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Exclusion criteria
rheumatoid arthritis, psychopathy, systemic infections
RHEUMATOID ARTHRITIS, CARDIAC DISEASES, CONTAGIOUS DISEASES, CHRONIC FATIGUE SYNDROME, KIDNEY DISEASES, PULMONARY DISEASES, MALIGNANT TUMORS, SYSTEMIC INFECTION, LIVER DISEASES, ANKYLOSING SPONDYLITIS
Individuals with knee-related conditions such as rheumatoid arthritis, fibromyalgia syndrome, chronic fatigue syndrome, and ankylosing spondylitis were not included in the study. Additionally, individuals who met the following criteria were also excluded.Those who had taken steroid medication or undergone acupuncture/m...
PMC10666435
Randomization and blinding
A total of 392 eligible participants were divided into two groups: the LM group and the sham LM group. The allocation of patients to these groups was determined through a computer-generated randomization sequence. The subjects were assigned numbers based on the order in which they completed the forms. A statistician ge...
PMC10666435
Intervention
PMC10666435
CO
In this clinical study, the SX10-C1 CO
PMC10666435
Duration and method of treatment
Participants were positioned in a supine posture with both knees exposed and padded below the popliteal fossa using a small pillow to maintain a slightly bent and relaxed position. Two specific acupoints were chosen, namely the Dubi point (ST35, situated on the outer side of the patella and in the recess of the patella...
PMC10666435
Outcome
The fasting 15-m walking time was recorded prior to the intervention, during Week 4, and at Week 12.
PMC10666435
Statistical methods
The statistical analysis of the data involved was conducted using SPSS version 22.0 software. To assess whether the data followed a normal distribution, the Wilcoxon test was employed. If the data exhibited a normal distribution, it was presented as the mean ± standard deviation. Alternatively, for data that did not ad...
PMC10666435
Discussion
pain, knee joint injuries, TCM, KOA
OSTEOARTHRITIS, SYNDROME, DYSFUNCTION
KOA, referred to as “Knee Arthralgia” in traditional Chinese medicine (TCM), falls under the category of “Bi syndrome” in TCM [Building on this foundation, we conducted a randomized, double-blind controlled trial involving LM. After a four-week treatment period, we observed significant improvements in pain symptoms in ...
PMC10666435
Acknowledgements
The authors would like to thank the patients in this study for their cooperation and commitment.
PMC10666435
Author contributions
SXY was involved in conception and design of the research and obtaining financing. Z.L., C.K., W.F, and L.L. were involved in acquisition of data. C.K., W.F., and L.L. analyzed and interpreted the data. C.L.S. performed statistical analysis and wrote the manuscript. Z.L. and S.X.Y. were involved in critical revision of...
PMC10666435
Funding
This trial was supported by the National Natural Science Foundation of China (81320108028) and the National Program on Key Basic Research Project of China (2015CB554505).
PMC10666435
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC10666435
Declarations
PMC10666435
Ethical approval and consent to participate
All procedures performed in studies involving human patients were in accordance with the ethical standards of the Ethical and Scientific Committee of Six hospitals with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Specifically, the IRBs that approved the study were the IRB of ...
PMC10666435
Consent for publication
Not applicable.
PMC10666435
Competing interests
The authors declare that they have no competing interests.
PMC10666435
References
PMC10666435
Background
Aerobic exercise promotes cognitive function in older adults; however, variability exists in the degree of benefit. The brain-derived neurotropic factor (BDNF) Val66Met polymorphism and biological sex are biological factors that have been proposed as important modifiers of exercise efficacy. Therefore, we assessed whet...
PMC10069071
Methods
SECONDARY
We used data from a single-blind randomized controlled trial in older adults with subcortical ischemic vascular cognitive impairment (NCT01027858). Fifty-eight older adults were randomly assigned to either the 6 months, three times per week progressive aerobic training (AT) group or the usual care plus education contro...
PMC10069071
Results
Analysis of covariance, controlling for baseline global cognition and baseline executive functions performance (Trail Making Test or Digit Symbol Substitution Test), tested the three-way interaction between experimental group (AT, CON), BDNFval66met genotype (Val/Val carrier, Met carrier), and biological sex (female, m...
PMC10069071
Conclusions
vascular cognitive impairment
VASCULAR COGNITIVE IMPAIRMENT
These results suggest that future randomized controlled trials should take into consideration BDNF genotype and biological sex to better understand the beneficial effects of AT on cognitive function in vascular cognitive impairment to maximize the beneficial effects of exercise and help establish exercise as medicine f...
