Mediterranean Diet (Med Diet) is one of the healthiest dietary patterns. We aimed to verify the effects of weaning (i.e., the introduction of solid foods in infants previously fed only with milk) ...using adult foods typical of Med Diet on children eating habits, and on the microbiota composition. A randomized controlled clinical trial on 394 healthy infants randomized in a 1:1 ratio in a Med Diet group weaned with fresh; seasonal and tasty foods of Med Diet and control group predominantly weaned with industrial baby foods. The primary end point was the percentage of children showing a good adherence to Med Diet at 36 months. Secondary end points were mother’s changes in adherence to Med Diet and differences in children gut microbiota. At 36 months, children showing a good adherence to Med Diet were 59.3% in the Med Diet group and 34.3% in the control group (p < 0.001). An increase in adherence to the Med Diet was observed in the mothers of the Med Diet group children (p < 0.001). At 4 years of age children in the Med Diet group had a higher gut microbial diversity and a higher abundance of beneficial taxa. A Mediterranean weaning with adult food may become a strategy for early nutritional education, to develop a healthy microbiota, to prevent inflammatory chronic diseases and to ameliorate eating habits in children and their families.
Sunitinib is the most commonly prescribed drug for advanced renal cell carcinoma in the first-line setting and has been associated with multiple adverse events related to its on-and off-target ...effects, including hand and foot syndrome and fatigue. It was hypothesized that sunitinib-induced fatigue may be related to off target inhibition of the AMPK enzyme, which results in impairment of energy-producing processes at a systemic level. Quercetin is a naturally occurring flavonol with established AMPK-stimulating activity. While clinical use of quercetin is limited by its poor bio-availability, quercetin-3-O-β-d-glucopyranoside, that is isoquercetin, has an improved pharmacokinetic profile. On the grounds of the
stimulatory activity with respect to AMPk, we hypothesized that oral isoquercetin could improve fatigue in kidney cancer patients receiving sunitinib. Given the lack of data on the safety of isoquercetin given concomitantly with sunitinib, we conducted a phase I trial to assess the safety of GMP manufactured isoquercetin given at two dose levels (450 and 900 mg a day). In the 12-patient study cohort included in this study, isoquercetin was administered concomitantly with 50 mg sunitinib for a median 81 days (IQR, 75.5, 86.5). None of the 12 patients required isoquercetin suspension or isoquercetin dose reduction because of adverse events. No abnormalities in ECG, heart or lower limbs doppler ultrasound were detected. A statistically significant improvement was reported for the FACIT fatigue score (6.8 points; 95% CI: 2.8-10.8;
= 0.002) and for the FACIT Adverse Events score (18.9 points; 95% CI: 9.1-28.8;
< 0.001) after isoquercetin consumption vs. baseline. In this phase I trial, isoquercetin was remarkably safe, with a preliminary signal of activity in terms of improvement of sunitinib adverse events.
Atrial fibrillation (AF) often occurs after cardiac surgery and is associated with increased risk of stroke and mortality. Prior studies support the important role of inflammation in the pathogenesis ...of postoperative atrial fibrillation (POAF). It is known that an increased volume and a pro-inflammatory phenotype of epicardial adipose tissue (EAT) are both associated with AF onset in non surgical context. In the present study, we aim to evaluate whether also POAF occurrence may be triggered by an increased production of inflammatory mediators from EAT.
The study population was composed of 105 patients, with no history of paroxysmal or permanent AF, undergoing elective cardiac surgery. After clinical evaluation, all patients performed an echocardiographic study including the measurement of EAT thickness. Serum samples and EAT biopsies were collected before surgery. Levels of 10 inflammatory cytokines were measured in serum and EAT conditioned media. After surgery, cardiac rhythm was monitored for 7 days.
Forty-four patients (41.3%) developed POAF. As regard to cardiovascular therapy, only statin use was significantly lower in POAF patients (65.1% vs. 84.7%;
-0.032). Levels of Monocyte Chemoattractant Protein-1 (MCP-1), in both serum and EAT, were significantly higher in POAF patients (130.1 pg/ml vs. 68.7 pg/ml;
= <0.001; 322.4 pg/ml vs. 153.4 pg/ml;
= 0.028 respectively). EAT levels of IL-6 were significantly increased in POAF patients compared to those in sinus rhythm (SR) (126.3 pg/ml vs. 23 pg/ml;
= <0.005).
Higher EAT levels of IL-6 and MCP-1 are significantly associated with the occurrence of POAF. Statin therapy seems to play a role in preventing POAF. These results might pave the way for a targeted use of these drugs in the perioperative period.
Background
The accumulation of
p
-cresol, a metabolic product of aromatic amino acids generated by intestinal microbiome, increases the cardiovascular risk in chronic kidney disease (CKD) patients. ...Therefore, therapeutic strategies to reduce plasma
p
-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer (SEV) sequesters
p
-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of SEV on
p
-cresol levels in non-dialysis CKD patients.
