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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: NCT03862417 Recruiting - Clinical trials for Degenerative Scoliosis

The Adult Degenerative Scoliosis Exercise Trial (Pilot Study)

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

Adult degenerative scoliosis is the most common spine deformity in adults. Patients present a lateral curvature of the spine and vertebra rotation. Curves meeting indications for treatment affect 24% of the aging adult population. Adult scoliosis causes pain, curve progression, and cosmetic deformity affecting quality of life and function. Pain affects 90% of patients with AS. Other than surgery for severe cases and pain medication, very little non-operative treatments have been investigated. Scoliosis-specific exercises have shown promise in a single study in adults and in an Alberta adolescent study. The goal of this pilot randomized controlled trial on the effect of Schroth exercises in adults with degenerative scoliosis compared to observation is to determine the feasibility of conducting a larger study. This study will help plan and secure funding for a larger study by examining the ability to recruit enough eligible participants, whether patients can follow the prescribed program session attendance and complete the home exercises prescribed. The early estimate the effects of the exercises on pain, quality of life, disability, deformity and posture measurements will help determine the potential of this approach and the likely success of a larger RCT. This study addresses a need of adults with degenerative scoliosis who do not meet surgical indications but still experience pain and disability by exploring a promising exercise approach.

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: NCT03862287 Recruiting - Orthopedic Disorder Clinical Trials

Incidence of TNS After Intrathecal Lidocaine v.s Bupivacaine

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

This study will look into the incidence of Transient neurological symptoms (TNS) after the intrathecal use of lidocaine in comparison to intrathecal Bupivacaine.

NCT ID: NCT03862170 Suspended - Prostate Cancer Clinical Trials

Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer

BRP30
Start date: February 10, 2015
Phase: Phase 3
Study type: Interventional

Phase III study that aims to evaluate the necessity of prophylactic antibiotics use after HDR brachytherapy in the treatment of prostate adenocarcinomas.

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: NCT03861507 Recruiting - Prostate Cancer Clinical Trials

Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound

Start date: March 4, 2020
Phase: N/A
Study type: Interventional

This study involves patients who are scheduled for standard care brachytherapy of focal tumours within the prostate, which is normally performed under standard 2-dimensional (2D) ultrasound guidance. The purpose of this study is the acquire power Doppler ultrasound while using a simple oscillator in physical contact with the end of a brachytherapy needle. The vibrations along the needle should be visible in the power Doppler ultrasound, helping to visualize the needle position within the anatomy.

NCT ID: NCT03861273 Active, not recruiting - Hemophilia B Clinical Trials

A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

BENEGENE-2
Start date: July 29, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objective of the study will evaluate the annualized bleeding rate [ABR] for participants treated with gene therapy versus standard of care (SOC) therapy (FIX prophylaxis replacement regimen).

NCT ID: NCT03861026 Recruiting - Surgery Clinical Trials

Cerebral Oximetry to Reduce Organ Dysfunction After Non-cardiac Surgery

Start date: October 5, 2018
Phase: N/A
Study type: Interventional

Number of elderly patients requiring general anesthesia for major surgical procedures is increasing dramatically. It is estimated that 20% of these patients will develop major complications after surgery. Monitoring brain oxygen saturation may be helpful in reducing the postoperative complication rates. A decrease in brain oxygen is a sign that all other vital organs such as kidneys, heart, liver, and intestines have reduced blood supply and are starved from oxygen. This happens in 1 out of 5 patients undergoing major complex surgeries. Brain oxygen saturation monitor at this time is not used routinely during surgery, primarily due to the added cost, as well as, insufficient evidence that restoring the brain oxygen saturation to baseline would result in better outcomes. Patients will be randomly assigned to either study or control groups. In the study group, a special algorithm will be used to restore brain oxygen saturation. In the control group, the brain oxygen saturation will be monitored continuously, but the monitor screen will be electronically blinded, and standard clinical care applied. The objective of this study is to see if restoring the brain oxygen saturation to baseline results in less complication rates after surgery. The objective of this study is to reduce the incidence of postoperative morbidity due to end organ dysfunction after major non-cardiac surgery in elderly patients. The primary aim is to determine if restoration of rSO2 to baseline levels results in reduced incidence of major organ morbidity and mortality (MOMM). A secondary aim is to determine a cost-effectiveness of this monitoring modality.

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).