Research, Development and Education Priorities for the Aquaculture Sector in Maine

The research priorities survey has been an ongoing initiative coordinated by the Maine Aquaculture Innovation Center in collaboration with Maine Aquaculture Association, Maine Sea Grant, and the University of Maine’s Aquaculture Research Institute since 2012. This report is based on the research priorities survey conducted in June 2019 of Maine’s aquaculture community, and is compared with surveys from 2012 and 2016 to look at trends. There have been some changes in the prioritization of needs since 2016, but many of the same research, development, and education (R&D&E) needs persist and remain unaddressed. As expected, there are different R&D&E priorities for different aquaculture sectors

A multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/− nab-paclitaxel in elderly pancreatic cancer patients (GrantPax)

Background: In the group of elderly patients (≥70 years) with metastatic pancreatic ductal adenocarcinoma (mPDAC), it is not known who benefits from intensive 1st line nab-paclitaxel/gemcitabine (nab-p/gem) combination chemotherapy or who would rather suffer from increased toxicity. We aim to determine whether treatment individualization by comprehensive geriatric assessments (CGAs) improves functional outcome of the patients. Methods/Design: GrantPax is a multicenter, open label phase 4 interventional trial. We use a CGA to stratify elderly patients into three parallel treatment groups (n = 45 per arm): 1) GOGO (nab-p/gem), 2) SLOWGO (gem mono) or 3) FRAIL (best supportive care). After the 1st cycle of chemotherapy (or 4 weeks in FRAIL group) another CGA and safety assessment is performed. CGA-stratified patients may not decline in their CGA performance in response to the first cycle of chemotherapy (primary objective), measured as a loss of 5 points or less in Barthels activities of daily living. Based on the second CGA, patients are re-assigned to their definite treatment arm and undergo further CGAs to monitor the course of treatment. Secondary endpoints include CGA scores during the course of therapy (CGA1–4), response rates, safety and survival rates. Discussion: GrantPax is the first trial implementing a CGA-driven treatment to personalize therapy for elderly patients with pancreatic cancer. This may lead to standardization of therapy decisions for elderly patients and may optimize standard of care for this increasing group of patients. Trial registration: NCT02812992 , registered 24.06.2016

Cohort profile: the Swiss Cerebral Palsy Registry (Swiss-CP-Reg) cohort study.

BACKGROUND Cerebral Palsy (CP) is a group of permanent disorders of movement and posture that follow injuries to the developing brain. It results in motor dysfunction and a wide variety of comorbidities like epilepsy; pain; speech, hearing and vision disorders; cognitive dysfunction; and eating and digestive difficulties. Central data collection is essential to the study of the epidemiology, clinical presentations, care, and quality of life of patients affected by CP. CP specialists founded the Swiss Cerebral Palsy Registry (Swiss-CP-Reg) in 2017. This paper describes the design, structure, aims and achievements of Swiss-CP-Reg and presents its first results. METHODS Swiss-CP-Reg records patients of any age diagnosed with CP who are born, are treated, or live in Switzerland. It collects data from medical records and reports, from questionnaires answered by patients and their families, and from data linkage with routine statistics and other registries. The registry contains information on diagnosis, clinical presentation, comorbidities, therapies, personal information, family history, and quality of life. RESULTS From August 2017 to August 2021, 546 participants (55% male, mean age at registration 8 years [interquartile range IQR: 5-12]), were enrolled in Swiss-CP-Reg. Most had been born at term (56%), were less than two years old at diagnosis (73%, median 18 months, IQR: 9-25), and were diagnosed with spastic CP (76%). Most (59%) live with a mild motor impairment (Gross Motor Function Classification System [GMFCS] level I or II), 12% with a moderate motor impairment (GMFCS level III), and 29% with a severe motor impairment (GMFCS level IV or V). In a subset of 170 participants, we measured intelligence quotient (IQ) and saw lower IQs with increasing GMFCS level. Swiss-CP-Reg has a strong interest in research, with four nested projects running currently, and many more planned. CONCLUSIONS Swiss-CP-Reg collects and exchanges national data on people living with CP to answer clinically relevant questions. Its structure enables retrospective and prospective data collection and knowledge exchange between experts to optimise and standardise treatment and to improve the health and quality of life of those diagnosed with CP in Switzerland

Does Physical Activity Improve Quality of Life in Cancer Patients Undergoing Chemotherapy?

