title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Author contributions | P.H. | P.H., Y.H. and C.Z., conceptualized the research question, designed the study. Y.D., Y.C., P.J. and J.C. performed the statistical data analysis, and wrote the article. Y.C., J.Z., and Y.Z. interpreted the results. S.E., Y.Z., and Z.L. revised the article for important intellectual content. All authors reviewed the man... | PMC10439129 | |
Funding | No competing financial interests exist. The authors had financial support for the submitted work as specified in the funding section, but the funding institutions did not have any role in the writing of the article or the decision to submit it for publication; no financial relationships with any organizations that migh... | PMC10439129 | ||
Data availability | The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. | PMC10439129 | ||
Competing interests | The authors declare no competing interests. | PMC10439129 | ||
References | PMC10439129 | |||
Key Contribution | temporomandibular disorders, headaches, TMDs, masticatory muscle pains, masticatory muscle pain, orofacial pain, headache, myogenous TMD, tenderness, capitis, OVAS | TEMPOROMANDIBULAR DISORDERS, DISORDERS | These authors contributed equally to this work.This study aimed to evaluate the efficacy of botulinum toxin type A (BoNT/A) in patients with temporomandibular disorders (TMDs) associated with masticatory muscle pain (MMP) and headaches. This randomized, double-blind, placebo-controlled pilot study is the first clinical... | PMC10610636 |
1. Introduction | myofascial pain, masticatory myalgia, TMD, traumatic injuries, TMDs, dystonia, masticatory muscle disorders, strabismus, pain, musculoskeletal disorders, parafunction, muscle hyperfunction, hyperhidrosis, blepharospasm | MYOFASCIAL PAIN, TMJ, DYSTONIA, STRABISMUS, MUSCULOSKELETAL DISORDERS, HEMIFACIAL SPASM, TEMPOROMANDIBULAR DISORDERS, BLEPHAROSPASM | Temporomandibular disorders (TMDs) refer to a range of conditions affecting the masticatory muscles or the temporomandibular joint (TMJ) and are the second most common musculoskeletal disorders causing pain and functional impairment [TMDs are considered to have a multifactorial etiology, commonly associated with muscle... | PMC10610636 |
2. Results | PMC10610636 | |||
2.1. Participants | A total of 21 patients (19 women and 2 men; age range of 21–53 years) clinically diagnosed with MMP were included in the study. They were randomly divided into two groups and received BoNT/A or saline injections. There were no significant differences in sex and age between the groups; thus, the homogeneity of the gener... | PMC10610636 | ||
2.2. Differences between Groups | PMC10610636 | |||
2.2.1. Comparison of Changes over Time within Groups | According to the Friedman test, which was used to verify whether the change over time was significant in the two groups, no significant difference in OVAS, TPs, MMO, HVAS, or HF was observed in the control group, whereas in the experimental group, except for MMO, OVAS ( | PMC10610636 | ||
2.2.2. Comparison of Changes between Groups | A Mann–Whitney U test was conducted to verify whether there was a significant difference between the groups in the amount of change after 4, 8, and 12 weeks of pre-injection. Consequently, the changes in OVAS, MMO, HVAS, and HF did not show significant differences between the experimental and control groups at all time... | PMC10610636 | ||
3. Discussion | TMD, Headache, migraine headaches, headaches, pain, orofacial pain, head and neck pain, headache, migraine | TENSION-TYPE HEADACHES, MIGRAINE HEADACHES, MIGRAINE | Instead of conservative treatments, such as physical therapy, the use of non-steroidal analgesic agents, and the local injection of anesthetics and steroids, BoNT/A is being increasingly used as an adjuvant treatment for head and neck pain, such as tension-type headaches and migraine headaches [In this study, OVAS and ... | PMC10610636 |
4. Conclusions | TMD, headache | According to our study results, after BoNT/A injection, significant values were observed in the experimental group over time, and TPs decreased. Therefore, BoNT/A injection can be suggested as a relatively effective treatment for patients with TMD presenting with MMP and headache compared to saline placebo. | PMC10610636 | |
5. Materials and Methods | PMC10610636 | |||
5.1. Subjects | joint-related disease, TMD, Orofacial Pain, TMDs, pain, headache, capitis, arthralgia | AMYOTROPHIC LATERAL SCLEROSIS, FIBROMYALGIA, MOTOR NEUROPATHY, MYASTHENIA GRAVIS, LAMBERT SYNDROME, DISEASES | The clinical trial included 21 patients (2 men and 19 women; age range of 21–53 years) with chief complaints of MMP with TMDs and headache who were enrolled at the Department of Orofacial Pain and Medicine, Dental University of Yonsei, Seoul, Republic of Korea. At their first visit, patients were screened to determine ... | PMC10610636 |
