bioihbjkbjnl/mcl2 huggingface dataset:
Coenzyme Q10 and Vitamin A, C, E in Relation to the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. However, the
      relationships between coenzyme Q10, antioxidant vitamins (Vitamin A, C, E) and the prevention
      of the risk of MS are still inconsistent. The purposes of this study are going to investigate
      the relation of coenzyme Q10, antioxidant vitamins concentration with the blood lipid levels,
      the markers of lipid peroxidation (TBARS), antioxidant enzymes activities (catalase,
      glutathione peroxidase and superoxide dismutase), and the inflammatory markers (hs-CRP,IL-6
      and adiponectin). The investigators will recruit MS patients (case group, n = 100) and
      age-gender matched healthy subjects from previous study(n = 105) as a control group . The
      inclusion criteria of MS are according to the Bureau of Health Promotion, Department of
      Health in Taiwan (2007).Hopefully, the results of this study could provide the information to
      what has been know in MS subjects. The investigators expect coenzyme Q10 or antioxidant
      vitamins could be a preventive supplement to reduce the risk of MS.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The investigators recruited MS patients (case group, n = 100). The inclusion criteria of MS
        are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007). The
        health subject were recrited from previous study (n = 105).
      
Biospecimen description: 
      Blood samples
Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The present clinical trial was designed to investigate the clinical and microbiological
      effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and
      root planing (SRP) in the treatment of chronic periodontitis (CP)
    

Detailed description: 
      OBJECTIVE: The present clinical trial was designed to investigate the clinical and
      microbiological effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to
      scaling and root planing (SRP) in the treatment of chronic periodontitis (CP).

      DESIGN: Sixty five subjects presenting at least twelve teeth with probing depth (PD) ≥4 mm
      were selected. 33 subjects were randomly assigned to full-mouth SRP + Septilin (group 1) and
      32 subjects were assigned to full-mouth SRP + Placebo (group 2). The clinical outcomes
      evaluated were plaque index (PI), gingival index (GI), clinical attachment level (CAL), PD
      and % of sites with bleeding on probing (%BOP) at baseline (B\L), 10 days, 1, 3 and 6 months
      interval and percentage of sites positive for A. actinomycetemcomitans, P. gingivalis and T.
      forsythia were recorded at B/L, 3 and 6 months using polymerase chain reaction.
    

Intervention name(s): Scaling and root planing, and Septilin for 7 days; Scaling and root planing, and Placebo drug for 7 days
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in septilin group received Septilin tablets (Septilin tablets, Himalaya Drug Company, India), 500 mg of 2 tablets to be taken thrice daily for 7 days after scaling and root planing and checked for clinical and micrbiological parameters at baseline, 10 days, 1 month, 3 months and 6 months.; Subjects in placebo group received placebo tablets taken thrice daily for 7 days and checked for clinical and microbiological parameters at baseline, 10 days, 1 month, 3 months and 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Septiline, chronic periodontitis, Immunomodulator, microbiology
Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis
Condition: Acute Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      The study aims to compare the efficacy of two different oxygenation methods on decrease
      respiratory rate, heart rate, and clinical respiratory score in children with moderate to
      severe bronchiolitis requiring oxygen therapy.

        1. Standard face mask oxygen therapy (St-FMOT)

        2. High-flow nasal cannula oxygen therapy (HFNCOT)
    

Detailed description: 
      Bronchiolitis is the most common cause of hospitalization for children under one year of age
      and, caused by respiratory viruses. Although several medications and interventions studied
      for bronchiolitis treatment, hydration and oxygenation are the main treatments. High-flow
      nasal cannula oxygen therapy (HFNCOT) has been widely used to provide respiratory support in
      children with acute respiratory diseases.

      Patients had earlier improvement with HFNCOT to decrease the respiratory rate and respiratory
      effort than patients with standard low-flow oxygen therapy (SOT).

      HFNCOT therapy reduced more effective in heart rate, respiratory effort, and length of
      supportive oxygen treatment (LOOT) compared with SOT. However, the length of hospital stay
      (LOS) and feeding ability had better consequences in patients with moderate and severe
      bronchiolitis treated with HFNCOT.

      Another published study shows that in infants with acute bronchiolitis, which required oxygen
      therapy, there was no significant difference between therapy groups in terms of LOOT, LOS,
      and admission to the intensive care unit (ICU). HFNCOT was more efficient than SOT and
      reduced the rate of intubation/invasive ventilation in severe bronchiolitis management.
      Despite these beneficial effects of HFNCOT, it was not recommended by international
      guidelines yet. However, well designed, prospective randomized controlled trials are still
      needed to use this therapy in the wards.
    

