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3.3. Secondary outcome: The scores of HDI and the HAMA | PMC10637508 | |||
3.3.1. The change of HDI scores. | migraine | MIGRAINE | The average scores of HDI in migraine patients were analyzed at the different treatment time points respectively. As we can see in Figure The change of HDI scores at the different treatment time points. The blue histogram represents the HDI scores of group A before and after every round treatment and the red histogram ... | PMC10637508 |
3.3.2. The change of HAMA scores. | anxiety | The incidence of anxiety symptoms was 68.3 % (41of 60) in our samples (HAMA > 7) which was similar to the results of a study from Spanish (69 %).The change of HAMA scores at the different treatment time points. The blue histogram represents the HAMA scores of group A before and after every round treatment and the red h... | PMC10637508 | |
4. Discussion | migraine, Headache-related disability | MIGRAINE, DISEASE, ADVERSE REACTION | In the 1930s, an osteopath named William Sutherland laid the groundwork for CST, after working extensively with patients who experienced a wide range of symptomsCST is based on the theory that the movement restriction at the cranial sutures of the skull negatively affects the rhythmic impulses transmitted from the skul... | PMC10637508 |
5. Limitations | The limitations of this study are the small sample size, and the potential differences in skills and techniques of therapists, even though we participated in 3 therapists. On the other hand, this is a single center clinical study and participants in this study were all indoor white-collar workers who had received highe... | PMC10637508 | ||
Acknowledgments | The authors are grateful to all staff members, doctors, and all participants who were involved in this study. | PMC10637508 | ||
Abbreviations: | migraine, Disability, Anxiety | MIGRAINE | complementary light-touch sham treatmentsCraniosacral therapyHamilton Anxiety ScaleHeadache Disability inventoryHeadache Impact Test-6All data generated or analyzed during this study are included in this published article [and its supplementary information files].The authors have no funding and conflicts of interest to... | PMC10637508 |
References | PMC10637508 | |||
Background | knee arthroplasty, TKA | The use of poly-ether-ether-ketone (PEEK) prosthesis during total knee arthroplasty (TKA) is a relatively new concept. Several studies have suggested that the thickness of cement penetration during TKA may affect the stability of the implants. The present study aimed to compare the cement penetration and clinical perfo... | PMC10410788 | |
Methods | This study was a randomized controlled trial with level I of evidence. A total of 48 patients were randomly assigned to either the PEEK group ( | PMC10410788 | ||
Results | According to the results of this study, the mean bone cement penetration exhibited no significant difference between PEEK and CoCrMo groups (2.49 ± 0.61 mm vs. 2.53 ± 0.68 mm, | PMC10410788 | ||
Keywords | PMC10410788 | |||
Background | knee arthroplasty, aseptic loosening of the tibial component, TKA | OSTEOARTHRITIS | Total knee arthroplasty (TKA) is commonly utilized to treat osteoarthritis, although aseptic loosening of the tibial component remains a primary concern [In order to increase the longevity of joint prostheses, researchers have explored various materials including cobalt chromium molybdenum, titanium, ceramic, and more ... | PMC10410788 |
Methods | comprehension disorders, ischemic osteonecrosis, alcoholism, neuromuscular insufficiency, traumatic arthritis, drug abuse, substance abuse | RHEUMATOID ARTHRITIS, OSTEOARTHRITIS | From June 2021 to December 2022, a prospective randomized clinical trial was conducted at Honghui Hospital affiliated to Xi'An Jiaotong University to investigate the safety and efficacy of PEEK knee prostheses for TKA. The study was approved by the local ethics committee (NO. 2021-008-001) and registered at Chinese Cli... | PMC10410788 |
Surgical technique | pulmonary embolism, postoperative pain, bleeding, Pain, fracture, Thrombosis, pain, DVT, cement mantle measurementsIn this study, PJI, patellar componentThe cementation, bipolar coagulation | PULMONARY EMBOLISM, BLEEDING, DELAYED WOUND HEALING, THROMBOSIS, JOINT INFECTION, EXSANGUINATION, DVT | All procedures were strictly standardized in accordance with preoperative tranexamic acid (TXA), general anesthesia, postoperative pain management, and rehabilitation regimen. Prior to surgery and immediately before skin incision, TXA (1 g) and cefuroxime (1.5 g) were administered intravenously. Following joint capsule... | PMC10410788 |
