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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Diagnosis of AMD | mydriasis | Fundus photography was performed on all study participants without previous pharmacological mydriasis by using a 35° color digital fundus camera (Canon CR-2 PLUS AF; Canon U.S.A., Inc., New York, USA). Fundus images were graded according to the Wisconsin AMD grading system [ | PMC10586687 | |
Other characteristics and methods | Anthropometric measurements were performed in a standard manner using certified equipment. Body weight and height were measured with the participants barefoot and wearing lightweight indoor clothing. Body mass index was calculated as weight (kg)/(height [m]) | PMC10586687 | ||
Statistical analysis | REGRESSION | Statistical analyses were performed using the R statistical package (version 4.1.3), with the α-value set to 0.05. Quantitative variables were compared between groups using the Mann–Whitney U-test or Student t-test for independent samples, as applicable. The normal distribution of the study variables was verified using... | PMC10586687 | |
Results | The study sample consisted of 436 patients aged 50–80 years (252 women). Detailed characteristics of the study participants are listed in | PMC10586687 | ||
Demographic, clinical, and densitometric characteristics of study participants. | AMD-1, AMD | AGE-RELATED MACULAR DEGENERATION | * Variables with normal distributions were compared using the Student t-test, and those with non-normal distributions were compared using Wilcoxon’s test for independent samples.AMD-0: group without AMD; AMD-1: group with AMD.AMD, age-related macular degeneration; BMD, bone mineral density.Women in the AMD-0 group were... | PMC10586687 |
The relationship between T-Score (Cutoff, −1.0) for femoral BMD and the occurrence of age-related macular degeneration in women and men. | AMD | REGRESSION, AGE-RELATED MACULAR DEGENERATION | AMD-0: group without AMD; AMD-1: group with AMD.AMD, age-related macular degeneration; CI, confidence interval.Femoral BMD was a significant predictor of AMD in men based on univariate logistic regression models. A one-unit increase in femoral BMD was associated with a 98% decrease in the risk of being in the AMD-1 gro... | PMC10586687 |
Univariate logistic regression models with age-related macular degeneration as an outcome variable in women and men. | AMD | REGRESSION | BMD, bone mineral density.Two multivariable logistic regression models were created for women and men, both with AMD as the outcome variable: the predictors were age and crude femoral BMD in one ( | PMC10586687 |
Multivariable logistic regression model with age-related macular degeneration as an outcome variable and age and femoral BMD as independent variables in women and men. | BMD, bone mineral density. | PMC10586687 | ||
Multivariable logistic regression model with age-related macular degeneration as an outcome variable and age and femur T-score as independent variables in women and men. | PMC10586687 | |||
Discussion | AMD, bone loss, osteopenia, senile osteoporosis, osteoporosis | FRAGILITY FRACTURE, BONE LOSS, OSTEOPENIA, BONE DISEASES, SENILE OSTEOPOROSIS, PATHOGENESIS, OSTEOPOROSIS | Our study revealed an association between a decrease in femoral BMD and the occurrence of AMD in men older than 50 years. In contrast, we did not observe any differences in the densitometric parameters of women in relation to AMD prevalence. The results of our study provide grounds for actively screening for AMD among ... | PMC10586687 |
Keywords | Communicated by Michael I Lindinger.The use of sodium bicarbonate (NaHCO | PMC10363041 | ||
Introduction | Sodium bicarbonate (NaHCOErgogenic benefits of NaHCOOne limitation of the work to date is passive rest periods between intervals have been employed. It is intuitive to suggest that active recovery periods could lead to greater acid base balance recovery, and clearance of HIf NaHCOIt is unknown, however, if improvements... | PMC10363041 | ||
Methods | PMC10363041 | |||
Participants | Fourteen trained male competitive swimmers (BM: 73 ± 8 kg) participated in this double-blind, randomised, crossover study. Randomisation was completed using a 4 × 4 block design (NaHCO | PMC10363041 | ||
Exercise protocol | All participants completed the exercise protocol during their normal training time and at the same time of day (± 1 h) (range: 5–8 pm). Following a familiarisation trial that entailed completing the interval sets, the experimental protocol was repeated on two occasions 1 week apart. Each participant was asked to swim 5... | PMC10363041 | ||
Statistical analysis | Data were initially checked for normality using Shapiro–Wilk and standard geographical methods (e.g. Q–Q plots and Histograms). For time to complete each 50 m set, a two-way (treatment: NaHCO | PMC10363041 | ||
