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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Statistics. | Differences in patient group characteristics were assessed using either Fisher’s exact test or Wilcoxon’s rank-sum test. Differences for biomarkers and liver functions between SOS yes or no were checked by 2-sample | PMC10322680 | ||
Study design and approval. | The study design and samples collection are summarized in Figure 1. The study was approved by the Institutional Review boards of all institutional participating centers. Written informed consent was obtained from all patients or their legal guardians. | PMC10322680 | ||
Author contributions | BPD, HL | SP designed and oversaw the study. YH, HL, and SP analyzed data and ensured data integrity. EDPA, RAK, JR, JLS, and SWC oversaw patient sample collection and processing at the respective centers. AB, BPD, AM, KBV, and SP were responsible for centralized sample processing, storage, and proteomic analysis with ELISAs. Al... | PMC10322680 | |
Supplementary Material | PMC10322680 | |||
04/18/2023 | In-Press Preview | PMC10322680 | ||
05/22/2023 | Electronic publication | PMC10322680 | ||
Study design. | confusion | Workflow illustrating the study population, biomarkers measurements, and time points.Diagram of the optimal algorithm for risk prediction of SOS, its confusion matrix, sensitivity, specificity, PPV, and NPV. | PMC10322680 | |
SOS cumulative incidence by day 35 stratified by high and low day 3 risk biomarkers using optimal cutpoints chosen by Youden’s index. | ( | PMC10322680 | ||
Cumulative incidence of SOS stratified by the 3-biomarker score. | PMC10322680 | |||
Day 100 OS stratified by high and low day 3 risk biomarkers using optimal cutpoints chosen by Youden’s index. | ( | PMC10322680 | ||
Kaplan-Meier estimates of OS stratified by the 3-biomarker score. | PMC10322680 | |||
Biomarker changes after defibrotide treatment. | PMC10322680 | |||
Patient demographics | PMC10322680 | |||
Outcome characteristics | PMC10322680 | |||
Parameter estimates and | PMC10322680 | |||
Rate of change for biomarkers after defibrotide treatment | PMC10322680 | |||
Univariate (top) and multivariate (bottom) Cox regression analyses for SOS incidence | PMC10322680 | |||
Abstract | PMC9972017 | |||
Background | toxicity, tumors | TUMORS | Patients with relapsed and refractory solid and central nervous system (CNS) tumors have poor outcomes and need novel therapeutic options. Vincristine, irinotecan, and temozolomide (VIT) is a common chemotherapy regimen in relapsed pediatric tumors with an established toxicity profile. Metformin shows preclinical anti‐... | PMC9972017 |
Methods | tumors | TUMORS | The objective of this Phase I trial was to establish the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of metformin in combination with VIT in children with relapsed and refractory solid and CNS tumors. A 3 + 3 design was used to test the addition of metformin at five dose levels (666, 999, 1333, 16... | PMC9972017 |
Results | toxicity, Ewing sarcoma | EWING SARCOMA | Twenty‐six patients (median age 13 years, range 2–18 years) were enrolled with 22 evaluable for toxicity. The most common diagnoses were Ewing sarcoma ( | PMC9972017 |
Conclusions | The MTD of VIT with metformin was not determined due to premature study closure. We recommend an RP2D of Dose Level 4, 1666 mg/m
| PMC9972017 | ||
Abbreviations | Acute Lymphoblastic LeukemiaArea Under CurveCentral Nervous SystemConcentration at Steady StateComplete ResponseDose‐limiting ToxicityFood and Drug AdministrationGastrointestinalInstitutional Review BoardIntravenousMaximum Tolerated DoseOverall Response RateProgressive DiseasePharmacokineticPartial ResponseStable Disea... | PMC9972017 | ||
BACKGROUND | pneumonitis, nausea/vomiting, fatigue, abdominal pain, cancer, toxicities, malignancies, cancer deaths, tumors | PNEUMONITIS, CANCER, THROMBOCYTOPENIA, MALIGNANCIES, TUMORS, TYPE II DIABETES | Solid tumors, including central nervous system (CNS) tumors, represent approximately 60% of all childhood malignancies and account for the majority of cancer deaths in children.Irinotecan and temozolomide are frequently used in pediatric solid and CNS tumors due to clinical tolerability and preclinical evidence of syne... | PMC9972017 |
MATERIALS AND METHODS | PMC9972017 | |||
Objectives | tumors | SECONDARY, TUMORS | The study's primary objectives were to determine the MTD and RP2D of metformin combined with VIT in pediatric relapsed and refractory solid and CNS tumors, and to describe pharmacokinetics (PKs) of metformin in combination with VIT. The secondary objective was to describe the radiologic responses seen with this regimen... | PMC9972017 |
