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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2.6.4. Sequential effects test. | Independent samples | PMC10553036 | ||
2.7. Experimental flow chart | PMC10553036 | |||
3. Results | PMC10553036 | |||
3.1. Basic information of participants | The Shapiro–Wilk test showed that all dependent variables were normally distributed (Baseline demographics of the study population. | PMC10553036 | ||
3.2. Results of the first trial | According to Table Analysis of variability of relevant indicators in the first trial.Significant difference compared with TimeSignificant difference compared with TimeSignificant difference compared with the Control group at the same time. | PMC10553036 | ||
3.3. Results of the second trial | According to Table Analysis of variability of relevant indicators in the second trial.Significant difference compared with TimeSignificant difference compared with Time | PMC10553036 | ||
3.4. Sequential effect analysis | Further comparisons were made to determine if there were any order effects in the 2 experiments. In Group 1, the first experiment was the speed and accuracy test (X1), and the second experiment (cross-over) was the same test for the exercise group (X2). The difference was calculated as X = |X1 − X2|. In Group 2, the fi... | PMC10553036 | ||
4. Discussion | muscle damage | CARDIOVASCULAR DISEASE, CHRONIC DISEASE | Our study aimed to investigate whether acute aerobic exercise benefits cognitive function in a specific occupational group of eSports players. As the best beneficiaries of cognitive executive function, eSports athletes urgently need an exercise training program that can rapidly improve their cognitive executive perform... | PMC10553036 |
4.1. Mechanisms of the benefits of exercise | There are currently several mechanisms regarding exercise-induced benefits, which include exercise increases microcirculation and mitochondrial function, which results in a significant ameliorative function for muscle,As “lack of time” is often cited as the most common barrier to increasing habitual physical activity, ... | PMC10553036 | ||
4.2. The effects of acute moderate-intensity aerobic exercise on different cognitive tasks vary | This study found that acute moderate-intensity aerobic exercise has varying effects on different cognitive tasks. Based on the results of the 2 experiments, exercise for 30 minutes can improve speed and accuracy, instant visual memory, and shorten reaction time. This is consistent with Peng and Zhou’sThe experiment res... | PMC10553036 | ||
4.3. Temporal characteristics of the effects of acute moderate-intensity aerobic exercise on cognitive tasks | frontal lobe dysfunction | Two experiments showed that the exercise intervention group had significantly improved speed and accuracy 30 minutes after exercise compared to before exercise. The exercise intervention group also had significantly shorter reaction times 30 minutes after exercise than before in the first experiment, but the second exp... | PMC10553036 | |
4.4. Limitation | Our research results were observed only at the macroscopic level, focusing on the actual changes in various cognitive functions of E-athletes. The findings confirmed that acute aerobic exercise contributes to the improvement of certain cognitive functions in E-athletes, providing a basis for further research. However, ... | PMC10553036 | ||
5. Conclusion | shortening visual reaction | Acute moderate-intensity aerobic exercise significantly improves cognitive function in e-sports players and exhibits temporal characteristics. Its characteristics are mainly reflected in improving speed and accuracy, shortening visual reaction time, and improving instantaneous memory ability. The improvement effect can... | PMC10553036 | |
Abbreviation: | brain derived neurotrophic factorThe source of funds is provided by the first author Zhang Weichao. The project number is 202202004.The authors have no conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable reque... | PMC10553036 | ||
References | PMC10553036 | |||
Abstract | PMC10485297 | |||
Background | cancer | CANCER | When cancer treatments have similar oncologic outcomes, the number of days with in-person healthcare contact (“”contact days’’) can help contextualize expected time use with each treatment. We assessed contact days in a completed randomized clinical trial. | PMC10485297 |
