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Conclusion | opioid use disorder | In this study, zinc supplementation in patients with opioid use disorder subjected to MMT was investigated. Although the study results showed that zinc intake had the capability to positively influence relapse reduction and mental health in such people, more studies are needed before including this supplement in the tr... | PMC9817328 | |
Acknowledgements | The authors hereby would like to extend their gratitude to all the participants and the staff of the addiction treatment clinic concerned, who cooperated to fulfill this study. They also appreciate the Vice-Chancellor’s Office for Research, affiliated with Isfahan University of Medical Sciences, Isfahan, Iran, for the ... | PMC9817328 | ||
Authors’ contributions | Both authors contributed to the study procedures, data collection, and analysis. The authors prepared the first draft and read and approved the final version. | PMC9817328 | ||
Funding | Not applicable. | PMC9817328 | ||
Availability of data and materials | The data used in this study will be made available from the corresponding author upon reasonable request. | PMC9817328 | ||
Declarations | PMC9817328 | |||
Ethics approval and consent to participate | A written informed consent form was obtained from all the participants once the research objectives and methodology were explained. The Ethics Committee of Isfahan University of Medical Sciences, Isfahan, Iran, approved this study with the ethics code no. (IR.MUI.MED.REC. 1399.385). Moreover, the principles of the Decl... | PMC9817328 | ||
Consent for publication | Not applicable. | PMC9817328 | ||
Competing interests | The authors did not declare any conflict of interest. | PMC9817328 | ||
References | PMC9817328 | |||
Background | memory complaints | DV and AS contributed equally to this work.There is evidence that both omega-3 long-chain polyunsaturated fatty acids (PUFAs) (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]) and cocoa flavanols can improve cognitive performance in both healthy individuals and in those with memory complaints. However, their... | PMC10447509 | |
Objectives | memory complaints | To investigate the combined effect of EPA/DHA and cocoa flavanols (OM3FLAV) on cognitive performance and brain structures in older adults with memory complaints. | PMC10447509 | |
Methods | cognitive impairment | A randomized placebo-controlled trial of DHA-rich fish oil (providing 1.1 g/d DHA and 0.4 g/d EPA) and a flavanol-rich dark chocolate (providing 500 mg/d flavan-3-ols) was conducted in 259 older adults with either subjective cognitive impairment or mild cognitive impairment. Participants underwent assessment at baselin... | PMC10447509 | |
Results | TG, alertness | 197 participants completed the study. The combined intervention had no significant effect on any cognitive outcomes, with the exception of reaction time variability (P = 0.007), alertness (P < 0.001), and executive function (P < 0.001), with a decline in function observed in the OM3FLAV group (118.6 [SD 25.3] at baseli... | PMC10447509 | |
Conclusions | cognitive impairment | These results suggest that cosupplementation with ω-3 PUFAs and cocoa flavanols for 12 mo does not improve cognitive outcomes in those with cognitive impairment.This trial was registered at | PMC10447509 | |
Keywords | PMC10447509 | |||
Abbreviations | Alzheimer’s diseaseblueberry powderbrain-derived neurotrophic factorbasal metabolic rateCognitive AgeingCDREFFLAVFOLPCMCIMoCAPCPPSCISwinburne University of TechnologyUniversity of East Anglia | PMC10447509 | ||
Introduction | dementia | SEPARATION | At a population level, interventions that delay the onset of dementia by 2 y are predicted to reduce the number of dementia patients by 20% [Investigations in model systems add validity to the prospective cohort evidence. Furthermore, they provide insights into the molecular and physiological mechanisms underlying long... | PMC10447509 |
Subjects and Methods | The study protocol and methods have been described in detail elsewhere [ | PMC10447509 | ||
Ethics | The conduct, evaluation, and documentation of this study abide by Good Clinical Practice guidelines and the guiding principles of the Declaration of Helsinki. The study was approved by the Bellberry Human Research Ethics Committee (Study ID: 2015-03-227) and Swinburne University Human Research Ethics Committee (SHR Pro... | PMC10447509 | ||
