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Abstract Background Cervical traumatic spinal cord injury is a devastating condition. Current management (bony decompression) may be inadequate as after acute severe TSCI, the swollen spinal cord may become compressed against the surrounding tough membrane, the dura. DISCUS will test the hypothesis that, after acute, severe traumatic cervical spinal cord injury, the addition of dural decompression to bony decompression improves muscle strength in the limbs at 6 months, compared with bony decompression alone. Methods This is a prospective, phase III, multicenter, randomized controlled superiority trial. We aim to recruit 222 adults with acute, severe, traumatic cervical spinal cord injury with an American Spinal Injury Association Impairment Scale grade A, B, or C who will be randomized 1:1 to undergo bony decompression alone or bony decompression with duroplasty. Patients and outcome assessors are blinded to study arm. The primary outcome is change in the motor score at 6 months vs. admission; secondary outcomes assess function (grasp, walking, urinary + anal sphincters), quality of life, complications, need for further surgery, and mortality, at 6 months and 12 months from randomization. A subgroup of at least 50 patients (25/arm) also has observational monitoring from the injury site using a pressure probe (intraspinal pressure, spinal cord perfusion pressure) and/or microdialysis catheter (cord metabolism: tissue glucose, lactate, pyruvate, lactate to pyruvate ratio, glutamate, glycerol; cord inflammation: tissue chemokines/cytokines). Patients are recruited from the UK and internationally, with UK recruitment supported by an integrated QuinteT recruitment intervention to optimize recruitment and informed consent processes. Estimated study duration is 72 months (6 months set-up, 48 months recruitment, 12 months to complete follow-up, 6 months data analysis and reporting results). Discussion We anticipate that the addition of duroplasty to standard of care will improve muscle strength; this has benefits for patients and carers, as well as substantial gains for health services and society including economic implications. If the addition of duroplasty to standard treatment is beneficial, it is anticipated that duroplasty will become standard of care. Trial registration IRAS: 292031 (England, Wales, Northern Ireland) - Registration date: 24 May 2021, 296518 (Scotland), ISRCTN: 25573423 (Registration date: 2 June 2021); ClinicalTrials.gov number : NCT04936620 (Registration date: 21 June 2021); NIHR CRN 48627 (Registration date: 24 May 2021).

BackgroundMicropore particle technology (MPPT) is a topical wound treatment. It is a passive immunotherapy, acting via the skin and wound microbiome without the use of antimicrobial action. In a general patient population, it removed wound infections 60% and initiated tissue regeneration 50% quicker than antibiotics and antiseptics. As MPPT supports the immune system, the aim was to confirm that MPPT is also effective in immunocompromised individuals. People with spinal cord injury (SCI) are immunodeficient due to their injury and not an underlying disease and recruit 50% fewer immune cells to an injury. The study, therefore, determined the efficacy, safety, health economics, and sustainability of MPPT in acute and chronic wounds and pressure ulcers in this patient population.MethodsPressure ulcers in SCI persons are an orphan indication, patient variability is high, and ICH E10 excludes comparators due to ethical concerns. The study design was, therefore, a single-arm, non-interventional, observational, post-market surveillance study of MPPT for treating wounds and pressure ulcers and removing soft tissue infection in connection with draining fistulas in SCI persons. The study was based on telemedicine in community care.ResultsThe study included 44 wounds. All acute and chronic grade 1–4 wounds and pressure ulcers reached stable closure. In wounds acting as fistulas draining from an underlying, primary focus of infection, e.g., osteomyelitis, MPPT removed the soft tissue infection in approx. 2.5 months and supported regeneration, considerably reducing fistula sizes. Compared to standard care, per-wound cost savings were 51 to 94% depending on wound grade and age, and substantial nursing resources were freed up. The telemedicine approach was well received by participants and supported independence and self-care. The use of antimicrobials, plastics, and synthetic polymers was essentially eliminated. MPPT did not require bed rest.ConclusionThe study confirmed that MPPT is safe and effective in treating acute and chronic wounds in immunocompetent and immunocompromised individuals, including wounds with antimicrobial-resistant infections. MPPT also removes soft tissue infections caused by an underlying primary focus of infection, such as osteomyelitis. Non-healing wounds currently represent an unmet clinical need. The findings suggest that a therapy acting via the microbiome without antimicrobial actions is effective.