Patient eligibility | infection, tumor, allergy | TUMOR, GRAFT VERSUS HOST DISEASE, DISEASE, ALLERGY, SOLID TUMORS, INFECTION | Patients 1–18 years of age with histologically or radiographically confirmed relapsed or refractory CNS or non‐CNS solid tumors with radiographically measurable disease and no known curative therapy options were eligible. A Karnofsky/Lansky score of 50 or above was required. Prior therapy including vincristine, irinote... | PMC9972017 |
Study design | Tumors, Cancer | TUMORS, PEDIATRIC CANCER, CANCER | This study was completed through the Sunshine Project, a multi‐institutional clinical trial consortium sponsored by the National Pediatric Cancer Foundation. Moffitt Cancer Center was the coordinating center, and the study was approved by the Moffitt Cancer Center Institutional Review Board (IRB) and each participating... | PMC9972017 |
Treatment schema | Tumor, diarrhea | ADVERSE EVENTS, DISEASE, TUMOR | Initially, protocol therapy included VIT (vincristine 1.5 mg/mTrial design: (A) Schema for the original trial VIT cycle without metformin prior to addition of metformin in Cycle 2 (or 3) depending on hematologic tolerance. “Heme Recovery” signifies ANC > 1000 and Platelets >100,000 on Day 21 of a cycle. (B) Post‐amendm... | PMC9972017 |
Pharmacokinetic studies | pre‐dose, NMS | NMS, COLD | PK samples for metformin were drawn at Hour 0 (pre‐dose) and Hours 6, 12, and 24 following the first metformin dose on Cycle 1 Day 1. Additional PKs were drawn at Hour 0 before the Cycle 1 Day 8 dose and Hour 6 post‐dose. One ml of whole blood was shipped on cold packs overnight to NMS Labs (Willow Grove, PA) where met... | PMC9972017 |
Statistical considerations | Patient and clinical characteristics were summarized using descriptive statistics including median and range for continuous measures and proportions and frequencies for categorical measures. | PMC9972017 | ||
RESULTS | toxicity, Twenty‐nine | Twenty‐nine patients consented and were screened (Figure The median age was 13 years (range 2–18 years), and patients received a median of two prior lines of therapy (range 1–5; Table Demographics and patient characteristicsNumber of patients receiving treatment by dose level and numbers evaluable for toxicity and resp... | PMC9972017 | |
Toxicity | toxicity, toxicities | Of 26 subjects enrolled, 22 received at least one dose of metformin and were included in toxicity analysis (Table Grade 3 and 4 toxicities, regardless of attribution, and percent of cycles in which each toxicity occurred for metformin‐containing and non‐metformin‐containing cycles of therapyEighteen patients were evalu... | PMC9972017 | |
Responses | ATRT, PD, tumor, brainstem glioma | ANAPLASTIC ASTROCYTOMA, TUMOR, GLIOBLASTOMA MULTIFORME, WILMS TUMOR, DISEASE, EMBRYONAL RHABDOMYOSARCOMA, GERM CELL TUMOR, ALVEOLAR RHABDOMYOSARCOMA, MEDULLOEPITHELIOMA, ATYPICAL TERATOID/RHABDOID TUMOR OF CNS, CLEAR CELL SARCOMA, OSTEOSARCOMA, EWING SARCOMA | Nineteen patients achieved the threshold metformin exposure defined in the methods section or progressed after initiation of metformin making them evaluable for response, with 16 patients evaluable for best overall response (Figure Swimmer's plot of 26 patients treated on study, with timing of overall best response and... | PMC9972017 |
Pharmacokinetics | Twenty patients had sufficient PK sample collection for metformin PK analysis on Cycle 1 Day 1. As shown in Table Pharmacokinetic analysis by dose levelAbbreviations: AUC(0–12 h), area under the curve from 0–12 hr; C | PMC9972017 | ||
DISCUSSION | DLTs, neutropenia, diarrhea, toxicity, toxicities, thrombocytopenia, GI toxicity, Toxicity, type 2 diabetes mellitus | PEDIATRIC ALL, THROMBOCYTOPENIA, TYPE 2 DIABETES MELLITUS, NEUTROPENIA | This Phase I trial found the MTD was exceeded at Dose Level 5, 2000 mg/mRecommended metformin dosing for newly‐diagnosed type 2 diabetes mellitus in children 10 years and older is initially 500–1000 mg daily with escalation as high as 1000 mg twice daily.This study collected all Grade 3 and 4 toxicities and assessed at... | PMC9972017 |
AUTHOR CONTRIBUTIONS | PMC9972017 | |||
FUNDING INFORMATION | PEDIATRIC CANCER | This study was funded by the National Pediatric Cancer Foundation and Rally Foundation. | PMC9972017 | |
CONFLICT OF INTEREST | The authors report no conflicts of interest with this work. | PMC9972017 | ||
Supporting information |
Tables S1‐S2
Click here for additional data file. | PMC9972017 | ||
ACKNOWLEDGMENTS | PEDIATRIC CANCER | This study was generously supported by the National Pediatric Cancer Foundation ( | PMC9972017 | |
DATA AVAILABILITY STATEMENT | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC9972017 | ||
REFERENCES | PMC9972017 | |||
Background | Current global trend of insufficient physical activity (PA) among children and adolescents highlights the necessity of finding effective ways to promote PA in childhood. Self-determination theory (SDT) has demonstrated efficacy as a conceptual framework for developing interventions aimed at promoting diverse health beh... | PMC10463639 | ||