Statistical analysis | Sample size was based on earlier studies, in which the priori power analysis was undertaken for an unpaired Student’s t-test, α at 0.05 and β at 0.2, i.e., Power (1 − β) or 0.8. A difference of 0.75 mm in the mean cement penetration between each group was determined to be clinically relevant. With a two-sided test, 58 ... | PMC10410788 | ||
Results | DEEP-VEIN THROMBOSIS, COMPLICATIONS | A total of 55 patients were enrolled in the trial, with 48 (37 males and 11 females) completing the study, as depicted in Fig. Flowchart of included participantsComparison of baseline information and surgical information between the two groupsThere was no statistically significant difference in mean cement penetration ... | PMC10410788 | |
Discussion | knee arthroplasty, fatigue, TKA | COMPLICATIONS | This study showed that the application of PEEK prostheses in primary TKA produced comparable cement penetration as the traditional CoCrMo prostheses, while simultaneously offering similar short-term clinical and functional outcomes without increased complications. This indicates that PEEK knee prostheses are a safe and... | PMC10410788 |
Limitations | TKA | This study has several limitations. Firstly, this study presents a randomized controlled trial evaluating the cement penetration of the tibial component in TKA. However, the small sample size limits the analysis of the results. Secondly, only the cement penetration of the tibial component was analyzed, the femoral comp... | PMC10410788 | |
Conclusions | prothesis | The PEEK knee prothesis can make a similar bone cement penetration satisfactory short-term clinical outcomes and safety compared to CoCrMo prothesis. Further studies are necessary to evaluate the potential benefits and long-term outcomes of PEEK TKA. | PMC10410788 | |
Acknowledgements | Not applicable. | PMC10410788 | ||
Author contributions | JM and SY contributed to the conceptualization and methodology. GZ and XS contributed to the validation and data curation. JW contributed to the data analyze and was a major contributor in writing the manuscript. All authors read and approved the final manuscript. | PMC10410788 | ||
Funding | Not applicable. | PMC10410788 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10410788 | ||
Declarations | PMC10410788 | |||
Ethics approval and consent to participate | The clinical and radiographic results, according to the ethical guidelines of the Helsinki Declaration, were approved by the Human Ethics Committee of Honghui hospital. Written informed consent was obtained from individual or guardian participants. | PMC10410788 | ||
Consent for publication | Not applicable. | PMC10410788 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10410788 | ||
References | PMC10410788 | |||
Introduction | muscle contraction | STS | The aim of this study was to compare the effects of sit-to-stand (STS) training programs with 5 Muscle power is a key factor for the health and well-being of individuals, as it not only allows them to carry out daily physical activities (Muscle power is defined as the product of muscle contraction force and velocity, a... | PMC10349562 |
Materials and Methods | PMC10349562 | |||
Study design | RECRUITMENT, -20 | This was a three-arm, parallel-group, randomized trial. The study was conducted at the Basic Sciences Laboratory, Universidad San Sebastian, Valdivia, Chile. Recruitment was conducted through social media and email during the months of June, July, and August 2022. The study protocol was approved by the Scientific Ethic... | PMC10349562 | |
Allocation | The principal investigator generated a randomization sequence using an Stata 17.0 with blocks of varying sizes that were combined randomly. The allocation was performed in a one-to-one ratio, and allocation concealment was ensured by using sealed envelopes. | PMC10349562 | ||
Blinding | Neither the participants nor the providers were blinded in this study.All participants were invited to a familiarization visit in the laboratory. During this visit, the descriptive, biometric, and medical variables were assessed for each participant. We also determined whether or not the participants met the inclusion ... | PMC10349562 | ||
