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Discussion | fifty-four | RECRUITMENT | Intention-to-treat analyses found no significant group-by-time interaction for diet quality outcomes in this RCT of three levels of personalised dietary feedback for young adults. Recruiting and retaining young adults over the 12-month intervention was a challenge. Web-based interventions tailored to young adults requi... | PMC10346011 |
Limitations | The high loss to follow-up needs to be considered when interpreting results. Process evaluation findings also need to be interpreted with caution as it is possible that satisfaction rates changed over time; however, this was not captured due to the high attrition rates. Dietary data were collected by self-report; there... | PMC10346011 | ||
Conclusions | RECRUITMENT | In this randomised trial investigating three levels of web-based personalised dietary feedback, no differences were seen for dietary outcomes over 12 months. We experienced challenges with the recruitment, engagement and retention of young adults. Future research could investigate co-design methods to explore suitable ... | PMC10346011 | |
Conflicts of interest: | The authors declare that they have no competing interests. | PMC10346011 | ||
Supplementary material | For supplementary material accompanying this paper visit https://doi.org/10.1017/S1368980023000253.click here to view supplementary material | PMC10346011 | ||
References | PMC10346011 | |||
Background: | knee pain, pain | DISEASE, CHONDROMALACIA PATELLAE | Chondromalacia patellae (CP) is a common and main cause of knee pain, the prevalence of the disease in the general population is as high as 36.2%, especially in middle-aged patients aged between 30 and 40 years (up to 50%). The use of manual therapy (MT) to dredge the meridians and muscles around the knee joint and sti... | PMC10270499 |
Methods: | Arthritis, pain | ARTHRITIS, ADVERSE REACTIONS | A prospective randomized controlled clinical trial design was used to study the efficacy and safety of MT in the treatment of CP. One hundred and twenty cases of CP patients will be recruited and randomly divided into experimental group and control group according to 1:1. The control group: sodium hyaluronate; experime... | PMC10270499 |
Discussion: | This study will precisely evaluate the effectiveness and safety of MT in the treatment of CP. The results of this experiment will provide more reliable clinical basis for the selection of MT for patients with CP. | PMC10270499 | ||
1. Introduction | patellofemoral joint syndrome, pain | ANTERIOR KNEE PAIN SYNDROME, PATELLOFEMORAL PAIN SYNDROME, CHONDROMALACIA PATELLAE, DISEASE | Chondromalacia patellae (CP), also known as patellofemoral pain syndrome, anterior knee pain syndrome, patellofemoral joint syndrome, etc., was first proposed by Aleman.CP is generally treated conservatively in the early stage of the disease, while surgical treatment is suitable for advanced patients. Through methods i... | PMC10270499 |
2. Materials and methods | PMC10270499 | |||
2.1. Study design | This is a prospective randomized controlled clinical trial studying the effects of MT on CP. This protocol follows the latest Consolidated Standards of Reporting Trials (2017) (flowchart is shown in Fig. Study flow chart. | PMC10270499 | ||
2.2. Ethics and registration | This research scheme is approved by the Clinical Research Ethics Committee of our hospital. This experiment has been registered om Chinese Clinical Trial Registry (registration number: ChiCTR2300068655). Before randomization, all patients needed to sign an informed consent form, and only patients who sign informed cons... | PMC10270499 | ||
2.3. Patients | PMC10270499 | |||
1.2.3. Inclusion criteria. | DISEASES, BONE DISEASES, CAVITY | Those who meet the diagnostic criteria of CP; age: ≥18 and ≤65 years old, regardless of gender; within 3 months before enrollment, they did not receive joint cavity injection treatment and did not take any drugs to treat CP; those who have certain communication and understanding ability, and can express their own will ... | PMC10270499 | |
2.2.3. Exclusion criteria. | mental illness, allergic, liver and kidney dysfunction, swelling, impairment of limb function, skin infection | SYSTEMIC ILLNESS, ULCERATION, SKIN INFECTION | Patients who suffer from acute systemic illness or acute swelling; patients who have severe impairment of limb function; patients with severe heart, lung, liver and kidney dysfunction; patients with local skin infection or ulceration; patients combined with severe mental illness; patients who are allergic to the drugs ... | PMC10270499 |