Patients and Methods | relapsed/refractory lymphoma | SECONDARY | We conducted a secondary analysis of the CCTG LY.12 RCT that evaluated 2-3 cycles of gemcitabine, dexamethasone, and cisplatin (GDP) vs. dexamethasone, cytarabine, and cisplatin (DHAP) in 619 patients with relapsed/refractory lymphoma prior to stem cell transplant. Primary analyses reported similar response rates and s... | PMC10485297 |
Results | The study period was longer in the GDP arm (median 50, vs. 47 days, | PMC10485297 | ||
Conclusions | hematological cancers, cancer | CANCER, SECONDARY | Measures of time use, such as contact days, can be extracted from RCTs. In LY.12, despite comparable oncologic outcomes, GDP was associated with fewer contact days. Such information can guide decision-making for patients with hematological cancers, who already face significant healthcare contact.When cancer treatments ... | PMC10485297 |
Implications of Practice | ONCOLOGY | We extracted a patient-centered and pragmatic measure of the time spent with healthcare contact from a completed clinical trial. We identified days with in-person healthcare contact (“”contact days’’) and days spent at home (“”home days’’). In the LY.12 trial, we demonstrate that although 2 different chemotherapy regim... | PMC10485297 | |
Introduction | lymphoma, cancer, hematological malignancies | COLORECTAL CANCER, CANCER, HEMATOLOGICAL MALIGNANCIES, SOLID TUMORS, MALIGNANCIES, SECONDARY, LYMPHOMA | The time burdens imposed by cancer care are increasingly recognized, especially among persons with advanced solid tumors where the absolute survival benefit offered by a treatment may be small.To optimize patient centeredness (since seemingly short days can turn into all-day affairs) and practicality (dichotomous and e... | PMC10485297 |
Methods | PMC10485297 | |||
Study Background, Procedures, and Initial Efficacy/Safety Data | B-cell malignancies, non-Hodgkin’s lymphoma, Cancer | ADVERSE EVENTS, SECONDARY, CANCER | We conducted a secondary analysis of the Canadian Cancer Trials Group LY.12 randomized clinical trial (ClinicalTrials.gov Identifier: NCT00078949). LY.12 recruited participants in Canada, Italy, US, and Australia during 2003-2011. Eligible adults had an aggressive histology relapsed/ refractory non-Hodgkin’s lymphoma t... | PMC10485297 |
Study Procedures for the Current Analyses | The study period for the current analysis was the date of assignment to the date of progression or the day before stem cell transplant (whichever was earlier), as in prior work.We considered any day with any amount of in-person healthcare system contact as a “”contact day’’. | PMC10485297 | ||
Statistical Analysis | We compared proportions and medians of time measures across arms by a χ | PMC10485297 | ||
Results | Six-hundred and 10 of the 619 (98.5%) trial participants had data on contact days available and were included in the current analyses. The median age was 55 years, 61% of participants were men, and 86% had an ECOG performance status of 0-1. Detailed baseline characteristics are available in prior publications.Data on c... | PMC10485297 | ||
Discussion | aggressive hematological cancers, hematologic malignancies | SECONDARY, HEMATOLOGIC MALIGNANCIES | In this secondary analysis of the LY.12 trial, we demonstrate that measures of time spent in healthcare can be extracted from completed RCTs. In LY.12, despite broadly comparable short- and long-term oncologic outcomes, the GDP arm experienced fewer contact days. The sources of contact days also differed between arms, ... | PMC10485297 |
Acknowledgments | We thank the participants in the study for volunteering. Prior presentation: We will present this work in abstract form to the 2023 ASCO Annual Meeting to be held in Chicago, IL, USA (and virtually) on June 2-6, 2023. | PMC10485297 | ||
Funding | Cancer | CANCER | The original LY.12 clinical trial was supported by grants nos. 015469 and 021039 from the Canadian Cancer Society Research Institute, and by Roche Canada and Eli Lilly Canada. Annette Hay has received research funding from Roche, AbbVie, Merck, Seattle Genetics, Janssen, Incyte, Amgen, Novartis. | PMC10485297 |
