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Conclusions | SARCOMA | Overall, MASCT-I plus camrelizumab and apatinib was safe and showed encouraging efficacy in advanced bone and soft-tissue sarcoma, and schedule-II administration method was recommended. | PMC10687909 | |
Trial registration | ClinicalTrials.gov, NCT04074564. | PMC10687909 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12916-023-03132-x. | PMC10687909 | ||
Keywords | PMC10687909 | |||
Background | cancers, tumor, bone sarcomas, chemotherapy-refractory, undifferentiated pleomorphic sarcoma, cancer, cancers of bone and soft tissue, soft-tissue sarcoma, Sarcomas, soft-tissue sarcomas | CANCERS, TUMOR, BONE SARCOMAS, CANCER, SOLID TUMORS, UNDIFFERENTIATED PLEOMORPHIC SARCOMA, SARCOMAS, DEDIFFERENTIATED LIPOSARCOMA | Sarcomas are a rare and heterogeneous group of cancers of bone and soft tissue that originate from mesenchymal cells [Immune checkpoint inhibitors (ICIs) have demonstrated remarkable clinical outcomes in many chemotherapy-refractory solid cancers. But ICI monotherapy only showed promising anti-tumor activity in certain... | PMC10687909 |
Methods | PMC10687909 | |||
Study design and patients | hepatitis B, death, Tumors, clear cell sarcoma, human immunodeficiency virus, 14–70, autoimmune diseases or syndrome, ASPS | DISORDER, ACTIVE TUBERCULOSIS, ALVEOLAR SOFT PART SARCOMA, HEPATITIS B, HUMAN IMMUNODEFICIENCY VIRUS, SARCOMAS, BRAIN METASTASES, RECRUITMENT, TUMORS, SARCOMA, CLEAR CELL SARCOMA, HEPATITIS C, ONCOLOGY, SOFT TISSUE AND BONE TUMOR, SYPHILIS INFECTION, METASTASES, BONE METASTASES | MASCT-I-1005 was a single-center, open-label, 2-part, phase 1 trial (clinicaltrials.gov, NCT04074564). Part A assessed the safety and efficacy of two administration schedules for MASCT-I when combined with camrelizumab and apatinib at fixed doses in patients with advanced bone and soft-tissue sarcomas, and part B furth... | PMC10687909 |
Preparation for MASCT-I | tumor | TUMOR | MASCT-I cells were manufactured by HRYZ Biotech Co. in a Good Manufacturing Practice grade facility according to the manufacturing protocol as previously described with some modifications [For dendritic cell preparation, PBMCs were thawed and incubated in a culture flask (Corning) at 37 °C, 5% COTo prepare tumor antige... | PMC10687909 |
Treatments | toxicity, death | DISEASE PROGRESSION | Eligible patients were randomly assigned (1:1) to 2 groups based on different administration schedules of MASCT-I in the first course, by the randomization specialist of Shanghai Canming Medical Technology Co., Ltd, using a central block randomization method. One MASCT-I course consisted of 3 DC subcutaneous injections... | PMC10687909 |
Outcomes and assessments | tumor, soft-tissue sarcoma, death, Cancer | ADVERSE EVENT, TUMOR, ADVERSE EVENTS, SECONDARY, CANCER | The primary endpoint was safety of MASCT-I in combination with camrelizumab plus apatinib in patients with advanced bone and soft-tissue sarcoma. The secondary endpoints included ORR, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and immune response.Safety assessments, including mo... | PMC10687909 |
Statistical analysis | Due to the exploratory nature of this phase 1 study, sample sizes of the 2 parts were not determined on the basis of statistical hypotheses. For part A reported here, a total of 20 patients were planned.Safety analyses were done in patients who received study treatment and had at least one record of safety assessment. ... | PMC10687909 | ||
Results | PMC10687909 | |||
Clinical efficacy | Tumor, soft-tissue sarcomas | TUMOR | In the intention-to-treat population, 6 of 19 patients achieved confirmed partial responses with MASCT-I plus camrelizumab and apatinib, resulting an ORR of 31.6% (95% CI, 12.6–56.6). The DCR was 68.4% (95% CI, 43.5–87.4). In total, 13 of 19 (68.4%) patients showed a decrease from baseline in the size of target lesions... | PMC10687909 |
Immune response | Of the 19 patients, 14 (73.7%) had an immune response, while the other 5 (26.3%) did not during the treated courses (Additional file Fig. S | PMC10687909 | ||
