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Funding | Esophageal Cancer | ESOPHAGEAL CANCER | This study was supported by the Science and Technology Program of Guangzhou, China (202103000064) and the Science and Technology Project of Guangdong Esophageal Cancer Research Institute (M202017). | PMC10290378 |
Availability of data and materials | Data are available upon reasonable request. All data relevant to this study are included in the article or uploaded as Supplemental information. | PMC10290378 | ||
Declarations | PMC10290378 | |||
Ethics approval and consent to participate | Cancer | CANCER | This study was approved by the institutional review boards at Sun Yat-sen University Cancer Center (B2019-226-01) and all patients provided written informed consents. | PMC10290378 |
Consent for publication | Not applicable. | PMC10290378 | ||
Competing interests | Yating Zheng, Ting Bei, Mengli Huang, and Yuezong Bai declare that they are employees of 3D Medicines Inc. | PMC10290378 | ||
References | PMC10290378 | |||
Materials and Methods: | Men were randomized 2:1 between iTind and sham procedure arms. The iTind was placed for 5–7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 3, and 12 months postoperatively using the Sexual Health Inventory for Men (SHIM) and Intern... | PMC9810348 | ||
Results: | erectile dysfunction | ERECTILE DYSFUNCTION | We studied 185 men with a mean age of 61.1 ± 6.5 years. There was no difference in SHIM or total IIEF between iTind and sham at 3 months or in the iTind arm at 12 months compared with baseline. Men in the iTind arm without erectile dysfunction at baseline showed an improvement in total IIEF score of +6.07 ± 21.17 point... | PMC9810348 |
Conclusion: | prostate | PROSTATE | No changes were observed in sexual and ejaculatory function of patients with iTind regardless of a man's age, prostate volume, and baseline sexual function.Clinicaltrials.gov: NCT02506465 | PMC9810348 |
Introduction | lower urinary tract symptoms, LUTS | SECONDARY, BENIGN PROSTATIC HYPERPLASIA (BPH), BPH, UROLOGICAL DISEASES, DISEASES | Benign prostatic hyperplasia (BPH), one of the most common diseases affecting men as they age, often causes lower urinary tract symptoms (LUTS) that can negatively affect daily activities and quality of life (QoL). The impact of BPH is significant, far exceeding other urological diseases, and is forecasted to continue ... | PMC9810348 |
Materials and Methods | PMC9810348 | |||
Study protocol and objectives | Medication-naive, cystolithiasis, prostate, hematuria, prostate or bladder cancer | RESPIRATORY DISORDERS, RECURRENT URINARY TRACT INFECTION, DIABETES MELLITUS, PROSTATE, HEMATURIA, CARDIAC DISEASE, PROSTATE, NEUROGENIC BLADDER | Details surrounding this study design have previously been reported.Subjects enrolled included: men ≥50 years, IPSS (International Prostate Symptoms Score) of ≥10, peak urinary flow rate of ≤12 mL/s with a 125 mL voided volume, prostate volume between 25 and 75 cc, and normal urinalysis, complete blood count, and bioch... | PMC9810348 |
iTind procedure | prostate | PROSTATE | As previously described, the iTind device comprises three elongated, intertwined nitinol struts at the 12, 5, and 7 o'clock positions, an antimigration anchoring leaflet at 6 o'clock, and a polyester retrieval suture for easy device removal.The device is implanted for 5–7 days, during which it expands and exerts radial... | PMC9810348 |
Sham procedure | The sham control was the insertion and removal of an 18F silicon Foley catheter to simulate both the implantation and retrieval procedures. Throughout the procedure, the surgeon gave verbal description as if deploying the iTind device, after which the catheter was removed. A similar protocol was followed for the sham d... | PMC9810348 | ||
Questionnaires | SIDE EFFECT | We evaluated sexual side effect profiles using validated patient-reported outcomes. The Sexual Health Inventory for Men (SHIM) is a validated tool for screening and diagnosis of ED and severity of ED in clinical practice and research.The total version of the IIEF-15 is a validated self-report questionnaire for measurin... | PMC9810348 | |
