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Procedures
Coma
COMA
Clinical status including a comprehensive neurological examination, measurement of the Glasgow Coma Scale (GCS) and mini-mental status was done at entry and repeated 2-weekly or more frequently as indicated and during progression of symptoms.Safety bloods and ECGs were done at baseline and repeated 2-weekly until week-...
PMC9925064
Treatment
toxicity
Fluconazole provided by Pfizer, was adjusted for body weight-below 60kg: 20mg/kg for 1200mg, 26mg/kg for 1600mg, and 33mg/kg for 2000mg cohorts. The induction phase of FCZ was continued until the CSF culture was negative or to week 10, whichever was earlier. Amphoterecin B was prescribed between 0ˑ7-1mg/kg/day for 2 we...
PMC9925064
Stopping rules and study discontinuation and treatment failure
toxicity
CO-INFECTIONS
Dose limiting toxicity (DLT) in Stage-1 was defined as interruption of FCZ for 3 or more consecutive days because of toxicity and where interruption was initiated prior to day 14. The DAIDS toxicity grading system was used [Treatment failure for any participant was defined as a positive culture from a CSF sample collec...
PMC9925064
Sample size
toxicity, CM
EVENTS, EVENT
The sample size was designed to have a 90% power and a one-sided 0.10 alpha test to detect a change in log10 CFU//ml CSF of about 80% of the standard deviation of the values in Stage 1. Based on this a sample size of 24 was determined and would also permit a dose limiting toxicity rate of >25%. This permitted the ident...
PMC9925064
Statistical analysis
EVENT
Participants who received at least one dose of randomised treatment (FCZ or AMB) were included in the safety analysis. Participants whose baseline CSF culture did not grow Comparisons for continuous data across the four cohorts used a Kruskal-Wallis test and a Wilcoxon rank sum test for pairwise comparisons. Categorica...
PMC9925064
Study history
EVENT
The study was opened to Accrual on February 19, 2010 and the first participant enrolled on April 16, 2010. The first international participant, was enrolled on December 22, 2010. Stage 1 closed to accrual on September 5, 2013. Stage 2 opened to accrual on September 15, 2014 under A5225 Version 3.0 and the first partici...
PMC9925064
Results
RECRUITMENT
The recruitment and entry into Stage-1 and Stage-2 is presented in the consort
PMC9925064
Accrual of participants by induction dose and ACTG sites.
*Induction dose of fluconazole**amphotericin B“
PMC9925064
Baseline demographic, clinical and laboratory characteristics.
AIDS, CM opportunistic infections, CM
AIDS
Note: Median (IQR) for continuous, count (%) for categorical* Wilcoxon rank sum test** Chi-square testThere were 10/22 participants in the 1200mg FCZ, 7/26 in the 1600mg, 11/24 in the 2000mg FCZ cohort and 10/24 in the AMB cohort in the Stage 1 with non CM opportunistic infections and AIDS defining conditions. None of ...
PMC9925064
Time to negative CM culture.
* In the 1600mg FZ arm, 4/45 subjects switched to Ampho B and culture converted by week 10, An additional 5/45 started ampho B and subsequently died. In the 2000mg FZ arm 5/43 subjects switched to Ampho B and culture converted by week 10. An additional 3/43 started ampho B and subsequently died. In the Ampho B arm, 1/4...
PMC9925064
Efficacy population: Cryptococcal CFU (Log10) at Weeks 0 and 2.
All p-values are calculated using the Kruskal-Wallis test for differences across the four treatment arms.The Kaplan-Meier proportion for mortality (90% CI) in the efficacy population at 10 and 24 weeks for AMB was 17% (10, 29) and 24% (15, 37), compared to 20% (12, 32) and 30% (20, 43) for 1600mg, and 33% (23, 46) and ...
PMC9925064
Time to death (safety population).
PMC9925064
Pairwise comparisons of FCZ with AMB.
death
APPENDIX
*All pairwise p-values calculated using the log-rank testThe presumed causes of death were classified according to the ACTG Appendix 60 and are shown in
PMC9925064
Time to progression of symptoms through end of study.
PMC9925064
Causes of death.
AIDS
AIDS, APPENDIX
*Defined by AIDS Clinical Trials Group (ACTG) Appendix 60“
PMC9925064
List of grade 2 or worse adverse events through end of study.