Background: The various techniques for performing a Cesarean Section (CS) have a long history. There are numerous surgical variations based on personal or local tradition, but these are not based on evidence and often have different outcomes on maternal and newborn health. Many modifications of the CS technique have been utilized in order to improve outcome with variable results both positive and negative. Several CS laparotomic methods have been developed but no consensus has been reached on the most optimal approach as related to safety and morbidity. Methods: The minimalistic approach of the Stark Cesarean Section (SCS) is compared to other methods thorugh an evaluation of the studies published in the last 20 years comparing this technique with others, the systematic reviews and the personal experience of the authors. Results and discussion: The abdominal incision done at the Stark Cesarean Section differs from the Pfannenstiel incision by its location being above the arcuate line eliminating the need to separate the fascia from the recti muscles. The muscle separations being away from the pubic bone and the iliohypogastric and ilioinguinal nerves eliminates the risk of damage. This unique surgical approach is a logical, fast and simple one that eliminates unnecessary operative steps saving time and reducing complications. After fifteen years of experience and thousands of SCS performed at our departments, we may conclude that this method has several advantages over other surgical methods as related to short and long-term outcomes, including chronic/neuropathic pain and quality of life.

Long-term enteral nutrition (LTEN) can induce gut microbiota (GM) dysbiosis and gastrointestinal related symptoms, such as constipation or diarrhoea. To date, the treatment of constipation is based on the use of laxatives and prebiotics. Only recently have probiotics and synbiotics been considered, the latter modulating the GM and regulating intestinal functions. This randomized open-label intervention study evaluated the effects of synbiotic treatment on the GM profile, its functional activity and on intestinal functions in long-term home EN (LTHEN) patients. Twenty LTHEN patients were recruited to take enteral formula plus one sachet/day of synbiotic (intervention group, IG) or enteral formula (control group, CG) for four months and evaluated for constipation, stool consistency, and GM and metabolite profiles. In IG patients, statistically significant reduction of constipation and increase of stool consistency were observed after four months (T1), compared to CG subjects. GM ecology analyses revealed a decrease in the microbial diversity of both IC and CG groups. Biodiversity increased at T1 for 5/11 IG patients and Methanobrevibacter was identified as the biomarker correlated to the richness increase. Moreover, the increase of short chain fatty acids and the reduction of harmful molecules have been correlated to synbiotic administration. Synbiotics improve constipation symptoms and influences Methanobrevibacter growth in LTHEN patients.

To review the evidence of thromboembolism incidence and prophylaxis in the sub-acute phase of spinal cord injury (SCI) 3–6 months post injury. All observational and experimental studies with any length of follow-up and no limitations on language or publication status published up to March 2015 were included. Two review authors independently selected trials for inclusion and extracted data. Outcomes studied were incidence of pulmonary embolism (PE) and deep vein thrombosis (DVT) in the sub-acute phase of SCI. The secondary outcome was type of thromboprophylaxis. Our search identified 4305 references and seven articles that met the inclusion criteria. Five papers reported PE events and three papers reported DVT events in the sub-acute phase of SCI. Studies were heterogeneous in populations, design and outcome reporting, therefore a meta-analysis was not performed. The included studies report a PE incidence of 0.5%–6.0% and DVT incidence of 2.0%–8.0% in the sub-acute phase of SCI. Thromboprophylaxis was poorly reported. Spinal patients continue to have a significant risk of PE and DVT after the acute period of their injury. Clinicians are advised to have a low threshold for suspecting venous thromboembolism in the sub-acute phase of SCI and to continue prophylactic anticoagulation therapy for a longer period of time.