Statistical methodology | mild/moderate, prostate | PROSTATE | Subjects were randomized in 2:1 ratio to either iTind or control (sham) group, respectively. Randomization was conducted using permuted blocks stratified by center by using a central electronic data program.Subjects were divided into subgroups according to age (three subgroups: 50–60, 61–70, >70), prostate volume (thre... | PMC9810348 |
Results | PMC9810348 | |||
Study population | Prostate | PROSTATE | We studied 185 men with a mean age of 61.1 ± 6.5 years who were randomized 2:1 to either iTind (Baseline DemographicsBaseline demographics are presented for both iTIND and sham groups.BMI = body mass index; IIEF = International Index of Erectile Function; IPSS = International Prostate Symptom Score; iTIND = temporarily... | PMC9810348 |
Sexual health inventory for men | There were no differences in the total SHIM score between iTind and sham at 3 months (13.13 ± 7.88 | PMC9810348 | ||
International Index of Erectile Function | prostate | PROSTATE | There were no differences in the total IIEF score between iTind and sham at 3 months (41.47 ± 22.56 When stratifying by prostate volume, men with smaller prostates (<40 mL), within the iTind arm at 12 months had a change in total IIEF of +4.95 (clinically meaningful), although it was not significant (Stratifying by bas... | PMC9810348 |
Ejaculatory dysfunction | There were no differences in IIEF question 9 between iTind and sham at 3 months (+0.09 Changes IIEF question 9 (ejaculation upon orgasm) scores from baseline within the iTind subgroup, baseline total SHIM >21. *Statistically significant value ( | PMC9810348 | ||
Discussion | LUTS, hematospermia, prostate | ANEJACULATION, ADVERSE EVENTS, PROSTATE, SECONDARY, BPH | iTind was an effective treatment for LUTS secondary to BPH while preserving sexual function regardless of age, prostate volume, or baseline ED status. ED, as measured by both total SHIM and IIEF scores and when stratifying by age, prostate volume, or baseline ED status, did not change significantly over the 12-month st... | PMC9810348 |
Conclusions | prostate | PROSTATE | iTind can maintain sexual and ejaculatory function regardless of a man's age, prostate volume, and baseline sexual function. | PMC9810348 |
Authors' Contributions | C.H. | Conceptualization: D.E. and B.C. Data curation: D.E., B.C., and M.N.A. Formal analysis: D.E., B.C., M.N.A, and S.M.D. Funding acquisition: D.E. and B.C. Investigation: D.E., M.N.A, N.S., M.G., J.M., S.P., C.H., W.T, A.K., R.G., A.K., J.S., E.G., I.G., L.M.T., J.K., and B.C. Methodology: D.E., M.N.A, N.S., M.G., J.M., S... | PMC9810348 | |
Author Disclosure Statement | D.E. is on the medical advisory board. B.C. is a consultant for Medi-Tate Ltd., Olympus, Boston Scientific, and Medeon Bio. The other authors have no conflicts of interest. | PMC9810348 | ||
Consent to Participate | Informed consent was obtained from all individual participants included in the study. | PMC9810348 | ||
Consent for Publication | The authors affirm that human research participants provided informed consent for publication. | PMC9810348 | ||
Funding Information | Medi-Tate Ltd. (acquired by Olympus) sponsored this study. | PMC9810348 | ||
References | PMC9810348 | |||
Abbreviations Used | devicelower urinary tract symptomsminimally, Comorbidity | PROSTATE, PROSTATE | 5-alpha-reductase inhibitorbody mass indexbenign prostatic hyperplasiaCharlson Comorbidity Indexerectile dysfunctionejaculatory dysfunction U.S. Food and Drug AdministrationInternational Index of Erectile FunctionInternational Prostate Symptoms Scoretemporarily implanted nitinol devicelower urinary tract symptomsminima... | PMC9810348 |
Background | Food systems highly contribute to anthropogenic greenhouse gas emissions and shifting towards more environmentally friendly diets is urgently needed. Enabling consumers to compare the environmental impact of food products at point-of-purchase with front-of-pack labelling could be a promising strategy to trigger more en... | PMC9881283 | ||
Methods | The effect of a new traffic-light front-of-pack environmental label on food choices was tested in a 2-arm randomised controlled trial in a virtual reality supermarket. Participants ( | PMC9881283 | ||
Results | In the everyday meal scenario, the environmental impact of meals was lower in the label condition than in the no label condition (-0.17 ± 0.07 mPt/kg, | PMC9881283 | ||