Design of the investigation. | PMC10349562 | |||
Participants | acute myocardial infarction, acute neuromuscular or joint injury, fracture | ACUTE MYOCARDIAL INFARCTION, HYPERTENSION, STS | Statistical software (G*Power, v3.1.9.7; Heinrich-Heine-Universität, Düsseldorf, Germany) was used to calculate the sample size. A moderate effect size of 0.95, obtained from a previous study (The participants selected for this study met the following criteria: 18 years of age or older, sedentary, and able to perform S... | PMC10349562 |
Primary outcomes | PMC10349562 | |||
Muscle function | STS | The Muscle Quality Index (MQI) was calculated using the formula proposed by Additionally, the relative mean STS power (W·KgRelative mean STS power = 0.9 × g × Height (0.5 × Chair height)/(Five STS time × 0.1). | PMC10349562 | |
Secondary outcomes | PMC10349562 | |||
Ultrasonography | In this study, ultrasound images were used to evaluate the muscle thickness (MT), pennation angle (PA), and fascicle length (FL) in each participant’s dominant lower limb. The probe was positioned on the longitudinal axis of the VL, and a linear B-mode probe with a frequency range of 7.5 10 MHz was used at a depth of 8... | PMC10349562 | ||
Anthropometry | stature | Body composition was assessed using bioelectrical impedance tetrapolar analysis (Rice Lake Body Composition D1000-3; Rice Lake, WI, USA). The stature was measured using a portable stadiometer (SECA, Model 213, Hamburg, Germany to 0.1 cm). Leg length was measured manually using an anthropometric measurement protocol ( | PMC10349562 | |
Sit-to-stand test | The time required for participants to complete five repetitions of the stand-and-sit exercise was established. During the evaluation, participants were advised to perform the repetitions as swiftly as possible, with their arms crossed over their chests at shoulder level. Three sets of five repetitions were timed, with ... | PMC10349562 | ||
Sit-to-stand training program | STS | During the first 4 weeks, the 5STS and 10STS groups performed the STS exercise three times per week. The 5STS performed three sets of five repetitions, and the 10STS three sets of 10 repetitions. A rest time of 30/60 s was considered for each set. During the last 4 weeks, the number of sets increased to five to continu... | PMC10349562 | |
Statistical analyses | Descriptive data are presented as mean ± standard deviation, with normality verified using the Shapiro-Wilk normality test. Additionally, the intraclass correlation coefficient (ICC), the standard error of measurement (SEM), and the minimal detectable change (MDC) were calculated ( | PMC10349562 | ||
Results | PMC10349562 | |||
CONSORT diagram of eligibility and inclusion of participants. | PMC10349562 | |||
Characteristics of the participants. |
Values are shown as mean ± standard deviation. | PMC10349562 | ||
Muscle function | STS | The study revealed significant time and group interactions for the MQI and relative STS power after 8 weeks of intervention. Specifically, both the 5STS and 10STS groups showed significant improvements in these parameters, with no notable differences between them.When comparing the pre- and post-measurements for each g... | PMC10349562 | |
Changes in muscle function. |
MQI, muscle quality index.= Significant change = Significant change | PMC10349562 | ||
Individual changes in functional performance. | PMC10349562 | |||
Muscle architecture | At the beginning of the study, no significant differences were detected among the 5STS, 10STS, and CG in any of the muscle architecture variables. Following the intervention, significant time × group interactions were observed for both MT and PA, but not for FL.When comparing the pre- and post-intervention measurements... | PMC10349562 | ||
Changes in muscle architecture of VL. |
MT, muscle thickness; PA, pennation angle. FL, fascicle length; VL, vastus lateralis.= Significant change = Significant change | PMC10349562 | ||
Individual changes in VL muscle architecture. | MT, muscle thickness; PA, pennation angle; FL, fascicle length. | PMC10349562 | ||
Discussion | CONTRACTION, STS | The objective of this research was to compare the effects of five and 10 repetitions of STS training programs on muscle function and muscle architecture in sedentary adults. The main findings of the study were that both the five and 10 repetitions of STS programs over an 8-week period resulted in significant increases ... | PMC10349562 | |