Gastrointestinal dysfunction, IRIS, Nausea, Vomiting,, Diarrhea/loose stools, Constipation
ADVERSE EVENT, IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME
Any (sign/symptom or lab) includes more levels than listed hereAny gastrointestinal includes: Appetite loss/decreased/anorexia, Constipation, Diarrhea/loose stools, Nausea, Vomiting, Gastrointestinal dysfunction.All p-values are calculated using the Kruskal-Wallis test for differences across the four treatment arms.The...
PMC9925064
Maximum DAIDS QTc* Grade of Visit or change from baseline.
*QTc calculated using the Frederica equation.Note: A change from baseline can result in a graded QTc while the QTc result at the visit is still in the normal range. There was no significant difference between groups using the Kruskall Wallis test.Functional status assessed as ability to work 6 weeks prior to study entr...
PMC9925064
Discussion
AIDS, PWH, toxicity, cardiac dysfunction, CM, ill, CM illness
DISEASE, AIDS, CARDIAC ARRHYTHMIAS
This study has shown that weight based FCZ higher than 1200mg and up to 2000mg/day in the induction phase of the first episode of CM in PWH is safe and effective. Amphotericin B was associated with better fungicidal activity than FCZ at any dose tested. Survival was improved but not statistically significantly in the A...
PMC9925064
Conclusion
CM
This study demonstrates that weight-based and eGFR adjusted doses of FCZ between 1600mg/day and 2000mg/day are safe, well tolerated and effective in the induction phase of CM treatment and had similar times to achieve CSF sterilization, but took longer than AMB. Survival at these doses of FCZ were not statistically dif...
PMC9925064
Supporting information
PMC9925064
CONSORT 2010 checklist of information to include when reporting a randomised trial*.
Noluthando, CRS
(DOC)Click here for additional data file.(DOC)Click here for additional data file.We thank the following A5225 researchers and research teams for their contribution to the study: Mohammed Rassool, MBCHB and Noluthando Mwelase, MBCHB- University of the Witwatersrand Helen Joseph Hospital Clinical Research Site (CRS), Dr...
PMC9925064
Objective
Knee osteoarthritis, chronic progressive disease, KOA
KNEE OSTEOARTHRITIS
Knee osteoarthritis (KOA) is a common chronic progressive disease. We aimed to evaluate the effects of ozone combined with articular injection of sodium hyaluronate on KOA patients and their inflammatory factors and hemorheological indices.
PMC10782347
Methods
KOA
A total of 292 KOA patients treated from October 2020 to October 2021 were randomly divided into observation and control groups (n=146). Observation group was treated with ozone combined with articular injection of sodium hyaluronate, while control group was routinely given glucosamine hydrochloride tablets and articul...
PMC10782347
Results
After treatment, observation group had significantly lower VAS score and higher HSS score than those of control group (P<0.05). The total response rate of observation group was higher than that of control group (P<0.05). The levels of inflammatory factors in the joint fluid were significantly lower in observation group...
PMC10782347
Conclusion
KOA
Ozone combined with articular injection of sodium hyaluronate has obvious therapeutic effects on KOA.
PMC10782347
Introduction
degenerative lesions, KOA, hyperostosis, Knee osteoarthritis, chronic progressive disease
SECONDARY, KNEE OSTEOARTHRITIS, HYPEROSTOSIS
Knee osteoarthritis (KOA) is a common chronic progressive disease, with the pathological basis of degenerative lesions in knee cartilage or secondary hyperostosis
PMC10782347
Materials and Methods
PMC10782347
Treatment methods
puncture mouth, knee joints
JOINT EFFUSION, INFILTRATION, CAVITY
Under a supine position, the knee joint was exposed and kept flexed at 70-90°, and the medial-lateral knee eyes were used as the puncture point. After routine disinfection and draping, the patients received infiltration anesthesia with 1% lidocaine injected layer by layer at the puncture point. The 7# puncture needle w...
PMC10782347
Observation indices
erythrocyte aggregation, tumor necrosis, TNF-α, KOA, pain
TUMOR NECROSIS
The degree of pain was assessed using the visual analogue scale (VAS) score before and after treatment, and the knee joint function was evaluated using the Hospital for Special Surgery (HSS) knee score. The overall therapeutic effect was evaluated according to the therapeutic effect criteria for KOA developed by the So...