Results | PMC10363041 | |||
Heart rate, GI and RPE | There were no differences in HR at any time point between NaHCO | PMC10363041 | ||
Discussion | This study aimed to investigate the effects of NaHCOThe current study corroborates with previous research reporting improvements in interval swimming performance following NaHCOAs a group, there was an improvement in swim performance during the latter half of the repeated sprints (sprints 5–8). However, the ergogenic e... | PMC10363041 | ||
Conclusion | To conclude, this study reports that the ingestion of NaHCO | PMC10363041 | ||
Acknowledgements | We would like to thank the participants for taking part in the research. | PMC10363041 | ||
Author contributions | MP | LAG and MP designed this work. LAG, MP, and JWN collected data. LAG drafted the work with contributions from MP and JWN. MP and JWN reviewed and approved the manuscript. All the authors are accountable for the accuracy and integrity of the work. | PMC10363041 | |
Funding | The study received no funding. | PMC10363041 | ||
Data availability | Data is available upon request to the corresponding author. | PMC10363041 | ||
Declarations | PMC10363041 | |||
Conflict of interest | All the authors have no competing interests to declare. | PMC10363041 | ||
References | PMC10363041 | |||
Background | anxiety disorder, SAD | SECONDARY | There is growing evidence that Internet-based cognitive behavioral therapy (ICBT) is as effective as a stand-alone treatment and helps facilitating access to treatment. Given the complexity of the treatment, we argue that the effect of ICBT could be even greater if guided by a therapist, as this could increase treatmen... | PMC9974392 |
Methods/design | depression, Anxiety, SAD | A within-between interaction design with randomization to one of three conditions will be used. In the APP condition, patients receive only the app without any additional contact with therapists, while in the TG-APP condition, therapists provide 8 sessions of video-based treatment in addition to using the app. The stud... | PMC9974392 | |
Discussion | SAD | The present study will be one of the first to examine the additional benefit of therapist-guided video sessions regarding the use of an app treating SAD. Study results are pivotal to future treatment application in SAD. | PMC9974392 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07168-5. | PMC9974392 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC9974392 | ||
Administrative information |
Trial registration: ClinicalTrials.gov, NCT05554718. Registered 16 September 2022, The pilot study was registered in the German Clinical Trials Register (DRKS), DRKS00029701. Registered 01 August 2022. J. M. Schittenhelm: Goethe Universitaet Frankfurt, GermanyC. von Borell: Technische Universitaet Dresden, GermanyC. C... | PMC9974392 | ||
Introduction | mental disorders, SAD | DISORDER, WELLS | Social anxiety disorder (SAD) is characterized by the fear of behaving in a way that is negatively perceived by others [On the one hand, there are ways to treat SAD. For example, a recent meta-analysis demonstrated that individualized cognitive therapy (CT) based on the model of Clark and Wells [Addressing these treatm... | PMC9974392 |
Objectives | anxiety disorder, psychological impairment, phobic, psychological distress, deterioration of SAD-related symptoms, depression | SECONDARY, WELLS | The main goal of the present study is to evaluate whether the use of the app-based intervention helps to decrease symptoms of social anxiety disorder and has positive effects on mental health. There will be two experimental treatment conditions: App-based CT (APP) and app-based CT plus 8 therapist-guided video-delivere... | PMC9974392 |
Trial design | Anxiety | The design of the planned bi-centric randomized controlled superiority trial will be based on a within-between interaction group design with three groups (WLC, APP, TG-APP) and parallel group assignment. The primary outcome criterion is the change in symptom severity of SAD, as measured by the Liebowitz Social Anxiety ... | PMC9974392 | |
Methods | PMC9974392 | |||
Design and sample size | SAD | We conducted a simulation-based a priori power analysis for a 3 × 2 interaction (group ( time) in a linear mixed model for the primary outcome of SAD symptom severity (according to the LSAS), using the R package “simr” [We chose these effect sizes as conservative estimates based on the results of a recent meta-analysis... | PMC9974392 | |
Procedure | anxiety disorder | The study will be conducted in Germany at the outpatient psychotherapy unit of the Clinical Psychology department of the Goethe University of Frankfurt as well as the outpatient psychotherapy unit of the Clinical Psychology department of the Technische Universitaet Dresden and two further CBT training centers in Dresde... | PMC9974392 | |
