Mind-body and art therapies impact on emotional regulation in patients with chronic diseases: a pragmatic mixed-methods randomized controlled trial.

BACKGROUND: Effective emotional regulation is recognized as essential to a good mental health of people with chronic diseases, and Mind-body and Art Therapies (MBATs) could have a positive effect on emotional regulation skills in this population. Thus, we aimed to evaluate the effect of MBATs on emotional regulation as measured by the Difficulties in Emotion Regulation Scale (DERS) questionnaire. METHODS: A convergent mixed approach nested in a pragmatic superiority two arms parallel randomized controlled trial was conducted. French speaking adults with one or more chronic somatic illnesses and not suffering from a chronic psychiatric disorder unrelated to one of their chronic somatic illness were included. At inclusion, non-directive interviews were conducted, followed by an initial DERS assessment. The same combination of evaluation was implemented after 6 months of activity (T1). After inclusion, each participant was randomized within either the intervention group (G1) or the control group (G2) following a controlled wait-list design by use of a pregenerated randomization list. Staff and patient were blinded to this list until the initial evaluation was completed, after which the trial was conducted in an open-label fashion. Participants chose 2 mediations: one creativity-focused (art-therapy, writing workshop, theatre of life, vocal workshop) and one mind-body-focused (mindfulness meditation, Pilates, shiatsu, ayurvedic massages). G1 started their mediations immediately after inclusion, while G2 started 6 months later. Primary outcome was the change in means at 6 months in the overall DERS score compared between each group. Non-directive interviews were carried out at the inclusion and after 6 months of MBATs. A continuous inductive analysis was carried out on gathered material in G1 to explore the participants' experiences regarding their disease and their perceived changes associated to the intervention. RESULTS: A total of 150 patients was randomized (75 per groups) at the end of the study. At T1, 133 patients filled out the final questionnaire (67 in G1 vs 66 in G2) and 112 interviews were analysed (54 in G1 vs 58 in G2). All 150 patients were analysed (intention to treat) using a multiple imputation approach. The mean DERS score at T0 was equal to 82.8 ± 21.1 and 85.0 ± 20.2 in G1 and G2 respectively. On average, at T1, the score decreased in the G1 (Δ = -4.8, SD = 21.3) and in G2 (Δ = -0.11, SD = 17.8). The difference in decrease, however, was not statistically significant (p = 0.13). Qualitative analysis underlined some MBATs benefits on emotional regulation, especially on regulation strategies. No harms related to the intervention has been observed. CONCLUSIONS: This study only partially supports benefits on MBAT on emotional regulation skills enhancement in patients with chronic disease receiving MBATs, as measured by the DERS scale. TRIAL REGISTRATION: The protocol was registered on Clinical Trials (NCT02911207).

Towards resource-efficient management of asphalt waste in Lombardy region (Italy): Identification of effective strategies based on the LCA methodology.

This study presents a comparison of alternative strategies for managing asphalt waste currently implemented in Lombardy Region (Italy). The waste under study is the one arising from deconstruction and milling of old pavements not containing tar, and, hereafter, it is referred as reclaimed asphalt pavement (RAP). The life cycle assessment (LCA) methodology was applied to the regional system to evaluate its current performance, to identify critical aspects and to suggest actions for improving it. As first step, the amount of RAP generated and recycled within the region was computed by elaborating raw waste data annually collected by the regional agency for the environmental protection. Roughly 1 million tonne of RAP was managed in Lombardy in 2014; most of it was recovered/recycled and only 1% was directly landfilled. Data revealed that RAP was mainly recovered as unbound aggregate for road bases and sub-bases or fillings (52.5%) whereas RAP addition into new asphalt mixtures was less widespread (39.4%). In this case, RAP was mostly recycled in stationary hot mix asphalt (HMAs) and cold mix asphalt (CMAs) plants. Hence, the present LCA focused on these two types of techniques. Primary data on both processes were directly collected from some investigated facilities to set out the current scenario. Sensitivity analyses were then performed to find out the key parameters and their influence on the LCA outcome. Results indicate that recycling RAP in hot/cold mixes is significantly more beneficial than its recovery as unbound material. Moreover, hot recycling provides better environmental performance than cold processes performed at stationary plants, despite the lower RAP addition (20% in HMAs vs 80% in CMAs); this is mainly due to the use of stabilizing agents in the production of CMAs and to the lower field performance of CMAs compared to virgin HMAs. Based on these results, a best-case scenario has been developed to quantify the benefits arising from the suggested actions.

Propofol and survival: a meta-analysis of randomized clinical trials.