PMC10782347
Evaluation criteria
flexion deformity, pain
DRUG WITHDRAWAL, RECURRENCE, HAND SWELLING
In terms of VAS score, 0 point: no pain; 1-3 points: mild pain; 4-6 points: moderate pain; 10 points: severe pain. A higher score means severer pain. For HSS score, the total scores of pain, mobility, function, joint stability, flexion deformity and muscle strength are 30, 18, 22, 10, 10 and 10 points, respectively, an...
PMC10782347
Statistical analysis
SPSS18.0 software (IBM Inc., USA) was used for statistical analysis. Measurement data were expressed as -(χ ± s). Independent t test was used for intergroup comparison, while paired t test was conducted for comparison at different time points. Numerical data were expressed as rate (%), and χ
PMC10782347
Results
PMC10782347
VAS and HSS scores
Before treatment, VAS score and HSS score had no significant differences between the two groups (P>0.05). Observation group had a significantly lower VAS score and a higher HSS score than control group after treatment (P<0.05). Besides, the VAS score declined and HSS score rose in both groups after treatment compared w...
PMC10782347
Treatment outcomes
The total response rate after treatment in observation group (97.26%) was significantly higher than that in control group (76.71%) (P<0.05) (Treatment outcomes
PMC10782347
Levels of inflammatory factors
Before treatment, no significant differences were found in the levels of inflammatory factors VEGF, TNF-α, IL-1β, IL-6, hs-CRP and MMP-13 in the joint fluid between the two groups (P>0.05). After treatment, the levels of the above inflammatory factors were significantly lower in observation group than those in control ...
PMC10782347
Hemorheological indices
erythrocyte aggregation
The hemorheological indices (erythrocyte sedimentation rate, hematocrit, erythrocyte aggregation index, fibrinogen, plasma viscosity, low-shear whole blood viscosity and high-shear whole blood viscosity) had no significant differences between the two groups before treatment (P>0.05). After treatment, the above indices ...
PMC10782347
Discussion
inflammation, deformityOsteoarthritis, pain, KOA
INFLAMMATION, DEGENERATIVE, DISEASE, DYSFUNCTION, HYPERTROPHIC ARTHRITIS, STASIS, INFLAMMATORY RESPONSE
KOA, also known as degenerative, hyperplastic or hypertrophic arthritis, is common among middle-aged and elderly women6. With further development, joint deformity and dysfunction occur in severe casesIn the present study, there were no significant differences in general data between the two groups (P>0.05). Before trea...
PMC10782347
Acknowledgment
None.
PMC10782347
Conflict of interest
The authors declare that they have no competing interests.
PMC10782347
Key Points
PMC10603581
Question
MEDULLOBLASTOMA
What is the outcome of an antiangiogenic metronomic combinatorial regimen in pediatric patients with recurrent or refractory medulloblastoma?
PMC10603581
Findings
DISEASE, MEDULLOBLASTOMA
In this single-arm, phase 2 nonrandomized controlled trial of 40 patients with previously irradiated recurrent or refractory medulloblastoma, a response rate of 45% was achieved. Six patients achieved a complete response, 9 patients achieved a partial response, and 5 patients had stable disease.
PMC10603581
Meaning
The use of an antiangiogenic metronomic combinatorial regimen warrants further investigation.
PMC10603581
Importance
Medulloblastoma
RECURRENCE, MEDULLOBLASTOMA
Medulloblastoma recurrence in patients who have previously received irradiation has a dismal prognosis and lacks a standard salvage regimen.
PMC10603581
Objective
medulloblastoma
RECURRENCE, MEDULLOBLASTOMA, MEDULLOBLASTOMA
To evaluate the response rate of pediatric patients with medulloblastoma recurrence using an antiangiogenic metronomic combinatorial approach (Medulloblastoma European Multitarget Metronomic Anti-Angiogenic Trial [MEMMAT]).
PMC10603581
Design, Setting, and Participants
medulloblastoma
MEDULLOBLASTOMA
This phase 2, investigator-initiated, multicenter nonrandomized controlled trial assessed 40 patients with relapsed or refractory medulloblastoma without a ventriculoperitoneal shunt who were younger than 20 years at original diagnosis. Patients were enrolled between April 1, 2014, and March 31, 2021.
