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NCT ID: NCT02736942 Enrolling by invitation - Surgery Clinical Trials

COLOR III Trial: Transanal vs Laparoscopic TME

COLORIII
Start date: December 2, 2016
Phase: Phase 3
Study type: Interventional

Background Surgery for mid and low rectal cancer is associated with relative high rates of incomplete mesorectal excisions and high rates of circumferential resection margin (CRM) involvement resulting in significant number of local recurrences. Moreover, patients with mid and low rectal cancer suffer from high rates of morbidity, permanent colostomies and impairment of quality of life. The transanal TME (TaTME) has been developed to improve the quality of TME surgery in mid and low rectal cancer. Study design The COLOR III trial is an international multicentre randomised study comparing short- and long-term outcomes of TaTME and laparoscopic TME for rectal cancer. The study will include a quality assessment phase before randomisation to ensure required competency level and uniformity of the new TaTME technique and the laparoscopic TME. During the trial clinical data will be reviewed centrally to ensure uniform quality. Endpoints The primary endpoint of the study is the local recurrence rate at 3-years follow-up. Secondary endpoints include sphincter saving procedures, short-term morbidity and mortality, involved circumferential resection margin (CRM), disease-free and overall survival at 3 and 5 years, completeness of mesorectum and quality of life. Statistics In laparoscopic TME the percentage of local recurrence at 3-years follow-up is estimated 5%. With the non-inferiority margin set at 4%, with a one-sided level of significance of 2.5% and a power of 80%, a total of 1104 patients is needed, 669 patients in the TaTME arm and 335 patients in the laparoscopic TME arm. All analyses will be performed on intention-to-treat basis. Main selection criteria Patients with histologically proven single mid or distal rectum carcinoma (0 to 10 cm from anal verge) at MRI, eligible for restorative surgery with a curative intent, are included. Patients with a T1 tumor suitable for local excision, T3 tumors with a suspected involved circumferential resection margin and T4 tumors are excluded. Hypothesis The hypothesis is that TaTME will result in a comparable local recurrence rate at 3-years follow-up with benefit of lower morbidity and conversions. Furthermore, because of direct endoscopic visualization, even in very low tumors a coloanal anastomosis can be created, resulting in a lower colostomy rate compared with laparoscopic and open resection. Because long-term outcomes are unknown, within a trial setting the technique can be standardized and quality control can be performed.

NCT ID: NCT04284007 Enrolling by invitation - Shoulder Pain Clinical Trials

Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

Start date: December 2, 2019
Phase: N/A
Study type: Interventional

Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management. The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.

NCT ID: NCT05335785 Enrolling by invitation - Supraspinatus Tear Clinical Trials

Efficacy of High Intensity Lazer Therapy in Partial Supraspinatus Tear

Start date: December 2, 2020
Phase: N/A
Study type: Interventional

Rotatorcuff lesions constitute 10% of the causes of shoulder pain. Supraspinatus tear is one of the common rotatorcuff lesions. It affects the quality of life negatively and causes loss of range of motion and muscle strength. It can be seen due to traumatic or degenerative causes. Its incidence increases with advanced age. While the incidence was reported as 4% in the population aged 40-60 years, this rate was reported to be 17-50% in the group over the age of 60 and 80% in the group over the age of 80. Radiologically, classification is made as partial or full-thickness tears. Rotatorcuff tears can be treated conservatively or surgically. Although the risk of post-surgical rupture is reduced with new methods, the lack of desired tendon healing has led to the search for alternative applications such as biological augmentation and high-intensity laser. The aim of this study is to reveal the effectiveness of high-intensity laser therapy in patients with partial supraspinatus tear.

NCT ID: NCT05492799 Enrolling by invitation - MPS III B Clinical Trials

Safety, Tolerability and Efficacy of ICV AX 250 Treatment in MPS IIIB -OLE

Start date: December 2, 2022
Phase: Phase 4
Study type: Interventional

This is a Phase 3B/4, multicenter, multinational, open label study to further evaluate intracerebroventricular (ICV) delivered AX 250 treatment in MPS IIIB subjects that complete Study 250-202 for up to an additional 3 years (144 weeks) of treatment with AX 250 administered by ICV infusion every other week. Subjects will be evaluated for neurocognitive function, communication, adaptive behavior, quality of life, imaging characteristics and biochemical markers of disease burden. Safety will be assessed by adverse events, clinical labs, and physical exams.

