bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Patients with chronic kidney disease (CKD) have a markedly higher prevalence of
      cardiovascular disease (CVD) than the general population. Dyslipidemia is considered a major
      cause of CVD in patients with CKD. Especially for peritoneal dialysis (PD) patients, the use
      of glucose as the osmotic agent in PD solutions has been associated with a variety of
      metabolic consequences ranging from acute hyperglycemia and hyperinsulinemia to dyslipidemia
      and weight gain. Among lipid abnormalities, hypertriglyceridemia is the most common in PD
      patients. A study showed that patients with high triglyceride levels were more
      insulin-resistant than those with normal triglyceride levels.

      Insulin resistant is associated with atherogenic response represented high plasma levels of
      monocyte chemotactic protein-1 in a large cohort of dialysis patients. Therefore, high
      triglyceride level may play an important role to CV outcome of PD patients. PD solution
      decreasing triglyceride levels is essential in PD patients.

      Icodextrin, a starch-derived high molecular weight glucose polymer was found to increase
      ultrafiltration compared to glucose solutions. Furthermore, a low peritoneal absorption of
      icodextrin, which is catabolized into maltose, considerably reduces caloric uptake.
      Therefore, icodextrin may have an additional favorable effect on triglyceride level.

      There are several studies regarding the effect of icodextrin on triglyceride level in PD
      patients. However, the outcomes are controversial, some studies showed no association between
      icodextrin and triglyceride change, even the others showed positive results but these also
      have study design limitations such as non-randomized study or secondary primary outcome. It
      is not clear about the effect of icodextrin on triglyceride especially in PD patients without
      diabetes.

      The investigators therefore want to conduct a randomized, cross-over, controlled multicenter
      trial comparing icodextrin solution and glucose solution in PD patients with and without
      diabetes, focusing on triglyceride change.
    


Intervention name(s): Extraneal (Icodextrin); Glucose solution
Intervention type(s): Drug; Drug
Other intervention name(s): Extraneal; Icodextrin; 2.5% dextrose solution; 4.25% dextrose solution
Intervention MeSH terms: Pharmaceutical Solutions; Icodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Icodextrin; Triglyceride
Open, Randomized, Two Way Crossover 40mg, Orally and Intravenously
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg
      Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people
      with symptoms of Gastroesophageal Reflux Disease (GERD)
    


Intervention name(s): Esomeprazole; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 40mg oral; 15 minute intravenous infusion
Other intervention name(s): Nexium; Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium
A Study Of The Effects Of CB2 Compound Of GW842166 In Patients With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, two-period, placebo controlled cross-over Phase IIa study. This study
      is to use CB2 compound of GW842166 in patients with osteoarthritis. The pain assessments and
      WOMAC questionnaires will be used in the study after the repeated dose to evaluate the
      efficacy of CB2 compound of GW842166.
    


Intervention name(s): GW842166; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg once daily; once daily
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: osteoarthritis pain assessments
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil
      compared with oseltamivir in a single influenza episode in otherwise healthy pediatric
      participants (i.e., 1 to <12 years of age) with influenza-like symptoms.
    


Intervention name(s): Baloxavir Marboxil; Oseltamivir
Intervention type(s): Drug; Drug
Intervention description(s): Baloxavir marboxil will be administered as oral suspension in a single dose on Day 1.
Oseltamivir matching placebo will also be administered as oral suspension twice daily (BID) for 5 days.; Oseltamivir will be administered as oral suspension BID for 5 days. Participants receiving oseltamivir will also receive baloxavir marboxil matching placebo as oral suspension, single dose on Day 1.
Intervention MeSH terms: Oseltamivir; Baloxavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare in healthy volunteers levels of TMC435 in the blood
      circulation after intake of 2 new capsule formulations with the level of TMC435 in the blood
      circulation after intake of the capsule formulation used in the Phase IIb studies.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), open-label (all people involved know
      the treatment), single dose, crossover (volunteers will receive different treatments
      sequentially during the trial) study in healthy volunteers. The trial will evaluate the
      levels of TMC435 in the blood circulation after a single dose of 150 mg TMC435 administered
      as 3 different capsule formulations following breakfast. There will be a 7-day washout period
      between treatments and a 4-5 week follow-up at the end. Each volunteer will receive all three
      treatments. The main focus of the trial is the pharmacokinetic characteristics (how drugs are
      absorbed in the body, how they are distributed within the body and how they are removed from
      the body over time) of the different formulations. This evaluation requires multiple blood
      samples from Day 1 through 72 hours after dosing. Safety assessments (lab work, blood
      pressure, pulse and electrocardiogram) will follow a different schedule and are measured on
      Day -1 (day prior to taking first dose of drug), Day 1 (without lab work) and Day 4 of each
      treatment period, and 1 and 4-5 weeks after the last treatment. Each volunteer will receive 3
      treatments, 7 days apart from each other. Each treatment consists of one single oral dose of
      150 mg TMC435.
    

