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NCT ID: NCT03841526 Completed - Hypoglycemia Clinical Trials

Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D

Start date: August 22, 2019
Phase: Phase 2
Study type: Interventional

This study is a randomized, placebo-controlled, double-blind, 2-treatment, 2-period, crossover comparison in a clinical research center (CRC) setting, followed by a randomized, placebo-controlled, double-blinded, 2-arm parallel comparison with a third open-label arm in an outpatient setting. The purpose of the study is to evaluate the preliminary efficacy and safety of Glucagon Ready-to-Use [RTU] to prevent exercise-induced hypoglycemia (EIH) in adults with Type 1 diabetes mellitus (T1D), who perform regular, moderate-to-high intensity aerobic exercise.

NCT ID: NCT03841448 Terminated - Clinical trials for Glomerulonephritis, IgA

A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)

Start date: September 30, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB). These participants are at high risk for progression of kidney disease, which can result in end-stage renal failure.

NCT ID: NCT03841409 Completed - Pharmacokinetics Clinical Trials

Peak Plasma Levels of Bupivacaine After an Erector Spinae Block (ESP)

Start date: June 14, 2019
Phase:
Study type: Observational

The primary objective of the study is to measure plasma levels of bupivacaine following erector spinae (ESP) regional block in patients undergoing mastectomy.

NCT ID: NCT03841292 Completed - Smoking Cessation Clinical Trials

Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco Dependence

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

The addition of tDCS as an adjunct to pharmacotherapy is a novel approach but one that is grounded in a growing evidence-base.The primary objective of this research is to provide preliminary evidence of the effectiveness of tDCS as an adjunct treatment to pharmacotherapy for smoking cessation. The investigators hypothesize that the addition of active tDCS to the left DLPFC will improve the effectiveness of varenicline as reflected by higher quit rates at end of treatment compared to the sham group. Smoking status will be biochemically confirmed at various time points using expired cotinine measures. Furthermore, the investigators will be collecting neuroimaging (fMRI) data as well as measures of attentional bias to explore the neurological and physiological correlates from using adjunct tDCS and varenicline therapy.

NCT ID: NCT03840980 Terminated - Microbiota Clinical Trials

The Alberta BLOOM Preterm Neonate Study

BLOOM-PTN
Start date: January 14, 2019
Phase:
Study type: Observational

This is a prospective, observational clinical cohort study involving 100 mothers and their very preterm infants born at less than 32 weeks gestation. The purpose of this study is to gain a thorough understanding of the microbiome (the collection of microbes in a biological site) establishment in very preterm infants. The study will also examine the perinatal factors associated with the pattern of microbiome development, the metabolome and immune development of this population in the first months of life. All participants will be recruited from the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre (FMC) in Calgary, Alberta, Canada. Premature birth (birth before 37 weeks of pregnancy) occurs in about one in ten pregnancies each year. Babies that are born after less than 32 weeks of pregnancy are considered to be very premature babies. When babies are born very prematurely their gut is not as developed. One important factor in gut health is the large community of microbes (tiny living things such as bacteria) that live on the human body called the microbiome. Recent studies have shown that premature babies are more likely to have changes in their gut microbiome that are associated with health issues. However, sciences has not yet discovered what specific microbiome features are involved in development of premature babies. Therefore, this study examines the impact of very premature birth on the premature baby's microbiome. The kind of microbes that make up the microbiome in the gut in the first months of life have a major impact on the microbiome that will form during childhood. There are many environmental factors during pregnancy, birth and in first months of life that can impact the microbiome development. These factors include diet, exposure to antibiotics, surgical procedures, and birth mode. This study will investigate how these factors influence the types of early microbes present in preterm infants. The hypothesis of the study is that specific microbial patterns, trajectories and/or metabolites will be significantly associated with single or a combination of perinatal maternal and/or infant factors. The primary objective of the study is to learn more about the development of the microbiome in very premature babies in the first months of their life. To do this, participating baby's stool and urine samples will be studied. A secondary objective of the study is to find out how environmental factors impact the development of the microbiome and the health of preterm infants. In order to do this, maternal microbiome samples will be studied and information regarding maternal health, nutrition and environment during pregnancy will be collected. As well, information about the birth and health of participating preterm neonates will be collected.