Ethical issues | psychiatric | ADVERSE EFFECTS | The study was approved by the Ethics Committee of the Department of Psychology at Goethe University Frankfurt. If post-trial care is required (e.g., in case of serious adverse effects), this will be provided by the outpatient clinics in Frankfurt and Dresden, and participants will be referred to a hospital or psychiatr... | PMC9974392 |
Recruitment | Advertisements for participation include print media (e.g., brochures or text in print media), posts on social media, and outreach to mental health professionals, inpatient and outpatient facilities, and general practitioners to identify appropriate participants. | PMC9974392 | ||
Eligibility criteria | Anxiety, Acute suicidalityActive substance abuse | Inclusion criteria:Current diagnosis of Social Anxiety DisorderWritten informed consent before the start of the studyAge: 18 to 65 yearsPossession of smartphoneFamiliarity with using appsExclusion criteria:Acute suicidalityActive substance abuse or dependenceSevere medical conditions (e.g., chronic cardiovascular disea... | PMC9974392 | |
Allocation and randomization | Randomization is performed using a randomization list in which, based on 165 randomly generated numbers sorted by size, each of the available options is assigned according to the planned sample size (WLC = 43, APP = 61, TG-APP = 61). The list is then sorted by sequential number. A study coordinator who is not involved ... | PMC9974392 | ||
Treatment | attention on external stimuli., anxiety, SAD | WELLS | The app offers an adaptation of scientifically proven techniques in the treatment of SAD based on Clark and Wells [Clark and Wells’ model [Module 1—Learning and Understanding: The goal of this module of the app is to provide the user with key information about SAD and to create an individualized model based on Clark an... | PMC9974392 |
Therapists | Therapists will be recruited mainly from the outpatient units of the Universities of Dresden and Frankfurt. All therapists must be either licensed psychotherapists or in advanced post-graduate CBT training (at least 1.5 years of training). Study-specific training will focus on how to use the app, how to conduct and ana... | PMC9974392 | ||
Outcomes | PMC9974392 | |||
Primary outcome measure | Anxiety | We defined the clinician-rated Liebowitz Social Anxiety Scale (LSAS) [ | PMC9974392 | |
Self-rating scales | Pain, depression, Depression, Disability, SAD | SECONDARY | As the secondary outcome measure for SAD, we use the Social Phobia Inventory (SPIN) [We also use the German version of the Social Cognitions Questionnaire (SCQ, German version: SPK) [Symptoms of depression and general psychological distress will be assessed using the Beck Depression Inventory Fast Screen (BDI-FS) [To a... | PMC9974392 |
Clinician-rated measures | borderline personality disorder, Depressive, BPD | The interview will include the Structured Clinical Interview for DSM 5 (SCID-5) [To screen for borderline personality disorder (BPD), we use a set of 5 questions suggested by Wongpakaran et al. [We further use the Clinical Global Impression (CGI) [Finally, the Quick Inventory of Depressive Symptomatology (QIDS-C) [Sche... | PMC9974392 | |
Statistical methods | PMC9974392 | |||
Sample | All analyses will be conducted in the intent-to-treat (ITT) sample, including all participants that were randomized into one of the three groups. | PMC9974392 | ||
Primary analysis | For our primary analysis, we plan to fit a linear mixed model with random intercepts for participants in the R package lme4 [ | PMC9974392 | ||
Secondary analyses | phobic, depression, anxiety, pain | ADVERSE EFFECTS, SECONDARY, ADVERSE EFFECT | As secondary analyses, we will evaluate treatment effects (from baseline to post-treatment, as described in hypothesis 2a and from post-treatment to follow-up, as described in hypothesis 2c) on quality of life, as measured by the WHO-QOL-BREF, interpersonal pleasure, as measured by the ACIPS, further SAD-related sympto... | PMC9974392 |
Drop-out analyses | We define as “drop-out” any participant who did not complete the post-treatment measurement. Systematic differences in dropout rates between the three groups will be analyzed by a Fisher exact test. In addition, differences between participants and drop-outs in terms of sociodemographic and clinical variables will be c... | PMC9974392 | ||
Interim analysis | In case of a rejection of the licensing process by the inspecting federal institute for drugs and medical devices, an interim analysis of the treatment effect of the APP condition on outcomes of the main study (LSAS, WHO-QOL-BREF, PDI) could turn out to be necessary. Such interim analysis will be blinded, that is, perf... | PMC9974392 | ||
