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Acknowledgements | The authors thank the study participants and their families, and the staff at all study centers. Research was sponsored by Takeda Development Center Americas, Inc. (TDCA), Lexington, MA, USA. The authors acknowledge Marcel Kuttab, PharmD, and LaVerne Mooney, DrPH, of Takeda Development Center Americas, Inc. (TDCA), for... | PMC10068631 | ||
Author contributions | JP | RK aided with conceptualization, formal analysis, supervision, methodology, validation, resources, investigation, project administration, visualization and writing the original draft. ADL assisted with supervision and investigation. AP contributed to the conceptualization, supervision, methodology and investigation. DP... | PMC10068631 | |
Funding | This work was supported by funding from Takeda Development Center Americas, Inc. (TDCA), Lexington, MA, USA. | PMC10068631 | ||
Data availability | The datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participants’ data supporting the results reported in this article, will be made available within 3 months from initial request, to researchers who provide a methodologically sound proposal. The data will be provided... | PMC10068631 | ||
Declarations | PMC10068631 | |||
Conflict of interest | Hutchinson Medipharma LTD, MPM, P. | ONCOLOGY | R. Kim reports honoraria fees from Pfizer and QED; and consulting fees from Incyte, Bayer, and Taiho. A. D. Leal reports employment with ClinicalPath Oncology, as a Pancreatic/Neuroendocrine Committee Chair; and research funds from Bristol Myers Squibb (Institution, Exelixis (Institution), Arrys Therapeutics, Inc. (Ins... | PMC10068631 |
Ethics approval | The study was conducted with the highest respect for the participants according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the International Conference on Harmonization Tripartite Guideline for Good Clinical Practice. The protocol was approved by the relevant cent... | PMC10068631 | ||
Consent to participate | All patients provided written informed consent. | PMC10068631 | ||
Consent for publication | Since all data are anonymized before publication, no additional consents were obtained. | PMC10068631 | ||
References | PMC10068631 | |||
Background | heart failure, HF | HEART FAILURE | Functional training may be an effective non-pharmacological therapy for heart failure (HF). This study aimed to compare the effects of functional training with strength training on peak VO | PMC10386700 |
Methods | A randomized, parallel-design and examiner-blinded controlled clinical trial with concealed allocation, intention-to-treat and per-protocol analyses. Twenty-seven participants with chronic HF were randomly allocated to functional or strength training group, to perform a 12-week physical training, three times per week, ... | PMC10386700 | ||
Results | Participants were aged 60 ± 7 years, with left ventricular ejection fraction 29 ± 8.5%. The functional and strength training groups showed the following results, respectively: peak VO | PMC10386700 | ||
Conclusions | Functional and strength training are equally effective in improving peak VO | PMC10386700 | ||
Trial registration | NCT03321682. Registered date: 26/10/2017. | PMC10386700 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12872-023-03404-7. | PMC10386700 | ||
Keywords | PMC10386700 | |||
Background | heart failure, HF, increased disability, muscular mass | HEART FAILURE | Reduced tolerance to exercise is a symptom of heart failure (HF) and it is associated with increased disability and mortality [Individuals with HF show a 30% decrease in their ability to perform daily activities compared to healthy individuals, which is attributed to reduced muscular mass and decreased VOIn this contex... | PMC10386700 |
Methods | This is a randomized, parallel-design, 1:1 ratio allocation, examiner-blinded controlled clinical trial with concealed allocation [ | PMC10386700 | ||
