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Article: Compatibility of PiC Insupen Needles with a Broad Range of Pens for the Injection of Subcutaneously Administered Drugs for Diabetes.

Nicolucci, Antonio / Leonardi, Luca

2022 Volume 15, Page(s) 71–77

Abstract: Purpose: To test the compatibility of PiC Insupen needles with a broad range of pens produced by different manufacturers for the injection of subcutaneously administered drugs.: Patients and methods: The "extreme" products in PiC pen needles range ... ...

Abstract	Purpose: To test the compatibility of PiC Insupen needles with a broad range of pens produced by different manufacturers for the injection of subcutaneously administered drugs. Patients and methods: The "extreme" products in PiC pen needles range were considered (G33x4 mm and G29x12 mm), to verify that the compatibility was not affected by the cannula diameter and length. Following the launch of the G34x3.5mm needle, additional tests were performed comparing G33x4 and G34x3.5 pen needles. A test medium with viscosity similar to insulin was used. Additional tests were performed with a liquid with a much higher viscosity. All the requirements of the technical standard ISO 11608-2 were satisfied, and the differences between G29, G33 and G34 were negligible. Therefore, the PiC Insupen needle G33x4mm was chosen as representative of the PiC pen needles. Dose accuracy and needle hub torque were assessed, according to the ISO 11608-2:2012 norms. For pens with variable volume, two different volumes were tested (Vlow and Vhigh) in random order, testing 60 needles with Vlow and 60 with Vhigh. Results: Overall, 50 different pens were tested. Dose accuracy acceptance criteria were met for all the pens tested, with the only exception of Vhigh for Berlipen Precision pen. The removal torque was adequate for all pens, with the only exception of Berlipen 301 and Berlipen 302 pens. Conclusion: We documented that Pikdare needles are compatible with a large array of different pens for the injection of insulin and other drugs administered subcutaneously.
Language	English
Publishing date	2022-03-29
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2520731-3
ISSN	1179-1470
ISSN	1179-1470
DOI	10.2147/MDER.S352849
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Article ; Online: The adolescent with obesity: what perspectives for treatment?

Nicolucci, Antonio / Maffeis, Claudio

Italian journal of pediatrics

2022 Volume 48, Issue 1, Page(s) 9

Abstract: The dramatic increase in overweight and obesity among children and adolescents has become a major public health problem. Obesity in children and young adults is associated with an increased prevalence of cardiometabolic risk factors. Obesity during ... ...

Abstract	The dramatic increase in overweight and obesity among children and adolescents has become a major public health problem. Obesity in children and young adults is associated with an increased prevalence of cardiometabolic risk factors. Obesity during adolescence represents a strong predictor of obesity and higher mortality in adulthood. Due to the serious implications of obesity in adolescents, effective treatments are urgently needed. Lifestyle interventions represent the recommended therapy. Nevertheless, real world data show that the majority of adolescents do not achieve weight loss in the long term, and are reluctant to participate in lifestyle interventions. Pharmacological treatment is recommended if a formal lifestyle modification program fails to limit weight gain or to improve comorbidities. However, until 2020 the European Medicines Agency (EMA) had not approved any pharmacotherapeutic agents for obesity in pediatric patients. On April 2021, EMA has authorized the use of Liraglutide, a glucagon-like peptide (GLP)-1 analog, for the treatment of obesity in adolescents (12-17 years). The efficacy and safety of Liraglutide were demonstrated in a randomized, double-blind trial, enrolling 251 adolescents. After 56 weeks, a reduction in BMI of at least 5% was observed in 43.3% of participants in the liraglutide group vs. 18.7% in the placebo group, and a reduction in BMI of at least 10% was observed in 26.1 and 8.1%, respectively. Gastrointestinal events were the events most frequently reported with liraglutide. Bariatric surgery represents another effective treatment for adolescents with severe obesity, with sustained benefits on weight loss and cardiometabolic risk factors. However, long-term safety and effectiveness data in adolescents are still scarce. Risks of bariatric surgery include the need for additional abdominal surgical procedures and specific micronutrient deficiencies. Hopefully, new pharmacological treatments in addition to lifestyle interventions will offer more chances of success.
MeSH term(s)	Adolescent ; Cardiometabolic Risk Factors ; Global Health ; Humans ; Life Style ; Morbidity ; Pediatric Obesity/complications ; Pediatric Obesity/epidemiology ; Pediatric Obesity/therapy
Language	English
Publishing date	2022-01-15
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2088556-8
ISSN	1824-7288 ; 1720-8424
ISSN (online)	1824-7288
ISSN	1720-8424
DOI	10.1186/s13052-022-01205-w
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Article ; Online: Intensive Glucose Control and Type 2 Diabetes - 15 Years On.

