Clinical Trials Logo

Filter by:
NCT ID: NCT02100696 Completed - Ulcerative Colitis Clinical Trials

A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

HICKORY
Start date: May 21, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

NCT ID: NCT02100514 Completed - Hyperlipidemia Clinical Trials

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events

SPIRE-LL
Start date: October 28, 2014
Phase: Phase 3
Study type: Interventional

This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.

NCT ID: NCT02100384 Completed - Ultrasonics Clinical Trials

Long Term Comparison of Ultrasonic and Hand Instrumentation in the Maintenance of Peri-implant Tissues: A Randomized Clinical Trial

Start date: April 2014
Phase: N/A
Study type: Interventional

Nowadays, dental implants are a very attractive and affordable treatment option for patients. According to the American Society of Implant Dentistry the dental implant market in the U.S is projected to reach $1.3 billion by 20101. Despite the high success rates of dental implants, it is clear that osseointegrated implants are susceptible to diseases. The prevalence of dental implant complications are rising as the number of individuals that are receiving implant treatment is also increasing. One of these peri-implant complications is an inflammatory condition known as peri-implant mucositis that occurs in 64.6% to 80% of the implant population. The lack of preventive maintenance therapy in subjects with peri-implant mucositis is associated with a high incidence of peri-implantitis, which eventually may lead to implant loss. One important method in the prevention of peri-implant mucositis is the reduction in plaque accumulation, through individual oral hygiene procedures and regular peri-implant professional maintenance. It is highly important that patients be educated about the importance of developing good oral hygiene habits and to attend regular periodontal maintenance appointments. The clinicians have to recognize the significance of monitoring and maintaining peri-implant health. Unfortunately, it is unclear which of the different maintenance regimens and treatments strategies for peri-implant mucositis and peri-implantitis are more effective. There is lack of information about which peri-implant maintenance protocol offers the best outcome in terms of reduction of inflammation and improved patient comfort. According to Grusovin et al, "there is only low quality evidence for which are the most effective interventions for maintaining or recovering health of peri-implant soft tissues and there is no reliable evidence as to which regimens are most effective for long term maintenance". Moreover, current approaches to implant maintenance are somewhat haphazard and not standardized. It is assumed that what is appropriate for teeth is also beneficial for implants; as stated by Persson et al, 2010 "therapies proposed for the management of peri-implant diseases are currently based on the evidence available from the treatment of periodontitis". Two conventionally used methods of biofilm and calculus removal from teeth in North America are hand instruments (curettes and scalers) and ultrasonics. In teeth these two modalities of treatment have been studied extensively; conversely, there are fewer studies on dental implants. Renvert et al, 2008 concluded that mechanical non-surgical treatment might be effective to treat peri-implant mucositis but not peri-implantitis; however, the data supporting this literature review was scarce. The same research group compared ultrasonic instrumentation with specific-implant tips to titanium curettes in the treatment of peri-implantitis founding no group differences in the treatment outcomes with improvements in plaque and bleeding scores but no effects on probing depths. In addition, both methods failed to eliminate or reduce bacterial counts and no group differences were found in the ability to reduce the microbiota in a six months period. One of the main concerns for dental implants is that metal scalers and ultrasonics generate a roughened surface on the implant, which in turn facilitates plaque accumulation and therefore makes maintenance of plaque free surfaces more difficult. It was observed in a recent study that special coated scalers and ultrasonic tips have been shown in vitro to be compatible with implant surfaces, however this has not been confirmed in vivo. The previous finding is in agreement with a current study, which demonstrated that the roughness values of the titanium surface of implants treated with piezoelectric ultrasonic scalers with a newly developed metallic tip and plastic hand curettes, are equal to the surface's roughness of untreated implants. Mann et al, 2012 showed in an in vitro study that plastic-coated scalers cause minimal damage to the implant surface but leave plastic deposits behind on the implant surface, suggesting further research is needed to evaluate the use of such plastic tips in the debridement of implants. An additional factor, in evaluating the efficacy of different instrumentation in peri-implant maintenance, which needs to be taken into consideration, is patient perception. There is currently no data evaluating patient perception of comfort in regards to hand vs. ultrasonic instrumentation. This information is very important because should both methods of debridement be considered of equal efficacy, patient preference may play a role in the practitioner's selection of instrumentation. Knowing that patient comfort will increase the patient's compliance to the maintenance therapy, further evaluation of this factor is necessary.

NCT ID: NCT02100371 Completed - Clinical trials for Basal Cell Nevus Syndrome

Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome

Start date: February 2014
Phase: N/A
Study type: Interventional

This is an extension study of Protocol CA194002 to allow 2 specific participants with basal cell nevus syndrome in the CA194002 study at Princess Margaret Cancer Centre who are still benefitting from the study drug BMS-833923 to continue receiving the study drug. This study will continue to evaluate the safety and tolerability of BMS-833923 in these participants.

