluation of the incidence of adverse events (predefined as ventricular arrhythmias,
      hospitalizations, drop-outs, complications and patient deaths) was done between groups at 6
      months. Patients were all programmed ON after 6 months and data was collected for an
      additional 6 months.
    

Intervention name(s): Contak heart failure devices
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU
Condition: ICU
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to measure the levels of ceftobiprole in the blood and
      urine during and after administration of four doses of ceftobiprole. Safety of the drug will
      also be evaluated.
    

Detailed description: 
      Patients will receive an intravenous dose of ceftobiprole infused over 4 hours. Multiple
      blood samples will be obtained to determine the concentration of ceftobiprole in the plasma.
      Pharmacokinetic parameters such as clearance and volume of distribution will be calculated.
      1000mg every 8hours or every 12 hours
    

Intervention name(s): ceftobiprole q12h; ceftobiprole q8h
Intervention type(s): Drug; Drug
Intervention description(s): Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2; Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
Intervention MeSH terms: Ceftobiprole; Ceftobiprole medocaril; Cephalosporins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ICU
Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9
      to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY
      when given to healthy subjects 11 to 55 years of age. In addition, the safety and
      immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects
      10 years after the primary vaccination will be evaluated.

      All Filipino subjects who received the primary vaccination in the primary vaccination study
      107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase.
      No new subjects will be enrolled.
    


Intervention name(s): Meningococcal vaccine GSK134612
Intervention type(s): Biological
Intervention description(s): 1 dose administered intramuscularly in the non-dominant deltoid region.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy; Adults; Safety; Neisseria meningitidis; Booster response; Immunogenicity; Adolescents; Serogroups A, C, W-135, and Y; long-term antibody persistence
Genetics, Metabolism and Weight Loss in Older, Obese Veterans
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study is designed to determine whether sequence variation in the lipoprotein lipase
      (LPQ) gene affects the amount of weight loss and metabolic responses during a hypocaloric
      diet treatment for overweight and obese (BMI=25-35 kg/m2), older (50-65 yrs), sedentary
      veterans.
    

Detailed description: 
      Veterans who are 50-65 yrs, non-smoking, sedentary and weight stable with a BMI between 25-35
      kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical
      history, and physical exam. Exclusion criteria are: diabetes, hypertriglyceridemia (>400
      mg/dl), history of cancer or myocardial infarction, clinical depression, renal, liver or
      hematologic disease, and medications that affect glucose or lipid metabolism (thiazides,
      estrogen replacement, beta-blockers). Changes in total and visceral body fat are measured by
      dual x-ray absorptiometry and computerized tomography, resting energy expenditure and fat
      oxidation rate by indirect calorimetry, and lipoprotein lipids by enzymatic assay. Glucose
      tolerance is assessed during a three-hour oral glucose tolerance test with measurement of
      glucose- and insulin levels every 30 minutes. LPL activity is measured in 3050mg pieces of
      subcutaneous abdominal and gluteal adipose tissue.
    

Intervention name(s): Weight Loss
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Behavioral; Weight Loss; Genetics; Lipoprotein lipase; Visceral fat; Lipoprotein
Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
Condition: Trauma; Critical Illness; Oxygen Toxicity
MeSH terms: Critical Illness; Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      The objective of this study is to conduct an observational pre/post study to evaluate the
      clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in
      critically ill trauma patients.
    

Detailed description: 
      Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance
      of hypoxia is vital, the current clinical practice of excessive oxygenation settings is
      common, and unnecessary, and may even be harmful.

      An expert panel convened to define optimal oxygenation targets in critically ill trauma
      patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of
      90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial
      implementation of this consensus will occur for the care of trauma patients.

      Specific Aim:

      This is an observational pre/post study to evaluate the impact of targeted normoxia
      implementation in optimizing oxygen delivery and oxygenation in critically ill trauma
      patients.

      Hypotheses:

      That the clinical efforts to improve adherence to oxygen guidelines will:

        1. improve the proportion of time spent with target normoxia thresholds (oxygen saturation
           SpO2 90-96%) by

        2. reducing utilization of unnecessary supplementation oxygen

        3. without a substantive increase in hypoxic episodes or an adverse impact on clinical
           outcomes.
    

Intervention name(s): Targeted Normoxia (oxygen saturation 90-96%); Usual Care Oxygenation
Intervention type(s): Other; Other
Intervention description(s): The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation; The control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Critically ill trauma patients
      
Keywords: Oxygenation; Hypoxia; Normoxia; Hyperoxia; Trauma; Critical Illness
Evaluating Processes of Care & the Outcomes of Children in Hospital (EPOCH)
Condition: Critically Ill Children
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the impact of Bedside Paediatric Early Warning
      System (Bedside-PEWS) on early identification of children at risk for near and actual
      cardiopulmonary arrest, hospital mortality, processes of care and PICU resource utilization.
    