Conclusions | Implementing a front-of-pack environmental label on food products in real supermarkets could increase awareness of the environmental impact of food and contribute to drive more environmentally friendly food choices. | PMC9881283 | ||
Trial registration | The study protocol was pre-registered prior to data collection at Clinicaltrials.gov (NCT04909372). | PMC9881283 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12966-023-01410-8. | PMC9881283 | ||
Keywords | PMC9881283 | |||
Background | Food systems play a major role in anthropogenic greenhouse gas emissions (GHGE) [In this context, highlighting the need for a global public awareness of the environmental impacts of food products, the French government has set up an interdisciplinary committee to assess the feasibility and efficiency of environmental l... | PMC9881283 | ||
Methods | PMC9881283 | |||
Data collection | The study protocol was pre-registered prior to data collection at Clinicaltrials.gov (NCT04909372). Participants were recruited using the PanelSens database declared to the relevant French authority ( | PMC9881283 | ||
Study design | RECRUITMENT | This study was a randomised controlled trial in a virtual reality supermarket with two experimental arms: (1) no front-of-pack environmental labelling (no label condition) and (2) front-of-pack environmental labelling (environmental label condition). A 1:1 2-block randomisation sequence (for male and female) was genera... | PMC9881283 | |
Procedure | Individual experimental sessions lasted on average 35 min (min: 25 min, max: 45 min). After participants gave their written informed consent to take part in the experiment, they sat on a chair and were equipped with a virtual reality (VR) headset by a research assistant. Participants were given instructions regarding t... | PMC9881283 | ||
Virtual supermarket environment | PMC9881283 | |||
Virtual reality functionalities | The virtual supermarket environment was inspired by recent work by Melendrez-Ruiz and colleagues (2021) [ | PMC9881283 | ||
Food products | Based on the results of a recent study in a virtual reality supermarket using similar food choice tasks [ | PMC9881283 | ||
Recorded data | Food choices were recorded for each task within the VR headset. Each participant had to rate the eight food products selected for their level of familiarity (frequency of consumption of a similar product, ranging from 1 = “never” to 5 = “very often”) and liking (continuous sale, ranging from 1 = “I do not like [the foo... | PMC9881283 | ||
Environmental label | PMC9881283 | |||
Calculation of the environmental score | The environmental impact, measured by the Environmental Footprint single score (EF single score), of the 96 foods items included in the virtual supermarket was retrieved from the open-access Agribalyse database [ | PMC9881283 | ||
Design of the environmental label | MAY | As there was neither an existing environmental label nor a consensus on an environmental label design for food products in France at the time of the present study (May 2021), we designed a new label. The ideal carbon label proposed by Carrero et al., 2021 is a traffic-light label. It has been shown that green is often ... | PMC9881283 | |
Additional questionnaires | Participants were asked to complete questionnaires on Qualtrics survey platform ( | PMC9881283 | ||
Outcomes | PMC9881283 | |||
Primary outcome | The primary outcome was the environmental impact (EF single score in mPt per kg of product) of the food products selected in each task. The environmental impact of the composed meal for Task 1 was calculated as the mean of the EF single scores per kg of the three selected meal components in each scenario. The environme... | PMC9881283 | ||
Secondary outcomes | The nutritional quality of the food products selected was assessed by the FSA score developed by the British Food Standards Agency [ | PMC9881283 | ||
Meal types | Meals types were defined based on the source of protein that was included in a meal: meat-meals (further distinction between beef/lamb meals and poultry/pork meals), fish meals and vegetarian meals (further distinction between lacto-ovo meals or plant-based meals). In total, there were three main meal types (meat-based... | PMC9881283 | ||