BACKGROUND: One of the most commonly used hypnotics is propofol. Several studies performed in cardiac surgery suggested an increased mortality in patients receiving a propofol-based total intravenous anaesthesia. Furthermore, the possibility of infections and the 'propofol syndrome' have suggested that propofol might be dangerous. Nonetheless, propofol is widely used in different settings because of its characteristics: fast induction, rapid elimination, short duration of action, smooth recovery from anaesthesia, few adverse effects, no teratogenic effects, characteristics that have undoubtedly contributed to its popularity. The effect of propofol on survival is unknown. We decided to carry out a meta-analysis of all randomized controlled studies ever performed on propofol vs. any comparator in any clinical setting. METHODS: Pertinent studies were independently searched in BioMedCentral, PubMed, Embase, Clinicaltrial.gov, and Cochrane Central Register of Clinical Trials by expert investigators. The following inclusion criteria were used: random allocation to treatment, comparison between propofol and any comparator in any clinical setting. RESULTS: One hundred thirty-three studies randomizing 14,516 patients were included. No differences in mortality between patients receiving propofol [349/6957 (5.0%)] vs. any comparator [340/7559 (4.5%)] were observed in the overall population [risk ratio = 1.05, 95% confidence interval (0.93 to 1.18), P = 0.5] and in several sub-analyses. CONCLUSION: Inspite of theoretical concerns, propofol has no detrimental effect on survival according to the largest meta-analysis of randomized trials ever performed on hypnotic drug.

Volatile compared with total intravenous anaesthesia in patients undergoing high-risk cardiac surgery: a randomized multicentre study.

BACKGROUND: The effect of anaesthesia on postoperative outcome is unclear. Cardioprotective properties of volatile anaesthetics have been demonstrated experimentally and in haemodynamically stable patients undergoing coronary artery bypass grafting. Their effects in patients undergoing high-risk cardiac surgery have not been reported. METHODS: We performed a multicentre, randomized, parallel group, controlled study among patients undergoing high-risk cardiac surgery (combined valvular and coronary surgery) in 2008-2011. One hundred subjects assigned to the treatment group received sevoflurane for anaesthesia maintenance, while 100 subjects assigned to the control group received propofol-based total i.v. anaesthesia. The primary outcome was a composite of death, prolonged intensive care unit (ICU) stay, or both. Thirty day and 1 yr follow-up, focused on mortality, was performed. RESULTS: All 200 subjects completed the follow-up and were included in efficacy analyses, conducted according to the intention-to-treat principle. Death, prolonged ICU stay, or both occurred in 36 out of 100 subjects (36%) in the propofol group and in 41 out of 100 subjects (41%) in the sevoflurane group; relative risk 1.14, 95% confidence interval 0.8-1.62; P=0.5. No difference was identified in postoperative cardiac troponin release [1.1 (0.7-2) compared with 1.2 (0.6-2.4) ng ml(-1), P=0.6], 1 yr all-cause mortality [11/100 (11%) compared with 11/100 (11%), P=0.9], re-hospitalizations [20/89 (22.5%) compared with 11/89 (12.4%), P=0.075], and adverse cardiac events [10/89 (11.2%) compared with 9/89 (10.1%), P=0.8]. CONCLUSIONS: There was no observed beneficial effect of sevoflurane on the composite endpoint of prolonged ICU stay, mortality, or both in patients undergoing high-risk cardiac surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: identifier NCT00821262. Eudra CT (2008-001752-43).

Intraoperative prophylactic and therapeutic non-invasive ventilation: a systematic review.

Non-invasive ventilation (NIV) has been used to prevent or to treat perioperative acute respiratory failure (ARF). Intraoperative prophylactic and therapeutic use of NIV could be of interest to patients with anticipated difficulty in postoperative weaning from mechanical ventilation or to patients refusing tracheal intubation. Intraoperative NIV might also be useful when deep sedation is required, as this can cause respiratory depression. PubMed, Embase, Google Scholar, and Cochrane Library were searched for pertinent studies. Inclusion criteria were NIV use during surgery and adult patients; the exclusion criteria were NIV application only in the preoperative or postoperative periods, paediatric patients, NIV applied as negative pressure ventilation. Thirty papers including 618 patients were included for final analysis. Intraoperative therapeutic NIV to treat ARF was reported for 92 patients and in all those cases, including six Caesarean sections, surgery was completed uneventfully. Intraoperative prophylactic NIV to avoid ARF was described in 24 patients with severe respiratory limitation and in 502 healthy patients during deep sedation. Three patients could not be successfully ventilated due to upper airway obstruction, but no further complication was reported. Intraoperative NIV appears feasible, safe, and potentially useful, particularly when tracheal intubation is best avoided. However, high-quality, randomized studies are required.