3.2.3. Elimination criteria. | ADVERSE EVENTS, DISEASE, COMPLICATIONS | Patients with serious adverse events or serious complications, which is not suitable for the next step; patients with poor compliance, affecting the judgment of efficacy and safety; the disease progresses during the treatment process, and the treatment plan needs to be changed; and for any reason, the subject asked to ... | PMC10270499 | |
2.4. Sample size calculation | According to the preliminary clinical trial, the total effective rate of MT combined with sodium hyaluronate was 93.4%, and that of sodium hyaluronate was 66.6%. Use PASS15.0 to estimate the sample size, adopt a superiority design, in which α = 0.05, β = 0.2, test power = 0.8, number of cases in experimental group: num... | PMC10270499 | ||
2.5. Interventions | This study will select patients who meet the study criteria by recruiting them at the hospital. A randomized controlled study will be conducted, in which sodium hyaluronate will be used in the control group and the experimental group will include MT exercise on the basis of the control group. If necessary, the attendin... | PMC10270499 | ||
2.5.1. Control group. | joints, depression, anxiety, damage joints | STERILE, JOINT EFFUSION, CAVITY | Patients will be placed in the sitting or supine position, and the knee joint will be kept bent 70° to 90°, sterilized strictly, with sterile towel laid and aseptic operation performed. The lower lateral or inner side of the patella will be used as the conventional puncture point, and the knee joint cavity will be punc... | PMC10270499 |
2.5.2. Treatment group. | The treatment group will be given MT on the basis of conventional treatment. Manual therapy is jointly completed by 2 experienced doctors, it lasts for about 20 minutes per time, once a day, and lasts for 4 weeks in total. | PMC10270499 | ||
2.6. Outcomes | PMC10270499 | |||
2.6.1. Observation indicator. | Arthritis, pain | ARTHRITIS | Improvement in joint pain and function is the main observation item, and which is respectively assessed by the visual analogue scale pain score or a comprehensive evaluation commonly using the Western Ontario and McMaster Universities Arthritis Index scores, Lysholm scores, or Bristol scores. | PMC10270499 |
2.6.2. Efficacy indicator. | pain | Main efficacy indicators: total effective rate: (clinical control + significantly effective number + effective number)/total number of people × 100%. Clinical control: pain and other symptoms disappear, joint activity is normal, integral reduction ≥ 95%; significantly effective: pain and other symptoms disappear, joint... | PMC10270499 | |
2.6.3. Adverse events rate. | dizziness, nausea | Including the number of patients who experience any uncomfortable symptoms during treatment (such as dizziness, nausea, etc). | PMC10270499 | |
2.7. Data collection and management | Data will be collected according to the evaluation criteria before and 4 weeks after the treatment, and each patient was followed up by telephone for 3 months after the end of treatment. It was impossible to collect follow-up information and record the reasons for loss to follow-up. Access to the database is limited to... | PMC10270499 | ||
2.8. Study quality control | EVENTS, ADVERSE EVENT | Throughout the trial, each participant will be monitored for safety. All adverse event occurrences will be referred to the office of the Clinical Research Ethics Committee, which will review the events and determine causal relationship. | PMC10270499 | |
2.9. Statistical analysis | In this study, SPSS25.0 statistical analysis software (IBM, Amenk, NY) will be used for data analysis. If the measurement data meet the normal distribution, independent-sample | PMC10270499 | ||
3. Discussion | osseous venous stasis, Pain | COLD, DYSFUNCTION, ADHESION, HEAT, HYPERTENSION, DISEASES | CP is one of the common diseases of knee joint. Pain and dysfunction caused by CP severely decreases the quality of life of patients. Currently, the diagnostic standard of CP has not yet formed a unified consensus. There is no effective cure for the treatment of CP, and the effects of surgical treatment which are widel... | PMC10270499 |
