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Instruments
Anxiety
The data collection for this study involved the use of two tools: a demographic information form and the Sarason Anxiety Inventory. The demographic information form included questions related to participants’ age, gender, marital status, residence, and their grade point average from previous semester(s). The Sarason An...
PMC10629063
Interventions
Anxiety, Sarason anxiety, anxiety, pain
One hour before the test, the demographic information form, and the Sarason anxiety inventory were completed by the samples of both groups. The place of auricular acupressure in the experimental group was the Shen Men point. This point is located in the lateral triangular fossa of the auricles [The interventions in thi...
PMC10629063
Data analysis
anxiety
The collected data were subjected to both descriptive and inferential statistical analyses. Descriptive statistics, including mean, standard deviation, frequency, and percentage, were employed to summarize the data. Inferential statistics, on the other hand, involved the use of several statistical tests, namely Chi-squ...
PMC10629063
Ethical considerations
The study with the code R.KUMS.MED.REC.1400.093 received approval from the Ethics Committee of Kermanshah University of Medical Sciences. Additionally, the study was registered and assigned the code IRCT20100913004736N24 in Iran’s clinical trials database at
PMC10629063
Discussion
anxiety
This trial aimed to examine the impact of auricular acupressure on test anxiety among medical students. Consistent with prior research [The findings of the study indicated that Shen Men auricular acupressure had a significant effect in reducing test anxiety. This outcome is consistent with the findings of Lee et al. (2...
PMC10629063
Limitations
anxiety
When applying the results of this study, several limitations should be taken into consideration. Firstly, the mental state of participants during acupressure could have potentially influenced the study outcomes, which was beyond the control of the researcher. Secondly, the study was conducted solely on university stude...
PMC10629063
Acknowledgements
The authors would like to express thanks to all the students who participated in the study.
PMC10629063
Authors’ contributions
ZM, HK, MJ, SR, and AK contributed to designing the study. ZM collected the data, and the data was analyzed by SR. The final report and manuscript were written by ZM, HK, MJ, SR, and AK. All the authors read and approved the version for submission.
PMC10629063
Funding
This study was funded by the Kermanshah University of Medical Sciences (Grant N0. 50000632). The funding was spent on sampling and conducting the study.
PMC10629063
Data Availability
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
PMC10629063
Declarations
PMC10629063
Ethics approval and consent to participate
The study with the code R.KUMS.MED.REC.1400.093 was approved by the Ethics Committee of Kermanshah University of Medical Sciences. Also, the study was registered with the code IRCT20100913004736N24 in Iran’s clinical trials database at Irct.ir (12/01/2022). The objectives of the study were explained to all participants...
PMC10629063
Consent for publication
Not applicable.
PMC10629063
Competing interests
The authors declare no competing interests.
PMC10629063
References
PMC10629063
Objective
DMO, peripheral retinal ischaemia
DIABETIC MACULAR OEDEMA
We tested the hypothesis that targeted retinal laser photocoagulation (TPRP) to peripheral retinal ischaemia reduces the overall burden of aflibercept injections when treating diabetic macular oedema (DMO) over a 24-month period.
PMC10630305
Methods
CMT
ADVERSE EVENTS
Prospective, double-masked, multicentre, randomised controlled trial in Australia comparing aflibercept monotherapy, following a treat-and-extend protocol, or combination therapy of aflibercept and TPRP for DMO. The aflibercept monotherapy group received placebo laser. The primary outcome measure was the mean number of...
PMC10630305
Results
We enrolled 48 eyes of 47 patients; 27 eyes were randomised to combination therapy (aflibercept and TPRP) and 21 to aflibercept monotherapy. Thirty-two eyes (67%) completed the 2-year study. The number of intravitreal treatments given were similar for combination therapy (10.5 (SD 5.8) and monotherapy (11.8 (SD5.6)) (
PMC10630305
Conclusions
RETINA, DIABETIC MACULAR OEDEMA
Laser to areas of ischaemic peripheral retina does not reduce the burden of intravitreal aflibercept injections when treating diabetic macular oedema.
