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Conclusions | Voluntary APN can be successfully implemented with a prison population and within a prison setting despite the many barriers to HIV notification that incarceration presents. Our findings suggest that the Impart model holds considerable promise to increase partner notification, HIV testing and diagnosis among sex and dr... | PMC10281637 | ||
INTRODUCTION | An estimated 3.8% of the world's prison population is HIV positive [With assisted partner notification (APN), health workers are trained to encourage and assist people diagnosed with HIV to inform their at‐risk partners of possible HIV exposure and the need for HIV testing. Research demonstrating APN's effectiveness in... | PMC10281637 | ||
METHODS | PMC10281637 | |||
Ethical statement | The Impart model and the procedures for this research were designed or selected in full recognition of the special ethical challenges of protecting the rights and safety of prisoners as a particularly vulnerable research population [ | PMC10281637 | ||
Study design | SECONDARY | Our study population is comprised of HIV‐diagnosed men (index participants) receiving health services through HIV subspecialty clinics located within each jail and prison facility. A two‐group randomized trial was used to evaluate the effects of the prison‐based Impart APN model on partner notification and HIV testing ... | PMC10281637 | |
Sampling procedures | From January 2020 to January 2021, we recruited 55 incarcerated men with HIV from six all‐male jail and prison facilities in Jakarta, Indonesia representing differing security levels, population sizes and inmate characteristics. Prison medical staff introduced the study to HIV‐positive inmates using a project‐prepared ... | PMC10281637 | ||
Soliciting partner names and contact information | A project‐trained APN counsellor met with each inmate enrolled in the study to explain the importance of informing former sex and/or drug injection partners of possible HIV exposure and to encourage them to get tested and into treatment if needed. Each participant was asked to identify and provide contact information f... | PMC10281637 | ||
Study conditions: self‐tell only notification versus Impart APN | PMC10281637 | |||
Self‐tell only notification | Participants randomized to self‐tell notification were assisted in developing a notification plan and coached in how to tell their at‐risk partners by the end of 6 weeks. They also were asked for permission to verify whom they had told or not when that period ended. Inmates could choose to tell their partner(s) by tele... | PMC10281637 | ||
Impart APN | Participants randomized to the Impart arm could choose per partner between sell‐tell notification or having an Impart APN‐trained nurse and community outreach healthcare provider work as a team to locate and notify their partners without revealing the identity of who had named them. With the latter choice, Impart notif... | PMC10281637 | ||
Partner HIV testing post notification | Partners notified by the Impart team were offered immediate HIV rapid testing using a fingerstick, combination antigen‐antibody test [ | PMC10281637 | ||
Data collection | Socio‐demographic and health information were obtained from all HIV‐positive inmates enrolled as index participants prior to randomized group assignment. Using code numbers instead of personal identifiers, research staff recorded group assignment for each index participant, the number and characteristics of partners na... | PMC10281637 | ||
Statistical analysis | REGRESSION, SECONDARY | Our primary analysis compared the study's two groups (self‐tell only to Impart assignment) on primary and secondary outcomes using intention‐to‐treat (ITT). All partners selected for notification were included in the analysis irrespective of group allocation or notification method. Partner notification outcomes were ex... | PMC10281637 | |
RESULTS | PMC10281637 | |||
Socio‐demographic characteristics of index participants ( | As shown in Table Characteristics of incarcerated men with HIV recruited as index participants (Abbreviations: ART, antiretroviral therapy; IQR, interquartile range.Three participants reported only needle‐sharing partners. | PMC10281637 | ||