Discussion | anxiety disorder, SAD | WELLS | Based on a recent meta-analysis, there is evidence that internet- or app-based interventions have moderate effect sizes in the treatment of SAD [We hypothesize that the addition of therapist-guided sessions will result in larger effect sizes than using the app alone. In agreement with Stott et al. [To summarize, our re... | PMC9974392 |
Organizational structure | PMC9974392 | |||
Coordinating center and trial steering committee | The present study is a bicentric study which is designed and coordinated in a cooperation between the Goethe University Frankfurt and the Technische Universitaet Dresden. The study team has weekly meetings. There is no additional steering committee.Support for the trial is provided by:Principal investigator: provides s... | PMC9974392 | ||
Data monitoring committee | ADVERSE EFFECTS | There is no data monitoring committee and no independent auditing process. The quality of the data is assured by the blinded clinical raters and there are no known serious adverse effects. If serious adverse effects occur, they will be reported to the principal investigator, who will then interview the patient in quest... | PMC9974392 | |
Data management and confidentiality | Questionnaires will be answered online. The screening is the only time participants enter personal contact information. In the subsequent assessments and questionnaires, participants are identified by a random computer-generated code. Other than the study coordinators, only therapists and clinical raters know the parti... | PMC9974392 | ||
Relevant concomitant care and interventions that are permitted or prohibited during the trial | There is no concomitant care additional to the intervention groups that we already described. If there are medical conditions of the patients, that need to be treated right away, patients will be send to a physician. If patients start a different psychotherapy while being part of the study, they will drop out. | PMC9974392 | ||
Trial status | RECRUITMENT, RECRUITMENT | Recruitment began in July 2022. The current protocol is version 2 of 16 December 2022. There have been no patients enrolled into the trial so far (16 September 2022). Approximate date of completed recruitment: 31 December 2023. | PMC9974392 | |
Authors’ contributions | US and JH: principal investigators. JMS: protocol development, trial coordination. JS: trial coordination, administrative tasks. CB: design of statistical analysis, trial coordination. CC: optimizing the protocols. All authors participated in the development of the app, contributed to the manuscript, and approved the f... | PMC9974392 | ||
Funding | Open Access funding enabled and organized by Projekt DEAL. This study is funded by Mindable Health GmbH, Berlin, Germany. The funders do not have a role in collection, analysis, and interpretation of data. | PMC9974392 | ||
Availability of data and materials | The data used in this study, including for example, the R code for randomization, are available from the corresponding authors upon reasonable request. | PMC9974392 | ||
Declarations | PMC9974392 | |||
Ethics approval and consent to participate | The study has been approved by the ethics committee of the psychology department of the Goethe University Frankfurt. All participants provide written informed consent. All substantial amendments will be reported to the responsible ethics committee, e.g., if there are changes that need to be made because it might affect... | PMC9974392 | ||
Consent for publication | Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are available from the corresponding author on request. | PMC9974392 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9974392 | ||
References | PMC9974392 | |||
Objective | knee arthroplasty, VTE, venous thromboembolism | To investigate the optimal duration of applying a venous foot pump (VFP) in the prevention of venous thromboembolism (VTE) following hip and knee arthroplasty. | PMC10691185 | |
Methods | intermuscular DVT, pain, Postoperative blood coagulation, DVT | DEEP VEIN THROMBOSES, DVT | A total of 230 patients undergoing hip and knee arthroplasty between March 2021 and March 2022 in orthopaedic departments of four major teaching hospitals were prospectively enrolled. Patients were randomly divided into five groups based on the duration of the VFP application. Postoperative deep vein thromboses (DVT), ... | PMC10691185 |
Results | DVT | DVT | Two of the 230 patients withdrew due to early discharge from the hospital, and 228 patients were included in the final analysis. The mean age was 60.38 ± 13.33 years. The baseline characteristics were comparable among the five groups. Compared with the other groups, patients treated with 6-hour VFP had the lowest incid... | PMC10691185 |