Single dilator vs. guide wire dilating forceps tracheostomy: a meta-analysis of randomised trials.

BACKGROUND: Single dilator technique (SDT) and guide wire dilating forceps (GWDF) are the two most commonly used techniques of percutaneous dilatational tracheostomy (PDT) in critically ill adult patients. We performed a meta-analysis of randomised, controlled trials comparing intraoperative, mid-term and late complications of these two techniques. METHODS: Pertinent studies were searched in BioMedCentral, PubMed, Embase and the Cochrane Central Register of clinical trials. We selected all randomised studies comparing SDT and GWDF techniques in adult critically ill patients published in a peer-reviewed journal. RESULTS: Among 1040 retrieved studies, five eligible studies randomising 363 patients (181 to GWDF, 182 to SDT) were identified. The incidence of the composite outcome difficult cannula insertion/difficult dilation or failure was higher with the GWDF technique (15.5% vs. 4.9 %, P = 0.02). Moreover, intraprocedural bleeding was more common in the GWDF group (19.3% vs. 7.6% in SDT group, P = 0.018). A trend towards an increased incidence of fracture of tracheal rings was noted in the SDT group (6.5% vs. 0.5% in the GWDF group, P = 0.13). No difference in mid-term or long-term complications was observed. CONCLUSION: GWDF technique is associated with a higher incidence of intraprocedural bleeding and of technical difficulties in completing the procedure (difficult cannula insertions/difficult dilations or failures) compared with the SDT technique. No differences were identified in mid-term and long-term complications. Further studies comparing SDT and GWDF in the general population and in subgroups of high-risk patients (like obese or hypoxaemic patients) are warranted.

Non-invasive ventilation during upper endoscopies in adult patients. A systematic review.

BACKGROUND: Upper endoscopies (UE) are widely performed. Non-invasive ventilation (NIV) during UE has been used to avoid respiratory complications, mainly in high-risk or sedated patients. We performed a systematic review on this topic. METHODS: BioMedCentral, PubMed, Embase and the Cochrane Central Register of Clinical Trials were searched (updated September 1, 2012). Further searches involved conference proceedings. RESULTS: We included in this systematic review 27 papers out of 405 publications retrieved. Ten studies reported the use without complications of NIV to assist fiberoptic bronchoscopy (FOB) and broncho-alveolar lavage (BAL). Ten studies described the use of NIV in fiberoptic-guided tracheal intubations. The authors reported no complications, even in hypoxemic patients and they observed only one failure (0.4%). Three studies evaluated the effectiveness of NIV during placement of percutaneous endoscopic gastrostomy in patients with neuromuscular diseases. In this group the failure rate was 4.4%. One study described the successful use of NIV in sedated patients undergoing gastroscopy. Three studies reported the successful application of NIV during trans-esophageal echocardiography. Overall, the procedure could not be performed due to inability of NIV to maintain safe intra-procedural ventilation in four out of total 515 cases of NIV-aided UE, suggesting a success rate higher than 99.2%. CONCLUSION: This is the first systematic review addressing the use of NIV during upper endoscopies. Its use seems feasible, and based on the limited data available NIV appears safe and likely effective. The patients who would benefit the most are: high-risk and patients undergoing sedation.

Occult HBV infection may represent a major risk factor of non-response to antiviral therapy of chronic hepatitis C.

Occult hepatitis B virus (HBV) infection is common in chronic hepatitis C patient. However, its significance and consequences are still unclear. The aim of this study was to evaluate the prevalence of occult HBV among HCV chronic carriers in France and to assess its impact on liver histology and response to antiviral therapy. To this end a cohort of 203 patients with chronic hepatitis C without hepatitis B surface antigen (HBsAg) has been examined. Serum HBV-DNA was detected using a highly sensitive PCR with primers located in the S and X genes. HBV viraemia levels were further determined by real-time PCR. Results showed that 47 of 203 (23%) patients had occult HBV infection with a low HBV load (10(2)-10(4) copies/ml) but significantly higher HCV-RNA titers (P < 0.05). No significant difference in age, gender, serum ALT level, HCV genotypes, and the presence of anti-HBc was observed between patients with or without HBV-DNA. When compared histologically, patients with occult HBV infection had higher activity (A2-A3 in 53% vs. 38%, P < 0.01) and more advanced fibrosis (60% vs. 33%, P < 0.001) than HBV-DNA negative cases. Sustained response to combination therapy against Chronic hepatitis C was achieved in 11 (28%) of 40 HBV-DNA positive cases, compared with 65 (45%) of the 144 HBV-DNA negative cases (P < 0.05). Among the 144 HBV-DNA negative HCV patients those with genotype 1 responded less frequently to therapy as compared to other genotypes infected patients (38% vs. 55%, P < 0.05). Surprisingly, when considering all patients studied, irrespective to the HBV-DNA status no significant difference was observed in response to combination therapy regarding HCV genotypes (39% vs. 44%, P > 0.05). In conclusion, HBV-DNA is found in 1/4 of French chronic hepatitis C patients regardless of the presence of anti-HBc. Such an occult HBV co-infection is associated with more severe liver disease, higher HCV viral load and decreased response to antiviral therapy irrespective of HCV genotypes.