PMC10069071
Highlights
vascular cognitive impairment
VASCULAR COGNITIVE IMPAIRMENT
Aerobic training improves cognitive health and identifying biological moderators of aerobic training will maximize the precision of exercise as medicine for cognitive health.The common BDNFval66met polymorphism and biological sex interact to moderate the cognitive-enhancing effects of aerobic training in older adults ...
PMC10069071
Keywords
PMC10069071
Background
vascular cognitive impairment, ischemic strokes, gait disturbances, white matter hyperintensities
VASCULAR COGNITIVE IMPAIRMENT, ISCHEMIC STROKES, WHITE MATTER HYPERINTENSITIES
Evidence supports aerobic training (AT) as a strategy to improve cognitive health, with the strongest evidence seen in older adults and for executive functions [It is hypothesized that one possible pathway through which AT benefits cognition is the induction of the brain-derived neurotrophic factor (BDNF) cascade, whic...
PMC10069071
Methods
PMC10069071
Study design
The data for this analysis originated from a 26-week randomized controlled trial at the University of British Columbia campus at the Vancouver General Hospital. The primary findings and methods of this randomized controlled trial are published [
PMC10069071
Participants
Alzheimer’s Disease, Stroke
DISORDERS, STROKE
All participants were recruited from the University of British Columbia Hospital Clinic for Alzheimer’s Disease and Related Disorders, the Vancouver General Hospital Stroke Prevention Clinic, and specialized geriatric clinics in Metro Vancouver, Canada. A complete description of the inclusion and exclusion criteria can...
PMC10069071
Descriptive and demographic variables
Baseline age, sex, education level, weight (kg), height (cm), body mass index (kg/m
PMC10069071
Executive functions
We previously found a sex-dependent effect of AT on the executive function of set-shifting using the Trail Making test in SIVCI adults [Biological sex interacts with the BDNFval66met polymorphism to influence Digit Symbol Substitution Test [
PMC10069071
Experimental groups
PMC10069071
Aerobic Training group (AT)
Classes were led by certified fitness instructors, were 60-min in duration (10-min warm-up, 40-min walking, 10-min cool down), and occurred 3×/week for 6 months. Adherence was monitored by recording class attendance. The AT intensity was monitored via heart rate monitors as well as the 20-point Borg Rating of Perceived...
PMC10069071
Usual care plus education group (CON)
VASCULAR COGNITIVE IMPAIRMENT
Participants in the CON group attended monthly education classes given by a registered dietician and read materials pertaining to vascular cognitive impairment and healthy diets. Information regarding exercise and physical activity were not provided.
PMC10069071
Genotyping
Peripheral whole blood samples were collected in BD Vacutainer lavender top blood collection tubes at baseline and were stored at − 80 °C. DNA was extracted from whole blood using an automated DNA extraction machine (AutoGen FLEX STAR, Hollisten, MA). Genotyping of the BDNFval66met polymorphism (GenBank dbSNP: rs6265) ...
PMC10069071
Statistical analyses
SECONDARY
The statistical package SPSS 23.0 (IBM Corporation Armonk, NY) was used to conduct analysis of covariance to evaluate the main effects of and interactions between experimental group (AT, CON), BDNF genotype (Val/Val carrier, Met carrier), and biological sex (female, male) for the primary (i.e., Trail Making Test) and s...
PMC10069071
Results
PMC10069071
Sample description
Of the 71 participants enrolled in the original trial, the present analyses are based on 58 of those participants that completed the trial with BDNF genotyping (Fig. CONSORT diagram for the flow of participants in a randomized controlled trialBaseline characteristics of male and female BDNF Val/Val carriers and Met car...
PMC10069071
Sex and genotype dependent effect of aerobic training on executive functions
Table There was a significant three-way interaction between experimental group, BDNF genotype, and sex [F(1,48) = 4.412, Total time taken to complete the Trail Making Test (B–A) in seconds at trial completion, adjusted for baseline Montreal Cognitive Assessment and baseline Trail Making Test (B–A) scores. A 6-month aer...
PMC10069071
Discussion
Alzheimer’s disease, dementia, Heras
Results from this randomized controlled trial provide preliminary evidence that BDNFval66met genotype interacts with biological sex to influence AT efficacy on executive functions in older adults with SIVCI, a clinical population with increased dementia risk. Specifically, we found that engaging in 6 months of AT compa...
PMC10069071
Limitations
As is the case with most studies examining the effects of polymorphisms on cognition, our analyses are limited by the small number of male and female BDNF Met allele carriers. The Met allele is found in 30–70% of the population, depending on ethnicity [
PMC10069071
Author contributions
CKB and TLA outlined and executed the analyses in this manuscript and drafted the manuscript. SYS helped with data analysis and contributed to the writing of the manuscript. GYRH and RT provided intellectual input and were involved in data collection for the primary RCT. All authors read and approved the final manuscri...