Socio‐demographic characteristic of partners (117) identified for HIV notification | All partners selected for notification were included in the analysis irrespective of group allocation or notification method. Figure Study flow diagram. Abbreviation: APN, assisted partner notification Partners ranged from 17 to 56 years of age (median of 28 years) and on average were younger than the index participant... | PMC10281637 | ||
HIV notification and testing outcomes | APPENDIX | Table Characteristics of partners selected for notification (Abbreviations: APN, assisted partner notification; SD, standard deviation.Partner notification and HIV testing outcomes after 6 weeks by group and notification methodTwo partners confirmed as having been notified.One partner confirmed as having been notified.... | PMC10281637 | |
DISCUSSION | Our research demonstrates that voluntary APN can be implemented successfully and ethically within the organizational structure of a prison setting. The Impart model's positive effects in increasing partner notification remained significant in and after adjusting for partner sex and type and even when assuming best‐case... | PMC10281637 | ||
Limitations of the study | Limitations of the study include relatively small sample size, short duration of follow‐up and possible bias due to incorrect self‐reporting of self‐tell outcomes. Nevertheless, to our knowledge, this research represents the first and largest study to develop and evaluate an APN model for use in prison settings. We are... | PMC10281637 | ||
CONCLUSIONS | Our results confirm that the Impart APN model can be implemented successfully in jail and prison settings despite the many barriers to HIV notification that incarceration presents. With its trained team of notifiers, the model provides an effective means for HIV‐positive prisoners to inform HIV‐exposed partners whom th... | PMC10281637 | ||
COMPETING INTERESTS | The authors declare no competing interests. | PMC10281637 | ||
AUTHORS’ CONTRIBUTIONS | VAE | All authors have contributed equally to the study's conceptualization and design. GJC obtained funding as Principal Investigator and wrote the initial manuscript with JL and AR. AW and AR supervised the research in Indonesia and analysed data with AS who planned the statistical analysis. VAE helped to develop the study... | PMC10281637 | |
FUNDING | Research reported in this publication was supported by the National Institute of Mental Health of the National Institutes of Health under award number R34 MH115779 to GJC. | PMC10281637 | ||
Supporting information |
Click here for additional data file. | PMC10281637 | ||
ACKNOWLEDGEMENTS | We thank the study participants for their time and effort to participate in the research. We gratefully acknowledge the cooperation of the Directorate General of Corrections, Ministry of Law and Human Rights, Republic of Indonesia and their staff in conducting the study. | PMC10281637 | ||
DATA AVAILABILITY STATEMENT | Data requests referencing protocol# 2019‐0196 (PI: Culbert) may be sent to the Director of Research Facilitation at the University of Illinois Chicago College of Nursing. | PMC10281637 | ||
REFERENCES | PMC10281637 | |||
Clinical trial registration | Tixagevimab/Cilgavimab, coronavirus disease | DISEASE, DISEASE PROGRESSION, VIRUS | Edited by: Tanushree Dangi, Northwestern University, United StatesReviewed by: Kin Israel Notarte, Johns Hopkins University, United States; Diego Cantoni, MRC-University of Glasgow Centre For Virus Research (MRC), United KingdomSeveral virus-neutralizing monoclonal antibodies (mAbs) have become new tools in the treatme... | PMC10623550 |
Introduction | Tixagevimab/Cilgavimab, coronavirus infection | CORONAVIRUS INFECTION | Vaccination against the new coronavirus infection COVID-19 has reduced morbidity, mortality and the burden on the healthcare system worldwide (We have observed a revolution in the treatment of coronavirus infection and development of passive immunity against it. Nowadays several SARS-CoV-2-specific neutralizing mAbs in... | PMC10623550 |
Materials and methods | PMC10623550 | |||