Ceriello, Antonio / Nicolucci, Antonio

The New England journal of medicine

2019 Volume 381, Issue 13, Page(s) 1292–1293

MeSH term(s)	Blood Glucose ; Diabetes Mellitus, Type 2 ; Follow-Up Studies ; Glycated Hemoglobin A/analysis ; Humans ; Hypoglycemic Agents
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; Hypoglycemic Agents
Language	English
Publishing date	2019-09-25
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc1909041
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Article ; Online: Accuracy of the Standard GlucoNavii Mentor in Blood Glucose Monitoring According to International Organization for Standardization 15197:2013 Criteria.

Hwang, Heeyoung / Leonardi, Luca / Nicolucci, Antonio

JMIR diabetes

2022 Volume 7, Issue 2, Page(s) e20774

Abstract: This study was performed to assess the system accuracy of the blood glucose monitoring system SD GlucoNavii Mentor (SD Biosensor Inc, Korea). The study procedures were based on International Organization for Standardization 15197:2013, in that capillary ... ...

Abstract	This study was performed to assess the system accuracy of the blood glucose monitoring system SD GlucoNavii Mentor (SD Biosensor Inc, Korea). The study procedures were based on International Organization for Standardization 15197:2013, in that capillary blood samples from 100 participants' fingertips were measured with three reagent system lots of the self-monitoring blood glucose system. Samples were collected for comparison measurements on a hexokinase-based glucose analyzer (Cobas Integra400 Plus, Roche Instrument Center, Switzerland). Glucose concentrations were distributed as required by International Organization for Standardization 15197. For each of the 100 evaluable samples, duplicate measurements were taken from three different reagent lots, for a total of 600 measurements. Overall, 98.3% (590/600) of individual measurement results (185/186, 99.5% for glucose values <100 mg/dl and 405/414, 97.8% for glucose values ≥100 mg/dl) were within ±15 mg/dl or ±15% of the corresponding comparison method results. All results (100%) fell into the consensus error grid zones A and B, indicating only clinically acceptable results. In conclusion, the blood glucose monitoring system SD GlucoNavii Mentor device fulfilled the system accuracy criteria of the International Organization for Standardization 15197, indicating measurement accuracy sufficient for diabetes therapy.
Language	English
Publishing date	2022-05-20
Publishing country	Canada
Document type	Journal Article
ISSN	2371-4379
ISSN (online)	2371-4379
DOI	10.2196/20774
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Article ; Online: Corrigendum to Comparative effectiveness of Glargine 300 U/mL vs. Degludec 100 U/mL in patients with type 2 diabetes switching from 1° generation basal insulins > Nutr Metab Cardiovasc Dis. 2022 Sep;32(9):2255-2263.

Buzzetti, Raffaella / Fadini, Gian Paolo / Nicolucci, Antonio / Larosa, Monica / Rossi, Maria Chiara / Cucinotta, Domenico

Nutrition, metabolism, and cardiovascular diseases : NMCD

2023 Volume 33, Issue 4, Page(s) 920–921

Language	English
Publishing date	2023-03-21
Publishing country	Netherlands
Document type	Published Erratum
ZDB-ID	1067704-5
ISSN	1590-3729 ; 0939-4753
ISSN (online)	1590-3729
ISSN	0939-4753
DOI	10.1016/j.numecd.2023.02.006
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Article ; Online: Lifetime costs of overweight and obesity in Italy.

Atella, Vincenzo / Belotti, Federico / Giaccherini, Matilde / Medea, Gerardo / Nicolucci, Antonio / Sbraccia, Paolo / Mortari, Andrea Piano

Economics and human biology

2024 Volume 53, Page(s) 101366

Abstract: We use longitudinal electronic clinical data on a large representative sample of the Italian population to estimate the lifetime profile costs of different BMI classes - normal weight, overweight, and obese (I, II, and III) - in a primary care setting. ... ...