Detailed description: 
      The Bedside Paediatric Early Warning System (Bedside PEWS) is a scientifically developed
      documentation-based system of care designed to identify children who are clinically
      deteriorating while admitted to hospital inpatient wards. It was developed and validated by
      the applicants. The investigators have preliminary data demonstrating that the Bedside PEWS
      addresses multiple factors (communication, hierarchy, secondary review) contributing to
      delayed treatment of children at risk. In our pilot study of implementation at a single site
      the investigators showed statistically significant reductions in late transfers, 'stat'
      calls, decreased apprehension when nurses called physicians to review patients, and improved
      communication. Our preliminary data show that the Bedside PEWS score is superior to other
      methods being used to identify children at risk for impending cardiopulmonary arrest. A
      2-year cluster-randomized trial will evaluate the impact of Bedside PEWS on clinical
      outcomes, processes of care and resource utilization in 22 paediatric hospitals.
    

Intervention name(s): Implementation of Bedside Paediatric Early Warning System; Hospital Standard of Care
Intervention type(s): Other; Other
Intervention description(s): The Bedside Paediatric Early Warning System (Bedside PEWS) is a documentation-based system of care that will replace existing documentation systems for vital signs in inpatient ward areas in hospitals randomized to implement Bedside-PEWS. Frontline staff education within each hospital will occur over a period of three months preceding a 5 week run-in implementation phase, which will be followed by hospital-wide implementation. The Bedside-PEWS documentation record will become the primary method of documentation for vital signs and related data.; Hospitals randomized to standard care will continue with established methods of care. This will include the use of calling criteria and/or the expert model to identify children at risk. As in intervention hospitals, existing MET-RRT practices, established staffing and documentation practices will continue.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BedsidePEWS; Intensive Care
Bioavailability of Levodopa 250 mg and Carbidopa 25 mg With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the bioavailability in fasting male and/or non-pregnant and non-
      breast feeding female subjects of 1 tablet formulation containing Levodopa 250 mg and
      Carbidopa 25 mg. The study will be performed at a single site with 44 subjects. Participants
      will take 1 tablet of the test product and reference product in 2 periods and 2 sequences
      (either test after reference or reference after test). There will be a washout of at least 2
      days between each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Oseltamivir Phosphate 75 mg of 1 capsule formulations with Oseltamivir Phosphate 75 mg and to
      demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Silesia S.A.

        -  Reference Product: Sinemet [Trademark], product of Savio Industrial S.R.L., Brazil. The
           90% confidence intervals for the intra-subject coefficient of variation (Test versus
           Reference Product) for the main pharmacokinetic parameters area under the plasma
           concentration-time curve from time zero to time t (AUC0 0-t) and from time zero to
           infinite (AUC0 0-∞), and maximum plasma concentration (Cmax) for total Levodopa and
           Carbidopa will be determined. Participants will be confined in the study site for
           approximately 68 hours during the entire study (for 10 hours pre-dosing and for 10 hours
           post dosing in period II) during which pharmacokinetic (PK) blood samples will be
           obtained. 23 blood samples will be taken up to 10 hours after the administration in each
           period. The washout period between the two study periods will be at least 2 days. The
           samples from each participant will be analyzed with validated LC-MS/MS method for
           estimation of Levodopa and Carbidopa in plasma. The safety objective is to evaluate the
           tolerability of both formulations in subjects by collecting adverse events.
    

Intervention name(s): Levodopa 250mg and Carbidopa 25mg Test Drug tablet; Levodopa 250mg and Carbidopa 25mg Referent Product tablet
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Sinemet (Savio Industrial S.R.L, Brazil)
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of a new medication for the treatment of cognitive impairments (thinking
      difficulties) and negative symptoms in people with schizophrenia. The new medication is
      rasagiline. Rasagiline is a drug which has been approved by the Food and Drug Administration
      for the treatment of Parkinson's disease. It is used to treat cognitive problems.
    

Detailed description: 
      The study will consist of two phases: a 4-week continued stability phase (lead-in phase) and
      a 12-week double-blind treatment phase. In the lead-in phase, subjects receiving
      antipsychotic medication, who manifest moderate to severe and persistent negative symptoms,
      will remain on their maintenance regimen for at least four weeks. The treatment phase will be
      a 12-week, parallel groups, double-blind, placebo-controlled trial of adjunctive rasagiline
      (1 mg/day), a selective MAO-B oxidase inhibitor.
    

Intervention name(s): rasagiline (Pharmacodynamics); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rasagiline 1 mg/day for 12 weeks; Placebo 1 tablet each day
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive impairments; Negative symptoms