PMC10630305
Subject terms
PMC10630305
Introduction
DMO, Retinal hypoxia, vision loss, diabetes [
DIABETIC MACULAR OEDEMA
Diabetic macular oedema (DMO) is the most frequent cause of vision loss in patients with diabetes [Retinal hypoxia elevates levels of VEGF through activation of hypoxia-inducible factor [The present study treated DMO with aflibercept following a treat-and-extend (T&E) protocol from enrolment. The DAVE Trial randomised ...
PMC10630305
Materials and methods
PMC10630305
Aim
peripheral retinal ischemia
The specific aim of this trial was to test the hypothesis that targeted laser therapy to areas of peripheral retinal ischemia reduces the overall number of intravitreal aflibercept injections required to control DMO over a 24-month period.
PMC10630305
Outcome measures
cataract, ocular adverse, CMT
CATARACT, PROLIFERATIVE DIABETIC RETINOPATHY (PDR), ADVERSE EVENTS, LOSS OF VISION
The primary outcome measure was the number of intravitreal aflibercept injections in each of the two treatment arms at 24 months. Secondary outcome measures at 24 months compared with baseline included: the proportion of eyes that have central macular thickness (CMT) < 300 µm, mean change in CMT, mean change in best co...
PMC10630305
Patient enrolment
panretinal, allergy, peripheral retinal ischemia, opacity, cataract, CMT, epiretinal, loss of vision
DISEASES, DIABETES MELLITUS, OPACITY, ALLERGY, CATARACT, EAR, MACULAR OEDEMA, EYE, LOSS OF VISION
This study was conducted in accordance with the Declaration of Helsinki and was approved by the Human Research Ethics Committees of Sydney Local Area Health Service, the University of Sydney and the Royal Victorian Eye and Ear Hospital (RVEEH) in Melbourne (Protocol number X14-0157). An independent safety monitoring co...
PMC10630305
Treatment allocation
visual improvements
Each study eye was randomised by the unmasked research officer to either the experimental group “combination therapy” with TPRP and aflibercept, or the active control group “aflibercept monotherapy”. In patients with both eyes eligible for the study, the eyes were randomised to have different therapies.Stratification t...
PMC10630305
Treatment with aflibercept
CMT
STERILE
Intravitreal aflibercept was administered in a designated treatment facility under sterile conditions as per local site practices. The injection eye was anaesthetised with topical drops and subconjunctival 2% lidocaine. Aflibercept (2 mg/0.05 ml) was injected into the vitreous 4 mm posterior to the limbus using a 30 G ...
PMC10630305
Treatment with Targeted peripheral retinal photocoagulation (TPRP)
burns, peripheral retinal ischemia
LENS, RETINA
TPRP was applied with a single spot 532 nm laser to areas of peripheral retinal ischemia in the combination therapy group. No burns were placed within 3000 microns of the optic disc or fovea. Using an appropriate contact lens, the burn size was 400 microns at the retina, with a one-burn width spacing.In the “combinatio...
PMC10630305
Rescue focal laser
Rescue focal laser could be added to treat the DMO at the investigator’s discretion.
PMC10630305
Data collection and masking
Cataracts, stroke
CATARACTS, EYE DISEASE, STROKE, HEART ATTACK
Measurement of BCVA was performed with ETDRS charts using standardized procedures. Cataracts were graded using Age-Related Eye Disease Study photographic standards. CMT was measured from the central 1 mm subfield from spectral domain OCT (Cirrus; Zeiss). Wide-field fundus imaging and FFA was performed (Optos®). Patient...
PMC10630305
Statistical analysis
Data were summarised using the mean, standard deviation (SD), median, first and third quartiles (Q1, Q3) and percentages. Baseline characteristics and 24-month outcomes were compared between the two groups using two sample t-tests, Wilcoxon rank sum tests and Chi-square tests for analysis of means, medians and categori...
PMC10630305
Power calculations
In Protocol T DRCRnet an average of 15 injections were given over 24 months in the aflibercept group [
PMC10630305
Results
Fifty-four eyes were screened, 48 eyes were randomised for treatment, 27 to combination therapy and 21 to monotherapy (Fig. 
PMC10630305
Intravitreal injections
The mean (SD) number of intravitreal injections over the 24 months trial was similar for each group (10.5 (5.8) combination; 11.8 (5.6) monotherapy group (Outcomes of Eyes at 24 months.