Participants | acute myocardial infarction, impaired cognitive status, valvular heart diseases, musculoskeletal disorders, asymmetric septal hypertrophic cardiomyopathy | ACUTE MYOCARDIAL INFARCTION, CARDIAC ARRHYTHMIAS, VALVULAR HEART DISEASES, MUSCULOSKELETAL DISORDERS, HEART | Individuals of both genders, aged ≥ 40 years, were recruited from the outpatient cardiology clinic of a tertiary public hospital in southern Brazil. The inclusion criteria were: clinically stable HF (ischemic and non-ischemic) for at least three months before randomization, diagnosed according to clinical records; New ... | PMC10386700 |
Training program | The participants were randomly allocated either to an experimental group (functional training group – FTG) or to an active comparator group (strength training group – STG). Each training consisted of 12 weeks, performed three times per week, totaling 36 sessions. The exercises were modified every 12 sessions and the pa... | PMC10386700 | ||
Outcomes | The outcomes were assessed by a blinded examiner at the end of the 12 weeks of both physical trainings. Baseline demographic and clinical information – age, gender, HF etiology, left ventricle ejection fraction, and NYHA functional class – were obtained from electronic health records. | PMC10386700 | ||
Measurement of primary outcomes | Heart Failure | HEART FAILURE | Peak VOQuality of life was assessed by the Minnesota Living with Heart Failure Questionnaire, a disease-specific instrument. Total score ranges from zero to 105 points, with low scores reflecting a better health-related quality of life [ | PMC10386700 |
Measurement of secondary outcomes | JAMAR | DILATION, VASODILATION | Functionality was evaluated by the Duke Activity Status Index (DASI) and the gait speed test. The DASI ranges from zero to 58.2 points, with a higher score representing a better functional capacity [The hand grip dynamometer (JAMAR®, Sammons Preston, Inc., Bolingbook, IL, USA) was used to evaluate peripheral muscular s... | PMC10386700 |
Sample size | A total sample size of 32 participants was estimated (16 in each study group), considering an 80% power, 5% significance level, a correlation of 0.7 among repeated measures, and a small effect size | PMC10386700 | ||
Randomization | Random allocation was determined by 10 blocks of 4 participants (Software Rx64 version 3.1.1), generated by an external researcher. Allocation concealment was implemented through a central randomization routine conducted by investigators with access to the randomized list and the investigator charged with requesting th... | PMC10386700 | ||
Statistical analyses | SECONDARY | Descriptive statistical analysis using mean and standard deviation was used initially, followed by testing of normality by the Shapiro–Wilk test. Fisher’s exact test, Yates’ chi-squared test and Student’s t-test were used to compare the groups at baseline. Differences within groups (mean and standard deviations) and be... | PMC10386700 | |
Discussion | HEART, SCHMIDT | To our knowledge, this is the first randomized clinical trial aimed at evaluating the effects of functional training in individuals with HF. We compared functional training to strength training due to similarities between both physical modalities and because the latter is traditionally recommended by the American Colle... | PMC10386700 | |
Conclusion | Our study showed that functional training and strength are equally effective in improving oxygen consumption, quality of life, and functionality of individuals with HF. Our findings suggest that functional training may be a promising and innovative exercise-based strategy to treat HF. Future research is needed to bette... | PMC10386700 | ||
Acknowledgements | Not applicable. | PMC10386700 | ||
Authors’ contributions | DMN and BDS were responsible for the study’s rationale and generated the operating hypothesis for the study. DMN, PMB, ADS, MALS, LAG, NOC and BDS made major contributions for the protocol manuscript. DMN, KCM, PMB, ADS, MALS, LAG, NC and BDS contributed in intellectual, organizational and logistic frameworks for data ... | PMC10386700 | ||
Funding | The study was supported by FIPE (Fundo de Incentivo à Pesquisa e Eventos, Hospital de Clinicas de Porto Alegre), IATS (Instituto de Avaliação de Tecnologia em Saúde) and CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico). DMN received doctoral funding support from CAPES (Coordenação de Aperfeiçoamento... | PMC10386700 | ||
