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Data analysis
Conscientiousness, Rash
SECONDARY, RASH, POSITIVE
Analyzes used Generalized Linear Models (GLM) to assess the effects of time, group and, the intervention over time compared with the control group for the following outcomes (dependent variables): a) UPPS-P: Perseverance, Premeditation, Sensation Seeking, Positive Urgency, Negative Urgency, Emotion-based Rash Action (f...
PMC10629638
Results
PMC10629638
Demographic characteristics
A total of 122 participants consented to participate in the randomized controlled trial. All participants answered at least one of the principal outcomes. Most of the sample responded self-report and behavioral measures (n = 86) attrition rate 32%, and responded only self-report (n = 36) attrition rate 28%. Any partici...
PMC10629638
IGT
IGT results are shown in
PMC10629638
GLM of Iowa gambling test (IGT), self-report impulsivity (UPPS-P) and stroop color task.
Note: All the outcomes were adjusted for age, gender and baseline. Bonferroni p = 0.0167.We performed a sensitivity analysis by adding abstinence days as a covariate to the IGT Total score model, which confirmed the significant effect for the interaction MBRP*time = 11.02, 0.67–21.37 p = 0.037.
PMC10629638
UPPS-P
UPPS-P results are shown in
PMC10629638
Stroop test
Stroop results are shown in
PMC10629638
Discussion
SUDs, impulsivity, impulsive behavior
The literature on impulsivity has already pointed out the challenge of measuring and understanding this construct, which leads to difficulty in intervening on it. With the benefit of investigating different dimensions of impulsivity through multiple measures, this study found the effects of the MBRP group overtime on t...
PMC10629638
Strengths
SUDs, impulsivity
DISORDERS
The use of multifaceted instruments in the study favored our understanding of this phenomenon involving dependence and impulsivity. In addition, it allowed us to make specific inferences regarding cortical functioning from the results obtained by scales and behavioral tests. Also, it is noteworthy that it was a control...
PMC10629638
Limitations and future directions
impairment in executive functions, impulsivity
Despite the positive sides, the highly controlled environment, a characteristic of the Therapeutic Community, is also a limitation of the study since the attended patients used to live alone or as homeless people, facing violence and financial/food deprivation daily. This fact has two possible important implications: p...
PMC10629638
Conclusion
SUDs, impulsivity
This study contributed for improvement in executive functions, specifically decision-making and no effect for self-reported impulsivity and inhibitory control among middle-aged patients after an 8-weeks intervention of MBRP protocol in an inpatient setting. It adds information to the subject, with implications and poss...
PMC10629638
Supporting information
(DOC)Click here for additional data file.
PMC10629638
Appendix study protocol–version EN-PT.
(DOCX)Click here for additional data file.We are grateful for the voluntary participation of the participants in this study as well as by the employees of the institutions that have made it possible. We are also grateful to our colleagues from NEPSIS for their relevant contributions to the design of the study and the d...
PMC10629638
References
PMC10629638
ABSTRACT
PMC10392243
Background
A majority of dental school students do not undergo hands-on clinical training in implantology in the undergraduate curriculum. Training is usually restricted to pre-implant evaluation and post-implant prostheses. Virtual implant planning software (VIPS) provides an alternative opportunity for undergraduate students to...
PMC10392243
Methods
GROUP B
A two-part theory lecture on fully guided implant planning was delivered to 90, 5th (final)-year dental undergraduate students by the oral radiology faculty. The students were then randomly divided into three groups. Group A was exposed to didactic lectures only. Group B was shown a video for fully guided implant plann...
PMC10392243
Results
The overall test score of students in Group C was higher than their colleagues in both Groups A and B and the differences were statistically significant (
PMC10392243
Conclusions
The utilization of VIPS in the training of dental undergraduate students improves their performance confirming better knowledge acquisition and content mastery.
