Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT

Combined ship routing and inventory management in the salmon farming industry

We consider a maritime inventory routing problem for Norway's largest salmon farmer both producing the feed at a production factory and being responsible for fish farms located along the Norwegian coast. The company has bought two new ships to transport the feed from the factory to the fish farms and is responsible for the routing and scheduling of the ships. In addition, the company has to ensure that the feed at the production factory as well as at the fish farms is within the inventory limits. A mathematical model of the problem is presented, and this model is reformulated to improve the efficiency of the branch-and-bound algorithm and tightened with valid inequalities. To derive good solutions quickly, several practical aspects of the problem are utilized and two matheuristics developed. Computational results are reported for instances based on the real problem of the salmon farmer

Hemorrhoidectomy using harmonic ultrasound scalpel : results of a series of 110 consecutive patients

As a very common and benign disease in surgical practice, hemorhoidal disease should have a very low level of postoperative morbidity and pain. The aim of this study was to evaluate postoperative pain and morbidity, time to complete healing and time off of work in a series of 110 consecutive hemorrhoidectomy patients using harmonic ultrasound scalpel device. One-hundred-and-ten consecutive three quadrant hemorrhoidectomy procedures for symptomatic prolapsed hemorrhoids (grade III and IV) were performed in our institution. Postoperative pain was assessed using a visual analogue pain scale (VAS). Outpatient`s follow-up was done at 3 weeks and 3 months. There were 72 males (65%) and 38 females (35%). Mean age was 48,5 years (22-76). Sixty-seven patients (61%) had grade III hemorrhoids and 43 patients (39%), grade IV. All operations were performed under spinal anaesthesia. Postoperative complications included 7 patients (6,3%): 2 patients were readmitted for haemorrhage without need for reintervention, and 5 had urinary retention. Postoperatively scheduled analgesia was enough for pain control in all patients. One-day surgery represents only 5% of our patients, 85% had a less than 24 hours hospital stay with surgery done the day of admission and 10% stayed for more than one day. Seventy-nine patients (92%) returned to work in between 3 weeks. Time to complete healing was 6 weeks. At the term of the follow-up, no recurrence was observed. In conclusion, hemorroidectomy using harmonic scalpel is a safe technique with very low morbidity rate, postoperative pain is acceptable and time off of work is low

A new case of sodium‐dependent multivitamin transporter defect occurring as a life‐threatening condition responsive to early vitamin supplementation and literature review

Abstract Background Biallelic pathogenic variants in SLC5A6 resulting in sodium‐dependent multivitamin transporter (SMVT) defect have recently been described as a vitamin‐responsive inborn error of metabolism mimicking biotinidase deficiency. To our knowledge, only 16 patients have been reported so far with various clinical phenotypes such as neuropathy and other neurologic impairments, gastro‐intestinal dysfunction and failure to thrive, osteopenia, immunodeficiency, metabolic acidosis, hypoglycemia, and recently severe cardiac symptoms. Methods We describe a case report of a 5‐month‐old girl presenting two recurrent episodes of metabolic decompensation and massive cardiac failure in the course of an infectious disease. We compare clinical, biological, and genetic findings of this patient to previous literature collected from Pubmed database (keywords: Sodium‐dependent multivitamin transporter (SMVT), SMVT defect/disorder/deficiency, SLC5A6 gene/mutation). Results We highlight the life‐threatening presentation of this disease, the stagnation of psychomotor development, the severe and persistent hypogammaglobulinemia, and additionally, the successful clinical response on early vitamin supplementation (biotin 15 mg a day and pantothenic acid 100 mg a day). Metabolic assessment showed a persistent increase of urinary 3‐hydroxyisovaleric acid (3‐HIA) as previously reported in this disease in literature. Conclusion SMVT deficiency is a vitamin‐responsive inborn error of metabolism that can lead to a wide range of symptoms. Increased and isolated excretion of urinary 3‐hydroxyisovaleric acid may suggest, in the absence of markedly reduced biotinidase activity, a SMVT deficiency. Prompt supplementation with high doses of biotin and pantothenic acid should be initiated while awaiting results of SLC5A6 sequencing as this condition may be life‐threatening