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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References | PMC10398902 | |||
1. Introduction | Obesity, obesity, cardiovascular diseases, cancer, eating disorders, weight gain, overweight, eating disorder, deaths, diabetes | OBESITY, OBESITY, CEREBROVASCULAR DISEASES, CARDIOVASCULAR DISEASES, CANCER, PATHOLOGY, DIABETES | Obesity and overweight cause 3.4 million deaths annually, primarily due to cardiovascular diseases, cerebrovascular diseases, diabetes, and cancer [It would be ideal if such prevention programs also reduced eating disorder onset because eating pathology predicts weight gain [Several prevention programs have been design... | PMC9960991 |
2. Methods | PMC9960991 | |||
2.1. Participants and Procedures | At baseline, participants ( | PMC9960991 | ||
2.4. Data Analyses | overweight, overweight/obesity or eating disorders | OBESE | To examine continuous outcome change by single-sex versus mixed-sex group and food response and attention training versus sham training, we fitted generalized additive models (GAM). GAMs were used because outcome change was nonlinear. These analyses were intent-to-treat and included all participants randomized to the c... | PMC9960991 |
3. Results | eating disorder | Participants with versus without complete data did not differ on any of the outcomes at baseline. For percent body fat, the model with the three-way interaction between group-type, response training, and time, fitted better than simpler models. Results for the percent body fat GAM are shown in Complier analysis reveale... | PMC9960991 | |
Author Contributions | Conceptualization, E.S. and P.R.; methodology, E.S. and P.R.; software, C.D.; validation, C.D.; formal analysis, C.D.; investigation, E.S., P.R., H.S. and M.L.B.; resources, E.S. and P.R.; data curation, C.D.; writing—original draft preparation, E.S., P.R. and C.D.; writing—review and editing, E.S., P.R., H.S. and M.L.... | PMC9960991 | ||
Institutional Review Board Statement | The Oregon Research Institute Institutional Review Board approved this study. | PMC9960991 | ||
Informed Consent Statement | Informed written consent was provided by all participants before data were collected. | PMC9960991 | ||
Data Availability Statement | Data can be requested from the first author. | PMC9960991 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9960991 | ||
References | Eating Disorder | Participant flow through the study.All panels present change in percent body fat over the 2-year follow-up in each of the four conditions. Model Predicted Change in Percent Body Fat by Condition.Descriptive Summary for Study Variables by Condition.Akaike Information Criteria (AIC) for Candidate Models by Outcome.Note. ... | PMC9960991 | |
Background | DJD, MEB, HMES | SCHISTOSOMIASIS | The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: PH, MEB, DJD and JB are patent holders for a multivalent anthelminthic vaccine including schistosomiasis. GAD is an employee of the Sponsor, NIAID. RLA, RC-O, CGF, FT, MR, SG, JKK, JSL,... | PMC10089325 |
Methods | A randomized, observer-blind, controlled, Phase 1b clinical trial was conducted in 60 healthy adults living in a region of Brazil with ongoing | PMC10089325 | ||
Conclusions | Vaccination of adults with | PMC10089325 | ||
Author summary | Infection | INFECTION | Infection caused by | PMC10089325 |
Data Availability | All relevant clinical data are within the manuscript and its | PMC10089325 | ||
Methods | PMC10089325 | |||
Ethics statement | The study was approved by the ethics committees of the Federal University of Minas Gerais, the George Washington University, Baylor College of Medicine, and the Brazilian Ministry of Health. Written informed consent was obtained from volunteers who successfully completed a questionnaire assessing comprehension of study... | PMC10089325 | ||
Study vaccines | The The comparator was the Euvax B (LG Life Sciences, South Korea) recombinant hepatitis B vaccine containing 20 μg hepatitis B surface antigen and 0.5 mg aluminum per dose. Euvax B was supplied in multi-dose vials each containing enough vaccine to deliver ten-1.0 ml doses. | PMC10089325 | ||
Study site and population | intestinal helminths, Infection | INFECTION | This Phase 1b, randomized, observer-blind (within cohort), controlled, dose-escalation clinical trial was conducted in Americaninhas, Minas Gerais, Brazil, by a research team based at the Instituto René Rachou, part of the Fundação Oswaldo Cruz of the federal Brazilian Ministry of Health. Previous studies conducted in ... | PMC10089325 |
Clinical procedures | Participants were progressively enrolled into 3 cohorts. In each cohort of 20, participants were randomly assigned to receive Within each cohort, an initial 5 participants (2 | PMC10089325 | ||