Conflict of Interest | Annette E. Hay has received research funding from Roche, AbbVie, Merck, Seattle Genetics, Janssen, Incyte, Amgen, Novartis. The other authors indicated no financial relationships. | PMC10485297 | ||
Author Contributions | Conception/design: A.G., A.E.H., M.C.C., C.M.B. Data analysis and interpretation: all authors. Administrative support: A.E.H., M.C., L.E.S., M.C.C. Manuscript writing (first draft): A.G. Manuscript revisions and final approval of manuscript: all authors. | PMC10485297 | ||
Data Availability | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10485297 | ||
References | PMC10485297 | |||
Background | thrombosis, thrombocytopenia, TTS, coronavirus disease 2019 | THROMBOSIS, THROMBOCYTOPENIA, CORONAVIRUS DISEASE 2019, SYNDROME | Edited by: Jochen Mattner, University of Erlangen Nuremberg, GermanyReviewed by: Qihan Li, Chinese Academy of Medical Sciences and Peking Union Medical College, China; Rezvan Hosseinzadeh, Babol University of Medical Sciences, Iran†These authors have contributed equally to this work and share first authorship‡These aut... | PMC10265469 |
Methods | hepatitis A | ADVERSE EVENT, HEPATITIS A, BLOOD | In this randomized, controlled, open-label phase IV clinical trial, 270 participants including 135 adults aged 18–59 years and 135 adults aged 60 years or older, were enrolled and randomized to the CoronaVac group or to the control group in a 2:1 ratio and received two doses of CoronaVac or one dose of the 23-valent pn... | PMC10265469 |
Results | ADVERSE REACTIONS, SEVERE ACUTE RESPIRATORY SYNDROME, CORONAVIRUS | Fourteen days after the second dose of CoronaVac, the seroconversion rates of neutralizing antibodies against the prototype strain and beta, gamma, and delta variants of concern (VOC) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) reached peak values of 89.31%, 23.3%, 45.3%, and 53.5%, respectively. Th... | PMC10265469 | |
Conclusion | CoronaVac showed a good safety profile and could induce a humoral response against the prototype and VOCs of SARS-CoV-2 in adults 18 years or older, with no abnormal effects on laboratory parameters of blood glucose and coagulation function. | PMC10265469 | ||
Introduction | death, coronavirus disease 2019 | ADVERSE REACTIONS, CORONAVIRUS DISEASE 2019, THROMBOCYTOPENIA, ADVERSE EFFECTS, ARTERIAL THROMBOSIS | The coronavirus disease 2019 (COVID-19) pandemic has led to millions of confirmed cases of COVID-19 worldwide and billions of vaccines against SARS-CoV-2 have been administered (TTS is a rare symptom characterized by acute venous or arterial thrombosis, thrombocytopenia, and positive PF4-heparin ELISA. The peak time fo... | PMC10265469 |
Methods | PMC10265469 | |||
Study design and participants | DISEASE | This single-site, randomized, controlled, open-label phase IV clinical trial was conducted by the Shandong Provincial Center for Disease Control and Prevention (CDC) in Rushan, Shandong province, China (NCT04953325). Participants 18 years or older were recruited and randomized to evaluate the immunogenicity and safety ... | PMC10265469 | |
Vaccines | hepatitis A | VIRUS, HEPATITIS A | Inactivated SARS-CoV-2 vaccine (CoronaVac), 23-valent pneumococcal polysaccharide vaccine (PPV23) and inactivated hepatitis A vaccine used in this trial were manufactured by Sinovac Biotech Ltd. and approved by the China National Medical Products Administration (NMPA). CoronaVac is an inactivated COVID-19 vaccine. Each... | PMC10265469 |
Procedures | thrombosis, bleeding, SARS-CoV-2 infection, abnormal fasting blood glucose or diabetes, coagulation abnormalities | THROMBOSIS, BLEEDING, SARS-COV-2 INFECTION, ADVERSE EVENTS, ADVERSE EVENT, CHRONIC DISEASES, DISEASES | Participants aged 18 years or older were selected by an oral consultant according to inclusion and exclusion criteria. Criteria for critical exclusion included participants with 1) a history of SARS-CoV-2 infection or vaccination, 2) severe chronic diseases, 3) abnormal fasting blood glucose or diabetes, or 4) diagnose... | PMC10265469 |
Outcomes | fasting blood glucose | ADVERSE EVENTS, ADVERSE REACTIONS, SECONDARY | The primary safety outcome was abnormal differences in the means of laboratory parameters between the CoronaVac group and the control group at seven time points. Laboratory parameters included fasting blood glucose, platelet count, prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT),... | PMC10265469 |