PMC10069071
Funding
Stroke
HEART, ALZHEIMER, STROKE, BROWN
Teresa Liu-Ambrose is a Canada Research Chair (Tier 1) in Healthy Aging. Cindy Barha is a Alzheimer’s Association and Brain Canada Postdoctoral Fellow. This study was funded by the Canadian Stroke Network, the Heart and Stroke Foundation of Canada, and the Jack Brown & Family Alzheimer’s Research Foundation, and the Ca...
PMC10069071
Availability of data and materials
The data sets used and analysed during the current study are available from the corresponding author on reasonable request.
PMC10069071
Declarations
PMC10069071
Ethics approval and consent to participate
Ethics approval was obtained from the Clinical Research Ethics Board at the University of British Columbia (H07-01160). All participants provided written informed consent.
PMC10069071
Consent for publication
Not applicable.
PMC10069071
Competing interests
The authors declare that they have no competing interests.
PMC10069071
References
PMC10069071
Background
POSTOPERATIVE ATELECTASIS
To compare the effects of laryngeal mask mechanical ventilation and preserved spontaneous breathing on postoperative atelectasis in children undergoing day surgery.
PMC10626763
Methods
Children aged 3–7 who underwent elective day surgery were randomly divided into a spontaneous breathing group (
PMC10626763
Results
atelectasis
ATELECTASIS
The incidence of atelectasis in the spontaneous breathing group was 91.30%, and 39.13% in the mechanical ventilation group, and the difference was statistically significant (
PMC10626763
Conclusion
postoperative atelectasis, reflux
POSTOPERATIVE ATELECTASIS, COMPLICATIONS, REFLUX
Laryngeal mask mechanical ventilation can reduce the incidence and severity of postoperative atelectasis in children undergoing day surgery, and we didn’t encounter any complications such as reflux and aspiration in children during the perioperative period, so mechanical ventilation was recommended to be used for airwa...
PMC10626763
Trial registration
The clinical trial was registered retrospectively at the Chinese Clinical Trial Registry. (
PMC10626763
Keywords
PMC10626763
Introduction
postoperative pulmonary complications, reflux, Atelectasis, supraglottic airway, atelectasis, pulmonary infection
REFLUX, ATELECTASIS, ATELECTASIS, PULMONARY INFECTION, PERIOPERATIVE COMPLICATION, POSTOPERATIVE ATELECTASIS, COMPLICATIONS
Atelectasis is a common perioperative complication. It has been reported [Day surgery refers to operations that require the participation of anesthesiologists within 24 h from admission to discharge. These children were hospitalised for a shorter period of time for observation and are prone to complications such as pul...
PMC10626763
Materials and methods
cryptorchidism
CARDIOPULMONARY DISEASE, RESPIRATORY INFECTION, DISEASE, NEUROMUSCULAR DISEASE, PULMONARY ATELECTASIS, DIRECT INGUINAL HERNIA
This study was performed at the Children’s Hospital of Nanjing Medical University from April to August 2022 and was approved by the Ethics Committee of the Children’s Hospital of Nanjing Medical University (approval number: 202112124–1). Inclusion criteria: 1) Children aged 3 ~ 7 years, ASA class I or II, undergoing da...
PMC10626763
Randomization and blinding
Group allocation was concealed in sequentially numbered, opaque, sealed envelopes that were opened by trained study personnel. Each envelope contained the group allocation and instructions for the attending anaesthesiologist. Weiwei Cai generated the random allocation sequence, Huanhuan Ni enrolled participants, and Lo...
PMC10626763
Anesthesia
An intravenous route was established before the patient was brought to the operating room. An electrocardiogram, pulse oxygen saturation, blood pressure, end-tidal carbon dioxide, respiratory rate and body temperature were monitored after entering the operating room. A standard anesthetic protocol was used for all pati...
PMC10626763
Lung ultrasound examination
pulmonary atelectasis, atelectasis
PULMONARY ATELECTASIS, LUNG, ATELECTASIS
Lung ultrasound was performed twice before the induction of anesthesia and 20 min after the removal of the laryngeal mask. The lung ultrasound was performed by a specialist anesthetist trained in lung ultrasound with an M7series ultrasound machine (Shenzhen Myriad Biomedical Electronics Co., Ltd.). A 4–10 MHz line arra...