PMC10603581
Interventions
Treatment consisted of daily oral thalidomide, fenofibrate, celecoxib, and alternating 21-day cycles of low-dose (metronomic) oral etoposide and cyclophosphamide, supplemented by intravenous bevacizumab and intraventricular therapy consisting of alternating etoposide and cytarabine.
PMC10603581
Main Outcomes and Measures
ADVERSE EVENT
The primary end point was response after 6 months of antiangiogenic metronomic therapy. Secondary end points included progression-free survival (PFS), overall survival (OS), and quality of life. Adverse events were monitored to assess safety.
PMC10603581
Results
infections, headaches, myelosuppression, seizures
RECURRENCES, RECURRENCE, ADVERSE EVENTS, DISEASE, SECONDARY ACUTE MYELOID LEUKEMIA, INFECTIONS
Of the 40 patients (median [range] age at treatment start, 10 [4-17] years; 25 [62.5%] male) prospectively enrolled, 23 (57.5%) achieved disease control after 6 months of treatment, with a response detected in 18 patients (45.0%). Median OS was 25.5 months (range, 10.9-40.0 months), and median PFS was 8.5 months (range...
PMC10603581
Conclusions and Relevance
MEDULLOBLASTOMA
This feasible and well-tolerated MEMMAT combination regimen demonstrated promising activity in patients with previously irradiated recurrent medulloblastoma. Given these results, this predominantly oral, well-tolerated, and outpatient treatment warrants further evaluation.
PMC10603581
Trial Registration
ClinicalTrials.gov Identifier:
PMC10603581
Introduction
tumor, tumors, aggressive embryonal tumor
TUMOR, MEDULLOBLASTOMA, PROLIFERATION, CENTRAL NERVOUS SYSTEM TUMORS, MEDULLOBLASTOMA, TUMOR GROWTH, TUMORS
Medulloblastoma, an aggressive embryonal tumor arising in the cerebellum or, less frequently, in the dorsal brain stem, is one of the most common malignant central nervous system tumors in children.The advantage of metronomic antiangiogenic therapies targeting the tumor microenvironment is that even drugs to which tumo...
PMC10603581
Methods
PMC10603581
Study Design and Patients
medulloblastoma
MEDULLOBLASTOMA
MEMMAT was a prospective, international, multicenter, single-arm, phase 2 study that included sites in Europe and the US. This academic trial depended on local institutions to generate funding to perform the study. The trial was conducted in accordance with the Declaration of HelsinkiPatients were enrolled from April 1...
PMC10603581
Study Treatment
Treatment consisted of daily oral thalidomide, fenofibrate, celecoxib, and alternating 21-day cycles of oral etoposide and cyclophosphamide, supplemented by intravenous bevacizumab and intraventricular therapy via an Ommaya reservoir consisting of alternating etoposide and liposomal or aqueous cytarabine. For an overvi...
PMC10603581
Response Assessments
DISEASE PROGRESSION, DISEASE
Magnetic resonance imaging with and without gadolinium enhancement was performed within 2 weeks before the start of protocol therapy. In case of surgery, postoperative MRI was required within 72 hours after surgery. Six months after the start of antiangiogenic treatment, MRI was mandatory to assess response. A CSF cyto...
PMC10603581
Response Criteria
tumor, enlargement of any existing lesion(s, NED, Cancer
ADVERSE EVENT, TUMOR, RECURRENCE, PROGRESSIVE DISEASE, ADVERSE EVENT, DISEASE, REGRESSION, CANCER
Complete response (CR) was defined as the total disappearance of all radiologic evidence of tumor, determined by 2 observations not less than 4 weeks apart, and no evidence of malignant cells in the CSF. No evidence of disease (NED) was defined as no recurrence or appearance of new lesions and no malignant cells in the...
PMC10603581
Statistical Analysis
tumor
TUMOR
Data cutoff was on March 7, 2022. Trial enrollment for this phase 2 cohort was planned for 40 patients (1 − β = 0.90; estimated dropout rate, 5%). The clinically sufficient response rate was specified with π1 = 35%; the clinically insufficient response rate was specified with π0 = 15%. In the primary efficacy analysis,...
