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Moderate salt restriction with or without paricalcitol in type 2 diabetes and losartan-resistant macroalbuminuria (PROCEED): a randomised, double-blind, placebo-controlled, crossover trial

Parvanova, Aneliya ; Trillini, Matias ; Podestà, Manuel A ; [et al.]

Elsevier BV ; 2018

In: The Lancet Diabetes & Endocrinology Vol. 6, No. 1 ( 2018-01), p. 27-40

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In: The Lancet Diabetes & Endocrinology, Elsevier BV, Vol. 6, No. 1 ( 2018-01), p. 27-40

Type of Medium: Online Resource

ISSN: 2213-8587

URL: Article

DOI: 10.1016/S2213-8587(17)30359-5

Language: English

Publisher: Elsevier BV

Publication Date: 2018

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Long-term kidney and systemic effects of calorie restriction in overweight or obese type 2 diabetic patients (C.Re.S.O. 2 randomized controlled trial)

Ruggenenti, Piero ; Cortinovis, Monica ; Trillini, Matias ; [et al.]

Elsevier BV ; 2022

In: Diabetes Research and Clinical Practice Vol. 185 ( 2022-03), p. 109804-

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In: Diabetes Research and Clinical Practice, Elsevier BV, Vol. 185 ( 2022-03), p. 109804-

Type of Medium: Online Resource

ISSN: 0168-8227

URL: Article

DOI: 10.1016/j.diabres.2022.109804

Language: English

Publisher: Elsevier BV

Publication Date: 2022

detail.hit.zdb_id: 2004910-9

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Heparin in pregnant women with previous placenta-mediated pregnancy complications: a prospective, randomized, multicenter, controlled clinical trial

Martinelli, Ida ; Ruggenenti, Piero ; Cetin, Irene ; [et al.]

American Society of Hematology ; 2012

In: Blood Vol. 119, No. 14 ( 2012-04-05), p. 3269-3275

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In: Blood, American Society of Hematology, Vol. 119, No. 14 ( 2012-04-05), p. 3269-3275

Abstract: To assess whether antithrombotic prophylaxis with low-molecular-weight heparin effectively prevents recurrence of late pregnancy complications, 135 women with previous history of preeclampsia, hemolytic anemia, elevated liver enzymes and low platelet count syndrome, intrauterine fetal death, fetal growth restriction, or placental abruption who had been referred within the 12th gestational week were randomized to medical surveillance alone (n = 68) or combined to open-label nadroparin (3800 IU daily subcutaneous injections) treatment (n = 67) in the setting of a randomized, parallel-group, superiority trial, run in Italy from April 2007 to April 2010. Primary outcome was a composite end point of late-pregnancy complications. Analysis was by intention to treat. The study was stopped for futility at the time of the first planned interim analysis. Among the 128 women eventually available for final analyses, 13 of the 63 (21%) randomized to nadroparin compared with 12 of the 65 (18%) on medical surveillance alone progressed to the primary end point. The absolute event risk difference between treatment arms (2.2; −1.6 to 16.0) was not statistically significant (P = .76). Thus, nadroparin did not prevent late-pregnancy complications in women at risk of recurrence. This finding challenges the role of antithrombotic prophylaxis with low-molecular-weight heparin in the prevention of recurrent late pregnancy complications The trial was registered at http://ricerca-clinica.agenziafarmaco.it as EudraCT 2006-004205-26.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood-2011-11-391383

RVK:

XA 33000

RVK:

XA 10000

Language: English

Publisher: American Society of Hematology

Publication Date: 2012

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7

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Immunophenotypic Alterations in Adult Patients with Steroid-Dependent and Frequently Relapsing Nephrotic Syndrome

Casiraghi, Federica ; Todeschini, Marta ; Podestà, Manuel Alfredo ; [et al.]

MDPI AG ; 2023

In: International Journal of Molecular Sciences Vol. 24, No. 9 ( 2023-04-22), p. 7687-

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In: International Journal of Molecular Sciences, MDPI AG, Vol. 24, No. 9 ( 2023-04-22), p. 7687-

