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2.1. Study Characteristics | drusen, ARDS | DRUSEN, ARDS | This is a double-blind, randomized controlled trial of parallel design, with 1:1 allocation. Inclusion criteria were AMD with persistent drusen, categorized according to ARDS categories 2 and 3, without GA or prior ocular surgery, and consent to participate. ARDS category 2 was defined as <63 µmin diameter or non-exten... | PMC10055796 |
2.2. Treatment Regime | BLIND | The participants were instructed to take one untagged pill daily for 12 months. Containers of pills were allocated by patient serial numbers, with the pharmacy blind to the content of the pills. Pills for the study group contained 400 mg of HCQ (plaquenil). Placebo pills for the control group contained calcium. Patient... | PMC10055796 | |
2.3. Follow-Up Time Line | toxicity, HCQ-induced retinal maculopathy, drusen | DRUSEN, ADVERSE EFFECT, ADVERSE EFFECTS, INTRAOCULAR PRESSURE | All the participants underwent a complete ophthalmic examination, including visual acuity (recorded as decimal score), intraocular pressure, anterior and posterior segment inspection and optical coherence tomography (OCT) for measuring central macular thickness. Since one of the first signs of macular toxicity of HCQ i... | PMC10055796 |
2.4. Evaluation of Drusen and Macular Appearance | drusen | DRUSEN | We used red-free images to evaluate the growth of new drusen or increased size of known drusen: Each participant underwent an initial red-free fundus snap-shot ( | PMC10055796 |
2.5. Clinical and Demographic Characteristics | drusen | DRUSEN | Demographic characteristics, visual acuity, retinal width, and initial and final follow-up drusen data were collected and analyzed. | PMC10055796 |
2.6. Statistical Analysis | For continuous variables, arithmetic means and standard deviations were calculated. For categorical variables, relative frequencies were calculated. The Mann–Whitney non-parametric test was applied to examine differences between the study groups for quantitative parameters; all the hypotheses were one-tail. Pearson chi... | PMC10055796 | ||
2.7. Sample Size | The sample size was calculated using a significance level of 5% and power of 80%, with an acceptable mean difference of 0.05 logMAR (half-line) [ | PMC10055796 | ||
3. Results | PMC10055796 | |||
3.1. Clinical and Demographic Characteristics | Of the 110 patients who enrolled in the study, 55 were randomized to the study group and 55 to the control group. Fourteen patients did not complete the trial due to loss of follow-up. Forty-six patients in the study group and fifty in the control group completed the study ( | PMC10055796 | ||
3.2. Visual Acuity | Visual acuity deterioration | Visual acuity deterioration at two-year follow-up compared to baseline was less in the study than in the control group (−0.03 ± 0.07 vs. −0.07 ± 0.07, | PMC10055796 | |
3.3. Central Macular Thickness | The difference between the study and control groups, in increased central macular thickness at two-year follow-up compared to baseline, was not statistically significant: 8.9 ± 21.6 and 13.2 ± 9.5, respectively, | PMC10055796 | ||
3.4. Drusen Number and Size | drusen, ARDS | DRUSEN, REGRESSION, ARDS | One year following the end of the treatment, the mean number of drusen per eye was lower in the study than the control group for ARDS type 2 (ARDS2) (8.1 vs. 12.3, The study and control groups showed similar proportions of eyes with regression of drusen size, as measured with macular OCT at the final examination, one y... | PMC10055796 |
3.5. Safety and Adverse Effects | scotoma | CHOROIDAL NEOVASCULARIZATION, ADVERSE EFFECTS, CORNEA | None of the participants showed HCQ toxicity manifested by cornea verticillata or changes in the red-to-white macular field of vision. Perimetric follow-up was performed by using the MP1 OCT and showed that none of the participants developed absolute or relative scotoma, and MP1 general-reduction-of-light threshold was... | PMC10055796 |
4. Discussion | rheumatoid arthritis, AMD, dry, dry AMD, retinal thinning, systemic lupus erythematosus, long-term damage, drusen, detachments of basal linear or laminar deposits, retinal nerve insult, RPE, non-exudative, Drusen, retinal toxicity, HIT | RHEUMATOID ARTHRITIS, ADVERSE EFFECTS, DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, RETINA, DRUSEN, ADVERSE EFFECTS, DRUSEN | The HIT study is the first study to address the effect of HCQ on the clinical and imaging characteristics of AMD. The main finding of this double-blind randomized controlled trial was less visual acuity deterioration at one-year follow-up among participants treated with HCQ than those treated with a placebo. Moreover, ... | PMC10055796 |