Methods | Sixty eight students (M | PMC10463639 | ||
Results | While a statistically significant intervention effect on children’s leisure-time PA was not found, students in the intervention group reported higher, albeit marginal, perceptions of intrinsic motivation ( | PMC10463639 | ||
Conclusions | Our pilot study highlights the importance of parental training and the potential for SDT-informed interventions to support children's intrinsic motivation towards physical activity. Further research is needed to test the intervention in other domains and combine interventions in several domains to have the highest impa... | PMC10463639 | ||
Trial registration | This pilot study is part of preparation for the main study, prospectively registered in ISRCTN registry as ISRCTN78373974 (15.12.2022). The current stage of the main study is ‘recruiting’. | PMC10463639 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-16528-4. | PMC10463639 | ||
Keywords | PMC10463639 | |||
Background | TCM | Physical activity (PA) has many known benefits for children and adolescents [PA in childhood predicts adult PA levels – being active as a child significantly increases the probability of being active as an adult [One of the prominent motivational theories frequently used in developing health interventions is the self-d... | PMC10463639 | |
The present study | Need-Supportive | SECONDARY | In light of the empirical finding above, we developed an entirely web-based intervention program for parents, considering that self-paced online learning might be convenient for parents. The aim of the pilot study was to test the effectiveness of an online need-supportive study program to help parents interact with the... | PMC10463639 |
Methods | PMC10463639 | |||
Participants | RECRUITMENT, RECRUITMENT | To estimate the required sample size to test the study hypotheses, power calculation was conducted using G*Power Version 3.1.9.7 [We managed to recruit a total sample size of 68 children (28 boys, 40 girls) and one parent for each child who participated in the study. Students’ ages ranged from 11 to 15 years (Participa... | PMC10463639 | |
Ethical considerations | The study was conducted in accordance with the Declaration of Helsinki and approved by the Research Ethics Committee of the University of Tartu (code: 327/T-4, 19.10.2020). We used the CONSORT checklist when writing our report [Informed consent forms and study information were distributed by research team members, who ... | PMC10463639 | ||
Experimental design | The study adopted a cluster-randomized controlled design with two study groups. Schools were randomly assigned to either intervention or control groups. Parents and their children were assigned to either intervention group or control group respective of the children’s school. Parents in the intervention group participa... | PMC10463639 | ||
Web-based need-supportive parenting program | A web-based format was chosen for the intervention as it is scalable, enables reaching larger audiences and offers the possibility of self-paced learning for the participants. The aim of the need-supportive parenting program was to educate parents about techniques directed at promoting children’s intrinsic motivation t... | PMC10463639 | ||
Outcome measures | For the outcome measures, students completed pen-and-paper questionnaires during pre-trial, post-trial and one-month follow-up data collection points. All measures were self-reported. Responses to items were collected using 7-point scales with endpoints meaning | PMC10463639 | ||
Physical activity | The behavioural outcome measure was the children’s participation in out-of-school MVPA. The choice of MVPA as the behavioural measure was based on the many health benefits MVPA has for adolescents (e.g., better mental health, better cardio-respiratory fitness, and less fat gain) [ | PMC10463639 | ||
Perceived need support | To measure students’ perceptions of their parents’ need-supportive behaviours regarding out-of-school PA, the modified versions of the perceived autonomy support scale [ | PMC10463639 | ||
Psychological need satisfaction and frustration | Students’ perceptions of their autonomy, competence, and relatedness satisfaction and frustration in relation to leisure-time PA were measured by the Basic Psychological Need Satisfaction and Need Frustration Scale (BPNSNF) [ | PMC10463639 | ||
Motivation towards PA | Autonomous and controlled forms of motivation towards out-of-school PA were measured using a modified version of the Perceived Locus of Causality Questionnaire [ | PMC10463639 | ||