PMC10392243
KEYWORDS
PMC10392243
Introduction
With the advancement of information technology, virtual simulation has become one of the newer methods of teaching during practical sessions [Traditionally, conventional radiographs have been utilized to view the complex internal structures of the human teeth and jaw [There are two distinct categories of guided implant...
PMC10392243
Materials and methods
EVENTS, GROUP B
The study was conducted on 90 final-year BDS students, after approval by the Research Ethics Committee. Written informed consent was obtained from all participants. A two-part theory lecture of one hour each on fully guided implant planning was delivered to final-year dental students by oral radiology faculty in the mo...
PMC10392243
Statistical analysis
The data obtained from the tests were analyzed using the IBM SPSS statistics (Version 22, IBM Corp,Armonk. NY, USA). The overall score, scores in the knowledge component and scores in the procedural component among the three study groups were compared using the ANOVA and Tukey Post Hoc Test.
PMC10392243
Results
The overall test score of Group C was higher than that of Group A and group B. Similarly Group C had higher test scores in the knowledge and the procedure components of the MCQs, when compared to Group A and Group B. Overall comparison of the scores using ANOVA test showed a significant difference (Overall Comparison ...
PMC10392243
MCQ analysis
Blackboard question analysis revealed that the majority (Question analysis of the MCQs used in the study.
PMC10392243
Feedback from Questionnaires
Majority of the students (Graph showing results of the questionnaire regarding fully guided implant planning.Pie chart showing students’ views on virtual implant planning.
PMC10392243
Discussion
GROUP B
In the present study VIPS training was given to final year BDS students (advanced beginners according Modified Dreyfus Model). The educational strategy was to assess the students ‘knows’ and ‘knows how’ components (Modified Millers model) of implant planning using VIPS (simulation) [The findings of this study demonstra...
PMC10392243
Limitations
One of the major limitations of the study is that long-term retention of knowledge has not been evaluated. Another limitation of the present study is that the number of MCQs are less. Lastly, the study was restricted to the student cohort of a single university only. Study involving students from multiple dental school...
PMC10392243
Future recommendations
Conduct follow-up studies should be performed to evaluate the long-term knowledge retention of the learners/students. 2) Introduce virtual implant planning software videos and hands-on training synergistically while teaching the theoretical concepts of implantology as a part of oral surgery, oral radiology, and prostho...
PMC10392243
Conclusions
Applying information technology to the practical aspects of training, creating a flexible and networked virtual simulation teaching platform, and establishing a training model can effectively compensate for the deficiencies of conventional practical teaching. A hybrid system of teaching dental students that incorporate...
PMC10392243
Supplementary Material
PMC10392243
Supplemental Material
Click here for additional data file.
PMC10392243
Disclosure statement
No potential conflict of interest was reported by the author(s).
PMC10392243
Availability of data and materials
The raw data is available at figshare; 10.6084/m9.figshare.22059254
PMC10392243
Supplementary material
Supplemental data for this article can be accessed online at
PMC10392243
References
PMC10392243
MCQs used for the evaluation of knowledge regarding fully guided virtual implant planning
HEAT
STLJPEGPNGTIFFTo stabilize the implantTo guide/position the surgical drillTo guide/position the surgical drill and subsequent implantTo dissipate heat produced during implant drillProsthesis driven implant can be achievedImplant driven prosthesis can be achievedImplants can be loaded immediatelyRequires less implant d...
PMC10392243
Background
gastric peritoneal carcinomatosis, adenocarcinoma
ADENOCARCINOMA
Studies from Asia indicate that normothermic intraperitoneal chemotherapy (NIPEC) may confer survival benefit in patients with gastric peritoneal carcinomatosis (PC). However, data regarding this approach is lacking in western population. The current STOPGAP trial is intended to assess 1-year progression-free survival ...