Abbreviations: | chondromalacia | CHONDROMALACIA, CHONDROMALACIA PATELLAE | chondromalacia patellaemanual therapyYC and YD contributed equally to this work.This work is supported by Hunan Traditional Chinese Medicine Science and Technology Plan Project (D2022037), Scientific Research Project Plan of Hunan Provincial Department of Education (21C0224), and Scientific Research Fund of Hunan Unive... | PMC10270499 |
References | PMC10270499 | |||
Background | Enhanced recovery after surgery (ERAS) is now widely used in various surgical fields including gynecological laparoscopic surgery, but the advantages of opioid-free anesthesia (OFA) in gynecological laparoscopic surgery under ERAS protocol are inexact. | PMC9881250 | ||
Aims | This study aims to assess the effectiveness and feasibility of OFA technique versus traditional opioid-based anesthesia (OA) technique in gynecological laparoscopic surgery under ERAS. | PMC9881250 | ||
Methods | Adult female patients aged 18 ~ 65 years old undergoing gynecological laparoscopic surgery were randomly divided into OFA group (Group OFA, | PMC9881250 | ||
Results | AUC | PMC9881250 | ||
Conclusion | PONV | In gynecological laparoscopic surgery under ERAS protocol, OFA technique is non-inferior to OA technique in analgesic effect and intraoperative anesthesia stability. Although awakening and orientation recovery times were prolonged compared to OA, OFA had lower incidence of PONV and improved postoperative sleep quality. | PMC9881250 | |
Trial registration | ChiCTR2100052761, 05/11/2021. | PMC9881250 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12871-023-01994-5. | PMC9881250 | ||
Keywords | PMC9881250 | |||
Introduction | postoperative adverse reaction, postoperative pain, nausea and vomiting, constipation, dizziness, skin itching, trauma | RESPIRATORY DEPRESSION, INFLAMMATORY RESPONSE | Gynecological laparoscopic surgery has become the main surgical method of gynecological surgery for its advantages of small trauma, light stimulation to patients and short recovery time. Although generally, laparoscopic technique is less painful than the open one, there are still about 20%-40% of patients have moderate... | PMC9881250 |
Materials and methods | PMC9881250 | |||
Study design | This prospective, randomized single-centre non-inferiority trial was approved by the Institutional Review Board (IRB) of Hefei Hospital affiliated Anhui Medical University (IRB approved registration number: 2021-KeYan-042) and was registered in the Chinese Clinical Trial Registry (ChiCTR2100052761, 05/11/2021). All met... | PMC9881250 | ||
Participants | comprehension impairment, allergy, alcohol abuse, drug dependence | MAY, ALLERGY, DYSFUNCTION | Adult female patients assessed as American Society of Anesthesiologists Grades I to III undergoing elective laparoscopic hysterectomy for benign causes under general anesthesia between November 2021 and May 2022 were enrolled, aged 18 ~ 65 years old. Exclusion criteria included: a. allergy to study drugs; b. language, ... | PMC9881250 |
Outcomes | According to Petersen’s study [ | PMC9881250 | ||
Randomization and blinding | All patients were randomly divided into OFA group (Group OFA) or OA group (Group OA). Randomization was conducted using a computer-generated allocation sequence with a 1:1 allocation by an independent investigator. The randomization sequence was placed in sequentially numbered opaque sealed envelopes and revealed by an... | PMC9881250 | ||
ERAS protocol [ | euvolemia, nausea and vomiting |
Carbohydrate-rich diet the day before surgeryNo mechanical bowel preparation6 h fast for solids and 2 h fast for clear liquidMaintain euvolemia during surgeryPreemptive analgesiaActive heating during surgeryPostoperative nausea and vomiting prophylaxisRestrictive fluid therapy after surgeryResumption of oral intake of... | PMC9881250 | |
Anesthetic management | All patients undergoing elective gynecological laparoscopic surgery were treated according to ERAS protocol during perioperative period and no preoperative drugs were administered before induction. All patients received total intravenous anesthesia (TIVA) without inhalation. | PMC9881250 | ||
Induction of general anesthesia | Routine monitoring devices were set up to monitor noninvasive blood pressure (BP), electrocardiogram (ECG), heart rate (HR), oxygen saturation (SpO | PMC9881250 | ||