PMC10630305
Visual acuity
The mean (95% CI) vision change was +4.0 (−1.8, 9.8) letters for combination and +7.8 (2.6, 12.9) letters for monotherapy (
PMC10630305
Spaghetti plot showing the visual acuity over 24 months for each eye (grey lines) and the locally weighted scatterplot smoothing (LOESS) curve of the overall trend with the shaded area showing the 95% confidence interval.
Analysis was performed on all eyes LOCF.
PMC10630305
Kaplan-Meier curve of time until achieving VA ≥ 85 letters.
Note that it is possible to return below 85 letters by the final visit.
PMC10630305
Diabetic macular oedema
Central macular thickness decreased by a mean of 154 µm in the combination therapy and 152 µm in the monotherapy group. Fourteen (67%) and 13 eyes (48%) did not have DMO at end of trial (combination therapy, monotherapy;
PMC10630305
Non-completers
Eleven patients and 16 eyes did not complete the two-year study, 9 eyes from the combined therapy and 7 from the monotherapy arm. The median (Q1, Q3) time to patient drop out was 30 weeks (4, 60) (Suppl. Fig. 
PMC10630305
Safety outcomes
cataract, endophthalmitis, loss of vision
PROLIFERATIVE DIABETIC RETINOPATHY, ISCHAEMIC HEART DISEASE, ENDOPHTHALMITIS, CATARACT, CEREBROVASCULAR ACCIDENT, VITREOUS HAEMORRHAGE, LOSS OF VISION
Rescue focal macular laser was required for two eyes from the combination treatment arm and one eye in the aflibercept only group. One eye from each treatment arm developed a small vitreous haemorrhage due to the injection procedure. No eyes developed endophthalmitis or proliferative diabetic retinopathy. One eye in th...
PMC10630305
Discussion
DMO, weakness, peripheral retinal ischemia, retinal ischemia
RETINAL ISCHEMIA
We found no evidence that the addition of targeted retinal laser photocoagulation to areas of retinal ischemia reduced the treatment burden of DMO compared with intravitreal aflibercept treatment alone. At 24 months, there were no significant differences in the vision gained, nor macular anatomical improvement. The 3-y...
PMC10630305
Summary
PMC10630305
What was known before
diabetic macular oedema
DIABETIC MACULAR OEDEMA
Targeted peripheral retinal laser (TPRP) photocoagulation with ranibizumab does not reduce the injection burden for patients with diabetic macular oedema compared to monotherapy ranibizumab.This was demonstrated with an initial intravitreal treatment with 3 monthly loading phase.
PMC10630305
What this study adds
peripheral retinal ischaemia
DIABETIC MACULAR OEDEMA
This study tests demonstrated that aflibercept with TPRP to areas of peripheral retinal ischaemia in naive and previously treated eyes does not reduce the injection burden for the treatment of diabetic macular oedema.In contrast to the pervious TPRP studies with ranibizumab, this study did not have a loading phase of ...
PMC10630305
Supplementary information
The online version contains supplementary material available at 10.1038/s41433-023-02525-9.
PMC10630305
Author contributions
Study conception and design: SFB, MG, HM, SW; Data collection: HM, EC, SW; Analysis and interpretation of results: EC, SW, VN, MG, SFB; Draft manuscript preparation: EC, VN, MG, SFB. All authors reviewed the results and approved the final version of the manuscript.
PMC10630305
Funding
Diabetes
DIABETES
This clinical trial received funding from the Diabetes Australia Research Program and an unrestricted educational grant from Bayer. Aflibercept was provided by Bayer. Open Access funding enabled and organized by CAUL and its Member Institutions.
PMC10630305
Data availability
Data generated during the current study are available from the corresponding author upon reasonable request.
PMC10630305
Competing interests
EEC: no financial disclosures; SW: no financial disclosures; HM: Consultant—Allergan, Bayer, Novartis, Roche; LLL: Consultant—Bayer, Novartis, AbbVie, Allergan; Speaker fees—Bayer, AbbVie; SSS: no financial disclosures; VN: no financial disclosures; MCG: Grant—Allergan; Personal fees—Bayer; Consultant—Allergan, Novarti...