Statistical analyses | SECONDARY | We followed an analysis plan pre-registered on Open Science Framework (EF single scores were standardised within the 66 meal components and the 30 ready-to-eat meals shelves because the scores of food products composing each shelf had different distributions (average environmental impact for the meal components shelf: ... | PMC9881283 | |
Sample size | We powered the primary analyses in order to detect a d = 0.50 effect size of labelling condition on EF single scores based on the results of a previous randomised controlled trial that tested the effect of an environmental label on canned soup choices [ | PMC9881283 | ||
Results | PMC9881283 | |||
Participants | A total of 435 participants were assessed for eligibility and data from 132 who completed the study were analysed (Fig. CONSORT flow diagram | PMC9881283 | ||
Effect of labelling on environmental impact of everyday meals | The participants were first asked to choose food products for an everyday main meal, in two distinct tasks in the virtual reality supermarket. During the first task, they selected three meal components for a composed meal and during the second task, they selected a ready-to-eat meal. Participants randomised in the envi... | PMC9881283 | ||
Effect of labelling on the environmental impact of environmentally friendly meals | After having selected food products for an everyday meal, all the participants were asked to choose food products for an environmentally friendly meal. In a linear mixed model, we found a main effect of the labelling condition (-0.18, t(394) = -3.44, | PMC9881283 | ||
Meal types selection | We showed that participants in the environmental labelling condition selected everyday meals of lower environmental impact than participants in the no label condition. We further investigated whether the cross-category nature of the environmental label led to a lower environmental impact of food choices through between... | PMC9881283 | ||
Nutritional quality, energy cost, familiarity and liking | In a linear mixed model, there were no significant effects of the environmental label on nutritional quality (-0.12, t(131) = -1.29, | PMC9881283 | ||
Perception of the label and virtual reality experience | Participants in the labelling condition were asked whether they noticed and understood the environmental label on the food products when they were in the virtual supermarket. Results showed that 89% declared having seen the environmental label and 96% that the environmental label depicted the environmental impact of th... | PMC9881283 | ||
Discussion | TRANSITION | For the first time, the effectiveness of traffic-light front-of-pack environmental labelling was tested in a randomised controlled trial conducted in a virtual reality supermarket, including a large and diverse range of food products. We demonstrated that the environmental label significantly reduced the environmental ... | PMC9881283 | |
Strengths and limitations | This study was a pre-registered randomised controlled trial in a realistic food choice environment and the first to test the effect of an environmental label on food choices in a virtual supermarket. Using questionnaires, we confirmed that the label had been seen, understood and used by a majority of the participants i... | PMC9881283 | ||
Conclusions | In the present study, we developed a new traffic-light front-of-pack environmental label based on a score that differentiated food categories. This label was highly noticed, well understood and provided new information that helped the participants to identify the food products of lower environmental impact. Using VR te... | PMC9881283 | ||
Acknowledgements | RECRUITMENT | We thank the ChemoSens platform for the help with the recruitment of participants, in particular C. Martin and F. Durey. We thank V. Feyen and L. Ben Sussan for their help with data collection and K. Pagnat for his help with the development of the virtual supermarket. We also thank L-G. Soler and L. Muller for their va... | PMC9881283 | |
Authors’ contributions | LA: conceptualization, investigation, formal analysis, writing – original draft; SC: conceptualization, writing – review and editing; GA: conceptualization, writing – review and editing; IG: methodology, writing – review and editing; JCC: methodology, software, data curation, writing – review and editing; SN: conceptua... | PMC9881283 | ||