Abstract: Immune dysregulation plays a key role in the pathogenesis of steroid-dependent/frequently relapsing nephrotic syndrome (SDNS/FRNS). However, in contrast with evidence from the pediatric series, no major B- or T-cell alterations have been described for adults. In these patients, treatment with rituximab allows safe discontinuation of steroids, but long-term efficacy is variable, and some patients experience NS relapses after B cell reconstitution. In this study, we aimed to determine disease-associated changes in the B and T cell phenotype of adult patients with SDND/FRNS after steroid-induced remission. We also investigated whether any of these changes in immune cell subsets could discriminate between patients who developed NS relapses after steroid-sparing treatment with rituximab from those who did not. Lymphocyte subsets in SDNS/FRNS patients (n = 18) were compared to those from patients with steroid-resistant NS (SRNS, n = 7) and healthy volunteers (HV, n = 15). Before rituximab, SDND/FRNS patients showed increased frequencies of total and memory B cells, mainly with a CD38-negative phenotype. Within the T-cell compartment, significantly lower levels of FOXP3+ regulatory T cells (Tregs) were found, mostly due to a reduction in CD45RO+ memory Tregs compared to both SRNS and HV. The levels of CD45RO+ Tregs were significantly lower at baseline in patients who relapsed after rituximab (n = 9) compared to patients who did not (n = 9). In conclusion, patients with SDND/FRNS displayed expansion of memory B cells and reduced memory Tregs. Treg levels at baseline may help identify patients who will achieve sustained remission following rituximab infusion from those who will experience NS relapses.

Type of Medium: Online Resource

ISSN: 1422-0067

URL: Article

DOI: 10.3390/ijms24097687

Language: English

Publisher: MDPI AG

Publication Date: 2023

detail.hit.zdb_id: 2019364-6

SSG: 12

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Measuring and Estimating GFR and Treatment Effect in ADPKD Patients: Results and Implications of a Longitudinal Cohort Study

Ruggenenti, Piero ; Gaspari, Flavio ; Cannata, Antonio ; [et al.]

Public Library of Science (PLoS) ; 2012

In: PLoS ONE Vol. 7, No. 2 ( 2012-2-28), p. e32533-

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In: PLoS ONE, Public Library of Science (PLoS), Vol. 7, No. 2 ( 2012-2-28), p. e32533-

Type of Medium: Online Resource

ISSN: 1932-6203

URL: Article

DOI: 10.1371/journal.pone.0032533

DOI: 10.1371/journal.pone.0032533.g001

DOI: 10.1371/journal.pone.0032533.g002

DOI: 10.1371/journal.pone.0032533.g003

DOI: 10.1371/journal.pone.0032533.g004

DOI: 10.1371/journal.pone.0032533.g005

DOI: 10.1371/journal.pone.0032533.g006

DOI: 10.1371/journal.pone.0032533.g007

DOI: 10.1371/journal.pone.0032533.g008

DOI: 10.1371/journal.pone.0032533.t001

DOI: 10.1371/journal.pone.0032533.t002

DOI: 10.1371/journal.pone.0032533.t003

DOI: 10.1371/journal.pone.0032533.s001

Language: English

Publisher: Public Library of Science (PLoS)

Publication Date: 2012

detail.hit.zdb_id: 2267670-3

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A GWAS in the pandemic epicenter highlights the severe COVID-19 risk locus introgressed by Neanderthals

Breno, Matteo ; Noris, Marina ; Rubis, Nadia ; [et al.]

Elsevier BV ; 2023

In: iScience Vol. 26, No. 10 ( 2023-10), p. 107629-

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In: iScience, Elsevier BV, Vol. 26, No. 10 ( 2023-10), p. 107629-

Type of Medium: Online Resource

ISSN: 2589-0042

URL: Article

DOI: 10.1016/j.isci.2023.107629

Language: English

Publisher: Elsevier BV

Publication Date: 2023

detail.hit.zdb_id: 2927064-9

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Safety of Iohexol Administration to Measure Glomerular Filtration Rate in Different Patient Populations: A 25-Year Experience

Gaspari, Flavio ; Thakar, Surabhi ; Carrara, Fabiola ; [et al.]

S. Karger AG ; 2018

In: Nephron Vol. 140, No. 1 ( 2018), p. 1-8

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In: Nephron, S. Karger AG, Vol. 140, No. 1 ( 2018), p. 1-8