Intervention name(s): TMC435 (G006); TMC435 (F021); TMC435 (G007)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one morning dose of 150 mg; one morning dose of 150 mg; one morning dose of 150 mg
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC435-TiDP16-C119; TMC435-C119; TMC435; Protease inhibitor; HCV; Hepatitis C; Bioavailability
Neuromuscular Electrical Stimulation Via the Peroneal Nerve Reduces Muscle Soreness Following Intermittent Exercise
Condition: Delayed Onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      Numerous techniques are reported to enhance recovery following intense exercise, however
      there is equivocal support for such claims. A novel technique of neuromuscular electrical
      stimulation (NMES) via the peroneal nerve has been shown to augment limb blood flow which
      could enhance recovery following exercise. The present study examined the effects of NMES,
      compared to graduated compression socks on muscle soreness, strength, and markers of muscle
      damage and inflammation following intense intermittent exercise.
    


Intervention name(s): control; graduated compression socks; neuromuscular electrical stimulation device
Intervention type(s): Other; Device; Device
Intervention description(s): passive recovery following exercise test; graduated compression socks worn after test exercise; neuromuscular electrical stimulation device worn after test exercise
Other intervention name(s): firefly device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: delayed onset muscle soreness; muscle damage; muscle function; inflammation
The Influence of Tissue Adhesive to Palatal Donor Site Healing.
Condition: Donor Site Complication
Study type: Interventional

Summary: 
      CTG was harvested from 21 patients in each group. Donor site was treated with either GS
      (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and
      primary bleeding time were recorded intraoperatively. Patients recorded the quantity of
      analgesics (QA) taken, presence of secondary bleeding (SB) and pain perception (PP) daily for
      first postoperative week. Sensation loss (SL), color match (CM), epithelization level (EL)
      were evaluated at days 7, 14, 21 and 28.
    


Intervention name(s): Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]; Cyanoacrylate, Isobutyl
Intervention type(s): Drug; Drug
Intervention description(s): Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group); Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group).
Intervention MeSH terms: Thrombin; Gelatin Sponge, Absorbable
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Observational

Summary: 
      This is a prospective cohort study study with the primary aim of identifying the strongest
      correlating parameters between voiding diaries and UDS studies most predictive for each type
      of urologic condition. Investigators will focus on OAB related conditions, as these are
      symptoms
    


Intervention name(s): Voiding Diary; Urodynamics Correlation Study
Intervention type(s): Other; Other
Intervention description(s): A log kept by each patient to record frequency and volume of urine output and fluid input.; Provides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients seen regularly with Overactive Bladder (OAB)
Compromised Microcirculation in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The scientific aims of the study are to determine how peripheral microcirculatory
      responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local
      heating and to determine the mechanism for testosterone effects on peripheral
      microcirculatory responsiveness in women with PCOS.
    

Detailed description: 
      In these studies, we propose to use the skin as a relatively non-invasive model to examine
      cardiovascular and endothelial function in obese women with and without PCOS. Data have
      indicated an important role for testosterone in influencing the peripheral microcirculation.
      While testosterone can lead to vasodilation in the peripheral microcirculation in both men
      and in women without PCOS, testosterone appears to induce vasoconstriction in women with
      PCOS. The differential response between women with and without PCOS, and between men and
      women may be the result of differential ET-1 actions in the vessel, and regulated by the
      receptor subtype is involved in these actions.
    

Intervention name(s): ganirelix acetate; methyl testosterone
Intervention type(s): Drug; Drug
Intervention description(s): GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days; testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day
Other intervention name(s): Antagon
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Ganirelix
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: skin blood flow; microcirculation
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the observer-blinded study is to determine the immunogenicity and safety of
      one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to
      one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study
      will compare the immunogenicity of two lots of GSK's 134612 vaccine.
    


Intervention name(s): Mencevax ACWY; GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Intervention type(s): Biological; Biological
Intervention description(s): One dose, Subcutaneous injection; One dose, Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adolescent; Vaccine, conjugate; Adult; Neisseria meningitidis; Immunogenicity; Meningococcal vaccine; Safety
Efficacy Study on Cognitive Functions in Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objectives

        -  To compare neurocognitive effects of amisulpride with those of risperidone in patients
           with chronic schizophrenia, as assessed by the general cognitive index, a measure of
           overall cognitive functioning in schizophrenia

      Secondary objectives

        -  Secondary analyses will be conducted to determine how the two atypical agents'
           neurocognitive effects compare with regard to their profile of therapeutic action (based
           on individual cognitive domain scores in seven cognitive domains, including speed of
           processing, attention/vigilance, working memory, verbal learning and memory, visual
           learning and memory, reasoning and problem solving and social cognition);

        -  Investigate whether amisulpride elicits more improvement on negative symptoms compared
           to risperidone treatment, as measured by the total score on the Scale of the Assessment
           of Negative Symptoms (SANS) 8 and by the Negative Symptom Subscale of the Positive and
           Negative Symptom Scale (PANSS);

        -  Assess whether amisulpride improves overall functioning and individual domains of
           psychotic symptoms compared to risperidone as measured by the Clinical Global Impression
           (CGI), and the total and positive and general psychopathology subscale scores of PANSS
           and by the individual domains of SANS, respectively;

        -  Evaluate the safety and tolerability of amisulpride and risperidone based on the study
           completion rates, and frequency of abnormal laboratory values, prolactin serum
           concentrations and on the Simpson Angus Scale for Extrapyramidal Symptoms (SAS) 10 and
           the Abnormal Involuntary Movement Scale (AIMS).
    