Study design and participants | MCI | RECRUITMENT | The CANN trial was a 12-mo randomized placebo-controlled parallel study with 2 intervention arms. There were 2 recruitment sites, the UEA (Norwich, UK) and SUT (Melbourne, Australia), with MRI analyzed centrally at the University of Illinois (Urbana Champaign, Urbana, IL, United States). Participants were asked to atte... | PMC10447509 |
Intervention, assignment to group, and blinding | Participants were asked to consume 3 × 1 g oil capsules and 33 g of chocolate drops of either test or control products daily with the main meal of the day. The test capsules provided 1.1 g DHA and 0.4 g EPA per day in triglyceride form. The control capsules contained a blend of 80% palm oil and 20% corn oil to deliver ... | PMC10447509 | ||
Cognitive outcomes | Bracket | As described previously, cognition was assessed at each clinical visit using the CDR computerized assessment system (Bracket Cognition), the MoCA, the Delis–Kaplan Executive Function System, the Verbal Fluency Test (0 and 12 mo only), and the iPosition task. Paper-and pencil Bond-Lader Visual Analogue Scale of Mood and... | PMC10447509 | |
MRI | APPENDIX | A subset of participants, representative of the full group, at both trial sites completed a neuroimaging session at baseline and 12 mo. Here, we report volumetric measures of brain structure in this neuroimaging subset derived from T1-weighted anatomical scans acquired at both sites. Further imaging modalities acquired... | PMC10447509 | |
Biological sample collection and analysis | Participants provided an overnight fasted blood sample and a spot urine sample that was their first void of the day.For FLAV and methylxanthine analyses, the metabolites were purified from 50 μL human urine by 96-well plate solid phase extraction (Strata™-X Polymeric Reversed Phase, microelution 2 mg/well). The solid p... | PMC10447509 | ||
Dietary assessment | Cancer | CANCER | Assessment of diet at baseline and 12 mo was conducted using a 130-item The European Prospective Investigation into Cancer and Nutrition FFQ [ | PMC10447509 |
Statistical analyses and sample size estimation | The sample size estimate has been detailed previously [All non-MRI analyses were conducted by ANCOVA using mixed models for repeated measures with SAS PROC MIXED. INTERVENTION was fitted as a fixed between-group factor (2 levels: intervention or control group). For non-MRI data, change from baseline was calculated for ... | PMC10447509 | ||
Results | PMC10447509 | |||
n-3 PUFA and FLAV response to intervention | PC 38:5 | As anticipated, OM3FLAV intervention resulted in a significant increase in NEFA EPA and DHA and LPC EPA and DHA, along with PC 38:5, PC 38:6, and PC 40:6 fractions (Plasma n-3 PUFA, and urinary flavonoids at baseline and in response to interventionData are mean (SD); ANCOVA using mixed models for repeated measures, wit... | PMC10447509 | |
Primary outcome measure | No significant impact of intervention on picture recognition performance was evident, with mean (SD) of 85.1 (1.3)% and 85.6 (1.4)% at baseline and 12 mo, respectively (Picture recognition new stimuli accuracy (%) at baseline and following 3 mo or 12 mo of a DHA-rich fish oil and cocoa flavanol mixture (OM3FLAV; | PMC10447509 | ||
Secondary cognitive outcome responses | SECONDARY | There was no significant effect of the intervention on any of the secondary composite or individual cognitive outcomes, with the exception of reaction time variability (Cognitive secondary endpoints and response to intervention as per protocol analysisData are mean (SD); ANCOVA using mixed models for repeated measures.... | PMC10447509 | |
Brain volumes | white matter volume | The baseline MRI data in the group as a whole (Structural MRI assessment of (A) hippocampal volume; (B) cortical volume; (C) cortical white matter volume; and (D) ventricular volume following 12-mo consumption of a DHA-rich fish oil and cocoa flavanol mixture (OM3FLAV; | PMC10447509 | |
Plasma biochemistry | The intervention decreased plasma triglyceride levels by 22% in the OM3FLAV group by 3 mo, with no change in the control group (Plasma biochemistry at baseline and in response to interventionData are mean (SD); ANCOVA using mixed models for repeated measures, with change from baseline (ie, 3 mo-0 mo and 12 mo-0 mo) fit... | PMC10447509 | ||
Dietary data | Habitual intakes of oily fish (main dietary source of EPA and DHA), total flavonoids and flavan-3-ol were 0.724 portions per week, 842 mg/d and 193 mg/d respectively, with no baseline difference between groups (Nutrient intake (derived from the Food Frequency Questionnaire) at baseline and 12 moData are mean (SD); Inte... | PMC10447509 | ||
