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Giovanni Liguori - One of the best experts on this subject based on the ideXlab platform.
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an observational cohort study investigating the incidence rate of infectious complications after routine office nephrostomy tube replacement without using antimicrobial prophylaxis
Urology, 2020Co-Authors: Michele Rizzo, Luca Ongaro, Francesco Claps, Paolo Umari, Stefano Bucci, Carlo Trombetta, Tony T Cai, Giovanni LiguoriAbstract:OBJECTIVE To investigate the incidence of infectious complications after routine office nephrostomy tube replacement (NTR) in patients that did not receive antimicrobial prophylaxis (AMP). METHODS We prospectively enrolled all patients undergoing routine office NTR between July 2018 and September 2019. Each procedure was considered an independent event. Clinical, microbiological, demographic data were collected. AMP was exclusion criterion. All patients received a questionnaire via phone call within 3 weeks after NTR investigating fever, antibiotics use, hospital admissions. Infectious complications risk was assessed with univariate and multivariate binomial logistic regression analysis. RESULTS One hundred forty-five routine NTRs were performed. Nineteen patients receiving AMP were excluded. Median age was 78 years (interquartile range 71-81). Charlson Comorbidity Index (CCI) score was ≥5 in 53.2% of patients, 34 had positive urine culture, none received AMP. Seventeen (13.49%) patients reported fever after procedure, 9 received antibiotic therapy while fever resolved spontaneously in 8. Three patients needed hospitalization, 2 for nephrostomy malfunction, 1 for infectious complications. At multivariate analysis only CCI score ≥3 was associated (P < .001) with increased infectious complications risk. CONCLUSION In this study fever occurs after the 13.5% of the routine NTRs, in almost half cases resolves spontaneously rather than with oral antimicrobial therapy. Avoiding AMP before routine NTR does not expose patients to life-threatening infections.
Tomoaki Ohtsuki - One of the best experts on this subject based on the ideXlab platform.
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indoor event detection with eigenvector spanning signal subspace for home or office security
IEICE Transactions on Communications, 2009Co-Authors: Shohei Ikeda, Hiroyuki Tsuji, Tomoaki OhtsukiAbstract:This paper proposes an indoor event detection system for homes and offices that is based on electric wave reception such as intrusion into home or office. The proposed system places antenna array on the receiver side and detects events such as intrusion using the eigenvector spanning signal subspace obtained by the antenna array. The eigenvector is based on not received signal strengths (RSS) but direction of arrival (DOA) of incident signals on the antenna array. Therefore, in a static state, the variance of the eigenvector over time is smaller than that of RSS. The eigenvector changes only when the indoor environment of interest changes intermittently and statically, or dynamically. The installation cost is low, because the detection range is wide owing to indoor reflections and diffraction of electric wave and only a pair of transmitter and receiver are used. Experimental results reveal that the proposed method can distinguish the state when no event occurs and that when an event occurs clearly. Since the proposed method has a low false detection rate, it offers higher detection rates than the systems based on RSS.
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indoor event detection with eigenvector spanning signal subspace for home or office security
Vehicular Technology Conference, 2008Co-Authors: Shohei Ikeda, Hiroyuki Tsuji, Tomoaki OhtsukiAbstract:This paper proposes an indoor event detection scheme using an electric wave such as intrusion into home or office. The proposed system exploits an antenna array on the receiver side and detects events such as intrusion using signal subspace spanned by eigenvector obtained by the antenna array. The eigenvector is not based on received signal strengths (RSS) but on the direction of arrival (DOA) of incident signals on an antenna array. Therefore, in a static state, the variance of the eigenvector over time is smaller than that of RSS. The eigenvector changes only when the indoor environment of interest changes statically or dynamically. The installation cost is low, because the detection range is wide owing to indoor reflections and diffraction of electric wave and only a pair of transmitter and receiver are used. Experimental results reveal that the proposed method can distinguish the state when no event occurs and that when an event occurs clearly. The proposed method has a superior detection performance to the event detection method based on RSS.
Philip Van Kerrebroeck - One of the best experts on this subject based on the ideXlab platform.
