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NCT ID: NCT03012334 Completed - Migraine Clinical Trials

The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants

Start date: January 16, 2017
Phase: Phase 1
Study type: Interventional

This will be a randomized, single dose, double-blind, placebo-controlled, Latin-square design with 5-period (full) crossover study with participants randomized to treatment sequences. Participants will complete all 5 Periods. During each Period, participants will come to the clinical research unit (CRU) and remain overnight before being dosed with a single dose of either lasmiditan, alprazolam, or placebo in the morning. Cognitive testing and driving simulation will be conducted post dosing. Participants will have a washout of at least 5 days between each Period. This study is designed to test non-inferiority of lasmiditan doses relative to placebo, with an alprazolam test versus placebo to confirm the sensitivity of the simulator to detect treatment effects.

NCT ID: NCT03012256 Completed - Heart Failure Clinical Trials

The DIVERT-CARE (Collaboration Action Research & Evaluation) Trial

DIVERT-CARE
Start date: February 6, 2018
Phase: N/A
Study type: Interventional

Rationale: In Canada, home care clients are a large and expanding subgroup of medically complex older adults with relatively poor access to effective chronic disease management. They have double the emergency department utilization rate compared to nursing home residents or other older populations. The investigators previously published a case-finding tool (the Detection of Indicators and Vulnerabilities for Emergency Room Trips (DIVERT) Scale) that has been recommended for chronic disease management case-finding in home care. The investigators recently conducted a pilot trial in Niagara, Canada, of a targeted, person-centered model of supportive cardio-respiratory disease management. Objectives: The investigators will evaluate a cardio-respiratory disease management model in home care to manage symptoms and avoid emergency department use. A pan-Canadian, pragmatic cluster-randomized trial will be conducted by a collaboration of trial investigators and public home care providers (i.e., health regions). The main objective is to evaluate the effectiveness and preliminary cost-effectiveness of a targeted, person-centered cardio-respiratory management model. The main question is: P: Among home care clients experiencing cardio-respiratory symptoms (objectively targeted using the DIVERT Scale), I: can a guideline-based, feasible, multi-component/complex, cardio-respiratory management model, C: compared to regular care, O: reduce cardio-respiratory symptoms, reduce/postpone unplanned emergency department (ED) visits, reduce unplanned hospital use, improve patient activation, or improve health-related quality of life for clients, T: over a 6-month follow-up period from baseline?

NCT ID: NCT03012061 Completed - Asthma Clinical Trials

Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma

Start date: January 25, 2017
Phase: Phase 2
Study type: Interventional

This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25 mcg on lung function versus placebo after 24 weeks of treatment. This study will provide important information regarding the efficacy and safety of UMEC when administered in a separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase IIb, randomized, double-blind, placebo controlled study that will compare the efficacy, safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects with asthma that is not well controlled. Eligible subjects will be requested to participate in the study for a maximum of approximately 31 weeks with 4 phases (pre screening, screening/run-in, randomization/treatment and safety follow-up). The total number of randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each of the 3 double-blind treatment arms.

NCT ID: NCT03011892 Completed - Atopic Dermatitis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

Start date: January 9, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

NCT ID: NCT03011320 Completed - Ovary Cancer Clinical Trials

An Exploratory Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Surgery

Start date: January 24, 2017
Phase: Phase 1
Study type: Interventional

This study looks to enroll subjects with ovarian cancer who will be having standard of care surgery to remove ovarian cancer tumors. The main aim of this study is to be able to observe how EC1456 has been taken in and broken down inside tumors. The effect of EC1456 on the tumor will also be studied. This study will also help us compare the amount of EC1456 seen in tumors and how the tumors are imaged by the 99mTc-etarfolatide single-photon emission tomography (SPECT) or single-photon emission tomography with in-line x-ray computed tomography (SPECT/CT). All subjects will undergo a 99mTc-etarfolatide SPECT or SPECT/CT scan within 2 weeks prior to EC1456 administration. Individual subjects will then receive 1 of the following 2 doses of EC1456 pre-operatively: - 4 mg/m2 - 8 mg/m2 EC1456 will be administered at 1 of the following 2 time points: - <8 hours before planned surgery - 48±4 hours before planned surgery Blood will be collected for pharmacokinetic (PK) studies right after EC1456 dosing and again right before surgery. At the time of surgery, tumor samples will be removed and sent to Endocyte for analysis.

NCT ID: NCT03010826 Completed - Clinical trials for Demyelinating Disease

Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children

Start date: December 2016
Phase:
Study type: Observational

The neural circuits in our brains require a layer of insulation in order to transmit signals in a rapid and efficient fashion. This insulation is called White Matter and is comprised of a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and cognitive problems. Currently there are no effective medical therapies to promote brain repair and reduce disability following damage to white matter. In this project, we hope to change the situation by encouraging the brain itself to generate new oligodendrocytes and thus new white matter. Our first step is to find measures sensitive to white matter growth.

NCT ID: NCT03010657 Completed - Clinical trials for Non-Small Cell Lung Cancer

Modifying Your Diet to Support Muscle During Cancer Treatment.

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

In a person with cancer, low muscle mass and strength increases the risks of suffering from severe complications of the disease, its treatment, and dying. To prevent muscle loss in cancer, stimulating muscle protein anabolism (growth) by fueling muscles with protein is crucial. Dairy products are not only a source of high-quality protein but are a preferred food choice for cancer patients as they progress through chemotherapy treatment. Although commercially available oral nutritional supplements containing essential amino acids are often promoted for protein anabolism, these products are not preferred by cancer patients. Moreover, our research group has shown that patients consuming oral nutritional supplements actually lose more weight than those who chose regular whole-food items. Evidence of the health effects of consuming dairy products is needed to influence dietary recommendations for people with cancer. The objective of our study is to perform a clinical trial to evaluate the efficacy of dairy products to maintain muscle mass and strength and improve patient outcomes in people undergoing chemotherapy treatment for cancer.

NCT ID: NCT03010527 Completed - Clinical trials for Chronic Plaque Psoriasis

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis

BE ABLE 2
Start date: December 14, 2016
Phase: Phase 2
Study type: Interventional

This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

NCT ID: NCT03010254 Completed - Cataract Clinical Trials

A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)

Start date: March 21, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.

NCT ID: NCT03009500 Completed - Neuralgia Clinical Trials

Randomized Controlled Trial of Efficacy and Safety of Local Anesthetics and Steroids for Chronic Peripheral Post-traumatic Neuropathic Pain

RESPERIST
Start date: January 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate three different injectable solutions used to block ankle nerves to manage ankle pain. The current standard of medical care is to inject a combination of local anesthetics and steroids around injured nerves. There is evidence that injection of local anesthetic (without the steroid) can calm the injured nerve and provide pain relief from a few days up to a few months. Injection of sterile salt water also has the potential to provide pain relief by breaking scar tissue around the nerve thereby relieving compression. Injections of local anesthetic and steroids around injured nerves have been used for many years to provide relief of pain but the specific reason is not well known for this benefit. There are three possibilities: 1) Steroids can reduce inflammation and calm the nerves, 2) local anesthetics can have similar actions but with shorter duration (few days), and 3) injection of any solution can break scarring around an injured/compressed nerve. The study will compare pain relief and possible adverse effects from these three different solutions. This study will help provide definitive answers regarding pain relief and possible adverse effects of the three solutions. This, in turn, will determine the best possible option for injection in patients with nerve-related injury pain.