Abstract	We use longitudinal electronic clinical data on a large representative sample of the Italian population to estimate the lifetime profile costs of different BMI classes - normal weight, overweight, and obese (I, II, and III) - in a primary care setting. Our research reveals that obese patients generate the highest cost differential throughout their lives compared to normal weight patients. Moreover, we show that overweight individuals spend less than those with normal weight, primarily due to reduced expenditures beginning in early middle age. Our estimates could serve as a vital benchmark for policymakers looking to prioritize public interventions that address the obesity pandemic while considering the increasing obesity rates projected by the OECD until 2030.
MeSH term(s)	Humans ; Italy/epidemiology ; Obesity/epidemiology ; Obesity/economics ; Middle Aged ; Female ; Male ; Overweight/epidemiology ; Overweight/economics ; Adult ; Body Mass Index ; Aged ; Young Adult ; Adolescent ; Longitudinal Studies ; Cost of Illness ; Child ; Health Expenditures/statistics & numerical data ; Primary Health Care/economics
Language	English
Publishing date	2024-02-06
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2099749-8
ISSN	1873-6130 ; 1570-677X
ISSN (online)	1873-6130
ISSN	1570-677X
DOI	10.1016/j.ehb.2024.101366
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Article ; Online: Continuous improvement of quality of care in pediatric diabetes: the ISPED CARD clinical registry.

Nicolucci, Antonio / Graziano, Giusi / Lombardo, Fortunato / Rabbone, Ivana / Rossi, Maria Chiara / Vespasiani, Giacomo / Zucchini, Stefano / Bonfanti, Riccardo

Acta diabetologica

2024

Abstract: Aim: In Italy, the ISPED CARD initiative was launched to measure and improve quality of care in children and adolescents with type 1 diabetes.: Methods: Process and outcome indicators and the related information derived from electronic medical ... ...

Abstract	Aim: In Italy, the ISPED CARD initiative was launched to measure and improve quality of care in children and adolescents with type 1 diabetes. Methods: Process and outcome indicators and the related information derived from electronic medical records were identified. A network of pediatric diabetes centers was created on a voluntary basis. Results: Overall, 20 centers provided data on 3284 patients aged < = 18 years. HbA1c was monitored ≥ 2/year in 81.2% of the cases. BMI was monitored ≥ 1/year in 99.0%, lipid profile in 45.3%, and blood pressure in 91.7%. Pubertal status, albuminuria, eye examination, and screening of celiac disease and thyroiditis were underreported. From 2017 to 2021, average HbA1c levels decreased from 7.8 ± 1.2 to 7.6 ± 1.3%, while patients with LDL cholesterol > 100 mg/dl increased from 18.9 to 36.7%. Prevalence of patients with elevated blood pressure and BMI/SDS values also increased. In 2021, 44.7% of patients were treated with the newest basal insulins, while use of regular human insulin had dropped to 7.7%. Use of insulin pump remained stable (37.9%). Conclusions: This report documents the feasibility of the ISPED CARD initiative and shows lights and shadows in the care provided. Improving care, increasing number of centers, and ameliorating data recording represent future challenges.
Language	English
Publishing date	2024-02-08
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1097676-0
ISSN	1432-5233 ; 0940-5429
ISSN (online)	1432-5233
ISSN	0940-5429
DOI	10.1007/s00592-023-02233-6
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Article ; Online: Vulvovaginal atrophy in women with and without a history of breast cancer: Baseline data from the PatiEnt satisfactiON studY (PEONY) in Italy.

Meriggiola, Maria Cristina / Villa, Paola / Maffei, Silvia / Becorpi, Angelamaria / Di Paolantonio, Tiziana / Nicolucci, Antonio / Salvatore, Stefano / Nappi, Rossella E

Maturitas

2024 Volume 183, Page(s) 107950

Abstract: Objectives: To assess clinical characteristics of postmenopausal women with moderate/severe vulvovaginal atrophy, as well as its impact on sexual function, well-being, and quality of life, and to provide an overview of most used treatments.: Study ... ...