PMC9985848
Methods
gastric/GEJ, peritoneal cancer, adenocarcinoma, CRS
PERITONEAL CANCER, METASTASIS, ADENOCARCINOMA, SECONDARY
This is a prospective, single center, single arm, phase II investigator-initiated clinical trial. Patients with histologically proven gastric/GEJ (Siewert 3) adenocarcinoma with positive peritoneal cytology or PC will be eligible to participate after three months of standard of care systemic chemotherapy and with no ev...
PMC9985848
Discussion
If the sequential approach of systemic chemotherapy followed by paclitaxel NIPEC proves beneficial, then this approach could be used in larger, muti-institutional randomized clinical trial of gastric PC.
PMC9985848
Trial Registration
The trial was registered on 21/02/2021, under clinical trials.gov; Identifier: NCT04762953.
PMC9985848
Keywords
PMC9985848
Background and rationale
Gastric cancer, cancer deaths, cancer, gastric cancer
GASTRIC CANCER, CANCER, GASTRIC CANCER
Gastric cancer is the fifth most common cancer and fourth leading cause of cancer deaths worldwide in 2020 [Efficacy of normothermic intraperitoneal chemotherapy (NIPEC) combined with systemic chemotherapy to treat gastric cancer PC has been extensively studied in Asia [Due to the inherent biologic differences in gastr...
PMC9985848
Methods
PMC9985848
Study design
adenocarcinoma, Cancer
ADENOCARCINOMA, CANCER
This is a single-center, single arm, phase II clinical trial for patients with histologically proven gastric or gastroesophageal junction (GEJ) (Siewert 3) adenocarcinoma with positive peritoneal cytology or PC. The primary treatment is iterative paclitaxel NIPEC with systemic paclitaxel and 5-fluorouracil after three ...
PMC9985848
Study population
PERITONEAL CARCINOMATOSIS, METASTASIS, ADENOCARCINOMA
Adult patients (18–75 years old) with gastric and GEJ adenocarcinoma with positive peritoneal cytology or peritoneal carcinomatosis detected by laparoscopy, laparotomy, or imaging and without evidence of distant organ metastasis and no evidence of progression after 3–4 months of first-line systemic therapy are eligible...
PMC9985848
Study procedures
peritoneal disease
PERITONEAL DISEASE
After enrollment, patients will undergo diagnostic laparoscopy, peritoneal washings, evaluation of PCI and biopsies if deemed necessary, and IP port placement (14.3 fr BARD IP port). PCI is a well-established scoring system described by Sugarbaker et al. that is used to assess and document the extent of peritoneal dise...
PMC9985848
Treatment
ascites
ASCITES, DISEASE, CAVITY, SENSORY NEUROPATHY
IP regimen consists of IV Paclitaxel, 5- FU and Leucovorin and IP Paclitaxel (Table STOPGAP intraperitoneal chemotherapy regimenPaclitaxel 40 mg/m2 in 500 ml of normal saline will be instilled into the peritoneal cavity through the IP port on days 1 and 8, repeated every 21 days for 4 cycles. In patients with moderate ...
PMC9985848
Endpoints
tumor
SECONDARY, TUMOR
The primary endpoint is 1-year progression free survival, and the secondary endpoints are overall survival and patient reported quality of life outcomes measured by EQ-5D-5L. Other planned correlative studies include plasma exosomal gene signature associated with response and comparison of plasma exosome NGS analysis w...
PMC9985848
Statistical design and sample size
carcinomatosis
CARCINOMATOSIS
The sample-size justification is based on the exact, one-sided, binomial test of the primary endpoint, progression free survival at 12 months (viz., PFS12). Based on current evidence, PFS-12 in gastric carcinomatosis with optimal treatment is estimated at less than 10% [
PMC9985848
Acknowledgements
Authors acknowledge the support of the Anti-Cancer Challenge fund
PMC9985848
Authors‘ contributions
Both Drs. Maheswari Senthil and Farshid Dayyani have equally contributed to the design of the study and serve as co- principal investigators. The author(s) read and approved the final manuscript.