Theory of planned behaviour constructs | PBC | Students’ attitude, subjective norms, perceived behavioural control (PBC), and intention for out-of-school PA were measured using the scales developed according to the recommended guidelines [ | PMC10463639 | |
Perceived Effort | Students’ self-reported effort to do leisure-time PA was measured using the scale developed according to Hagger and Hamilton [ | PMC10463639 | ||
Data analysis | The data analysis was conducted using JASP (Version 0.17.1; University of Amsterdam, Amsterdam, the Netherlands). Asymmetry values between -2 and + 2 and kurtosis values between -7 and + 7 were considered indicative of the data being normally distributed [Randomization check to examine the baseline differences between ... | PMC10463639 | ||
Results | PMC10463639 | |||
Preliminary analysis | PMC10463639 | |||
Discussion | Parental support is significantly correlated to children’s PA levels [According to SDT, satisfying the basic psychological needs enables the development of more autonomous forms of motivation [Previous research has shown that need-supportive behaviours from PE teachers and peers enhance need satisfaction and lower need... | PMC10463639 | ||
Conclusions | This study tested an online need-supportive training for parents to enhance children's leisure-time physical activity and autonomous motivation. There was a positive trend in vigorous and total MET-minutes per week for children in the intervention group, but no statistically significant intervention effect. However, th... | PMC10463639 | ||
Acknowledgements | The authors would like to thank master’s student Šerelin Bovt for her help in data collection. | PMC10463639 | ||
Authors’ contributions | HT | AK, HT and PRM designed the study. PRM, AK and HT developed the intervention. PRM drafted the manuscript. PRM, AK and HT edited the manuscript and approved the final version prior to submission. | PMC10463639 | |
Funding | This work was supported by the University of Tartu, Institute of Sport Sciences and Physiotherapy. The project has not received external funding. Trial sponsor: University of Tartu, Institute of Sport Sciences and Physiotherapy. Contact: Priit Kaasik, Head of Institute. Address: Ujula 4, 51008 Tartu, Estonia. | PMC10463639 | ||
Availability of data and materials | OSF | The datasets generated during and analysed during the current study are available in the Open Science Framework (OSF) repository, 10.17605/OSF.IO/DG534[ | PMC10463639 | |
Declarations | PMC10463639 | |||
Ethics approval and consent to participate | Ethical approval for this study was provided by the Research Ethics Committee of the University of Tartu (code: 327/T-4, 19.10.2020). Children and parents provided informed written consent to participate in the study. All methods were performed in accordance with the relevant guidelines and regulations. | PMC10463639 | ||
Consent for publication | Not applicable. | PMC10463639 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10463639 | ||
References | PMC10463639 | |||
Objective | Edited by: Daniel Adrian Gardan, Dunarea de Jos University, RomaniaReviewed by: Ezequiel Pinto, University of Algarve, Portugal; Paweł Bryła, University of Łódź, PolandWe designed a new type of ‘physical activity calorie equivalent’ (PACE) food label in Iran to compare its effect with that of the traffic light food lab... | PMC10683755 | ||
Design | Mixed-method study. | PMC10683755 | ||
Participants | Mothers of school children between the ages of 6–12 years. | PMC10683755 | ||
Setting | REGRESSIONS | In the qualitative phase, 10 focus group discussions (FGDs) were conducted with various groups of mothers, and two FGDs were conducted with food science and nutrition experts to design a new PACE label. In the quantitative phase, 496 mothers were randomly assigned to five groups: (1) no nutrition label, (2) current TLL... | PMC10683755 | |
Results | The mothers’ perspectives were classified into two sub-themes, the PACE label’s facilitators and barriers. The new PACE label’s characteristics were divided into two subcategories: (a) appearance, and (b) nutritional information, including 14 codes. In the quantitative section, mean calories of the selected foods were ... | PMC10683755 | ||
Introduction | obesity, TLL | OBESITY | The increasing prevalence of obesity has been, and remains, a major global challenge, where rapid changes in dietary and food behaviors –and as a consequence, excess energy intake- are the main causes of this rising trend (Energy imbalances and physical inactivity in children and adolescents are of particular concern (... | PMC10683755 |
Methods | This study was part of a larger mixed method research in which the strengths, weaknesses, and strategies of improving the use of nutrition labels were discussed (For the qualitative phase, the participants were informed of the research objectives before the interviews. Furthermore, participants were assured that the in... | PMC10683755 | ||
