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Rim Masmoudi,1 Faten Hadj Kacem,2 Maroua Bouattour,3 Fatma Guermazi,1 Rim Sellami,1 Ines Feki,1 Mouna Mnif,2 Jawaher Masmoudi,1 Imen Baati,1 Mohamed Abid2 1Psychiatry “A” Department, Hedi Chaker University Hospital, Sfax, Tunisia; 2Department of Endocrinology, Hedi Chaker University Hospital, Sfax, Tunisia; 3Department of Family Medicine, Faculty of Medicine of Sfax, University of Sfax, Sfax, TunisiaCorrespondence: Rim Masmoudi, Psychiatry “A” Department, Hedi Chaker University Hospital, Sfax, 3029, Tunisia, Tel +216 74 244 511, Email rim19masmoudi@gmail.comPurpose: Diabetes distress (DD) refers to the negative emotions and burden of living with diabetes. Illness perceptions are among the factors that can influence self-management and psychological distress in diabetics. This study aimed to determine the prevalence and the associated factors of DD in Tunisian patients with type 2 diabetes mellitus. We also studied the relationship between DD and illness perceptions in diabetics.Patients and Methods: This was a cross-sectional study conducted among individuals with type 2 diabetes, followed up at the outpatient endocrinology unit at the Hedi Chaker University Hospital, Tunisia. DD was assessed using the Diabetes Distress Scale (DDS-17). The Brief Illness Perception Questionnaire (Brief-IPQ) was used to assess diabetes illness perceptions. Multivariate logistic regression was used to determine independent factors associated with the presence of DD.Results: A total of 103 patients were recruited. The mean age was 59.31 (± 10.83) years; 54.4% were female. In total, 70.9% had DD. Using regression analysis, we demonstrated that the illness perceptions of personal control, HbA1C, absence of comorbidities, lower age at diabetes diagnosis, and socioeconomic status were significantly associated with DD.Conclusion: This study sheds light on the high prevalence of DD among patients with type 2 diabetes in Tunisia. Illness perception-focused psychological intervention would be efficacious in reducing diabetes distress in patients with type 2 diabetes mellitus.Keywords: diabetes mellitus, type 2, distress, illness perception, Tunisian patients

Romain Coriat,1 Sandrine J Faivre,2 Olivier Mir,3 Chantal Dreyer,2 Stanislas Ropert,3 Mohammed Bouattour,2 Robert Desjardins,4 François Goldwasser,3 Eric Raymond5 1Gastroenterology and Digestive Oncology Unit, Cochin Teaching Hospital, Université Paris Descartes Sorbonne Paris Cité, Paris, 2Department of Medical Oncology, Beaujon Teaching Hospital, Université Paris Diderot, Paris 7, Clichy, 3Department of Medical Oncology, Cochin Teaching Hospital, Université Paris Descartes Sorbonne Paris Cité, Paris, France; 4Drais Pharmaceuticals, Bridgewater, NJ, USA; 5Groupe Hospitalier Paris Saint-Joseph, Paris, France Background: DTS-108 is a hydrosoluble prodrug, where the SN-38 moiety is covalently linked to a 20-amino acid vector peptide by a specific esterase-sensitive cross-linker, releasing 7-ethyl-10-hydroxycampthotecin (SN-38) by esterase bond cleavage. Methods: The pharmacokinetics of DTS-108, adverse events graded according to NCI-CTCv3.1, dose-limiting toxicities at cycle 1, the maximum tolerated dose (MTD), and the recommended Phase II dose (RP2D) of intravenous DTS-108 (1–2 hours) every 2 weeks were evaluated in a first-in-human Phase I study in patients with advanced/metastatic carcinomas, according to an accelerated dose escalation design. SN-38 and SN-38 glucuronide (SN-38G) levels were evaluated with fluorescence high-performance liquid chromatography (HPLC) test, then liquid chromatography–tandem mass spectrometry (LC/MS/MS) methods. Results: Forty-two patients received DTS-108 across 14 dosing cohorts (range 3–416 mg/m2). At 416 mg/m2, three out of six patients had grade 4 neutropenia thereby defining the MTD and the RP2D at 313 mg/m2. Fluorescence HPLC was inaccurate to quantify DTS-108 and its metabolites (SN-38 and SN-38G). New processes and analytical LC/MS/MS methods for testing SN-38 were implemented. At a dose of 313 mg/m2, mean DTS-108, SN-38, and SN-38G area under the plasma concentration–time curve to infinity (coefficients of variation %) were 439,293 (24%), 1,992 (34%), and 4,538 (46%) h·ng/mL. Stable disease (according to Response Evaluation Criteria in Solid Tumors) was observed in nine patients. Conclusion: Assessing SN-38 concentration using fluorescence HPLC is questionable since this method failed to monitor dose escalation of DTS-108, a new topoisomerase I inhibitor, due to ex vivo degradation. LC/MS/MS methods were consistent in evaluating SN-38 exposures allowing drug monitoring. The maximum tolerated dose of DTS-108 was 416 mg/m2. The RP2D for intravenous DTS-108 was 313 mg/m2 every 2 weeks in patients with advanced/metastatic solid tumors. Keywords: Phase I, topoisomerase I inhibitor, irinotecan, fluorescence HPLC