Conclusions | knee arthroplasty, VTE, postoperative blood coagulation, pain | Six hours may be the optimal duration of applying VFP for the prevention of VTE in patients undergoing hip and knee arthroplasty in terms of VTE incidence, postoperative blood coagulation examinations, pain outcomes, and comfort scores. | PMC10691185 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12891-023-06921-w. | PMC10691185 | ||
Keywords | PMC10691185 | |||
Background | knee arthroplasty, abnormal coagulation of blood in the vein, VTE | COMPLICATIONS, VENOUS THROMBOEMBOLISM | Venous thromboembolism (VTE) is a serious health issue worldwide. It refers to the abnormal coagulation of blood in the vein. VTE is one of the most important complications after orthopaedic surgery [Currently, the preventive strategies for VTE mainly include pharmacologic and mechanical thromboprophylaxis among patien... | PMC10691185 |
Patients and methods | PMC10691185 | |||
Patients and study design | knee arthroplasty, VTE | A total of 230 patients undergoing hip and knee arthroplasty between March 2021 and March 2022 in orthopaedic departments of four major teaching hospitals, including the First Medical Center of Chinese PLA General Hospital, the Fourth Medical Center of Chinese PLA General Hospital, Hainan Hospital of Chinese PLA Genera... | PMC10691185 | |
Sample calculation | The study referred to the formula of multiple independent sample rates: n = | PMC10691185 | ||
Randomization and blinding | Patients were randomly divided into five groups by computer random method based on the duration of the VFP application. SPSS26.0 software was used to generate a random sequence, and the random assignment scheme was saved in light-tight envelopes. Envelopes were opened sequentially in the order of enrollment, and patien... | PMC10691185 | ||
Interventions | All patients received pharmacologic and mechanical thromboprophylaxis [
The foot venous pump worn by the patient | PMC10691185 | ||
Primary outcome | DVTs, DVT, intermuscular DVT, thromboses, postoperative DVT, dilated vena cava | DVT | The primary outcome was postoperative DVT, including proximal DVTs such as thromboses in the popliteal vein, femoral vein, or iliac vein, distal DVTs such as thromboses in the anterior tibial vein, posterior tibial vein, or peroneal vein, and intermuscular DVT. DVT was examined using colour Doppler flow imaging at post... | PMC10691185 |
Secondary outcome | postoperative blood coagulation, pain | SECONDARY | The secondary outcome included postoperative blood coagulation examinations, such as D-dimer and active partial thromboplastin time (APTT), pain outcome, and the degree of comfort. D-dimer and APTT were recorded on postoperative days 1 and 3. The visual analog scale (VAS) [ | PMC10691185 |
Variables and definitions | blood loss, diabetes | BLOOD LOSS, HYPERTENSION, DIABETES | Patient’s baseline characteristics included (1) demographics such as age, sex, nationality, body mass index (BMI), temperature, heart rate, respiration rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), blood type, hypertension, and diabetes, (2) surgery-related information such as the type of surgery... | PMC10691185 |
Quality control | dehydration, bleeding, thrombus, VTE | DEHYDRATION, BLEEDING, THROMBUS | A series of measures were considered to guarantee the quality of the study. Firstly, all investigators were trained on how to evaluate patients using the Caprini thrombus risk assessment scale, and all patients received the same education on thrombus prevention, including signs and symptoms of VTE and bleeding, the imp... | PMC10691185 |
Statistical analysis | DVT | DVT | Categorical variables were expressed as proportion and continuous variables as the mean ± standard deviation. The chi-square test was utilized to evaluate differences between categorical variables and analysis of variance (ANOVA) was used to compare the means between three or more groups for continuous variables. Repea... | PMC10691185 |
Results | PMC10691185 | |||
Baseline characteristics | Two of the 230 patients withdrew due to early discharge from the hospital. Thus, 228 patients were included in the final analysis. The mean age was 60.38 ± 13.33 years. The majority of patients were females, accounting for 63.2% of all patients. Regarding the surgical site, the right knee accounted for 31.6%, followed ... | PMC10691185 | ||
Comparison of the incidence of DVT among the five groups | VTE, venous thromboembolism, DVT | DEEP VEIN THROMBOSES, DVT | Compared with the other groups, patients treated with 6-hour VFP had the lowest incidence of DVT (8.7%, 4/46), followed by 1-hour VFP (15.2%, 7/46) and 12-hour VFP (15.6%, 7/45) (
Histogram of patient groups with venous thromboembolism.