Blinding | Participants, investigators, personnel performing study-related assessments following vaccine administration, and laboratory personnel performing antibody assays were blinded to study product assignment. Randomization was performed using an internet-based randomization system (Advantage eClinical, The Emmes Company, Ro... | PMC10089325 | ||
Clinical assessments | myalgia, fever, fatigue, toxicity, erythema, pain, dizziness, nausea,, headache, tenderness, chills, arthralgia | ADVERSE EVENTS, ERYTHEMA, INJECTION SITE SWELLING, REACTOGENICITY, EVENTS | Reactogenicity was measured from the time of each study vaccination (study days 1, 57, 113) through 7 days after each study vaccination by the occurrence of solicited injection site and systemic reactogenicity events. Solicited symptoms included erythema, induration/swelling, pain, and tenderness as injection site reac... | PMC10089325 |
Laboratory methods | Immunoglobulin E (IgE) antibodies specific to Cat. No.: 250203. Lot Number:2012283). In brief, 96-well plates were prepared with either 1 μg/mL recombinant Immunoglobulin G (IgG) antibodies specific to IgG subclass antibodies specific to All antibody data from the ELISAs have been uploaded to the Dryad Digital Reposito... | PMC10089325 | ||
Statistical methods | EVENTS, EVENT, EVENT | Safety data were summarized for the safety population consisting of all enrolled participants who received at least one dose of study product (Any medical condition that was present at the time that the participant was screened was considered baseline and not reported as an AE, unless it worsened in severity or increas... | PMC10089325 | |
Immunogenicity analysis | The immunology results described are restricted to the per-protocol immunogenicity population, which did not include all values from the 4 participants who did not receive all 3 doses of study product, as described below. For these participants, specimens collected after the missed vaccine dose were excluded from the i... | PMC10089325 | ||
Results | PMC10089325 | |||
Participant flow and baseline data | A total of 127 adults were screened and 60 were enrolled in the study ( | PMC10089325 | ||
CONSORT diagram: participant flow. | All 60 enrolled participants received at least 1 dose of study vaccine, while 56 (93%) received all 3 planned doses (Demographic and baseline characteristics are summarized in | PMC10089325 | ||
Demographic and baseline characteristics of study participants by vaccine group. | Note: N = Number of participants in the Safety Population; SD = standard deviation. | PMC10089325 | ||
Safety results | deaths | None of the study participants in the safety population discontinued the study due to an AE, and no AESIs, NOCMCs, or deaths occurred during the clinical trial. One participant who received 30 μg | PMC10089325 | |
Solicited AEs | EVENT | Out of 60 participants in the study, 45 (75%) experienced at least 1 solicited symptom, with 41 (68%) and 25 (42%) having at least 1 solicited injection site or systemic event, respectively ( | PMC10089325 | |
Number and percentage of participants experiencing solicited injection site events after any dose of vaccine by event, maximum severity, and vaccine group. | PMC10089325 | |||
Number and percentage of participants experiencing solicited systemic events after any dose of vaccine by event, maximum severity, and vaccine group. | EVENTS | No severe solicited AEs were observed in any study participant. In the combined group of participants who received any dose of A significantly greater percentage of participants experienced solicited events in the pooled group who received any dose of | PMC10089325 | |
Unsolicited AEs | pruritus | Forty-eight participants experienced 96 non-serious unsolicited AEs, most of which were mild in severity. Three out of 60 participants (5%) experienced at least 1 unsolicited AE of mild or moderate severity that was assessed as being related to study vaccine by the study investigators. These 3 participants experienced ... | PMC10089325 | |
Clinical laboratory AEs | Overall, 10 participants experienced 13 mild or moderate clinical laboratory abnormalities following vaccination ( | PMC10089325 | ||
Immunogenicity | PMC10089325 | |||
ELISA quality control statistics | The R | PMC10089325 | ||
Total IgG responses | Several participants across all vaccine groups had detectable, albeit low, levels of total IgG and IgG subclass antibodies to | PMC10089325 | ||