Conclusions | STS | In conclusion, the results of this study suggest that STS training effectively improves muscle quality and generates adaptations in the AP and MT muscles. These findings are important to understand that although a low volume of training was used, the results were positive in the study population. This finding indicates... | PMC10349562 | |
Supplemental Information | PMC10349562 | |||
Reporting checklist for randomised trial. | Click here for additional data file. | PMC10349562 | ||
Categorical Data. | Click here for additional data file. | PMC10349562 | ||
Study Data. | Pre and post intervention variables.Click here for additional data file.This article will be part of the Rodrigo Lizama-Pérez Doctoral thesis conducted in the Biomedicine Doctorate Program of the University of Granada, Spain. | PMC10349562 | ||
Additional Information and Declarations | PMC10349562 | |||
Competing Interests | The authors declare that they have no competing interests. | PMC10349562 | ||
Human Ethics | -20 | The following information was supplied relating to ethical approvals (The study protocol was approved by the Scientific Ethics Committee of the University of Granada, Spain (2380/CEIH/2021) and of the Universidad San Sebastián, Chile (55-2021-20). | PMC10349562 | |
Clinical Trial Ethics | -20 | The following information was supplied relating to ethical approvals (The study was conducted at the Basic Sciences Laboratory, Universidad San Sebastian, Valdivia, Chile. The study protocol was approved by the Scientific Ethics Committee of the University of Granada, Spain (2380/CEIH/2021) and of the Universidad San S... | PMC10349562 | |
Data Availability | The following information was supplied regarding data availability:The raw measurements are available in the | PMC10349562 | ||
References | PMC10349562 | |||
Abstract | HIV exhibit immune dysfunction | CHRONIC INFLAMMATION | The anti‐diabetic drug metformin may promote healthy aging. However, few clinical trials of metformin assessing biomarkers of aging have been completed. In this communication, we retrospectively examined the effect of metformin on epigenetic age using principal component (PC)‐based epigenetic clocks, mitotic clocks, an... | PMC10776116 |
INTRODUCTION | diabetes | DIABETES | Metformin is an FDA‐approved diabetes drug impacting aging biology (Barzilai et al., | PMC10776116 |
RESULTS AND DISCUSSION | First, we examined epigenetic clocks of monocyte cells from a 24‐week clinical trial of 12 participants (time since HIV diagnosis ranged from 13 to 29 years) that were randomized 1:1 to receive either adjunctive metformin (500 mg extended release increasing to 1000 mg at Week 4 until 24 weeks) or observation. The study... | PMC10776116 | ||
AUTHOR CONTRIBUTIONS | Michael J. Corley and Lishomwa C. Ndhlovu conceived, designed and carried out experiments. Alina PS Pang contributed to data analysis and interpretation. Cecilia M Shikuma contributed biological specimens and clinical data. Michael J. Corley and Lishomwa C. Ndhlovu drafted the manuscript. All authors critically reviewe... | PMC10776116 | ||
FUNDING INFORMATION | L. C. N. and M.J.C. were supported during the draft of the manuscript in part by the National Institutes of Health (NIH) grant number UM1AI164559. | PMC10776116 | ||
CONFLICT OF INTEREST STATEMENT | L.C.N. reports grants from the NIH and has received consulting fees from work as a scientific advisor for AbbVie, ViiV Healthcare, and Cytodyn and for service on the Board of Directors of CytoDyn and has financial interests in Ledidi AS, all for work outside of the submitted work. All other authors declare no competing... | PMC10776116 | ||
Supporting information |
Figure S1:
Click here for additional data file. | PMC10776116 | ||
ACKNOWLEDGMENTS | AIDS | AIDS | We gratefully acknowledge the study participants and the Hawaii Center for AIDS (HICFA) clinical study staff who made this work possible. We acknowledge support from Annette Jones at the UH Cancer Center for DNA methylation profiling of all samples. | PMC10776116 |
DATA AVAILABILITY STATEMENT | The data from this study was submitted to the NCBI Gene Expression Omnibus (GEO) | PMC10776116 | ||
REFERENCES | PMC10776116 | |||