Availability of data and materials | We support the reuse of scholarly data and intend that the collected data in this trial may contribute beyond our actions to the knowledge on exercise and non-pharmacological management of HF. First, we provided in writing the final results of the research for each participant. Second, we have obtained ethical consent ... | PMC10386700 | ||
Declarations | PMC10386700 | |||
Ethics approval and consent to participate | The study procedures were approved by the research ethics board from the Hospital de Clínicas de Porto Alegre on 8 August, 2017 (protocol no. 20170291). The informed consent document includes the objectives of the study, a description of the testing procedures, explanation about interventions and its randomized allocat... | PMC10386700 | ||
Consent for publication | Not applicable. | PMC10386700 | ||
Competing interests | The authors declare no competing interests. | PMC10386700 | ||
References | PMC10386700 | |||
Introduction | Various nursing models are usually employed to achieve self-management and improve the quality of life in chronic conditions. Given its person-based characteristics, the 5 A nursing model can improve the quality of life of hemodialysis patients. | PMC10017059 | ||
Purpose | This study aimed to determine the role of a self-management program based on the 5 A nursing model in the quality of life of patients undergoing hemodialysis. | PMC10017059 | ||
Materials and methods | This clinical trial was conducted on hemodialysis patients in Iran. Random sampling was adopted to assign 60 patients to intervention and control groups. After the participants completed a demographic questionnaire and the | PMC10017059 | ||
Findings | renal complications | There were significant differences after the intervention between the intervention and control groups in specific dimensions of quality of life, such as cognitive functions, symptoms, sleep, dialysis, social support, and renal complications (P < 0.05). The two groups also had significant differences in the general scor... | PMC10017059 | |
Conclusion | The 5 A self-management intervention as a person-based model could improve self-care in hemodialysis patients. Nurses can implement this model to mitigate care costs, enhance interventions, and improve patients’ quality of life. | PMC10017059 | ||
Trial registration | Iranian Registry of Clinical Trials (IRCT20211103052955N1; 19/11/2021). | PMC10017059 | ||
Keywords | PMC10017059 | |||
Introduction | nausea, headaches, renal failure, vomiting, blood pressure disorders, muscle cramps, skin irritation, insomnia, chronic kidney failure, Chronic kidney disease, diabetes | VASCULAR COMPLICATIONS, RENAL FAILURE, ACUTE CORONARY SYNDROME, CHRONIC KIDNEY FAILURE, HYPERTENSION, CHRONIC KIDNEY DISEASE, COMPLICATIONS, DIABETES | Chronic kidney disease is a public health threat worldwide. The global prevalence of chronic kidney failure is 262 cases per one million. Hemodialysis patients experience various side effects such as insomnia, skin irritation, headaches, blood pressure disorders, vascular complications, muscle cramps, itches, nausea, a... | PMC10017059 |
Methods and materials | PMC10017059 | |||
Design and setting | This parallel-group randomized clinical trial was conducted in the Dialysis Center of Imam Ali Hospital, affiliated with Ahvaz Jundishapur University of Medical Sciences in Khuzestan Province, Iran, in 2021–2022 (Iranian Registry of Clinical Trials; IRCT20211103052955N1; 19/11/2021). | PMC10017059 | ||
Participants | Alzheimer’s disease, cognitive disorders | DISORDERS | In this trial, the convenience sampling method was adopted to select 60 patients undergoing hemodialysis. The inclusion criteria were literacy, no history of psychological disorders, age of 18 to 65 years old, and no history of cognitive disorders such as Alzheimer’s disease. The participants were randomly assigned to ... | PMC10017059 |
Intervention | The intervention group received a self-management program based on the 5 A model, which was implemented in five stages through face-to-face meetings, phone calls, and SMSs in three months. Figure
The 5 A model algorithm