Methods
This was a single-blind, randomized placebo-controlled trial (Registration number NCT02199444) carried on 69 CKD patients (stage 3–5, not on dialysis), randomly assigned (1:1) to receive either SEV or placebo for 3 months. Total
p
-cresol serum levels were evaluated at baseline (T0), and 1 (T1) and 3 months (T3) after treatment start. The primary end-point was to evaluate the effect of SEV on
p
-cresol levels.
Results
Compared to baseline (
T
0, 7.4 ± 2.7 mg/mL),
p
-cresol mean concentration was significantly reduced in SEV patients after one (− 2.06 mg/mL, 95% CI − 2.62 to − 1.50 mg/mL;
p
< 0.001) and 3 months of treatment (− 3.97 mg/mL, 95% CI − 4.53 to − 3.41 mg/mL;
p
< 0.001); no change of plasma
p
-cresol concentration was recorded in placebo-treated patients. Moreover, P and LDL values were reduced after 3 months of treatment by SEV but not placebo.
Conclusions
In conclusion, our study represents the first evidence that SEV is effective in reducing
p
-cresol levels in CKD patients in conservative treatment, and confirms its beneficial effects on inflammation and lipid pattern.
The characteristics of scoliosis were investigated in a large cohort of children and adults with Prader-Willi syndrome (PWS), analysing the role of age, gender, puberty, body mass index (BMI), ...genotype and growth hormone therapy (GHT) on its onset and severity. A retrospective cross-sectional study was performed in 180 patients with genetically confirmed PWS (96 females), aged 17.6 ± 12 years. Eighty-five subjects (47%) were obese. One hundred and fifty subjects (83.3%) were on GHT, while 30 patients had never been treated. Overall, 150 subjects (83.3%) were affected by scoliosis, 80.2% of children and adolescents and 87.8% of adults. A mild degree of scoliosis was observed in 58 patients (38.7%), moderate in 43 (28.7%) and severe in 49 (32.6%). Median age at diagnosis of scoliosis was 6.3 years, while the severe forms were diagnosed earlier (median age: 3.8 years). The cumulative probability at 5 years of age was equal to 0.403 and almost doubled at 15 years. No significant associations were found between scoliosis and genotype, gender, pubertal stage, GHT and BMI. A corset was prescribed to 75 subjects (50%) at a median age of 7.5 years, while 26 subjects (17.3%) underwent surgery at a median age of 13.1 years. Our data indicate that scoliosis is one of the major concerns for PWS patients that increases with age, and therefore suggest the need for regular systematic monitoring of spinal deformity from paediatric age.
Systemic biomarkers for severity of SARS-CoV-2 infection are of great interest. In this study, we evaluated a set of collagen metabolites and extracellular matrix remodeling biomarkers including ...procollagen type III amino terminal propeptide (PIIINP), tissue inhibitor of metalloproteinases 1 (TIMP-1) and hyaluronic acid (HA) as prognostic indicators in COVID-19 patients.
Ninety COVID-19 patients with the absence of chronic liver diseases were enrolled. Serum PIIINP, TIMP-1, and HA were measured and correlated with inflammatory indices and clinical variables. Patients were stratified for disease severity according to WHO criteria in two groups, based on the requirement of oxygen support.
Serum TIMP-1, but not PIIINP and HA was significantly higher in patients with WHO score ≥5 compared to patients with WHO score <5 PIIINP: 7.2 (5.4-9.5) vs. 7.1 (4.5-9.9),
= 0.782; TIMP-1: 298.1 (20.5-460) vs. 222.2 (28.5-452.8),
= 0.01; HA: 117.1 (55.4-193.7) vs. 75.1 (36.9-141.8),
= 0.258. TIMP-1 showed moderate correlation with CRP (r = 0.312,
= 0.003) and with LDH (r = 0.263,
= 0.009). CRP and serum LDH levels were significantly higher in COVID-19 patients with WHO score ≥5 compared to the group of patients with WHO score < 5 15.8 (9-44.5) vs. 9.3 (3.4-33.8),
= 0.039 and 373 (282-465) vs. 289 (218-383),
= 0.013, respectively.
In patients with COVID-19, circulating TIMP-1 was associated with disease severity and with systemic inflammatory index, suggesting that TIMP-1 could represent a promising non-invasive prognostic biomarker in COVID-19 patients. Interestingly, our results prompted that serum TIMP-1 level may potentially be used to select the patients for therapeutic approaches targeting matrix metalloproteases pathway.