Maintenance of general anesthesia | Intravenous infusion of flurbiprofen axate 50 mg for preventive analgesia were administered 10 min before skin incision in both groups. In group OFA, continuous intravenous infusion of dexmedetomidine 0.1–0.3 μg/kg/min, esketamine 0.3 mg/kg/h [ | PMC9881250 | ||
After anesthesia | Patients were transferred to PACU after surgery. When patient was conscious and responsive according to command as well as the BIS index was more than 90, I-gel was removed. | PMC9881250 | ||
Postoperative analgesia and acute pain management | pain | All patients received postoperative controlled intravenous analgesia (PCIA). PCIA protocol of group OFA: esketamine 2.5 mg/kg + flurbiprofen axate 2.5 mg/kg + azasetron 30 mg with total amount of 100 ml and constant infusion rate of 2 ml/h, and in group OA: sufentanil 2 µg/kg + flurbiprofen axate 2.5 mg/kg + azasetron ... | PMC9881250 | |
Observation indicators | PMC9881250 | |||
Demographic data | bleeding | BLEEDING | We collected data on demographic characteristics (including age, BMI, duration of surgery, duration of anesthesia and amount of bleeding). | PMC9881250 |
Intraoperative data | The MAP and HR prior to induction (T | PMC9881250 | ||
Postoperative data | PMC9881250 | |||
Recovery time assessment | nodding | Awakening time (i.e. time from withdrawal of drugs to patient opening eyes and nodding according to command) and orientation recovery time (i.e. time from withdrawal of drugs to patient’s orientation to time, place and person) were recorded. | PMC9881250 | |
Postoperative pain assessment | pain | All patients were instructed to use a 0 to 10 cm VAS (“0” representing no pain and “10” representing the worst imaginable pain) preoperatively. VAS scores were collected at the time of leaving PACU (T | PMC9881250 | |
Postoperative adverse events | PONV, forceful expulsion of gastric contents [, vomiting, Nausea | The incidence of PONV during postoperative 48 h were recorded. Nausea refers to an uneasy feeling in the stomach while vomiting refers to the forceful expulsion of gastric contents [ | PMC9881250 | |
Perioperative sleep quality assessment | PSQI scores were assessed 1 day before the surgery (T | PMC9881250 | ||
Sample size calculation | In our pilot study, we enrolled 16 patients randomly being allocated in two groups with 8 patients in each group, and they were not enrolled in the final study. The sample size was calculated by 2-Sample Non-Inferiority test in Power and Sample Size software. The mean AUC | PMC9881250 | ||
Statistical analysis | All data were analyzed by SPSS software package (version 26.0; IBM Corporation, Armonk, NY). Continuous data were tested for normality using Shapiro–Wilk test. The independent-samples t test was used for analysis of normally distributed measurement data and non-normally distributed data, which were expressed as median ... | PMC9881250 | ||
Results | PMC9881250 | |||
Primary outcome | AUCArea under curve(AUC) of VAS scores in two groups (Group OFA, | PMC9881250 | ||
Discussion | postoperative pain, ’, Postoperative pain, pain, PONV | ADVERSE REACTIONS, MOTION SICKNESS, POSTOPERATIVE COMPLICATIONS | In this non-inferiority randomized controlled trial in patients undergoing gynecological laparoscopic surgery, under ERAS protocol, OFA with esketamine and dexmedetomidine was non-inferior to OA with sufentanil and remifentanil in pain scores calculated as the area under the curve for the first 48 h postoperatively. Fu... | PMC9881250 |
Conclusion | PONV | ADVERSE EFFECT | Compared to OA technique, OFA technique, which is represented by non-opioid drugs esketamine and dexmedetomidine, may be an alternative anesthesia in gynecological laparoscopic surgery under ERAS protocol with its non-inferiority of analgesic effect, intraoperative anesthesia stability and lower incidence of PONV. Alth... | PMC9881250 |
Acknowledgements | We thank all the participants and study staffs involved in this study for their great contributions. | PMC9881250 | ||
Authors’ contributions | Liang Chen helped design the study, analyse the data, and write the manuscript. Yuanhai Li helped design the study and revise the manuscript. Wensheng He and Xue Liu helped conduct the study and collect the data. Fahui Lv helped enroll participants and collect the data. The author(s) read and approved the final manuscr... | PMC9881250 | ||