5.2. Study Design | orofacial pain, TMD, headache pain, headaches | This was a prospective, randomized, double-blind, placebo-controlled clinical trial. Clinicians checked the demographic information, medical history, and medication history of participants. Participants completed questionnaires regarding TMD and headache pain for measurement and assessment of clinical values. The inten... | PMC10610636 | |
Author Contributions | Conceptualization, A.H.K. and S.T.K.; methodology, A.H.K. and S.T.K.; formal analysis, S.R.K.; investigation, M.C. and S.T.K.; data curation, S.R.K. and M.C.; writing—original draft preparation, S.R.K.; writing—review and editing, S.R.K. and S.T.K.; supervision, S.T.K. All authors have read and agreed to the published ... | PMC10610636 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of the Yonsei University Dental Hospital (Approval No. 2-2019-0061, date of approval; 14 November 2019). | PMC10610636 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10610636 | ||
Data Availability Statement | The data presented in this study are available in this article. | PMC10610636 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10610636 | ||
References | orofacial pain, headache | (Homogeneity of general characteristics between the experimental and control groups.Exp, experimental group; Con, control group.Differences in variables in the experimental and control groups according to time.Exp, experimental group; Con, control group; OVAS, the intensity of orofacial pain; TPs, the number of tender ... | PMC10610636 | |
Subject terms | disability, pain | ADVERSE EVENTS, RECRUITMENT, CORTEX, CHRONIC LOW BACK PAIN | Chronic low back pain (CLBP) is a disabling condition worldwide. In CLBP, neuroimaging studies demonstrate abnormal activities in cortical areas responsible for pain modulation, emotional, and sensory components of pain experience [i.e., pregenual and dorsal anterior cingulate cortex (pgACC, dACC), and somatosensory co... | PMC9860016 |
Introduction | pain | CHRONIC LOW BACK PAIN | Chronic low back pain (CLBP) is a significant and disabling health condition affecting individuals, the wider community, and the healthcare systemResting-state cortical activity alterations have been demonstrated in individuals with CLBPElectroencephalography (EEG) based Neurofeedback (NF) is a brain-computer interface... | PMC9860016 |
Methods | PMC9860016 | |||
Trial registration and ethical approval | Prospectively registered in Australian and New Zealand Clinical Trials Registry ( | PMC9860016 | ||
Study design | SECONDARY, CORTEX | Double-blind, randomized, placebo-controlled feasibility study with four parallel intervention arms (Fig. Study design and timelines. ISF-NF: infraslow frequency neurofeedback, pgACC: pregenual anterior cingulate cortex, dACC: dorsal anterior cingulate cortex, SSC: primary somatosensory cortex. Study assessment session... | PMC9860016 | |
Randomization | pain | A research administrator, not involved in treatment/assessment, randomized, and assigned participants using a computerized open-access randomization software program without applying any restrictions (on a 1:1:1:1 basis) to either:Group-1: ISF-NF up-training pgACC, i.e., modulate the descending pain inhibitory pathwayG... | PMC9860016 | |
Blinding | Participants and outcome assessor were blinded. The success of blinding was assessed after completion of intervention using the question, “What type of treatment do you believe that you/the participant received respectively?” The confidence in their judgement was assessed on an 11-point NRS | PMC9860016 | ||
Participants and eligibility criteria | All participants were voluntarily recruited from the community through advertisement flyers. All participants provided written informed consent prior to study enrolment. Participants were screened for eligibility and enrolled by a musculoskeletal physiotherapy researcher. | PMC9860016 | ||
Inclusion and exclusion criteria | Morris Disability, disability, pain | CENTRAL SENSITIZATION | Ages of 18 to 75 years, pain in the lower back region for ≥ 3 months, a score of ≥ 4 on an 11-point NPRS in 4 weeks prior to enrolment, a disability score of ≥ 5 on Roland–Morris Disability Questionnaire (RMDQ)At baseline assessment, all participants completed questionnaires to capture demographics, and clinical charac... | PMC9860016 |