Author Contributions | Conceptualization, J.P.; Methodology, J.P.; Validation, J.P. and Y.P.; Formal Analysis, J.P. and T.Y.; Investigation, J.P. and T.Y.; Data Curation, R.A. and D.P.; Writing–Original Draft Preparation, T.Y.; Writing–Review and Editing, R.A. and Y.P.; Visualization, D.P.; Supervision, J.P. All authors have read and agreed ... | PMC10055796 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of Ziv Medical Center, Zefat, Israel (Zefat ZIV 061/11; 07.February.2013). | PMC10055796 | ||
Informed Consent Statement | Informed consent was obtained from all the participants. | PMC10055796 | ||
Data Availability Statement | This study was registered in the United States National Library of Medicine Clinical Trials Registry CLINICALTRAILS.GOV–Identifier number: NCT01541449. | PMC10055796 | ||
Conflicts of Interest | The authors declare no conflict of interest related to this work. | PMC10055796 | ||
References | Drusen, AMD, tumor necrosis | AGE-RELATED MACULAR DEGENERATION, TUMOR NECROSIS, RETINA, DRUSEN | The Beckman clinical classification of age-related macular degeneration (AMD) [Red-free fundus snap-shot. (Flow Diagram of the study’s participants. Of the 110 patients who enrolled in the study, 55 were randomized to the study group, and 55 to the control group. Fourteen patients did not complete the trial due to loss... | PMC10055796 |
Background | trichomoniasis, gonorrhea, chlamydia | STIS, SEXUALLY TRANSMITTED INFECTION, TRICHOMONIASIS, GONORRHEA | Prevalence of gonorrhea, chlamydia, and trichomoniasis is high among adolescents and young adults in rural South Africa, and higher among women and those residing in urban/periurban areas.Recent population-representative estimates of sexually transmitted infection (STI) prevalence in high HIV burden areas in southern A... | PMC10655853 |
Methods | trichomoniasis, gonorrhea, chlamydia | STIS, MAY, REGRESSION, TRICHOMONIASIS, GONORRHEA | Between March 2020 and May 2021, a population-representative sample of AYA aged 16 to 29 years were randomly selected from a Health and Demographic Surveillance Site in rural KwaZulu-Natal, South Africa, for a 2 × 2 factorial randomized controlled trial. Participants in 2 intervention arms were offered baseline testing... | PMC10655853 |
Results | gonorrhea, chlamydia | STIS, TRICHOMONIASIS, GONORRHEA | Of 2323 eligible AYA, 1743 (75%) enrolled in the trial. Among 863 eligible for STI testing, 814 (94%) provided specimens (median age of 21.8 years, 52% female, and 71% residing in rural areas). Population-weighted prevalence estimates were 5.0% (95% confidence interval [CI], 4.2%–5.8%) for gonorrhea, 17.9% (16.5%–19.3%... | PMC10655853 |
Conclusions | syphilis, Curable, gonorrhea, chlamydia | SEXUALLY TRANSMITTED INFECTIONS, STIS, SYPHILIS, TRICHOMONIASIS, GONORRHEA | We identified a high prevalence of curable STIs among AYA in rural South Africa. Improved access to STI testing to enable etiologic diagnosis and rapid treatment is needed.Curable sexually transmitted infections (STIs) are common worldwide, with more than 1 million new cases of gonorrhea, chlamydia, trichomoniasis, or ... | PMC10655853 |
MATERIALS AND METHODS | PMC10655853 | |||
Study Setting | deaths | This study was conducted within the HDSS in uMkhanyakude district in rural KwaZulu-Natal, South Africa. Since 2000, the Africa Health Research Institute (AHRI; formerly Africa Centre for Health and Population Studies) has been conducting annual household-based surveys to collect data on births, deaths, demographics, an... | PMC10655853 | |
Study Design | This study reports baseline data from a 2 × 2 factorial randomized controlled trial evaluating the acceptability, feasibility, and preliminary population-level impact of integrated sexual and reproductive health (SRH) services with or without peer support on the prevalence of transmissible HIV. | PMC10655853 | ||
Study Procedures | gonorrhea, chlamydia | TRICHOMONIASIS, GONORRHEA | After informed consent, participants randomized to either of the 2 SRH arms were offered home-based STI specimen collection. For female participants, research staff described the procedure to self-collect a vaginal swab. Menstruating females provided urine specimens. Male participants were instructed to collect a first... | PMC10655853 |