Discussion | diarrhea, soft-tissue sarcomas, sarcomas, proteinuria, anemia, rash, sarcoma, lung vein embolism, deaths, hypertension, TRAEs | HYPERCHOLESTEROLEMIA, PNEUMOTHORAX, INTERSTITIAL PNEUMONIA, SARCOMAS, DISEASE, EVENTS, ANEMIA, SARCOMA, HYPERTRIGLYCERIDEMIA, HYPOTHYROIDISM, HYPERTENSION, PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME | Patients with unresectable recurrent or metastatic bone and soft-tissue sarcoma have limited treatment options after failure of chemotherapy. Although monotherapy with angiogenesis-targeted TKI or ICI has been developed, the outcomes are far from satisfactory. In this study, we adopted intensive immunotherapy-antiangio... | PMC10687909 |
Conclusions | Overall, MASCT-I plus camrelizumab and apatinib had acceptable safety profile and promising efficacy in patients with unresectable recurrent or metastatic bone and soft-tissue sarcoma. After comprehensive consideration of efficacy and safety, schedule-II administration method was recommended. Our study displayed more f... | PMC10687909 | ||
Acknowledgements | The study was sponsored by HRYZ Biotech Co. We are grateful to the patients and their families as well as the investigators and personnel for their contribution in this study. We also thank Shanghai Canming Medical Technology Co., Ltd, for statistical analyses. | PMC10687909 | ||
Authors’ contributions | YZ: conceptualization, data curation, supervision, funding acquisition, investigation, methodology, writing—original draft, project administration, writing—review and editing. ML: conceptualization, data curation, investigation, writing—original draft, writing—review and editing. BZ, CY, YW1, SZ, LT, CZ, GQ, YH, WY, HL... | PMC10687909 | ||
Funding | The study was sponsored by HRYZ Biotech Co and supported by the National Natural Science Foundation of China (grant number: 82072967, 82102866), Shanghai Pujiang Program (NO. 21PJD051), and Science Foundation of Shanghai Sixth People’s Hospital (NO. ynqn202114). | PMC10687909 | ||
Availability of data and materials | The data generated in this study are available within the article and its Supplementary Data Files or from the corresponding author 24 months after study completion upon reasonable request. | PMC10687909 | ||
Declarations | PMC10687909 | |||
Ethics approval and consent to participate | The study was done in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. The protocol and all amendments were approved by the Ethics Committee of Shanghai Sixth People’s Hospital (approval number: 2019–086-(5)), and all patients provided written informed consent. | PMC10687909 | ||
Consent for publication | Not applicable. | PMC10687909 | ||
Competing interests | XL is an employee of HRYZ Biotech Co. All other co-authors declare no competing interests. | PMC10687909 | ||
References | PMC10687909 | |||
Key Points | PMC10018327 | |||
Question | Does losing sleep affect health-related quality of life in children? | PMC10018327 | ||
Findings | SECONDARY | In this secondary analysis of a randomized crossover trial involving 100 healthy children aged 8 to 12 years, receiving 39 minutes less sleep per night resulted in significantly lower physical and overall well-being, ability to cope well at school, and total health-related quality of life, especially in children with a... | PMC10018327 | |
Meaning | SECONDARY | Findings of this secondary analysis of a randomized clinical trial indicate that ensuring children receive sufficient good-quality sleep is an important child health issue. | PMC10018327 | |
Importance | LITTLE | Little is known regarding the effect of poor sleep on health-related quality of life (HRQOL) in healthy children. | PMC10018327 | |
Objective | To determine the effect of induced mild sleep deprivation on HRQOL in children without major sleep issues. | PMC10018327 | ||
Design, Setting, and Participants | SECONDARY, -11 | This prespecified secondary analysis focused on HRQOL, a secondary outcome of the Daily Rest, Eating, and Activity Monitoring (DREAM) randomized crossover trial of children who underwent alternating weeks of sleep restriction and sleep extension and a 1-week washout in between. The DREAM trial intervention was administ... | PMC10018327 | |
Interventions | Bedtimes were manipulated to be 1 hour later (sleep restriction) and 1 hour earlier (sleep extension) than usual for 1 week each. Wake times were unchanged. | PMC10018327 | ||