Comparison of the incidence of VTE between groupsVTE: venous thromboembolism; DVT... | PMC10691185 |
Comparison of D-dimer and APTT AMONG the five groups | timeP | SECONDARY | D-dimer significantly increased on a postoperative day 1 compared with that on preoperative 1 day, and it significantly decreased on postoperative day 3 among all five groups (
Radar chart of secondary outcomes in the five groups.
Comparison of D-dimer levels and APTT between the five groups before and after surgeryAP... | PMC10691185 |
Comparison of pain and comfort outcomes among the five groups | pain | The 6-hour VFP group had the lowest pain score (
Comparison of pain and comfort scores between five groups before and after surgeryVAS: visual analogue scaleP | PMC10691185 | |
Analysis of risk factors for predicting DVT | DEEP VEIN THROMBOSIS | Multivariate analysis revealed that older age (
The area under the receiver operating characteristic curves for variables used to predict deep vein thrombosis.
Multivariate analysis of risk factors for predicting deep vein thrombosesOR: odds ratio; CI: confident interval; LL: lower limit; UP: upper limit; BMI: body ma... | PMC10691185 | |
Discussion | PMC10691185 | |||
Main findings | postoperative blood coagulation, DVT, knee arthroplasty, pain, VTE | DVT | The present study investigated the duration of applying VFP for the prevention of VTE in patients receiving hip and knee arthroplasty and found that six hours a day might be the optimal duration of using VFP in terms of VTE incidence, postoperative blood coagulation examinations, pain outcomes, and comfort scores. Pati... | PMC10691185 |
Incidence of VTE in arthroplasty | knee arthroplasty, VTE | Previous studies showed that the incidence of VTE after hip and knee arthroplasty was 20.6–58.2% [In addition, our study showed that the D-dimer was decreased and APTT was increased after using VFP, and the difference was statistically significant ( | PMC10691185 | |
Duration of VFP application for prevention of VTE | VTE, pain | EVENTS | At present, there is no consensus on the duration of VFP application to prevent VTE events in patients undergoing knee and hip orthopaedic surgery. Some studies have proposed the continuous application of 20-hour VFP, while others have recommended a 30-minute to 1-hour VFP application. Charalambous et al. [Comfort scor... | PMC10691185 |
Mechanism of using VFP for prevention of VTE | intermuscular DVT, VTE, DVT | STASIS, CONTRACTION, DVT | The mechanism of using VFP for the prevention of VTE involves venous hemodynamics of the lower extremity, which is mainly relevant to the physiology of the human plantar venous pump. Through pulsatile pressure release, VFP promotes venous blood return by rapidly squeezing blood from the plantar venous plexus back into ... | PMC10691185 |
Risk factors for predicting DVT | VTEs, DVT | DVT | Multivariate analysis demonstrated that older age, higher temperature, lower SBP, AB or B blood type, drainage, and lower platelet count were significantly positively associated with DVT. Previous studies found that older age [We also found that patients with non-O blood types—especially type B or AB—were at a signific... | PMC10691185 |
Limitations | VTE | COMPLICATIONS | This study has study several drawbacks. First, this study only investigated the early prognosis of applying VFP to prevent VTE; the follow-up was only three days after surgery, while relative long-term outcomes were not evaluated in the study. Second, this study did not assess the occurrence of complications such as sk... | PMC10691185 |
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