Data collection | SEXUALLY TRANSMITTED INFECTION | Sexually transmitted infection specimens were transported to the AHRI central laboratory in Durban. Testing for | PMC10655853 | |
Statistical analysis | REGRESSION | We summarized participants' demographic data using medians and interquartile ranges (IQRs) for continuous variables and frequency counts and percentages for categorical variables. Frequency counts and percentages with 95% confidence intervals (CIs) were calculated for the prevalence estimate of each individual STI and ... | PMC10655853 | |
Ethical considerations | The study protocol was approved by the Biomedical Research Ethics Committee of the University of KwaZulu-Natal (BREC/00000473/2019), the University College of London Research Ethics Committee (5672/003), and the Mass General Brigham Institutional Review Board (2021P002574). Written informed consent was obtained from al... | PMC10655853 | ||
Patient and public involvement | The peer support and sexual health intervention was co-created with young people in uMkhanyakude district and delivered by peers. Young people and the AHRI community advisory board were involved from research inception through to analysis. Study findings were shared with the research participants and their communities,... | PMC10655853 | ||
DISCUSSION | infection, chlamydia, HIV among adolescent girls, trichomoniasis, gonorrhea, decrease loss | STIS, INFECTION, TRICHOMONIASIS, SEQUELAE, GONORRHEA | We found a very high prevalence of curable STIs among adolescents and young adults in a predominantly rural area of KwaZulu-Natal, South Africa. This study confirms the acceptability of home-based STI specimen collection among adolescents and young adults, as more than 90% of study participants who were offered STI tes... | PMC10655853 |
Supplementary Material | PMC10655853 | |||
SUPPLEMENTARY MATERIAL | N.M. | ALLERGY, INFECTIOUS DISEASE | Acknowledgments: The authors thank all the participants who contributed data to this study, as well as the entire Africa Health Research Institute (AHRI) research team.Conflict of Interest and Sources of Funding: J.J. has received in-kind research support from Binx Health. All other authors declare no conflicts of inte... | PMC10655853 |
REFERENCES | PMC10655853 | |||
Objective: | anaemia | ANAEMIA, SECONDARY | To assess the effect of daily egg consumption for six months on linear growth (primary outcome), weight-for-age, weight-for-length, mid-upper arm circumference-for-age, head circumference-for-age Z-scores, gross motor milestones development, anaemia and iron status (secondary outcomes) in a low socioeconomic community. | PMC10830362 |
Participants: | Infants aged 6 to 9 months living in the peri-urban Jouberton area, in the Matlosana Municipality, South Africa. | PMC10830362 | ||
Design: | A randomised controlled trial with a parallel design was implemented. Eligible infants were randomly allocated to the intervention ( | PMC10830362 | ||
Results: | anaemia, overweight | ANAEMIA, WASTING | Baseline prevalence of stunting, underweight, wasting, overweight and anaemia was 23·8 %, 9·8 %, 1·2 %, 13·8 % and 29·2 %, respectively, and did not differ between groups. Overall, 230 and 216 participants in the intervention and control groups completed the study, respectively. There was no intervention effect on leng... | PMC10830362 |
Conclusions: | wasting, motor milestones, anaemia | ANAEMIA | Daily egg intake did not affect linear growth, underweight, wasting, motor milestones development, anaemia and iron status. Other interventions are necessary to understand the effect of animal-source food intake on children’s growth and development. This trial was registered at | PMC10830362 |
Keywords | head circumference (HC)-for-age, animal-source foodsAgainst, stunting, anaemia | ANAEMIA, SECONDARY | Although the global prevalence of childhood stunting is decreasing gradually, it continues to remain high in Asia and sub-Saharan AfricaChicken eggs (hereafter ‘egg’) have been identified as easily accessible and relatively more affordable in comparison to other animal-source foodsAgainst this background, the primary a... | PMC10830362 |
Methods | PMC10830362 | |||