Methods | RESPIRATORY FAILURE | In an open-label, single site randomized controlled trial (RCT), hospitalized COVID-19 patients were assigned to adjunctive Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally) with standard of care treatment compared to standard of care treatment alone. Primary endpoint was illness severity according to cha... | PMC9886260 | |
Results | Respiratory failure | RESPIRATORY FAILURE | From October 1, 2020 to April 30, 2021, a total of 98 patients, who had a median [IQR] age of 57 [47, 62] years and were 53.1% (n = 52) female, were randomized equally between study groups (n = 49 Aggrenox plus standard of care versus n = 49 standard of care alone). No clinically significant differences were found betw... | PMC9886260 |
Conclusion | respiratory failure, COVID illness | RESPIRATORY FAILURE | In this study of hospitalized patients with COVID-19, while the outcomes of COVID illness severity, odds of mortality, and chance of respiratory failure were better in the Aggrenox group compared to standard of care alone, the data did not reach statistical significance to support the standard use of adjuvant Aggrenox ... | PMC9886260 |
Data Availability | All relevant data are within the paper and its | PMC9886260 | ||
1 Introduction | deaths | VIRUS, INFLAMMATION, ADHESION, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME | A novel coronavirus was first reported in December 2019 and declared an international pandemic by the World Health Organization (WHO) on March 11, 2020. Approximately, 18–19 months later, more than 250 million cases have been confirmed resulting in over 5 million deaths [COVID-19 is caused by severe acute respiratory s... | PMC9886260 |
2 Methods | PMC9886260 | |||
2.1 Study design and participants | myocardial infarction, SARS-CoV-2 infection, angina, fever, shock, sub-valvular aortic stenosis, cough, hypoxemia | MYOCARDIAL INFARCTION, SARS-COV-2 INFECTION, SHOCK, ASYMPTOMATIC SARS-COV-2 INFECTION, BILATERAL PULMONARY INFILTRATES, GASTRIC OR DUODENAL ULCER, BLEEDING DISORDER, S; HEMOGLOBIN, G6PD DEFICIENCY | This study was a two-arm, open-label, single site randomized controlled trial (RCT) conducted in an urban academic medical center in New Jersey, United States of America. FDA-approval was obtained for exemption from Investigational New Drug Application (IND) to conduct a clinical investigation with the drug Aggrenox (D... | PMC9886260 |
Randomization and masking | CRF | CRF | Participants were randomly assigned to receive either adjunctive Aggrenox treatment along with standard of care (SOC) (Aggrenox group) or SOC (control group) alone in a 1:1 ratio using random permuted blocks. The randomization sequence was concealed from study staff and was integrated into the REDCap electronic data ca... | PMC9886260 |
Procedures | Patients in the Aggrenox group received Aggrenox (dipyridamole ER 200mg and aspirin 25mg), 2 times daily for a total of 2 weeks along with the SOC treatment. Standard of care treatment consisted of an intravenous Remidesivir 200 mg loading dose and then 100 mg daily for a total of 4 days for non-intubated patients and ... | PMC9886260 | ||
Outcomes | death, CPD, HTN, respiratory failure, CVD, Respiratory failure, diabetes | CVD, RESPIRATORY FAILURE, HTN, SECONDARY, RESPIRATORY FAILURE, DIABETES | The primary study outcome was change in composite COVID-ordinal scale (S1 Table in The secondary study outcomes included all-cause mortality and/or respiratory failure through days 14, 28, or final follow-up, compared between the study groups. Respiratory failure was defined as those requiring high-flow oxygen therapy,... | PMC9886260 |
2.2 Statistical analysis | ±, respiratory failure | REGRESSION, RESPIRATORY FAILURE, SECONDARY, EVENT | A sample size of 132 patients (66 patients per arm) was estimated to provide 90% power, while a sample size of 100 patients (50 patients per arm) was estimated to provide 80% power, to detect a relative between-group difference of 20% reduction in composite ordinal scale (from baseline to day 14) with an assumption of ... | PMC9886260 |
3 Results | PMC9886260 | |||
3.1 Demographics and presenting symptoms | From October 1, 2020 to April 30, 2021, a total of 98 patients with RT-PCR confirmed COVID-19 were enrolled and randomized equally between study groups (n = 49 per group). See consort flow diagram for details on enrollment and analysis ( | PMC9886260 | ||