The main etiological factor of precancerous lesion and invasive cervical cancer are oncogenic human papillomaviruses types (HPVs). The objective of this study was to establish the distribution of the most common HPVs in different cervical lesions and cancer prior to the implementation of organized population-based cervical screening and HPV vaccination in Croatia. In this study, 4,432 cervical specimens, collected through a 16-year period, were tested for the presence of HPV-DNA by polymerase chain reaction (PCR) with three sets of broad-spectrum primers and type-specific primers for most common low-risk (LR) types (HPV-6, 11) and the most common high-risk (HR) types (HPV-16, 18, 31, 33, 45, 52, 58). Additional 35 archival formalin-fixed, paraffin embedded tissue of cervical cancer specimens were analyzed using LiPA25 assay. The highest age-specific HPV-prevalence was in the group 18-24 years, which decreased continuously with age (P

Obstructive sleep apnoea syndrome (OSAS) is a common sleep disorder, affecting over 4% of the general population, and is associated with metabolic syndrome and cardiovascular disease, independent of obesity and traditional risk factors. OSAS has been recently connected to nonalcoholic fatty liver disease (NAFLD), the most common chronic liver disease in the world, which can be found in 30% of the general adult population. Several studies suggest that the chronic intermittent hypoxia (CIH) of OSAS patients may per se trigger liver injury, inflammation, and fibrogenesis, promoting NAFLD development and the progression from steatosis to steatohepatitis, cirrhosis, and hepatocellular carcinoma. In NAFLD patients, liver disease may be caused by hypoxia both indirectly by promoting inflammation and insulin resistance and directly by enhancing proinflammatory cytokine production and metabolic dysregulation in liver cells. In this review, we focus on molecular mechanisms linking OSAS to NAFLD, including hypoxia inducible factor (HIF), nuclear factor kappa B (NF-κB), YKL-40, unfolded protein response, and hypoxic adipose tissue inflammation, which all could provide novel potential therapeutic approaches for the management of NAFLD patients with OSAS.

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in the Western world (it affects 30% of the general adult population). The NAFLD encompasses a histological spectrum ranging from simple steatosis to nonalcoholic steatohepatitis (NASH), defined by steatosis, hepatocellular damage, and lobular inflammation in individuals without significant alcohol consumption and negative viral, congenital, and autoimmune liver disease markers. Currently, NAFLD is considered an emerging epidemic in light of the dramatic increase in obesity rates. With the progressive nature of NASH and its rising prevalence there is a significant need for a specific and targeted treatments since to date there has not been any validated therapies for NAFLD other than weight loss, which is well known to have a poor long-term success rate. In recent years, visceral adipose tissue has taken an important role in NAFLD pathogenesis, and current therapeutic approaches aim at reducing visceral obesity and free fatty acid overflow to the liver. This paper is focused on the treatments used for NAFLD and the potential new therapy.

Objectives To describe and compare epidemiologic characteristics and clinical outcomes of patients with nontraumatic spinal cord dysfunction according to etiology. Design Retrospective, multicenter open-cohort case series. Setting Spinal rehabilitation units (SRUs) in 9 countries. Participants Patients (N=956; men, 60.8%; median age, 59.0y [interquartile range, 46–70.0y]; paraplegia, n=691 [72.3%]) with initial onset of spinal cord dysfunction consecutively admitted between January 1, 2008, and December 31, 2010. Interventions Not applicable. Main Outcome Measures Etiology of spinal cord dysfunction, demographic characteristics, length of stay (LOS) in rehabilitation, pattern of spinal cord dysfunction onset, discharge destination, level of spinal cord damage, and the American Spinal Injury Association Impairment Scale (AIS) grade on admission and discharge. Results The most common etiologies were degenerative (30.8%), malignant tumors (16.2%), infections (12.8%), ischemia (10.9%), benign tumors (8.7%), other vascular (8.5%), and other conditions (12.1%). There were major differences in epidemiologic characteristics and clinical outcomes of patients with different etiologies of spinal cord dysfunction. Paraplegia was more common in patients with a malignant tumor and vascular etiologies, while tetraplegia was more common in those with a degenerative etiology, a benign tumor, and infections. Patients with a malignant tumor tended to have the shortest LOS in the SRU, while those with a vascular etiology tended to have the longest. Except for patients with a malignant tumor, all patient groups had a significant change in their AIS grade between admission and discharge. Conclusions This international study of spinal cord dysfunction showed substantial variation between the different etiologies regarding demographic and clinical characteristics, including changes in AIS between admission and discharge. [ABSTRACT FROM AUTHOR]