Opioid-related side-effects after intrathecal morphine: a prospective, randomized, double-blind dose-response study.

BACKGROUND AND OBJECTIVE: The aim of this prospective, randomized, double-blind investigation was to assess the dose-effect characteristics of postoperative nausea and vomiting after intrathecal administration of small doses of morphine (from 0.015 to 0.25 mg) in opioid-naïve, non-surgical patients. METHODS: With Ethic Committee approval and written informed consent 144 opioid-naïve patients suffering from non-cancerous chronic back-pain, and receiving intrathecal morphine as diagnostic test for their chronic pain, were randomly allocated to receive intrathecal injection of 0.015 mg (Group I, n=25), 0.03 mg (Group II, n=30), 0.06 mg (Group III, n=31) or 0.25 mg (Group IV, n=33) morphine. The control group consisted in 25 further patients not included in the dose-effect study and receiving a placebo injection of normal saline in the interspinous ligament. A blinded observer recorded the occurrence of pruritus, nausea, vomiting, urinary retention and respiratory depression (respiratory rate<6 bpm) at 2, 4 and 24 h after injection. RESULTS: Clinically significant pain relief was observed in all patients receiving intrathecal morphine but only six patients (25%) of the control group (P=0.0005). The incidence of pruritus was lower in patients of Groups III (6%) and IV (3%) than in Groups I (12%) and II (20%) (P=0.002). The incidence of nausea and vomiting was higher at 2- and 4-h observation times, and decreased 24 h after intrathecal injection. Surprisingly, nausea was more frequent in Groups I (56%) and II (50%) than in Groups III (33%) and IV (24%) (P=0.0005). Vomiting was higher in patients receiving morphine than in control group, but without differences among the four doses. No urinary retention was observed in the control group, while 2 h after intrathecal injection urinary retention was observed in 20-40% of cases, and decreased to less than 10% 24 h after spinal injection without differences among the four doses. CONCLUSIONS: The onset and incidence of minor opioid-related side-effects after intrathecal morphine administration do not depend on its dose, occurring with even very small doses of morphine. Accordingly, they can be considered as a patient-dependent effect of the drug, suggesting the presence of a primary dose-independent excitatory component that might be related to the theory of the bimodal activation of opioid receptors. The very low incidence major respiratory depression prevents us from drawing any conclusion about the dose-effect relationship for this side-effect, and further properly powered studies should be advocated to evaluate major respiratory depression after spinal morphine.

Behavior analysis and training-a methodology for behavior engineering.

We propose Behavior Engineering as a new technological area whose aim is to provide methodologies and tools for developing autonomous robots. Building robots is a very complex engineering enterprise that requires the exact definition and scheduling of the activities which a designer, or a team of designers, should follow. Behavior Engineering is, within the autonomous robotics realm, the equivalent of more established disciplines like Software Engineering and Knowledge Engineering. In this article we first give a detailed presentation of a Behavior Engineering methodology, which we call Behavior Analysis and Training (BAT), where we stress the role of learning and training. Then we illustrate the application of the BAT methodology to three cases involving different robots: two mobile robots and a manipulator. Results show the feasibility of the proposed approach.

Analysis of genetic markers by random amplified polymorphic DNA polymerase chain reaction (RAPD-PCR).

RAPD-PCR is a new technique that, starting from genomic DNA allows, with the use of a single primer of "random" base composition to amplify a variable number of sequences that can give important informations if analyzed for linkage studies, gene mapping or phylogenetic purposes. In order to detect the possible application of this simple way of DNA-fingerprinting in individual identification and in cell lineages characterization we analyzed human and non-human Primates DNA. Six different single primers of variable length were used and resulted in individual or specific electrophoretic patterns. As already reported we found a better resolution using "short" primers. The individual electrophoretic patterns obtained by RAPD-PCR can be a simple and reliable approach to DNA analysis.

The influence of thyroid hormones on colony growth of peripheral CFU-GM from normal and leukemic subjects.