Qualitative phase | A flowchart showing the study’s processes is presented in Study flowchart. | PMC10683755 | ||
FGDs with mothers as household representatives | CHILDHOOD OBESITY, RECRUITMENT | Sixty-three mothers participated in our study. The mothers’ general characteristics have been presented in Ten FGDs were conducted with mothers of school children aged 6–12 years in ten primary schools from southern, northern, eastern, western, and central Tehran. Two primary schools were randomly selected from each di... | PMC10683755 | |
FGDs with experts | Two FGDs were held with ‘food science and nutrition experts’ (hereinafter referred to as ‘FSN experts’ for the sake of brevity). For this group, the sampling method was purposeful and FSN experts from two universities of Tehran participated in the FGDs. First, official letters were sent to the Heads of Departments of N... | PMC10683755 | ||
Label printing | After confirming the label image for print, we had to determine the size and definitions on each label. For this purpose, the information on the purchased products, such as definitions of serving, weight of each serving, total weight of the product, and the label size were entered into Excel 2010 software, and understa... | PMC10683755 | ||
Qualitative phase data analysis | The conventional content qualitative analysis approach was applied to determine the main themes (All the FGDs were transcribed verbatim and typed in Microsoft Word. Notes taken by the note taker were added to the transcription to ensure accuracy and clarity of any instances which might not have been recognized by the t... | PMC10683755 | ||
Quantitative phase | Similar to the qualitative phase, the participants were mothers of 6-12-year-old schoolchildren. Ten schools were randomly selected from the same regions used in the qualitative phase, but the schools were different this time, so the mothers would be blinded toward the study goal regarding their caloric choices. The in... | PMC10683755 | ||
Sample size calculation and randomization | Using G*Power software, sample size was calculated based on caloric choices –which is the primary outcome of our study. A sample size of 481 was calculated considering the expected effect size of 0.15, α = 0.05, and power = 90% (We applied stratified block randomization, using STATA software, where stratums were school... | PMC10683755 | ||
Study procedure | First, a pilot study was conducted in one school (on 50 mothers) to assess the likely problems, practicality, and feasibility of the study. In the second phase, mothers were randomized into five arms, including the traffic light label (TLL)- which is currently mandatory in Iran-, TLL plus the educational brochure (The ... | PMC10683755 | ||
Quantitative phase data analysis | REGRESSION | Continuous variables were analyzed by analysis of variance (ANOVA) (comparing mean calories of selected foods between the groups), and categorical variables by chi-square tests [comparing general characteristics including marital status, education, economic status, satiety status, BMI (normal/overweight/obese), and phy... | PMC10683755 | |
Results | PMC10683755 | |||
Qualitative phase: designing a new PACE label | In this section, two main themes were defined. First, the mothers’ perspectives on PACE were examined, and then the new label’s expectations were drafted upon taking into account the viewpoints of mothers and FSN experts. The aforementioned are presented in | PMC10683755 | ||
Mothers’ perspectives as household representatives | 1-no | Mothers’ perspectives were classified into two sub-themes, the physical activity label’s facilitators and barriers. The facilitators were categorized into four codes: 1- healthier food choices, 2-easy to understand, 3-suitable solution, 4-creating incentives to lose weight and be physically active. The barriers were ca... | PMC10683755 | |
Mothers’ expectations of the new PACE label | TLL | SAID | The participants unanimously agreed that graphics were more understandable than digits. They also said that walking was the most feasible form of physical activity, as compared to other exercises, such as swimming. Colorful labels were highly recommended, especially for children. In addition, most of the mothers believ... | PMC10683755 |
Experts’ expectations of the new PACE label | The food science and nutrition (FSN) experts approved the graphic design of the new label, and believed it to be easily understood by the public. However, some of them suggested the PACE information to be included in the nutrition fact table.All the experts believed that using a single color instead of three would simp... | PMC10683755 | ||
Discussion | PMC10683755 |
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