Study design and participants | CORONAVIRUS INFECTION | We conducted a non-randomized, single-center, prospective observational cohort study. The study was performed between August 20, 2022 and February 1, 2023 within the facilities of the multidisciplinary City Clinical Hospital No. 52 (Moscow, Russian Federation) and the N.F. Gamaleya Research Institute of Epidemiology an... | PMC10623550 | |
Description of medical intervention | Tixagevimab/Cilgavimab, groups:15, coronavirus infection | DISEASE PROGRESSION, VIRUS, CORONAVIRUS INFECTION, DISEASE COURSE, RECRUITMENT | The study included 77 patients diagnosed with COVID-19 as outpatients by qualitative determination of the SARS-CoV-2 antigen or SARS-CoV-2 RNA, with mild or moderate disease course and a high risk of disease progression. The severity of coronavirus infection and the risks were determined according to the Russian Interi... | PMC10623550 |
Neutralization assay | Investigations of live SARS-CoV-2 viruses were performed in BSL-3 facilities. We used the following SARS-CoV-2 sublineages for neutralization assays: B.1.1.1 (Wuhan, S:D614G hCoV-19/Russia/Moscow_PMVL-1/2020), B.1.1.529 Omicron BA.1 (hCoV-19/Russia/MOW-Moscow_PMVL-O16/2021), B.1.1.529 Omicron BA.2 (hCoV-19/Russia/MOW-P... | PMC10623550 | ||
Outcomes | inflammation, death | DISEASE, INFLAMMATION, VIRUS, SECONDARY | We evaluated the laboratory efficacy, clinical results and titers of virus neutralizing antibodies (nAbs) against the Wuhan variant and Omicron sublineages BA.1, BA.2, BA.5. Primary endpoints included decrease of the positive SARS-CoV-2 PCR results on Day 4 and the nAbs increase after administration one hour and on Day... | PMC10623550 |
Statistical analysis | Principles for calculating the sample size: no preliminary calculation of the required sample size was carried out. Statistical data analysis: nonparametric methods of descriptive statistics were used. The median and interquartile range (IQR) were determined; the geometric mean was used in the description of relative v... | PMC10623550 | ||
Results | PMC10623550 | |||
Description of patients and laboratory indicators | DM, comorbidity, Gastric ulcer disease, COPD | ISCHAEMIC HEART DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIABETES MELLITUS, COPD, IHD, ATRIAL FIBRILLATION | The general characteristics of COVID-19 patients admitted to the day patient facility for antiviral therapy are presented in General patient data.IV, intravenously; IM, intramuscularly; F, female; M, male; BMI, body mass index; mg, milligram, kg, kilogram.Quantitative data are presented as median and interquartile rang... | PMC10623550 |
Levels of virus-neutralizing antibodies | Tixagevimab/Cilgavimab, ground-glass opacities | DISEASE, VIRUS, SECONDARY | The study was conducted during the surge of the SARS-CoV-2 Omicron BA.5 sublineage. Genetic analyses of the patients’ nasopharyngeal swabs by real-time PCR confirmed that all swabs contained SARS-CoV-2 Omicron sublineage BA.5 RNA.We determined the levels of nAbs to the initial SARS-CoV-2 variant (Wuhan D614G) and to th... | PMC10623550 |
Discussion | Tixagevimab/Cilgavimab, tixagevimab/cilgavimab | SYSTEMIC INFLAMMATORY RESPONSE, PROGRESSION | During COVID-19 pandemic, SARS-CoV-2 was rapidly acquiring new mutations with the wide spread of new variants among the world population. At the start of our research in September 2022, the Omicron variant consisted of 5 main sublineages, BA.1, BA.2, BA.3, BA.4, and BA.5 (According to our previous study from February 2... | PMC10623550 |
Conclusion | Tixagevimab/Cilgavimab | Tixagevimab/Cilgavimab, in contrast to Regdanvimab, demonstrated higher nAbs titers to BA.1, BA.2, and BA.5 Omicron sublineages, as well as better laboratory efficacy and clinical results by Day 4 after the drug administration. The IV route of administration of Tixagevimab/Cilgavimab was associated with greater efficie... | PMC10623550 | |
Limitations | VIRUS | Limitations of this study include the lack of evaluation of virus neutralizing activity of serum after 4 days post-injection. There is also no evaluation of the effect of administered virus neutralizing antibodies on the development of long COVID-19. | PMC10623550 | |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10623550 | ||
Ethics statement | The studies involving humans were approved by Local ethics committee City Clinical Hospital 52 (version 1.1 of 478 08.09.2022). The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study. | PMC10623550 | ||