PMC10603581
Results
PMC10603581
Study Patients
DISEASE CHARACTERISTIC
Baseline demographic and disease characteristics of the 40 analyzed patients (median [range] age at treatment start, 10 [4-17] years; 25 [62.5%] male and 15 [37.5%] female) are summarized in
PMC10603581
Baseline Demographic and Disease Characteristics
Medulloblastoma
MEDULLOBLASTOMA
Abbreviation: MEMMAT, Medulloblastoma European Multitarget Metronomic Anti-Angiogenic Trial; SHH, sonic hedgehog signaling molecule; WNT, wingless-related integration site.Data are presented as number (percentage) of patients unless otherwise indicated. Data on race and ethnicity were not collected by MEMMAT.
PMC10603581
Study Flow Diagram
PD
DISEASE
CR indicates complete response; NED, no evidence of disease; PD, progressive disease; PR, partial response; SD, stable disease.
PMC10603581
Efficacy
DISEASE PROGRESSION, DISEASE, BEST
Among the 40 patients, 23 (57.5%) achieved disease control (NED, CR, PR, and stable disease) after 6 months of treatment, whereas 17 patients (42.5%) discontinued treatment because of disease progression within the first 6 months. A total of 16 patients (40.0%) received the MEMMAT treatment for at least 1 year. Three p...
PMC10603581
Kaplan-Meier Estimates of Survival Outcomes of the 40 Study Participants
Medulloblastoma
MEDULLOBLASTOMA
The shaded areas represent 95% CIs; vertical dashed lines indicate the 6-month, 12-month, 36-month, and 60-month time points; and crosses represent censored participants. MEMMAT indicates Medulloblastoma European Multitarget Metronomic Anti-Angiogenic Trial.
PMC10603581
Progression-Free Survival After 12 Months for Medulloblastoma Subgroup Distribution
Medulloblastoma
DISEASE, MEDULLOBLASTOMA
The shaded areas represent 95% CIs; vertical dashed lines indicate the 12-month, 36-month, and 60-month time points; and crosses represent censored participants. MEMMAT indicates Medulloblastoma European Multitarget Metronomic Anti-Angiogenic Trial; SHH, sonic hedgehog signaling molecule; and WNT, wingless-related inte...
PMC10603581
Safety and QOL
ADVERSE EVENTS, HEMATOLOGIC DISORDERS
The most frequently reported adverse events of any grade were hematologic disorders (
PMC10603581
Treatment-Related Adverse Events in the Study Patients
The QOL results measured by the KINDL questionnaire indicated a medium or low QOL before initiation of protocol therapy. Quality of life did not further decrease considerably once therapy was initiated and slightly improved, although results were heterogeneous (eTable 6 in
PMC10603581
Discussion
tumor, neutropenic, cancer, nephrotic syndrome, infections, medulloblastoma
TUMOR, RECURRENCE, PROLIFERATION, CANCER, DISEASE, NEPHROTIC SYNDROME, INFECTIONS, ADVERSE EFFECTS, MEDULLOBLASTOMA, LUPUS NEPHRITIS
Effective treatment for recurrent medulloblastoma remains a significant unmet need, with no approved therapies and only rare long-term survivors. The metronomic antiangiogenic drug combination with intraventricular therapy used in MEMMAT significantly prolonged survival and was able to produce durable responses in pati...
PMC10603581
Limitations
medulloblastoma
MEDULLOBLASTOMA
There are some important limitations of our study. The patient population reported in this trial, although all having relapsed medulloblastoma after standard up-front surgery, radiation therapy, and chemotherapy, is heterogeneous with regard to their molecular subgrouping, and the study was underpowered to detect true ...
PMC10603581
Conclusions
medulloblastoma, difficult-to-treat
MEDULLOBLASTOMA
This nonrandomized controlled trial found that the MEMMAT regimen is a feasible and promising strategy for patients who have previously received irradiation. Given this meaningful clinical benefit in a difficult-to-treat population, further evaluation of the combination is warranted. In the future, an improved understa...