PMC9985848
Funding
Cancer
CANCER
The study is supported by the Stern Center Clinical Trials Office at University of California-Irvine (UCI) and an UCI Cancer Center anti-cancer challenge grant.
PMC9985848
Availability of data and materials
The datasets used and/or analyzed during the current study can be made available from the corresponding author on reasonable request.
PMC9985848
Declarations
PMC9985848
Ethics approval and consent to participate
The study was reviewed and approved by the institutional review board and ethics committee at University of California-Irvine in accordance with Declaration of Helsinki. Informed consent will be obtained from all study participants.
PMC9985848
Consent for publication
Not applicable.
PMC9985848
Competing interests
Authors declare no competing interests specific to this study.
PMC9985848
References
PMC9985848
Background
HeFH
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
Heterozygous familial hypercholesterolemia (HeFH) is largely underdiagnosed and undertreated in China where few patients achieved recommended target levels of low density lipoprotein cholesterol (LDL-C). We conducted the first randomized, placebo-controlled clinical trial in Chinese patients with HeFH to assess the eff...
PMC9976471
Methods
HeFH
Patients diagnosed with HeFH by Simon Broome criteria and on a stable lipid-lowering therapy for at least 4 weeks were randomized 2:2:1:1 to receive subcutaneous tafolecimab 150 mg every 2 weeks (Q2W), tafolecimab 450 mg every 4 weeks (Q4W), placebo Q2W or placebo Q4W in the 12-week double-blind treatment period. After...
PMC9976471
Results
In total, 149 participants were randomized and 148 received at least one dose of the study treatment. At week 12, tafolecimab treatment induced significant reductions in LDL-C levels (treatment difference versus placebo [on-treatment estimand]: −57.4% [97.5% CI, −69.2 to −45.5] for 150 mg Q2W; −61.9% [−73.4 to −50.4] f...
PMC9976471
Conclusions
HeFH
Tafolecimab administered either 150 mg Q2W or 450 mg Q4W yielded significant and persistent reductions in LDL-C levels and showed a favorable safety profile in Chinese patients with HeFH.
PMC9976471
Trial registration
ClinicalTrials.gov, NCT04179669.
PMC9976471
Supplementary Information
The online version contains supplementary material available at 10.1186/s12916-023-02797-8.
PMC9976471
Keywords
PMC9976471
Background
HeFH, metabolic disorders
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA, HYPERCHOLESTEROLEMIA, CARDIOVASCULAR DISEASES, METABOLIC DISORDERS
Heterozygous familial hypercholesterolemia (HeFH) is one of the most common inherited metabolic disorders in humans, with an estimated prevalence of 1:311 worldwide and 1:500 to 1:200 in China in the general population [Clinical practice guidelines recommend the initiation of lipid-lowering therapy as soon as possible ...
PMC9976471
Methods
PMC9976471
Study design
This was a randomized, double-blind, placebo-controlled phase 3 study conducted from December 2019 to June 2021 across 22 study centers in China. The study protocol was approved by each center’s institutional review board or independent ethics committee. This study was conducted in accordance with the principles of Dec...
PMC9976471
Participants
HeFH
Patients (aged 18–80 years) diagnosed with definite or possible HeFH by Simon Broome criteria [
PMC9976471
Procedures
Eligible participants were randomized in a 2:2:1:1 ratio to receive subcutaneous tafolecimab 150 mg Q2W, tafolecimab 450 mg Q4W, placebo Q2W or placebo Q4W, respectively, in the 12-week double-blind treatment period. Randomization was implemented by an interactive web response system and was stratified by LDL-C levels ...
PMC9976471
Endpoints
ADVERSE EVENTS, ADVERSE EVENT
The primary endpoint was the percent change from baseline to week 12 in LDL-C levels. Secondary endpoints included proportion of participants achieving ≥50% LDL-C reductions and proportion of participants with LDL-C <1.8 mmol/L at week 12 and 24, the change from baseline to week 12 in non-HDL-C, apolipoprotein B and li...