NCT ID: NCT05584553 Enrolling by invitation - Clinical trials for Biceps Tendon Disorder

PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder

Start date: December 2, 2022
Phase:
Study type: Observational

The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the ToggleLoc 2.9 mm and the JuggerLoc Soft Tissue Systems when used for soft tissue to bone fixation in the shoulder. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the shoulder. The secondary objective is the assessment of safety and clinical benefits. Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to device, instrumentation and/or procedure will be specified. Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs) at the longest follow-up after surgery (minimum one year).

NCT ID: NCT06071806 Enrolling by invitation - Odontogenic Cyst Clinical Trials

Recurrence of Odontogenic Keratocyst

Start date: December 2, 2022
Phase: N/A
Study type: Interventional

The aim of current cross over clinical trial is to evaluate the effect of topical 5-FU as adjunct therapy in reducing risk of the recurrence of OKCs

NCT ID: NCT06238765 Enrolling by invitation - Atopic Dermatitis Clinical Trials

CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry

Start date: December 2, 2023
Phase:
Study type: Observational

Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.

NCT ID: NCT03089021 Enrolling by invitation - Clinical trials for Nonspecific Neck Pain

Maitland Mobilization Versus Mulligan Mobilization in Sub-Acute and Chronic Non-Specific Neck Pain

Start date: December 20, 2016
Phase: N/A
Study type: Interventional

This study investigate the short term effect of Maitland in comparison to Mulligan mobilization with sub-acute and chronic non specific neck pain to improve neck pain, pain pressure threshold, rang of motion, joint position sense, disability, and to evaluate the interaction with psychological factors. Study design: experimental study

NCT ID: NCT03508817 Enrolling by invitation - Myopia, Progressive Clinical Trials

Atropine 0.01% Eye Drops in Myopia Study

AIMS
Start date: December 20, 2018
Phase: Early Phase 1
Study type: Interventional

Control of myopia progression has become an important goal because of concerns regarding significantly increased risks of retinal degeneration, retinal detachment, glaucoma and cataract associated with high myopia. It is also clear there prevalence of myopia in children and young adults is increasing all over the world. Several methods including use of progressive addition lenses, rigid gas-permeable contact lenses, and life-style modifications (increased outdoor activity) have reported to alter myopia progression with varying efficacy. In general they have yielded clinical results of marginal significance. Atropine sulphate eye drops has consistently been demonstrated to inhibit axial myopia progression in both humans and animal models. Yet it has not found widespread clinical application for myopia control due to ocular side-effects of cycloplegia and pupil dilation. Recently 0.01% atropine has been shown to be effective in arresting myopia progression without side-effects of cycloplegia and near vision impairment and pupil dilatation and increased light sensitivity. Almost all studies on atropine have been carried out on children of Chinese origin. Efficacy (concentration and dosing) and safety need to be established in the population of interest, before routine use can be recommended. We plan to evaluate the efficacy and safety of topical 0.01% atropine eye drops in slowing the progression of myopia and ocular axial elongation in Omani children. A total of 150 children of ages 6-16 years will be randomized to two groups. Intervention group will receive atropine 0.01% once daily in each eye for two years (Phase 1). Control group will not receive any medications. Follow up visits will be scheduled every three months in Phase 1. Subsequently, medication will be stopped and the study patients will be followed up every six months for one year (Phase 2). The progression of myopia (change in refractive error and axial length) will be compared in the two groups by objective methods.

NCT ID: NCT04872296 Enrolling by invitation - Fibula Fracture Clinical Trials

Weight Bearing for Fibular Fractures

Start date: December 20, 2018
Phase: N/A
Study type: Interventional

It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Isolated lateral malleolar fractures after ORIF may benefit from earlier weight bearing in terms of patient satisfaction, short-term functionality, and return to work. The purpose of this study is to determine if early weight bearing at 2 weeks postoperatively for isolated lateral malleolar fractures leads to a higher satisfaction with surgery as compared to standard protocol for postoperative ankle fractures and better functional outcomes