Intervention name(s): amisulpride and risperidone
Intervention type(s): Drug
Intervention description(s): amisulpride tablet 400-800 mg/day risperidone tablet 4-8 mg/day
Intervention MeSH terms: Risperidone; Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oxytocin and Social Decision Making in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      schizophrenia patients and healthy volunteers will be included. Subjects who meet the
      inclusion and exclusion criteria for the study will be recruited. After completion of
      clinical assessments and neuropsychological assessments, all subjects will undergo two fMRI
      scans. In one scan subjects will receive a single dose of intranasal oxytocin and in another
      scan, they will receive intranasal saline. The order of administration of oxytocin or saline
      will be counterbalanced so that they are not administered in the same order to all subjects.
      Subjects will be blind to the drug administered.
    


Intervention name(s): Oxytocin nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose oxytocin will be administered intranasally
Intervention MeSH terms: Oxytocin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Application of Esketamine in Anesthesia of Autism Children
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Autistic
      children appear with significant frequency for medical services, lots of which requiring
      procedural sedation or anaesthesia. Autistic children have often been described as difficult
      to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to
      provide safe and effective sedation during the procedure of colonic TET for FMT in autism
      children. The investigators intend to explore an optimum anesthetic regimen for autism
      children undergoing endoscopic procedures.
    

Detailed description: 
      Autistic children appear with significant frequency for medical services, lots of which
      requiring procedural sedation or anaesthesia. The participants have often been described as
      difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task
      to provide safe and effective sedation during the procedure of colonic TET for FMT in autism
      children. The primary objective was to compare the clinical efficacy and safety of
      propofol-esketamine (PE) with propofol-sufentanil (PS) for deep sedation in the procedure of
      colonic TET in ASD children. A secondary objective was to compare adverse events (AEs) and
      recovery in those children during/after either PE or PS sedation.
    

Intervention name(s): propofol combined with esketamine; propofol-sufentanil
Intervention type(s): Drug; Drug
Intervention description(s): In group PE, esketamine was firstly administered at a dose of 0.3 mg.kg-1, followed immediately by propofol with a single intravenous dose of 2.0 mg.kg-1.; In group PS, sufentanil was administered intravenously at a dose of 0.2 μg.kg-1, then 2.0 mg.kg-1 propofol was intravenously injected.
Intervention MeSH terms: Sufentanil; Propofol; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: fecal Microbiota Transplantation; transendoscopic enteral tube; Gut microbiota; anaesthesia
Tampere Traumatic Head and Brain Injury Study
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      Tampere Traumatic head and brain injury study is a prospective study aiming to explore
      neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic
      brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi.
      The study is conducted in Tampere University Hospital's emergency department between the 1st
      of August 2010 and 31st of July 2013.
    

Detailed description: 
      Aims of the study:

        1. To improve clinical assessment of mTBI in the acute phase

        2. To assemble better knowledge of diffusion tensor imaging as a diagnostic tool in mTBI

        3. To improve neuropsychological evaluation of mTBI Main focus on psychosocial functioning
           / outcome / correlates E.g. Resilience, PTSD
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community sample consisting of consecutive mild traumatic brain injury patients metting the
        enrollment criteria.
      
Biospecimen description: 
      1. 10ml whole blood

        2. 10ml EDTA-blood x2
Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19
Condition: Covid19; Lymphopenia
MeSH terms: COVID-19; Lymphopenia
Study type: Interventional

Summary: 
      The mechanism of peripheral blood lymphocyte decline in COVID-19 patients is not yet clear.
      However, one theory demonstrated that in the whole progression of COVID-19, the extensive
      activation of poly-ADP-ribose polymerase (PARP) may reduce the cellular NAD+ and dampen the
      adaptive immune system. So investigators presume that replenishing the NAD+ using
      nicotinamide as the precursor may improve the lymphocyte counts and boost the adaptive immune
      system. As a result, the study using nicotinamide as a kind of supportive therapy provide
      further evidence of their efficiency and safety in treating lymphopenia in patients with
      COVID-19.
    


Intervention name(s): nicotinamide
Intervention type(s): Drug
Intervention description(s): In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: nicotinamide; COVID19; lymphopenia