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Methods
PMC10589316
Subjects
epilepsy, somatic pain, psychiatric, MDD, NRS
WEST, DISORDERS, EPILEPSY
Eighty MDD patients with moderate somatic pain were recruited from the Mental Health Center and the Neurobiological Laboratory, Sichuan University, West China Hospital. They had not received any analgesics or anti-depressants for at least 2 weeks before enrollment. Patients were randomly assigned to the DT group (n = 4...
PMC10589316
rTMS stimulation and evaluations
NRS
rTMS simulations were carried out using a Magstim Rapid2 stimulator (Magstim Company, Spring Gardens, UK) with a figure-of-eight coil (double wings of 70-mm diameter). Coil placement was 5 cm anterior to the left and right motor hotspots. The resting motor threshold (RMT) of the right abductor pollicis brevis muscle wa...
PMC10589316
Author contributions
Y.S. wrote the main manuscript text; F.L., K.Z. and Z.Z. provided the conception and modified this text. All authors reviewed the manuscript.
PMC10589316
Funding
This work was supported by Sichuan Province cadres health research subject 2016-107, the Sichuan Natural Science Foundation (2023NSFC01235), the National Natural Sciences Foundation of China (81300065).
PMC10589316
Data availability
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
PMC10589316
Competing interests
The authors declare no competing interests.
PMC10589316
References
PMC10589316
Key Points
PMC10401301
Question
HEART, CARDIAC ARREST
Does the use of a tablet application cognitive aid reduce deviations from American Heart Association (AHA) resuscitation guidelines and improve the management of pediatric cardiac arrest?
PMC10401301
Findings
In this randomized clinical trial including 300 participants in 100 teams, the use of an interactive tablet application led to fewer deviations from AHA guidelines and better team performance compared with use of the AHA pocket reference card or no cognitive aid.
PMC10401301
Meaning
CARDIAC ARREST
This randomized clinical trial found that the use of the cognitive aid tablet application improved adherence to resuscitation guidelines, thus demonstrating promise for improving patient outcomes, although further studies are necessary to confirm these findings and demonstrate its impact in clinical practice.This rando...
PMC10401301
Importance
cardiac arrest
CARDIAC ARREST
Deviations from international resuscitation guidelines during the management of pediatric cardiac arrest are frequent and affect clinical outcomes. An interactive tablet application (app), PediAppRREST, was developed to reduce guideline deviations during pediatric cardiac arrest.
PMC10401301
Objective
PediAppRREST
CARDIAC ARREST
To assess the effectiveness of PediAppRREST in improving the management of simulated in-hospital pediatric cardiac arrest.
PMC10401301
Design, Setting, and Participants
This multicenter 3-group simulation-based randomized clinical trial was conducted from September 2020 to December 2021 at 4 Italian university hospitals (Padua, Florence, Rome, Novara). Participants included residents in pediatrics, emergency medicine, and anesthesiology. Analyses were conducted as intention-to-treat. ...
PMC10401301
Interventions
PediAppRREST
AIDS, CARDIAC ARREST
Teams were randomized to 1 of 3 study groups: an intervention group that used the PediAppRREST app; a control group that used a paper-based cognitive aid, the Pediatric Advanced Life Support (PALS) pocket card; and a control group that used no cognitive aids. All the teams managed the same standardized simulated scenar...
PMC10401301
Main Outcomes and Measures
SECONDARY
The primary outcome was the number of deviations from guidelines, measured by a 15-item checklist based on guideline recommendations. The main secondary outcomes were quality of chest compressions, team clinical performance (measured by the Clinical Performance Tool), and perceived team leader’s workload. Study outcome...
PMC10401301
Results
Overall 100 teams of 300 participants (mean [SD] age, 29.0 [2.2] years; 195 [65%] female) were analyzed by intention-to-treat, including 32 teams randomized to the PediAppRREST group, 35 teams randomized to the PALS control group, and 33 teams randomized to the null control group. Participant characteristics (210 pedia...