Sample size | As this was a pilot study to determine the feasibility of a future fully powered RCT, sample size calculation was not performed. Based on statistical advice, a sample of 60 participants (15/group) was considered enough to determine feasibility issues and obtain treatment estimates for designing the full trial. | PMC9860016 | ||
Intervention | Source localised EEG ISF-NF was administered three times a week (30 min/session) for four consecutive weeks (12 sessions) by the researcher (physiotherapy background) experienced in delivering neuromodulation techniques. Treatment was delivered using a 21-channel DC coupled amplifier and BrainAvatar™ sLORETA software v... | PMC9860016 | ||
ISF-NF treatment groups | chronic pain, pain | CHRONIC PAIN | It has been demonstrated that chronic pain can be considered as an imbalance between pain input and pain suppression. Our protocols are derived from this theory utilizing source localization neurofeedback targeting the ratio between pgACC, SSC, and dACC. For the current study, we developed EEG-NF training programs to u... | PMC9860016 |
Placebo-NF group | To create identical auditory feedback to ISF-NF groups, participants in placebo-NF group listened to a random set of pre-recorded sound files (n = 12), sourced from a database of recorded audio files (using audacity software) of healthy participants that underwent EEG source localised ISF-NF training (targeting ratio b... | PMC9860016 | ||
Outcome measures | PMC9860016 | |||
Feasibility measures | RECRUITMENT | Included recruitment rate (number of participants recruited per month), proportion of participants recruited from total number screened (expressed as a percentage), adherence to intervention (measured as number of treatment sessions attended by each participant expressed as a percentage of the total number of sessions)... | PMC9860016 | |
Clinical measures | Pain | Brief Pain Inventory (BPI) | PMC9860016 | |
Electroencephalogram | Resting-state eyes-closed EEG (~ 10 min) was obtained using SynAmps-RT Amplifier (Compumedics-Neuroscan). Sixty-four electrodes were placed in 10–10 International placement and impedances were checked to remain below 5kΩ. Data were resampled (128 Hz), band-pass filtered (0.005–0.2 Hz), plotted in EEGLAB and ICoN softwa... | PMC9860016 | ||
Data analysis | primary pain, pain | Data were analysed using SPSS_v27.0. As this was a feasibility study, tests for significance to compare clinical and EEG measures between study groups were not performed, but descriptive statistics were applied. Feasibility outcomes are reported based on recommendations.Clinical outcomes were analyzed based on intentio... | PMC9860016 | |
Protocol changes | Following changes were made to the registered protocol based on the ethical review and the peer reviewer comments. | PMC9860016 | ||
Results | PMC9860016 | |||
Participants | CORTEX | Sixty participants were enrolled and randomised equally into four treatment groups (Fig. Flow of participants through the study phases. pgACC: pregenual anterior cingulate cortex, dACC: dorsal anterior cingulate cortex, SSC: primary somatosensory cortex, ITT: intention to treat.Demographics and clinical characteristics... | PMC9860016 | |
Feasibility | PMC9860016 | |||
Recruitment | MAY, RECRUITMENT | The total recruitment period was 9 months (July 2020 to March 2021), with the last follow up completed in May 2021. This feasibility trial was stopped in May 2021 as the desired sample size was reached (n = 60) and all follow ups completed. Our average recruitment rate was seven participants per month. The proportion o... | PMC9860016 | |
Dropouts | Of the total participants enrolled (n = 60), we lost 8 participants following baseline assessment session (Fig. | PMC9860016 | ||
Treatment adherence and engagement | NRS | The average treatment adherence rate for all groups was 80%. The individual treatment adherence scores were 88%, 73%, 76%, and 81% for pgACC, dACC + SSC, Ratio, and Placebo groups respectively.The NRS scores for mood, motivation, and treatment engagement were comparable between treatment groups. The Median (95% CI) for... | PMC9860016 | |
Integrity of blinding | Participant blinding was deemed successful as the treatment group was not revealed to them in any way. In total, 51% of participants incorrectly predicted the treatment group or responded, “don’t know”. The remaining 49% of participants, although correctly predicted their treatment groups, based their decision primaril... | PMC9860016 | ||
Adverse effects | ADVERSE EFFECTS, ADVERSE EFFECTS, CORTEX | No serious adverse effects were reported. Several transient low intensity (< 3 on NRS) negative side effects, rated to be related to ISF-NF treatment, were reported by a few participants (Fig. Adverse effects reported by participants during the neurofeedback treatment sessions. pgACC: pregenual anterior cingulate corte... | PMC9860016 | |