Background: Improved cancer treatments have resulted in prolonged survival. Nevertheless, tumor symptoms and side effects still compromise physical activity and quality of life (QoL). Patients and Methods: We conducted an anonymous survey among cancer patients undergoing chemotherapy using standardized questionnaires: the ‘Freiburger Fragebogen zur körperlichen Aktivität’ (Freiburg Questionnaire on Physical Activity) and European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. Two main questions were addressed: were there differences (1) in physical activity and QoL between patients who do not believe that sport could improve their QoL and those who believe it could (group A vs. B); and (2) in QoL between patients with a total activity (TA) < 18 metabolic equivalent of task (MET) h/week and those with a TA of ˰ 18 MET h/week (group C vs. D)? Results: 276 of 400 questionnaires were completed. Groups A and B were balanced in terms of baseline characteristics. Group A suffered significantly more from fatigue and pain; group B reported higher levels of global health status (GHS) and TA. Groups C and D differed in gender distribution, age, and educational background. Group D had significantly higher levels of GHS, group C suffered more from fatigue, pain, and appetite loss. Conclusion: Physical activity correlates with a better QoL of cancer patients undergoing chemotherapy

A multicenter open-label phase II trial to evaluate nivolumab and ipilimumab for 2nd line therapy in elderly patients with advanced esophageal squamous cell cancer (RAMONA)

Background: Advanced esophageal squamous cell cancer (ESCC) is frequently diagnosed in elderly patients. The impact of 2nd line chemotherapy is poorly defined. Recent data demonstrated effectiveness of checkpoint inhibitors in different squamous cell carcinomas. Therefore, we assess combined nivolumab/ipilimumab as 2nd line therapy in elderly ESCC patients. Methods: RAMONA is a multicenter open-label phase II trial. The primary objective is to demonstrate a significant survival benefit of nivolumab/ipilimumab in advanced ESCC compared to historical data of standard chemotherapy. Primary endpoint is therefore overall survival (OS). Major secondary objective is the evaluation of tolerability. Time to QoL deterioration will thus be determined as key secondary endpoint. Further secondary endpoints are tumor response, PFS and safety. We aim to recruit a total of n = 75 subjects that have to be &gt; 65 years old. Eligibility is determined by the geriatric status (G8 screening and Deficit Accumulation Frailty Index (DAFI)). A safety assessment will be performed after a 3 cycle run-in phase of nivolumab (240 mg Q2W) to justify escalation for eligible patients to combined nivolumab (240 mg Q2W) and ipilimumab (1 mg/kg Q6W), while the other patients will remain on nivolumab only. RAMONA also includes translational research sub-studies to identify predictive biomarkers, including PD-1 and PD-L1 evaluation at different time points, establishment of organoid cultures and microbiome analyses for response prediction. Discussion: The RAMONA trial aims to implement checkpoint inhibitors for elderly patients with advanced ESCC as second line therapy. Novel biomarkers for checkpoint-inhibitor response are analyzed in extensive translational sub-studies. Trial registration: EudraCT Number 2017–002056-86; NCT03416244, registered: 31.1.2018

Laparoscopic Heller Myotomy Versus Endoscopic Balloon Dilatation for the Treatment of Achalasia A Network Meta-Analysis