Author contributions | MSL: Writing – original draft, Writing – review & editing. DF: Writing – original draft, Writing – review & editing. AI: Writing – original draft. AKo: Writing – original draft. AS: Writing – original draft. SA: Writing – original draft. AC: Writing – original draft. ID: Writing – original draft, Writing – review & edi... | PMC10623550 | ||
Acknowledgments | This study is supported by local Research Ethics Committee of Clinical City Hospital 52 (version 1.1 of 08.09.2022). | PMC10623550 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10623550 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10623550 | ||
References | PMC10623550 | |||
Introduction | pulmonary embolism, thrombosis, bleeding, thrombo-embolic, cancer, VTED, digestive cancer, venous thrombosis | PULMONARY EMBOLISM, THROMBOSIS, BLEEDING, DEEP VEIN THROMBOSIS (DVT), BLOOD CLOTS, VENOUS THROMBOEMBOLIC DISEASE, CANCER, EVENT, DIGESTIVE CANCER, VENOUS THROMBOSIS, POSTOPERATIVE THROMBOSIS, BSE | Venous thromboembolic disease (VTED) refers to a condition characterized by the formation of blood clots within the veins, commonly has two main clinical presentations: deep vein thrombosis (DVT) and/or pulmonary embolism (PE) [The high risk of postoperative thrombosis is due to the combination of two risk factors: can... | PMC10619849 |
Materials and methods | cancers of the abdomen, disorder of haemostasis, bleeding, chronic renal failure, thrombosis, intraoperative bleeding, death, WBH.8, tumours, ICH, cancer, digestive cancer, Digestive cancers, diabetes, cardiovascular disease, CRF, thrombotic | BLEEDING, CHRONIC RENAL FAILURE, CRF, REGRESSION, EVENTS, INTRAOPERATIVE BLEEDING, THROMBOSIS, DEEP VEIN THROMBOSIS, CANCER, RESPIRATORY FAILURE, BLIND, POLYCYTHAEMIA, RENAL FAILURE, DIGESTIVE CANCER, DISEASE, COMPLICATIONS, THROMBOEMBOLIC EVENT, TUMOURS, EVENT, HEPARIN-INDUCED THROMBOCYTOPENIA, DISEASE, SECONDARY, DIS... | This is a prospective, comparative, randomized study, conducted in a single centre during four years and nine months: from October 12, 2015, to July 08, 2020.1. Patients:Included patients were: 1) over 18 years of age with proven, known or newly diagnosed, operable digestive cancer regardless of its nature, location, o... | PMC10619849 |
Results | PMC10619849 | |||
Comparability of groups | DIGESTIVE CANCER | Over four years and nine months, 168 eligible patients, had been operated in the surgical department B of Charles Nicolle Hospital for digestive cancer. Of 188 patients enrolled to participate in the study ( | PMC10619849 | |
Screening, randomization, and follow-up of study participants. | thrombosis | THROMBOSIS | No statistically significant difference was found in patients demographics and thrombosis factors ( | PMC10619849 |
Comparative study: Demographic variables (branded enoxaparin vs biosimilar enoxaparin groups). | BSE | * SD: Standard Deviation BE: Branded Enoxaparin BSE: Biosimilar Enoxaparin.# Student’s t-test or ## the non-parametric Mann-Whitney U test used for comparison of continuous variables.Categorical variables were compared by $ Pearson’s chi-squared test or $ $ Two-sided Fisher’s exact test, when appropriate.There was also... | PMC10619849 | |
Comparative study: Pre and intraoperative variables (branded enoxaparin vs biosimilar enoxaparin groups). | Median [ext] = Median [extreme].# Student’s t-test or## the non-parametric Mann-Whitney U test used for comparison of continuous variables.Categorical variables were compared by $ Pearson’s chi-squared test or $ $ Two-sided Fisher’s exact test, when appropriate. | PMC10619849 | ||
Rate of thromboembolic events | BSE | Seventy-one patients (87.7%) in the BE group had an ultrasound scan during the study and seventy-four patients (85.1%) in the BSE group with no statistically significant difference between the two groups (p = 0.625) ( | PMC10619849 | |
Equivalence between branded enoxaparin and biosimilar enoxaparin. | deaths, death, postoperative bleeding | BSE, HEPARIN-INDUCED THROMBOCYTOPENIA, POSTOPERATIVE BLEEDING, COMPLICATION | The number of patients who developed a post-operative complication was 14 (17.3%) in the BE group and eight (9.2%) in the BSE group (p = 0.120). Two patients (2.5%) had postoperative bleeding in the BE group and one patient (1.1%) had postoperative bleeding in the BSE group (p = 0.610). No incident of heparin-induced t... | PMC10619849 |
