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NCT ID: NCT04225481 Not yet recruiting - Clinical trials for Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPL

Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis

Start date: January 2020
Phase:
Study type: Observational

Osteoarthritis (OA) is a highly progressive and debilitating joint disease. Recently, it was demonstrated the existence of an important link between OA inflammation and progression of structural changes. Therapy with intra-articular injection of stromal vascular fraction (SVF) holds great promises and its efficacy could be further augmented with the addition of biological adjuvants. In the present project, we aim at demonstrating that human platelet lysate (HPL) increases the intrinsic beneficial properties of SVF on cartilage regeneration and joint environment. Moreover, we want to verify if SVF-conditioned medium (CM) obtained from SVF primed with HPL yields comparable or superior outcomes than whole SVF.

NCT ID: NCT04224909 Not yet recruiting - Clinical trials for Sudden Sensorineural Hearing Loss

Video HIT in Sudden Sensorineural Hearing Loss

Start date: February 1, 2020
Phase:
Study type: Observational

The function of the vestibular system among patients with Sudden Sensori Neural Hearing Loss will be evaluted using the video Head Impulse Test

NCT ID: NCT04224363 Not yet recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction

Start date: January 2020
Phase: N/A
Study type: Interventional

The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus (upward)during chromoendoscopy.

NCT ID: NCT04224246 Not yet recruiting - Clinical trials for Weaning From Mechanical Ventilation

Impact of Gamma-OH on Sleep in ICU Patients

GO-SLEEP
Start date: January 2020
Phase: Phase 2
Study type: Interventional

The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.

NCT ID: NCT04223817 Not yet recruiting - Systemic Sclerosis Clinical Trials

7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis

PREM'S
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a rare systemic autoimmune disease with specific osteoarticular pattern of unknown mechanism. Ischemic phenomenon have been suggested to participate to the osteoarticular involvement in SSc. To date, osteoarticular pattern and hand vascular involvement have been few studied in magnetic resonance imaging in SSc, and most often with low resolution RMI. 7 Tesla RMI allows high resolution for morphology examination, together with dynamic and functional vascular study and sodium articular concentration. Indeed, the aim of the study is to describe hand osteoarticular and vascular involvement in SSc, as well as sodium articular concentration. Clinico-biological association will be also assessed.

NCT ID: NCT04222140 Not yet recruiting - Clinical trials for Post-Traumatic Osteoarthritis of Knee

Early Regenerative Intervention for Post-Traumatic Osteoarthritis

ERIPTO
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The goal of the proposed research is to compare the ERIPTO protocol for post-traumatic osteoarthritis of the knee with that of bone marrow aspirate concentrate (BMAC) only. The investigators will also conduct a statistical regression analysis looking into factors such as time frame from initial injury, the type of injury, gender, and age when injury first occurred. The investigators plan on evaluating clinically and radiographically the effects of the ERIPTO Protocol. There will be two arms of this study. The first arm will be our protocol arm and the second arm will be our BMAC treatment only arm. The investigators plan on collecting objective data on osteoarthritis (OA) severity by taking plain films and assessing the Kellgren-Lawrence (KL) grading scheme in assessing OA severity. The investigators will also administer MRI evaluations for cartilage and meniscal growth prior to treatment and after 1 year. The investigators also plan on collecting subjective symptom scores in the form of knee injury and osteoarthritis outcomes scores (KOOS), visual analog scores (VAS), and international knee documentation criteria (IKDC) score for OA severity. The investigators plan to track changes in both subjective and objective measures of knee OA in our patients through the course of one year.

NCT ID: NCT04220398 Not yet recruiting - Prostate Cancer Clinical Trials

Neoadjuvant Chemo-hormonal Therapy Combined With Radical Prostatectomy for Locally Advanced Prostate Cancer

Start date: January 10, 2020
Phase: N/A
Study type: Interventional

To evaluate of the value of radical prostatectomy and extended pelvic lymph node dissection in locally advanced prostate cancer after neoadjuvant hormonal therapy with or without docetaxel chemotherapy.

