Kusajili – Centralise les essais cliniques mondiaux

Drug eluting balloon venoplasty in arterio-­venous fistula stenosis Background and study aims Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work properly. In a healthy person, the kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. In patients suffering from CKD, the kidneys are unable to do this, and so the body is unable to get rid of the waste products building up in the blood. Haemodialysis is one of the most common treatments for CKD patients, and involves diverting the blood into an external machine so that it can be “cleaned”, before being returned to the body. It requires direct access to the circulatory system (blood stream) and the best option for this is a by creating an arterio-venous fistula (AVF), which is made by surgically joining an artery and a vein in the arm. AVFs have a limited lifespan, and over time can become narrowed (stenosed) or blocked (thrombosed). The fistula can be used for haemodialysis again if it is “re-opened”. This is done by inflating a small balloon inside the fistula to flatten any blockages against the artery wall (fistuloplasty). In many cases however, the fistula re-narrows and becomes blocked again (restenosis). New techniques have been developed where the balloon used in the fistuloplasty is coated in a drug, such as Paclitaxel (drug-eluting balloon, DEB). This drug slows the growth of new smooth muscle cells in the vessel wall that may lead to re-narrowing (restenosis). The aim of this study is to find out whether a DEB is more effective than standard balloons (with no drug coating) at slowing down and preventing restenosis. Who can participate? Adults who have a narrowed AVF, which has been in use for at least 1 month. What does the study involve? Participants are randomly allocated to one of two groups. Participants in the first group receive the standard fistuloplasty procedure, in which a plain balloon is inflated until the fistula becomes wide enough to become usable. Participants in the second group receive the standard fistuloplasty procedure, in which a balloon coated in a drug called paclitaxel is used. Participants attend follow-up appointments 3, 6 and 12 months after their operation so that the openness (patency) of the fistula can be monitored. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Queen Elizabeth Hospital, Birmingham (UK) When is the study starting and how long is it expected to run for? January 2016 to October 2018 Who is funding the study? Boston Scientific Corporation (USA) Who is the main contact? Mrs Nicola Anderson

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A randomized, Phase III study of Fotemustine versus the Combination of Fotemustine and Ipilimumab in Patients with Metastatic Melanoma with brain metastasis Studio randomizzato di fase III di confronto tra Fotemustina e la combinazione di Fotemustina e Ipilimumab in pazienti con Melanoma metastatico con metastasi cerebrali To compare the efficacy of the combination of ipilimumab and fotemustine versus fotemustine in terms of overall survival (OS) in patients with metastatic melanoma with brain metastasis Paragonare l’efficacia della combinazione ipilimumab più fotemustna vs fotemustina da sola in termini di sopravvivenza globale (OS) in pazienti con melanoma metastatico con metastasi cerebrali

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Computed tomography lymphography with bronchoalveolar injection of iopamidol using ultrathin bronchoscope for preoperative lung cancer patients

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Study of Initial Treatment With Elotuzumab, Carfilzomib, Lenalidomide and Dexamethasone in Multiple Myeloma This study will be a multi-center, open-label, Phase 2 study where newly diagnosed Multiple Myeloma requiring systemic chemotherapy will be eligible for enrollment. A total of 55 subjects will be enrolled. Time to progression or death will be calculated from the date of first treatment on protocol until the date of disease progression or death from any cause. Patients can expect to participate between 12-24 cycles. The primary endpoint will be the rate of response by next generation gene sequencing at the end of 8 cycles among non-transplant candidates and transplant candidates who agreed to defer transplant.

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Effectiveness of an intervention program to improve the nutritional quality of lunchboxes in elementary school children

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Network-based standardized control and management of chronic heart failure patients in Shaanxi rural areas

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Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. Estudio para evaluar la eficacia y la seguridad de givinostat en pacientes ambulantes con distrofia muscular de Duchenne (DMD) To establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects Establecer los efectos de givinostat en comparación con placebo cuando se administra de forma crónica durante más de 18 meses para frenar la progresión de la enfermedad en pacientes ambulantes con DMD.

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Phlebotomy to Prevent Blood Loss in Major Hepatic Resections Major liver resection is associated with substantial intraoperative blood loss. Blood loss in elective liver surgery is a significant factor of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. The purpose of this study is to use whole blood phlebotomy to decrease the central venous pressure, resulting in a state of relative hypovolemia. It is hypothesized that this intervention will lead to a decrease in blood loss at the time of liver resection.

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Conservative versus arthroscopic refixation of the Medial PatelloFemoral Ligament (MPFL) after traumatic first time dislocation of the patella in children Not provided at time of registration

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Metabolic Activation With Protein-rich Formula Diet Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT 01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE insulin/day. The aim of the present study was to investigate in a randomized-controlled trial if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or insulin.

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