Main Outcomes and Measures | Sleep Disturbance | All outcome measures were assessed during both intervention weeks. Sleep timing and duration were assessed using 7-night actigraphy. Children and parents rated the child’s sleep disturbances (night) and impairment (day) using the 8-item Pediatric Sleep Disturbance and 8-item Sleep-Related Impairment scales of the Patie... | PMC10018327 | |
Results | sleep disturbance, −0.21 | The final sample comprised 100 children (52 girls [52%]; mean [SD] age, 10.3 [1.4] years). During the sleep restriction week, children went to sleep 64 (95% CI, 58-70) minutes later, and sleep offset (wake time) was 18 (95% CI, 13-24) minutes later, meaning that children received 39 (95% CI, 32-46) minutes less of tota... | PMC10018327 | |
Conclusions and Relevance | SECONDARY | Results of this secondary analysis of the DREAM trial indicated that even 39 minutes less of sleep per night for 1 week significantly reduced several facets of HRQOL in children. This finding shows that ensuring children receive sufficient good-quality sleep is an important child health issue. | PMC10018327 | |
Trial Registration | Australian New Zealand Clinical Trials Registry: | PMC10018327 | ||
Introduction | OBSTRUCTIVE SLEEP APNEA | While inadequate or poor-quality sleep has been associated with a wide range of adverse physical and psychological health outcomes in infants, children, and adolescents,To date, most research has examined the association of more medically related sleep issues, such as obstructive sleep apnea,To our knowledge, no experi... | PMC10018327 | |
Methods | PMC10018327 | |||
Study Design | eating behaviors | The DREAM randomized crossover trial investigated how mild sleep deprivation influenced eating behaviors and activity patterns in children aged 8 to 12 years in the naturalistic home environment. Detailed information on this trial is provided in the protocol | PMC10018327 | |
Participants | Healthy children were recruited by advertisement between October 2018 and March 2020 and were eligible to participate if they were aged 8 to 12 years; lived in the wider Dunedin area in New Zealand; had no underlying medical conditions or medications that could affect sleep; and scored 39 or lower, which indicated no m... | PMC10018327 | ||
Randomization and Masking | Children were randomized to the order in which they underwent sleep restriction and sleep extension weeks and were stratified by age group (8-10 years or 11-12 years) and sex (male or female). Randomization to order was generated by one of us (J.J.H., the study biostatistician) using random block lengths in Stata, vers... | PMC10018327 | ||
Procedures | To achieve mild sleep deprivation, children were asked to go to bed 1 hour earlier than usual for 1 week (sleep extension) and 1 hour later than usual for 1 week (sleep restriction), separated by a 1-week washout to allow sufficient time for children to return to their usual sleeping habits before the next intervention... | PMC10018327 | ||
Measures Collected at Baseline | Demographic data were obtained from the parent, including age, sex, and race and ethnicity of the child; presence of any siblings; and maternal educational level (the index used in New Zealand; and all participating parents or guardians identified as mothers). Area-level deprivation for a family was measured with the 2... | PMC10018327 | ||
Measures Collected During Each Intervention Week | Actigraphy data were collected for each child for the duration of each intervention week, as occurred at baseline. Questionnaire data were collected at the end of each intervention week (day 8) during an assessment session.Children also completed the 27-item KIDSCREEN questionnaire, which assessed HRQOL over the past w... | PMC10018327 | ||
Statistical Analysis | REGRESSION | All analyses were undertaken in Stata, version 17.0 (StataCorp LLC). Effects of mild sleep deprivation were estimated by mixed-effects regression models, with the child as a random effect. Mean differences and 95% CIs were determined for sleep restriction compared with sleep extension. Standardized mean differences (SM... | PMC10018327 | |
Results | The | PMC10018327 | ||
CONSORT Flow Diagram | Sleep Disturbance | HRQOL indicates health-related quality of life; SDSC, Sleep Disturbance Scale for Children. | PMC10018327 | |
Effect of Restricting and Extending Sleep on Health-Related Quality of Life (N = 100) | Calculated as sleep restriction compared with sleep extension.Effect sizes were standardized using a pooled SD.Scale ranged from 1 (never) to 5 (always) or 1 (not at all) to 5 (extremely), as appropriate. | PMC10018327 | ||