Objective To describe and compare epidemiologic characteristics of patients with spinal cord dysfunction admitted to spinal rehabilitation units (SRUs) in 9 countries (Australia, Canada, Italy, India, Ireland, The Netherlands, Switzerland, United Kingdom, and United States). Design Retrospective multicenter open-cohort case series. Setting SRUs. Participants Patients (N=956) with initial onset of spinal cord dysfunction consecutively admitted between January 1, 2008, and December 31, 2010. Median age on admission was 59 years (interquartile range [IQR], 46–70), and 60.8% of patients were men. Interventions Not applicable. Main Outcome Measures Demographic characteristics (eg, age, sex), time frame over which clinical symptoms of spinal cord dysfunction developed, etiology, length of stay in hospital, level of lesion and American Spinal Injury Association Impairment Scale (AIS) grade, discharge destination, and inpatient mortality. Results The time frame of onset of spinal cord dysfunction symptoms was as follows: ≤1 day (28.5%); ≤1 week (13.8%); >1 week but ≤1 month (10.5%), and >1 month (47.2%). Most common etiologies were degenerative conditions (30.8%), malignant tumors (16.2%), ischemia (10.9%), benign tumors (8.7%), and bacterial infections (7.1%). Most patients (72.3%) had paraplegia. The AIS grade on SRU admission was grade A in 14%, grade B in 6.5%, grade C in 24%, grade D in 52.4%, grade E in 0.2%, and missing in 2.9%. AIS grade significantly improved by discharge ( z =−10.1, P <.0001). Median length of stay in the SRU was 46.5 days (IQR, 17–89.5). Most (80.5%) patients were discharged home. Differences between countries were found for most variables. Conclusions This international study of spinal cord dysfunction showed substantial variation of etiology, demographic, and clinical characteristics across countries. Further research, including multiple centers per country, are needed to separate country effects from center effects. [ABSTRACT FROM AUTHOR]

Urban sprawl has been plaguing Western European and American cities for the last 70 years. One has fought against this phenomenon all over the world with a combination of strategic planning and urban regulations, focusing on growth management, sustainable development and preservation of farmland. East European cities, Romanian cities included, have been rapaciously consuming the free natural and agricultural land around them, without long-term development policies. The aim of this paper is analyzing urban sprawl around Timişoara and finding efficient ways of economizing urban and rural land. The article is based on several urban studies, statistical and traffic data showing the magnitude of the phenomenon and its dramatic effects on the environment. The European Union required to recent members to follow the path set by the developed countries, even if their economies have a system more or less centralized inherited from communism. It is still unclear who should be responsible for urban planning; the rules and regulations are made along the way, while the investors' pressure is huge. Meanwhile extended rural and agricultural land might be destroyed. Most politicians do not acknowledge this problem as they approve further expansion into farmland without any previous planning. This paper might be just tackling this subject, but its target should be making urban sprawl more visible, understanding its dimension and dramatic effects around Romanian cities. [ABSTRACT FROM AUTHOR]

Objectives: To outline a range of minimally invasive image-guided procedures that benefit spinal cord-injured patients and may expedite clinical care. Study design: Pictorial review. Results/Conclusions: Image-guided procedures have made a significant impact in medical management in many specialties. These techniques continue to evolve rapidly and afford opportunities to reduce patient morbidity and in-patient length of stay. [ABSTRACT FROM AUTHOR]

Long-term enteral nutrition (LTEN) can induce gut microbiota (GM) dysbiosis and gastrointestinal related symptoms, such as constipation or diarrhoea. To date, the treatment of constipation is based on the use of laxatives and prebiotics. Only recently have probiotics and synbiotics been considered, the latter modulating the GM and regulating intestinal functions. This randomized open-label intervention study evaluated the effects of synbiotic treatment on the GM profile, its functional activity and on intestinal functions in long-term home EN (LTHEN) patients. Twenty LTHEN patients were recruited to take enteral formula plus one sachet/day of synbiotic (intervention group, IG) or enteral formula (control group, CG) for four months and evaluated for constipation, stool consistency, and GM and metabolite profiles. In IG patients, statistically significant reduction of constipation and increase of stool consistency were observed after four months (T 1 ), compared to CG subjects. GM ecology analyses revealed a decrease in the microbial diversity of both IC and CG groups. Biodiversity increased at T 1 for 5/11 IG patients and Methanobrevibacter was identified as the biomarker correlated to the richness increase. Moreover, the increase of short chain fatty acids and the reduction of harmful molecules have been correlated to synbiotic administration. Synbiotics improve constipation symptoms and influences Methanobrevibacter growth in LTHEN patients.

