bioihbjkbjnl/mcl2 huggingface dataset:
Pre-analytical Sample Handling Conditions and Their Effects on the Human Urine Metabolome
Condition: Healthy
Study type: Observational

Summary: 
      This study evaluates how urine handling conditions can affect the concentrations of ~1,000
      urine metabolites and attempts to quantify the degree of attenuation and/or potential bias in
      epidemiologic associations that may result from less than optimal sample handling conditions.
    

Detailed description: 
      Metabolomics, the simultaneous quantification of concentrations of hundreds or thousands of
      metabolites simultaneously in a biological matrix, is a versatile analytical technique
      capable of accelerating biomarker-based discoveries in nutritional science. Recently,
      metabolomics has been applied to samples collected in feeding studies (1) and epidemiologic
      studies (2) to identify dozens of novel potential dietary biomarkers. Several large
      prospective cohort studies, many of which are collaborating in a metabolomics consortium led
      by the National Cancer Institute, have recently applied metabolomics to banked samples. This
      has made nutrition-related biomarkers suddenly available for tens of thousands of
      participants with follow-up for disease endpoints, enabling truly large-scale nutritional
      biomarkers and disease studies.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Men and women will be recruited from the area surrounding the BHNRC. There are several
        thousand government and privately employed workers located within a 10-mile radius of the
        BHNRC and several residential communities from which a cohort of volunteers will be
        recruited. The population includes an ethnically diverse group of subjects.
Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is being conducted to characterize the pharmacokinetic properties of a
      new topical medication (MFC51123) that contains two active ingredients (diclofenac and
      menthol) in two formulation packages. One formulation package is in the form of a gel in
      aluminum tube and the other one in the form of a gel in roll-on applicator bottle.
      Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel
      and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol
      gel has being developed to treat mild to moderate pain and inflammation, such as acute sport
      injuries, sprains and strains. The rationale for conducting the study is to prove that
      repeated topical treatment of the new diclofenac + menthol formulation in either of the two
      packages does not result in unsafe systemic exposure.
    


Intervention name(s): Diclofenac sodium; Menthol
Intervention type(s): Drug; Drug
Intervention description(s): Diclofenac sodium; Menthol
Intervention MeSH terms: Diclofenac; Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison Between Oral and Enema of Chloral Hydrate
Condition: Congenital Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To compare the clinical sedative effect and safety using 10% chloral hydrate during
      ophthalmic examinations for oral vs enema group.The patients were randomly divided into two
      groups (oral group and enema group) using a computer random number generator with a 1:1
      allocation (simple randomization, odd number for oral group and even number for enema group).
    

Detailed description: 
      To compare the clinical sedative effect and safety using 10% chloral hydrate during
      ophthalmic examinations for oral vs enema group.The patients were randomly divided into two
      groups (oral group and enema group) using a computer random number generator with a 1:1
      allocation (simple randomization, odd number for oral group and even number for enema
      group).One hundred and twenty children aged from 3 to 36 months (5-15 kg) scheduled to
      ophthalmic examinations were randomly sedated by oral chloral hydrate(80 mg×kg-1, n = 60) or
      enema chloral hydrate(80 mg×kg-1, n = 60). The primary endpoint was successful sedation to
      complete the examinations including slit-lamp photography, tonometry, anterior segment
      analysis, and refractive error inspection. The secondary endpoints included onset time,
      duration of examination, recovery time, discharge time, any side effects during examination,
      and within 48 h after discharge.
    

Intervention name(s): oral chloral hydrate; enema chloral hydrate
Intervention type(s): Drug; Drug
Intervention description(s): Chloral hydrate syrup was available in a concentration of 100 mg×ml-1.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by oral.; Chloral hydrate syrup was available in a concentration of 100 mg×ml-1 at our hospital.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by enema.
Intervention MeSH terms: Chloral Hydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pediatric ophthalmic examination; chloral hydrate; Effects Comparison
Positron Emission Tomography (PET) Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's
      (NNRs) and to determine the relation between plasma concentration of AZD1446 and the
      occupancy at α4β2 NNRs.
    


Intervention name(s): AZD1446; 2-[18F]-F-A85380
Intervention type(s): Drug; Radiation
Intervention description(s): Solution, oral, single dose; iv, single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AZD1446; PET examination
Evaluation of the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using
      midazolam as a probe. Twenty healthy male subjects will participate
    

Detailed description: 
      This will be an open label study of midazolam (dose 2 mg orally, Day 1) followed by midazolam
      (2 mg orally) given after dosing with intravenous F901318 4 mg/kg bid for one day followed by
      2.5 mg/kg bid for 7 doses (Day 7). Up to twenty subjects will be included in two cohorts
      which will undergo the same dosing schedules of midazolam and F901318 and undergo the same
      procedures. The first cohort will consist of 12 subjects studied in two groups of six
      subjects each. If there is clearly a difference in midazolam kinetics detectable between the
      first and second doses of midazolam, in this first cohort, the second cohort will not be
      studied. If there is no clear difference, the second cohort will also be studied to give a
      final result. PK sampling for midazolam and 1- and 4-hydroxymidazolam plasma and urine
      concentrations will continue for up to and including 24 hours after dosing with midazolam on
      both occasions. PK sampling for F901318 will continue from before the first dose and up to 24
      hours after the ninth dose. A follow up visit will be conducted 7 +/- 2 days after discharge
      from the clinical unit following completion of blood sampling following the second dose of
      midazolam and the ninth dose of F901318.
    