PMC10401301
Conclusions and Relevance
CARDIAC ARREST
In this randomized clinical trial, the use of the PediAppRREST app resulted in fewer deviations from guidelines and a better team clinical performance during the management of pediatric cardiac arrest.
PMC10401301
Trial Registration
ClinicalTrials.gov Identifier:
PMC10401301
Introduction
cardiac arrest
HEART, SEQUELAE, CARDIAC ARREST
Pediatric cardiac arrest is a rare emergency associated with high mortality and important clinical sequelae.In 2019, we developed an interactive, multimodal, electronic cognitive aid in the form of a tablet application (app), named PediAppRREST, to provide decision support to the team leader through a clickable list of...
PMC10401301
Methods
This randomized clinical trial was deemed a negligible risk study by the human ethics committee of the University Hospital of Padua and granted approval via a fast-tracked review process. All participants provided written informed consent. The study was reported according to the extended Consolidated Standards of Repor...
PMC10401301
Design, Setting, and Participants
This was a multicenter, simulation-based, 3-group parallel randomized clinical trial. The study was carried out between September 2020 and December 2021 at 4 Italian University Hospitals (Padua, Florence, Rome, and Novara), with analysis performed between January and June 2022. Residents in pediatrics, emergency medici...
PMC10401301
Interventions
cardiac arrest, PediAppRREST
CARDIAC ARREST
Participants were stratified by hospital location and residency specialty. Among PALS-certified residents, 1 participant was randomly assigned to each team with the role of team leader. Among the remaining PALS- and non-PALS–certified residents, 2 participants were randomly assigned to each team to obtain teams of 3 me...
PMC10401301
Outcomes
Two independent and trained reviewers (G.T. and E.F.)
PMC10401301
Primary Outcome
CARDIAC ARREST
The main outcome of the study was the number of deviations from PALS guidelines during the management of pediatric cardiac arrest, as measured by a 15-item checklist. For each item, a score of 1 point was assigned if a deviation (ie, delay, error, or omission) occurred, while zero was assigned if the action was correct...
PMC10401301
Error Score Items for Nonshockable Pediatric Cardiac Arrest
pulseless, Shock
BLOOD, SHOCK, CARDIAC ARREST
CPR started within 30 s from recognition of pulseless state.CPR board or rigid surface positioned underneath the manikin within 60 s from recognition of pulseless state.Compression and ventilation ratio of 15:2.Help called (hospital emergency response system activated) within 60 s from recognition of pulseless state.Co...
PMC10401301
Secondary Outcomes
SECONDARY
We assessed 6 secondary outcomes. Performance and time (in seconds) to accomplish critical resuscitation interventions were measured.
PMC10401301
Statistical Analysis
Sample size was calculated considering the results obtained during our previous observationalThe results were summarized with counts and percentages for categorical variables and mean and SD for normally distributed quantitative variables. For variables with asymmetric distribution, we also reported the median and IQR....
PMC10401301
Results
We recruited 324 residents (108 teams). Eight teams did not participate in the trial due to sickness or withdrawal of consent, leaving 100 teams for the intention-to-treat analysis: 32 teams in the PediAppRREST group, 35 in the PALS group, and 33 in the null control group (
PMC10401301
Participant Demographic Characteristics and Previous Experience in Simulation and Resuscitation
ALS
Abbreviations: ALS, Advanced Life Support; ACLS, Advanced Cardiac Life Support; BLS, Basic Life Support; CPR, cardiopulmonary resuscitation; PALS, Pediatric Advanced Life Support; PBLS, Pediatric Basic Life Support.Data missing for 1 participant.Data missing for 2 participants.Data missing for 3 participants.Includes d...