Background: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of pathologies characterized by liver damage without history of excessive alcohol intake. Advanced fibrosis, generally detected by transient elastography (TE), is the most significant predictor of poor prognosis and mortality among these patients. This study aimed at assessing the accuracy of five noninvasive methods, compared to TE, for the evaluation of severity of liver fibrosis in patients with NAFLD., Methods: The cohort included 41 patients, in whom the result of TE was compared to AST/ALT ratio, BARD Score (Body Mass Index, AST/ALT ratio, diabetes), AST To Platelet Ratio Index (APRI), Fibrosis-4 Index (FIB-4 Index) and NAFLD Fibrosis Score (NFS)., Results: The severity of fibrosis, assessed by TE, was the following: F0 (absence of fibrosis): 17%, F1 (mild): 39%, F2 (moderate): 17%, F3 (advanced): 10%, F4 (cirrhosis): 17%. Performances of the diagnostic scores were: 49% for AST/ALT ratio, 68% for BARD Score, 73% for APRI, 59% and 71% for the lower and upper cut-off of FIB-4 Index, 61% and 76% for the lower and upper cut-off of NFS., Conclusions: Considering the scores compared to TE, AST/ALT ratio was not enough sensitive, while BARD Score had better diagnostic performance and APRI had a superior accuracy than the formers. However, FIB-4 and NFS were the most useful tests and their performance could be improved through the use of a single cut-off. These findings demonstrated that the most accurate scores, compared to TE, were NFS and FIB-4.

Background: There are 1.2 million of immigrant children living in Italy. However, data on their nutritional habits are limited. The aim of this study was to assess the nutritional profile in a cohort of both Italian and immigrant children., Methods: The study included 86 children aged 5-15 consecutively enrolled from January 2016 to May 2017 within a larger epidemiological study on determinants of diabetes. Immigrant state was defined on the basis of the parent origin. Data on nutritional profile, frequency of food group consumption, and eating habits were collected using the 24-hour dietary recall method and a questionnaire. Anthropometric parameters were measured., Results: In the cohort of immigrant children there was a higher prevalence of both overweight (27.3 vs. 14.1%) and obesity (18.2 vs. 3.1%) subjects and a greater total calorie intake compared to Italian children, mainly due to excess simple carbohydrate intake. Immigrant children had a higher consumption of sweets, snacks, and drinks with added sugar. Moreover, unhealthy habits, such as eating alone and eating while watching TV, were more frequent among immigrant children., Conclusions: In this cohort, immigrant children had a higher prevalence of overweight/obesity possibly due to less healthy nutritional habits. Culturally-tailored nutritional interventions may help preventing the development of obesity-related diseases in this population.

Background: Therapy in chronic hepatitis B (chronic hepatitis B) patients aims at improving their survival by preventing disease progression to cirrhosis and its complications. Entecavir (ETV) is currently a first line therapeutic agent recommended for the treatment of CHB. Our aim was to evaluate the long term outcome of a cohort of CHB patients treated with ETV., Methods: Thirty-four patients treated with ETV for at least 6 months were included in this study. The virologic response was determined by the dosage of serum HBV-DNA, HBsAg, HBeAg, anti-HBs and anti-HBe antibodies. Death, acute pancreatitis, lactic acidosis and kidney function impairment were considered as major adverse events., Results: The median period of treatment was 55 months (range 15-81). Thirty-three (97%) patients responded to the therapy after a mean time of 14.7 weeks (4-60); of these, 29 (85.3%) maintained the HBV-DNA negativity in serum, while 4 patients (11.8%) had a breakthrough. The remaining patient did not respond. Seroconversion to anti-HBs and anti-HBe was not observed, although 2 patients lost the e and the s antigen, respectively. Baseline alanine aminostransferase (ALT) levels in serum were altered in 18 patients (52.9%), and returned to normal levels during the follow-up, with a reduction of 87.7 IU/L (P<0.0001). A case (3.4%) of hepatocellular carcinoma was observed after 24 months. No major adverse events were recorded., Conclusions: ETV is effective in suppressing viral replication as well as in normalizing serum ALT levels, without anti-HBs seroconversion. Finally, ETV is a safe drug, substantially free of major side effects.