PMC10630305
References
PMC10630305
Objectives
radial artery occlusion
This study investigated the contemporary incidence and predictors of radial artery occlusion as well as the effectiveness of antithrombotic treatment for radial artery occlusion following transradial coronary angiography.
PMC10449957
Background
Postprocedural radial artery occlusion
COMPLICATION
The radial artery is the standard access for coronary angiography and even complex interventions. Postprocedural radial artery occlusion is still a common and significant complication.
PMC10449957
Methods
This prospective study enrolled 2004 patients following transradial coronary angiography. After sheath removal, hemostasis was obtained in a standardized fashion. Radial artery patency was evaluated by duplex ultrasonography in all patients. In case of occlusion, oral anticoagulation was recommended and patients were s...
PMC10449957
Results
new-diagnosed radial occlusion, radial occlusion
A new-diagnosed radial occlusion was found in 4.6% of patients. The strongest independent predictors of radial occlusion were female sex and active smoking status. In the subgroup of patients with percutaneous coronary interventions, female sex followed by sheath size > 6 French were the strongest predictors of radial ...
PMC10449957
Conclusion
thrombotic, radial artery occlusion, radial occlusion, traumatic
COMPLICATION
The incidence of radial artery occlusion following coronary angiography in contemporary practice appears with 4.6% to be lower as compared to previous cohorts. Female sex and smoking status are the strongest independent predictors of radial occlusion followed by procedural variables. The limited effectiveness of oral a...
PMC10449957
Graphical abstract
PMC10449957
Supplementary Information
The online version contains supplementary material available at 10.1007/s00392-022-02094-z.
PMC10449957
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC10449957
Introduction
radial artery occlusion, occlusion of the radial artery, pain
VASCULAR COMPLICATIONS, COMPLICATION
The transradial access is recommended by current guidelines as a standard approach for diagnostic coronary angiography and interventions [Despite many advantages, the radial access can be associated with certain disadvantages such as pain or vascular complications. The persistent occlusion of the radial artery is certa...
PMC10449957
Methods
PMC10449957
Study population
dementia
HEART
The proRadial study was a prospective observational study enrolled patients undergoing coronary angiography with or without percutaneous coronary intervention (PCI) between March 2019 and August 2020 at the University Heart Center Freiburg · Bad Krozingen (Campus Bad Krozingen, Germany). All patients underwent coronary...
PMC10449957
Procedural details
artery occlusion
ARTERY OCCLUSION
Transradial coronary angiography was performed in a very standardized fashion. Only hydrophilic coated introducer sheaths from 5 to 7 French and 10 cm length were used (Glidesheath SlenderOn the day following angiography, patients underwent a physical examination of the arm and the vascular access site. A duplex ultras...
PMC10449957
Statistics
Data are presented as median with interquartile range or numbers with percent. Continuous variables were compared using the Mann–Whitney
PMC10449957
Results
PMC10449957
Antithrombotic treatment of radial artery occlusion
death, radial artery occlusion, bleeding
BLEEDING
Patients diagnosed with a new radial artery occlusion received the recommendation for oral anticoagulation regardless of symptoms for at least 30 days according to the local standard of care. These patients were also scheduled for a clinical follow-up after 30 days. Of the 93 patients with radial artery occlusion, a co...
PMC10449957
Discussion
postprocedural radial occlusion, bleeding, transient ulnar compression, radial occlusion, lower radial occlusion, contemporary radial occlusion rate, obstructive coronary artery disease, vascular spasm, vascular damage, artery occlusion, radial artery occlusion
BLEEDING, VASCULAR SPASM, EVENT, VASCULAR ACCESS SITE COMPLICATION, PATHOGENESIS, ARTERY OCCLUSION, CORONARY HEART DISEASE, ARTERIAL HYPERTENSION
This study evaluated the incidence of vascular access site complications following transradial coronary angiography in a large cohort of unselected patients including a significant proportion of patients undergoing complex coronary intervention with large-bore access. Key finding was that the contemporary radial occlus...
PMC10449957
Limitations
spasm, Radial occlusion, radial occlusion
This is a monocentric study with all adherent limitations. The majority of patients received a 6 F sheath and only about 10% of patients a 5 F or 7 F sheath limiting the informative value for these less frequently used sizes.Radial occlusion was examined one day following coronary angiography given that most patients w...
