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NCT ID: NCT03864224 Completed - Low Back Pain Clinical Trials

A Pilot Implementation Study of GLA:D Back

Start date: February 11, 2019
Phase:
Study type: Observational

GLA:D Back is a program developed in Denmark to help people with persistent low back pain. This pilot study will assist in contextualizing Danish content into an English version of the program.

NCT ID: NCT03863561 Completed - Diabetes Mellitus Clinical Trials

The Skills, Confidence & Preparedness Index (SCPI)

SCPI
Start date: October 11, 2017
Phase:
Study type: Observational

The LMC Skills, Confidence and Preparedness Index (SCPI) is a tool that was developed by diabetes specialists to individualize the education/support that a healthcare provider delivers to patients with diabetes. It has been shown to have high reliability, validity and generalizability. This study assessed the validity and reliability of a revised, final version of the SCPI in a large sample of patients with type 1 and type 2 diabetes, as well as the clinical responsiveness of the SCPI to a diabetes self-management education intervention in a smaller cohort of patients with poor glycemic control.

NCT ID: NCT03863080 Completed - Myasthenia Gravis Clinical Trials

A Study of RVT-1401 in Myasthenia Gravis (MG) Patients

Start date: May 21, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the current study is to assess safety/tolerability and key pharmacodynamic (PD) effects that are considered to be associated with clinical benefit (reduction of total IgG and anti-AChR-IgG) in Myasthenia Gravis patients following treatment with RVT-1401 (also known as IMVT-1401) compared to placebo.

NCT ID: NCT03862716 Completed - Clinical trials for Type 2 Diabetes Mellitus

Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira

REMITiDegLira
Start date: April 23, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising IDegLira, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.

NCT ID: NCT03862482 Completed - Jaw, Edentulous Clinical Trials

Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function

Start date: June 3, 2019
Phase: N/A
Study type: Interventional

Brånemark System® dental implant osseointegration was introduced in 1965 as a novel approach to the replacement of missing teeth. Although this implant's machined, screw-shaped surface had excellent, well-documented, short- and long-term clinical success (Adell, R. 1987; Albrektsson, T., et al., 1981; Albrektsson, T., et al., 1986; Brånemark, P-I. , 1983; Brånemark P-I. 1987), newer implant designs were introduced that could enhance fusion of the implant to jaw bones, and better resist functional forces. One such implant, Screw-Vent®, has a fixture macro structure very similar to that of the Brånemark® implant. However, its fixture surface was acid etched (1-3µm) which could enhance osseointegration, and it has a longer, narrower machined internal-hex, friction-fit collar that could better resist functional forces.These characteristics should lead to less bone loss (Niznick, G. A., 1989). However, one clinical study (De Bruyen, et al., 1992) reported greater short-term bone loss with this implant compared to the Brånemark® implant, possibly due to its longer machined collar, and advocated long-term clinical studies. Therefore, this prospective within-subject clinical trial was undertaken in 1993 to first compare the Brånemark® implant with another implant, Swede-Vent®, a copy of the Brånemark® macro structure except for its fixture surface that was identically micro textured as that of Screw-Vent® by the same manufacturer. The effect on bone healing could then be compared between Brånemark®'s machined and Swede-Vent®'s micro textured fixture surfaces in the short- and long-terms. Since Screw-Vent®'s fixture surface was identically micro textured as that of Swede-Vent®, the investigators could then evaluate and compare the effects on bone healing of Screw-Vent®'s longer, narrower, internal-connection machined collar to the identical shorter, wider, external-connection machined collars of the Swede-Vent® and Brånemark® implants. All three two-part, platform-matched, parallel-wall implants were made of commercially pure titanium, had a very similar fixture macro design, were approved by the Food and Drug Administration (USA) and Health and Welfare Canada, and were commercially available in North America. Brånemark® and Screw-Vent® implants are still available, but the Swede-Vent® implant is not.

NCT ID: NCT03862404 Completed - Clinical trials for Post Thoracic Surgery

Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

Start date: July 1, 2017
Phase: Phase 4
Study type: Interventional

While thoracic epidural could control incisional pain after thoracotomy, an excruciating ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy patients. It is often difficult to manage and relatively resistant to opioids. The investigators postulate that in the presence of a functioning thoracic epidural, intrapleural bupivacaine administered through the chest tube could be effective in reducing post thoracotomy ipsilateral shoulder pain.

NCT ID: NCT03861793 Completed - Clinical trials for Advanced Solid Tumors

A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)

Start date: February 26, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.

NCT ID: NCT03860935 Completed - Heart Diseases Clinical Trials

Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

ATTRibute-CM
Start date: March 19, 2019
Phase: Phase 3
Study type: Interventional

Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

NCT ID: NCT03860701 Completed - Clinical trials for Enterocolitis, Necrotizing

Remote Ischemic Conditioning in Necrotizing Enterocolitis

Start date: December 17, 2018
Phase:
Study type: Observational

Necrotizing enterocolitis (NEC) affects up to 10% of very preterm infants. NEC mortality is high (30-50 %) and has remained unchanged over the last decades. New treatments are urgently needed. NEC pathogenesis is multifactorial, but bowel ischemia plays an essential role in NEC development. Remote ischemic conditioning (RIC) consists in inducing brief periods of non-lethal ischemia in a limb distant to an organ suffering from ischemia. RIC has been used in adults, children and term neonates with a variety of diagnosis. However, no study has been done including preterm infants with NEC.

NCT ID: NCT03860480 Completed - Clinical trials for Thoracic Surgery, Video-Assisted

Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery

Start date: November 29, 2018
Phase: N/A
Study type: Interventional

Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.