Trial design and participants | WEST, RECRUITMENT | This study was a 6-month follow-up randomised controlled trial with parallel design conducted in the peri-urban Jouberton area, Klerksdorp, in the Matlosana Municipality in North West province, South Africa. Recruitment and enrolment occurred from 16th February 2021–7th July 2021, while exiting from the study occurred ... | PMC10830362 | |
Interventions | The randomised controlled trial consisted of two groups, the intervention group (Trained fieldworkers visited participants weekly to distribute the eggs and to remind the mothers to give one egg per day. Information on adherence to egg intake, morbidity symptoms using a diary, gross motor milestones development using t... | PMC10830362 | ||
Sample size calculation | stunting reduction | The sample size calculation was done by considering two primary outcomes representing stunting reduction in relation to the intervention. Based on previous studies | PMC10830362 | |
Outcomes | Outcome assessment of the trial occurred at three time points, baseline, midpoint (three months from baseline) and endpoint (six months from baseline). In general, all assessments took place at the central study site, except for weekly morbidity, adherence, food frequency questionnaire and follow-up gross motor milesto... | PMC10830362 | ||
Anthropometric outcome procedures | Anthropometric data on the infants were collected at all three time points. Infants were undressed and weighed to the nearest 0·01 kg using two standardised digital infant scales (Seca 334 and 727). Recumbent length was measured to the nearest 0·1 cm using an infantometer (Seca 416). Mid-upper arm circumference and hea... | PMC10830362 | ||
Gross motor milestone development outcome procedures | Information on developmental milestones was collected at baseline and during the weekly home visits, using a 14-item (pull to sit, creep 1, sit 1, sit 2, all fours, creep 2, crawl, stand 1, walk 1, stand 2, walk 2, run, jump and stand on one foot) pictorial chart based on the WHO’s standards | PMC10830362 | ||
Anaemia and iron status outcome procedures | A trained professional nurse collected capillary blood samples by means of finger and/or heel prick at baseline and endpoint. Hb was measured on the day of blood collection using a portable Hb HemoCue Hb 201+ system (Angelholm, Sweden). In addition to these, blood samples were collected into lithium heparin Microvette®... | PMC10830362 | ||
Randomisation | There was a random assignment of eligible infants in a 1:1 ratio. A randomisation sequence of pseudo-random numbers, generated by the RANNOR function of the SAS software package version 9·4, generated the allocation codes. There was a dataset with a list of 500 tags (250 tags for each group) generated. This list of tag... | PMC10830362 | ||
Blinding | BLIND | Due to the nature of the study, the intervention was not blind to field staff, the nurse and mothers; however, there was blinding of all questionnaire and anthropometric assessments to the assessors and the statistician during the effect and sensitivity analysis of both the intervention and control group. | PMC10830362 | |
Statistical methods | Baseline characteristics were described using median and interquartile range or counts and percentages for continuous and categorical variables, respectively. A linear mixed model analysis with random intercept unstructured covariance of the repeated measures was applied. The same model based on the binomial distributi... | PMC10830362 | ||
Sensitivity analysis | SENSITIVITY | Sensitivity analyses were done by excluding infants with low birthweight (birthweight < 2·5 kg), those with Hb, PF and sTfR out of the range of ± 3 | PMC10830362 | |
Results | Figure
Flow chart of study participants | PMC10830362 | ||
Baseline analysis | inflammation, disability | INFLAMMATION, IRON DEFICIENCY, IRON DEFICIENCY ANAEMIA | Table
Baseline characteristics of participants by intervention groupLAZ: length-for-age Z-score, WAZ: weight-for-age Z-score, WLZ: weight-for-length Z-score, MUACZ: Mid-upper arm circumference-for-age Z-score, HCZ: head circumference-for-age Z-score, IDA: iron deficiency anaemia, IDE: iron deficiency erythropoiesis.Co... | PMC10830362 |
Ancillary analyses | SECONDARY | No statistically significant difference was observed for primary and secondary outcomes of interests when sensitivity analyses were done by excluding infants with low birthweight (Supplementary Table | PMC10830362 | |