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This paper presents a robust Fault Tolerant Tracking Control (FTTC) design for nonlinear uncertain systems described by Takagi Sugeno (T-S) fuzzy models with unmeasurable premise variables subject to sensor faults. A Proportional Integral Observer (PIO) is proposed to estimate the faulty states and the time-varying sensor faults. The FTTC is synthesized based on the estimation derived from the PIO with a guaranteed H∞ performance to minimize the effect of the external disturbance. The trajectory tracking performances and the stability of the closed loop system are analyzed based on the Lyapunov theory and the L2 optimization. The stability condition are formulated in terms of Linear Matrix Inequality (LMI). The proposed robust FTTC is illustrated using simulation results. [ABSTRACT FROM AUTHOR]

This paper proposes simultaneous estimation of states and sensor faults of Takagi-Sugeno (T-S) fuzzy models in the presence of bounded disturbances. The method uses the technique of singular systems by considering sensor faults as an auxiliary state variable. An H∞ fuzzy singular observer is proposed to simultaneously estimate system state and sensor faults. Then a controller based observer for active fault tolerant control (FTC) system is designed in terms of linear matrix inequality (LMI). Finally, a numerical example is given to demonstrate the effectiveness of the proposed method. [ABSTRACT FROM AUTHOR]

A total of 24 Murciano-Granadina dairy goats milked once daily throughout lactation were used to study the effects of including soybean oil (SBO) in the diet on lactational performance and milk fatty acid (FA) content, particularly conjugated linoleic acid (CLA) and trans-vaccenic acid (trans- 11 C 18:1, TVA). Three weeks after parturition, goats were allocated to 2 balanced groups according to lactation number, body weight, and daily milk yield, and were kept in separate pens. The experiment consisted of a 2-period (28 d each) crossover with 2 dietary treatments: control and SBO (6% as fed in the concentrate). Goats were fed dehydrated fescue (ad libitum), alfalfa pellets (0.5 kg/d), and concentrate (1 kg/d) to which the SBO was or was not added. Forage was fed in the pens, and concentrate was fed individually in 2 equal portions at milking (0900 h) and in the afternoon (1700 h). Final SBO content in the consumed SBO diet was 2.5% (dry matter basis). Diets were isonitrogenous (17.4% crude protein), but their total FA content varied from 2.2% (control) to 4.6% (SBO). There was no effect of SBO on dry matter intake, milk yield, energy-corrected milk, body weight, or body condition score. Compared with the control diet, feeding SBO increased milk fat content (4.57 vs. 5.24%) and yield as well as total solids content. Soybean oil had no effect on milk crude and true protein contents, but it reduced milk casein content (2.48 vs. 2.34%). Short- and medium-chain FA decreased by feeding SBO, whereas long-chain FA increased. Feeding preformed linoleic acid through SBO increased milk concentrations of linoleic, oleic, and stearic FA but reduced levels of linolenic and palmitic FA. As a consequence, feeding SBO decreased the saturated-to-unsaturated FA ratio and the atherogenicity index. Compared with the control treatment, milk contents of cis-9, trans-11 CLA (0.68 vs. 2.03%) and TVA (2.04 vs. 6.41%) in the SBO treatment increased by approximately 200%. In conclusion, feeding a moderate dose of SBO to dairy goats was a useful way to increase milk fat, CLA, and TVA contents in milk and to reduce the atherogenicity index without negative effects on intake, milk yield, and protein content. [ABSTRACT FROM AUTHOR]

A total of 24 Lacaune dairy ewes milked twice daily were used to study the effects of adding whole safflower seeds (WSF) to their concentrate, on dairy performances, milk, fatty acids (FA) profile and CLA. Ewes were allocated to two balanced groups according to number of lactation, BW and daily milk yield, and kept in two separate pens. TMR fed to ewes was a mixture of 55% forage (dehydrated fescue:alfalfa hay; 1:1), and 45% concentrate, to which the WSF was or not added. Dietary treatments were: C (control) and WSF (16.2% in the concentrate). Ether extract in the two experimental concentrates were similar (8.01%) due to the incorporation of calcium soaps of palm oil FA (6.25%) to the control concentrate. The experiment consisted of a two periods crossover design (20d each), during which the TMR was offered ad libitum in the pens (09:00 and 18:00). Addition of WSF decreased (P<0.05) DMI (2.42 vs. 2.34 kg/d), milk yield (1.58 vs. 1.48 L/d), ECM (1.47 vs. 1.34 L/d) and milk conversion rate (0.60 vs. 0.57 L/kg DM), but did not modify milk fat (6.7%), protein (5.3%), casein (4.19%) and TS (17.9%) contents. True protein content was increased (5.16 vs. 5.43%; P<0.0001) and fat (108 vs. 96g) and protein (83 vs. 73) yields were decreased (P<0.05) by WSF, mainly because of the milk yield depression. The WSF treatment increased (P<0.05) ewes BCS (3.11 vs. 3.24) but decreased (P<0.05) blood concentrations of cholesterol (96.2 vs. 84.5 mg/dL) and glucose (51.6 vs. 44.9 mg/dL). Safflower addition increased (P<0.0001) LCFA (35.2 vs. 45.4%) and MUFA (24.4 vs. 27.1%), and decreased MCFA (49.3 vs. 39.9%), but no changes were observed in SCFA (12.7%), PUFA (4.1%), n3 (0.86%) and n6 (3.25%). In contrast, the addition of WSF increased (P<0.01) the concentration of cis 9- trans 11 C18:2 (CLA, 0.62 vs. 0.93%), reduced (P<0.05) the saturated/unsaturated ratio (2.52 vs. 2.12) and the atherogenicity index (2.75 vs. 2.2), which is positive in terms of human health. [ABSTRACT FROM AUTHOR]