PMC9976471
Statistical analysis
EVENTS, EVENT, SECONDARY, ADVERSE EVENT
Assuming a common standard deviation of 40% and a dropout rate of 10%, the sample size of 148 participants was sufficient to generate 99% power to detect ≥40% LDL-C reductions [Efficacy endpoints were analyzed in the efficacy analysis population, defined as participants who received at least one dose of tafolecimab or ...
PMC9976471
Results
PMC9976471
Discussion
HeFH
CARDIOVASCULAR DISEASES
HeFH is significantly underdiagnosed and undertreated in many countries and the situation is even worse in China, posing a great threat to the patients and necessitating earlier and more effective pharmacological intervention on the basis of statins and ezetimibe [The average age of HeFH diagnosis in this study (49.6 y...
PMC9976471
Conclusions
HeFH
DISEASE
In summary, tafolecimab dosed 150 mg Q2W and 450 mg Q4W demonstrated robust and persistent lipid-lowering efficacy in Chinese patients with HeFH. Participants on tafolecimab achieved a 12-week reduction in LDL-C levels around 60% and were significantly more likely to attain ≥50% LDL-C reductions and LDL-C<1.8 mmol/L. T...
PMC9976471
Acknowledgements
We thank all the participants, investigators and study site staff who were involved in the conduct of this trial.
PMC9976471
Authors’ contributions
YZ, MC, HD and LQ designed the study. YZ, MC, YH, WZ, XH, GZ, XM, PQ, DS, YL, WH and PA did the trial and collected the data. PA, HL, SY and QM analyzed the data. YZ, YH, MC, PA, HL, QM, HD and LQ interpreted the data. QM wrote the manuscript. All authors had full access to all the data in the study and had critically ...
PMC9976471
Funding
This study was sponsored by Innovent Biologics, Inc. The sponsor was involved in the study design, data collection, data review, data analysis, and drafting of the manuscript.
PMC9976471
Availability of data and materials
The data supporting the analyses contained in the manuscript will be made available upon reasonable written request from researchers whose proposed use of the data for a specific purpose has been approved by the corresponding authors.
PMC9976471
Declarations
PMC9976471
Ethics approval and consent to participate
The study protocol was approved by each center’s institutional review board or independent ethics committee (Beijing Anzhen Hospital, Capital Medical University [2019-15]; General Hospital of Ningxia Medical University [2019-YW-063]; The First Affiliated Hospital of Xinjiang Medical University [D190924-01]; The First H...
PMC9976471
Consent for publication
Not applicable.
PMC9976471
Competing interests
YZ, MC, YH, WZ, XH, GZ, XM, PQ, DS, YL an WH report personal fees from Innovent Biologics, Inc., during the conduct of the study. PA, HL, SY, QM, HD and LQ were employees of Innovent Biologics, Inc.
PMC9976471
References
PMC9976471
Subject terms
pain
It has already been described that transcutaneous spinal direct current stimulation (tsDCS) can selectively influence nociceptive evoked potentials. This study is the first aiming to prove an influence of tsDCS on pain-related evoked potentials (PREP) using concentric surface electrodes (CE), whose nociceptive specific...
PMC10684856
Introduction
pain
SPINAL CORD
Spinal cord stimulation (SCS) using electrical currents applied through epidural electrodes is an established method for neuromodulation in pain treatmentPrevious studies show heterogenous results regarding the effects of tsDCS on nociception. Some studies did not find a significant effect on pain perceptionThis specif...
PMC10684856
Methods
The study was approved by the local ethic committee of the Faculty of Medicine, Ruhr-Universität Bochum (Reg. Nr. 20-6929, 27.4.2020) and carried out according to the Helsinki Declaration. Written informed consent was obtained from all participants.