Acceptability and satisfaction | SD | All participants, irrespective of treatment group, reported moderate to high levels of acceptability with Mean ± SD of 7.8 ± 2.0 (pgACC), 7.5 ± 2.7 (dACC + SCC), 8.2 ± 1.9 (Ratio), and 7.7 ± 1.5 (Placebo), respectively. Further, moderate to high levels of satisfaction were also reported with Mean ± SD of 5.7 ± 2.9 (pgA... | PMC9860016 | |
Pain | pain | All treatment groups demonstrated a favourable change in pain measures at all timepoints (Table | PMC9860016 | |
Function | disability | The RMDQ scores demonstrated a trend of reduction in disability in all treatment groups (Table | PMC9860016 | |
Global perceived effect | At 1-month follow-up, the proportion of participants who perceived meaningful (≥ + 2) global effect was higher in pgACC (67%) and dACC + SSC (64%) group, when compared to ratio (46%) and sham (46%) group. | PMC9860016 | ||
QST | Due to high variability in measures, no differences in trends were observed in any of QST variables at 1-month follow-up (Table | PMC9860016 | ||
EEG measures | CORTEX | Descriptive data for CD and FC measures at all time points are presented in Supplementary Tables Heatmaps for mean percentage change to baseline in functional connectivity in the infraslow frequency bands. pgACC: pregenual anterior cingulate cortex, dACC: dorsal anterior cingulate cortex, SSC: primary somatosensory cor... | PMC9860016 | |
Discussion | chronic pain, disability, pain | CHRONIC PAIN, SECONDARY, RECRUITMENT | Re-training cortical activity through real-time EEG-based source localised ISF-NF is a novel approach for treatment of chronic painOur results demonstrate that a fully powered trial to test efficacy of EEG-based ISF-NF training for treatment of CLBP is feasible. A sizable number of individuals with CLBP were interested... | PMC9860016 |
Limitations | LBP, disability, pain | The primary limitations of this pilot feasibility study were small sample size and descriptive comparisons to infer trends in clinical and EEG outcomes. However, these limitations reflect the purpose of our feasibility study, which was to provide estimates of clinical outcome measures (pain and disability) to support s... | PMC9860016 | |
Conclusions | disability, pain | The ISF-NF training is feasible, safe, and an acceptable treatment approach for CLBP. A positive trend of the effect of ISF-NF treatment was observed on pain and disability outcomes in all groups. In particular, the pgACC uptraining group experienced favourable outcomes and perceived the intervention to be highly effec... | PMC9860016 | |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-28344-2. | PMC9860016 | ||
Author contributions | Conceptualization: D.B.A., D.D.R., R.M., and S.V.; Methodology: D.B.A., D.D.R., R.M., and S.V.; N.F. protocol programming: M.S.; Data curation: JM, FO, D.B.A.; Writing—original draft preparation: D.B.A., D.D.R., and R.M.; writing—review and editing: D.B.A., D.D.R., R.M., S.V., M.S., J.M., and F.O. All authors have crit... | PMC9860016 | ||
Funding | BRAIN | This work was funded by the Otago Medical School Trust (Dean’s Bequest) Funding and Brain Health Research Centre (through a Philanthropist). The funding sources were not involved in the study design; the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the ar... | PMC9860016 | |
Data availability | Datasets generated during and/or analysed during the current study are available from the corresponding author upon reasonable request. | PMC9860016 | ||
Competing interests | DDR | MS is the owner of Neurofeedback Therapy Services of New York. He helped with the programming of the neurofeedback protocols tested in the current study. The cortical areas to be targeted, its co-ordinates and the desired training protocol (uptraining/downtraining) were provided by the principal investigators (DDR and ... | PMC9860016 | |
References | PMC9860016 | |||
1. Introduction | Obesity, T2D, cardiovascular disease | OBESITY, TYPE 2 DIABETES, CARDIOVASCULAR DISEASE | Liver-expressed antimicrobial peptide-2 (LEAP-2) is associated with caloric intake and glucose metabolism. Obesity raises type 2 diabetes (T2D) and cardiovascular disease risk [LEAP-2 is expressed from the small intestine and liver [ | PMC9918887 |
2. Methods | obesity, Appetite | OBESITY, BLOOD, TOLERANCE | Participants: Twenty-five females were randomized into LCD (Cardiorespiratory Fitness: A cycle ergometer with indirect calorimetry (Carefusion, Vmax CART, Yorba Linda, CA, USA) was used to determine the cardiorespiratory fitness (VOAnthropometrics: Participants were instructed to fast for approximately 4 h prior to bod... | PMC9918887 |