Funding | This work was supported by grants from ADEME (2103D0040-A, ADAE grant to LM), the Conseil Régional Bourgogne, Franche-Comte (PARI grant) and the FEDER (European Funding for Regional Economic Development). The funders had no role in planning, conducting, or interpreting the study. | PMC9881283 | ||
Availability of data and materials | The datasets analysed during the current study will be made available on the Open Science Framework project page at the time of publication ( | PMC9881283 | ||
Declarations | PMC9881283 | |||
Ethics approval and consent to participate | The study was approved by the CEEI-IRB ethical committee (N°21–780, Institutional Review Board INSERM). Informed consent was obtained from all the participants before they started the study. | PMC9881283 | ||
Consent for publication | Not applicable. | PMC9881283 | ||
Competing interests | The authors declare that they have no competing interest. | PMC9881283 | ||
References | PMC9881283 | |||
Background | cancer, gastric cancer | CANCER, COLORECTAL CANCER, ADENOCARCINOMA, GASTRIC CANCER | Trifluridine/tipiracil (FTD/TPI) prolongs survival in the third- or later-line treatment for advanced gastric cancer (GC), esophagogastric junction (EGJ) adenocarcinoma, and colorectal cancer. While single-arm phase II trials showed promising outcomes of FTD/TPI plus ramucirumab (RAM) as third- or later-line treatments... | PMC10403909 |
Methods | ADENOCARCINOMA | This RETREVE trial (WJOG15822G) is a prospective, open-label, randomised, multicentre phase II trial comparing FTD/TPI plus RAM versus FTD/TPI monotherapy in a third- or later-line setting. Eligibility criteria include age of > 20 years; performance status of 0 or 1; unresectable or recurrent gastric or EGJ adenocarcin... | PMC10403909 | |
Discussion | EGJ cancer | DISEASE PROGRESSION | This study will clarify the additional effect of RAM continuation beyond disease progression on FTD/TPI in the third- or later-line setting for patients with advanced GC or EGJ cancer. | PMC10403909 |
Trial registration | jRCTs041220120. | PMC10403909 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12885-023-11199-1. | PMC10403909 | ||
Keywords | PMC10403909 | |||
Background | Gastric cancer, cancer, unresectable or recurrent gastric cancer, tumour, adenocarcinoma | GASTRIC CANCER, CANCER, TUMOUR, ADENOCARCINOMA | Gastric cancer (GC) is the fifth most common and fourth most deadly cancer worldwide [As later-line treatment in patients with advanced gastric and EGJ adenocarcinoma, monotherapy with trifluridine/tipiracil (FTD/TPI), irinotecan, and nivolumab are recommended in the Japanese treatment guideline, regardless of HER2 sta... | PMC10403909 |
Methods/design | PMC10403909 | |||
Objectives | cancer | CANCER, SECONDARY | The objective of this RETRIEVE study (WJOG15822G) is to evaluate the efficacy and safety of FTD/TPI plus RAM as a third- or later-line treatment for patients with unresectable or recurrent GC or EGJ cancer, compared with FTD/TPI monotherapy. The primary endpoint is PFS and the secondary endpoints are OS, ORR, DCR, and ... | PMC10403909 |
Study design | arrhythmia, multiple cancer, inflammatory bowel disease, diabetes mellitus, autoimmune diseases, Hypersensitivity, Unstable angina, allergy, non-haematological toxicity, arrhythmias, gastrointestinal obstruction, thrombosis, ascites, mental illness, pulmonary artery thrombosis, HBV infection, cancer, vasculitis, gastro... | PLEURAL EFFUSION, RECURRENCE, ARRHYTHMIA, MULTIPLE CANCER, INFLAMMATORY BOWEL DISEASE, DIABETES MELLITUS, AUTOIMMUNE DISEASES, HYPERSENSITIVITY, UNSTABLE ANGINA, ALLERGY, WEST, ONCOLOGY, ARRHYTHMIAS, GASTROINTESTINAL OBSTRUCTION, CEREBRAL INFARCTION, THROMBOSIS, ASCITES, DEEP VEIN THROMBOSIS, CANCER, ADVERSE EVENT, VAS... | This is a prospective, open-label, randomised, multicentre phase II study, conducted in 47 centres of the West Japan Oncology Group (WJOG) in Japan (Fig. Study schema of RETRIEVE studyKey eligibility criteria for the RETRIEVE study1) Age of 20 years or above2) ECOG PS of 0 or 13) Histologically diagnosed as gastric ade... | PMC10403909 |
Procedures | FTD/TPI (35 mg/mThree dose reduction levels were set: 35 (starting level), 30 (level -1), 25 (level -2), and 20 mg/m | PMC10403909 | ||