Intervention name(s): Midazolam with F901318
Intervention type(s): Drug
Intervention description(s): Pharmacokinetics of midazolam with F901318
Intervention MeSH terms: Olorofim; Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study of the Bioavailability of Nasal Naloxone
Condition: Drug Overdose
MeSH terms: Drug Overdose
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall is aim of this pilot study is to give a preliminary estimation of key parameters
      of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be
      used to design a well justified protocol for the final estimation of these parameters:

        -  Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy
           volunteers

        -  Preliminary estimation of the maximum serum concentration (Cmax) of this formulation

        -  Preliminary estimation of the time to maximum serum concentration (Tmax) of this
           formulation

        -  Safety of the formulation
    


Intervention name(s): naloxone intranasal; naloxone intravenous
Intervention type(s): Drug; Drug
Intervention description(s): If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally; The parenteral dose reflects clinically used doses for overdoses (0.4 - 1.0 mg). A washout period of at least 3 days between each intervention. IV naloxone (Naloxone B. Braun 0.4mg/ml) administered slowly over 1-2 min in the recumbent position
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Antidotes; naloxone; administration, intravenous; administration, intranasal; pharmacology
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
Condition: ADHD; Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Quillivant XR is effective in the treatment
      of ADHD in children with Autism Spectrum Disorder (ASD).
    

Detailed description: 
      To evaluate the safety and tolerability of low to moderate dose effects of Quillivant XR
      (liquid methylphenidate) and to observe changes in ADHD symptoms and functional outcomes in
      children with ASD and ADHD. The investigators propose to investigate the low to moderate dose
      range of methylphenidate compared with a very low dose with a gradual dose escalation
      schedule because children with ASD have been found to be more sensitive to the adverse
      effects of methylphenidate (especially in medium to high doses) than children without ASD.
    

Intervention name(s): Very Low Dose Quillivant XR; Low Dose Quillivant XR; Moderate Dose Quillivant XR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral suspension dose once a day increasing to a 10mg dose; Oral suspension dose once a day increasing to a 20mg dose; Oral suspension dose once a day increasing to a 40mg dose
Other intervention name(s): Methylphenidate HCl; Methylphenidate HCl; Methylphenidate HCl
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Quillivant
Exercise Effects on Brain Health and Learning From Minutes to Months
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      Given the accelerating growth of older adults worldwide and the decline in cognitive function
      with aging, therapeutics that remediate age-related cognitive decline are needed more than
      ever. The proposed research seeks to better understand and enhance the detection of exercise
      effects on hippocampal network function and learning and memory, which decline with aging and
      Alzheimer's. Success would lead to new ways to detect benefits of exercise on cognitive aging
      and would lead to mechanistic insight on how such plasticity is possible while also informing
      prevention strategies.
    

Detailed description: 
      Animal models robustly support that exercise protects brain areas vulnerable to aging such as
      the hippocampus and that these benefits lead to better learning. In contrast, there are mixed
      findings from human studies on the cognitive benefits of exercise with healthy older adults.
      This contrast indicates there is still a lack of understanding for how exercise could change
      the course of cognitive decline in aging adults. However, no human studies have
      comprehensively tested exercise effects on cognition in older adults with learning tasks
      inspired from basic exercise neuroscience. The objective in the proposed research is to fill
      this translational gap by determining if different types of exercise improve the same kinds
      of learning in older adults that have been shown to improve in animal models by improving
      hippocampal function. This will bring the investigators closer to a long-term goal of
      determining how exercise protects the brain from adverse effects of aging in order to develop
      interventions that minimize age-related cognitive decline. The overall hypothesis is that
      exercise improves learning when it increases functional hippocampal-cortical communication
      that otherwise declines with aging. The investigators will test this in a sample of healthy
      older adults by determining if increases in functional hippocampal-cortical connectivity from
      exercise training improve learning on an array of tasks that require the hippocampus for
      acquisition of new relational memories compared to conditions of the same tasks that should
      not require the hippocampus for learning and memory.
    

Intervention name(s): Cardiorespiratory fitness training; Functional fitness training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physical exercise of moderate intensity designed to improve cardiorespiratory fitness; Physical exercise of light intensity designed to improve functional fitness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: physical activity; aging; learning and memory; exercise; brain
Effectiveness of Smartconsent in Improving Understanding of Informed Consent
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The general objective of the study is to assess whether the new smartconsent tool improves
      patients' understanding of the intervention to be performed, compared to standard practice.

      A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC
      ENUCLEATION.
    

