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NCT ID: NCT05396222 Not yet recruiting - Spinal Tumor Clinical Trials

A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar Spine

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Vertebral body resection is a wide accepted procedure in tumor resection, deformity correction, and anterior decompression in spondylosis, ossification of posterior longitudinal ligaments, and spondylodiscitis surgery. However, reconstruction of segmental defect is still challenging to spine surgeon, especially in 3-column resection, such as total en bloc spondylectomy in tumor patients. Various graft or prosthesis for reconstruction has been reported, such as structural allograft, Harms mesh cages, expandable cages, and carbon fiber stackable cages. There are no high evidence level study examining the superiority of those different methods. Recently, 3D printed vertebral body replacement has been reported in different disease entities as well, such as tumor, Kümmell's disease in osteoporosis, and spondylosis. 3D printed implant comes with superiority in production of complex geometries and regularity of the fine surface detailed that promote bone ingrowth. Although, 3D-printed titanium vertebra could achieved bone integration in human, a systemic review showed that the subsidence noted in 31.4% of spine surgery with 3D printed implants. In spine surgery, the fixation construct is sufficiently stiff, interbody motion can be reduced, and loading sharing promotes bone fusion. On the other hand, if the reconstruction is too stiff, stress shielding at fusion site occurs. The concept of dynamic fusion, as opposed to rigid fusion, has been demonstrated by an anterior cervical interbody fusion study in porcine model, demonstrating good bone formation, less postfusion stiffness, and a trend to less subsidence. Thus, we developed a 3D printed, custom-made, biomimetic prosthesis, with non-rigid structure, which has been tested in biomechanical study and porcine model, showing good bone formation and less stiffness as well. Therefore, we proposed a prospective clinical study to investigate safety, subsidence, and fusion of this prosthesis.

NCT ID: NCT05385861 Not yet recruiting - GEP-NET Clinical Trials

Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic GEP-NET

Start date: July 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The current study is an investigator-initiated, single-arm phase 1/2 study that enrolled patients with advanced or recurrent and/or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma for the treatment of nal-IRI (ONIVYDE®) plus carboplatin as the first-line chemotherapy.

NCT ID: NCT05341206 Not yet recruiting - Clinical trials for Head and Neck Neoplasms

Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.

Start date: April 15, 2022
Phase: Phase 2
Study type: Interventional

The aim of the study is to evaluate the effects of Herbal gargle on chemoradiotherapy-induced stomatitis in head & neck cancer patients.

NCT ID: NCT05329688 Not yet recruiting - Clinical trials for Radiotherapy Side Effect

Nutrition Education Program for Cancer Patients Receiving Radiotherapy

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Using randomized control study, explore the effect of novel nutrition education program on the nutrition status and life quality of cancer patients receiving radiotherapy

NCT ID: NCT05325099 Not yet recruiting - Clinical trials for Acute Kidney Disease

Demethylating Agent Azacitidine on Prevention of Acute Kidney Injury-chronic Kidney Disease Continuum

Start date: June 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Acute kidney injury (AKI) is increasing worldwide in recent years and is a major risk factor of chronic kidney disease (CKD). AKI, acute kidney disease (AKD) and CKD form a continuum whereby initial kidney injury leads to ongoing renal injury and eventually end-stage renal disease if no effective treatment is applied. Nevertheless, there are no useful pharmacotherapies approved clinically for the treatment of AKI and subsequent CKD. Previous studies of the investigators have confirmed that pericytes are the primary cell source of scar-producing myofibroblasts. Furthermore, the investigators had demonstrated that significant epigenetic modification in transcriptome analysis of pericytes develops in different stage of AKI-CKD continuum. These epigenetic memory made pericytes obtain proliferative and pro-fibrotic phenotypes in activated status and persist in inactivated status. Demethylation by azacitidine prevented AKI-CKD transition, and attenuated fibrogenesis induced by a second adenine-AKI. Azacitidine has been approved in the United States Food and Drug Administration and European Union for treatment of adult acute myeloid leukemia (AML), particularly recommended front-line treatment for older patients with acute myeloid leukemia who are not candidates for intensive treatment regimens. Dosage of azacitidine in clinical trial is calculated according to previous study and is lower than chemotherapeutic dose. Low dose azacitidine has demethylation effect and less cytotoxicity. CSA-AKI is the second commonest cause of AKI in ICU. The investigators plan to initiate a double-blind randomized controlled trial (RCT) to recruit CSA-AKI patients. The patients will be divided as azacitidine group and placebo group. Patients in azacitidine group will receive three doses of low dose azacitidine in one week when AKI is diagnosed. After that, the investigators will follow up their renal function and urine protein every three month. Primary composite outcomes include a decline of at least 50% in the estimated GFR, an increase of urine protein-creatinine ratio (UPCR) over 1000 mg/g, and the development of end stage renal disease (ESRD). Secondary outcome is overall mortality.