Adverse events | death, allergy | ADVERSE EVENTS, ALLERGY | There was no difference between the incidence of adverse events among the intervention and control groups. Only eight (1·6 %) infants experienced severe adverse events, defined based on hospitalisation, six (2·4 %) infants in the intervention group and two (0·8 %) in the control group. There were no egg-related serious... | PMC10830362 |
Discussion | anaemia, wasting, stunting, allergies | ANAEMIA, SECONDARY, WASTING, ALLERGIES | This randomised controlled trial investigated the effects of daily consumption of an egg for a period of six months on growth, gross motor milestone development, anaemia and iron status of 6- to 9-month-old infants from a low socioeconomic community in South Africa. We found no significant intervention effect on linear... | PMC10830362 |
Supporting information | PMC10830362 | |||
Ricci et al. supplementary material 1 | Ricci et al. supplementary material | PMC10830362 | ||
Ricci et al. supplementary material 2 | Ricci et al. supplementary material | PMC10830362 | ||
Ricci et al. supplementary material 3 | Ricci et al. supplementary material | PMC10830362 | ||
Acknowledgements | WEST, BENSON | The authors thank the Eggcel-growth study team and the mothers/caregivers who consented for their children to participate in the study. We thank the fieldworkers for their hard work during the data collection. We also thank the Walk a Mile in My Shoe, the North West Department of Health, the local clinics and the Matlo... | PMC10830362 | |
Financial support | This study was funded by the Douglas George Murray Trust. The funders had no influence on the study design, data collection, analysis, interpretation of the data, writing of the manuscript or the decision to submit the manuscript for publication. | PMC10830362 | ||
Conflict of interest | The authors declare that they have no known competing financial and non-financial interests with the potential to bias the work reported in this paper. | PMC10830362 | ||
Authorship | C.M.S., M.F., H.S.K., L.M., C.R. and H.R. designed the study. H.R. was the study coordinator and contributed by supervising field data collection, quality control and the conceptualisation and design of the manuscript. H.R. wrote the first draft of the manuscript, coordinated the statistical analysis, interpretation of... | PMC10830362 | ||
Ethics of human subject participation | This manuscript forms part of a PhD thesis. The study was conducted according to the guidelines laid down in the Declaration of Helsinki, and all procedures involving research study participants were approved by the North-West University Health Research Ethics Committee (NWU-00452–19-A1) and was registered on the clini... | PMC10830362 | ||
Supplementary material | For supplementary material accompanying this paper visit | PMC10830362 | ||
References | PMC10830362 | |||
Objective: | To examine the influence of the LOGICA RCT (randomized controlled trial) upon the practice and outcomes of laparoscopic gastrectomy within the Netherlands. | PMC10829898 | ||
Background: | Following RCTs the dissemination of complex interventions has been poorly studied. The LOGICA RCT included 10 Dutch centers and compared laparoscopic to open gastrectomy. | PMC10829898 | ||
Methods: | Gastrointestinal Cancer | REGRESSION, GASTROINTESTINAL CANCER | Data were obtained from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) on all gastrectomies performed in the Netherlands (2012–2021), and the LOGICA RCT from 2015 to 2018. Multilevel multivariable logistic regression analyses were performed to assess the effect of laparoscopic versus open gastrectomy upon clinica... | PMC10829898 |
Results: | COMPLICATIONS, CARDIAC COMPLICATIONS | Two hundred eleven patients from the LOGICA RCT (105 open vs 106 laparoscopic) and 4131 patients from the DUCA data set (1884 open vs 2247 laparoscopic) were included. In 2012, laparoscopic gastrectomy was performed in 6% of patients, increasing to 82% in 2021. No significant effect of laparoscopic gastrectomy on posto... | PMC10829898 | |
Conclusions: | The wider benefits of the LOGICA trial included the safe dissemination of laparoscopic gastrectomy across the Netherlands. The robust surgical quality assurance program in the design of the LOGICA RCT was crucial to facilitate the national dissemination of the technique following the trial and reducing potential patien... | PMC10829898 | ||