PMC10449957
Conclusion
thrombotic, radial artery occlusion, radial occlusion, traumatic
COMPLICATION
The incidence of radial artery occlusion following coronary angiography in contemporary practice is with less than 5% lower as compared to previous studies. Female sex and smoking status are the strongest independent predictors of radial artery occlusion followed by procedural variables. These results might guide clini...
PMC10449957
Supplementary Information
Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 33 kb)
PMC10449957
Abbreviations
Bleeding
BLEEDING
Bleeding academic research consortiumCoronary artery bypass graftingConfidence intervalChronical total occlusionEjection fractionLeft ventriclePercutaneous coronary interventionTransient ischemic attackOral anticoagulantNovel oral anticoagulant
PMC10449957
Funding
Open Access funding enabled and organized by Projekt DEAL. This research received no external funding.
PMC10449957
Declarations
PMC10449957
Conflict of interest
NEUMANN, EDWARDS
Franz-Josef Neumann received institutional research grants, consultancy fees and speaker honoraria from Daiichi-Sankyo, AstraZeneca, Sanofi-Aventis, Bayer, The Medicines Company, Bristol, Novartis, Roche, Boston Scientific, Biotronik, Medtronic and Edwards. Willibald Hochholzer received lecture fees from Bayer Vital, B...
PMC10449957
References
PMC10449957
2. Materials and Methods
hypothermia, fever, cognitive impairment, infections, anemia, burns, skin alterations, blood transfusions, shivering, diabetes
INFECTIONS, ANEMIA, PRESSURE ULCERS, PERIPHERAL NEUROPATHY, CHRONIC ANEMIA, DIABETES
We performed a single-center, pragmatic randomized clinical trial (RCT) with adults planned for elective non-cardiac surgery. The study was approved by the Getafe University Hospital Ethics Committee and by the Torrejón University Hospital research committee (30 November 2018, A10/18, President of Hospital Ethics Commi...
PMC10744774
2.1. Procedures, Randomization and Interventions
tremors
BLIND
In the pre-assessment clinic, subjects were informed of the study and offered participation. For patients accepting participation and signing written consent, we used a block randomization schedule generated by the Epidat v4.1 (Consellería de Sanidade, Xunta de Galicia, Spain) program and placed in sealed envelopes. On...
PMC10744774
2.2. Statistical Analysis
Sample size calculation was based on the studies of Horn et al. [The analysis between groups for continuous variables was performed using Student’s T and Mann–Whitney U for quantitative variables according to normal or non-normal distribution, respectively. For the categorical variables, Chi square and Fisher’s tests w...
PMC10744774
3. Results
During a study period of one year (November 2018–October 2019), 197 patients were analyzed, with 104 allocated to the control group and 93 to the intervention (prewarming,
PMC10744774
3.1. Preoperative Period
There were no significant differences in the temperatures of both groups of patients at any time during their stay in the pre-anesthesia room, with a maximum median difference of 0.2 °C (
PMC10744774
3.2. Intraoperative and Postoperative Period
SECONDARY
As shown in Intraoperative secondary endpoints only showed a significant difference in the interruption of intraoperative active warming (due to core temperature > 37.5 °C), which was less frequent in controls (
PMC10744774
4. Discussion
shivering, hypothermia
HEAT, SECONDARY, ADVERSE EFFECTS
In our study, we selected a population of patients scheduled for elective surgery and undergoing general or neuroaxial anesthesia with intraoperative warming. In these patients, a prewarming of at least 10 min with hot air devices did not show differences in the incidence of hypothermia, the duration of hypothermia or ...
PMC10744774
5. Conclusions
hypothermia
In conclusion, our single center RCT does not suggest the usefulness of a period of at least 10 min of active preoperative warming with warm air blankets before the transfer to the operating room. In the presence of strict pre-anesthesia room temperature control, short distances to the operating room, a culture of intr...
PMC10744774
Supplementary Materials
The following supporting information can be downloaded at: Click here for additional data file.
