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Filter by:A prospective, multicenter, open-label, randomized and parallel-group clinical trial was conducted at four transplant centers in Korea. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) versus standard-dose tacrolimus with reduced-dose MMF.
To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy
Chronic inflammatory demyelinating polyradiculoneuropathy (PIDC) is an acquired dysimmune polyneuropathy whose prevalence is estimated to be between 1 to 4 per 100,000 depending on the study, with an incidence of less than 1 per 100,000 per year. The clinical presentation of PIDC is heterogeneous, characterized by a symmetrical lesion predominating generally on large fibers, the most myelinated, responsible for ataxia and a motor deficit in the foreground. In the typical form, patients describe a proximal and distal motor or sensory deficit associated with isflexia that signifies a peripheral neurogenic syndrome. The physiopathological hypothesis is that of an inflammation responsible for demyelinating nerve fibers, which results in electroneuromyogram (ENMG) by conduction abnormalities and histologically when a neuromuscular biopsy is performed by segmental demyelination. Given the heterogeneity of the clinical presentation, electrical diagnostic criteria are proposed by the European Federation of Neurological Society in order to classify IPDCs into three categories: certain, probable and possible. In the absence of sufficient criteria to make the diagnosis of IPDC, it is also possible to use criteria of support, using a paraclinical report including the presence of an increase in protein (hyperproteinorachie) without cells for cerebrospinal fluid analysis, visualization of radicular inflammation on imaging (MRI of lumbar and / or brachial plexus), proximal peripheral involvement with somatosensory evoked potentials. Therapeutically, a joint management between rehabilitation and the introduction of a background treatment allows the clinical improvement of certain patients. To date, the treatments proposed in first intention are corticosteroids, intravenous immunoglobulins (IVIg) and plasma exchanges. In fact, the efficacy of intravenous immunoglobulins has been widely shown by controlled and randomized therapeutic trials. Efficacy studies of IVIg in the literature are most often based on an assessment of clinical response after 24 weeks, but in clinical practice the response to treatment and continuation of treatment is often evaluated after 3 courses of treatment with the help of a clinical evaluation and the realization of an electroneuromyogram. These are administered in day hospitalization or traditional hospitalization, every four weeks, to patients whose diagnosis of PIDC has been established by electroneuromyogram according to the EFNS criteria. Clinical prognostic factors for good response to IVIG therapy have been described in previous studies, including subacute disease, symmetrical involvement, and absence of amyotrophy. In order to optimize the management of IPDCs, it is important to identify patients who respond to IVIg. Thus, the objective of our study is to look at the electroneuromyogram, the presence of electrical predictors of good response to treatment with IVIg.
This study evaluates the effects of corticosteroid injections over time, as well as the additional effect provided by subsequent transcranial direct current stimulation (tDCS) of the motor cortex on patients with rotator cuff tendinopathy of the shoulder. All patients will receive a subacromial corticosteroid injection. Two weeks later, a third will receive a treatment of tDCS, a third will receive a placebo a-tDCS treatment, and the last third will not receive any additional treatment.
A cluster randomized controlled pre-post effectiveness trial of behavioral preschool teacher training (BPTT) delivered in a practitioner assisted group format for children with externalizing behavior problems. Preschools were randomized to either intervention in 25 preschools or as 22 waiting list control preschools, where teachers in preschool classes with the target child or children were program receivers. Participants were 100 target children 3-5 years old together with 72 enrolled preschool teachers and 83 parents as informants of behavioral outcomes after a five months period of implementation (at six months). The intervention was part of the Swedish evidence-based parent and teacher training programs (Comet) for children and youth with elevated externalizing behavior, and here an adapted version was tried in preschool for the first time. Also investigated was eventual generalized effects to the children's homes and improved social competence as an intermediate mechanism for reduced problem behavior. Effects of implementation fidelity in addition to social acceptability and relevance, such as reliable change, was investigated as well.
Background: Skin grafting; both partial and complete thickness is frequently used in reconstruction of traumatic soft tissue defects. It is of great value not only for functional and aesthetic purposes in the field of plastic surgery, but also for other surgical specialties. Of all the problems in the early postoperative period, pain is considered the most important, ameliorating it can lead to significant reduction in postoperative morbidity and faster recovery of the skin donor site. Objective: To evaluate use of dexamethasone as adjuvant for bupivacaine in subcutaneous local anesthesia infiltration for skin graft donor sites, on quality of pain relief and total dose of analgesic requirements in the early hours postoperatively. Methods: 97 patients were randomly allocated to receive local bupivacaine infiltration (group LB), or dexamethasone plus bupivacaine (group LB + D) in skin donor site after skin harvesting. In addition to basic demographic data; patients were compared for Numerical Rating Scale (NRS), total dose of morphine or morphine equivalents, time to 1st breakthrough pain, and duration of surgery. Keywords: Donor site. skin graft. Breakthrough pain. Rescue analgesia. Bupivacaine
This study is designed to evaluate the effects of a diet rich in unsaturated fatty acids (UFA)-also known as 'healthy fats'-in patients with obesity and heart failure with preserved ejection fraction (HFpEF) on dietary consumption of UFA as well as fatty acids plasma levels.
In this study Drug-eluting microbeads (DEB) loaded with Doxorubicin will be delivered into the target Desmoid Fibromatoses (DF) tissue via selective arterial embolization by angiographic technique. The objective of the study is to demonstrate the safety and efficacy of this treatment.
In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.
The purpose of this preliminary study is to help clarify our hypotheses for the longitudinal study by investigating the relationship between vocal cord paralysis and central auditory processes and thus the interpretation of auditory inputs into the central nervous system.