The 5 A Model Steps in Hemodialysis Patients | PMC10017059 | ||
Data Collection | A three-section tool was employed for data collection. The first section gathered data on clinical and demographic variables such as age, gender, educational attainment, and hemodialysis treatment duration. The second section comprised the | PMC10017059 | ||
Data Analysis | Data analysis was performed in SPSS 18 at a significance level of 0.05 using the independent | PMC10017059 | ||
Results | COMPLICATIONS | The age variable is expressed separately as mean and standard deviation for the control and intervention groups. The average age was 52.83 ± 8.71 years in the control group and 52.66 ± 9.23 years in the intervention group, without a statistically significant difference (P = 0.943).The findings indicated that most patie... | PMC10017059 | |
Discussion | HYPERTENSION, COMPLICATIONS, ACUTE CORONARY SYNDROME | This study aimed to determine the role of a self-management program based on the 5 A nursing intervention model in the quality of life of hemodialysis patients. According to the findings, there were significant differences between the two groups after the intervention regarding the specific dimensions of life quality, ... | PMC10017059 | |
Acknowledgements | This study was adapted from a master’s thesis in nursing funded by Ahvaz Jundishapur University of Medical Sciences (IR.AJUMS.REC.1400.465). | PMC10017059 | ||
Authors’ contribution | All authors countributed in all stages and reviewed and approved the final manuscript. | PMC10017059 | ||
Funding | This study was funded by Ahvaz Jundishapur university of medical sciences. | PMC10017059 | ||
Data Availability | The datasets used during the current investigation are available from the corresponding author on reasonable request. | PMC10017059 | ||
Declarations | PMC10017059 | |||
Conflict of interest | According to the authors, this paper has no conflicts of interest. | PMC10017059 | ||
Ethical consideration | This study was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (IR.AJUMS.REC.1400.465) (Iranian Registry of Clinical Trials; IRCT20211103052955N1; 19/11/2021). This trial was conducted in accordance with the Declaration of Helsinki, and written informed consent forms were received f... | PMC10017059 | ||
Consent for publication | Not applicable. | PMC10017059 | ||
References | PMC10017059 | |||
Abstract | Increasing skeletal muscle carnitine content can manipulate fuel metabolism and improve exercise performance. Intravenous insulin infusion during hypercarnitinemia increases plasma carnitine clearance and Na
| PMC9938004 | ||
INTRODUCTION | Carnitine primarily exists within skeletal muscle where it is a crucial cofactor for the rate limiting step of fat oxidation and as a buffer to maintain oxidative flux through the pyruvate dehydrogenase complex (PDC) at times of high glycolytic demand (e.g., high intensity exercise) (Stephens, Constantin‐Teodosiu, & Gr... | PMC9938004 | ||
METHODS | PMC9938004 | |||
Ethics statement | The study was approved by the Department of Sport and Health Sciences, University of Exeter's Research Ethics Committee (reference: 180207/B/01) in accordance with the latest Declaration of Helsinki (version October 2013). All participants were informed on the nature and risks of the experiment before written informed ... | PMC9938004 | ||
Participants | Six healthy, young, omnivorous adults (4 males and 2 females, age 24 ± 2 years, body mass 68 ± 5 kg, height 173 ± 4 cm, BMI 23 ± 1 kg/m | PMC9938004 | ||
Experimental protocol | In a randomized, placebo‐controlled, double‐blind (for both participant and experimenter and for both caffeine and carnitine administrations) trial, participants arrived at the laboratory on three occasions at 11:00 having followed a controlled diet the evening prior (900 kcals; 20/25/55% fat/protein/CHO, respectively)... | PMC9938004 | ||
Sample analyses | Arterialized venous blood samples | Arterialized venous blood samples were immediately analyzed for blood glucose and lactate (YSI 2300 STATplus, YellowSprings Instruments), and Na | PMC9938004 | |
Statistics | All data are expressed as mean ± SD. Data were analyzed using repeated measures two‐way ANOVAs (time | PMC9938004 | ||