Discussion | memory deficits, MCI, dementia, atrophy, cognitive impairments, cognitive decline, OM3FLAV | SECONDARY, ATROPHY, INSULIN SENSITIVITY, CORTEX | The current study provides the first long-term data to suggest that supplementation with long-chain ω-3 fatty acids and FLAVs over 1 y does not improve cognitive function or brain volumes in individuals with subjective and objective cognitive impairments. The combined dietary intervention resulted in the expected sever... | PMC10447509 |
References | PMC10447509 | |||
Author contributions | The authors’ responsibilities were as follows –; AMM, AS, NJC, AC, DV: designed the research; DJW, MI, RG, RK: delivered the clinical trial; AS, NJC, HS: designed the cognitive assessment strategy; CK: designed and managed the flavonoid metabolite analysis of the urine samples; MK: undertook the lipidomic analysis unde... | PMC10447509 | ||
Conflict of interest | DJW has received research funding from Arla Foods, Bayer Healthcare, and Fonterra and consultancy/speaker honoraria from Neurobrands, Naturex, and Bayer Healthcare. AS has received research funding from: Abbott Nutrition, Arla Foods, Bayer, DuPont, Fonterra, GlaxoSmithKline, Nestlé, Nutricia-Danone, and Sanofi. He has ... | PMC10447509 | ||
Funding | The research was funded in part by | PMC10447509 | ||
Data availability | Data described in the manuscript, code book, and analytic code will be made available upon request pending application and approval. | PMC10447509 | ||
Supplementary data | The following is the Supplementary data to this article: | PMC10447509 | ||
Multimedia component1 | PMC10447509 | |||
Acknowledgments | We acknowledge the large contribution by our colleague and friend Prof Keith Wesnes, who sadly died in 2020. Keith was largely responsible for the statistical analysis planning and execution of the CANN study. We thank our nursing and other support staff at our clinical research facilities at the University of East Ang... | PMC10447509 | ||
Background | Type 2 diabetes, impairments in cognitive function, T2DM | TYPE 2 DIABETES | Type 2 diabetes (T2DM) and poor glucose regulation in the immediate postprandial period are both associated with impairments in cognitive function. There is evidence that foods that generate a better postprandial glycemic response, such as low GI foods (which produce a lower glycemic peak, less variability, and a more ... | PMC10206291 |
Objectives | noninsulin-dependent T2DM | The primary aim of this research was to investigate whether a multimeal paradigm producing a low glycemic response was associated with cognitive benefits in patients with noninsulin-dependent T2DM relative to a multimeal paradigm producing a high glycemic response. | PMC10206291 | |
Methods | noninsulin-dependent T2DM | Twenty-five adults with noninsulin-dependent T2DM (mean age: 57 y) consumed 2 multimeal profiles consisting of a breakfast, lunch, and afternoon snack on 2 separate test days following a randomized, counterbalanced, crossover design. The 2 conditions were a low GI profile (LGIP) and a high GI profile (HGIP). | PMC10206291 | |
Results | satiety, cognitive and executive functions | Cognitive function, glycemic response, mood, and satiety were assessed over the day from 8:30 to 17:00. Overall, there were limited cognitive effects. However, there was evidence for cognitive benefits in the period before lunch, as demonstrated by better global cognitive and executive functions for the LGIP relative t... | PMC10206291 | |
Conclusions | T2DM | This study shows that a multimeal paradigm producing a low glycemic response was associated with some benefits for cognitive function in patients with T2DM. | PMC10206291 | |
Clinical Trail Registry reference | NCT03360604 (clinical | PMC10206291 | ||
Keywords | PMC10206291 | |||
Abbreviations | DIABETES | blood-brain barrierchoice reaction timedynamic cerebral autoregulationdependent variableglobal cognitive performancehigh GIhigh GI profilelow GIlow GI profilerapid visual information processingtype 2 diabetes | PMC10206291 | |
Introduction | cognitive impairments, cognitive effect [Cognitive function, T2DM | SECONDARY, TYPE 2 DIABETES | Given that glucose is the main fuel for the brain, it is perhaps not surprising that conditions that are associated with abnormalities in glucose regulation, such as type 2 diabetes (T2DM), are associated with cognitive impairments [Interestingly, dietary intervention studies that have investigated the link between gly... | PMC10206291 |
Method | PMC10206291 | |||