Abstract: 〈 b 〉 〈 i 〉 Background/Aim: 〈 /i 〉 〈 /b 〉 In clinical research setting, accurate and precise measurement of glomerular filtration rate (GFR) is essential to overcome the limitations of GFR estimation with equations, which are often unreliable. In recent decades, a method for measuring GFR by plasma clearance of iohexol, a non-ionic radiocontrast agent, was developed. To evaluate the safety of the procedure, we aimed to review all immediate adverse reactions that could be related to iohexol administration in our group’s 25 years worth of experience. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 We retrospectively reviewed all GFR investigations in 2,891 patients, between 1992 and 2016, as part of 37 clinical trials coordinated by our group. Subjects with disparate renal diseases, kidney transplant recipients, and living donors – all with different renal function categories – were included in the surveyed clinical trials. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 During 15,147 GFR measurements, only one treatment-related event of moderate intensity was identified. Flushing, urticaria, and itching were observed in a diabetic patient a few minutes after iohexol administration during the first GFR measurement. The event recovered without sequelae after intravenous injection of methylprednisolone sodium succinate. The patient was not hospitalized and the event was categorized as non-serious. Eight additional non-serious events observed closely following iohexol injection were considered as not related to treatment. Thus, independent of disease conditions and GFR categories, the overall rate of treatment-related events was 0.0066%. 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 Iohexol administration for GFR measurement is a safe procedure, even in repeated investigations in the same subject, that should be adopted in clinical research and, when needed, also in clinical practice.

Type of Medium: Online Resource

ISSN: 1660-8151 , 2235-3186

URL: Article

DOI: 10.1159/000489898

Language: English

Publisher: S. Karger AG

Publication Date: 2018

detail.hit.zdb_id: 2810853-X

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Effects of valsartan, benazepril and their combination in overt nephropathy of type 2 diabetes: A prospective, randomized, controlled trial

Ruggenenti, Piero ; Trillini, Matias ; P. Barlovic, Drazenka ; [et al.]

Wiley ; 2019

In: Diabetes, Obesity and Metabolism Vol. 21, No. 5 ( 2019-05), p. 1177-1190

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In: Diabetes, Obesity and Metabolism, Wiley, Vol. 21, No. 5 ( 2019-05), p. 1177-1190

Abstract: To evaluate whether angiotensin‐converting enzyme (ACE) inhibitor and angiotensin II receptor blocker (ARB) combination therapy is more nephroprotective than ACE inhibitor or ARB monotherapy in people with type 2 diabetes and overt nephropathy. Materials and methods In this prospective, randomized, open, blind‐endpoint phase III trial sponsored by the Italian Drug Agency, 103 consenting patients with type 2 diabetes, aged 〉 40 years, with serum creatinine levels 159 to 309 μmol/L, spot morning urinary albumin–creatinine ratio 〉 1000 mg/g (or 〉 500 mg/g in those on ACE inhibitor or ARB therapy at inclusion) were stratified by centre and randomized to 4.5‐year treatment with valsartan 320 mg/d (n = 36), benazepril 20 mg/d (n = 34) or halved doses of both medications (n = 33). The primary endpoint was end‐stage renal disease (ESRD). Modified intention‐to‐treat analyses were performed. Results Recruitment took place between June 2007 and February 2013 at 10 centres in Italy and one in Slovenia. A total of 77 participants completed the study and 26 were prematurely withdrawn. During a median (interquartile range) of 41 (18–54) months, 12 participants on benazepril (35.3%) and nine on combination therapy (27.3%) progressed to ESRD, versus five on valsartan (13.9%). Differences between benazepril (hazard ratio [HR] 3.59, 95% confidence interval [CI] 1.25–10.30; P = 0.018) or combination therapy (HR 3.28, 95% CI 1.07–10.0; P = 0.038) and valsartan were significant, even after adjustment for age, gender and baseline serum creatinine, systolic blood pressure and 24‐hour proteinuria (HR 5.16, 95% CI 1.50–17.75, P = 0.009 and HR 4.75, 95% CI 1.01–22.39, P = 0.049, respectively). Adverse events were distributed similarly among the groups. Conclusions In people with type 2 diabetes with nephropathy, valsartan (320 mg/d) safely postponed ESRD more effectively than benazepril (20 mg/d) or than halved doses of both medications.

Type of Medium: Online Resource

ISSN: 1462-8902 , 1463-1326

URL: Issue

URL: Article

DOI: 10.1111/dom.2019.21.issue-5

DOI: 10.1111/dom.13639

Language: English

Publisher: Wiley

Publication Date: 2019

detail.hit.zdb_id: 2004918-3

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Eculizumab in patients with severe coronavirus disease 2019 (COVID-19) requiring continuous positive airway pressure ventilator support: Retrospective cohort study

Ruggenenti, Piero ; Di Marco, Fabiano ; Cortinovis, Monica ; [et al.]