PMC10684856
Participants
pain, psychiatric, migraine, substance abuse, diabetes
MIGRAINE, NEUROLOGICAL DISEASE, DIABETES
During the time from July 2020 to January 2021, we recruited 28 healthy volunteers, older than 18 years. Subjects with relevant medical conditions (e.g., diabetes, migraine, pacemaker, psychiatric or neurological diseases), recent use of local anesthetics, topical capsaicin, anticonvulsants or antidepressants, as well ...
PMC10684856
Procedure
The subjects were randomly assigned to eight groups according to the order of testing by limb (foot first/hand first), by test method (PREP first/SEP first) and by order of stimulation types (sham stimulation first/anodal tsDCS first). Subjects and examiner were blinded to the order of stimulation types, but not to ord...
PMC10684856
Somatosensory evoked potentials (SEP)
SEP was recorded by stimulation of the right median nerve (hand) and the right tibial nerve (foot), using a block electrode, which was fixed to the stimulation site with a velcro strap. The used parameters were in accordance with standard protocols recommended in the literature
PMC10684856
Pain-related evoked potentials (PREP) using concentric surface electrodes
The procedure followed previous protocols
PMC10684856
Transcutaneous spinal direct current stimulation (tsDCS)
For tsDCS, two saline-soaked sponge electrodes (7 × 5 cm) were fixed to the volunteers' skin. The cathode was fixed to the right shoulder, while the anode was fixed to the spinous process of thoracic vertebra 10 (Th10). The stimulation device was a DC-stimulator produced by neuroConn GmbH, Ilmenau, Germany. For anodal ...
PMC10684856
Data analysis
BRAIN
Storage for offline analysis was achieved by a 32-channel-amplifier (Brain Amp, Brain Products, Germany; Bandwidth: 0.1 Hz–1 kHz; digitization sampling rate: 5 kHz). Employing Vision Recorder Version 1.03 offline analysis was carried out. For this, the data was segmented into epochs from 200 ms before and 800 ms after ...
PMC10684856
Statistical analysis
pain
Before testing for effects of tsDCS modality, Shapiro–Wilk-tests for normal distribution, as well as tests for group effects and carry-over effects were performed. Because not all variables were normally distributed in all measurements, nonparametric tests were used to check for group effects, comparing 4 groups denote...
PMC10684856
Results
’, pain
The demographic data of the examined subjects are presented in Table Subjects demographics.We tested our data for normal distribution, group effects depending on the randomization order, and carry-over effects, as described in the methods section. For a detailed description of the results of the tests for group effects...
PMC10684856
Discussion
The present study found an effect of anodal low-thoracic tsDCS on PREP using CE, but it was not an inhibitory effect as excepted. While the N1P1-amplitude of PREP decreased under all other measuring conditions, it remained unchanged after low-thoracic anodal tsDCS when stimulating the lower limb. This missing decrease ...
PMC10684856
Effect of limb on current intensity used for SEP
muscle contraction
Our results showed a significant effect of the independent variable “limb” on the dependent variable “current intensity used for SEP”. Further analysis showed that the current intensity used in tibial nerve SEP was significantly higher than that used in median nerve SEP. Since the current intensity was set to reliably ...
PMC10684856
Effect of low-thoracic tsDCS on SEP
The study results show no effect of stimulation modality on any of the SEP values, which was in accordance to our hypothesis and underlines the validity of the significant findings regarding the effects on PREP parameters. This additional evidence that anodal tsDCS does not significantly affect the spinal transmission ...
PMC10684856
Effect of low-thoracic anodal tsDCS on N1P1-amplitudes of PREP using CE
pinprick pain
In contrast to the SEP, we were able to demonstrate an effect of low-thoracic tsDCS on N1P1-amplitudes of PREP using CE after stimulation of the lower limb. This difference suggests that signal transmission after electrical stimulation with CE must be different from that via Aß-fibers stimulated by SEP electrodes. Leno...
PMC10684856