RESULTS | PMC9938004 | |||
Plasma variables | Plasma caffeine (a) and carnitine (b) concentrations are displayed in Figure Plasma caffeine (a) and free carnitine (b) concentrations at baseline (i.e., 0 min) and throughout 5 h primed and continuous intravenous infusions of saline (CAFF) or Plasma carnitine concentrations were also comparable across conditions at ba... | PMC9938004 | ||
Blood variables | BLOOD | Blood KBlood potassium (KBlood glucose (a) and lactate (b) concentrations at baseline (i.e., 0 min) and throughout 5 h primed and continuous intravenous infusions of saline (CAFF) or | PMC9938004 | |
DISCUSSION | hyperinsulinemia | HYPERINSULINEMIA | In the present study, we reasoned that caffeine ingestion would stimulate NaWe have previously demonstrated that hypercarnitinemia combined with hyperinsulinemia (achieved via intravenous infusion of insulin [105 mU·mWhile the plasma carnitine concentration achieved in the present study is around fivefold higher than t... | PMC9938004 |
AUTHOR CONTRIBUTIONS | FRANCIS | Benjamin T. Wall, David Machin, and Francis B. Stephens contributed to the conception and design of the experiment. Benjamin T. Wall, David Machin, Mandy V. Dunlop, and Francis B. Stephens contributed to data collection and analysis. Benjamin T. Wall, David Machin, and Francis B. Stephens drafted the manuscript. All au... | PMC9938004 | |
FUNDING INFORMATION | This study was funded by the University of Exeter. | PMC9938004 | ||
CONFLICT OF INTEREST STATEMENT | None of the authors disclose any conflicts of interest. | PMC9938004 | ||
ACKNOWLEDGMENTS | We would like to thank all the participants who took part in the present study and acknowledge members of the Nutritional Physiology Group for their technical assistance. | PMC9938004 | ||
References | PMC9938004 | |||
Background | BPD | SEQUELAE, BRONCHOPULMONARY DYSPLASIA (BPD), CHRONIC LUNG DISEASE | Bronchopulmonary dysplasia (BPD), an inflammatory-mediated chronic lung disease, is common in extremely preterm infants born before 28 weeks’ gestation and is associated with an increased risk of adverse neurodevelopmental and respiratory outcomes in childhood. Effective and safe prophylactic therapies for BPD are urge... | PMC10629198 |
Methods | BPD, death, prematurity | An international, multicenter, double-blinded, randomized trial of intratracheal budesonide (a corticosteroid) mixed with surfactant for extremely preterm infants to increase survival free of BPD at 36 weeks’ postmenstrual age (PMA; primary outcome). Extremely preterm infants aged < 48 h after birth are eligible if (1)... | PMC10629198 | |
Statistical analysis plan | BPD, death | REGRESSION, EVENT | A sample size of 1038 infants (519 in each group) is required to provide 90% power to detect a relative increase in survival free of BPD of 20% (an absolute increase of 10%), from the anticipated event rate of 50% in the control arm to 60% in the intervention (budesonide) arm, alpha error 0.05. To allow for up to 2% of... | PMC10629198 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07650-0. | PMC10629198 | ||
Study synopsis | BRONCHOPULMONARY DYSPLASIA (BPD) | The PLUSS trial is a multicenter, two-arm, parallel, double-blind, randomized controlled trial, enrolling at least 1060 extremely preterm infants in 21 participating hospitals across four countries (Australia, New Zealand, Canada, and Singapore). Enrolment commenced in January 2018 and was completed in March 2023. The ... | PMC10629198 | |
Secondary objectives | death, pneumothorax, ’ PMA➢, brain injury, patent ductus arteriosus, BPD | NECROTIZING ENTEROCOLITIS, BRONCHOPULMONARY DYSPLASIA (BPD), PNEUMOTHORAX, INTESTINAL PERFORATION, RETINOPATHY OF PREMATURITY | To determine whether intratracheal budesonide mixed with surfactant increases survival free of bronchopulmonary dysplasia (BPD) at 36 weeks’ postmenstrual age (PMA) in extremely preterm infants born before 28 weeks’ gestation.To determine whether intratracheal budesonide mixed with surfactant:
➢ Reduces BPD and/or BPD ... | PMC10629198 |
Study population | Extremely preterm infants (specifically 22–27 weeks’ completed gestation) admitted to a participating neonatal intensive care unit (NICU), who fulfill the entry criteria detailed below. | PMC10629198 | ||