PMC10626763
Outcome variables
postoperative atelectasis, atelectasis, reflux
POSTOPERATIVE ATELECTASIS, ATELECTASIS, COMPLICATIONS, REFLUX
The primary outcomes were the incidence of postoperative atelectasis (Because grade 1 atelectasis is easy to recover, only patients with grade 2 or higher atelectasis were included in the calculation of the incidence of atelectasis) and the postoperative atelectasis score. Secondary outcomes were baseline data, duratio...
PMC10626763
Study sample size and statistical analysis
atelectasis
ATELECTASIS
Our sample size was calculated using data obtained from pre-test results, the incidence of atelectasis in the spontaneous breathing group was approximately 90% and in the mechanical ventilation group was 40%. The sample size was calculated using G Power software, the require sample size was at least 22 patients in each...
PMC10626763
Acknowledgements
Not applicable.
PMC10626763
Authors’ contributions
Weiwei Cai is the first author, he designed the study, peformed the research, analysed most of the data and wrote the paper. Wei Gu was responsible for data analysis. Huanhuan Ni and Longde Zhao were responsible for data collection. Shan Zhong and Wei Wang were correspondence author and they were contributed equally to...
PMC10626763
Funding
Not applicable.
PMC10626763
Availability of data and materials
The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.
PMC10626763
Declarations
PMC10626763
Ethics approval and consent to participate
The experimental protocol was established, according to the ethical guidelines of Helsinki Declaration and was approved by the Ethics Committee of the Children’s Hospital of Nanjing Medical University (approval number: 202112124–1). Written informed consent was obtained from guardian participants.
PMC10626763
Consent for publication
Not applicable.
PMC10626763
Competing interests
The authors declare no competing interests.
PMC10626763
References
PMC10626763
Background
bleeding, abdominal injuries, trauma
BLEEDING
Previous observational studies showed higher rates of abdominal wall closure with the use of hypertonic saline in trauma patients with abdominal injuries. However, no randomized controlled trials have been performed on this matter. This double-blind randomized clinical trial assessed the effect of 3% hypertonic saline ...
PMC9830760
Methods
abdominal injuries, DCL
Double-blind randomized clinical trial. Patients with abdominal injuries requiring damage control laparotomy (DCL) were randomly allocated to receive a 72-h infusion (rate: 50 mL/h) of 3% HS or 0.9 N isotonic saline (NS) after the index DCL. The primary endpoint was the proportion of patients with abdominal wall closur...
PMC9830760
Results
The study was suspended in the first interim analysis because of futility. A total of 52 patients were included. Of these, 27 and 25 were randomly allocated to NS and HS, respectively. There were no significant differences in the rates of abdominal wall closure between groups (HS: 19 [79.2%] vs. NS: 17 [70.8%];
PMC9830760
Keywords
PMC9830760
Introduction
injuries, abdominal trauma
Since patients with abdominal trauma often present severe injuries and impaired physiology, they tend to require damage-control abdominal surgery followed by damage-control resuscitation [A potential intervention to reduce the volume of intravenous fluids infused without putting resuscitation in peril is hypertonic sal...
PMC9830760
Methods
PMC9830760
Setting, study design, and oversight
FVL, trauma
DEL
This double-blind, randomized, placebo-controlled trial was conducted at Fundación Valle del Lili (FVL) University hospital between November 2015 and August 2018. The FVL is a fourth-level university hospital equivalent to a US-level I trauma center, and it has 523 beds. Of these, 205 are ICU beds and 10 are reserved f...
PMC9830760
Patients
bleeding, hypothermia, traumatic injuries, hemoperitoneum, hyperlactatemia, abdominal injuries, intra-abdominal organ injuries, DCL, metabolic acidosis, trauma
METABOLIC ACIDOSIS, BLEEDING, HEMOPERITONEUM
Adult patients with traumatic injuries were eligible for the study if they were to undergo damage control abdominal surgery in the index laparotomy. Specific inclusion criteria were: 1. informed consent obtained before any trial-related activities, 2. age above or equal to 18 years at the time of inclusion, and 3. pati...
PMC9830760
Exclusion criteria
death, traumatic injuries, traumatic brain injury, post-traumatic intrabdominal infections, postoperative bleeding, DCL, deaths, trauma
POSTOPERATIVE BLEEDING
Patients were excluded if the time between the occurrence of his/her traumatic injuries and the randomization was longer than four hours, had a severe traumatic brain injury, and had a high probability of death in the first 48 h. Although the treating surgeon subjectively determined this, the decision was based on what...
PMC9830760
Study protocol
organ injury, DCL, trauma
COMPLICATIONS
Patients in both study groups received trauma care in the emergency department and the operating group following current clinical practice guidelines and institutional protocols. After the decision to perform a DCL, patients underwent randomization in a double-blind manner. Randomization was performed in permuted block...