Serum-neutralizing antibodies detection | The neutralizing antibodies against the prototype strain of SARS-CoV-2 (SARS-CoV-2/human/CHN/CN1/2020, GenBank number MT407649.1) and variants Beta (B.1.351), Gamma (P.1) and Delta (B.1.617.2) were quantified using a microcytopathogenic effect assay according to previous trials ( | PMC10265469 | ||
Anti-platelet factor 4/Heparin antibody detection | SECONDARY | The enzyme-linked immunosorbent assay (ELISA) kit for anti-heparin/platelet factor 4 antibodies (Anti-PF4) was purchased from Cloud-Clone Corp. (Wuhan, China). Serum samples were detected strictly according to the manufacturer’s instructions.Standards or samples were added to the microtiter plate wells, which had been ... | PMC10265469 | |
Glucose detection | The glucose hexokinase reagent kit was purchased from Medicalsystem Biotechnology Co., Ltd. (Ningbo, China). All samples were detected by the hexokinase/glucose-6-phosphate dehydrogenase method according to the manufacturer’s instructions. | PMC10265469 | ||
Statistical analysis | Because there were no previous studies relevant to the primary safety outcome of the three vaccines used in this trial, no statistical methods were used to calculate the sample size. Based on practical considerations and guidelines in China that the minimum sample size for each group in a phase I clinical trial should ... | PMC10265469 | ||
Results | PMC10265469 | |||
Participants | HEPATITIS A | From 30 July to 25 August 2021, a total of 355 participants aged 18 years or older were selected, 270 participants were enrolled and underwent randomization. One hundred and eighty participants were assigned to the CoronaVac group (including 90 adults aged 18 to 59 years and 90 adults aged 60 years or older), and 90 pa... | PMC10265469 | |
Demographic characteristics | At baseline, the demographic characteristics between the control group and the CoronaVac group were generally similar in terms of mean age, height, weight, sex, and ethnicity (Demographic characteristics.*Data are mean (SD) or n (%). | PMC10265469 | ||
Immunogenicity | PMC10265469 | |||
GMTs and seroconversion rates of neutralizing antibodies against the prototype strain | To assess the dynamic changes of neutralizing antibodies before and after immunization, blood samples from participants in the CoronaVac group were detected at seven time points. Four days after the first dose of CoronaVac, GMTs and seroconversion rates (SCR) of neutralizing antibodies against the prototype strain of S... | PMC10265469 | ||
GMTs and seroconversion rates of neutralizing antibodies against VOCs | To analyze the neutralizing antibody titers against beta, gamma, and delta variants of concern (VOC), blood samples from participants in the CoronaVac group were detected at four time points. All participants were seronegative and susceptible to any VOCs at baseline.The GMTs and seroconversion rates of neutralizing ant... | PMC10265469 | ||
Safety | PMC10265469 | |||
Changes in laboratory parameters before and after vaccination | CHRONIC DISEASES | Ten parameters were detected at seven time points to assess the safety profile of CoronaVac in coagulation activity and blood glucose levels. The nine parameters related to coagulation function were platelet count, PT, APTT, TT, fibrinogen, INR, D-dimer, ESR and anti-heparin/platelet factor 4 antibody.At each time poin... | PMC10265469 | |
Adverse reactions | headache, fatigue, pain | ADVERSE REACTIONS, ADVERSE REACTION, INDURATION | A total of 125 (46.5%) of the 269 participants reported at least one adverse reaction within 28 days of either vaccination, of which 78 participants were in the CoronaVac group and 47 participants were in the control group. In addition, 74 (55.2%) of the 134 participants aged 1859 years reported adverse reactions, whic... | PMC10265469 |