Risk factors of clinical and subclinical thrombosis events | venous thrombosis | VENOUS THROMBOSIS | The crude bivariate analysis showed no statistically significant difference between the two groups of patients regarding the occurrence of venous thrombosis postoperatively (Tables | PMC10619849 |
Demographic variables predicting clinical and subclinical thrombosis (crude bivariate analysis). | SD = standard deviation—# Student’s t-test or## the non-parametric Mann-Whitney U test used for comparison of continuous variables.Categorical variables were compared by $ Pearson’s chi-squared test or $ $ Two-sided Fisher’s exact test, when appropriate. | PMC10619849 | ||
Pre- and intra-operative variables predictive of clinical and subclinical thrombosis (crude bivariate analysis). | POSTOPERATIVE THROMBOSIS | SD = standard deviation.# Student’s t-test or## the non-parametric Mann-Whitney U test used for comparison of continuous variables.Categorical variables were compared by $ Pearson’s chi-squared test or $ $ Two-sided Fisher’s exact test, when appropriate.There were no predictors of postoperative thrombosis after digesti... | PMC10619849 | |
Discussion | postoperative thromboembolic | THROMBOEMBOLIC EVENT, ADVERSE EVENTS, HEPARIN-INDUCED THROMBOCYTOPENIA, POSTOPERATIVE THROMBOSIS, BSE | Our randomized clinical trial showed that there was no statistically significant difference between BE and BSE groups in the occurrence of postoperative thromboembolic events. There was no statistically significant difference between BE and BSE groups regarding incident heparin-induced thrombocytopenia. No predictors f... | PMC10619849 |
Predictive factor for thromboses | thrombosis, cancers, cancer, thrombocytopenia, tumour, non-thrombosis, sepsis, postoperative haemorrhage, weight loss | THROMBOSIS, THROMBOEMBOLIC EVENT, CANCERS, POSTOPERATIVE COMPLICATIONS, ADVERSE EVENTS, CANCER, THROMBOCYTOPENIA, TUMOUR, SEPSIS, POSTOPERATIVE HAEMORRHAGE, POSTOPERATIVE THROMBOSIS, BSE | In this study, there were no predictors of postoperative thrombosis after digestive oncology surgery between the thrombosis and non-thrombosis groups. This was probably due to the relatively low number of thromboembolic events. In the literature, several factors for thrombosis have been determined: patient-related fact... | PMC10619849 |
Supporting information | PMC10619849 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file.(DOCX)Click here for additional data file.(DOCX)Click here for additional data file.We thank Mr Rabii Razgallah for his assistance during redaction of protocol and made available to us DACIMA platform.We thank Mrs Marwa Naimi for revising the English of the manuscript. | PMC10619849 | ||
References | PMC10619849 | |||
Background | PDO, NMIBC | In intermediate-risk non-muscle invasive bladder cancer (NMIBC) clinical guidelines suggest an adjuvant instillation with a chemotherapeutic agent. However, the agent and regimen are not clearly defined. Worldwide, less than 15% of patients receive this adjuvant chemotherapeutic instillation. We recently developed a pi... | PMC10176900 | |
Methods | tumor, bladder tumor, NMIBC, PDO, TURBT | TUMOR, BLADDER TUMOR | Patients with first diagnosis of intermediate-risk NMIBC that are directed to transurethral resection of bladder tumor (TURBT) are enrolled. During TURBT, tumor is sampled, and specimens are directed to generate PDO. Once the PDO are formed, drug screens on them for Epirubicin, Mitomycin C, Gemcitabine and Docetaxel ar... | PMC10176900 |
Keywords | PMC10176900 | |||
Background | cancers, tumor, bladder tumor, genitourinary malignancy, TURBT, Bladder cancer, bladder cancer | CANCERS, TUMOR, BLADDER TUMOR, RECURRENCE, DISEASE, PROSTATE, BLADDER CANCER, BLADDER CANCER, PRIMARY TUMOR | Bladder cancer is one of the most common cancers in the Western World and the second most common genitourinary malignancy [Prior to the final histological diagnosis during a transurethral resection of the bladder tumor (TURBT) patients undergo a cystoscopy and cytological analysis. Depending on the macroscopical result... | PMC10176900 |
