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NCT ID: NCT04674969 Recruiting - Clinical trials for Peripheral Vascular Diseases

Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature

ELEGANCE
Start date: March 29, 2021
Phase:
Study type: Observational [Patient Registry]

The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

NCT ID: NCT04673578 Recruiting - Clinical trials for Obsessive-Compulsive Disorder

Adjunctive Celecoxib in Childhood-onset OCD Study

ACE-OCD
Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, controlled, single-centre phase II superiority trial to determine the efficacy of 12 weeks of celecoxib (50 mg or 100 mg orally twice daily, dosed based on weight) compared to placebo as an adjunct to treatment-as-usual in children and youth with moderate-to-severe obsessive-compulsive disorder.

NCT ID: NCT04671862 Recruiting - Clinical trials for Head and Neck Cancer

Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

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

Radiotherapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated with radiotherapy for head and neck cancer Previous studies in head and neck cancer patients have shown that photobiomodulation (light therapy) can prevent mucositis. There are currently no centers in Canada using this technique in routine practice, but this is recommended in International guidelines and widely used in Europe. The investigators therefore wish to implement this technique in Ottawa under the umbrella of a clinical trial to insure its safety and efficacy in a Canadian context.

NCT ID: NCT04671511 Recruiting - Clinical trials for Breast Cancer Female

Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer

TADEN
Start date: March 30, 2021
Phase: N/A
Study type: Interventional

RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population. PURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.

NCT ID: NCT04670016 Recruiting - Radiation Toxicity Clinical Trials

HRQL and Symptom Assessment for Patients With DIPG or Recurrent and Re-irradiated Brain Tumours and Their Caregivers

Start date: July 2, 2020
Phase:
Study type: Observational [Patient Registry]

Although many children with brain tumours are successfully cured of their disease, a substantial proportion of patients suffer disease recurrence and require further treatment. This therapy may involve a repeat course of radiation (RT2). Based on retrospective data, re-irradiation may provide palliative and even potentially curative benefit. However, such retrospective data are subject to bias, which may over-report survival and under-report toxicity. Furthermore, we do not know how re-irradiation affects patients' HRQOL. The goal of this research is to prospectively describe the HRQOL of patients diagnosed with DIPG and recurrent brain tumors and their families before and after re-irradiation to more accurately assess the benefit versus the toxicity of this treatment. In addition, if we are able to demonstrate the feasibility of collecting HRQOL information on a routine basis we will be able to justify the need to conduct this research further and implement HRQOL screening as a standard of care for these patients. Re-irradiation for children with DIPG and recurrent brain tumours will not cure these children from their disease but may improve neurological function and wellbeing. We postulate that the opportunity of more time to say the final good bye and creating memories will facilitate bereavement and prevent psychological dysfunction of parents and siblings. A greater understanding of what helps these families may enable clinicians to better support these children and their families in this difficult disease course. Ultimately our goal is to improve the psychological experience of these patients and their families.

NCT ID: NCT04669015 Recruiting - Covid19 Clinical Trials

Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19

NOVATION-1
Start date: June 10, 2021
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, multicenter, placebo-controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalized adult patients diagnosed with COVID-19. The study is comprised of two cohorts: - Cohort A: This is a blinded safety lead-in comprising two arms. 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus Standard of Care (SOC) - Cohort B: This is the main portion of the study, which comprises two arms. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC

NCT ID: NCT04666974 Recruiting - Anxiety Disorders Clinical Trials

Delivering iCBT to Address Mental Health Challenges in Correctional Officers and Other Public Safety Personnel

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

Public safety personnel (PSP) have regular and often intense exposure to potentially traumatic events at work and are at higher risk for developing mental health problems such as posttraumatic stress disorder (PTSD). Studies have shown up to 4 times higher suicidal ideation, attempt and death among this population compared to the general population. Despite the high rate of mental health problems among PSPs, their willingness to receive mental healthcare support is fairly low, mainly due to the stigma attached to these disorders. Those who are willing to seek help face unique barriers including their irregular shift hours, limiting their access to resources otherwise available to the public. Given these challenges and the critical contribution of PSPs to public safety, developing innovative solutions to address their mental health must be a healthcare priority. This proposal aims to study the efficacy of using an innovative approach in delivering mental health online, to address mental health problems among correctional workers (CW), who are especially prone to mental health problems given the high rate of workplace violence. It is hypothesized that using an online platform to deliver cognitive behavioural therapy (CBT), would lower the stigma of receiving care in a secure and confidential environment, easing CW's concerns about stigma from co-workers. The content is delivered through interactive and engaging therapy modules, designed for specific groups of CWs and customized by situational examples to make therapy more relatable. These online modules would provide CWs with 24/7 access to therapy content, solving the irregular work hour problem. The online CBT modules developed in this study would provide high quality and clinically validated resources to address mental health problems of CWs all across Canada. Knowledge acquired through this project could also be beneficial to using iCBT in general for addressing mental health challenges among other PSPs.

NCT ID: NCT04666493 Recruiting - Clinical trials for Autism Spectrum Disorder

Adapting Anxiety Intervention for Youth With Autism for Rapid Response to COVID-19

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

This study will examine if a virtual delivery of a group Cognitive Behavioural Therapy (CBT) program, specifically using "Facing Your Fears" (FYF) curriculum, is helpful in improving anxiety symptoms for children and youth with ASD. This study will adapt the FYF program for virtual delivery using a platform called "Zoom for Healthcare" and examine its effectiveness.

NCT ID: NCT04665388 Recruiting - Solid Tumor Clinical Trials

LANDscape MApping of Epitopes and T Cell Receptors for Selected Cancers

LANDMARC
Start date: November 30, 2020
Phase:
Study type: Observational

This is a correlative research project aimed at characterizing the T cell mediated immune responses to hepatocellular carcinoma (HCC), as well as Epstein-Barr virus (EBV)- and human papillomavirus (HPV)-related cancers. This study will enroll approximately 105 patients over 48 months. Of these 105 patients, 30 are EBV-related cancer, 45 are HPV-related cancer, and 30 are HCC. Patients will have blood samples collected one time to identify cancer specific T cells and T cell receptors in their blood. They will also have tissue samples collected one time to study the different types of immune cells, especially the T cells and their receptors. The 105 patients enrolled in this study will be compared to retrospective samples (N=210; 30 from EBV-related cancer cohort, 180 from HPV-related cancer cohort).

NCT ID: NCT04664582 Recruiting - Sentinel Lymph Node Clinical Trials

Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck

Start date: November 26, 2020
Phase: N/A
Study type: Interventional

Current guidelines in management of regional lymph node metastases for cSCC patients include surgical resection with or without adjuvant therapy as well as chemotherapy and interdisciplinary management; in advanced disease, supportive and palliative care is recommended. These guidelines also define the role of SLNB in management of high-risk cSCC as unclear and suggest further studies need to determine its utility and indications11. Currently, routine practice of performing SLNB in cSCC varies across Quebec and within Canada. At many institutions, SLNB is not routinely performed on patients with cSCC. The current standard of treatment is to observe closely when a patient is deemed to have a high-risk cancer, and if they have clinical or radiological findings of lymphadenopathy, a formal surgical neck dissection is performed. Given the comorbidities and risks involved in treatment of regional lymph nodes in cSCC, the role of SLNB in cSCC patients needs further clarification. This multicentre prospective study aims to better clarify this role and formulate suggested criteria for its indications.