PMC9830760
Study end points and definitions
intra-abdominal hypertension, organic dysfunction
ABDOMINAL COMPARTMENT SYNDROME, DYSFUNCTION, INTRA-ABDOMINAL HYPERTENSION
The primary endpoint of the trial was the proportion of patients with abdominal wall closure in the first seven days after the index surgery.Secondary endpoints were: 28-day mortality, the fluid balance during the first 72 h, the proportion of patients requiring reoperation for intra-abdominal hypertension, the proport...
PMC9830760
Statistical analysis
®
The trial was designed on the assumption of the superiority principle to have 80% power with a The trial team had full access to the data and was responsible for the analysis. All analyses were performed in a blinded manner so that investigators could not know if subjects were assigned to the control or treatment group...
PMC9830760
Early termination of the clinical trial
hypernatremia
HYPERNATREMIA
After recruiting the first 50 cases, an independent statistician performed the first interim analysis. A power of 0.09 was found, and a conditional power of 0.34 was calculated for the planned sample size. The 95% CI for the RR at this level would have been 0.99–1.27. The recalculation of the sample size at the same p ...
PMC9830760
Limitations
Our study has limitations. First, the small number of patients available for analysis limits the results’ generalizability despite the randomization. Second, one of the most obvious shortcomings of this study is its potentially limited external validity derived from its single-center nature. Third, related to its low s...
PMC9830760
Conclusion
HYPERNATREMIA
This randomized clinical trial showed no benefit of hypertonic saline solution in primary fascial closure rates. Patients randomized to HS had higher sodium concentrations after the first day and were more likely to present hypernatremia. We do not recommend using HS in patients undergoing damage control laparotomy.
PMC9830760
Acknowledgements
The authors of this manuscript want to thank the Clinical Research Center staff for their constant support.
PMC9830760
Author contributions
JCP
Trial design: AFG, GAOT, and JCP. Writing of the trial protocol: AFG. Screening, randomization, and follow-up of the patients: MPN, JCY, JGB, and RMN. Statistical analyses: AFG and AIS. Critical evaluation of the results: AFG, DCC, AIS, JHM, GAOT, CAO, and JCP. Writing of the first draft of the manuscript: AFG and RMN....
PMC9830760
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
PMC9830760
Availability of data and materials
The datasets generated and/or analyzed during the current study are not publicly available due to privacy concerns but are available from the corresponding author on reasonable request.
PMC9830760
Declarations
PMC9830760
Competing interests
The authors declare no competing interests.
PMC9830760
Ethics approval and consent to participate
DEL
All research involving human participants reported in the present randomized controlled trial was performed in accordance with the declaration of Helsinki and was approved by the ethical and biomedical research committee at Fundación Valle del Lili University Hospital.
PMC9830760
Consent for publication
DEL
Written informed consent was obtained from patients or another surrogate decision-maker before any trial-related activities. The informed consent process was approved by the ethical and biomedical research committee at Fundación Valle del Lili University Hospital.
PMC9830760
Competing interest
The authors declare that they have no competing interests.
PMC9830760
References
PMC9830760
Background
pain
Evidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain has been documented in several phase 2 trials, but comparison with standard treatments in large, randomized studies is needed.
PMC9978987
Objective
In this open-label, multicenter, randomized, phase 3 trial, we evaluated the safety and efficacy of a novel VR therapy solution for distraction in the context of bone marrow biopsy.
PMC9978987
Methods
anxiety, pain
Bliss is a VR software with 4 imaginary interactive environments in 3 dimensions with binaural sound (head-mounted display). Efficacy regarding pain intensity was evaluated using a visual analog scale (VAS; score from 0 to 10) immediately after the biopsy. Secondary end points were anxiety and tolerance. Modified inten...
PMC9978987
Results
malignant hemopathy, hemopathy, –1.6, pain
MAY
Overall, 126 patients with previously documented untreated or suspected malignant hemopathy between September 6, 2018, and May 18, 2020, were randomly assigned in a 1:1 ratio to receive pain prevention with a mixture of nitrous oxide/oxygen (MEOPA; n=63) or VR (n=63) before and during the bone marrow biopsy. We exclude...
PMC9978987
Conclusions
pain
The intensity of pain did not significantly differ between both arms. VR was well tolerated, and the satisfaction of patients, nurses, and physicians was very high. VR could be an alternative treatment in case of contraindication or intolerance to MEOPA.
PMC9978987
Trial Registration
ClinicalTrials.gov NCT03483194; https://clinicaltrials.gov/ct2/show/NCT03483194
PMC9978987