Participants | T2DM | Twenty-five adults with a medical diagnosis of T2DM were recruited through a local advertisement at the University of Reading and the surrounding areas. These included 17 men and 8 women, with a mean age of 56.9 y (SD = 7.8), a mean BMI of 30.6 kg/m | PMC10206291 | |
Design | sleepiness, meal carbohydrate | The study followed a counterbalanced, randomized, crossover design with 2 nutritional interventions that produced 2 different glycemic profiles (2 conditions); (1) a low GI profile (LGIP) and (2) a high GI glycemic profile (HGIP). Both conditions consisted of breakfast, lunch, and an afternoon snack (details below), an... | PMC10206291 | |
Procedure | Diabetes | BLOOD, DIABETES | All exclusion criteria were checked with a self-report questionnaire which participants completed and returned by e-mail prior to a screening session. A 1-h screening session was arranged for the morning at the Hugh Sinclair Unit of Human Nutrition, University of Reading, when height and weight were measured with a Tan... | PMC10206291 |
Cognitive function | alertness | The cognitive task battery was administered with E-Prime 2.0 (Psychology Software Tool, Inc). There were 4 separate cognitive tasks: CRT, Rapid Visual Information Processing (RVIP), a merged CRT-RVIP task, and Letter Memory. The CRT task was a measure of general alertness and psychomotor speed. For each trial, a fixati... | PMC10206291 | |
Glycemic response | Diabetes | DIABETES | Glucose concentrations were measured using a FreeStyle Libre continuous glucose monitoring system (Abbott Diabetes Care Inc). The sensor automatically measured interstitial glucose concentrations every minute and stored readings at 15-min intervals for 8 h. The data was wirelessly transmitted to the reader held by the ... | PMC10206291 |
Subjective mood and satiety | The Bond-Lader mood questionnaire [ | PMC10206291 | ||
Analysis | Linear mixed models were used for all analyses. For glycemic response, the independent variables condition (LGIP and HGIP) and time (22-time points) were included as fixed factors, with the following covariates included as fixed factors; sex, age, BMI, baseline glucose, and baseline DV score. Baseline glucose was the f... | PMC10206291 | ||
Results | Background characteristics according to the randomization sequence for this crossover trial are shown in Baseline characteristics of participants by randomization sequence (either LGIP first and HGIP second or HGIP first and LGIP second) data are means and SELGIP, low GI profile; HGIP, high GI profile. | PMC10206291 | ||
Glycemic response | BLOOD | As shown in Blood glucose concentrations (mmol/L) for the low GI profile (LGIP) and the high GI meal profile (HGIP) for the test day following breakfast ( | PMC10206291 | |
Mood and satiety | sleepiness | As shown in Subjective ratings of hunger (A) and sleepiness (B) for the low GI profile (LGIP) and the high GI meal profile (HGIP) ( | PMC10206291 | |
Discussion | cognitive and executive functions, cognitive impairment, noninsulin-dependent T2DM, prediabetes, cognitive or mood effects of the meal profiles, sleepiness, cognitive and mood benefits, satiety, T2DM | EFFECTS LATE, PREDIABETES, OTHER METABOLIC DISORDERS | The aim of this study was to explore the cognitive effects of a multimeal paradigm that produced an LGI response over the course of the day relative to meals which produced an HGI response in patients with noninsulin-dependent T2DM. Overall, there were no cognitive effects for 7 of the 9 cognitive performance measures.... | PMC10206291 |
Author contribution | The authors’ responsibilities were as follows–MG, DL, and JL: designed the research; MG and DL: wrote the manuscript; JL: edited the manuscript; MG: collected and analyzed the data; and all authors: read and approved the final manuscript. | PMC10206291 | ||
Conflict of intrest | The authors report no conflicts of interest. | PMC10206291 | ||
Data Availability | Data described in the manuscript will be made available upon request to the corresponding author | PMC10206291 | ||
Funding | The authors reported no funding was received for this study. | PMC10206291 | ||
References | PMC10206291 | |||
Background | hemorrhagic transformation, reperfusion injury, acute ischemic stroke, HT | Cerebrolysin could mitigate reperfusion injury and hemorrhagic transformation (HT) in animal models of acute ischemic stroke. | PMC10041692 | |