Intervention name(s): HFNCOT; St-FMOT
Intervention type(s): Device; Other
Intervention description(s): The patient will receive a high flow nasal of humidified oxygen, set between 2 to 25 l/min. The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.; The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Bronchiolitis; High Flow Nasal Cannula; Standard Face Mask
Ciclesonide for the Treatment of Airway Hyperresponsiveness
Condition: Asthma
MeSH terms: Asthma; Respiratory Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The study objective is to investigate in a placebo-controlled, double-blind manner the effect
      of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15
      mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or
      placebo will be inhaled once daily. The study duration consists of a treatment period of 4
      weeks. The study will provide further data on safety of ciclesonide.
    


Intervention name(s): Ciclesonide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 320µg Ciclesonide versus Placebo; Placebo
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide
Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma
Condition: Neuroblastoma; Ewings Sarcoma; Osteogenic Sarcoma; Rhabdomyosarcoma; Synovial Sarcoma
MeSH terms: Sarcoma; Neuroblastoma; Rhabdomyosarcoma; Sarcoma, Ewing; Sarcoma, Synovial; Osteosarcoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic
      sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT)
      antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating
      chemotherapy.
    

Detailed description: 
      For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from
      full-length NY-ESO-1, MAGE-A1, and MAGE-A3.
    

Intervention name(s): Autologous dendritic cell vaccine with adjuvant
Intervention type(s): Biological
Intervention description(s): Week 1:
Decitabine (DAC): 10 mg/m2/day IV (Mon-Fri)
Weeks 2 and 3:
Vaccine: 3-5 E6 peptide pulsed DC (Mon)
Hiltonol applied topically to vaccine site before and after vaccination
Other intervention name(s): Decitabine (trade name Dacogen or 5-aza-2'-deoxycytidine/DAC; Hiltonol
Intervention MeSH terms: Decitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuroblastoma; Ewings sarcoma; osteogenic sarcoma; rhabdomyosarcoma; synovial sarcoma; high-risk; relapsed; children
Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose of this study was to evaluate the feasibility and compliance with a novel method
      for assessing mood and cognition in participants with major depressive disorder (MDD).
    

Detailed description: 
      The novel method being tested in this study for assessing mood and cognition in participants
      with MDD was wearable technology. This study looked at the correlation of mood and cognition
      outcomes on wearable technology with traditional objective neuropsychological cognitive
      function tests and self-reported mood outcomes.

      The study enrolled approximately 30 patients. Participants were provided with a watch on
      which brief cognitive and mood tests were evaluated daily up to 6 weeks.

      All participants prompted to complete cognitive and mood assessments on 3 occasions across
      the day. Two occasions (morning and afternoon) comprised assessment of cognition, and the
      final assessment in the evening constituted a review of the day focusing on self-reported
      depressed mood.

      This single-center trial was conducted in United Kingdom. The overall time to participate in
      this study was 6 weeks. Participants took part up to 5 study visits (1 in-person on-site
      visit, 3 web-based and 1 at home visit) assessing performance on traditional objective
      neuropsychological cognitive function tests and self-reported measures of depression symptom
      severity and social function.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with major depressive disorder (MDD) were provided with an Apple watch on
        which brief cognitive and mood tests were evaluated daily up to 6 weeks.
      
Keywords: Drug Therapy
Pattern - Reach Aim 2
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this research study is to learn about different approaches to promoting
      healthy growth among infants, and understanding parents' likes and dislikes of an approach to
      reducing risk factors for obesity later in life. The study includes filling out some forms
      with questions about your baby and your thoughts about your baby's growth and health, and
      engaging in a pattern of changes in or prevention of risk factors in the first year of life.
      Parents will receive information about changes and some tools and materials to take home with
      them. Some parents may receive phone calls between visits as well. The study takes place from
      soon after birth through the infant's age of 9 months. The estimated total time of
      interaction between the study staff and parents during the study period is 4 hours.
    

Detailed description: 
      As this is a dyad study, each dyad is considered to be a participant and demographic
      information will reflect the infant in the dyad, per parent report.
    

Intervention name(s): Standard response; Targeted response
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parents pick from a menu of behavior changes; Stepped up phone interaction with parents based on menu of behavior changes
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: infant; mother-baby
A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse
      events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after
      discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of
      Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the opportunity
      to better understand the natural course of eosinophilic esophagitis and define the treatment
      modalities of eosinophilic esophagitis with EUR-1100, such as the need for chronic
      maintenance or intermittent treatment.

      All subjects who complete PR-021 will be offered the opportunity to participate in this
      study. The duration of this follow-up study is six months, during which subjects will visit
      the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8,
      Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week
      20.
    


Intervention name(s): EUR-1100; Placebo
Intervention type(s): Drug; Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who received study drug and completed the PR-021 study (Safety and Tolerability
        Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis)
Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this early phase clinical research study, the investigational drug will be administered to
      64 healthy volunteers in a double-blind, placebo-controlled manner, at a one research center.
      The objectives of the study are to assess what the body does to the investigational drug,
      what the investigational drug does to the body and also to observe the safety and
      tolerability of the investigational drug healthy volunteers.
    