Discussion | thrombosis, abnormal fasting glucose, HIT, venous or arterial thrombosis, diabetes | THROMBOSIS, ASH, THROMBOCYTOPENIA, HEPARIN-INDUCED THROMBOCYTOPENIA, STREPTOCOCCUS PNEUMONIAE INFECTION, THROMBOEMBOLISM, EVENTS, DIABETES | In this phase IV clinical trial, two doses of CoronaVac with an interval of 28 days exhibited good immunogenicity and safety profiles. CoronaVac did not have any effect on laboratory parameters related to coagulation function and blood glucose.Considering the vaccination policy in China stipulating that all participant... | PMC10265469 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10265469 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Shandong Provincial CDC Ethics Committee. The patients/participants provided their written informed consent to participate in this study. | PMC10265469 | ||
Author contributions | RECRUITMENT | QX, XL, XDL, YZ, DS, YG, and LZ designed the clinical trial and the documents used in this trial. QC and HL organized the recruitment and visits of participants at the trial site. XL, XDL, TY, DS, JJL, PX, JS and MX monitored the progress of the trial. YS cleaned and analyzed the data. JL detected serum neutralizing an... | PMC10265469 | |
Acknowledgments | DISEASE | We would like to thank all the investigators from the Rushan Center for Disease Control and Prevention and the People’s Hospital of Rushan City for the contribution to this trial. | PMC10265469 | |
Conflict of interest | Authors XL, TY, YS, and YG are employed by Sinovac Biotech Co., Ltd., YZ, JL, and JS are employed by Sinovac Life Sciences Co., Ltd.The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.The au... | PMC10265469 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10265469 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC10265469 | ||
References | PMC10265469 | |||
Background | renal angiomyolipoma, SEGA, epilepsy, rAML, TSC | RENAL ANGIOMYOLIPOMA, SUBEPENDYMAL GIANT CELL ASTROCYTOMA, EPILEPSY, TUBEROUS SCLEROSIS COMPLEX, ADVERSE EFFECTS | The randomised double-blinded placebo-controlled EXIST-1–3 studies have showed everolimus effective with adverse effects reported as acceptable in treatment of symptoms in patients with tuberous sclerosis complex (TSC), although evidence of outcomes in clinical practice remains limited. This study aimed to investigate,... | PMC10693167 |
Results | seizure, epilepsy | EPILEPSY | The study included 64 patients with TSC (median age: 19, range 0.9–54 years) receiving everolimus treatment (Norway: n = 35; Denmark: n = 29). Among 45 patients with epilepsy, 14 (31%) were responders experiencing ≥ 50% reduction in seizure frequency in the last 3 months of treatment compared with the last 3 months bef... | PMC10693167 |
Conclusions | Seizure, SEGA | ADVERSE EFFECTS | Seizure reduction in this study sample was consistent with results from EXIST, but might be lower than expected, given that changes in concomitant ASMs are part of clinical practice. Seizure reduction was associated with younger age. As with EXIST, everolimus reduced or stabilised rAML size in most patients. SEGA volum... | PMC10693167 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13023-023-02982-1. | PMC10693167 | ||
Keywords | Open access funding provided by University of Oslo (incl Oslo University Hospital) | PMC10693167 | ||
Background | SEGA, rAML, and, epilepsy, TSC, tumour, autosomal dominant genetic disease | TUBEROUS SCLEROSIS COMPLEX, TUMOUR, EPILEPSY | Tuberous sclerosis complex (TSC) is a rare autosomal dominant genetic disease caused by genetic variants in TSC1 [TSC treatment involves mTOR-inhibitors. These drugs block the mTOR-complex activation, reducing tumour growth, and offer a potential disease-modifying approach [The safety and efficacy of the mTOR inhibitor... | PMC10693167 |
Results | PMC10693167 | |||
Patient characteristics | Table Patient characteristics | PMC10693167 | ||
Epilepsy | seizure, Seizure, epilepsy | CLONIC SEIZURE, EPILEPSY | Twenty-eight of 64 patients (44%) were treated with everolimus for epilepsy as the primary indication (epilepsy indication group). Further, 17 (27%) had epilepsy but were primarily treated with everolimus for other indications (other indication group). Thus, in total, there were 45 patients in the entire epilepsy group... | PMC10693167 |
SEGA | SEGA | Five patients were treated with everolimus for SEGA. For two of them, the first available imaging were taken 5 and 7 months after start of treatment, making only three available for evaluation of the effects. The SEGA volume of the largest SEGA decreased from 111.52 mm | PMC10693167 | |