NCT ID: NCT02100228 Completed - Atrial Fibrillation Clinical Trials

Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)

EMANATE
Start date: July 14, 2014
Phase: Phase 4
Study type: Interventional

Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart. Those clots can travel in the blood circulation to the brain and cause a brain attack ("a stroke"). To prevent those clots forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works by stopping one of the blood substances required for clotting ("Factor Xa"). It is approved and used to prevent clots forming in people with "AF". Other established blood thinners work by stopping clotting substances being made, known as "Vitamin K antagonists" or "VKAs". An example of this type is Warfarin (Coumadin). The good effects of all blood thinners are preventing clots, and they may also have bad effects of increasing the chance of bleeding. People with "AF", abnormal heart beat, may benefit from changing it back to a normal regular rhythm, known medically as "cardioversion". When this is done, people are currently most commonly treated with a "VKA" blood thinner (e.g. warfarin). The purpose of this study is to assess the good and bad effects ("efficacy" and "safety") of apixaban compared with warfarin in people with "AF" in whom an early cardioversion is planned.

NCT ID: NCT02100020 Completed - Multiple Sclerosis Clinical Trials

Implementing Physical Activity Guidelines for Adults With MS

Start date: May 2014
Phase: N/A
Study type: Interventional

The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life. This randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.

NCT ID: NCT02099890 Completed - Depression Clinical Trials

The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury

Start date: September 2014
Phase: Phase 3
Study type: Interventional

Spinal cord Injury (SCI) is a condition commonly associated with a state of chronic low-grade inflammation due to a variety of factors such heightened risk for infection and development of metabolic disorders. Many disorders which have been demonstrated to have an inflammatory basis have also been found to be at much higher prevalence following SCI. Such conditions include, but are not limited to, depression, cognitive impairment, neuropathic pain, and somatic/autonomic nerve function. The fact that such disorders have an inflammatory basis provides a unique opportunity to treat them with intervention strategies which target the immune system. Natural anti-inflammatory interventions including a diet consisting of foods and supplements with anti-inflammatory properties may be an effective option for treating inflammation in this population. As this treatment strategy will target the inflammatory basis of many disorders it would be expected to lead to a reduction in pro-inflammatory mediators thereby leading to more sustainable long-term immune improvements regarding enzyme function and protein balances. Despite this, surprisingly little research has focused on the use of anti-inflammatory foods for the treatment of chronic inflammatory conditions, and effects specific to SCI have been almost completely neglected. As such, the current study will focus on the daily intake of natural supplements with anti-inflammatory properties over a 3 month intervention and the effects on inflammation and associated disorders will be assessed. It is hypothesized that the supplementation will result in positive alterations in enzyme regulation and protein balances resulting in improvements in each of the outcome measures of interest.

NCT ID: NCT02099656 Completed - Asthma Clinical Trials

A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma

Start date: November 6, 2014
Phase: Phase 2
Study type: Interventional

This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.

NCT ID: NCT02099435 Completed - Colonic Polyp Clinical Trials

Study of Hemospray for Lower Gastrointestinal Hemorrhage

Start date: January 2015
Phase: N/A
Study type: Observational

This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.

NCT ID: NCT02098967 Completed - Clinical trials for Neoplasms, Myelogenous Leukemia, Acute

A Study of the Safety and Pharmacokinetics of RO6839921, An MDM2 Antagonist, in Patients With Advanced Cancers, Including Acute Myeloid Leukemia.

Start date: April 21, 2014
Phase: Phase 1
Study type: Interventional

This open label, Phase I study of RO6839921 is a dose-escalation study with two arms. Prior to investigations in either arm, patients in a single cohort, Cohort 0, will receive non-escalating, intravenous (IV) doses of RO6839921 daily on Days 1-5 of a 28-day cycle. Interim PK and safety data from this cohort will be evaluated before initiating dose-escalation. In arm A, RO6839921 will be given to patients with advanced solid tumor malignancies. In Arm B, RO6839921 will be given to patients with relapsed/refractory acute myeloid leukemia (AML). The arms will escalate independently. Escalation will begin in solid tumor patients (Arm A) in single patient cohorts, using a new Continual Reassessment Method (n-CRM). Escalation for AML patients will be initiated at or below the dose level that causes >/= Grade 2 hematologic side effects in Arm A. Escalation in AML patients will follow a rolling 6 design. In both arms, RO6839921 will be administered by IV infusion on Days 1-5 of 28-day cycles. There will be no intrapatient dose escalation. All patients may be treated until disease progression/relapse or unacceptable toxicity.