Keywords: | tumor | GASTRIC CANCER, TUMOR, COMPLICATION | Randomized controlled trials (RCTs) of surgical interventions represent the highest level of clinical evidence and often can lead to the widespread adoption of new surgical techniques. However, surgical RCTs are often undertaken in highly controlled clinical environments, in selected patients, and with procedures perfo... | PMC10829898 |
METHODS | PMC10829898 | |||
Data Sets | POSTOPERATIVE COMPLICATIONS | Data were obtained from the DUCA, which provided comprehensive data on all gastrectomies performed in the Netherlands between 2012 and 2021, and the LOGICA RCT, which ran from February 2015 to August 2018. The LOGICA data set included 46 variables, registering postoperative complications in accordance with the requirem... | PMC10829898 | |
Patients | GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA, COMPLICATIONS | All patients who underwent gastrectomy within the LOGICA RCT were included. From the DUCA data set, all patients who underwent a gastrectomy for gastric or gastroesophageal junction adenocarcinoma were included. We excluded all patients with missing data regarding overall complications (n=4), 30-day or in-hospital mort... | PMC10829898 | |
Statistical Analysis | tumor, pneumonia, anastomotic leakage, Comorbidity | TUMOR, INTRAOPERATIVE COMPLICATIONS, PNEUMONIA, EVENT, PULMONARY COMPLICATIONS, CARDIAC COMPLICATIONS, REGRESSION, COMPLICATIONS | Patient, tumor, and treatment characteristics of patients who underwent laparoscopic versus open gastrectomy were compared within the LOGICA and DUCA data sets using univariate analyses. These characteristics included sex, age, body mass index, American Society of Anesthesiologists score, Charlson Comorbidity Index, tu... | PMC10829898 |
RESULTS | PMC10829898 | |||
Baseline Characteristics | tumor, Tumor, Comorbidity | TUMOR, TUMOR, COMPLICATION | In total, 211 patients from the LOGICA RCT (105 open vs 106 laparoscopic) and 4131 patients from the DUCA data set (1884 open vs 2247 laparoscopic) were included. In the LOGICA RCT, patients who underwent laparoscopic gastrectomy had a significantly higher body mass index and more often did not receive neoadjuvant ther... | PMC10829898 |
Effects of Laparoscopic Gastrectomy on Clinical Outcomes Compared With Open Gastrectomy | tumor, cardiac complications, Comorbidity | TUMOR, CARDIAC COMPLICATIONS | Besides a significantly reduced risk of an in-hospital stay above the median of 7 days [adjusted odds ratio (aOR): 0.56; 95% CI: 0.31–0.99], no significant effect of laparoscopic gastrectomy on postoperative clinical outcomes was observed within the LOGICA RCT (Table Multivariate Comparison of Clinical and Pathologic O... | PMC10829898 |
Effects of Laparoscopic Gastrectomy on Outcomes Before, During, and After the LOGICA Trial |
Figure Forest plots showing the effect of laparoscopic versus open gastrectomy on postoperative clinical outcomes during: the LOGICA RCT (A); the DUCA data set before the start of the LOGICA RCT (B); the DUCA data set during the LOGICA RCT (C); the DUCA data set after the end of the LOGICA RCT (D). | PMC10829898 | ||
DISCUSSION | learning or proficiency gain, cancer, tumor, upper gastrointestinal Dutch | TUMOR, POSTOPERATIVE COMPLICATIONS, CANCER, PULMONARY COMPLICATIONS, GASTRIC CANCER | The results of the LOGICA randomized controlled trial across 10 experienced upper gastrointestinal Dutch centers showed that laparoscopic gastrectomy was associated with no significant improvements in length of hospital stay or postoperative complications when compared with open gastrectomy.When considering the externa... | PMC10829898 |
Supplementary Material | PMC10829898 | |||
ACKNOWLEDGEMENTS | The authors thank to all surgeons, physician assistants and registrars for registration of data in the DUCA database, as well as the DUCA scientific committee for the approval and scientific input on this study.S.R.M. and M.R.V. are to be credited as joint first authors.The authors report no conflicts of interest.Suppl... | PMC10829898 | ||
REFERENCES | PMC10829898 | |||
Background | pancreatic tumors | PANCREATIC TUMORS | Academic Editor: Hu Wang Nimotuzumab exerts its antitumor effect (mainly antiproliferative, proapoptotic, and antiangiogenic) by blocking the epidermal growth factor receptor overexpressing between 30 and 95% in pancreatic tumors cells. | PMC10162878 |