In order to clarify the alterations of granuloblastic cells in chronic and acute myeloid leukemia, the colony growth behavior of cultured CFU-GM from the peripheral blood of normal and leukemic subjects was examined in basal conditions and after adding to the medium T3 or T4 and/or thioproline and/or flurbiprofen. These drugs had in previous investigations proved their ability to modify cellular receptors and the uptake of thyroid hormones. The study was carried out in semisolid (double agar layer) and liquid medium, utilizing the techniques described previously. Both thyroid hormones enhanced the colony growth from normal peripheral blood CFU-GM and the response was more evident with T4 than T3. The effect on leukemic CFU-GM (from CML and AML) was less clear, probably due to the presence in leukemic cells of a defect of cellular uptake and to the utilization of T3 and T4. Indeed, on addition to the culture medium of thioproline, which modifies membrane permeability, and of fluorbiprofen, which inhibits PGE synthesis, the colony number and growth from leukemic CFU increased considerably in accordance with the results of our previous studies on these substances showing that they are able to modify cellular receptors for thyroid and several other hormones.

Dopaminergic treatment of acromegaly: different effects on hormone secretion and tumor size.

We studied the effects of long term treatment with bromocriptine (Br) or lisuride (L) on GH secretion and tumor size in 19 acromegalic patients with large pituitary adenomas. In 22 additional patients with smaller adenomas, only plasma GH levels were monitored during treatment. All patients underwent an acute test with 2.5 mg Br or 0.3 mg L and, on the basis of GH changes, were classified as responders, i.e. reduction in circulating GH concentrations by at least 50% below baseline, or as nonresponders. The chronic treatment was 5-20 mg/day Br in 26 patients or 0.3-2.0 mg/day L in 15 patients. Treatment was given for 4-26 months (mean +/- SE, 13.3 +/- 2.8 months). Plasma GH levels (baseline, 46.3 +/- 8.3 ng/ml) were significantly lower in the group as a whole (22.7 +/- 3.6 ng/ml; P less than 0.01) after the first month of treatment with dopamine agonist agents. GH levels decreased significantly in those acromegalic patients who responded to the acute test (P less than 0.001), but were unchanged in the nonresponders. In addition, there was a significant correlation between the maximal percent GH decrease in the acute test and the response during chronic treatment (r = 0.73; P less than 0.01). Computed tomography failed to show any tumor size changes in any of the GH nonresponders who had a macroadenoma . However, in two patients in the acute responder group with macroadenomas, chronic dopamine agonist therapy resulted in reduction of the extrasellar portion of the tumor (-30% and -40% of tumor area, respectively). These data show that although dopaminergic drugs lower GH levels and reverse signs and symptoms of active disease in those acromegalic patients who are responsive to an acute challenge, tumor size reduction occurred in a minority of such patients.

Size reduction of macroprolactinomas by bromocriptine or lisuride treatment.

We have administered to 29 patients with macroprolactinoma the dopamine agonists bromocriptine and lisuride for 1-50 months (mean +/- SE, 12.7 +/- 1.8) in order to assess the effects of these drugs on tumor size. Fourteen patients were treated with bromocriptine (dose range, 7.5-20 mg/day), 12 patients were treated with lisuride (0.6-2 mg/day), and 3 patients were given both drugs. Computed tomography performed before and during treatment showed the occurrence of tumor shrinkage in 18 patients (62%), but in no case was a complete disappearance of the tumor observed. In 5 of these patients, it was even possible to document tumor shrinkage within the first month of treatment with low doses of the dopamine agonists, whereas in other patients, tumors shrank only after prolonged treatment with higher doses. Visual field and acuity improved or normalized in 8 of the 13 patients with visual defects; in some cases, the improvement was reported as early as 2 days after the treatment was started. Plasma PRL levels fell in all patients who showed a reduction in tumor size; in 2 other patients, PRL levels were only poorly suppressed, and tumor size remained unchanged. In the remaining patients, PRL levels were lowered without convincing evidence of tumor shrinkage. In considering the high percentage of patients showing tumor shrinkage under medical treatment, we propose a course with dopamine agonists as the first step in the management of patients with macroprolactinomas regardless of the presence of visual impairments.

[Thyroiditic reactions during a course of thyroid cancer]. / Reazioni tiroiditiche in corso di carcinoma della tiroide

The clinical, immunological, and immunoistochemical features of 10 thyroid cancers associated with intra and extra tumoral thyroiditis are described. These cases have been obtained from a review of 806 thyroidectomies. A proper distinction of the described pathology from the immunological and histological point of view, is emphasized, especially if compared with the prognosis of other thyroid cancers.