NCT ID: NCT04220073 Not yet recruiting - Clinical trials for Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005

Phase I Study of Comparing Single Dose JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) With Placebo in Tolerability, Safety, Immunogenicity and Pharmacokinetic in Healthy Volunteers

Start date: January 5, 2020
Phase: Phase 1
Study type: Interventional

JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers. A total of 5 dose groups are set in the study, i.e., 15 mg, 60 mg, 150 mg, 300 mg and 600 mg, single dose will be given subcutaneously in abdomen. A total of 40 subjects are planned to be enrolled, 8 subjects will be enrolled in each group. Each dose group will be given the study drug and placebo at a ratio of 3:1. Each subject can only receive one single dose at one dose level. Sentinel method will be used for dose escalation, and one independent safety evaluation team (SET) will be set up. 2 subjects (one receiving study drug, the other receiving placebo) will be randomized preferably and followed up until 3 days after administration when the dose starts in each dose group, the remaining 6 subjects (5 receiving study drug, 1 receiving placebo) can continue to be randomized after confirmation with the sponsor, if no any dose-limiting event (DLE) is observed during that period. Only when all the subjects at present dose level complete the follow-up for at least 14 days after administration, and no dose-limiting event (DLE) is observed in any one subject, the next dose level can be initiated after confirmation with the independent safety evaluation team and the sponsor, otherwise they must be observed for the full term of follow-up (i.e., on Day 85). If DLE is observed throughout the observational period, it is confirmed that ≤2/6 subjects have DLE after administration of the study drug through unblinding by the independent safety evaluation team, the next dose level can be initiated; if >2/6 subjects have DLE, the dose escalation will be terminated. The previous dose before that dose will be regarded as the maximum tolerated dose (MTD). When the dose for single dose is escalated to the preset maximum dose, and no safety endpoint is observed, it can be considered to continue to explore higher dose after joint decision by investigators and the sponsor.

NCT ID: NCT04219683 Not yet recruiting - Clinical trials for Mandibular Reconstruction Using Free Fibula Flap

Mandibular Vertical Height Augmentation in Segmental Defects Using Combined Vascularized and Non-Vascularized Fibula Flap

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Segmental mandibulectomy, often employed for resection of a tumour, and occasionally for trauma, osteoradionecrosis, or osteomyelitis, adversely affects patient's quality of life (QoL) to a varying degree. It inflicts a significant defect in the head and neck region, impacting on facial appearance, and the functions of speech, malocclusion, mastication, swallowing, and health-related QoL. Mandible resection thus creates a significant impact on a patient's life, both aesthetically as well as functionally. Restoration of the defects following resection of any part of the mandible presents a challenging problem for reconstructive surgeons. Since the introduction of fibula free flap (FFF) by Taylor in 1975, it has become the most popular choice for mandible reconstruction. Hidalgo popularized the FFF, and reported on its versatility with satisfactory outcomes. The utility and techniques of free flap mandible reconstruction have advanced in the past 2 decades, with success rate up from 82.6% to 100%. As the longest bone segment available for reconstructive purpose, FFF is known for its wide variety of applications, following mandible resection, including angle-to-angle reconstruction. The fibula-free flap is currently considered the most popular, 'the gold standard and the workhorse flap' for mandibular reconstruction. However, because of the limited diameter of the fibula flap compared with the height of the mandible, vertical distance between the reconstructed segment and the occlusal plane can be substantial. This is a particular problem in the dentate mandible, especially when rehabilitation with dental implants or an implant-borne denture is contemplated. Insufficient bone height leads to overloading of osteointegrated implants and endangers the longevity of the prosthetic restoration. Insufficient bone height and poor soft tissue overlying the bone flap also create an unfavourable environment for the tissue-borne prosthesis. Such issues are particularly acute in patients with intact alveolar bone and dentition at healthy sites. The double-barrel technique, distraction osteogenesis, non-vascularized bone grafts, and guided-bone regeneration have all been used to resolve this. The double-barrel technique is a good method, but drawbacks include excess height of the neomandible and the considerable time required to contour and adapt the upper barrel. Distraction osteogenesis is a valuable and predictable treatment option; however, its wide application is limited by complexity of the surgery and the need for additional secondary surgery. To Overcome these challenges the investigators design a technique for mandibular reconstruction where free vascularized fibula flap is splitted and non-vascularized fibula graft is harvest from same leg and is placed between two splitted parts of free fibula flap to increase vertical height of fibula.

NCT ID: NCT04215510 Not yet recruiting - Clinical trials for Recurrent Nasopharyngeal Carcinoma

Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.