Methods/design | PMC10176900 | |||
Study aim and objectives | The aim of this trial is to test the possibility of using drug screens in PDO to guide intravesical instillation. | PMC10176900 | ||
Overall objective | NMIBC | Currently, the drug for chemotherapeutic instillation after TURBT in patients with intermediate-risk low grade NMIBC is selected based on doctors’- and institutional preferences. Most frequently, Epirubicin or MMC are used. Currently, no comparative studies focus on this patient population between the different drugs a... | PMC10176900 | |
Primary objective | The primary objective of this study is to evaluate the rate of successful drug selection by using drug screens in PDO generated from patients with low grade intermediate-risk NMIBC. This will allow to determine the rate of patients in which drug selection can successfully be performed for adjuvant intravesical instilla... | PMC10176900 | ||
Secondary objectives | RECURRENCE | Secondary objectives of the trial are to evaluate the rate of recurrence, the recurrence free survival and the progression free survival in this population. Further quality of life and safety of instillation will be assessed. | PMC10176900 | |
Ethical approval and consent | The GAIN-INST Trial (NCT05024734) has been approved by swissethics and the district ethical board from Bern (BASEC ID 2021-02369). All included patients have read the study information and signed the informed consent for this trial. | PMC10176900 | ||
Enrollment and trial design | amenorrhea | The Department of Urology at the Hospital Center in Biel is conducting the GAIN-INST Trial in which from September 2022 for two years, patients with intermediate-risk NMIBC are recruited according to the criteria in Table Inclusion and exclusion criteriaFemale subject of childbearing potential who is unwilling to use a... | PMC10176900 | |
Sample size | PDO | The alternative hypothesis states that a successful drug prediction using drug screens in PDO is possible in more than 65% of cases. Sample size was determined using a one sample test. The null hypothesis that a drug prediction will only be possible in 65% of patients will be tested against a one-sided alternative (tha... | PMC10176900 | |
Tissue sampling, PDO generation and drug treatment | PDO | COLD | During surgery, cold cup biopsies will be harvested, digested to single cells and plated organoids are allowed to form. Thereafter, PDO are dissociated to single cells, plated and formed after 48 h. These PDO are then exposed to the compounds in the following conditions: untreated (medium) or treated (0.1% DMSO vehicle... | PMC10176900 |
Readout, drug selection and instillation | Each condition will be investigated in triplicates; triplicates and average will be used for drug selection. Only drugs that reduce viability by 50% or more compared to the vehicle, will be considered. In case that more than one drug reduces viability by 50% or more compared to the vehicle, a pairwise Wilcoxon test wil... | PMC10176900 | ||
Follow-up and data collection | CRF | CRF | The patients will be followed by cystoscopy according to the clinical guidelines [The CRF will be electronic. All data requested on the eCRF must be recorded and the recorded data should be consistent with the source documents or the discrepancies should be explained. The Investigator ensures the accuracy, completeness... | PMC10176900 |
Statistical methods for primary and secondary outcomes | REGRESSION, SECONDARY | The predictive potential of biomarkers for the primary and secondary outcome will be analysed using logistic regression.Missing data is expected to occur due to drop-outs. The amount and reason of missing data will be reported for all outcomes. For survival outcomes drop-outs will be censored at the time of the drop-ou... | PMC10176900 | |
Data monitoring | For quality control of the study conduct and data retrieval, monitoring will be performed according to a monitoring plan determined by the Clinical Trial Unit from the University of Bern. Any findings and comments will be documented in site visit reports and communicated to the Sponsor-Investigator as applicable. Site ... | PMC10176900 | ||
