bioihbjkbjnl/mcl2 huggingface dataset:
Postprandial Effects of Functional Bread
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      This study investigates whether bread with added galactomannan, a soluble fiber, can reduce
      the postprandial glucose response in healthy overweight adults.
    

Detailed description: 
      This single-blind crossover-designed study wants to investigate the postprandial effect of
      functional bread in healthy overweight adults. Therefore, four types of bread, consumed by
      the participants, have added galactomannan in different amounts and viscosities, and one
      bread is the control bread.

      The participants arrive after an overnight fast and before the consumption of bread, a
      fasting blood sample is taken.

      After the ingestion, blood samples are taken at specific times. The area under the curve of
      the postprandial glucose is expected to differ between the functional breads.
    

Intervention name(s): Functional bread
Intervention type(s): Dietary Supplement
Intervention description(s): Postprandial effects of bread containing galactomannan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Coronary Heart Disease Risk in Type 2 Diabetes
Condition: Coronary Heart Disease; Type 2 Diabetes
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The primary objective of the CORDIA study is to use an effective evidence-based
      self-management intervention (SMI) for type 2 diabetes, with and without a novel test to give
      a personalised genetic and lifestyle risk of coronary heart disease, to examine their
      capacity to reduce the risk of coronary heart disease (CHD) and improve diabetes management
      in primary care patients with type 2 diabetes. The effect of these interventions on clinical,
      behavioural and psychological outcomes will be investigated.
    


Intervention name(s): Self-Management Intervention; Risk Result
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The SMI will incorporate a discussion to introduce self-management and why it is important, and about problems associated with reducing CHD risk and managing type 2 diabetes. Specific topics addressed will include health behaviours to reduce CHD risk and manage diabetes including diet and exercise, as well as behaviours specific to managing diabetes, including medication adherence and self-care behaviours (e.g. footcare). Sessions are patient-directed and employ a shared decision-making approach, such that participants work with one another and the practice nurse facilitator to identify specific problems that they wish to address, and to identify solutions and approaches to managing their diabetes and CHD risk; Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study
    

Detailed description: 
      A Multi-Centre, Multi-country, Randomized, Double-Blind (Subject, Investigator),
      Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous
      GSK679586 in Patients with Severe Asthma
    

Intervention name(s): INTRAVENOUS GSK679586; INTRAVENOUS PLACEBO; FLUTICASONE PROPIONATE
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump; Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump; Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Asthma control questionnaire
A Drug Interaction Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of
      Ibrutinib in Healthy Adults.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      sequential-design drug interaction study to assess the effect of omeprazole on
      pharmacokinetics of ibrutinib and metabolite PCI-45227 in healthy participants. The study
      mainly consists of 3 Phases: Screening Phase (within 21 days prior to the first dose of study
      medication), treatment Phase, and a follow up Phase (10 to 12 days after the last dose of
      study medication). In the treatment Phase, participants will receive Ibrutinib 560 milligram
      (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7. participants will receive Omeprazole at
      a dose of 40 mg tablets orally once on Days 3 through 7. The total duration of study for each
      participant will be approximately for 29 to 32 days. Blood samples will be collected for
      evaluation of pharmacokinetics of Ibrutinib. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): Ibrutinib; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Ibrutinib will be administered at a dose of 560 milligram (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7.; Omeprazole will be administered at dose of 40 mg tablets orally once daily from Day 3 to Day 7.
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ibrutinib; Proton pump inhibitors; Pharmacokinetics; Drug Interaction
Effect of Sensory Adapted Dental Environment on Dental Anxiety of Children With Intellectual and Developmental Disabilities
Condition: Developmental Disability; Intellectual Disability; Dental Anxiety
MeSH terms: Intellectual Disability; Anxiety Disorders; Developmental Disabilities
Study type: Interventional

Summary: 
      Children with intellectual/developmental disabilities (ID/DD) will experience less dental
      anxiety and cooperate better in a Sensory Adapted Dental Environment (modified visual,
      sensory, and somatosensory stimuli in a regular dental setting) than in a regular dental
      environment (RDE).
    