Safety | anaemia, immunodeficiency disorder, leucopoenia, neutropenia, fever, leukopenia, epilepsy, rAML, Hypercholesterolemia, infection, testes infection, skin infections, upper respiratory tract infections, Cancer | ANAEMIA, ADVERSE EFFECTS, IMMUNODEFICIENCY DISORDER, UPPER RESPIRATORY TRACT INFECTIONS, NEUTROPENIA, LEUKOPENIA, EPILEPSY, CNS INFECTIONS, VAGINAL INFECTION, HYPERCHOLESTEROLEMIA, COVID-19 INFECTION, SKIN INFECTION, CEREBRAL OEDEMA, ADVERSE EFFECTS, INFECTION, ULCERATION, ORAL ULCERATION, CANCER | Sixty-one of the 64 (95%) patients reported clinical adverse effects after follow-up periods of 1–12 months (n = 10), 13–24 months (n = 13), 25–36 months (n = 18), and > 36 months (n = 23) (Table Adverse effects with dose modification over time during the treatment period*Genital infection (vaginal infection n = 2, tes... | PMC10693167 |
Discussion | TSC | In this study, we demonstrated the effectiveness and safety aspects of treatment with everolimus in 64 patients with TSC in Norway and Denmark. This is one of few unselected, population-based studies from clinical practice in countries with similar health care systems, characterised by high-quality follow-up and equal ... | PMC10693167 | |
Epilepsy effectiveness | rAML, seizure, epilepsy | ADVERSE EFFECTS, INTERACTIONS, ADVERSE EFFECT, EPILEPSY | The effectiveness of epilepsy treatment with everolimus, defined as at least 50% seizure reduction, was observed in one-third of patients with epilepsy in this study. This proportion is similar to the patients treated with a low dose of everolimus in EXIST-3 [This finding might be lower than expected, since most patien... | PMC10693167 |
RAML effectiveness | Tumors | TUMORS | About one-third of our patients were responders (> 30% reduction of LD) versus 42% in EXIST-2 [Volume measurement was not feasible for various reasons; it was too time-consuming, the automated method used for volume measurement did not capture accurate volume assessment, and some images were only taken in single sectio... | PMC10693167 |
SEGA effectiveness | SEGA, volume reduction | SEGA volume decreased in all three patients. Our observation (43–71% volume reduction) is in line with or better than results from the EXIST-1 trial, in which 35% [ | PMC10693167 | |
Safety | immunodeficiency disorder, infections, [Immunodeficiency disorder | IMMUNODEFICIENCY DISORDER, PRIMARY IMMUNODEFICIENCY, INFECTIONS, ADVERSE EFFECTS, ADVERSE EVENT, ULCERATION, IMMUNODEFICIENCY DISORDER | The frequency of adverse effects was in line with EXIST-1–3 [Notably, patients with adverse effects ≥ grade 3 were younger than patients without adverse effects ≥ grade 3, this is in line with results in the extension study of EXIST-3 [The frequency of stomatitis/oral ulceration was slightly lower than those reported i... | PMC10693167 |
Strengths and limitations | epilepsy, seizure, ’ | DISORDERS, EPILEPSY | The study included unselected patients from two countries with similar health care systems and follow-up from specialists. The patients were recruited from the Norwegian TSC population and from two regions in Denmark. It is possible that some treated patients invited through the National Centre for Rare Epilepsy-Relate... | PMC10693167 |
Methods | PMC10693167 | |||
Patient selection and inclusion | Patients with a confirmed TSC diagnosis based on recommendations of the 2012 International TSC Consensus Conference [In Norway, 190 TSC patients from the registries were contacted about the use of everolimus: 75 replied, 35 of those were treated with everolimus and were included in the study. Two patients treated with ... | PMC10693167 | ||
Study design | epilepsy, lymphangiomyomatosis, seizure | ADVERSE EFFECTS, LYMPHANGIOMYOMATOSIS, EPILEPSY | This was a retrospective observational study. Demography, patient history, indication for and duration of treatment, dosage, serum concentration measurements, dose modifications/discontinuation and adverse effects, and seizure response in epilepsy patients were collected from medical records through a web-based form. I... | PMC10693167 |