Funding | None. | PMC9881250 | ||
Availability of data and materials | The datasets used and analysed during the current study available from the corresponding author on reasonable request. | PMC9881250 | ||
Declarations | PMC9881250 | |||
Ethics approval and consent to participate | This prospective, randomized single-centre non-inferiority trial was approved by the Institutional Review Board (IRB) of Hefei Hospital affiliated Anhui Medical University (IRB approved registration number: 2021-KeYan-042) and was registered in the Chinese Clinical Trial Registry (ChiCTR2100052761, 05/11/2021). All met... | PMC9881250 | ||
Consent for publication | Not applicable. | PMC9881250 | ||
Competing interests | We declare that we have no financial and personal relationships with other people or organizations that can inappropriately influence our work, there is no professional or other personal interest of any nature or kind in any product, service and/or company that could be construed as influencing the position presented i... | PMC9881250 | ||
References | PMC9881250 | |||
Background | high-grade gliomas, postoperative seizures | This study aimed to develop an integrated model for predicting the occurrence of postoperative seizures in patients with diffuse high-grade gliomas (DHGGs) using clinical and RNA-seq data. | PMC9835377 | |
Methods | Patients with DHGGs, who received prophylactic anti-epileptic drugs (AEDs) for three months following surgery, were enrolled into the study. The patients were assigned randomly into training ( | PMC9835377 | ||
Results | postoperative seizures | REGRESSION | A seven-gene signature for predicting the occurrence of postoperative seizures was developed using LASSO logistic regression analysis of 623 DEGs. The gene-signature showed satisfactory predictive capacity in the training cohort [area under the curve (AUC) = 0.842] and validation cohort (AUC = 0.751). The final integra... | PMC9835377 |
Conclusion | postoperative seizures | We developed an integrated prediction model for the occurrence of postoperative seizures in patients with DHGG using clinical and RNA-Seq data. The findings of this study may contribute to the development of personalized management strategies for patients with DHGGs and improve our understanding of the mechanisms under... | PMC9835377 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12885-022-10385-x. | PMC9835377 | ||
Keywords | PMC9835377 | |||
Background | tumor, seizures, seizure, neurological disorder, glioma, Epilepsy, gliomas | TUMOR, NEUROLOGICAL DISORDER, GLIOMA, EPILEPSY, GLIOMAS | Epilepsy is a common neurological disorder characterized by unprovoked seizures that affects approximately 70 million people worldwide [The main reason for the increased concern over GRE is its adverse impact on the quality of life of patients following tumor resection. Studies have focused on GRE associated with diffu... | PMC9835377 |
Materials and methods | PMC9835377 | |||
Patient characteristics and data collection | tumor, Tumor, illness, seizure, seizures, epileptic seizure, Seizure, intracranial diseases, 1p19q | EPILEPTIC SEIZURE, TUMOR, TUMOR, MALIGNANT DISEASE | Data from 208 patients who underwent craniotomy and were diagnosed with primary DHGG at Beijing Tiantan Hospital, China, were retrospectively reviewed. Patients who previously underwent surgery for other intracranial diseases or had any other concomitant malignant diseases were excluded from the study. All patients had... | PMC9835377 |
Identification of differentially expressed genes and enrichment analysis | Patients were randomly assigned to either a training or validation cohort in a 4:1 ratio. The prediction model was established using the training cohort and validated using the validation cohort. The R package “Limma” was used to screen for differentially expressed genes (DEGs) between patients with or without preopera... | PMC9835377 | ||
Assessment of tumor-infiltrating immune cells | tumor | TUMOR, INFILTRATION | Immune cell infiltration in tumor samples was analyzed using the “CIBERSORT” algorithm ( | PMC9835377 |
Weighted correlation network analysis | seizure | Weighted correlation network analysis (WGCNA), implemented using the R package “WGCNA,” was conducted to identify key modules and genes with the highest correlation with preoperative GRE history, postoperative seizure occurrence, and the obtained gene-signature. Age, WHO grade, IDH1/2 mutation status, chromosome 1p/19q... | PMC9835377 | |