PMC10401301
Primary Outcome
The mean number of deviations from guideline recommendations, as measured by the error score, was significantly lower in the PediAppRREST group (mean [SD] 3.4 [2.0] points) compared with the 2 control groups (PALS: mean difference, −3.0; 95% CI, −4.0 to −1.94;
PMC10401301
Error Scores Overall and for Individual Items
Abbreviations: CPR, cardiopulmonary resuscitation; EKG, electrocardiogram; IO, intraosseous; IV, intravenous; NE, not estimable; PALS, Pediatric Advanced Life Support.Range, 0 to 15, with higher score indicating more errors.Expressed as mean difference (95% CI).Details of the correct performance of each item are provid...
PMC10401301
Secondary Outcomes
PediAppRREST
Use of the PediAppRREST app, compared with both control groups, was associated with a significantly higher percentage of teams that positioned a CPR board or rigid surface underneath the patient (78.1% of PediAppRREST teams; 20.0% of PALS teams; The analysis of chest compression quality metrics did not show any statist...
PMC10401301
Principle Secondary Outcomes Results
chest compression, PediAppRREST
Abbreviations: CC, chest compression; CPT, Clinical Performance Tool; PALS, Pediatric Advanced Life Support; R-TLX, raw NASA Task Load Index.Scores range from 0 to 13, with higher score indicating better performance. Includes data for 32 PediAppRREST teams, 35 PALS teams, and 33 null control teams.Scores range from 0 t...
PMC10401301
Discussion
ROSC, cardiac arrest, PediAppRREST
AIDS, CARDIAC ARREST
In this randomized clinical trial, we analyzed the effect of the use of the PediAppRREST tablet app on the management of a simulated case of pediatric cardiac arrest and found that its use was associated with fewer deviations from guidelines and a better team clinical performance compared with the use of the AHA refere...
PMC10401301
Limitations
cardiac arrest
CARDIAC ARREST
This study has some limitations. The main limitation is that only residents were included as participants. We elected to include residents because they are frequently the frontline physicians managing the first minutes of a pediatric cardiac arrest in many institutions.
PMC10401301
Conclusions
CARDIAC ARREST
In this randomized clinical trial, teams using the PediAppRREST app had fewer deviations from international guidelines and a better clinical team performance during the management of simulated pediatric cardiac arrest. Further studies are necessary to understand the effectiveness of this aid in multidisciplinary team c...
PMC10401301
Objectives
MIDDLE EAR
The aim of this work is to compare between different techniques of adenoidectomy: endoscopic microdebrider-assisted, coblation and conventional adenoidectomy and its effect on middle ear pressure.
PMC10764527
Background
inflammation, obstruction of the tubal, Eustachian tube dysfunction
INFLAMMATION, MIDDLE EAR, EUSTACHIAN TUBE DYSFUNCTION
Adenoidectomy, either alone or with tonsillectomy, is considered among the most performed procedures in pediatric otorhinolaryngology. This procedure usually related to the Eustachian tube function and middle ear status. Eustachian tube dysfunction is mainly caused by mechanical obstruction of the tubal orifice, insuff...
PMC10764527
Methods
adenoid hypertrophy, pain
ADENOID HYPERTROPHY, RECURRENCE, POSTOPERATIVE BLEEDING
This prospective randomized study was conducted on 90 patients with symptomatic adenoid hypertrophy confirmed by nasopharyngeal X-ray and endoscopic grading preoperatively. Patients were admitted at Otorhinolaryngology department of our institute during the period from January 2022 to January 2023. They were divided in...
PMC10764527
Results
Mean age in group A was 9.03 years and in group B was 8.99 years and was 8.99 years in group C with insignificant differences between three groups. There is significant improvement of tympanographic results comparing all groups of the patients at 6 months postoperatively. There is significant relation between the mean ...
PMC10764527
Conclusion
There are better results in tympanographic data at conventional adenoidectomy versus other techniques. However, there are also better postoperative results after either coblation or endoscopic microdebrider adenoidectomy over the conventional technique.