Detailed description: 
      The aim of this pilot study is to determine the effect of sensory adapted dental environment
      (SADE) on reducing dental anxiety of children with intellectual and/or developmental
      disabilities (ID/DD). With the growing number of children diagnosed with ID/DD and their
      inclusion in the community, there are more opportunities for dentists to encounter this
      population for their routine oral health care. If improvement in dental anxiety and behavior
      is evident from the study, as other pilot studies have suggested, it can be applied as one of
      clinical tools for treating children with ID/DDs. Furthermore, utilization of a SADE in
      clinical training of pediatric dentists or general dentists can improve clinicians' comfort
      level in managing behavior of individuals with ID/DD. This will encourage more clinicians to
      provide care and address the unmet oral health needs of this vulnerable population.
    

Intervention name(s): Sensory Adapted Dental Environment (SADE)
Intervention type(s): Behavioral
Intervention description(s): No fluorescent room lights, solar projector on ceiling, regular dental x-ray apron laying on patient, quiet music playing in background
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: sensory adapted environment; pediatric dentistry; oral health; Developmental Disability; Intellectual Disability; dental anxiety; autism spectrum
A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if zonisamide is effective as a preventative
      medication for individuals with migraine headache.
    

Detailed description: 
      The pharmacologic treatment of migraine may be acute (abortive, symptomatic) or preventive
      (prophylactic). Preventive medication is usually given daily for months or years; however,
      treatment may also be given in an intermittent regimen. Most migraine prophylactic
      medications were designed to treat other disorders, and they can be divided into three
      groups:

        1. Serotonergic or monoaminergic agents such as methysergide, which have demonstrated high
           degrees of effectiveness;

        2. Non-serotonergic drugs such as beta-blockers, tricyclic antidepressants, valproate; and

        3. Drugs with lesser demonstrated effectiveness, such as selective serotonin reuptake
           inhibitors, calcium channel antagonists, and non-steroidal anti-inflammatory drugs.

      The choice of treatment must be individualized, and is influenced by contraindications,
      potential side effects, the need to treat associated symptoms like tension-type headache and
      insomnia, and drug cost.

      Anticonvulsants, such as valproate, have shown significant degrees of efficacy in migraine
      prophylaxis when used in low doses. Considering the differences in proposed mechanisms of
      action of these agents, it is likely that a novel anticonvulsant such as zonisamide may also
      be an effective prophylactic treatment for migraine.
    

Intervention name(s): zonisamide
Intervention type(s): Drug
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Migraine Headache; prophylaxis; AED; migraine prophylaxis
Respiratory Protection Effect of Ear-loop-type KF94 Mask
Condition: Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      Ear-loop-type Korean Filter 94 masks (KF94 masks, equivalent to the N95 and FFP2) are broadly
      used in health care settings in Korea for the COVID-19 pandemic. However, no studies have
      assessed the adequacy of respiratory protection. In this prospective randomized open-label
      study, the investigators aimed to evaluate the fitting performance of ear-loop-type KF94
      masks by the quantitative fit test according to the occupational safety and health
      administration (OSHA) protocol. In addition, by quantitatively comparing the "tight-fitting"
      method using a clip and the "general-fitting" method, the investigators tried to evaluate
      whether the tight-wearing method improves the fitting performance of KF94 masks.
    

Detailed description: 
      Sample size: The sample size was calculated based on a pilot study of 10 participants, which
      examined the FF of general-fitting. The mean FF was 20.3, and the log-transformed FFs were
      assessed due to skewed data, which was 1.98 (standard deviation 1.34). We assumed that the FF
      for tight-fitting would increase by 50%, with an α value of .05, and a β error of .10 (power
      = 90%) for two-sided hypothesis testing. The estimated sample size calculation revealed a
      required sample of 24 participants. Therefore, 30 participants were enrolled to account for a
      20% dropout rate.