Outcome measures of epilepsy | epilepsy, seizure, Seizure, myoclonic, atonic, Epilepsy | EPILEPSY, MINOR, CLONIC SEIZURES, EPILEPSY, ATYPICAL ABSENCE | We investigated changes in seizure frequency from baseline to the last three months of everolimus treatment. We defined seizure frequency during the last three months before treatment as the baseline. Seizure response was divided into seizure freedom, ≥ 50% reduction, ≥ 30% reduction, clinically relevant reduction with... | PMC10693167 |
Outcome measures of RAML and SEGA | SEGA, rAML, haemorrhage, tumour, SEGA lesions, RAMLs | HAEMORRHAGE, TUMOUR, COMPLICATIONS | We investigated the change in the size of rAML (largest lesion and mean diameter change of largest lesion in both kidneys) from baseline to the last imaging and the change in SEGA volume from baseline to the last imaging. RAMLs with the longest diameter (LD) in both kidneys and overall were identified. The change in si... | PMC10693167 |
Outcome measures of adverse effects | Cancer | ADVERSE EFFECTS, ADVERSE EFFECTS, HYPERCHOLESTEROLEMIA, CANCER | We investigated adverse effects possibly or probably related to everolimus treatment mapped and graded by the National Cancer Institute Common Terminology Criteria version 5 [Hypercholesterolemia was not graded using this terminology. Grading was based on total cholesterol levels (grade 1: increased from start or under... | PMC10693167 |
Statistical analysis | seizure | ADVERSE EVENTS, ADVERSE EFFECTS | The data were coded and analysed with SPSS (version 28.0.1.1 (14)). Continuous variables were analysed with frequency, mean, standard deviation, median, minimum, and maximum. Contingency tables with chi-square test for independence (Pearson’s chi-square and Fisher’s exact test) were used to test group differences betwe... | PMC10693167 |
Conclusions | autism disorders, intellectual disabilities, seizure, epilepsy | EVENTS, HYDROCEPHALUS, ADVERSE EFFECTS, EPILEPSY | The effectiveness of everolimus in epilepsy was acceptable and in line with EXIST-3. In this study, however, most patients also changed their concomitant ASM treatments. This may suggest that everolimus was not the only cause of the improvement in the seizure situation. Treatment effectiveness with everolimus was assoc... | PMC10693167 |
Acknowledgements | Tuberous Sclerosis | TUBEROUS SCLEROSIS | We thank all patients, family members, and others participating in the study. We further thank Arnt Egil Trelsgård from the Norwegian Association of Tuberous Sclerosis for pilot testing the parent/patient interview. | PMC10693167 |
Author contributions | RS, CHH | RECRUITMENT | Responsible/contributed to study design: IC, JC, AIIE, BN, RS, KH, CJL, CL, TN; Recruitment of patients, collection, and interpretation of data: IC, JC, CHH, LH, MGF; Re-evaluation of imaging: AIIE, BN; Data analyses: IC, CL, CJL, TN; Writing/revising of manuscript: IC, JC, CHH, LH, MGF, AIIE, BN, RS, KH, CJL, CL, TN; ... | PMC10693167 |
Funding | RARE DISORDER | Open access funding provided by University of Oslo (incl Oslo University Hospital) This work was supported by the Norwegian National Advisory Unit on Rare Disorders and KG Jebsen Stiftelsen (SKGJ-MED-021). | PMC10693167 | |
Availability of data and materials | The datasets generated during and/or analysed during the current study are not publicly available due to them containing information that could compromise research participant privacy/consent but are available from the corresponding author on reasonable request. | PMC10693167 | ||
Declarations | PMC10693167 | |||
Ethics approval and consent to participate | The Norwegian Medical Ethics Committee reviewed and approved the study (ethic committee number 2013/176-36). The Central Denmark Region Committees on Health Research Ethics declared the study exempted from notification, as a data processing contract was completed. | PMC10693167 | ||
Consent for publication | Written informed consent was received from patients ≥ 16 years and from parents/guardians of patients < 16 years and of patients without competence to consent. | PMC10693167 | ||
Competing interests | Ine Cockerell gave an unpaid lecture to UCB Nordic. Jakob Christensen has received honoraria from serving on the scientific advisory board of UCB Nordic and Eisai AB, received honoraria for giving lectures from UCB Nordic and Eisai AB, and received funding for a trip from UCB Nordic. Cecilie Johannessen Landmark has re... | PMC10693167 | ||
References | PMC10693167 |
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