PMC10764527
Keywords
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).
PMC10764527
Background
cor-pulmonale, inflammation, airway obstruction, adenoid hypertrophy, hemorrhage, obstruction of the tubal, Sleep-related breathing disorder, adenoid, maxillofacial anomalies, trauma
INFLAMMATION, AIRWAY OBSTRUCTION, SLEEP-RELATED BREATHING DISORDERS, EUSTACHIAN TUBE DYSFUNCTION, HEMORRHAGE, ADENOID HYPERTROPHY, MIDDLE EAR, PULMONARY HYPERTENSION, COMPLICATIONS
The adenoid also known as nasopharyngeal tonsils is a lymphatic tissue in the nasopharynx. It is situated in the midline on the roof and posterior wall of the nasopharynx. The adenoids are midline structures situated on the roof and posterior wall of the nasopharynx [Adenoid hypertrophy is one of the common causes of u...
PMC10764527
Methods
bleeding, sleep disorder, Pain, choanal atresia, adenoid, Postoperative bleeding, ’ postoperative pain, palate, retrognathia or macrognathia, sleep disordered breathing, nasal obstruction, adenoid hypertrophy, maxillofacial anomalies, cleft lip, adenoid mass
OTITIS MEDIA WITH EFFUSION, HYPERTROPHIED, BLEEDING, POSTOPERATIVE BLEEDING, ALLERGIC RHINITIS, OTITIS MEDIA, PAD, BLIND, SLEEP DISORDERED BREATHING, COAGULATION DISORDER, ADENOID HYPERTROPHY, COMPLICATIONS
This prospective randomized study was conducted on 90 patients with symptomatic adenoid hypertrophy such confirmed by nasopharyngeal X-ray and endoscopic grading preoperatively. Patients were selected from general population including patients reporting to Otorhinolaryngology outpatient clinics of Al-Azhar University h...
PMC10764527
Discussion
deafness, bleeding, Adenoid enlargement, hearing loss, adenotonsillar hypertrophy, edema, Eustachian tube dysfunction, adenoid hyperplasia, OME, temporary dysfunction of Eustachian tube, pain, infection, fullness, hypoacusis, adenoid hypertrophy, adenoid tissue hypertrophy, Eustachian dysfunction
MIDDLE EAR EFFUSION, BLEEDING, HEARING LOSS, ADENOTONSILLAR HYPERTROPHY, BLOOD CLOTS, EDEMA, ADENOID HYPERPLASIA, EUSTACHIAN TUBE DYSFUNCTION, RECURRENT OTITIS MEDIA, HEARING IMPAIRMENT, INFECTION, ADENOID HYPERTROPHY, MIDDLE EAR
Adenoid enlargement is an important cause for Eustachian tube dysfunction and recurrent otitis media in pediatric population. In recent study by Somayaji et al., incidence of adenoid hypertrophy was more in 4–6-year age group, followed by 7–9-year age group. This observation was similar to the study by Fujioka et al., ...
PMC10764527
Author contributions
AS collected patients from outpatient clinic and was responsible for the design and analyzing data and share in writing the manuscript. AS and AN were major contributors in writing the manuscript. AS and AF analyzed and interpreted the patient data regarding the diagnosis and management of the cases. All authors read a...
PMC10764527
Funding
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). There is no funding.
PMC10764527
Availability of data and materials
The data sets used and/or analyzed in the current study are available from the corresponding author on reasonable request.
PMC10764527
Declarations
PMC10764527
Conflict of interest
The authors declare that they have no competing interests in this section.
PMC10764527
Ethics approval and consent to participate
Consent was taken from patients before performing any operation, and they had the right to refuse at any time. The study was approved by the Research Ethics Committee of the Faculty of Medicine, Al-Azhar University. Ethics committee reference number is 8/2022ENT/231.
PMC10764527
Consent for publication
Not applicable.