      Data analyses: Repeated-measures analysis of variance or generalized estimating equations
      were used to compare the FFs or passing rate of the QNFTs for the three mask types according
      to the wearing method. Paired t-tests or Wilcoxon signed-rank tests were used to compare the
      FFs according to the wearing method for each mask type. McNemar's test was used to compare
      the passing rate of the QNFT according to the wearing method. Bonferroni's correction was
      performed for all results of each subgroup analysis. SAS ver. 9.4 software (SAS Institute,
      Cary, NC) was used to perform all statistical analyses.
    

Intervention name(s): tight-fitting of KF94 mask with clip
Intervention type(s): Device
Intervention description(s): The general-fitting method involved wearing a mask with ear loops, and the tight-fitting method involved wearing a clip that connected ear loops on the occiput after wearing a mask according to the general method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Respiratory protective devices; quantitative fit test; N95 filtering facepiece respirators; infection control; KF94 mask
Dovitinib Plus Docetaxel in Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Docetaxel is currently one of standard second-line therapy in patients with gastric cancer.
      As angiogenesis and FGFR pathway has been suggested to be associated with gastric cancer,
      dovitinib, dual VEGFR and FGFR inhibitor, may have the potential to improve the outcomes of
      patients with gastric cancer. Therefore, we investigated the combination regimen of docetaxel
      and dovitinib.
    


Intervention name(s): Dovitinib and docetaxel
Intervention type(s): Drug
Intervention description(s): In phase I portion of the study Docetaxel 45-75 mg/m2, intravenous, every 3 weeks Dovitinib 200-500 mg, oral, 5 days on/2 days off
In phase II portion of the study Recommended dose of docetaxel and dovitinib in phase I portion will be used.
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric cancer; Phase I/II; Second-line chemotherapy; Dovitinib; Docetaxel; Refractory to first-line chemotherapy
Validation of the Chinese Version of the SECONDs
Condition: Minimally Conscious State; Vegetative State
MeSH terms: Persistent Vegetative State
Study type: Interventional

Summary: 
      The aim of this study was to translate the SECONDs from English into Chinese and determine
      the validity of this Chinese version
    

Detailed description: 
      The assessment is of great importance for the management and treatment in patients with
      disorders of consciousness. The Simplified Evaluation of CONsciousness Disorders is a useful
      tool to assess consciousness of DOC patients in bedside. The aim of this study was to
      translate the SECONDs from English into Chinese and determine the validity of this Chinese
      version. To test internal reliability and inter-rater reliability, both rater A and rater B
      assess the perception of pain on day 1; and to obtain test-retest reliability, rater A
      assessed all patients repeatedly on day 2.
    

Intervention name(s): Simplified Evaluation of CONsciousness Disorders (SECONDs)
Intervention type(s): Diagnostic Test
Intervention description(s): All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The order of the administration was randomly selected. All patients' total scores assessed by rater A were recorded to test the internal consistency of SECONDs (A1). Meanwhile, to assess the concurrent validity, the scores of the CRS-R were recorded together with SECONDs by rater A on day 1. In order to analyze the test-retest reliability, rater A complete the second evaluation of SECONDs on day 2 (A2).
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: disorders of consciousness; vegetative state; minimally conscious state; consciousness
Risk Factors of Perforated HSCR in Neonates
Condition: Hirschsprung Disease; Bowel; Perforation, Fetus or Newborn
MeSH terms: Hirschsprung Disease; Intestinal Perforation
Study type: Observational

Summary: 
      Hirschsprung's disease (HSCR) is a common digestive malformation with radiographic evidence
      of distal bowel obstruction and clinical signs of abdominal distension, vomiting,
      constipation, and failure to pass meconium. Bowel perforation (perforated HSCR) is a very
      serious complication of HSCR, but if this occurs it is most often in the neonatal period. The
      current study collected information on all cases diagnosed with perforated HSCR from
      multi-centers in China over 10 years, the aim was to evaluate the clinical features of
      perforated HSCR, and investigate possible risk factors for perforated HSCR in neonates.
    