Geometric mean anti- | B hepatitis B | Per-protocol immunogenicity population. Vaccinations were administered on study days 1, 57, and 113. Error bars represent 95% confidence intervals. Euvax B hepatitis B recipients were pooled across cohorts.Only 1 comparator vaccine recipient developed a significant rise in anti-There were significantly more (86%) antig... | PMC10089325 | |
Fold change from baseline in anti- | B hepatitis B | Per-protocol immunogenicity population. Vaccinations were administered on study days 1, 57, and 113. Error bars represent 95% confidence intervals. Euvax B hepatitis B recipients were pooled across cohorts.When assessed by ANCOVA, there were no significant differences in adjusted mean log IgG antibody responses at stud... | PMC10089325 | |
Supporting information | PMC10089325 | |||
Summary statistics for the duration (days) of solicited adverse events, by vaccine group. | (DOCX)Click here for additional data file.(DOCX)Click here for additional data file. | PMC10089325 | ||
Listing of clinical laboratory adverse events experienced by study participants. | (DOCX)Click here for additional data file.We thank the study participants for their cooperation throughout the trial; the study team in Brazil, especially Cássia Senra, Simone Pinto, Stella Sobrinho, Ana Raquel Godoy, Fernanda Gambogi, and Roberta Rodrigues; Christiane Correa Rodrigues Cimini for being the independent ... | PMC10089325 | ||
Background/aims: | The stepped-wedge design has been extensively studied in the setting of the cluster randomized trial, but less so for the individually randomized trial. This article derives the optimal allocation of individuals to treatment sequences. The focus is on designs where all individuals start in the control condition and at ... | PMC10262341 | ||
Methods: | DECAY | The statistical model that takes into account the nesting of repeated measurements within subjects is presented. It is also shown how possible attrition is taken into account. The effect of the intervention is assumed to be sustained so that it does not change after the treatment switch. An exponential decay correlatio... | PMC10262341 | |
Results: | Results are presented for three to six treatment sequences. It is shown that the optimal allocation highly depends on the correlation parameter | PMC10262341 | ||
Conclusion: | This article provides the methodology for designing individually randomized stepped-wedge designs, taking into account the possibility of attrition. As such it helps researchers to plan their trial in an efficient way. To use the methodology, prior estimates of the degree of attrition and intraclass correlation coeffic... | PMC10262341 | ||
Introduction | Since the study by Hussey and Hughes,Graphical representation of a stepped-wedge design with five sequences.The implementation of a stepped-wedge design has seen an increasing use in cluster randomized trials.Stepped-wedge designs are often implemented such that an equal number of clusters or individuals is assigned to... | PMC10262341 | ||
Methods | PMC10262341 | |||
Statistical model | All individuals start in the control condition, and in each time period a number of individuals crosses over the intervention. The number of time periods
Here, The model can be written in matrix–vector notation. The model for individual
where
is the vector of length
is the
is the vector of length
is the vector of ... | PMC10262341 | ||
Relative efficiency | Once the optimal allocation has been derived, it can be compared to the uniform allocation. The relative efficiency quantifies the loss of efficiency of using the uniform allocation | PMC10262341 | ||
Results | PMC10262341 | |||
References | PMC10262341 | |||
Purpose | Communicated by Michael I Lindinger.Sodium bicarbonate (SB) supplementation can improve exercise performance, but few studies consider how effective it is in female athletes. The aim of the study was to establish the effect of individually timed pre-exercise SB ingestion on 2 km rowing time trial (TT) performance in fe... | PMC10191925 | ||
Methods | SD, ® | Eleven female CrossFit® athletes (mean ± SD age, 29 y ± 4 y, body mass, 64.5 kg ± 7.1 kg, height, 1.7 m ± 0.09 m, peak oxygen uptake [VO | PMC10191925 | |
Results | The ingestion of SB improved rowing performance (514.3 ± 44.6 s) compared to the PLA (529.9 ± 45.4 s) and FAM trials (522.2 ± 43.1 s) ( | PMC10191925 | ||
Conclusions | Ingesting a 0.3 g·kg | PMC10191925 | ||
Keywords | PMC10191925 | |||
Introduction | alkalosis, metabolic alkalosis, ®, fatigue | METABOLIC ALKALOSIS, ALKALOSIS | During high-intensity exercise, fatigue refers to the abrupt deterioration of exercise performance, a gradual increase in perceived exertion which inevitably leads to an inability to maintain the intended magnitude of intensity (Ament and Verkerke et al. 2009). Performance of high-intensity exercise, which demands a la... | PMC10191925 |