PMC10764527
References
PMC10764527
Subject terms
tumor, clear cell carcinoma
REGRESSION, ENDOMETRIAL CANCER, CLEAR CELL CARCINOMA, TUMOR
Uterine clear cell carcinoma (UCCC) is a relatively rare endometrial cancer. There is limited information on its prognosis. This study aimed to develop a predictive model predicting the cancer-specific survival (CSS) of UCCC patients based on data from the Surveillance, Epidemiology, and End Results (SEER) database bet...
PMC10247799
Introduction
tumor, clear cell carcinoma
TUMOR, CLEAR CELL CARCINOMA, MULTIPLE CANCER
Uterine clear cell carcinoma (UCCC) is a relatively rare endometrial cancerDue to the rarity of UCCC, there is limited information on its biology and pathogenesisAccurately predicting the survival probability of an individual tumor patient may change the pattern of medical practice and aid in clinical decision-making. ...
PMC10247799
Results
PMC10247799
Validation of the nomogram
The C-index of the nomogram in the training set and validation set is 0.778 (95% CI 0.758–0.798) and 0.765 (95% CI 0.743–0.787), respectively, indicating that the nomogram has good prediction accuracy. Calibration curve analysis showed that the survival rate predicted by the nomogram was in good agreement with the actu...
PMC10247799
Discussion
tumor
TUMOR, METASTASIS
In this study, we developed a nomogram for predicting CSS in UCCC patients based on eight predictors of patient’s age, tumor size, SEER stage, surgery, number of lymph nodes detected, lymph node metastasis, radiotherapy and chemotherapy. The predictors included in the model can be easily obtained from clinical practice...
PMC10247799
Methods
PMC10247799
Patient selection
tumor, death
DISEASES, TUMOR, PRIMARY TUMORS, DISEASE, ONCOLOGY
Data on UCCC patients registered between 2000 and 2018 were extracted from the SEER database using SEER* Stat (version 8.4.0.1) software. Inclusion criteria included: (1) pathologically confirmed UCCC, coded as 8310/3 according to the International Classification of Diseases for Oncology, Third Edition (ICD-O-3); (2) p...
PMC10247799
Statistical analysis
REGRESSION
The final included UCCC patients were randomly assigned to the training set and the validation set in a 7:3 ratio using R software. The training set was used to build a risk prediction model and to construct a nomogram to predict a patient's CSS at 5 and 10 years. Validation groups are used for internal validation. For...
PMC10247799
Acknowledgements
We acknowledged the contributions of the Surveillance, Epidemiology, and End Results (SEER) Program registries for creating and updating the SEER database.
PMC10247799
Author contributions
This study was designed by W.L.C and J.C. Data extraction, statistical analysis and interpretation of data were performed by W.L.C., R.M.W. and Y.Z. All authors were involved in drafting and revision of the manuscript and approved the final version to be published.
PMC10247799
Data availability
The data that support the findings of this study are openly available in software package SEER*Stat 8.4.0.1 (
PMC10247799
Competing interests
The authors declare no competing interests.
PMC10247799
References
PMC10247799
Background:
Remimazolam is a novel, ultrashort-acting benzodiazepine that can be antagonized by flumazenil. This study aimed to determine whether remimazolam-based anesthesia with flumazenil provides a more rapid emergence than propofol-based anesthesia in older patients undergoing spinal surgery.
PMC10659722
Methods:
SECONDARY
This was a prospective, single-blind, randomized controlled trial. Forty-four patients > 75 years old who had undergone spinal surgery were enrolled in this study. They were randomly assigned to the remimazolam or propofol group (1:1) using a computer randomization system stratified by age and body weight. For anesthes...
PMC10659722
Results:
Thirty-nine patients were finally analyzed: remimazolam group (n = 20), propofol group (n = 19). There were no significant differences in intraoperative variables, such as operative time, anesthesia time, and patient background, between the 2 groups. Extubation times were significantly shorter in the remimazolam group ...