3. Results | ± | BLOOD | Participant Characteristics: LCD and LCD+INT reduced caloric intake over the intervention by design, and there was no difference between groups (−752.1 ± 230.4 vs. −422.7 ± 203.3 kcals/day; Blood Lipids and Glucose Metabolism: LCD and LCD+INT reduced cholesterol (Circulating LEAP-2: Both LCD and LCD+INT decreased fasti... | PMC9918887 |
4. Discussion | obesity, T2D, fat loss, hypoglycemia, caloric deficit | OBESITY, HYPOGLYCEMIA, CVD | The main observation of this work is, short-term caloric restriction with or without exercise decreased fasting LEAP-2 in women with obesity. However, when examining the impact of glucose ingestion on LEAP-2, it was observed that LCD raised LEAP-2 more than LCD+INT. The observed reductions in fasting LEAP-2 and rise in... | PMC9918887 |
Author Contributions | Conceptualization and work design by S.K.M. Data collection and/or analysis by S.K.M. and T.J.R. Statistical analysis by T.J.R. and S.K.M. All authors have read and agreed to the published version of the manuscript. | PMC9918887 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the University of Virginia Ethics Committee (IRB-HSR #18316). | PMC9918887 | ||
Informed Consent Statement | All participants gave their informed consent before they participated in the study. | PMC9918887 | ||
Data Availability Statement | These data have not been made publicly available. However, the corresponding author (S.K.M.) can provide further information on the data upon reasonable request. | PMC9918887 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9918887 | ||
References | INSULIN RESISTANCE | Circulating LEAP-2 before and after treatments. Note: Raw data shown as mean ± SEM, log transformed for analysis. (Correlations of LEAP-2 to Appetite, Acyl-Ghrelin, and Free Fatty Acids. Note: LOG indicates variables transformed for analysis, (Body composition, Fitness, and Dietary Intake.Note: Data expressed as mean ±... | PMC9918887 | |
1. Introduction | overweight or obesity, T2DM, prediabetes, diabetes | PREDIABETES, EVENTS, TYPE 2 DIABETES MELLITUS, INSULIN SENSITIVITY, DIABETES | These two authors contributed equally to this work.The global prevalence of type 2 diabetes mellitus (T2DM) has surged in recent decades, and the identification of differential glycemic responders can aid tailored treatment for the prevention of prediabetes and T2DM. A mixed meal tolerance test (MMTT) based on regular ... | PMC10609681 |
2. Materials and Methods | PMC10609681 | |||
2.1. Clinical Trial and Dietary Intervention | T2D, T2DM | TYPE 2 DIABETES, INSULIN SENSITIVITY | Data from the MEDGI-Carb trial were used in the present study because participants were at risk of developing T2DM, and the intervention tested the effect of a high vs. low GI diet within the context of a healthy eating pattern, i.e., a Mediterranean diet. By including individuals with elevated risk of T2D and using da... | PMC10609681 |
2.2. Mixed Meal Tolerance Tests | BLOOD | Breakfast and lunch MMTT were performed at baseline, mid-testing (USA only), and post-intervention. Prior to all testing days, participants were instructed not to eat or drink anything (except a small amount of water) from 10:00 p.m., the evening before the visit. Fasting blood samples were collected at the time point ... | PMC10609681 | |
2.3. Oral Glucose Tolerance Test | BLOOD | Participants completed OGTT at baseline, mid-testing (USA only), and post-intervention. Fasting blood samples were collected at TP −15 after 15 min of rest and at TP −5. At TP 0, participants were instructed to consume a test beverage containing 75 g glucose dissolved in water within 5 min. No additional fluids were pe... | PMC10609681 | |
2.4. Fecal Microbiota | LYSIS | During pre- and post-intervention study days, participants were asked to collect fecal samples using a stool sampling collection kit. Samples were taken using an EasySampler Stool Collector and a sample tube with a spoon lid. The sample was protected by being placed in yet another tube and stored immediately in the fre... | PMC10609681 | |
2.5. Mechanistic Model of Glucose Regulation | A modified version of the minimal glucose model [The dynamics of the model are described using compartments that represent mechanisms in the glucose–insulin system, and the exchange rates between compartments are described using rate constants. The model assumes that the ingested glucose is delayed by the digestive sys... | PMC10609681 | ||
2.6. Statistical Analyses | The parameters of the model were estimated within the nonlinear mixed effects model framework [The individual parameters The association between response clusters and gut microbiota was investigated using ANOVA on selected genera (explained in the fecal microbiota section) that were reported to associate with glycemic ... | PMC10609681 | ||