Intervention name(s): Gen1E-1124; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenously-infused Gen1E-1124 in vehicle.; Intravenously-infused vehicle.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Carnitine and Liver Mitochondria Fatty Acid Processing
Condition: Diabetes Mellitus, Type 2; Insulin Resistance; Obesity
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      This double-blind, placebo-controlled randomized trial will assess whether 14 days of oral
      carnitine supplementation modifies mitochondrial fatty acid processing in healthy young
      adults.
    

Detailed description: 
      This project will use stable isotope techniques and magnetic resonance spectroscopy (MRS) to
      take a first step toward clarifying how the benefit of oral carnitine supplementation depends
      on basal mitochondrial fatty acid processing (MFAP) and MFAP modification, with a specific
      focus on the liver. Approximately 24 healthy young individuals will be enrolled, with 20
      expected to complete. Before and after 14 days of oral carnitine supplementation or placebo,
      MFAP will be measured using measures of acetyl-carnitine concentration (from long-TE proton
      MRS) and de novo lipogenesis (DNL, from analysis of blood metabolites following 13C-labeled
      acetate infusion and high-fructose drink challenge). The MFAP measures will be collected
      before and after loading participants with a high-fructose drink. Fructose is solely
      metabolized by the liver.
    

Intervention name(s): L-Carnitine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mg tablets of L-Carnitine taken 3 times daily before meals.; 500 mg tablets of L-Carnitine taken 3 times daily before meals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      An intense inflammatory reaction is triggered by the ischemic injury during myocardial
      infarction. The inflammatory processes involved are complex and haven't been explored in
      detail in human patients. This inflammatory response can increase myocardial damage following
      reperfusion, leading to adverse remodeling and adverse events (heart failure, sudden cardiac
      death).

      Cardiac MRI can assess the size of myocardial infarction and many other parameters associated
      with myocardial injury: edema, hemorrhage, micro-vascular obstruction.

      (However the association between biomarkers of inflammation and these imaging parameters is
      not known).

      There is very little data correlating imaging markers of myocardial injury to the biokinetics
      of inflammation biomarkers.

      In this study, the aim is to assess the relationship between the kinetics of specific
      inflammatory biomarkers (interleukin-1beta, interleukin 6, interleukin 17, Tumor Necrosis
      Factor (TNF)-alpha, C reactive protein (CRP), soluble toll-like receptor-2 (ST2),
      neutrophils) and imaging markers of injury measured by cardiac MRI at the acute phase in 20
      acute mycardial infarction (AMI) patients.
    


Intervention name(s): MRI at D7; Blood samples
Intervention type(s): Other; Biological
Intervention description(s): The infarct size measured on MRI at 7 days.; Blood samples at H0; H4; H12; H24, H48, D7 and 1 month post MI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: myocardial infarction; MRI; inflammatory biomarkers
Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study
Condition: Gastric Emptying Time
Study type: Interventional

Summary: 
      In the recent literature, pre-operative fasting times for pediatric patients are limited to
      one hour for clear fluids. Studies related to gastric emptying times mostly searched for
      normal-weight children. These studies have claimed that 3 mL/kg clear fluid can be allowed up
      to 1 hour before surgery. There is a lack of interest in the gastric emptying time of obese
      pediatric patients during the preoperative period. In addition, there is controversy about
      gastric emptying times of obese healthy children. Some research committed the decrease of
      gastric emptying because of a high level of sensitivity to cholecystokinin, while others
      postulated that no change in gastric emptying time of obese children compared to normal
      weight. The aim of this trial is to compare the gastric volume and gastric emptying time
      after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the
      pre-operative period.
    

Detailed description: 
      After receiving informed consent from the children and their families, American Society of
      Anesthesiologists (ASA) 1-2 pediatric patients between 6-14 years, who will recruit for
      elective surgery will be included for this study. The children over 95% percentile will be
      accepted as obese. After, the basal gastric volume will be calculated with the help of
      Ultrasonography (USG). The children will receive oral 3 mL/kg(max 250 mL) 5% dextrose .USG
      evaluation will be made every 5 minutes until the gastric volume reaches the basal level.
      Children reaching basal gastric volume will be accepted as suitable for the surgery. The aim
      of this study is to compare the gastric volume and gastric emptying time after ingestion of 3
      mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.
    

Intervention name(s): 5% Dextrose
Intervention type(s): Drug
Intervention description(s): All the patients will receive oral 3mL/kg 5%Dextrose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Pediatric patients will be divided into two groups as obese and non-obese. Children above the 95% percentile will be considered as obese.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric volume; Gastric emptying time; Antral cross-sectional area (ACSA); Obese pediatric patients