PMC10659722
Conclusion:
Remimazolam-based anesthesia with flumazenil resulted in a faster emergence than propofol-based anesthesia in older patients undergoing spinal surgery.
PMC10659722
1. Introduction
ADVERSE EVENTS, NEUROLOGICAL COMPLICATION
Delayed emergence from general anesthesia interferes with operating room (OR) management and increases adverse events such as delayed recovery of airway reflexes.Spinal surgery, which often involves older patients, requires intraoperative motor-evoked potential (MEP) monitoring to reduce perioperative neurological comp...
PMC10659722
2. Methods
PMC10659722
2.1. Study design
This prospective, multicenter, single-blind, randomized controlled study was conducted at Hiroshima University Hospital and JA Hiroshima General Hospital (a regional hospital). The study was approved by the Ethics Committee of Hiroshima University on November 25, 2020 (C-306) and the Ethics Committee of JA Hiroshima Ge...
PMC10659722
2.2. Participants
liver dysfunction, dementia
OBESE, SPINAL TUMORS
Patients who met the inclusion criteria underwent spinal surgery including laminoplasty, laminectomy, posterior spinal fusion, and resection of spinal tumors.The inclusion criteria were as follows: >75 years old, American Society of Anesthesiologists (ASA) physical status classification 1 to 3, and written informed con...
PMC10659722
2.3. Randomization and masking
The patients underwent single-blind randomization (1:1) into 2 groups (remimazolam group - group R, or propofol group - group P) via the Research Electronic Data Capture (REDCap) computer randomization system stratified by age (75–79 years old or ≥ 80 years old) and body weight (<60 kg or ≥ 60 kg). Patients and operato...
PMC10659722
2.4. General anesthesia protocol
All patients were randomly managed by staff anesthesiologists at each hospital. None of the patients received any premedication. Standard monitoring included electrocardiography, noninvasive blood pressure or arterial blood pressure monitoring, pulse oximetry, capnography, electroencephalogram-based monitoring using th...
PMC10659722
2.5. Outcome measures
ADVERSE EVENTS, SECONDARY
The primary outcome was the elapsed time from the discontinuation of anesthesia to extubation. Extubation time can be an indicator of the emergence of the patient from general anesthesia, as extubation requires the recovery of respiratory function and consciousness.The secondary outcomes were the elapsed time from the ...
PMC10659722
2.6. Sample size
Previously, we found that the average time to extubation at our institution was 17 ± 5 minutes in 37 patients who were > 75 years old and underwent spinal surgery under propofol-remifentanil anesthesia from April 2019 to March 2020 in Hiroshima University Hospital.The G*power 3.1.0 program (We used a type 1 error of α ...
PMC10659722
2.7. Statistical analyses
All data are expressed as interquartile range, or numbers (%). Continuous variables were compared using the Mann–Whitney U test, and the Fisher exact test was used to compare categorical variables. Statistical significance was set at
PMC10659722
3. Results
thirty-nine, hypotension
The CONSORT flow diagram of this study is shown in Figure The CONSORT flow diagram.Forty-four patients were enrolled between January 2021 and September 2022 and were randomly allocated to either group R (n = 22) or group P (n = 22). Following randomization, 2 patients declined to participate. One patient was unable to ...
PMC10659722
4. Discussion
re-sedation, emesis, pain
ADVERSE EVENTS
This study showed that the time to extubation, eye opening, obeying commands, and achieving a WFTS score of 12 were all significantly shorter under remimazolam-based anesthesia with flumazenil than under propofol-based anesthesia in older patients who underwent spinal surgery. There were no prolonged extubation (define...
PMC10659722
Acknowledgments
We also would like to thank Editage (
PMC10659722
Abbreviations:
Kondo T
gamma-aminobutyric acidmotor evoked potentialsoperating roomoxygen saturationwhite fast-track scoreThe datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.Supplemental Digital Content is available for this article.The authors have no confl...