Obstructive sleep apnoea syndrome (OSAS) is a common sleep disorder, affecting over 4% of the general population, and is associated with metabolic syndrome and cardiovascular disease, independent of obesity and traditional risk factors. OSAS has been recently connected to nonalcoholic fatty liver disease (NAFLD), the most common chronic liver disease in the world, which can be found in 30% of the general adult population. Several studies suggest that the chronic intermittent hypoxia (CIH) of OSAS patients may per se trigger liver injury, inflammation, and fibrogenesis, promoting NAFLD development and the progression from steatosis to steatohepatitis, cirrhosis, and hepatocellular carcinoma. In NAFLD patients, liver disease may be caused by hypoxia both indirectly by promoting inflammation and insulin resistance and directly by enhancing proinflammatory cytokine production and metabolic dysregulation in liver cells. In this review, we focus on molecular mechanisms linking OSAS to NAFLD, including hypoxia inducible factor (HIF), nuclear factor kappa B (NF-κB), YKL-40, unfolded protein response, and hypoxic adipose tissue inflammation, which all could provide novel potential therapeutic approaches for the management of NAFLD patients with OSAS.

Gender medicine focuses on the patho-physiological, clinical, prevention and treatment differences in diseases that are equally represented in men and women. The purpose of gender medicine is to ensure that each individual man and woman receives the best treatment possible based on scientific evidence. The concept of "gender" includes not only the sexual characteristics of individuals but also physiological and psychological attributes of men and women, including risk factors, protective/aggravating effects of sexual hormones and variances linked to genetics and corporal structures that explain biological and physiological differences between men and women. It is very important to consider all the biological, physiological, functional, psychological, social and cultural characteristics to provide patients with individualized disease management. Herein, we critically analyze the literature regarding gender differences for diseases and acquired conditions of the most representative hepatic pathologies: primary biliary cirrhosis, autoimmune hepatitis, primary sclerosing cholangitis, non alcoholic fatty liver disease and alcoholic liver disease, and viral chronic hepatitis B and C. The last section addresses hemochromatosis, which is a prevalent iron overload disorder in the Caucasian population. This review aims to describe data from the literature concerning viral chronic hepatitis during pregnancy, management during pregnancy and delivery, and new effective drugs for the prevention of maternal infection transmission without significant adverse effects or complications.

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in the Western world (it affects 30% of the general adult population). The NAFLD encompasses a histological spectrum ranging from simple steatosis to nonalcoholic steatohepatitis (NASH), defined by steatosis, hepatocellular damage, and lobular inflammation in individuals without significant alcohol consumption and negative viral, congenital, and autoimmune liver disease markers. Currently, NAFLD is considered an emerging epidemic in light of the dramatic increase in obesity rates. With the progressive nature of NASH and its rising prevalence there is a significant need for a specific and targeted treatments since to date there has not been any validated therapies for NAFLD other than weight loss, which is well known to have a poor long-term success rate. In recent years, visceral adipose tissue has taken an important role in NAFLD pathogenesis, and current therapeutic approaches aim at reducing visceral obesity and free fatty acid overflow to the liver. This paper is focused on the treatments used for NAFLD and the potential new therapy.

In opposition to opinions of a sectorialization of psychiatric illness, phenomena of comorbidity due to susceptibility of psychiatric patients to contract other diseases--whose co-presence is difficult to translate and treat--are more and more evident. In this review we have marked main issues of internal medicine in psychiatric patients. This review will discuss particularly main cardiovascular diseases (CAD, VTE), lung diseases (COPD,asthma, restrictive lung disease) gastroenterologic disease (IBS, coeliac disease, ulcerous rectocolitis), diabetes and metabolic syndrome, more likely infections verified in these patients (HIV, viral hepatitis), cancers considerably underlined (breast cancer, colon-rectal cancer and lung cancer), internistic issues in alcohol abuse which is a frequent state in these subjects. A special chapter is dedicated to antipsychotics. These drugs are characterized by a complex action modality and by frequent interactions with a large number of other drugs.