Intervention name(s): Emergency surgical enterostomy
Intervention type(s): Procedure
Intervention description(s): Emergency surgical enterostomy
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        -Neonates (≤1 month age) with HSCR who suffered with bowel perforation.
Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions
Condition: Magnetic Marker Monitoring; Gastrointestinal-transport; Gastric Emptying Time; Small Intestinal Transit Time; Time for Colon Arrival; Food Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix
      placebo tablets in healthy male volunteers under fasting and fed conditions. The method which
      is used is an imaging technique.
    


Intervention name(s): D1000078; D1000082; D1000083; D1000085
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral, one single dose; Oral, one single dose; Oral, one single dose; Oral, one single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Imaging technique; gastric transport through the gut
An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
Condition: Pain; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the analgesic effect of combination of tramadol
      hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic
      widespread pain and presence of tender points).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention) and multi-center
      (conducted in more than one center) study of combination of tramadol hydrochloride and
      acetaminophen in treatment of participants with pain of fibromyalgia. The duration of this
      study will be 56 days per participant. The study consists of 2 parts: Screening (that is, 3
      weeks before study commences on Day 1) and Treatment (that is, up to Day 56). All the
      eligible participants will receive oral tablet for combination of tramadol hydrochloride and
      acetaminophen. Rescue medication (a medication intended to relieve symptoms immediately) of
      tylenol (500 milligram, up to 6 oral tablets daily) will be permitted throughout the study
      duration. Efficacy of the participants will primarily be evaluated by Pain Visual Analog
      Scale. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Tramadol hydrochloride; Acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.; Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Intervention MeSH terms: Acetaminophen; Tramadol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Fibromyalgia; Ultracet; Tramadol Hydrochloride; Acetaminophen
Non-Eosinophilic Neutrophilic Asthma
Condition: Neutrophilic Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Define and characterize the neutrophilic phenotype of severe asthma.
    

Detailed description: 
      Neutrophilic asthma (NA) is the asthma phenotype less known, causes a severe disease and does
      not have a specific treatment. Research on the neutrophilia mechanisms, new neutrophil (NEU)
      types and bronchial microbiome, can provide an opportunity to better understand the NA
      pathogenesis.

      OBJECTIVES: 1. To describe the clinical characteristics of NA and its sub-phenotypes
      (SUBSTUDY 1); 2. To determine the NEU types associated with the NA and its sub-phenotypes
      (SUBSTUDY 2); and 3. To identify the bronchial microbiological flora of the NA, specifically
      related to lung microbiome and the immune response against Chlamydia Pneumoniae (SUBSTUDY 3).

      METHODS: Multicenter prospective study including 100 patients with severe asthma (GINA/GEMA
      criteria): 50 with non-neutrophilic asthma (<65% NEU in induced sputum [IS]); and 50 with NA
      (> 64% NEU in IS). SUBSTUDY 1: clinical variables (years of evolution, exacerbations, asthma
      control test, mini asthma quality of life questionnary), comorbidities (GERD, nasal
      polyposis, obesity, ASS), pulmonary function (FEV1, exhaled fraction of nitric oxide, total
      lung capacity, Aspergillus), prick-test and CT scan chest; SUBSTUDY 2 (in IS and plasma):
      apoptotic index by means NE culture and flux cytometer (Annexin-V-FITC), NEU phenotype by
      surface markers (CD16, CD66b, CD62L, HLADR, CD177, CD11b, CD63, CXCR2, CXCR4) with density
      gradient study and determination of cytokines (IL-6, IL-8, IL-17, IL-1, IL-22) by ELISA;
      SUBSTUDY 3 (in IS): bronchial microbiome for 16 subunit rRNA by Phylogenetic Investigation of
      Communities by Reconstruction of Unobserved States (PICRUSt), and anti-Chlamydia Pneumoniae
      Immunoglobuling A by ELISA.
    

Intervention name(s): Induced sputum
Intervention type(s): Diagnostic Test
Intervention description(s): Characterization with flow cytometry of the phenotype of the neutrophils isolated in the sputum, microbiome
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients bewteen 18-80 years with severe asthma.
      
Biospecimen description: 
      Induced Sputum
    
Keywords: severe asthma; induced sputum; asthma phenotypes; neutrophilic inflammation; microbiome