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incidence of urinary retention during treatment with single tablet combinations of solifenacin tamsulosin ocas for up to 1 year in adult men with both storage and voiding luts a subanalysis of the neptune neptune ii randomized controlled studies
PLOS ONE, 2017Co-Authors: Marcus J Drake, Matthias Oelke, Robert Snijder, Monique Klaver, Klaudia Traudtner, Karin Juliette Van Charldorp, Dominique Bongaerts, Philip Van KerrebroeckAbstract:Introduction The emergence of urinary retention (UR), specifically acute urinary retention (AUR), has been a concern when treating men with lower urinary tract symptoms (LUTS) with antimuscarinic drugs. Materials and methods In NEPTUNE (12-week, double-blind), men (≥45 years) with LUTS were randomized to receive tamsulosin oral-controlled absorption system (TOCAS) 0.4 mg, fixed-dose combination (FDC) of solifenacin (Soli) 6 mg + TOCAS 0.4 mg, FDC Soli 9 mg + TOCAS 0.4 mg, or placebo. In NEPTUNE II (40-week, open-label extension of NEPTUNE), continuing patients received 4-week FDC Soli 6 mg + TOCAS, then FDC Soli 6 mg or 9 mg + TOCAS for the remainder of the study, switchable every 3 months. Results Across both studies, 1208 men received ≥1 dose of FDC Soli 6 mg or 9 mg + TOCAS for up to 52 weeks; 1199 men completed NEPTUNE and 1066 received ≥1 dose in NEPTUNE II. In total, 13 men (1.1%; 95% CI, 0.6%–1.8%) reported a UR event while receiving FDC, eight of which were AUR (0.7%; 95% CI, 0.3%–1.3%, incidence 7/1000 man-years). Six men reported UR events while taking Soli 6 mg + TOCAS (three AUR), and seven men reported a UR event while taking Soli 9 mg + TOCAS (five AUR). One man developed AUR while taking TOCAS alone and four reported UR (three AUR) during placebo run-in. Most AUR/UR events occurred within 4 months of treatment initiation. Conclusions FDC Soli and TOCAS was associated with a low rate of UR and AUR in men with LUTS.
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Incidence of urinary retention during treatment with single tablet combinations of solifenacin+tamsulosin OCAS™ for up to 1 year in adult men with both storage and voiding LUTS: A subanalysis of the NEPTUNE/NEPTUNE II randomized controlled studies
2017Co-Authors: Marcus J Drake, Matthias Oelke, Robert Snijder, Monique Klaver, Klaudia Traudtner, Karin Juliette Van Charldorp, Dominique Bongaerts, Philip Van KerrebroeckAbstract:IntroductionThe emergence of urinary retention (UR), specifically acute urinary retention (AUR), has been a concern when treating men with lower urinary tract symptoms (LUTS) with antimuscarinic drugs.Materials and methodsIn NEPTUNE (12-week, double-blind), men (≥45 years) with LUTS were randomized to receive tamsulosin oral-controlled absorption system (TOCAS) 0.4 mg, fixed-dose combination (FDC) of solifenacin (Soli) 6 mg + TOCAS 0.4 mg, FDC Soli 9 mg + TOCAS 0.4 mg, or placebo. In NEPTUNE II (40-week, open-label extension of NEPTUNE), continuing patients received 4-week FDC Soli 6 mg + TOCAS, then FDC Soli 6 mg or 9 mg + TOCAS for the remainder of the study, switchable every 3 months.ResultsAcross both studies, 1208 men received ≥1 dose of FDC Soli 6 mg or 9 mg + TOCAS for up to 52 weeks; 1199 men completed NEPTUNE and 1066 received ≥1 dose in NEPTUNE II. In total, 13 men (1.1%; 95% CI, 0.6%–1.8%) reported a UR event while receiving FDC, eight of which were AUR (0.7%; 95% CI, 0.3%–1.3%, incidence 7/1000 man-years). Six men reported UR events while taking Soli 6 mg + TOCAS (three AUR), and seven men reported a UR event while taking Soli 9 mg + TOCAS (five AUR). One man developed AUR while taking TOCAS alone and four reported UR (three AUR) during placebo run-in. Most AUR/UR events occurred within 4 months of treatment initiation.ConclusionsFDC Soli and TOCAS was associated with a low rate of UR and AUR in men with LUTS.
Michele Rizzo - One of the best experts on this subject based on the ideXlab platform.
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an observational cohort study investigating the incidence rate of infectious complications after routine office nephrostomy tube replacement without using antimicrobial prophylaxis
Urology, 2020Co-Authors: Michele Rizzo, Luca Ongaro, Francesco Claps, Paolo Umari, Stefano Bucci, Carlo Trombetta, Tony T Cai, Giovanni LiguoriAbstract:OBJECTIVE To investigate the incidence of infectious complications after routine office nephrostomy tube replacement (NTR) in patients that did not receive antimicrobial prophylaxis (AMP). METHODS We prospectively enrolled all patients undergoing routine office NTR between July 2018 and September 2019. Each procedure was considered an independent event. Clinical, microbiological, demographic data were collected. AMP was exclusion criterion. All patients received a questionnaire via phone call within 3 weeks after NTR investigating fever, antibiotics use, hospital admissions. Infectious complications risk was assessed with univariate and multivariate binomial logistic regression analysis. RESULTS One hundred forty-five routine NTRs were performed. Nineteen patients receiving AMP were excluded. Median age was 78 years (interquartile range 71-81). Charlson Comorbidity Index (CCI) score was ≥5 in 53.2% of patients, 34 had positive urine culture, none received AMP. Seventeen (13.49%) patients reported fever after procedure, 9 received antibiotic therapy while fever resolved spontaneously in 8. Three patients needed hospitalization, 2 for nephrostomy malfunction, 1 for infectious complications. At multivariate analysis only CCI score ≥3 was associated (P < .001) with increased infectious complications risk. CONCLUSION In this study fever occurs after the 13.5% of the routine NTRs, in almost half cases resolves spontaneously rather than with oral antimicrobial therapy. Avoiding AMP before routine NTR does not expose patients to life-threatening infections.