Identification of hub genes | WE generated a new set of DEGs based on risk scores (RDEGs) by identifying genes that were differentially expressed between high-risk and low-risk groups and selecting genes with potential effect on both the occurrence and outcome of GRE. Genes overlapping upregulated or downregulated RDEGs and genes extracted from WGC... | PMC9835377 | ||
Construction of a prediction model for postoperative seizure occurrence | postoperative seizure | REGRESSION | A multivariate logistic regression analysis of clinical and gene-signature data was conducted to identify the independent risk factors associated with postoperative seizure occurrence. Statistically significant factors ( | PMC9835377 |
Statistical analysis | Statistical analysis was performed using R software version 4.0.5 (R Foundation for Statistical Computing, Vienna, Austria, | PMC9835377 | ||
Results | PMC9835377 | |||
Identification and enrichment analysis of DEGs | epilepsy | EPILEPSY | Based on the “Limma” algorithm, 623 DEGs were associated with preoperative GRE in the training cohort, including 381 upregulated and 242 downregulated genes (Fig. Identification and functional enrichment analysis of differentially expressed genes (DEGs) associated with preoperative glioma-related epilepsy (GRE). | PMC9835377 |
Construction of a predictive gene-signature for postoperative seizure occurrence | postoperative seizure, seizure | REGRESSION | LASSO logistic analysis of DEGs was used to identify genes with the highest ability to predict postoperative seizure occurrence. Seven genes: Construction and receiver operating characteristic (ROC) analysis of a gene-signature for postoperative seizure occurrence using Lasso logistic regression analysis. Postoperative... | PMC9835377 |
Discussion | PMC9835377 | |||
Risk factors and prediction of postoperative seizure occurrence in patients with glioma | glioma, postoperative seizure, seizures | GLIOMA, COMPLICATION | Postoperative GRE is a disturbing complication to both patients and treating physicians. Most neurosurgeons routinely prescribe postoperative AED prophylaxis for patients with glioma, even though their ability to reduce seizures is not clear [This is the first study to generate a predictive gene-signature for postopera... | PMC9835377 |
Potential mechanisms underlying GRE | seizures, epilepsy, neuronal hyperexcitability, immune dysfunction, Epilepsy seizure, glioma | GLIOMA, EPILEPSY | GRE and glioma are comorbidities and share common pathogenic mechanisms. In this study, we explored the mechanisms underlying GRE and discovered that ion channel and immune system dysfunctions may play a major role in the epileptogenesis of GRE.Epilepsy is correlated with changes in neuronal excitation/inhibition balan... | PMC9835377 |
Potential therapeutic targets for GRE | postoperative seizure | Seven genes were selected from the 623 DEGs and used to generate a predictive gene-signature for postoperative seizure occurrence. Of these, Additionally, WGCNA, RDEG identification, and PPI analysis were performed to identify additional potential therapeutic targets for GRE. Of the final six selected genes, the expres... | PMC9835377 | |
Limitations | This study is limited by its retrospective nature and relatively small sample size, and the prediction model needs to be further validated in large-scale prospective studies. The proposed mechanisms and therapeutic targets also need to be verified. | PMC9835377 | ||
Conclusions | postoperative seizures | We used RNA-seq data to propose a seven-gene signature for predicting the occurrence of postoperative seizures in patients with DHGGs. We then developed a prediction model including the identified gene-signature and clinical characteristics of the patients. Finally, we examined the potential mechanisms underlying GRE. ... | PMC9835377 | |
Acknowledgements | Not applicable. | PMC9835377 | ||
Authors’ contributions | LLW and FX: study concept and design. LLW, ZCB and WZ: data acquisition and analysis. LLW and FX: formal analysis and investigation. LLW and GYH: writing—original draft preparation. FX, WYY and YG: writing—review and editing. YG, FX, QC and JT: funding acquisition. YG, ZZ, FX and JT: supervision. All authors contribute... | PMC9835377 |
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