Public Library of Science (PLoS) ; 2021

In: PLOS ONE Vol. 16, No. 12 ( 2021-12-20), p. e0261113-

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In: PLOS ONE, Public Library of Science (PLoS), Vol. 16, No. 12 ( 2021-12-20), p. e0261113-

Abstract: Complement activation contributes to lung dysfunction in coronavirus disease 2019 (COVID-19). We assessed whether C5 blockade with eculizumab could improve disease outcome. Methods In this single-centre, academic, unblinded study two 900 mg eculizumab doses were added-on standard therapy in ten COVID-19 patients admitted from February 2020 to April 2020 and receiving Continuous-Positive-Airway-Pressure (CPAP) ventilator support from ≤24 hours. We compared their outcomes with those of 65 contemporary similar controls. Primary outcome was respiratory rate at one week of ventilator support. Secondary outcomes included the combined endpoint of mortality and discharge with chronic complications. Results Baseline characteristics of eculizumab-treated patients and controls were similar. At baseline, sC5b-9 levels, ex vivo C5b-9 and thrombi deposition were increased. Ex vivo tests normalised in eculizumab-treated patients, but not in controls. In eculizumab-treated patients respiratory rate decreased from 26.8±7.3 breaths/min at baseline to 20.3±3.8 and 18.0±4.8 breaths/min at one and two weeks, respectively (p 〈 0.05 for both), but did not change in controls. Between-group changes differed significantly at both time-points (p 〈 0.01). Changes in respiratory rate correlated with concomitant changes in ex vivo C5b-9 deposits at one (rs = 0.706, p = 0.010) and two (rs = 0.751, p = 0.032) weeks. Over a median (IQR) period of 47.0 (14.0–121.0) days, four eculizumab-treated patients died or had chronic complications versus 52 controls [HR Crude (95% CI): 0.26 (0.09–0.72), p = 0.010]. Between-group difference was significant even after adjustment for age, sex and baseline serum creatinine [HR Adjusted (95% CI): 0.30 (0.10–0.84), p = 0.023]. Six patients and 13 controls were discharged without complications [HR Crude (95% CI): 2.88 (1.08–7.70), p = 0.035]. Eculizumab was tolerated well. The main study limitations were the relatively small sample size and the non-randomised design. Conclusions In patients with severe COVID-19, eculizumab safely improved respiratory dysfunction and decreased the combined endpoint of mortality and discharge with chronic complications. Findings need confirmation in randomised controlled trials.

Type of Medium: Online Resource

ISSN: 1932-6203

URL: Article

DOI: 10.1371/journal.pone.0261113

DOI: 10.1371/journal.pone.0261113.g001

DOI: 10.1371/journal.pone.0261113.g002

DOI: 10.1371/journal.pone.0261113.g003

DOI: 10.1371/journal.pone.0261113.g004

DOI: 10.1371/journal.pone.0261113.t001

DOI: 10.1371/journal.pone.0261113.t002

DOI: 10.1371/journal.pone.0261113.s001

DOI: 10.1371/journal.pone.0261113.s002

DOI: 10.1371/journal.pone.0261113.s003

DOI: 10.1371/journal.pone.0261113.s004

DOI: 10.1371/journal.pone.0261113.s005

DOI: 10.1371/journal.pone.0261113.s006

DOI: 10.1371/journal.pone.0261113.s007

DOI: 10.1371/journal.pone.0261113.r001

DOI: 10.1371/journal.pone.0261113.r002

DOI: 10.1371/journal.pone.0261113.r003

DOI: 10.1371/journal.pone.0261113.r004

Language: English

Publisher: Public Library of Science (PLoS)

Publication Date: 2021

detail.hit.zdb_id: 2267670-3

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Sirolimus Therapy to Halt the Progression of ADPKD

Perico, Norberto ; Antiga, Luca ; Caroli, Anna ; [et al.]

Ovid Technologies (Wolters Kluwer Health) ; 2010

In: Journal of the American Society of Nephrology Vol. 21, No. 6 ( 2010-06), p. 1031-1040

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In: Journal of the American Society of Nephrology, Ovid Technologies (Wolters Kluwer Health), Vol. 21, No. 6 ( 2010-06), p. 1031-1040

Type of Medium: Online Resource

ISSN: 1046-6673

URL: Article

DOI: 10.1681/ASN.2009121302

Language: English

Publisher: Ovid Technologies (Wolters Kluwer Health)

Publication Date: 2010

detail.hit.zdb_id: 2029124-3

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