Discussion | fits, cancer, NMIBC | CANCER, RECURRENCE | The major clinical challenges in NMIBC are the high rate of recurrence and the lack of a more precise delivery of care. Despite the molecular heterogeneity of NMIBC, all patients are treated according to the same protocol and followed by invasive and potentially harmful procedures.Therefore, we aim to precise the treat... | PMC10176900 |
Acknowledgements | None | PMC10176900 | ||
Name and contact information for the trial sponsor | Spitalzentrum Biel, 2501 Biel, Switzerland. Represented by: Prof. Dr. med. Roland Seiler, Chairman. Department of Urology, Spitalzentrum Biel. Vogelsang 84, 2501 Biel, Switzerland. Email: Roland.Seiler-Blarer@szb-chb.ch | PMC10176900 | ||
Role of sponsor | The sponsor does not have a role in study design, collection, management, and decision to submit the report for publication. The sponsor provides the facility for the clinical work during this trial. | PMC10176900 | ||
Composition of the coordinating center and trial steering committee | Since this is a single center trial, coordinating center and trial steering committee are identical. It composes of Sponsor, Administrative study personal from the Department of Urology at the Hospital Center Biel and the Head of the group from the Translational Organoid CORE (TOR), University of Bern. Department for B... | PMC10176900 | ||
Composition of the data monitoring committee, its role and reporting structure | For quality control of the study conduct and data retrieval, monitoring will be performed according to a separate monitoring plan. Any findings and comments will be documented in site visit reports and communicated to the Sponsor-Investigator as applicable. Site staff will support the Monitor in his/ her activities. Al... | PMC10176900 | ||
Access to data | The trial protocol will be published in an open access journal. Study results will be presented at national and international meetings and will be submitted for publication to high impact, peer reviewed journals. Upon completion of the analysis, trial results will be communicated to all participants. Public reporting w... | PMC10176900 | ||
Dissemination plans | The trial protocol will be published in an open access journal. Study results will be presented at national and international meetings and will be submitted for publication to high impact, peer reviewed journals. Upon completion of the analysis, trial results will be communicated to all participants. Public reporting w... | PMC10176900 | ||
Confidentiality | The Investigator will maintain appropriate medical and research records for this trial, in compliance with ICH-GCP and regulatory and institutional requirements for the protection of confidentiality of subjects. The Principal Investigator, Sub-investigators, and Clinical Research Nurses or Coordinators will have access... | PMC10176900 | ||
Author contributions | RS, MR, MM, MDM | RS: conception, design and draft of the work. ME: Acquisition and interpretation of data. MDM: Conception and design of the work, acquisition and interpretation of data. MM: Acquisition and interpretation of data. MR: Acquisition and interpretation of data. SW: Data acquisition, protocol revision. PL: Conception, desig... | PMC10176900 | |
Funding | Jetty, Aron und Simon Blum-Foundation and SNSF 310030_184933/1. | PMC10176900 | ||
Availability of data and materials | The trial sponsor will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators. | PMC10176900 | ||
Declarations | PMC10176900 | |||
Consent for publication | Not applicable. | PMC10176900 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10176900 | ||
References | PMC10176900 | |||
Background | Supplementation of calcium during continuous venovenous hemofiltration (CVVH) with citrate anticoagulation is usually titrated using a target blood ionized calcium concentration. Plasma calcium concentrations may be normal despite substantial calcium loss, by mobilization of calcium from the skeleton. Aim of our study ... | PMC10227114 | ||
Methods | This is a single-center retrospective observational cohort study. In a subcohort of patients, all calcium excretion measurements in patients treated with citrate CVVH were randomly divided into a development set ( | PMC10227114 |
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