Abstract	Objectives: To assess clinical characteristics of postmenopausal women with moderate/severe vulvovaginal atrophy, as well as its impact on sexual function, well-being, and quality of life, and to provide an overview of most used treatments. Study design: Ongoing longitudinal, observational study conducted in 17 Italian gynecology centers, involving women already treated or initiating a local vaginal estrogen therapy or ospemifene. We report baseline data for women with and without a history of breast cancer. Participants filled in self-reported questionnaires at study entry. Main outcome measures: Severity of vulvovaginal atrophy; ongoing treatments; patient-reported outcomes, including severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and SF-12® Health Survey. Results: Overall, 334 women (20.4 % with a history of breast cancer) started or continued local therapy (61.1 %) or ospemifene (38.8 %) at study entry. Vulvovaginal atrophy was severe in 28.6 %, and was responsible for severe symptoms, particularly vulvar dryness with burning or irritation and pain during sexual intercourse. Both sexual dysfunction (FSFI≤26) (81.5 %) and sexual distress (FSDS-R ≥ 11) (74.4 %) were common. A reduction in the SF-12 mental component score was documented. Women with breast cancer more often had severe vulvovaginal atrophy (41.2 %), had more severe symptoms, and the impact of vaginal symptoms on emotional well-being, sexual functioning and self-concept/body image was greater. The majority of them (83.8 %) received ospemifene as a treatment. Conclusions: Moderate/severe vulvovaginal atrophy is a common, often neglected condition with an impact on QoL and sexuality, particularly in women with a history of breast cancer. It is important to alleviate the burden associated with the disease.
MeSH term(s)	Female ; Humans ; Atrophy/pathology ; Breast Neoplasms/complications ; Breast Neoplasms/pathology ; Patient Satisfaction ; Quality of Life ; Tamoxifen/analogs & derivatives ; Vagina/pathology ; Vaginal Diseases/drug therapy ; Vulva/pathology
Chemical Substances	Ospemifene (B0P231ILBK) ; Tamoxifen (094ZI81Y45)
Language	English
Publishing date	2024-03-05
Publishing country	Ireland
Document type	Journal Article ; Multicenter Study ; Observational Study
ZDB-ID	80460-5
ISSN	1873-4111 ; 0378-5122
ISSN (online)	1873-4111
ISSN	0378-5122
DOI	10.1016/j.maturitas.2024.107950
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Zs.A 1432: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Treatment intensification following glucagon-like peptide-1 receptor agonist treatment in type 2 diabetes: The RESTORE-G real-world study.

Candido, Riccardo / Nicolucci, Antonio / Larosa, Monica / Rossi, Maria Chiara / Napoli, Raffaele

Nutrition, metabolism, and cardiovascular diseases : NMCD

2023 Volume 33, Issue 11, Page(s) 2294–2305

Abstract: Background and aims: To assess intensification approaches with basal insulin (BI) following glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment in type 2 diabetes (T2D).: Methods and results: Real-world data were collected in electronic ... ...

Abstract	Background and aims: To assess intensification approaches with basal insulin (BI) following glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment in type 2 diabetes (T2D). Methods and results: Real-world data were collected in electronic medical records by 32 Italian diabetes clinics between 2011 and 2021. Primary endpoint was the proportion of insulin-naïve T2D patients treated with GLP-1 RA who initiated (add-on or switch) BI. Secondary endpoints were: treatment approaches, mean time to BI start, effectiveness and safety. Among 7,962 eligible patients, BI was prescribed to 3,164 (39.7%; 95%CI 38.7; 40.8): 67.6% switched to BI (22.1% also starting 1-3 injections of short-acting insulin), 22.7% added BI while maintaining GLP-1 RA, and 9.7% switched to a fixed-ratio combination of GLP-1 RA and BI (FRC). Median time since the first GLP-1 RA to BI/FRC prescription was 27.4 (IQ range 11.8-53.5) months. In this study 60.3% of patients did not start BI/FRC, among whom 15.2% intensified GLP-1 RA therapy with other oral agents. Effectiveness and safety were documented in all intensification approaches with BI/FRC, but HbA1c level at intensification time of ≥9.0% and suboptimal BI titration suggested clinical inertia. Use of second generation BI and add-on to GLP-1 RA schemes increased over time and effectiveness improved. Conclusion: Clinical inertia should be overcome using innovative insulin options. Timely combination therapy of BI and GLP-1 RA is a valuable choice.
Language	English
Publishing date	2023-07-22
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1067704-5
ISSN	1590-3729 ; 0939-4753
ISSN (online)	1590-3729
ISSN	0939-4753
DOI	10.1016/j.numecd.2023.07.025
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Article ; Online: Effectiveness of Ascophyllum nodosum and Fucus vesiculosus on Metabolic Syndrome Components: A Real-World, Observational Study.