PMC10603581
Background
bowel gangrene, gangrene, peritonitis
ACUTE MESENTERIC ISCHEMIA, EVENT, GANGRENE, PERITONITIS
Bowel gangrene represents a major fatal event in acute mesenteric ischemia. Intestinal resection is inevitable in patients with peritonitis and bowel gangrene. This retrospective study aimed to elucidate the benefit of postoperative parenteral anticoagulation in patients with intestinal resection.
PMC9996985
Methods
acute mesenteric ischemia, gangrene
ACUTE MESENTERIC ISCHEMIA, GROUP B, GANGRENE
Patients with acute mesenteric ischemia and bowel gangrene were recruited retrospectively between January 2007 and December 2019. All patients underwent bowel resection. They were categorized into two groups: patients without immediate parenteral anticoagulant therapy (Group A) and those with immediate parenteral antic...
PMC9996985
Results
GROUP B
A total of 85 patients were included, with 29 patients in Group A and 56 patients in Group B. Patients in Group B had lower 30-day mortality (16.1%) and a higher 2-year survival rate (45.4%) than patients in Group A (30-day mortality: 51.7%, p = 0.001; 2-year survival rate: 19.0%, p = 0.001). In the 30-day mortality mu...
PMC9996985
Keywords
PMC9996985
Background
tissue injury, Mesenteric ischemia
MESENTERIC ISCHEMIA
Mesenteric ischemia is characterized by insufficient splanchnic perfusion leading to failure to meet the intestinal metabolic demands, eventually resulting in ischemic tissue injury [In the past two decades, early diagnosis with successful revascularization has been able to improve survival, with 30-day mortality rates...
PMC9996985
Methods
PMC9996985
Patient recruitment
nonmalignant lesions, abdominal wall hernia, intestinal gangrene, Gangrene of the bowel, herniation, ischemic colitis, malignancy
INTESTINAL GANGRENE, ISCHEMIC COLITIS, ADHESION, AMI, PATHOLOGY
Between January 2007 and December 2019, we retrospectively reviewed patients who underwent emergent small bowel resection for nonmalignant lesions, by operative notes as well as by pathology results. We aimed to identify patients with AMI and intestinal gangrene. Patients who experienced intestinal gangrene and resecti...
PMC9996985
Data collection
atrial fibrillation, chronic lung disease, coronary arterial bypass
ESSENTIAL HYPERTENSION, ATRIAL FIBRILLATION, END-STAGE RENAL DISEASE, LIVER CIRRHOSIS, CEREBRAL VASCULAR EVENTS, CORONARY ARTERY DISEASE, TYPE 2 DIABETES MELLITUS, CHRONIC LUNG DISEASE, DYSLIPIDEMIA
Preoperative factors were collected, including age, sex, recent major cardiovascular procedure (within 3 months), coronary artery disease, cerebral vascular events, chronic lung disease, essential hypertension, dyslipidemia, liver cirrhosis, atrial fibrillation, type 2 diabetes mellitus, end-stage renal disease with di...
PMC9996985
Prognosis analysis
death
Patients underwent emergent laparotomy under general anesthesia. The periods between definite diagnosis (by contrast CT scan) and surgery were measured. Operative factors included combined colon resection, end-enterostomy or reanastomosis, length of functional residual small intestine (length between the Treitz ligamen...
PMC9996985
Statistical method
Prognosis
REGRESSION
We used IBM SPSS version 22.0 for the statistical analysis. Continuous data are presented as the median with range. Categorical variables were compared by Pearson’s chi-square or Fisher’s exact as appropriate. Continuous variables were compared by the Mann–Whitney U test (nonparametric method). Multivariate analysis fo...
PMC9996985
Results
PMC9996985
Overall results
death, respiratory failure, renal failure, non-septic insults, sepsis
RESPIRATORY FAILURE, RENAL FAILURE, HEPATIC FAILURE, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, SEPSIS
We found six hundred and three patients who underwent emergent small bowel resection for benign lesions between January 2007 and December 2019. One hundred and seven patients with Flow chartOf the 85 patients, 40 patients died within 3 months. Definite sepsis (positive bacterial cultures and systemic inflammatory respo...
