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NCT ID: NCT04923984 Recruiting - Subdural Hematoma Clinical Trials

Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can)

EMMA-Can
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

EMMA-Can is a prospective cohort study to assess the safety and effectiveness of MMA-embolization for the treatment of CSDH. Hypothesis- EMMA reduces the recurrence rate of SDH with or without concomitant surgical evacuation.

NCT ID: NCT04923893 Recruiting - Multiple Myeloma Clinical Trials

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

CARTITUDE-5
Start date: August 19, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

NCT ID: NCT04923659 Recruiting - Clinical trials for Low Intensity Focussed Ultrasound

Pharmacological Mechanisms of Low-intensity Focused Ultrasound for Motor Cortex Neuroplasticity

LIFUS-Pharma
Start date: May 25, 2021
Phase: Early Phase 1
Study type: Interventional

Low-intensity focused ultrasound (LIFUS) has been shown to be an effective and safe non-invasive brain stimulation technique, capable of reaching greater brain depth and a greater spatial resolution than other brain stimulation tools. Its use as a potential clinical tool for treatment of neurological disorders is reliant on an understanding of its mechanisms of action. Although it has been shown to induce immediate (online) and prolonged (offline) changes in plasticity in the motor cortex, researchers have not studied its effects on neurotransmitter receptors and ion channels responsible for neuronal signaling in humans. The purpose of this study is to explore the effects of online and offline LIFUS stimulation in tandem with administration of various brain-active drugs, to elucidate the effects of this technique on specific cortical receptors and channels. 20 healthy, screened subjects will be recruited to participate in 5 sessions in-lab. Each session will represent the double-blinded administration of four known and studied pharmacological agents known to safely induce changes in the motor cortex, as well as a placebo. Investigators will use carbamazepine (sodium channel blocker), lorazepam (GABAA positive allosteric modulator), nimodipine (calcium channel blocker), and dextromethorphan (glutamate N-Methyl-D-aspartate receptor antagonist). Single- and paired-pulse transcranial magnetic stimulation (TMS) measures will be recorded for online LIFUS before and after drug intervention, and induction of offline LIFUS during placebo will be compared with its induction following the various drug interventions. Investigators predict that due to the differential effects of online and offline LIFUS on motor parameters, the mechanisms in which it alters the receptors and channels of interest will also be differentially modulated.

NCT ID: NCT04923308 Recruiting - Low Back Pain Clinical Trials

The Effect of Chiropractor-informed Triage on Low Back Pain Patient Outcomes and Trajectories

Start date: July 6, 2021
Phase:
Study type: Observational

Almost everyone will have low back pain (LBP) at some point in their lives. LBP is a complex multifactorial condition for which diagnosis and clinical management remains a challenge. Factors such as wait times, delays in diagnosis or proper referral can result in Canadian patients having difficulty getting the care that they need. The overall objective of this project is to explore how chiropractors, who specialize in the diagnosis and clinical management of spinal conditions, can transform healthcare trajectories and improve the health of patients with LBP by integrating medical specialist team.To do so, patients with low back pain seeking medical care within the public health system will be first seen by chiropractors. Chiropractors will play a key role in identifying the type of low back pain and subsequently offering guidance to medical specialists with regard to the best treatment and management options that are currently recommended. Participating patients will be followed over a year while extensive health-related data will be collected and compared to non-triage patients with LBP.

NCT ID: NCT04922528 Not yet recruiting - Choledocholithiasis Clinical Trials

Visualization of the Extrahepatic biliaRy Tree Trial

VERT
Start date: August 2021
Phase: N/A
Study type: Interventional

This study is a prospective randomized controlled trial evaluating the use of a fluorescent dye, indocyanine green (ICG), in the identification of important bile duct anatomy during emergent same-admission cholecystectomy. Participants will be randomized into either the control arm, which uses the standard of care white light during laparoscopy or the intervention arm, which will use ICG fluorescent cholangiography as an adjunct to white light to visualize the biliary anatomy. The investigators hypothesize that the use of fluorescent cholangiography will increase the rates of identification of important biliary anatomy during laparoscopic cholecystectomy. The effectiveness, feasibility, and safety will be compared between the two groups using a post-operative survey form the surgeons will complete prior to exiting the operating room.

NCT ID: NCT04922385 Recruiting - Perimenopause Clinical Trials

Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Given the high rates and associated impairment of sexual concerns during the menopausal transition, and specifically during perimenopause, our team has developed a CBT protocol specifically designed to target these prevalent and distressing sexual concerns. The broad aim of the proposed study is to validate this new protocol in a clinic that provides empirically-supported assessment and intervention services for women with menopause-related symptoms. The primary objective of this study is to evaluate the efficacy of a four-week individual CBT protocol in improving sexual satisfaction and reducing distress during perimenopause. The secondary objective of this study is to evaluate the efficacy of this CBT protocol to improve sexual functioning (e.g., desire, arousal), relationship satisfaction, and body image. Exploratory analyses will examine the impact on this CBT protocol on vasomotor symptoms, depression, and anxiety.

NCT ID: NCT04922021 Completed - Atopic Dermatitis Clinical Trials

An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.

Start date: July 14, 2021
Phase: Phase 2
Study type: Interventional

This is a clinical study in adult participants with moderate to severe atopic dermatitis (AD). The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are when compared with a placebo injection with no medical ingredient. The study will last up to 36 weeks for each participant. The study will include a treatment period of 16 weeks, during which the participants will receive the injections, followed by a period of 16 weeks without treatment with the main purpose of continuing safety evaluations. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms and quality of life.

NCT ID: NCT04921969 Completed - Atopic Dermatitis Clinical Trials

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)

Start date: July 19, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).

NCT ID: NCT04921943 Recruiting - Clinical trials for Nontuberculous Mycobacterium Infection

Hypertonic Saline for MAC

Start date: May 18, 2021
Phase: Phase 4
Study type: Interventional

The MAC-HS study is a testing whether hypertonic saline helps improve symptoms and clearance of mycobacteria in patients with M. avium complex lung infections.

NCT ID: NCT04921137 Recruiting - Breast Cancer Clinical Trials

Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer

Start date: August 19, 2021
Phase: Phase 4
Study type: Interventional

The current standard of care for stage 1 hormone receptor-positive (HR+) breast cancer consists of breast-conserving surgery followed by adjuvant radiotherapy (RT) and endocrine therapy (ET) for at least 5 years. The benefit of adjuvant ET for older patients is mitigated because of their increase risk of death from other causes and shorter time horizon to live. Clinical and pathological factors such as low-intermediate grade, tumor size ≤2 cm, and older age have been used in a few studies to identify patients with a lower risk of recurrence that might benefit from adjuvant therapy de-escalation, i.e. omission of RT or ET. Since there is no dedicated randomized clinical trial (RCT) conducted to evaluate the omission of ET, there is clinical equipoise as to whether we can omit adjuvant ET in older patients with lower-risk early-stage breast cancer. Therefore, we propose a randomised, multicentre trial evaluating harms and benefits of endocrine therapy in patients ≥70 years of age with lower risk breast cancer.