Transarterial chemoembolization (TACE) is a standard of care for embolization-eligible unresectable hepatocellular carcinoma (uHCC); however, most people with uHCC treated with TACE progress within one year. The primary endpoint of the Phase 3 EMERALD-1 study (NCT03778957) was positive, with a statistically significant improvement in progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1 with durvalumab (D) + bevacizumab (B) + TACE versus TACE (Table). In addition to RECIST v1.1, efficacy of the regimens was assessed using modified RECIST (mRECIST). The hypothesis was that PFS improvement with D + B + TACE versus TACE was consistent, as assessed per mRECIST and RECIST v1.1. Embolization-eligible participants (pts) were randomized 1:1:1 to receive D + B + TACE, D + TACE, or TACE (cTACE or DEB-TACE per investigator choice). Pts received D (1500 mg) or placebo for D (Q4W) plus TACE. After completion of last TACE, pts received D (1120 mg) plus placebo for B, D (1120 mg) plus B (15 mg/kg), or placebos for D and B (Q3W). PFS was assessed by BICR and the investigator per mRECIST as a secondary endpoint. PFS improved with D + B + TACE versus TACE as assessed by BICR and the investigator per mRECIST (Table). The estimation of effect was consistent with that of the primary endpoint, which showed a statistically significant improvement in PFS with D + B + TACE versus TACE, as assessed by BICR per RECIST v1.1 (p = 0.032, significance threshold 0.0435; Table). D + TACE versus TACE showed similar PFS results as assessed per mRECIST and RECIST v1.1 (Table). D + B + TACE is the first immune checkpoint inhibitor-based regimen in a global Phase 3 trial to show statistically significant improvement in PFS versus TACE in pts with embolization-eligible uHCC, as assessed by BICR per RECIST v1.1, with consistent PFS results, as assessed per mRECIST. These results further support the potential for D + B + TACE to set a new standard of care in uHCC. [ABSTRACT FROM AUTHOR]

This study was performed to investigate the effects of feeding whole linseed (WLS) or linseed oil (LSO) to dairy ewes on lactational performances, and milk fatty acids profile and CLA content. Thirty Lacaune dairy ewes were blocked in 3 pens of 10 animals, and used in a 3 × 3 Latin square (20 d periods). Ewes were fed a TMR with 55% forage (alfalfa and fescue dehydrated mixture, 1:1) and 45% concentrate. Treatments were: 1) C (control); 2) WLS (8.2% of TMR, DM basis); and, 3) LSO (2.7%). Diets were isonitrogenous (18.5% CP), and had the same level of fat (5.3% EE), being a 6.3% of calcium soap of palm oil included in the control concentrate. Feed intake (C: 2.65; WLS: 2.72; LSO: 2.7 kg DM/d) was increased (P<0.05) by WLS, but milk yield (1.9 L/d), ECM (1.6 L/d) and milk protein (5.23%) and casein (4.1%) contents were unaffected by treatments. In contrast, true protein content (5.2; 5.11; 4.97%) was reduced and milk fat (5.7; 5.85; 6.08%) content and yield (107; 107; 114 g/d) and total solids content (16.3; 16.6;16.9%) where increased (P<0.05) by LSO. Regarding blood metabolites, both linseed treatments increased (P<0.01) triglycerides concentration (12.7; 19.2; 17.6%) but did not affect glucose (53.6 mg/dL), cholesterol (100.6 mg/dL), NEFA (0.11 mmol/L), HDL (1.78 mmol/L) or LDL (0.67 mmol/L) concentrations. Both linseed treatments increased (P<0.01) SCFA and LCFA, but decreased (P<0.0001) MCFA. The cis 9- trans 11 C18:2 (CLA) was only improved by LSO (0.65; 0.6; 1.23%) and no changes were observed in C18:1 (23.4%) and MUFA (24.6%), while PUFA (4.03; 4.68; 4.54) were higher (P<0.05), and saturated FA (70.02; 67.6; 68.8%) and atherogenicity index (2.66; 2.31; 2.35%) lower (P<0.05) in linseed treatments than in control. In conclusion, LSO was more effective than WLS to increase CLA in milk, but both linseed treatments were useful to increase PUFA and reduce atherogenicity index of milk fat. [ABSTRACT FROM AUTHOR]