M Lichinitser - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for her2 positive early breast cancer final analysis of the randomised two cohort prefher study
European Journal of Cancer, 2017Co-Authors: Xavier Pivot, Sunil Verma, Lesley Fallowfield, Volkmar Muller, M Lichinitser, Valerie Jenkins, Sanchez A Munoz, Z Machackova, S Osborne, Joseph GligorovAbstract:Abstract Aim To assess efficacy (event-free survival, EFS) and safety in patients followed up for 3 years in the PrefHer study (NCT01401166). Patients and methods Post surgery and post chemotherapy in the (neo)adjuvant setting, patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer were randomised to receive four cycles of the subcutaneous form of trastuzumab (Herceptin® SC [H SC] via single-use injection device [Cohort 1] or delivery via a hand-held syringe from an SC Vial [Cohort 2]; 600 mg fixed dose) followed by four of the intravenous form of trastuzumab (Herceptin® [H IV]; 8 mg/kg loading, 6 mg/kg maintenance doses) in the adjuvant setting or vice versa every 3 weeks. Patients could have received H before randomisation. H was then continued to complete a total of 18 cycles, including any cycles received before randomisation. Results A total of 488 patients were randomised across both cohorts. After median follow-up of 36.1 months, 3-year EFS across both groups in the evaluable intention-to-treat population (467 patients) was 90.6% overall, 89.9% in Cohort 1, and 91.1% in Cohort 2. No new safety signals were identified during long-term follow-up, with only one cardiac serious adverse event in the safety population (483 patients). Conclusions Three-year EFS data following H SC and H IV treatment are consistent with those reported by previous trials for H in the adjuvant setting. The overall safety profile during adjuvant treatment was as expected.
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neoadjuvant and adjuvant trastuzumab in patients with her2 positive locally advanced breast cancer noah follow up of a randomised controlled superiority trial with a parallel her2 negative cohort
Lancet Oncology, 2014Co-Authors: Luca Gianni, Wolfgang Eiermann, V F Semiglazov, Ana Lluch, Sergei Tjulandin, Milvia Zambetti, Angela Moliterni, Federico Vazquez, Mikhail Byakhov, M LichinitserAbstract:Summary Background In our randomised, controlled, phase 3 trial NeOAdjuvant Herceptin (NOAH) trial in women with HER2-positive locally advanced or inflammatory breast cancer, neoadjuvant trastuzumab significantly improved pathological complete response rate and event-free survival. We report updated results from our primary analysis to establish the long-term benefit of trastuzumab-containing neoadjuvant therapy. Methods We did this multicentre, open-label, randomised trial in women with HER2-positive locally advanced or inflammatory breast cancer. Participants were randomly assigned (1:1), by computer program with a minimisation technique, to receive neoadjuvant chemotherapy alone or with 1 year of trastuzumab (concurrently with neoadjuvant chemotherapy and continued after surgery). A parallel group with HER2-negative disease was included and received neoadjuvant chemotherapy alone. Our primary endpoint was event-free survival. Analysis was by intention to treat. This study is registered at www.controlled-trials.com, ISRCTN86043495. Findings Between June 20, 2002, and Dec 12, 2005, we enrolled 235 patients with HER2-positive disease, of whom 118 received chemotherapy alone and 117 received chemotherapy plus trastuzumab. 99 additional patients with HER2-negative disease were included in the parallel cohort. After a median follow-up of 5·4 years (IQR 3·1–6·8) the event-free-survival benefit from the addition of trastuzumab to chemotherapy was maintained in patients with HER2-positive disease. 5 year event-free survival was 58% (95% CI 48–66) in patients in the trastuzumab group and 43% (34–52) in those in the chemotherapy group; the unadjusted hazard ratio (HR) for event-free survival between the two randomised HER2-positive treatment groups was 0·64 (95% CI 0·44–0·93; two-sided log-rank p=0·016). Event-free survival was strongly associated with pathological complete remission in patients given trastuzumab. Of the 68 patients with a pathological complete response (45 with trastuzumab and 23 with chemotherapy alone), the HR for event-free survival between those with and without trastuzumab was 0·29 (95% CI 0·11–0·78). During follow-up only four cardiovascular adverse events were regarded by the investigator to be drug-related (grade 2 lymphostasis and grade 2 lymphoedema, each in one patient in the trastuzumab group, and grade 2 thrombosis and grade 2 deep vein thrombosis, each in one patient in the chemotherapy-alone group). Interpretation These results show a sustained benefit in event-free survival from trastuzumab-containing neoadjuvant therapy followed by adjuvant trastuzumab in patients with locally advanced or inflammatory breast cancer, and provide new insight into the association between pathological complete remission and long-term outcomes in HER2-positive disease. Funding F Hoffmann-La Roche.