PMC9996985
Discussion
bleeding, hypercoagulation, shock, ischemia, sepsis, hypertension, thromboembolic occlusive, diabetes
HYPOALBUMINEMIA, BLEEDING, HYPERCOAGULATION, CORONARY THROMBOSIS, DIABETES MELLITUS, INTESTINAL GANGRENE, AMI, EVENTS, ISCHEMIA, GASTROINTESTINAL BLEEDING, METABOLIC ACIDOSIS, DIABETES, SHOCK, CRITICAL ILLNESS, SEPSIS, MYOCARDIAL INFARCTION, GROUP B, INTRACRANIAL HEMORRHAGE, EVENT, HEPARIN INDUCED THROMBOCYTOPENIA, HYP...
Intestinal gangrene is a severe event with a poor prognosis in patients with AMI [LMWHs have more effective anti-Xa activity than anti-IIa activity, a more predictable anticoagulant response, and a lower incidence of heparin induced thrombocytopenia [In patients with sepsis, hypercoagulation is induced by impairing bot...
PMC9996985
Conclusions
Immediate postoperative parenteral anticoagulant use can increase survival in patients with
PMC9996985
Acknowledgements
We thank Ms. Fen-Ling Kuo, the paramedical staff of surgery department of Taichung Veterans General Hospital, for helping data storage. We also thank Mr. Peter Wilds, the language editor at Taichung Veterans General Hospital, for linguistic consultant.
PMC9996985
Author contributions
H-TL
C-CW, S-BC, and H-TL conducted the study design. J-JL and Y-JC collected and investigated data. Formal analysis was performed by H-TL. C-YL and H-TL wrote the original draft. H-TL performed the final review and editing of the manuscript. All authors read and approved the final manuscript.
PMC9996985
Funding
Taichung Veterans General Hospital (TCVGH-1114601A).
PMC9996985
Availability of data and materials
The data generated and analyzed during the current study are not publicly available because the Taiwan (R.O.C.) government legally restricts by Personal Data Protection Act and Human Subjects Research Act. Data however are available from the corresponding author with de-linkage and de-identification on reasonable reque...
PMC9996985
Declarations
PMC9996985
Ethics approval and consent to participate
This research was retrospectively approved by Institutional Review Board (IRB) I&II of Taichung Veterans General Hospital (TCVGH-IRB No.CE21256B) on July 28th, 2021. Informed consent waiver was also approved by IRB I&II of Taichung Veterans General Hospital. Declaration of Helsinki and ICH-GCP guidelines were followed ...
PMC9996985
Consent for publication
Not applicable.
PMC9996985
Competing interests
All authors declared no competing interests.
PMC9996985
References
PMC9996985
Background
HD, sarcopenia, Sarcopenia
SARCOPENIA, SARCOPENIA
Sarcopenia is highly prevalent in haemodialysis (HD) patients and linked to a poor prognosis regarding comorbidities and premature mortality. Previous studies assessed the effects of neuromuscular electrical stimulation in haemodialysis patients. This study adds to the relevance of neuromuscular electrical stimulation ...
PMC10464068
Methods
We conducted a 12-week multicenter prospective randomised controlled trial. The patients were randomly assigned to one of the three groups: neuromuscular electrical stimulation with or without combined virtual reality distraction or control group.
PMC10464068
Results
INTERACTION
The final analysis included 32 haemodialysis patients (mean age of 68 ± 10 years, 26 men). Interaction effects between groups and time (12 weeks) were significant regarding serum albumin levels (
PMC10464068
Conclusion
Intradialytic
Intradialytic NMES increases serum albumin level, functional capacity, muscle strength in lower limb and in tendency weight and body mass index of HD patients. Effects on VR distraction are inconclusive. Large-scaled follow-up studies on integrated sports programs with NMES and active training in combination with VR as...
PMC10464068
Trial registration
German Clinical Trial Register: DRKS00029276 (Retrospectively registered: 30/06/2022).
PMC10464068
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC10464068
Background
loss of skeletal muscle mass, HD, sarcopenia, pain, PEW, Sarcopenia
DISEASE, SARCOPENIA, CHRONIC RENAL INSUFFICIENCY, LOSS OF SKELETAL MUSCLE MASS, SARCOPENIA
As of 2019, over 850 million people worldwide suffered from a chronic renal insufficiency representing over 10% of the global population [Patients on dialysis have a significantly reduced life expectancy compared to the general population. 5-year mortality ranges from 10 to over 80%, depending on age and comorbidities ...
PMC10464068