NCT ID: NCT03840902 Terminated - Clinical trials for Non-small Cell Lung Cancer

M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Start date: April 16, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of this study was to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

NCT ID: NCT03840369 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Pathophysiological Understanding and Treatment of PTSD: an rTMS Approach

PTSD
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

In Canada, the prevalence of PTSD is approximately 12%, similar to Canadian military personnel. Current treatments for PTSD are limited in efficacy and durability - indicating a dire need for novel interventions in this population. Transcranial magnetic stimulation (TMS) has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions; even showing initial promise for PTSD. We propose to study this further in a randomized sham controlled trial of TMS for PTSD.

NCT ID: NCT03839953 Enrolling by invitation - Clinical trials for Peripheral Arterial Disease

Exercise Rehabilitation for Patients With Critical Limb Ischemia After Revascularization

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Peripheral arterial disease (PAD) affects more than 200 million people worldwide. This disease occurs with narrowing and occlusion of arteries supplying oxygenated blood to the organs and limbs. Symptomatic patients typically experience leg pain with physical activity. More advanced disease states are referred to as critical limb ischemia (CLI), where patients may have leg pain at rest or non-healing wounds. Primary treatment of PAD involves risk factor management; smoking cessation, management of blood pressure, blood cholesterol, diabetes, and exercise prescription. Patients with CLI typically require interventions to reestablish blood supply to their limbs. There is currently minimal understanding of the role for exercise rehabilitation after revascularization procedures in this vulnerable population. This is the first clinical to understand the role of exercise for these patients. We hypothesize that exercise rehabilitation after revascularization will improve quality of life and functional capacity in these patients.

NCT ID: NCT03839758 Recruiting - Shoulder Arthritis Clinical Trials

Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study

PITSA
Start date: October 8, 2019
Phase: N/A
Study type: Interventional

Total shoulder arthroplasty is an effective procedure to improve patients function and to relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this procedure is implanting the glenoid component. Indeed, surgical exposure is difficult and proper visualization of the glenoid is demanding. The current free-hand method is not precise and especially unreliable in glenoids with severe deformity. Inappropriate reaming and glenoid positioning can cause more bone loss during surgery. In anatomic prostheses, glenoid component fixation is demanding and is the first component to present loosening at long term follow-up. When it comes to reverse arthroplasty, the glenoid component, once again, requires the most attention. Malpositioning of the glenosphere can cause notching, loosening, and instability. In order to prevent these complications, precision in glenoid implantation is key. To this end, intraoperative computer navigation would be a helpful tool, but the increased expenses in computer equipment represent massive costs and possibly increases in surgical time. A more affordable option is a personalized guide, for which the only extra expense is the customized guide. These guides are based on precise 3D CT scan templates. Previous studies have evaluated the precision of the guide in vivo and in vitro, but none have measured it in a randomized study. As it represents additional costs, its efficacy needs to be proven before widespread use. This method may also provide secondary benefits, such as decreasing operating time, lowering short- and long-term complications, and improving efficacy. The objective of this study is to evaluate the performance of a patient specific glenoid guide.

NCT ID: NCT03839706 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Relationship Between 18FDG PET/MRI Patterns and ctDNA to Predict HCC Recurrence After Liver Transplantation

PETMRIinHCC
Start date: August 22, 2018
Phase: N/A
Study type: Interventional

Liver transplantation is the standard treatment for patients with early-stage Hepatocellular Carcinoma (HCC). Currently, important treatment decisions, like the selection of patients for transplantation, are made on crude, static tumour characteristics such as the size and number of lesions that do not reflect other aspects of tumour biology. To date, pre-transplantation percutaneous biopsy is the best strategy to assess tumoral differentiation and, consequently, tumor biological behavior. Previous studies have demonstrated that 18F-Fluorodeoxyglucose Positron Emission Tomography Magnetic Resonance Imaging (18F-FDG PET/MRI) may have role in assessing the HCC tumoral differentiation and predict survival after LT. The Investigators will assess the accuracy of 18F-FDG PET/MRI as a tool to predict HCC recurrence after liver transplant. To understand the role of 18F-FDG PET/MRI in prediction of HCC's biological behavior and upon recurrence, the investigators will try to assess whether the findings in 18F-FDG PET/MRI can predict HCC poor tumoral differentiation, if the findings in 18F-FDG PET/MRI are related to presence of circulating tumoral DNA in plasma and try to determine the role of 18F-FDG PET/MRI in predicting HCC recurrence after resection. These findings may impact the selection criteria for liver transplantation.