Detailed description: 
      Male patients aged between 50 and 70 years, belonging to the Hospital Universitario Araba who
      are going to undergo PROSTATIC LASER ENUCLEATION, and who attend urology consultation between
      December 2019 and December 2020, and who meet the inclusion criteria and none of the
      exclusion criteria.

      Inclusion criteria:

        -  Patients willing to receive information via tablet.

        -  Patients who know how to and can read.

      Exclusion criteria:

      -Not applicable.

      Main variable: score on the Multiple choice test questionnaire (designed specifically for
      each type of procedure, following the recommendations proposed by Kehoe, Jerard and
      Fathelrahman et al. and developed on the basis of the information that an informed consent
      should provide (1, 2), with 4 response options and only one correct answer. An average score
      will be calculated for each patient.

      This test evaluates the comprehension of the information provided through the informed
      consent.
    

Intervention name(s): Smartconsent application; Control group
Intervention type(s): Procedure; Other
Intervention description(s): Patients asigned to smartconsent group will sign informed consent through a Tablet.; Patient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Pharmacokinetics of Gefapixant (MK-7264) in Participants With Renal Insufficiency (MK-7264-026)
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial aims to evaluate the plasma pharmacokinetics of gefapixant (MK-7264) administered
      to participants with varying degrees of renal insufficiency (RI) compared to healthy matched
      controls; and to investigate the extent of MK-7264 removal by hemodialysis (HD) in
      participants with end stage renal disease (ESRD), following administration of a single 50 mg
      dose of gefapixant.
    


Intervention name(s): Gefapixant
Intervention type(s): Drug
Intervention description(s): After an overnight fast participants receive a single oral dose of 50 mg gefapixant, in one 50 mg tablet.
Other intervention name(s): MK-7264
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Quadratus Lumborum Block and Epidural Analgesia Following Kidney Transplant Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Quadratus lumborum block as an alternative for postoperative analgesia compared with epidural
      block
    

Detailed description: 
      Epidural analgesia is the main choice of analgesia following kidney transplant surgery.
      However, continuous epidural technique had some concerning side effects such as hemodynamic
      instabilities, urine retention, motor/sensory disturbances/weakness, and mobilisation
      comfort, it could also cause hypotension which could affect graft success. Quadratus lumborum
      (QL) block had lesser side effects thus could be an option for postoperative analgesia,
      however there are no study showing the safety and success rate of QL block techniques for
      patients who underwent kidney transplant surgery.
    

Intervention name(s): Continuous Epidural analgesia; Bilateral Quadratus Lumborum block
Intervention type(s): Procedure; Procedure
Intervention description(s): Continuous Epidural catheter is inserted at the Thoracic 11-T12 level, using Ropivacaine 0.375% 3 mL bolus followed by Ropivacaine 0.2% with rate 6 mL/hour for 24 hours after laparoscopic nephrectomy; Bilateral anterior Quadratus Lumborum block using Ropivacaine 0.375% 20 mL each injection as postoperative analgesia treatment for 24 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: quadratus lumborum block; continuous epidural; postoperative analgesia; kidney transplant
EFFicacy Optimization Research of Telbivudine Therapy
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to prove that the strategy of treatment adjustment at W24
      according to virological response based on ROADMAP concept is better than standard of care
      strategy.
    


Intervention name(s): telbivudine; telbivudine
Intervention type(s): Drug; Drug
Intervention description(s): telbivudine, 600mg, oral, daily; telbivudine, 600mg, oral, daily
Other intervention name(s): Sebivo®; Sebivo®
Intervention MeSH terms: Telbivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B
Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy
Condition: Immunity
Study type: Observational

Summary: 
      This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer
      surgery compared to open colon surgery.
    

Detailed description: 
      Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned
      to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total
      lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on
      monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the
      5th day of operation (POD5).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        hospital based cohort
      
Keywords: colon cancer; laparoscopic colorectal surgery; cellular immunity; HLA-DR expression on monocyte
Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients
Condition: Anesthesia Morbidity
Study type: Interventional

Summary: 
      In this study we try to review the possible effects when using modern hydroxyethylstarch
      solutions 6 % versus albumin 5% during living donor renal transplantation.
    


Intervention name(s): Albumin resuscitation; Hydroxyethylstarch resuscitation; Albumin 5%; Hydroxyethylstarch 6%
Intervention type(s): Other; Other; Drug; Drug
Intervention description(s): Albumin 5% is used as the intra-operative colloid; Hydroxyethyl starch 6% is used as the intra-operative colloid; Infusion of Albumin 5% intra-operatively; Infusion of Hydroxyethylstarch 6% intra-operatively
Other intervention name(s): Albumin; Tetraspan
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
The Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity
Condition: Immunity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators performed randomized, double-blind, placebo-controlled human trial to
      evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces
      hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity
      parameters , including Cytotoxicity, Cytokine (IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ,
      TNF-α).
    


Intervention name(s): Cordyceps sinensis mycelium culture extract 1.68 g; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cordyceps sinensis mycelium culture extract 1.68 g
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention