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In this study, we investigated the relationship of demographic variables with mental disorders generally encountered by the caregivers. The cohort includes 109 caregivers (38.53 ± 9.62 year-old) of pediatric cerebral palsy patients (1–18 year-old) taken more than 3 months of caregiving. Data were obtained via face-to-face interviews and a 13-questioned survey followed by a statistical correlation with Zarit-Caregiver-Burden-Scale (Zarit-CBS), Beck Anxiety Inventory (BAI), and Beck Depression Inventory-II scores (BDI-II). BAI scores were lower in the case of collaborative caregiving (p =.034) and a better financial status (p =.045) but higher in families having more than 1 disabled child (p =.019). Zarit-CBS scores were significantly higher in caregiving mothers with older age (p =.027) and lower in families having only 1 disabled child (p =.025). Mental disorders related to caregiving are dependent on the burden directed on the caregivers and having collaboration decreases anxiety. Medical assistance should be provided to caregivers showing signs of a mental disorder. [ABSTRACT FROM AUTHOR]

Aims: Coeliac disease (CD) is an autoimmune disorder with a prevalence ≤2% that causes an immune reaction to gluten. Growth retardation (GR) generally accompanies CD due to gastrointestinal complications and should be treated as early as possible along with initiation of a gluten‐free diet. The aim of this study was to determine the indicators of GR in patients with CD. Methods: This single‐centre retrospective study included paediatric outpatients with CD. All patients were diagnosed with CD via serological analysis and upper gastrointestinal endoscopy if necessary. Patient records were obtained from Adana City Training and Research Hospital. Patients that were diagnosed with GR accompanying CD were given oral nutritional supplements and followed‐up every 3–6 months. Statistical relationships between demographics, and anthropometric measurements, duration of breastfeeding, gluten contact time, diet duration, presenting complaints and serological findings were evaluated. Results: This study included 169 paediatric outpatients between ages 1 and 18. Longer symptom duration and shorter breastfeeding duration were significantly correlated with GR accompanying CD (P = 0.007 and P = 0.029, respectively). Vomiting was the only symptom that was correlated with the presence of GR (P = 0.010). Helicobacter pylori infection was not correlated with the presence of GR (P = 0.277). Conclusions: GR should be treated as early as possible to reduce the severity of CD and a 6 months sole breastfeeding followed by solid foods accompanied by breastfeeding for 2 years is crucial for preventing GR. Moreover, vomiting as a presenting complaint in patients with CD might be indicative of the presence of GR. [ABSTRACT FROM AUTHOR]

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Aims: Malnutrition (MN) is associated with an increased mortality rate in infants and children and is an important comorbidity. Adherence to MN treatment is critical for a successful outcome, as are early diagnosis and administration of an appropriate treatment regimen. This study aimed to identify the factors pediatricians perceive to be associated with adherence to MN treatment in children. Materials and Methods: This mixed-methods study employed both qualitative and quantitative methods. The study included 136 pediatricians from various geographical regions of Turkey. Data were obtained via face-to-face interview, questionnaire, and group discussion. Results: Physicians perceived that among the patients that were diagnosed with MN, 66% underwent enteral nutrition therapy and that the treatment adherence rate was 59%. Patient-related factors associated with adherence to MN treatment were treatment tolerability, the severity of MN, and comorbidities. Nutritional product-related factors associated with treatment adherence were cost and flavor. Family-related factors associated with treatment adherence were parental level of education, economic status, and the level of confidence in the treatment modality. Use of an unflavored pediatric oral nutritional product increased the treatment adherence in patients aged 18–24 months (60% vs. 40%), whereas flavored varieties increased the treatment adherence rate after 2 years of age. Conclusion: The prevalence of MN is high in Turkey and non-adherence to MN treatment is common. Increasing awareness of the factors that contribute to adherence to MN treatment among physicians, the general public, and government are important for improving the rate of adherence to MN treatment. [ABSTRACT FROM AUTHOR]

Background: Adherence with treatment is critical for a successful outcome in cow's milk protein allergy (CMPA). Determination of the factors associated with non-adherence will enable us to develop effective approaches to increase the adherence rates, thus better cost-effectiveness of the treatment. The aim of this study was to identify the main factors associated with non-adherence with treatment for CMPA in children through the view of the physicians. Materials and methods: This focus-group study involved 51 pediatricians. Data were obtained using face-to-face surveys and subsequent discussions with the physicians. Results: Based on the treating physician's opinion, adherence to treatment was 65.7%. Of the patients, 55.4% and 29.3% were treated with an amino-acid-based formula (AAF) and an extensively hydrolyzed formula (eHF) with the tolerability rates of 77.4% and 77.2%, respectively. Remaining patients were treated with elimination diet. For patient-related factors, CMPA severity and the existence of underlying morbidities, of family-related factors, the education level of the family and their confidence in the treatment, and of product-related factors, product taste/aroma and formula choice were most strongly associated factors with treatment adherence. Conclusions: The main obstacles in treating CMPA in clinical practice were intolerability or incorrect use of the formula, dislike of its flavor and odor, and difficulties in implementation of elimination diet by parents. Determination of the factors associated with non-adherence is important in order to develop effective strategies to increase the adherence rates which will in turn improve the outcome and cost-effectiveness of the treatment. [ABSTRACT FROM AUTHOR]

Background This study was conducted to evaluate the efficacy and safety of once-monthly continuous erythropoietin receptor activator (CERA) for maintenance of stable haemoglobin (Hb) levels in adult chronic renal anaemia patients on dialysis according to local clinical judgment in Turkey. Methods This was a prospective, open-label, single-arm, multi-centre study conducted in 20 centres in Turkey. After a 4-week screening period, eligible patients receiving conventional erythropoiesis-stimulating agents were converted to monthly intravenous CERA and entered a 16-week CERA dose-titration period (DTP) followed by an 8-week efficacy evaluation period (EEP) and a 4-week safety follow-up. The primary endpoint was the proportion of patients whose Hb concentration remained stable within ±1.0 g/dL of their reference Hb and within the range of 10.0–12.0 g/dL during the EEP. Results A total of 173 patients were screened, 132 entered the DTP and 84 completed the study. Thirty-nine patients [46.4% (95% confidence interval: 35.5–57.7%)] maintained stable target Hb concentrations. The mean change in time-adjusted average Hb concentration was 0.29 ± 1.08 g/dL between baseline and the EEP. The mean CERA monthly dose was 112.4 ± 76.78 µg during the EEP, and the CERA dose was adjusted in 39 patients (36.4%). Eleven patients (8.4%) reported 13 treatment-related adverse events, the most frequent adverse events being infections and infestations, gastrointestinal and vascular disorders. Conclusions Once-monthly CERA maintains stable Hb concentrations in chronic renal anaemia patients on dialysis in Turkey. The study results confirm the known efficacy and safety profile of CERA. [ABSTRACT FROM AUTHOR]

Objective: It was the aim of this study to evaluate maintenance therapy with bevacizumab + capecitabine following induction with bevacizumab + capecitabine + oxaliplatin (XELOX) versus bevacizumab + XELOX until progression as first-line therapy in metastatic colorectal cancer (mCRC). Methods: Patients received either bevacizumab (7.5 mg/kg) + XELOX (capecitabine 1,000 mg/m2 twice daily on days 1-14 + oxaliplatin 130 mg/m2 on day 1 every 3 weeks) until disease progression (arm A) or the same doses of bevacizumab + XELOX for 6 cycles followed by bevacizumab + capecitabine until disease progression (arm B). The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate (ORR) and safety. Results: One hundred and twenty-three patients were randomized. Treatment compliance was similar in both groups. Median PFS was significantly longer for arm B than for arm A (11.0 vs. 8.3 months; p = 0.002). There was no significant difference between the two arms for ORR (66.7 vs. 59.0%; p = 0.861) or median OS (23.8 vs. 20.2 months; p = 0.100). Tolerability was acceptable in both treatment arms; the most frequent grade 3/4 treatment-related adverse events (arm B vs. arm A) were fatigue (6.6 vs. 16.1%), diarrhoea (3.3 vs. 11.3%), anorexia (3.3 vs. 11.3%), and neuropathy (1.6 vs. 8.1%). Conclusions: Maintenance therapy with bevacizumab + capecitabine can be considered an appropriate option following induction bevacizumab + XELOX in patients with mCRC instead of continuation of bevacizumab + XELOX. © 2013 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Objective  Rotavirus is a highly infectious and prevalent ribonucleic acid (RNA) virus that causes fatal gastroenteritis in children. Despite vitamin D deficiency is associated with susceptibility to infections, the relationship between ferritin and vitamin B12 levels is not known. This study aimed to investigate and compare the effect of rotavirus on micronutrient levels, atopy, and the frequency of allergic diseases in children with rotavirus. Methods  There were rotavirus gastroenteritis (RVG) (N  = 92) and non-rotavirus (control) groups (N  = 95). Serum micronutrient levels (B12, ferritin, and 25-hydroxyvitamin D [25-OH-D3]) were checked during the first control after gastroenteritis healed. Patients were also examined for allergic diseases on an average of 17 (14–32) months following rotavirus infection. Serum immunoglobulin E (IgE), eosinophil count, and percentage were analyzed. Skin tests and respiratory function tests were also performed on patients with allergic disease and asthma symptoms. Results  Mean ferritin, B12, and 25-OH-D3 levels were lower in the RVG group compared with the control group. Allergic diseases in the RVG group were more frequent than in the control group. The prevalence of the allergic disease in the RVG group was 16.3%, as opposed to 5.2% in the control group (p  = 0.014). The IgE level was significantly higher in the RVG group. Conclusion  Children with rotavirus infection should be followed closely in terms of allergic diseases and micronutrient deficiency. Furthermore, rotavirus infection should be prevented in the society and early treatment should be made available via tests detecting micronutrient deficiency. [ABSTRACT FROM AUTHOR]

Introduction: Cow's milk protein allergy (CMPA) is the most commonly encountered food allergy in the world, usually seen in infants under the age of 2 years. This study aims to determine the factors including COVID-19 affecting formula compliance of CMPA patients., Methods: This study is a prospective, observational study based on 10 different Paediatric Allergy-Immunology clinics in Turkey. Patients aged between 6 months and 2 years, who were followed up with IgE-mediated CMPA treatment or newly diagnosed and using breast milk and/or formula were included in the study. The sociodemographic characteristics of the patients, their symptoms, the treatments they received, and the effects of the COVID-19 pandemic on adherence to formula were evaluated with a questionnaire administered to the parents., Results: The compliance rate for formula-based treatment was 30.8% (IQR: 28.3, SD: 21.86). The number of patients with a single and multiple food allergy was 127 (51.6%) and 71 (28.9%), respectively. Breastfeeding duration, daily amount of prescribed formula and addition of sweetener to the formula were found to reduce compliance ( p  = 0.010, p  = 0.003, and p  = 0.004, respectively). However, it was determined that the patient's height, weight, age at diagnosis, and age of formula onset did not have a significant effect on compliance., Conclusion: It was found that the duration of breastfeeding, the increase in the daily amount of formula requirement, and the addition of sweeteners had adverse effects on formula compliance. There was no significant correlation between the formula adherence of CMPA patients and the pandemic., Competing Interests: 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., (© 2023 Uygun, Karaatmaca, Topal, Arga, Sancakli, Ozcan, Igde, Cekic, Bingol, Buyuktiryaki, Sackesen, Sursal, Ozdener and Bingol.)

Cancer patients often face malnutrition, which negatively affects their response to cancer treatment. This study aims to analyze the effects of the COVID-19 pandemic on nutritional status and anxiety in cancer patients with different types and stages of cancer. This is a cross-sectional cohort study that includes 1,252 patients with varying cancer types from 17 radiation oncology centers. The nutritional risk scores (NRS-2002) and coronavirus anxiety scale (CAS) scores of all patients were measured. NRS-2002 ≥ 3 and CAS ≥ 5 were accepted as values at risk. Of all patients, 15.3% had NRS-2002 ≥ 3. Breast cancer was the most prevalent cancer type (24.5%) with the lowest risk of nutrition (4.9%, p  < 0.001). Nutritional risk was significantly higher in patients with gastrointestinal cancer, head and neck cancer, and lung cancer ( p  < 0.005) and in patients with stage IV disease ( p  < 0.001). High anxiety levels (CAS ≥ 5) were significantly related to voluntary avoidance and clinical postponement of hospital visits due to the pandemic ( p  < 0.001), while clinical postponement was particularly frequent among patients with NRS-2002 < 3 ( p  = 0.0021). Fear and anxiety in cancer patients with COVID-19 cause hesitations in visiting hospitals, leading to disrupted primary and nutritional treatments. Thus, nutritional monitoring and treatment monitoring of cancer patients are crucial during and after radiotherapy.

Aim: To assess pediatric clinical nutrition research by analyzing clinical studies in the Middle East (ME) and globally., Methods: Using ClinicalTrials.gov, the numbers of clinical studies in the ME and globally were analyzed., Results: The majority of clinical nutrition trials are in North America and Europe. The ME accounts for 4% of all nutrition trials. The majority of pediatric nutrition studies in the ME are in the later phases or are observational and/or epidemiological studies with a focus on poor nutrition or nutrition disorders. Industry funding in the ME is mostly by regional or local companies; few major global companies are involved., Conclusion: The ME is not well represented in clinical nutrition studies involving children. Effort should be expended to rectify this., Competing Interests: Financial & competing interests disclosure This study was supported by Nutricia Advanced Medical Nutrition, Turkey. F Kirbiyik and AE Dogan are employees of Nutricia Advanced Medical Nutrition, Medical Department, Turkey. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

Background/aims: To evaluate the association between insulin resistance and hepatic fibrosis in patients with chronic hepatitis C., Materials and Methods: A total of 104 chronic hepatitis C patients were included in this non-interventional, open-label, observational, multicenter, cross-sectional study conducted at 20 gastroenterology clinics in Turkey. The primary end point was the correlation between stage of hepatic fibrosis and insulin resistance evaluated via the homeostasis model of assessment-insulin resistance index. Confounders of hepatic fibrosis and insulin resistance were the secondary end points., Results: The mean age of patients was 52.8 years; 65.4% were female. Type 2 diabetes was present in 6.8% and insulin resistance noted in 38.0% of patients. Further, 45.7% of the patients had mild (A0/A1) and the remaining had moderate/severe (A2/A3) hepatic necroinflammatory activity. Patient distribution according to Metavir fibrosis stage was as follows: F0/F1 (57.0%); F2 (6.5%); F3 (23.7%); and F4 (12.9%). A univariate analysis revealed significant positive correlations between Metavir fibrosis stage and insulin resistance (r=0.297; p=0.007). Logistic regression analysis showed that significant predictors of insulin resistance were high alanine transaminase levels (odds ratio, 0.97; 95% confidence interval, 0.944-0.997) and liver fibrosis stage (odds ratio, 0.114; 95% confidence interval, 0.021-0.607)., Conclusion: Our findings revealed significant associations between insulin resistance and hepatic fibrosis.

Objective: The aim of this study was to determine the rate of Her-2 gene amplification in breast cancer cases with a previous negative Her-2 result as determined by immunohistochemistry (score 0 or 1)., Material and Method: 552 cases of invasive breast carcinoma were assessed with the contribution of 9 centers. Previous immunohistochemistry score was either 0 or 1+ in all cases. These cases were re-tested by Her-2 silver in situ hybridization in the central laboratory. Her-2 gene amplification was defined as Her-2/CEP 17 ratio of more than 2.2. Cases with a ratio between 1.8 and 2.0 were defined as equivocal and cases with a ratio of less than 1.8 were defined as negative., Results: Re-testing of the 552 cases with silver in situ hybridization showed a total of 22 cases with Her-2 gene amplification, of which 11 (3.2%) were found to be score 0, and 11 were found to be score 1+ (5.3%) by immunohistochemistry previously. Her-2 gene amplification rate of cases (score 0 and 1+) ranged from 0% to 10.48% among the centers. Polysomy was found in 28 (8.1%) of the score 0 cases and 25 (12.1%) among the score 1+ cases. Five (9.4%) of the cases with polysomy were found to be amplified, and 48 (90.6%) were not., Conclusion: The results of the study show that a group of cases (3.98%) with a potential to benefit from anti-Her-2 therapy may be missed with the immunohistochemical method. This indicates the importance of quality assurance, especially in central laboratories with many breast cancer cases in daily practice.

Objective: To evaluate the association of insulin resistance (IR), viral load, and adipokine levels with liver histology in patients with chronic hepatitis C (CHC)., Patients and Methods: In this noninterventional, multicenter study carried out at 11 infectious diseases clinics in Turkey, 103 CHC patients [mean (SD) age: 50.2 (11.0) years, 60 (58.3%) women] planned to be treated by ribavirin and peginterferon-α2a were included. Data on hepatic fibrosis and steatosis, IR, viral load, and hepatitis C virus-RNA genotyping, adipokine, and cytokine levels were collected., Results: The mean (SD) Knodell score was 8.1 (3.6); grade I steatosis was evident in 46 (44.7%) patients and IR was identified in 56 (54.9%). There was a significant positive correlation of the homeostasis model assessment-IR index with Knodell fibrosis (r=0.235; P=0.027) and hepatic steatosis (r=0.435; P<0.001). There was a significant positive correlation of leptin levels with Knodell fibrosis (r=0.265; P=0.013) and hepatic activity index (r=0.218; P=0.041). Hepatic steatosis was correlated negatively with adiponectin (r=-0.320; P=0.001) and positively with leptin (r=-0.368; P<0.001) levels. Logistic regression analysis showed that increase in age [odds ratio (OR), 1.056; 95% confidence interval (CI), 1.005-1.110; P=0.030] was the only significant predictor of hepatic fibrosis (OR, 1.056; 95% CI, 1.005-1.110; P=0.030), whereas increase in age (OR, 1.066; 95% CI, 1.006-1.130; P=0.030), the presence of IR (OR, 5.621; 95% CI, 1.547-20.425; P=0.009), and decrease in adiponectin levels (OR, 0.808; 95% CI, 0.682-0.957; P=0.013) were the significant predictors of hepatic steatosis., Conclusion: Our findings indicate a significant relationship of hepatic fibrosis and hepatic steatosis with IR and leptin levels, but not with the viral load in Turkish patients with CHC.

Lilly is developing fasidotril, a diester prodrug of the active metabolite fasidotrilat, for the potential treatment of hypertension and congestive heart failure (CHF). Phase II trials to investigate the potential of fasidotril for the treatment of hypertension and CHF had commenced by the late 1990s, and were ongoing in July 2003 in the US and Europe.

Phospholipase C-gamma-2 (PLCgamma2) activation is a key signaling event for many cell functions. In order to delineate the pathways that lead to PLCgamma2 activation, we devised a quick method for obtaining sufficient PLCgamma2. We obtained the full-length cDNA for human PLCgamma2 and expressed it in E. coli using the expression vector pT5T. To enhance the protein expression, tandem AGG-AGG arginine codons at the amino acid positions 1204-1205 were replaced by CGG-CGG arginine codons. The protein expression was detected in a Western blot analysis by both anti-PLCgamma2 antibodies and the antibodies that are raised against the tripeptide epitope (Glu-Glu-Phe) tag that are genetically-engineered to its carboxyl terminal. Crude lysates that were prepared from bacteria that express PLCgamma2 were found to catalyze the hydrolysis of phosphatidylinositol 4,5 bisphosphate. Similar to previous reports on PLCgamma2 that is isolated from mammalian tissue, the recombinant enzyme was Ca2+ dependent with optimal activity at 1-10 microM Ca2+.