Methods | pancreatic tumors | PANCREATIC TUMORS, ADVERSE EVENT, ADVERSE EVENT | A prospective, nonrandomized, uncontrolled, open-label, and multicenter clinical trial was conducted to evaluate the safety and effectiveness of nimotuzumab combined with gemcitabine as first-line treatment in unresectable locally advanced or metastatic pancreatic tumors in a real-world condition. Adverse events, thei... | PMC10162878 |
Results | nausea, anemia, abdominal pain | ADVERSE EVENTS, DISEASE, METASTATIC DISEASE, ANEMIA | 69 patients were included. The proportion of related serious adverse events was 1.2%. The most frequent adverse events were nausea (10%), anemia (8%), and abdominal pain (8%). Objective response was achieved in 18.5% of the patients and disease control in 43.1%. Patients with locally advanced disease achieved a median... | PMC10162878 |
Conclusions | pancreatic adenocarcinoma | PANCREATIC ADENOCARCINOMA | Nimotuzumab combined with gemcitabine represents a safe and effective first-line treatment option for patients with advanced pancreatic adenocarcinoma in real-world conditions. Survival benefits were increased in those patients who received 8 or more doses of nimotuzumab. This trial is registered with | PMC10162878 |
1. Introduction | tumor, cancer of the pancreas [, cancer, pancreatic tumors, pancreatic cancer, tumors, arrest, pancreatic adenocarcinoma | TUMOR, LYSIS, PANCREATIC DUCTAL ADENOCARCINOMA, TISSUE INVASION, PROLIFERATION, CANCER, GROWTH SUPPRESSION, TUMOR GROWTH, CYTOTOXICITY, DISEASES, PANCREATIC TUMOR, PANCREATIC CANCER, METASTASIS, PANCREATIC TUMORS, DISEASE, CANCER OF THE PANCREAS, TUMORS, ARREST, PANCREATIC ADENOCARCINOMA | In 2020, pancreatic cancer (of 36 most common types of cancer) was ranked the 14The most used cytotoxic drug for the treatment of pancreatic adenocarcinoma has been gemcitabine, as monotherapy or combined with other treatments. The combination of gemcitabine plus nab-paclitaxel results more effective for locally advanc... | PMC10162878 |
2. Materials and Methods | PMC10162878 | |||
2.1. Study Design | toxicity, death, pancreatic tumor | PANCREATIC TUMOR | A prospective, uncontrolled, nonrandomized, open, and multicenter study was conducted, to evaluate the safety and effectiveness of nimotuzumab, in combination with gemcitabine, in first-line treatment or recurrent patients with locally advanced and unresectable or metastatic pancreatic tumor in the real-world condition... | PMC10162878 |
2.2. Ethical Considerations | ICH | The study was conducted in agreement with the general principles adopted by the international community regarding biomedical research in human subjects, with current state regulations according to the requirements of the Cuban national regulatory agency, as well as in the Guide to Good Clinical Practices of the Interna... | PMC10162878 | |
2.3. Eligible Patients | malignancy, ascites | ASCITES, PANCREATIC CANCER | The main inclusion criteria are as follows: patients aged ≥ 18years who meet the diagnostic criteria and expressed written willingness to participate in the study by signing the informed consent, life expectancy equal to or greater than 3 months, clinical status according to ECOG criteria ≤ 2, and patients fit for chem... | PMC10162878 |
2.4. Methods | Tumors | ADVERSE EVENT, ADVERSE EVENTS, EVENT, TUMORS, ADVERSE EVENT | The safety and effectiveness analyses were performed with all included patients who received at least one dose of nimotuzumab. The main variable was the proportion of patients with serious adverse events related to the administration of nimotuzumab (very probable, probable, and possible), and the corresponding 95% conf... | PMC10162878 |
2.5. Statistical Analysis | Descriptive methods were used for patient's demographic and clinic characteristics, treatment exposure, and safety analysis. For the analysis of overall survival, median values and 95% confidence interval (CI) were estimated. OS and PFS were determined by the Kaplan-Meier methodology, and 1- and 2-year survival rates w... | PMC10162878 | ||
3. Results | MAY, METASTATIC DISEASE | Between June 2017 and May 2020, 177 patients were evaluated. Of these, 69 were included in the study (The largest number included were patients with metastatic disease. The data on the baseline characteristics of all the patients analyzed are summarized in | PMC10162878 |
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