Methods | Stroke, HT | SECONDARY, STROKE | This was a prospective, randomized, open-label, parallel-group with active control, multicenter pilot study. Cerebrolysin (30 mL/day over 14 days) was administered concurrently with alteplase (0.9 mg/kg) in 126 patients, whereas 215 control patients received alteplase alone. The primary outcomes were the rate of any an... | PMC10041692 |
Results | Cerebrolysin treatment resulted in a substantial decrease of the symptomatic HT rate with an odds ratio (OR) of 0.248 (95% CI: 0.072–0.851; | PMC10041692 | ||
Conclusions | neurological deficit, HT | Early add-on of Cerebrolysin to reperfusion therapy was safe and significantly decreased the rate of symptomatic HT as well as early neurological deficit. No effect on day 90 functional outcome was detected. Improvements in the imaging metrics support the neuroprotective and blood–brain barrier stabilizing activity of ... | PMC10041692 | |
Trial registration | Name of Registry: ISRCTN.Trial Registration Number: Trial Registration Date: 16/02/2021. | PMC10041692 | ||
Keywords | PMC10041692 | |||
Introduction | neuroinflammation, stroke, AIS, HT, excitotoxicity, rtPA, acute ischemic stroke | STROKE, SECONDARY | Intravenous thrombolysis (IVT) within 4.5 h after acute ischemic stroke (AIS) substantially improves functional outcome [A plethora of experimental stroke models have demonstrated neuroprotective effects of Cerebrolysin and its ability to attenuate blood–brain barrier (BBB) permeability [In our current study, we looked... | PMC10041692 |
Methods | EMERGENCY | CEREHETIS was a prospective, randomized, open-label, active control, multicenter, parallel-group phase IIIb pilot study. The patients were enrolled across 8 centers in Russia – the Interregional Clinical Diagnostic Center (Kazan), Municipal Clinical Hospital #7 (Kazan), Kazan Federal University Hospital (Kazan), Perm T... | PMC10041692 | |
Inclusion and exclusion criteria | arteriovenous malformation, bleeding, Gastrointestinal or genitourinary bleeding, Stroke, stroke, Seizure, intracranial aneurism, brain abscess, liver and kidney failure)• Known, neoplasm, HT, rtPA, head trauma, allergic reactions, trauma | BLEEDING, STROKE, ACUTE MYOCARDIAL INFARCTION, INTRACRANIAL HEMORRHAGE, STROKE, INFECTIVE ENDOCARDITIS, BRAIN TUMOR, ALLERGIC REACTION, BRAIN ABSCESS, ISCHEMIC STROKE, DISORDERS, SUBARACHNOID HEMORRHAGE, PERICARDITIS, NEOPLASM, ACUTE PANCREATITIS, BLOOD, DUODENAL ULCER, BLEEDING DIATHESIS | Main inclusion and exclusion criteria are outlined in Table Inclusion and exclusion criteria
• Confirmed diagnosis of acute ischemic stroke• Age ≥ 18 years• Onset of stroke symptoms within 4.5 h before initiation of rtPA administration
• Current or previous intracranial hemorrhage• Symptoms suggestive of subarachnoid h... | PMC10041692 |
Randomization and blinding | SECONDARY, RECRUITMENT | Each eligible patient was randomly assigned into either the Cerebrolysin or control group by simple randomization procedure. One randomization list for all centers was issued by generating Bernoulli variates with the probability parameter of 0.333. The Mersenne twister was used as an active generator and the starting p... | PMC10041692 | |
Study treatment | stroke, death | STROKE | Both groups received a standard dose of 0.9 mg/kg rtPA (alteplase) administered intravenously within 4.5 h after symptom onset (maximal dosage 90 mg, 10% of the drug given in bolus and the rest in 60 min via intravenous infusion). In addition, measures of standard care for AIS patients were applied for both groups. Pat... | PMC10041692 |
Study procedures | stroke, Stroke | STROKE, STROKE | At the time of admission (day 0), the screening and baseline assessment was performed. Routine clinical, laboratory, and imaging data were collected. Follow-up visits were scheduled in 24 h (day 1, visit 1), on day 7 (visit 2), 14 (visit 3) and 90 (visit 4).The National Institutes of Health Stroke Scale (NIHSS) score w... | PMC10041692 |
Outcome measures | neurologic deterioration, death, liver and kidney function, HT | ADVERSE EVENTS | The study primary endpoints were any and symptomatic HT verified on a follow-up CT scan from day 0 to day 14. Symptomatic HT was defined according to the ECASS III trial: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration, as defined by an increase of 4... | PMC10041692 |
Advanced brain imaging procedures | infarct | INFARCT | On day 1 and 14, a routine brain MRI was acquired followed by an axial DTI scan. The MRI exam was performed on a GE Signa HDx 1.5 T scanner (GE Healthcare, USA). The DTI sequence parameters were as follows: spin-echo echo-planar imaging, repetition time = 6000 ms, echo time = 102.9 ms, field of view = 260 mm, b-value =... | PMC10041692 |