Inclusion criteria (all must be satisfied) | gestationLess |
Born before 28 weeks’ gestationLess than 48 h of ageNo more than one prior dose of exogenous surfactant administeredReceiving either:Mechanical ventilation via an endotracheal tube, regardless of ventilation settings or oxygen requirement (automatically qualify for the intervention), orNon-invasive respiratory support... | PMC10629198 | |
Exclusion criteria (any one or more mandates exclusion) | lung disease, congenital anomaly, pulmonary hypoplasia | LUNG DISEASE |
More than one prior surfactant dosePrior treatment with postnatal corticosteroids for the prevention of lung disease (inhaled, nebulized, intratracheal, or systemic)The infant is considered unlikely to survive the immediate postnatal transition and/or is not going to be admitted to the NICUKnown or suspected major con... | PMC10629198 |
Intervention | The intervention is budesonide (0.25 mg/kg) mixed with | PMC10629198 | ||
Randomization and blinding | The randomization schedule is provided by the Clinical Epidemiology and Biostatistics Unit at the Murdoch Children’s Research Institute, Melbourne, Australia. Randomization with balanced variable block sizes is used, stratified by study center, gestational age (22–25 weeks’ vs. 26–27 weeks’ completed gestation), prior ... | PMC10629198 | ||
Sample size | BPD | EVENT | The estimated incidence of the composite primary outcome of survival free of BPD is 50%, based on a review of data from the lead center (The Royal Women’s Hospital, Melbourne, Australia) and published studies enrolling extremely preterm infants. With a sample size of 1038 infants (519 in each group), the study has 90% ... | PMC10629198 |
General statistical methodology | PMC10629198 | |||
Objectives of analysis plan | SECONDARY | This statistical analysis plan (SAP) is designed to cover the analysis of:The primary outcomeIn hospital secondary outcomesOutcomes related to the safety of the interventionThis SAP Outcomes at 2 years of age (corrected for prematurity)Health economic evaluationSubstudies | PMC10629198 | |
Analysis software | Data will be exported from the study database to Stata (StataCorp 2019. Stata Statistical Software: Release 18.0 College Station, TX: StataCorp LLC) for analysis. | PMC10629198 | ||
Data verification | All data will be checked and cleaned by the trial data manager and trial statistician prior to analysis. Data analysis will not commence until the database is locked and the SAP has been submitted for publication. | PMC10629198 | ||
Definition of analysis populations | The analysis population will comprise at least 1038 infants (as per the sample size calculation) randomized to either receive the intervention (budesonide mixed with surfactant) or control (surfactant alone).The intention-to-treat (ITT) population will include all randomized infants, regardless of exposure to the alloc... | PMC10629198 | ||
Definitions of adverse events (AEs) and serious adverse events (SAEs) | deaths, death, necrotizing enterocolitis, candidiasis, insertion)Gastrointestinal hemorrhage, pulmonary hemorrhage, sepsis, respiratory death | NECROTIZING ENTEROCOLITIS, ADVERSE EVENTS, CANDIDIASIS, STERILE, PULMONARY HEMORRHAGE, SEPSIS | AEs and SAEs are assessed from randomization until death, primary hospital discharge, or 52 weeks’ PMA, whichever occurs sooner. AEs are:Spontaneous intestinal perforation (perforation not associated with necrotizing enterocolitis or other known pathology)*The need for cardiopulmonary resuscitation (chest compressions)... | PMC10629198 |
Adjustment for multiplicity | There will be no adjustment for multiplicity. | PMC10629198 | ||
Interim analyses | BPD, death | RECRUITMENT | The DSMB have conducted multiple interim analyses for safety through the trial, and a single analysis for efficacy at the halfway point of recruitment when primary outcome endpoint data (death or BPD at 36 weeks’ PMA) were available for 530 infants (50% of the planned sample size). As per the PLUSS Trial DSMB Charter (... | PMC10629198 |
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