PMC10659722
References
PMC10659722
Introduction
COMPLICATIONS
ureteral stents have common complications like ureteral stent-related symptoms (SRSs). This study investigated the effectiveness of tadalafil compared to mirabegron and solifenacin combination therapy in patients with ureteral SRSs after double-J (DJ) stent insertion.
PMC10620325
Methods
pain
this double-blind, randomized clinical trial used consecutive random sampling in participants with SRSs after double-J stent insertion. The study was conducted at four different hospitals in Makassar, Indonesia, from July to December 2020. Ureteral stent-related morbidity indices which analyzed include urinary symptoms...
PMC10620325
Results
pain
before the treatment procedure, the groups were comparable in age, gender, body mass index, DJ stent procedures, type, and indication. In general, the score in all parameters declined over the follow-up time for both groups. Group A had a lower urinary symptom score than group B at week III and week IV (all p-value < 0...
PMC10620325
Conclusion
according to our results, we suggest tadalafil to minimize stent-related urinary symptoms and improve general health in patients with double J stent.
PMC10620325
Introduction
urinary complaints, pain
SIDE EFFECTS
A ureteral stent is a tool to facilitate the flow of urine from the kidney to the bladder that is disturbed due to obstruction. Ureteral stents have an important role in the temporary drainage of the upper urinary tract and are a frequently performed procedure in endourological surgery [Given the large number of patien...
PMC10620325
Discussion
sexual dysfunction, complaints of urinary symptoms, complaints of sexual activity, pain
This study revealed that male patients comprised more than 70% of the occurrence in both group and the majority (52.84%) in the age of 26-45 years. The findings of this study are comparable with those of Pansota Post-DJ-stent patients who experienced SRSs were divided into 2 groups and treated with Tadalafil 10 mg/day ...
PMC10620325
Conclusion
Tadalafil and a combination of mirabegron and solifenacin improved the SRSs in three weeks. However, additional benefits can be achieved using tadalafil 10 mg. This may imply the single use of tadalafil 10 mg in overcoming SRSs is more considered than the combination therapy, particularly in patients with drug complian...
PMC10620325
Competing interests
The authors declare no competing interests.
PMC10620325
Authors' contributions
Conceived and designed the analysis: Tjia Adynata Ciayadi, Muhammad Asykar Palinrungi, Khoirul Kholis, Syakri Syahrir, Syarif Syarif, and Abdul Azis; data collection: Tjia Adynata Ciayadi; data analysis: Tjia Adynata Ciayadi and Joko Hendarto; wrote the paper: Tjia Adynata Ciayadi; final approval: Muhammad Asykar Palin...
PMC10620325
Purpose
TYPE 2 DIABETES
To assess the magnitude and durability of the metabolic benefits by simplification of complex insulin treatments in patients with type 2 diabetes inadequately controlled by a full basal-bolus insulin regimen. Herein we report the results of the scheduled 2-year extension of the BEYOND trial.
PMC10850008
Methods
Originally, 305 participants with inadequate glycemic control (HbA1c > 7.5%) were randomly assigned to intensification of basal-bolus insulin regimen (
PMC10850008
Results
SD
Fifty-five percent of patients completed the study in the two comparison arms. Compared with patients randomized to basal-bolus, patients of the other groups experienced non statistically different reductions in HbA1c level according to either an intention-to-treat analysis (−0.8 ± 1.1%, −0.7 ± 1.1%, and −1.3 ± 1.1%, m...
PMC10850008
Conclusion
TYPE 2 DIABETES
Simplification of complex insulin regimen may be a durable option in at least one-half of patients with type 2 diabetes.
PMC10850008
Clinical trial registration
Clinical trial registration no. NCT04196231, clinicaltrials.gov.
PMC10850008