Methods | SD | Eleven female CrossFit athletes took part in this study (mean ± SD age, 29 y ± 4 y, body mass, 64.5 kg ± 7.1 kg, height, 1.7 m ± 0.09 m, peak oxygen uptake [VODuring visit one, participants completed a maximal cardiopulmonary exercise test to determine VOTo determine VOGiven the large inter-individual variability in ti... | PMC10191925 | |
Statistical analysis | stroke | STROKE, BLOOD | Normality testing was completed using a Shapiro–Wilk test on all variables to determine the appropriate statistical test. Performance measures, time to completion, stroke rate and power output and GI symptoms were then subsequently analysed using a one-way analysis of variance (ANOVA) for repeated measures. Blood metab... | PMC10191925 |
Results | blood [HCONo gastrointestinal symptoms | The peak [HCOIndividual time to peak and mean (± SD) metabolite responses to 0.3 g·kgTime to Peak(min)Mean ± SD 2 km TT performance time (During the time trials, the ingestion of SB resulted in significantly altered blood [HCOMean ± SD blood [HCONo gastrointestinal symptoms were observed either prior to ingestion in an... | PMC10191925 | |
Discussion | alkalosis | TTP, ALKALOSIS | The present study is the first to investigate the effects of SB ingestion on exercise performance in trained female CrossFit athletes. Furthermore, this study also used the contemporary approach of determining the individualised time to peak alkalosis to optimise the pre-exercise ingestion time whilst also delivering t... | PMC10191925 |
Conclusion | alkalosis, ® | ALKALOSIS | This is the first study to investigate the effects of enteric-coated SB ingestion on 2 km TT performance in trained female CrossFit® athletes. The main finding is that optimising the timing of the start of exercise to coincide with peak alkalosis, improves TT performance by ~ 2.24% in female athletes. The ingestion of ... | PMC10191925 |
Author contributions | RM and LM conceived and designed research. RM and SAS conducted experiments and undertook the data analysis with BS. RM, LM, NH, AS wrote the manuscript. All authors read and approved the manuscript. | PMC10191925 | ||
Funding | No funding was received for planning or conducting this work. | PMC10191925 | ||
Data availability | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10191925 | ||
Declarations | PMC10191925 | |||
Conflict of interest | All authors declare that they have no competing Interest and have no financial or non-financial interests. | PMC10191925 | ||
References | PMC10191925 | |||
Background | Postoperative rehabilitation after primary total hip arthroplasty (p-THA) differs between the Netherlands and Germany. Aim is to compare clinical effectiveness and to get a first impression of cost effectiveness of Dutch versus German usual care after p-THA. | PMC10294515 | ||
Methods | A transnational prospective controlled observational trial. Clinical effectiveness was assessed with self-reported questionnaires and functional tests. Measurements were taken preoperatively and 4 weeks, 12 weeks, and 6 months postoperatively. For cost effectiveness, long-term economic aspects were assessed from a soci... | PMC10294515 | ||
Results | 124 working-age patients finished the measurements. German usual care leads to a significantly larger proportion (65.6% versus 47.5%) of satisfied patients 12 weeks postoperatively and significantly better self-reported function and Five Times Sit-to-Stand Test (FTSST) results. German usual care is generally 45% more e... | PMC10294515 | ||
Conclusions | German rehabilitation is clinically advantageous yet more expensive, although comparisons are less straightforward as the socioeconomic context differs between the two countries. | PMC10294515 | ||
Trial registration | The study is registered in the German Registry of Clinical Trials (DRKS00011345, 18/11/2016). | PMC10294515 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12891-023-06654-w. | PMC10294515 | ||
Keywords | PMC10294515 | |||
Background | Osteoarthritis, OA | OSTEOARTHRITIS, JOINT DISORDER | Osteoarthritis (OA) is an age-related chronic progressive joint disorder [THA-related procedures and recovery differ significantly between Germany and the Netherlands. In the Netherlands, as in many other Western countries, there is an increasing tendency to perform p-THA following a fast-track approach. This allows pe... | PMC10294515 |
Methods | PMC10294515 | |||
Study design | Trauma | The study was conducted as a transnational prospective controlled observational trial analyzing the clinical and cost effectiveness of the Dutch versus the German rehabilitation approach following p-THA. It is a mutual project of the orthopedic departments of University Medical Center Groningen (UMCG) in the Netherland... | PMC10294515 | |