PMC10744774
Author Contributions
RECRUITMENT
J.R.-P.: This author helped in planning, design, patient recruitment and data collection, statistical analysis, writing and translation of the present study. M.M.M. (Miguel Miró Murillo): This author helped in planning, design, patient recruitment and data collection, statistical analysis, writing and translation of th...
PMC10744774
Institutional Review Board Statement
The study was approved by the Getafe University Hospital Ethics Committee and by the Torrejón University Hospital research committee (30 November 2018, A10/18, President of Hospital Ethics Committee: Ricardo Sanz Fernandez).
PMC10744774
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10744774
Data Availability Statement
Data will be available on request to the corresponding authors.
PMC10744774
Conflicts of Interest
The authors certify that there are no conflict of interest with any financial organization regarding the material discussed in the manuscript. Miró Murillo, M. works with 3M as a consultant for teaching and training purposes.
PMC10744774
References
hypothermia
Flow chart of patients’ enrolment, showing allocation and randomization of participants. ASA: American Society of Anesthesiologists classification on physical status.Median core temperature in the pre-anesthesia room. Values are median. Median core temperatures were not significantly different between groups. Active pr...
PMC10744774
Methods
RECURRENCE
The open-label randomized crossover study enrolled 67 patients (63.1±10.6 years old, 53 men) who had undergone initial AF ablation. Three months after ablation, patients were randomly assigned to group 1 (n = 35), 2-week Garment ECG followed by 24-hour Holter ECG, or group 2 (n = 32), 24-hour Holter ECG followed by 2-w...
PMC9955627
Results
RECURRENCE
The Garment ECG showed AF recurrence in 12 patients (18%) compared to 4 patients for the Holter ECG (6%, p = 0.008). The ECG acquisition rate was higher for Holter ECG than for Garment ECG (100.0% [interquartile range 100.0–100.0%] versus 82.4% [71.1–91.0%], p<0.001), but the Garment ECG provided longer total analysis ...
PMC9955627
Conclusions
RECURRENCE
Despite the lower ECG acquisition rate, the 2-week Garment ECG revealed instances of AF recurrence after ablation in patients who were underdiagnosed by 24-hour Holter ECG.
PMC9955627
Data Availability
Data cannot be shared publicly because of limited permission from the participating patients and University of Tsukuba Clinical Research Review Board has imposed them. Data are available from the Clinical Research Support Center, Tsukuba Clinical Research and Development Organization, University of Tsukuba (2-1-1 Amaku...
PMC9955627
Introduction
death, dementia
EVENTS, ATRIAL FIBRILLATION (AF), CEREBRAL INFARCTION
Atrial fibrillation (AF) constitutes a major risk factor for cardiovascular events, cerebral infarction, dementia, and death [The actual rate of AF detection depends on the duration of electrocardiogram (ECG) monitoring, but the current standard of care for post-ablation AF relies on 24-hour continuous monitoring using...
PMC9955627
Materials and methods
PMC9955627
Study design and participants
This was a randomized crossover comparative study with open design and block randomization (
PMC9955627
Patient flow diagram.
ECG, electrocardiogram.This study was registered in the Japan Registry of Clinical Trials (jRCT) as jRCTs 032180018. Patients provided written informed consent before enrollment. The protocol was approved by the University of Tsukuba Clinical Research Review Board, and the study was conducted in accordance with the Dec...
PMC9955627
Garment ECG system with hitoe
A, The hitoe
PMC9955627
Endpoints
redness, erosion, non-AF arrythmia
EROSION, RECURRENCE, SECONDARY, FLUTTER, SCARRING, EVENTS
The primary endpoint was the detection rate of patients with AF recurrence. AF recurrence was defined as AF or arterial flutter lasting 30 seconds or longer, a definition that is widely used for assessing AF after catheter ablation [The major secondary endpoint was the ECG acquisition rate, which was defined as the rat...
PMC9955627
Procedures
burn injuries, cutaneous pruritus
ADVERSE REACTIONS, EVENTS, EVENT
After catheter ablation, patients provided informed consent to participate in this study. Those who met the inclusion criteria and did not meet the exclusion criteria were enrolled and randomly allocated to one of the two groups. Three months after catheter ablation, patients started ECG monitoring using the device tha...
PMC9955627