Consort 2010 flow diagram. | PMC9886260 | |||
3.2 Primary outcome | CPD, HTN, CVD, diabetes | CVD, REGRESSION, HTN, DIABETES | Based on univariate analyses, both groups demonstrated statistically similar mean (SD) changes on the 8-point COVID ordinal scale of increasing illness severity through day 14 (Aggrenox: 2.3 (1.8) vs control: 2.1 (2.0); p = 0.74) and day 28 (Aggrenox: 2.5 (1.7) vs control: 2.0 (2.2), p = 0.24). More specifically, the m... | PMC9886260 |
3.3 Secondary outcomes | death | The overall mortality rate was 11.2% (n = 11). Univariate analyses suggested non-significant differences between study groups for the outcome of all-cause mortality, although less patients in the Aggrenox group died compared to the control group (Aggrenox: 4 vs control: 7; p = 0.34). Furthermore, while not statisticall... | PMC9886260 | |
Overall K-M Mortality (a), day 14 (b) and day 28 (c). | obesity, death, respiratory failure, CVD, CPD, diabetes | OBESITY, CVD, RESPIRATORY FAILURE, REGRESSIONS, DIABETES | A total of 11 (11.2%) patients experienced respiratory failure, defined as those requiring high-flow oxygen therapy, noninvasive ventilation, invasive ventilation, and/or death (levels 5–8 on COVID ordinal scale). Most of the patients who experienced respiratory failure were in the control group (Aggrenox: 4 vs control... | PMC9886260 |
3.4 COVID-19 related complications | acute renal injury, liver dysfunction, Disseminated intravascular coagulation | COMPLICATIONS, DISSEMINATED INTRAVASCULAR COAGULATION | The median [IQR] duration of hospital stay was 6 [4, 9] days, which was similar between groups (p = 0.45). A total of 12 patients were admitted to the ICU or high dependency unit (Aggrenox: 5 vs control: 7, p = 0.88), which lasted a median of 2 [1, 5] days. All patients required some form of oxygen therapy, which laste... | PMC9886260 |
3.5 Study drug-related adverse and SAEs | ADVERSE EVENTS, SECONDARY | No adverse or serious adverse events secondary to the study drug were seen in patients in the experimental treatment group. | PMC9886260 | |
3.6 Inflammatory markers for illness severity | respiratory failure | RESPIRATORY FAILURE, DECREASED LYMPHOCYTES | Inflammatory markers at patient presentation (day 1) which correlated with increased mortality through day 28 include decreased lymphocytes and platelets, as well as increased D-dimer, creatinine, C-reactive protein (CRP), urea, troponin, potassium, lactate dehydrogenase (LDH), and blood glucose levels. Patients that h... | PMC9886260 |
4 Discussion | death, critically ill, respiratory failure, stroke, venous thromboembolism, reduced overall illness, platelet aggregation | PERIPHERAL ARTERIAL DISEASE, CRITICALLY ILL, RESPIRATORY FAILURE, STROKE, DISEASE, COVID-19 INFECTION, ADHESION, EVENTS, COMPLICATIONS, INFLUENZA | In this RCT involving 98 hospitalized patients with confirmed COVID-19, an FDA-approved standard therapeutic-dose of Aggrenox in addition to the SOC treatment did not result in significantly reduced overall illness severity on the COVID ordinal scale, all-cause mortality, or respiratory failure as compared to the patie... | PMC9886260 |
4.1 Limitations | respiratory failure, deaths | RESPIRATORY FAILURE | The ATTAC-19 trial is not without its limitations. It is important to mention the current trial did identify a decrease in respiratory failure and all-cause mortality for the Aggrenox group compared to SOC alone, despite these data not reaching statistical significance. For instance, Aggrenox resulted in nearly half th... | PMC9886260 |
5 Conclusion | RESPIRATORY FAILURE | Adjuvant Aggrenox therapy was not associated with significantly reduced illness severity, respiratory failure, or all-cause mortality in hospitalized COVID-19 patients as compared with standard of care treatment alone. While these outcomes were numerically reduced in patients on both Aggrenox and SOC treatment, there i... | PMC9886260 | |
Supporting information | Yesenia | (DOCX)Click here for additional data file.(PDF)Click here for additional data file.We thank Roxanne Nagurka, Randall Teeter, Nancy Reilly, Olga Kovalenko and Yesenia Sanchez from the clinical research unit to help coordinate different research activities. We also thank Roxanne Nagurka and Yesenia Sanchez to help gather... | PMC9886260 | |
References | PMC9886260 |
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