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Filter by:This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.
The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will then be used in Phase 2 (dose expansion) of the study.
Exercise therapy is a cornerstone in the management of patients with Chronic Obstructive Pulmonary disease (COPD), and supervised walking exercise three times a week over 12 weeks improves walking ability and quality of life. Despite this, very few patients exercise on a regular basis. The underuse of exercise in COPD patients can partly be explained by discomfort during exercise because it evokes dyspnea, and thereby explain lack of participation in exercise. If the goal is to offer the best medical therapy to these patients, new and effective exercise training methods must be explored and defined since exercise training is an important part of pulmonary rehabilitation. Intention is to study a new training method called sprint interval training (SIT), which consists of high intensity bouts with very short duration. The idea behind SIT is to avoid the dyspnea associated with traditional endurance training, thus maximizing exercise power without excessive discomfort. The investigators will study training adaptations in patients with COPD and compare the results with age-matched controls. It is expected that both COPD-patients and healthy elderly will improve exercise cycle time until exhaustion after SIT training, and also that the improvement will be larger in the healthy group due to higher absolute training intensity.
This study addresses the unmet medical problem of insufficient treatment of late life depression (LLD). Compared with depression in early adulthood, treatment options of LLD are limited. This trial is the first confirmatory multicentre study to test the efficacy of an LLD-adapted cognitive behavioural therapy (CBT) program. It will test the hypothesis, that LLD-specific cognitive behavioural therapy (CBT) is superior to unspecific supportive intervention (SUI) with regard to reducing symptoms of depression over the course of 6 months. Secondary goals are to test the efficacy of LLD-CBT in comparison with SUI on patient reported outcome in major depressive disorders (PRO-MDD), anxiety, cognition, quality of life, overall health status, sleep and global clinical impression.
This study is one of the largest ongoing prospective population studies to evaluate target organ damages (TODs) and Left Ventricular Diastoic Dysfunction in the community-dwelling elderly Chinese, which is authorised and funded by the Shanghai municipal government.This study was approved by the Shanghai Tenth People's Hospital Institutional Review Board and was conducted under financial support from the Shanghai municipal government (grant ID: 2013ZYJB0902 and 15GWZK1002). The preliminary sample size is expected to be 3000-4000 participants.
Following tooth extraction, the socket heals naturally with bone in 1 to 2 months. This healing process occurs with substantial reduction of the original height and width of the alveolar ridge. In a significantly resorbed ridge, bone augmentation procedures are necessary before dental implant placement. Autogenous bone is the gold standard for this purpose but the harvesting procedure results in additional morbidities and expenses. Ridge preservation techniques have been introduced, using xenografts, allografts or synthetic materials to fill the tooth socket immediately after extraction. While the current materials used have improved ridge dimensions to various extents, their osteoconductivity is suboptimal and unpredictable. They do not reduce vertical resorption of the bony walls and often interfered with the normal healing process. Polycaprolactone - tricalcium phosphate (PCL-TCP) is a bioactive, bioresorbable composite polymer that is non-toxic and tissue-compatible. This study will test the use of a novel 3D printed PCL-TCP device for ridge preservation, leveraging on its 3D shape that fits snugly in the tooth socket, high porosity and bioactivity to promote osteogenesis and reduce resorption. The hypothesis is that the insertion of a PCL-TCP scaffold in extraction sockets allows normal bone healing and better maintenance of ridge dimensions after 6 months compared to extraction sockets without a space filler. This will be a prospective, randomized controlled clinical trial in patients who require single tooth extraction and replacement with a dental implant. The study will compare the ridge dimensions and the quality and quantity of bone formed in tooth sockets, using histology and microcomputed tomography, in both groups after 6 months. The PCL-TCP scaffold to be used in this study will be fabricated by a local spin-off company, Osteopore International Pte Ltd. The market potential for this device is tremendous due to a growing demand for tooth replacement from an ageing population worldwide.
Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.
To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.
The aim of this study is to assess the utility of two interventional videos, showed to patients discharged from the ED with a diagnosis of atrial fibrillation or deep vein thrombosis. We have focused our attention on these two medical conditions because they share some important features: they are frequently seen in EDs; their main complication (stroke and pulmonary embolism) can cause significant morbidity and mortality; both conditions and their related complications are probably not very intuitive to comprehend for the general population. In fact, the understanding of these conditions implies the knowledge of a number of pathological processes, with which most people are unfamiliar. The primary hypothesis is that patients enrolled in the study group will show a higher degree of comprehension of their medical condition and its related complications, as compared to the control group. Secondly, we will also analyze any possible effect of the videos on the knowledge of the therapy prescribed, return instructions and patients' satisfaction with the quality of communication in the ED. Eventually, we will examine the association of some factors with the outcomes (age, sex, level of education, atrial fibrillation vs. deep vein thrombosis group).
In this study phenylbutyrate is used for patients with pyruvate dehydrogenase complex deficiency. The aim of the study is to investigate the safety and efficacy of therapy.