Statistical analysis | REGRESSION | Sample size calculation was performed by means of power analysis for matched case–control studies [The estimated number of subjects needed for the advanced brain imaging analysis, computed by power analysis for a two-sample means test [Once the desired sample size of 264 participants had been achieved, it became clear ... | PMC10041692 | |
Results | stroke, hypertension, HT | INTRACRANIAL HEMORRHAGE, STROKE, ATRIAL FIBRILLATION, DIABETES MELLITUS, REGRESSION, HYPERTENSION | Of 1,117 assessed patients with AIS who were eligible for IVT, 341 subjects were recruited and constituted the ITT population. Twenty-three participants (6.7%) did not complete the study with the dropout rate being equal between the groups. Thus, 318 patients formed the dataset for PP analysis (Fig. CONSORT flow chartA... | PMC10041692 |
Primary endpoints | stroke, hypertension, HT | REGRESSION, STROKE, HYPERTENSION | In both arms, HT occurred mostly within 24 h after IVT. In the ITT population, Cerebrolysin set a favorable trend to lower any HT with a rate of 15.9% versus 23.3% in the control group and a corresponding OR of 0.543 (95% CI: 0.281–1.05; Study endpointsLikewise, Cerebrolysin treatment resulted in a substantial decrease... | PMC10041692 |
Secondary endpoints | agitation, HT | SIDE EFFECT | The percentage of patients with a favorable functional outcome was approximately the same in both groups. Early neurological recovery on day 14 was more noticeable in the Cerebrolysin group. However, the difference disappeared in patients with HT (Table Secondary endpoint. Modified Rankin Scale score on day 90. No seri... | PMC10041692 |
Advanced brain imaging | infarct | INFARCT | A total number of patients included in the advanced brain imaging analysis was 33 (Fig. Baseline characteristics (No differences in the DTI metrics and DWI infarct volume between the groups were observed on day 1 (Table DTI data, day 1However, patients treated with Cerebrolysin showed a significant improvement of their... | PMC10041692 |
Discussion | post-stroke, axonal and myelin damage, stroke, AIS, neurological deficit, HT, rtPA, intracranial hemorrhagic | DRUG-DRUG INTERACTION, STROKE, SECONDARY, EVENTS | The results of this randomized, open-label, multicenter pilot trial in stroke patients demonstrate beneficial effects of Cerebrolysin as an early add-on to IVT on the primary (the rate of symptomatic HT) and secondary (early neurological recovery) endpoints. Although we found a significant improvement in the DTI and PS... | PMC10041692 |
Conclusions | neurological deficit, HT | Early add-on of Cerebrolysin to reperfusion therapy was safe and significantly decreased the rate of symptomatic HT as well as early neurological deficit. However, no significant effect on day 90 functional outcome was detected. Improvements in the imaging metrics of the infarcted area support the neuroprotective and B... | PMC10041692 | |
Acknowledgements | EMERGENCY | This study would not have been possible without the CEREHETIS investigators: Chauzov E.I., Nizhnekamsk District Hospital, Nizhnekamsk, Russia; Faskhutdinova A.T., Kazan Federal University Hospital, Kazan, Russia; Khastiev R.M., Arsk District Hospital, Arsk, Russia; Kulesh A.A., Perm Territorial Clinical Hospital, Perm,... | PMC10041692 | |
Authors’ contributors | DRK: project design and execution, analysis, interpretation, manuscript review. MNK: project design and execution, manuscript preparation and review, data acquisition, analysis, interpretation. All authors have read and approved the manuscript. | PMC10041692 | ||
Funding | This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. | PMC10041692 | ||
Availability of data and materials | The datasets acquired and analyzed for this study are available from the corresponding author upon reasonable request. | PMC10041692 | ||
Declarations | PMC10041692 | |||
Ethics approval and consent to participate | This study was approved by the Local Ethics Committee of the Interregional Clinical Diagnostic Center, Kazan, Russia (Protocol #81 of 04/24/2018). However, there was a change in the list of the study centers after that approval, and the final version of the study protocol was issued on 04/30/2018. The amendment did not... | PMC10041692 | ||
Consent for publication | Not applicable. | PMC10041692 | ||
Competing interests | The authors declare that there is no conflict of interest. | PMC10041692 | ||
References | PMC10041692 | |||
2. Patients and Methods | PMC10055796 |
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