Study population | The following criteria were set up to determine patient eligibility. Inclusion criteria were employable patients aged 18–65, clinical evidence of hip OA according to Altman et al. [ | PMC10294515 | ||
Outcome measures | Preoperative demographic data, preoperative diagnosis, height, weight, body mass index (BMI), American Society of Anesthesiologists (ASA) classification, and perioperative/postoperative complications were recorded from electronic patient files. Measurements were taken preoperatively (T | PMC10294515 | ||
Primary outcome measure | Primary outcome was the patient acceptable symptom state (PASS), an instrument to measure a patient’s response to a treatment or intervention [ | PMC10294515 | ||
Secondary outcome measures | disability, pain | To measure health-related quality of life, the Short Form 36 (SF-36) and the EuroQol 5 Dimensions 3 Level Questionnaire (EQ-5D-3L) were used. SF-36 is a widely used generic health status questionnaire, consisting of 36 questions organized into eight multi-item scales: physical functioning, role limitations due to physi... | PMC10294515 | |
Cost effectiveness | hip complaints, Productivity loss calculations, pain | The economic evaluation was conducted in collaboration with the Patient Centered Health Technology Assessment Unit of UMCG. The aim was to obtain a first impression of the direct and indirect costs of postoperative care incurred in each of the two countries, since no pertinent data were previously available in the lite... | PMC10294515 | |
Sample size | PASS | The sample size calculation was based on the PASS. The PASS is a novel approach to measure patients’ response to a treatment or intervention, and is an easy method to establish whether a patient has achieved therapeutic success [ | PMC10294515 | |
Statistical analyses | POSTOPERATIVE COMPLICATIONS | Collected data were analyzed using SPSS software (V.23; IBM, Armonk, NY, USA). Main characteristics of both groups as well as intraoperative and postoperative complications were analyzed descriptively. | PMC10294515 | |
Primary Outcome Data Analysis | To distinguish patients who benefited from their p-THA and subsequent medical rehabilitation or follow-up (responders) from those who did not (non-responders), a receiver operating characteristic (ROC) curve was calculated as recommended in literature [ | PMC10294515 | ||
Secondary Outcome Data analysis | SECONDARY | Because data were collected at four timepoints, a multilevel analysis was performed to compare the secondary outcome measures. This made it possible to compare differences in both within-country and between-countries data at the different timepoints [ | PMC10294515 | |
Cost Analysis | The respective mean values of all costs were calculated. Additionally, based on bootstrapping (5000 replications) the corresponding 95% CI were calculated. In a scenario analysis the correspondence between amount of work (in weekly hours) and productivity costs (per hour) in both countries was simulated in order to bet... | PMC10294515 | ||
Results | PMC10294515 | |||
Discussion | Primary aim of this study was to compare clinical effectiveness between the common medical rehabilitation approach after p-THA in Germany and the common approach in the Netherlands for working-age patients against the background of the prognosis that the majority of p-THA patients will be from the working-age populatio... | PMC10294515 | ||
Conclusions | This study identified that a more intense aftercare following p-THA as performed in Germany is clinically advantageous. From a cost-effectiveness perspective comparisons are less straightforward, as the socioeconomic context differs between the two countries. The results nonetheless give food for thought as to whether ... | PMC10294515 | ||
Acknowledgements | We would like to thank the students who assisted with the measurements, R.E. Stewart and I.H.F. Reininga for their statistical help, and Dr. F. Diederich for the health economic advice. | PMC10294515 | ||
Authors’ contributions | There are no conflicts of interest. AH is a coordinating manager in social medicine at one of the third-party funders (DRV Oldenburg-Bremen), but this did not affect the results of the present study.GHS Conceptualization, Methodology, Investigation, Resources, Writing - Original Draft, Writing - Review & Editing, Super... | PMC10294515 | ||
Funding | This study was partly funded by the intramural research fund | PMC10294515 | ||
Availability of data and materials | Available upon request from the corresponding author (Martin Stevens). | PMC10294515 | ||
Declarations | PMC10294515 |
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