Discussion | SECONDARY | Results of this secondary analysis of the DREAM trial demonstrated that even relatively small reductions in nightly sleep duration can have a considerable effect on HRQOL in children. These children received 39 minutes less sleep per night between sleep conditions over only 1 week. This loss of sleep resulted in signif... | PMC10018327 | |
Strengths and Limitations | SECONDARY | This study has several strengths. These strengths primarily centered on the randomized crossover trial design, wherein each child participant was able to act as their own control, with the sleep extension week providing the conditions for more sleep opportunity compared with the sleep restriction week that provided les... | PMC10018327 | |
Conclusions | SECONDARY | In this secondary analysis of the DREAM randomized crossover trial of sleep manipulation, we showed that after only 1 week of receiving 39 minutes less sleep per night between sleep conditions, children reported significantly lower HRQOL in terms of their physical and overall well-being and ability to cope well at scho... | PMC10018327 | |
References |
Protocol
Click here for additional data file.
Data Sharing Statement
Click here for additional data file. | PMC10018327 | ||
Objectives | To investigate rates of mpox beliefs, knowledge and intended behaviours in the general population and in gay, bisexual or other men who have sex with men (GBMSM), and factors associated with intended behaviours. To test the impact of motivational messages (vs a factual control) on intended behaviours. | PMC10583036 | ||
Design | Cross-sectional online survey including a nested randomised controlled trial. | PMC10583036 | ||
Setting | Data collected from 5 September 2022 to 6 October 2022. | PMC10583036 | ||
Participants | Participants were aged 18 years or over and lived in the UK (general population). In addition, GBMSM were male, and gay, bisexual or had sex with men. The general population sample was recruited through a market research company. GBMSM were recruited through a market research company, the dating app Grindr and targeted... | PMC10583036 | ||
Main outcome measures | Intention to self-isolate, seek medical help, stop all sexual contact, share details of recent sexual contacts and accept vaccination. | PMC10583036 | ||
Results | Sociodemographic characteristics differed by sample. There was no effect of very brief motivational messaging on behavioural intentions. Respondents from Grindr and Meta were more likely to intend to seek help immediately, completely stop sexual behaviour and be vaccinated or intend to be vaccinated, but being less lik... | PMC10583036 | ||
Conclusions | GBMSM were more likely to intend to enact protective behaviours, except for self-isolation. This may reflect targeted public health efforts and engagement with this group. Associations with socioeconomic factors suggest that providing financial support may encourage people to engage with protective behaviours. | PMC10583036 | ||
STRENGTHS AND LIMITATIONS OF THIS STUDY | A strength of this study is that it collected data from four large samples, including the general population and men who are gay, bisexual or have sex with men.Data collection occurred over a short period (5 September 2022 to 6 October 2022) during the mpox outbreak.Limitations include that responses may have been affe... | PMC10583036 | ||
Introduction | fever, rash, headache, blisters, aches | MONKEYPOX, PMT, VIRUS, MPOX | Mpox (also known as monkeypox) is an orthopox virus that causes fever, headache, exhaustion, swollen glands and aches (joint, muscle, back), followed by a rash with blisters.In the UK, people who thought they might have mpox were asked to call a sexual health clinic, to stay at home (self-isolate) and avoid close conta... | PMC10583036 |
Method | PMC10583036 | |||
Design | Online cross-sectional survey conducted by Savanta, a Market Research Society Company Partner. Data were collected between 5 September 2022 and 6 October 2022. | PMC10583036 | ||
