Active clinical trials for "Constriction, Pathologic"

Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space available for the neural and vascular tissues in the lumbar spine. Patients with LSS,who do not respond to conservative treatments after 3 months or more, will be eligible for spinal decompression surgery in order to improve functional outcomes. While various studies have shown that preoperative exercises (prehabilitation) may benefit patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament reconstruction), little is known regarding the effect of prehabilitation for patients undergoing LSS surgery. The aim of the current randomized controlled trial is to compare the effectiveness of a 6-week prehabilitation program with usual preoperative care in improving multiple outcomes of patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and 6 months postoperatively. It is hypothesized that prehabilitation will yield significantly better pre- and post-operative clinical outcomes as compared to usual preoperative care.

The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator in children (<13 years old) with subglottic or tracheal stenosis. The hypothesis is that the device will effectively dilate the stenotic segment, whilst maintaining oxygenation (if applicable). The primary aim is to measure the stenosis prior to, and after dilatation; using diameter and the modified Myer-Cotton grading system. Secondary aims include assessment of stenosis at six-week follow-up and monitoring arterial oxygenation nadir (using peripheral plethysmography) during the procedure.

Degenerative lumbar spinal stenosis (DLSS) is a condition which there is narrowing space of sagittal diameter of spinal canal or nerve root canal for spinal nerve or cauda equina secondary to degenerative changes. DLSS is a common cause of gluteal or lower extremity pain, women and elderly people aged 60-70 are more likely to have DLSS. The early symptoms of this disease are soreness and pain in the low back, gluteal region and posterior region of thighs which can be relieved after resting or changing posture. Being accompanied with gradually aggravated symptoms, patients with DLSS may have neurogenic claudication with hypoesthesia and numbness in lateral lower legs and feet, additionally, few patients may have bowel and bladder disturbances. In accordance of the guidelines of North American Spine Society (NASS), treatment options comprise surgical therapy, epidural steroid injections and physical therapy and transcutaneous electrical stimulation, however, the long-term efficacy of surgery is not superior to that of non-surgical therapy. Moreover, the short-term efficacy of non-surgical therapy is with insufficient evidence. According to a systematic review and recent studies, acupuncture may improve the symptoms of patients and their quality of life, however, there is a lack of placebo-controlled and large sample sized study.

Aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost especially in the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia. In addition to the expensive cost, patients who have mechanical prosthetic valve have an increased risk of infection of the prosthetic valve and developing thrombo-embolism thus have to consume a lifelong anticoagulant therapy that increase risk of bleeding. A surgical technique using autologous pericardium is an alternative to prosthetic valve replacement, one of which is a single pericardium strip technique that uses modified autologous pericardium technique from Ozaki et al and Duran et al. The objective of this study is to investigate the outcome of aortic valve replacement with a single pericardium strip of autologous pericardium in patients with aortic stenosis. This study will be conducted at the Integrated Heart Center of Cipto Mangunkusumo Hospital, Jakarta, Indonesia, by using quasi experimental type time series design. Subjects are patients with aortic stenosis who are candidates for valve replacement. Inclusion criteria is having low to moderate surgical risk (EuroScore II <5). The sampling method used in this study is non-probability consecutive sampling. This study will assess the outcome of the aortic valve replacement (valve hemodynamic, left ventricular reverse remodelling, sST2, 6MWT) at 3 months and 6 months post-aortic valve replacement. It is expected that aortic valve replacement using a single strip of autologous pericardium will have good valve hemodynamic outcome, yield left ventricular reverse remodelling, decrease sST2 level, show upgrade in 6MWT, and have shorter aortic cross clamp time so that it can be an alternative to aortic valve replacement using mechanical prosthetic valve that is less expensive and have good outcomes in patient with aortic stenosis.

The trial aims to compare the effectiveness of three methods of conservative treatment of degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections, steroid epidural injections and manual therapy.

The average life expectancy in Denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back, especially when standing and walking, known as neurogenic claudication(Goh KJ FAU - Khalifa et al.). LSS occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavus, arthrosis of the facet joints and bulging of the disc. Current treatment of LSS is varied ranging from non-operative conservative treatment to operation. Operative intervention shows very good results according to physical ability and pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.), but the most optimal treatment is still debated. Nevertheless, a decompression and, if needed, a spinal fusion is recommended.(Ausman). Clinical improvement including decrease of pain, improved ADL-function and an increased quality of life are parameters of highest interest and the purpose of an operation is clear: Making sufficient room for the affected nerves. In addition fusion is desired achieving stability avoiding a new compression of the nerves. Studies attending these issues find a correlation between fusion and clinical outcome, why obtained fusion of the affected levels are very important(Andersen et al.;Andersen et al.;Girardo et al.;Kornblum MB FAU - Fischgrund et al.). P-15, bound to Anorganisk Bone Mineral (ABM), called i-FACTOR®, shows fusion superiority, no side effects and no risk of transferring disease(Thorwarth et al. 5648-57;Thorwarth et al. 789-95;Wenz, Oesch, and Horst 1599-606;Scarano et al. 318-24;Kubler et al. 171-79) why the investigators find this material suited for fusion surgery in the elderly. To the investigators knowledge this is the first prospective study comparing fusion rates and postoperative clinic with i-FACTOR vs allograft in older patients operated with decompression and spondylodesis because of spinal stenosis due to degenerative spondylolisthesis. Hypothesis: There are no difference in the clinical parameters measured by ODI and fusion rates comparing i-FACTOR® and allograft in non-instrumented posterolateral spondylodesis-operations in patients 60 years and older.

The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.

Early development of calcified aortic valve disease (CAVD) is a commonly occurring complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may lead to necessity of valve replacement, since to date, no other therapies have been shown effective in the treatment of CAVD. The primary objective of our study is to test the hypothesis that supplementation of vitamin K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of calcification. In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2 or placebo group. To assess the calcification process in a detailed manner in these patients, a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF]) that has been shown to bind to regions of newly developing microcalcification in aortic valve tissue is used. We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium score on CT and echocardiography after 18 months (secondary endpoints), when compared to placebo.

The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months. There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction. The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.

Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000 patients are registered with the Japan Organ Transplant Network (JOTN) with the hope for a renal transplantation. If the renal function is restored by transplantation, the quality of life (QOL) improves and more than 90% are reportedly comeback to their normal life activities and get relieved from the burden of dialysis. Furthermore, it can reduce the dialysis related medical cost by as much as 50%. However, only about 1,000 renal transplantation cases are annually carried out in Japan. Among them, 80-85% are living renal transplantations offered by family members or relatives, and the rest are from deceased donors. Due to the fact that the number of deceased donors are scarce and only living renal transplantations between the family members or relatives are currently allowed in Japan, the approximate waiting time to receive a renal transplantation is 16 years. For that reason, many patients travel abroad to receive a renal transplantation. There are reports that total nephrectomies are performed as a treatment for small size (4 cm or less) renal tumors, renal stones, ureteral tumors and ureteral strictures in many cases and that many of these nephrectomized kidneys can be successfully transplanted after surgical restoration with satisfactory results. However, due to the lack of necessary evidence it is currently not allowed in Japan. Therefore, the investigators planned the present clinical study to evaluate the curative efficacy (renal function, QOL) and safety (side effects, complications or occurrence of renal cancer) of living renal transplantations between family members and relatives with restored donor kidneys after the surgical removal or repairment of a small size (4 cm or less) renal tumor or renal stone, ureteral tumor or ureteral stricture, in order to acquire necessary clinical data for potential enrichment of the renal donor pool in Japan as well as to develop useful medical care for our patients who are on dialysis for many years due to the renal failure.