Assessment | Tumour | ADVERSE EVENTS, TUMOUR | Tumour was assessed using CT scan of the chest, abdomen, and pelvis within 2 weeks before randomisation and every 8 weeks after randomisation until discontinuation of the protocol treatment. Patients are required to visit the hospital every 2 weeks to check their physical condition and adverse events during the protoco... | PMC10403909 |
Evaluation of outcomes | death, Tumour, Cancer | DISEASE PROGRESSION, ADVERSE EVENT, TUMOUR, DISEASE, ADVERSE EVENT, CANCER | PFS is defined as the time from randomisation to disease progression or death from any cause. OS is defined as the time from randomisation to death from any cause. Tumour response is assessed according to the RECIST (version 1.1). Objective response rate (ORR) is defined as the proportion of patients with a complete re... | PMC10403909 |
Sample size calculation and statistical analysis | SECONDARY | The statistical hypothesis is set with reference to the PFS of previous clinical studies in advanced GC. The PFS rate at 4 months was reported as approximately 27% in the FTD/TPI arm of the TAGS trial [The analyses of the primary and secondary efficacy endpoints are planned to be performed in the full analysis set, and... | PMC10403909 | |
Study organization | The WJOG is responsible for project management during the trial. The tasks of the WJOG include the coordination of investigator meetings, monitoring, data management, and audits. Central monitoring but not onsite monitoring will be performed regularly according to the monitoring procedures which are adapted to study-sp... | PMC10403909 | ||
Data management, control of data consistency, and quality control | To protect patient privacy, the investigator or designated representative is required to enter all information required into the electronic case report form after anonymisation. Automatic checks for data completeness, validity, and consistency were performed using the data capturing system of WJOG. The investigator or ... | PMC10403909 | ||
Ethical aspects and trial registration | Cancer | CANCER | The RETRIEVE study (WJOG15822G) was approved by the Certified Review Board of Shizuoka Cancer Center (CRB4180010) and prospectively registered in the Japan Registry of Clinical Trials (jRCTs041220120, 24 January 2023 | PMC10403909 |
Discussion | cancer, tumour, CRC | CANCER, TUMOUR, ADENOCARCINOMA, GASTRIC CANCER | Paclitaxel plus RAM is established as a standard treatment of second-line treatment for advanced GC according to the result of RAINBOW trial [The therapeutic development of FTD/TPI plus anti-angiogenic drugs is more advanced for CRC than for gastric cancer. Preclinical studies have reported that the combination of FTD/... | PMC10403909 |
Acknowledgements | We would like to thank the data managers and other supporting staff at WJOG, Kaori Mori, Shinichiro Nakamura, and Koji Takeda. | PMC10403909 | ||
Authors’ contributions | NB | NT and HH developed the concept of the study and initiated the project. KN performed the statistical analyses. KH, TM, TM, HK, KY, SH, NB, and KM contributed to the trial design, modifications, and data collection. NT drafted the paper. All the authors have read and approved the final manuscript. | PMC10403909 | |
Funding | This clinical trial was funded by Taiho Pharmaceutical Co. Ltd., Japan. The funding source had no role in the study design and has no role in data collection, data analysis, and interpretation or the decision to submit results for presentation or publication. | PMC10403909 | ||
Availability of data and materials | RECRUITMENT | Patient recruitment began in January 2023 and is currently ongoing. We plan to publish these results in a future study. Authorship will be conducted according to the standards set by the International Committee of Medical Journal Editors ( | PMC10403909 | |
Declarations | PMC10403909 | |||
Ethics approval and consent to participate | Cancer | CANCER | This study was approved by the Certified Review Board of Shizuoka Cancer Center (CRB4180010), and permission to conduct the study was obtained from the management of all participating facilities. Written informed consent is obtained from all participants. | PMC10403909 |
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