Participants | RECRUITMENT | Eligibility criteria for the general population sample were living in the UK and being aged 18 years or over. For the GBMSM samples, additional criteria were being a man and identifying as being gay, bisexual or having sex with men.Recruitment for the general population sample used quota sampling, a standard opinion po... | PMC10583036 | |
Study materials | Full study materials are in
| PMC10583036 | ||
Outcome measures | blisters, rash | EMERGENCY, SMALLPOX | Self-isolation intention was measured using two items, asking participants to imagine that they were contacted by public health officials and told that they needed to self-isolate for 21 days because they had mpox, and because they had come into high-risk contact with a case. Responses were given on a five-point scale ... | PMC10583036 |
Motivational messaging | PMT | Very brief motivational messages were constructed based on components of the PMT. | PMC10583036 | |
Psychological factors | We asked participants how much they had seen or heard about mpox, how worried they were about mpox, and how much risk they thought mpox posed to people in the UK and themselves personally. For these items, answers of ‘don’t know’ were coded as missing.Participants were also asked about their perceived susceptibility to... | PMC10583036 | ||
Sociodemographic characteristics | hepatitis A | CHRONIC ILLNESS, HEPATITIS A, SMALLPOX | Participants were asked to report their age, gender,We asked participants if they or a household member had a chronic illness, whether they were pregnant, had ever taken pre-exposure prophylaxis (PrEP) for HIV, and for their vaccination status for smallpox (in 2022 and before 2022), hepatitis A and COVID-19 (two doses ... | PMC10583036 |
Patient and public involvement | To ensure the research aims and study information were appropriate, members of the public were involved in the development of the funding application and survey materials. For the funding application, six people gave feedback on the initial proposal resulting in changes to aims of the study and terminology used. For th... | PMC10583036 | ||
Power | REGRESSION | A sample size of 3000 allows a 95% CI of plus or minus 1.8% for the prevalence estimate for a survey item with a prevalence of around 50% (sample size of 250 gives a 95% CI of plus or minus 6.2%; sample size of 1000 gives a 95% CI of plus or minus 3.1%).For multiple linear regression analyses, a sample of 830 allowed o... | PMC10583036 | |
Analysis | chronic illness | SMALLPOX, CHRONIC ILLNESS, RECRUITMENT, REGRESSIONS, REGRESSION | Information about data preparation is reported in
We tested whether sociodemographic characteristics of GBMSM samples were different depending on the recruitment method (Savanta, Grindr, Meta). Due to significant differences, further analyses were conducted in each sample separately.First, we tested the influence of m... | PMC10583036 |
Results | REGRESSION | Top-line results for all survey materials, by sample, are shown in For regression analyses, we report imputed values. Results using imputed values were compared with non-imputed data. There were no substantial differences in results with and without imputed values. | PMC10583036 | |
Participant characteristics | RECRUITMENT | There were significant differences in participant characteristics by sampling method. Most notably, participants recruited from Grindr and Meta were more likely to be working, need to leave home for work, more highly educated, higher socioeconomic grade and have less financial hardship (Participant characteristics, by ... | PMC10583036 | |
Motivational messaging | There was no effect of motivational messaging on outcomes, except for in the sample recruited from Meta (see
| PMC10583036 | ||
Self-isolation | sampleA | REGRESSION | Rates of intended self-isolation were higher when imagining you were a case than a high-risk contact. Three-quarters of the general population sample intended to self-isolate for 21 days if they were to develop mpox (75.2%, 95% CI 73.7% to 76.7%, n=2294; Main behavioural outcomes, by sample*p≤0.001.†Answers of ‘don’t k... | PMC10583036 |
Help seeking | Approximately half of participants in the general population, Savanta GBMSM and Grindr samples indicated that they would seek help immediately (95% CI 49.2% to 53.3%; In the general population, intention to seek help immediately was associated with being older (aOR (adjusted Odds Ratio) 1.012, 95% CI 1.006 to 1.019, p<... | PMC10583036 | ||