NCT ID: NCT05314322 Not yet recruiting - Parkinson Disease Clinical Trials

Deep Brain Stimulation on Dual-task Gait Performance in PD

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease. Motor symptoms include rigidity, bradykinesia, tremor, and postural instability, these motor symptoms can cause gait dysfunction. Non-motor symptoms include depression, dysarthria, cognitive disability, and sleep disturbance. Although these symptoms can be improved through drug treatment, when the course of PD reaches the middle to late stage, it will still face the situation of weakened drug efficacy and the drug side effects increased. When medication can no longer adequately control the motor symptoms of PD, deep brain stimulation (DBS) becomes a powerful option. DBS is a surgical treatment that involves implanting one or more electrodes into specific areas of the brain, which deliver electrical stimulation to regulate or destroy abnormal neural signal patterns in the target area. The effect of DBS has been proven whether it is in improving motor-related symptoms or non-motor-related symptoms, but there are still some areas that have not been compared before and after the surgery, such as: gait variability, executive functions and dual-task walking. In addition, the parameters of electrical stimulation for DBS will also affect the clinical characteristics of patients. Due to the large difference between individual cases, the recommendation of the electrical stimulation frequency still not be established. Therefore, the influence of DBS and its parameters on the symptoms of PD is a topic worthy of discussion. Purposes: (1) To investigate the long-term effects of DBS on the symptoms of PD. (2) To investigate the effects of DBS stimulation frequencies on walking performance and executive function in individuals with PD.

NCT ID: NCT05286320 Not yet recruiting - Clinical trials for Unresectable Hepatocellular Carcinoma

Phase Ib/II Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.

Start date: March 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

HCC patients with PVTT (main trunk or the first-degree branch) treated with the combination of pembrolizumab (Ketruda), lenvatinib (Lenvima), and SBRT.

NCT ID: NCT05263856 Not yet recruiting - Knee Osteoarthritis Clinical Trials

The Effect of Laser Acupuncture Intervention to the Prognosis After TKR Surgery

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

This study protocol is mainly focus on the patients, who suffer pain, swelling, or range of motion limitation after total knee replacement (TKR) surgery procedure,would be relieved by use non-invasive laser acupuncture to stimuli on 1) the reflection areas of ear acupuncture point associated knee and pain mechanism; 2) muscle trigger points around knee joint with adequate frequency and energy power to stimuli.

NCT ID: NCT05225181 Not yet recruiting - Clinical trials for Mild Cognitive Impairment

Effects of the Combining Physical Exercise and Cognitive Training for the Community-based Elderly

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

This study aims to (1) determine the intervention effects of sequential and simultaneous training on cognitive function and health-related function for cognitively-normal elderly and elderly with Mild Cognitive Impairment(MCI) and Subjective Cognitive Decline(SCD); (2) compare which combination approach is more advantageous for improvement on outcome measures.

NCT ID: NCT05200637 Not yet recruiting - Clinical trials for Coronary Artery Disease

Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting stent (Xience, Abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. How the differences in stent platforms affect vessel healing process will be examined by optical coherence tomography.