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Filter by:This phase Ib trial tests the safety, side effects, and best dose of STI-3031 given directly into the into the lymph nodes or the lymph vessels (intra-lymphatic) using the Sofusa DoseConnect device in treating patients with melanoma that has spread through a lymph vessel and begins to grow more than 2 centimeters away from the primary tumor but before it reaches the nearest lymph node (in-transit). Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.
The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.
Introduction: The scientific support for prescribed rehabilitation programs for upper extremity fractures is scarce, early mobilization has previously been shown to benefit the speed of recovery at the activity and participation level. Different (inter)national protocols for fracture rehabilitation of the upper extremity are not very specific with regard to the content of (para)medical treatment. The above underlines the need for a clearly defined and practically feasible treatment method. That is why the PERformance guided Fracture Rehablitation Method (PERForRM) protocol was drawn up, in which the treatment method is clearly described in a structured and protocol-based manner. The ultimate goal of the PERformance guided Fracture Rehablitation Method (PERFoRM) protocol is to optimize recovery, with maximum recovery of activity and participation level in upper extremity fractures. Expert opinion/empiricism was used during the writing of the protocol, partly arising from the earlier development of a protocol for the lower extremity. The approach according to the PERForRM protocol does not focus on the time-contingent load on the fracture, but rather on the functional use of the extremity, whereby the quality of movement is paramount. The PERForRM protocol proposes a "gold standard" in the form of milestones for describing the quality of movement of the upper extremity for (para)medics. Method: The aim of this pilot study is to test the manageability/feasibility of this protocol in clinical practice in patients with peri-articular fractures of the upper extremity (proximal humeral and distal radius fractures). It also describes the recovery in the area of the ICF domains and the complications that occurred when applying the PERForRM protocol. The inclusion period consists of 3 months, with a follow-up of 6 months. The manageability is measured by means of a questionnaire that is administered to the practitioners (2x during the study period). The data analysis will mainly have a descriptive character
This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.
This is a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in Chinese pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx® for up to 52 weeks.
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
The clinical investigation is a randomized, subject- and evaluator-blinded, active treatment controlled, multicenter, clinical investigation, to demonstrate the non inferiority of saypha® VOLUME Lidocaine to one of the devices approved for the same indication (Juvéderm® Voluma™ XC).
This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab.
MIST+ is studying a nasal spray to see if it will reduce the need for surgery for snoring. Children aged 3-12 are invited to take part. Snoring affects up to 10% of children and can cause sleeping problems and concentration or behavioural issues in the daytime. Currently the most common treatment for snoring is surgery to remove the tonsils and/or adenoids, however many children wait a long time to see a specialist. This research is trying to find if nasal sprays can help children with snoring, and whether this can reduce the need for surgery.