Sexual contact behaviour when symptomatic | blisters, rash | REGRESSION | In the general population and Savanta GBMSM, 77.2% (95% CI 75.6% to 78.9%, n=1923) and 79.2% (73.7% to 84.6%, n=171) intended to completely stop sexual contact if they were to develop an unexplained rash with blisters and learn that they had come into contact with a mpox case (In the general population, intending to co... | PMC10583036 |
Sharing details of contacts | sampleA | REGRESSION | There was no difference in intention to share details of all sexual partners in the last 7 days between samples (In the general population sample, intention to share details of every sexual contact in the last 7 days was associated with being female, older, less financial hardship, higher perceived susceptibility to an... | PMC10583036 |
Vaccination | SMALLPOX | Few people had been vaccinated for smallpox in 2022 in the general population sample (5.3%, 95% CI 4.5% to 6.1%, n=162; In the general population, being vaccinated for smallpox in 2022 or intending to be vaccinated if offered a vaccine was associated with being older (aOR 1.015, 95% CI 1.007 to 1.023, p<0.001), more wo... | PMC10583036 | |
Discussion | gonorrhoea reinfection | SMALLPOX, RECRUITMENT, INFLUENZA A H1N1, STIS, REINFECTED | We investigated mpox attitudes, beliefs and intended behaviours in a general population sample and three GBMSM samples. Samples differed by sociodemographic characteristics. This was reflected in intended behaviours, with GBMSM recruited from Grindr or Meta being more likely to intend to seek help immediately for mpox ... | PMC10583036 |
Supplementary Material | PMC10583036 | |||
Reviewer comments | PMC10583036 | |||
Data availability statement | Data are available in a public, open access repository. Anonymised data are available online. | PMC10583036 | ||
Ethics statements | PMC10583036 | |||
Patient consent for publication | Not applicable. | PMC10583036 | ||
Ethics approval | Ethical approval for this study was given by the King’s College London Psychiatry, Nursing and Midwifery Research Ethics Panel (reference number: LRS/DP-21/22-32287). Participants gave informed written consent before beginning survey materials. | PMC10583036 | ||
References | PMC10583036 | |||
Supplementary Information | COVID-19-related stress, familial COVID-19-related stress, AD, affective dysregulation | Analyzing COVID-19-related stress in children with affective dysregulation (AD) seems especially interesting, as these children typically show heightened reactivity to potential stressors and an increased use of maladaptive emotion regulation strategies. Children in out-of-home care often show similar characteristics t... | PMC9668221 | |
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC9668221 | ||
Introduction | COVID-19-related stress, AD, affective dysregulation | VIRUS | Following the first reported cases of COVID-19 in China in December 2019, the virus spread rapidly across the world (As a result of these measures, families were faced with persistent changes to their daily life. In accordance with these changes, empirical data suggest a negative effect of the COVID-19 crisis on the me... | PMC9668221 |
Methods | PMC9668221 | |||
Participants | AD [ | The present sample comprised subsamples of the research consortium ADOPT (Affective Dysregulation—Optimizing Prevention and Treatment), which analyzes the effects of stepped care interventions in children with AD [ | PMC9668221 | |
Pre-pandemic recruitment | AD | Before the pandemic, three samples with AD (AD group, | PMC9668221 | |
Pre-pandemic data collection | Data on potential risk and protective factors including sociodemographic characteristics, child characteristics, and caregiver characteristics were taken from the first in-depth assessment following the screening questionnaire, in which clinical, caregiver, and child report were used. In the No AD | PMC9668221 | ||
COVID-19 data collection | COVID-19-related stress | All families who participated in the intensive assessment following the screening questionnaire were asked to participate in the present study on COVID-19-related stress ( | PMC9668221 | |
Measures | PMC9668221 | |||
COVID-19-related stress | The | PMC9668221 | ||
Predictors of COVID-19-related stress | PMC9668221 |
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