Phospholipase Cgamma2 (PLCgamma2) has been implicated in collagen-induced signal transduction in platelets and antigen-dependent signaling in B-lymphocytes. It has been suggested that tyrosine kinases activate PLCgamma2. We expressed the full-length cDNA for human PLCgamma2 in bacteria and purified the recombinant enzyme. The recombinant enzyme was Ca(2+)-dependent with optimal activity in the range of 1 to 10 microM Ca(2+). In vitro phosphorylation experiments with recombinant PLCgamma2 and recombinant Lck, Fyn, and Lyn tyrosine kinases showed that phosphorylation of PLCgamma2 led to activation of the recombinant enzyme. Using site-directed mutagenesis, we investigated the role of specific tyrosine residues in activation of PLCgamma2. A mutant form of PLCgamma2, in which all three tyrosines at positions 743, 753, and 759 in the SH2-SH3 linker region were replaced by phenylalanines, exhibited decreased Lck-induced phosphorylation and completely abolished the Lck-dependent activation of PLCgamma2. Individual mutations of these tyrosine residues demonstrated that tyrosines 753 and 759, but not 743, were responsible for Lck-induced activation of PLCgamma2. To confirm these results, we procured a phosphospecific antibody to a peptide containing phosphorylated tyrosines corresponding to residues 753 and 759. This antibody recognized phosphorylated wild-type PLCgamma2 on Western blots but did not interact with unphosphorylated PLCgamma2 or with PLCgamma2 containing mutated tyrosine residues at 753 and 759. Using this antibody, we showed in intact platelets that collagen, a PLCgamma2-dependent agonist, induces phosphorylation of PLCgamma2 at Y753 and Y759. These studies demonstrate the importance of these two tyrosine residues in regulating the activity of PLCgamma2.

Otsuka Pharmaceuticals in collaboration with Bristol-Myers Squibb is developing aripiprazole, a dual dopamine autoreceptor agonist and postsynaptic D2 receptor antagonist, for the potential treatment of psychoses including schizophrenia [281327], [340364]. A regulatory filing for schizophrenia in the US was submitted at the end of 2001 [340364]. The compound entered phase III trials in Japan in 1995 [192966]. Although presynaptic dopamine autoreceptor agonists may be efficacious in the treatment of schizophrenia, they may also potentially increase the risk for exacerbation of psychosis through stimulation of postsynaptic dopaminergic receptors [245791], [350478], [350479]. However, earlier neuropharmacology studies have shown that aripiprazole can act as a presynaptic D2 agonist while displaying an antagonistic effect at the postsynaptic D2 receptors [281327], [337126], [350479], [424587], [424588]. In animal models, aripiprazole inhibits the apomorphine-induced stereotypy, without causing catalepsy [281327], [337126]. Moreover, in contrast to classical antipsychotics that produce disabling movement disorders, aripiprazole does not cause an upregulation of D2 receptors or an increase in expression of the c-fos mRNA in the striatum, in agreement with the low risk for extrapyramidal side effects (EPS) during aripiprazole treatment [245781], [262096], [350481], [350483]. Collectively, aripiprazole is an important atypical antipsychotic candidate with a favorable safety profile. Moreover, the mechanism of action of aripiprazole differentiates it from both typical and atypical antipsychotics and hence, may provide important leads for pharmacotherapy of schizophrenia and other psychotic disorders. In January 2000, Lehman Brothers predicted peak sales of aripiprazole could reach US $500 million [357788]. In February 2001, Credit Suisse First Boston predicted sales of US $403 million in 2005 [399484].