Polyphenols are the largest class of bioactive compounds in plants, which are synthesized as secondary metabolites. In the last few years, interesting studies have demonstrated the efficacy of ...polyphenols against coronavirus infections.
we conducted a phase II multicentric clinical trial (TAEROVID-19) during the first wave of the COVID-19 pandemic in order to assess the safety and feasibility of Taurisolo
aerosol formulation in hospitalized patients suffering from SARS-CoV-2 pneumonia.
we observed a rapid decline of symptoms and a low rate of intensive care in patients treated with Taurisolo
, with a faster decline of symptoms.
This is the first trial assessing the safety and feasibility of Taurisolo
aerosol formulation. We could argue that this treatment could act as an add-on therapy in the treatment of COVID-19 patients, owing to both its anti-inflammatory and antioxidant effects. Further controlled trials are needed, which may be of interest to evaluate the compound's efficacy.
Objective:
Inappropriate use of the emergency department (ED) represents a major worldwide issue both in pediatric and adult age. Herein, we aim to describe features of pediatric visits to the ED of ...Salerno University Hospital and to evaluate parental reasons behind the decision to walk in.
Materials and Methods:
We performed a retrospective observational study evaluating ED encounters for children from January 2014 to December 2019. The appropriateness of visits was measured with a national tool assessing every ED encounter, namely, “the Mattoni method,” which consists of the combination of the triage code assigned, the diagnostic resources adopted, and the consultation outcomes. Moreover, 64 questionnaires were collected from a sample of parents in the waiting rooms in January 2020.
Results:
A total number of 42,507 visits were recorded during the study period (19,126 females; mean age ±
SD
: 4.3 ± 3.8 years), the majority of whom were inappropriate (75.8% over the considered period; 73.6% in 2014; 74.6% in 2015; 76.3% in 2016; 76.7% in 2017; 77.9% in 2018; 75.5% in 2019). Most of the inappropriate consultations arrived at the ED by their own vehicle (94.4%), following an independent decision of the parents (97.2%), especially in the evening and at night on Saturdays/Sundays/holidays (69.7%). A multivariate analysis revealed the following: patients of younger age (OR: 1.11, 95% C.I. 1.06–1.16;
p
< 0.0019), night visits (OR 1.39; 95% C.I.: 1.32–1.47;
p
< 0.001), patients living in the municipality of Salerno (OR 1.28; 95% C.I.: 1.22–1.34;
p
< 0.001), weekend day visits (OR 1.48; 95% C.I.: 1.41–1.56;
p
< 0.001), and independent parental decision without previous contact with primary care pediatrician (OR 3.01; 95% C.I.: 2.64–3.44;
p
< 0.001) were all significant independent predictors of inappropriate consultation. The most frequent trigger of ED encounters was fever (51.4%). Hospital admission made up 17.6% of all consultations. The questionnaire showed that most parents were aware of the lack of urgency (20.3%) or minor urgency (53.1%) of the visit. The reasons for walking in were the impossibility to receive a home consultation (70%), the difficulty of contacting their family pediatrician during weekends and holidays (54.4%), as well as the search for a quick, effective, diagnosis and therapy (48.4%).
Conclusions:
The study suggests a highly inappropriate use of ED for children in our region. This issue deserves considerable attention by health care system leaders in order to optimally integrate hospitals and primary care.
A comprehensive evaluation of obstructive sleep apnoea (OSA) may allow for the development of more efficient management of Down syndrome (DS). We aimed to evaluate the effect of a multidisciplinary ...approach to DS with OSA. A total of 48 DS children aged 4−12 years were prospectively investigated with nasal endoscopy, orthodontic examination, and overnight polygraphy (PG); the Italian Child Sleep Habits Questionnaire (CSHQ-IT) was filled out by the mothers. The total CSHQ-IT score was 63 (96% of children reporting sleep problems). The major ear, nose, and throat characteristics were enlarged palatine tonsils (62%), adenoid tonsils (85%), and chronic rhinosinusitis (85%). DS children showed orthognathic profile in 68% of cases, class I relationship in 63%, and cross-bite in 51%. PG revealed OSA in 67% of cases (37% mild, 63% moderate−severe). The oxygen desaturation index (ODI) was higher in the group with OSA (5.2) than with non-OSA (1.3; p < 0.001). The ODI was higher (p = 0.001) and SpO2 lower (p = 0.03) in children with moderate−severe OSA than with mild OSA. The apnoea−hypopnea index (AHI) and percentage time with SpO2 < 90% were higher in DS children with grade III than with grade I or II adenoids (5 vs. 1, p = 0.04, and 1.2 vs. 0.1, p = 0.01, respectively). No significant correlations were found between PG and the total CSHQ-IT score or orthodontic data. However, children showing associated cross-bite, grade III adenoids and size 3 or 4 palatine tonsils showed higher AHI and ODI than those without (p = 0.01 and p = 0.04, respectively). A coordinated multidisciplinary approach with overnight PG is a valuable tool when developing diagnostic protocols for OSA in DS.