3. Results | In total, 155 individuals completed the two MMTTs and OGTTs (baseline and wk. 12) and were included in the analyses. Calculations on fecal microbiota were based on 130 individuals who provided two fecal samples within the participants that performed the two MMTT and OGTTs (baseline and wk. 12) ( | PMC10609681 | ||
Postprandial MMTT Glucose Responses | diabetic, prediabetes | PREDIABETES | Individual parameters of the kinetic model (baseline, amplitude, damping, and frequency) from Equation (1) were estimated using the postprandial MMTT glucose response at baseline and wk. 12. The parameters were successfully estimated with RSE < 43% in all cases, which indicated certainty in the estimates. Variation amo... | PMC10609681 |
4. Discussion | T2D, T2DM, nausea | EVENTS, INSULIN SENSITIVITY | To dissect glucose data into features representing postprandial events, we used a model with only four parameters to identify clusters from standardized breakfast meal tolerance test responses that strongly related to T2DM risk factors. Although the model did not capture all systematic variation in the data, it was fle... | PMC10609681 |
5. Conclusions | T2D, T2DM | We used a simple model to successfully describe glucose response to a standardized breakfast MMTT based on common foods and identified two response clusters that were associated differently with T2DM risk markers and gut microbiota. Future studies should investigate if such clusters can be identified by an algorithmic ... | PMC10609681 | |
Supplementary Materials | The following supporting information can be downloaded at Click here for additional data file. | PMC10609681 | ||
Author Contributions | Conceptualization, R.L. and V.S.; methodology, V.S. and M.W.; software, V.S.; validation, V.S.; formal analysis, V.S.; investigation, V.S. and T.H.; resources, R.L., G.R. and W.W.C.; data curation, R.L., G.R., R.E.B. and W.W.C.; microbiota analyses, J.D., E.A.P. and V.S.; writing—original draft preparation, T.H. and V.... | PMC10609681 | ||
Institutional Review Board Statement | RECRUITMENT | The study was conducted in accordance with the Declaration of Helsinki and approved by The Regional Ethical Review Board, Gothenburg, Sweden (DNR 663-17, approved: 14 December 2017), the institutional review board of Federico II University (n. 175/17, approved: 25 October 2017), and the biomedical institutional review ... | PMC10609681 | |
Informed Consent Statement | Written informed consent was obtained from all participants involved in the study and was obtained prior to any collection of data or sampling. | PMC10609681 | ||
Data Availability Statement | The data presented in this study are available upon reasonable request from the corresponding author. | PMC10609681 | ||
Conflicts of Interest | G.R. is a member of the Scientific Advisory Board of the Nutrition Foundation of Italy and the Istituto Nutrizionale Carapelli Foundation; he is a member of the Health and Wellbeing Advisory Board of the Barilla G&R. Fratelli Company and Consultant for a Metabolic Health Masterclass sponsored by Nestlè. R.B. is current... | PMC10609681 | ||
References | diabetic”, diabetic, diabetes | IMPAIRED GLUCOSE TOLERANCE, DIABETES | Example dynamics generated from the model in Equation (1). The blue curve is characterized by a fast biphasic response to the MMTT, thus having high frequency (Model fit to postprandial breakfast MMTT response at baseline of 16 randomly selected representative subjects. Here, points represent measurements, and lines re... | PMC10609681 |
Background | anxiety | Full list of collaborator names appear in Child anxiety before general anaesthesia and surgery is common. Midazolam is a commonly used premedication to address this. Melatonin is an alternative anxiolytic, however trials evaluating its efficacy in children have delivered conflicting results. | PMC10797512 | |
Methods | This multicentre, double-blind randomised trial was performed in 20 UK NHS Trusts. A sample size of 624 was required to declare noninferiority of melatonin. Anxious children, awaiting day case elective surgery under general anaesthesia, were randomly assigned 1:1 to midazolam or melatonin premedication (0.5 mg kg | PMC10797512 | ||
Results | The trial was stopped prematurely ( | PMC10797512 | ||
Conclusion | anxiety | Melatonin was less effective than midazolam at reducing preoperative anxiety in children, although the early termination of the trial increases the likelihood of bias. | PMC10797512 | |
Clinical trial registration | ISRCTN registry: ISRCTN18296119. | PMC10797512 | ||
Keywords | Handling Editor: Rupert Pearse
| PMC10797512 |
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