Nicolucci, Antonio / Rossi, Maria Chiara / Petrelli, Massimiliano

Journal of diabetes research

2021 Volume 2021, Page(s) 3389316

Abstract: Introduction: Gdue is a nutraceutical obtained from the association of two marine algae, Ascophyllum nodosum and Fucus vesiculosus, in addition to chromium picolinate, which could be useful for the treatment of dysglycemia, overweight, and the other ... ...

Abstract	Introduction: Gdue is a nutraceutical obtained from the association of two marine algae, Ascophyllum nodosum and Fucus vesiculosus, in addition to chromium picolinate, which could be useful for the treatment of dysglycemia, overweight, and the other components of the metabolic syndrome. The aim of the study was to assess the real-world effectiveness and safety of Gdue when administered to subjects with one or more components of the metabolic syndrome. Methods: A longitudinal, retrospective, observational study, conducted among primary care physicians, nutritionists, and specialists from various disciplines. The impact of 180 days of administration of Gdue was assessed on body weight, waist circumference, fasting blood glucose, HbA1c, lipid profile, and blood pressure levels. The likelihood of experiencing a first major cardiovascular event over ten years was estimated using Italian risk charts. General linear models for repeated measures were applied to assess changes in the parameters of interest during the follow-up. Results are expressed as estimated marginal means with their 95% confidence interval. Results: Overall, 505 patients were enrolled by 282 physicians. After 6 months of treatment with Gdue, body weight was reduced on average by 7.3 kg (-8.0; -6.6), waist circumference by 7.5 cm (-8.2; -6.8), fasting blood glucose by 16.3 mg/dL (-17.8; -14.7), HbA1c by 0.55% (-0.62; -0.49), systolic and diastolic blood pressure by 7.1 mmHg (-8.3; -6.0) and 4.2 mmHg (-5.0; -3.5), respectively, LDL cholesterol by 18.2 mg/dL (-21.2; -15.3), and triglycerides by 39 mg/dL (-45; -32). HDL cholesterol was significantly increased by 2.9 mg/dL (0.7; 5.0). The 10-year risk of cardiovascular events significantly decreased by 1.8%, corresponding to a relative risk reduction of 27.7%. Conclusion: Our real-world study shows that 6 months of treatment with Gdue have an impact on all the components of the metabolic syndrome, thus offering the potential for decreasing the cardiovascular risk associated with metabolic syndrome.
MeSH term(s)	Adult ; Aged ; Ascophyllum/chemistry ; Biomarkers/blood ; Blood Glucose/drug effects ; Blood Glucose/metabolism ; Blood Pressure/drug effects ; Cardiometabolic Risk Factors ; Cardiovascular Diseases/blood ; Cardiovascular Diseases/diagnosis ; Cardiovascular Diseases/physiopathology ; Cardiovascular Diseases/prevention & control ; Dietary Supplements/adverse effects ; Female ; Fucus/chemistry ; Glycated Hemoglobin/metabolism ; Humans ; Lipids/blood ; Longitudinal Studies ; Male ; Metabolic Syndrome/blood ; Metabolic Syndrome/diagnosis ; Metabolic Syndrome/drug therapy ; Metabolic Syndrome/physiopathology ; Middle Aged ; Retrospective Studies ; Risk Assessment ; Time Factors ; Treatment Outcome ; Weight Loss/drug effects
Chemical Substances	Biomarkers ; Blood Glucose ; Glycated Hemoglobin A ; Lipids ; hemoglobin A1c protein, human
Language	English
Publishing date	2021-09-30
Publishing country	England
Document type	Journal Article ; Observational Study
ZDB-ID	2711897-6
ISSN	2314-6753 ; 2314-6753
ISSN (online)	2314-6753
ISSN	2314-6753
DOI	10.1155/2021/3389316
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