Objective: Comparison of short-and long-term effects after laparoscopic Heller myotomy (LHM) and endoscopic balloon dilation (EBD) considering the need for retreatment. Background: Previously published studies have indicated that LHM is the most effective treatment for Achalasia. In contrast to that a recent randomized trial found EBD equivalent to LHM 2 years after initial treatment. Methods: A search in Medline, PubMed, and Cochrane Central Register of Controlled Trials was conducted for prospective studies on interventional achalasia therapy with predefined exclusion criteria. Data on success rates after the initial and repeated treatment were extracted. An adjusted network meta-analysis and meta-regression analysis was used, combined with a headto-head comparison, for follow-up at 12, 24, and 60 months. Results: Sixteen studies including results of 590 LHM and EBD patients were identified. Odds ratio (OR) was 2.20 at 12 months (95% confidence interval: 1.18-4.09; P = 0.01); 5.06 at 24 months (2.61-9.80; P &lt; 0.00001) and 29.83 at 60 months (3.96-224.68; P = 0.001). LHM was also significantly superior for all time points when therapy included re-treatments , and 17.90 (2.17-147.98); P ≤ 0.01 for all comparisons) Complication rates were not significantly different. Meta-regression analysis showed that amount of dilations had a significant impact on treatment effects (P = 0.009). Every dilation (up to 3) improved treatment effect by 11.9% (2.8%-21.8%). Conclusions: In this network meta-analysis, LHM demonstrated superior short-and long-term efficacy and should be considered first-line treatment of esophageal achalasia. Keywords: achalasia, economic cost, endoscopy, esophagus, health, idiopathic achalasia, laparoscopic surgery, meta-analysis, motility disorders, network meta-analysis, review, surgery (Ann Surg 2013;258:943-952 A chalasia is a rare esophageal motility disorder caused by degeneration of the myenteric plexus, resulting in esophageal dysmotility and incomplete lower esophageal sphincter relaxation. The disease is likely caused by a virus-induced autoimmune response, but this is still debated. 1 The incidence in the Western world is 1/100 000. 2-4 Treatment can be pharmacological, endoscopic, or surgical. Pharmacological treatment is only marginally effective and is reserved for patients with mild symptoms or who refuse other treatments. 7-9 Several studies and a large meta-analysis have indicated that laparoscopic Heller myotomy (LHM) is the most effective treatment for achalasia. 3,4,10 However, a recent large prospective randomized controlled trial (RCT) comparing EBD and LHM has challenged this view. 11 This study found similar success rates for EBD and LHM 2 years after initial treatment. However, the number of EBD interventions per patient was notably higher than other studies. 3,11 The purpose of this meta-analysis is to determine which treatment is most effective at relieving symptoms and to further clarify the impact of retreatments for patients with achalasia. METHODS This meta-analysis was registered in the international register of systematic reviews (PROSPERO) (CRD42012002071). 12 Search Strategy and Trial Selection A prospective search of Medline, PubMed, and Cochrane Central Register of Controlled Trials was performed to identify relevant publications. The search keyword was &quot;Esophageal Achalasia.&quot; Subsequently, the search was limited by the terms &quot;Human,&quot; &quot;Clinical Trial,&quot; and publication language &quot;English.&quot; Publications from 1975 through October 2011 were considered for review To obtain indirect evidence by adjusted network meta-analysis, relative evidence is needed (LHM vs X; EBD vs X). Therefore, success rates were compared with those of either EBTI or open Heller myotomy (OHM). Direct evidence was achieved from head-to-hea

Dual-source computed tomography in patients with acute chest pain: feasibility and image quality

The aim of this study was to determine the feasibility and image quality of dual-source computed tomography angiography (DSCTA) in patients with acute chest pain for the assessment of the lung, thoracic aorta, and for pulmonary and coronary arteries. Sixty consecutive patients (32 female, 28 male, mean age 58.1±16.3 years) with acute chest pain underwent contrast-enhanced electrocardiography-gated DSCTA without prior beta-blocker administration. Vessel attenuation of different thoracic vascular territories was measured, and image quality was semi-quantitatively analyzed by two independent readers. Image quality of the thoracic aorta was diagnostic in all 60 patients, image quality of pulmonary arteries was diagnostic in 59, and image quality of coronary arteries was diagnostic in 58 patients. Pairwise intraindividual comparisons of attenuation values were small and ranged between 1±6 HU comparing right and left coronary artery and 56±9 HU comparing the pulmonary trunk and left ventricle. Mean attenuation was 291±65 HU in the ascending aorta, 334±93 HU in the pulmonary trunk, and 285±66 HU and 268±67 HU in the right and left coronary artery, respectively. DSCTA is feasible and provides diagnostic image quality of the thoracic aorta, pulmonary and coronary arteries in patients with acute chest pain