Clinical Trials Logo

Filter by:
NCT ID: NCT05522959 Recruiting - Breast Cancer Clinical Trials

Cardio-Oncology Rehabilitation Exercise

CORE
Start date: March 14, 2022
Phase:
Study type: Observational

Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.

NCT ID: NCT05522374 Recruiting - Clinical trials for Neurodegeneration With Brain Iron Accumulation (NBIA)

TIRCON International NBIA Registry

TIRCON
Start date: June 14, 2012
Phase:
Study type: Observational [Patient Registry]

TIRCON-reg aims to - continue the provision of a global registry and natural history study for NBIA disorders - harmonize and cover existing national and single site registries - enable participation of countries and single sites that so far have no access to an NBIA registry - join forces in order to recruit sufficient numbers of patients - define the natural history of NBIA disorders - define the most appropriate outcome measures - inform the design and facilitate the conduction of clinical trials

NCT ID: NCT05522244 Recruiting - Clinical trials for Acute Ischemic Stroke

The Extended CTA for the Successful Screening of Cardioaortic Thrombus in Acute Ischemic Stroke and TIA (DAYLIGHT) Trial

DAYLIGHT
Start date: July 17, 2023
Phase: N/A
Study type: Interventional

Embolic strokes of undetermined source (ESUS) represent a subset of cryptogenic strokes that are suspected to have an occult embolic source. The risk of stroke recurrence in patients with ESUS varies between 1.9%/year and 19.0%/year depending on the prevalence of vascular risk factors. Part of the elevated recurrence rate is due to the inability to identify high-risk treatable causes such as cardiac thrombi as those found in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), valves, or aortic arch. The most frequently used diagnostic method in clinical practice to detect cardioaortic thrombi is transesophageal echocardiography (TEE). However, the relatively low availability, higher cost, and invasive nature of TEE limit its large-scale usability. In most stroke centers, patients presenting with an acute ischemic stroke or TIA undergo a tomography (CT) angiography (CTA) of the neck and intracranial vessels. This standard of care CTA (sCTA) classically includes the aortic arch, the higher portion of the ascending/descending aorta, and the rostral portion of the cardiac chambers, but does not involve the LAA, LV, or cardiac valves. A recent study performed among 300 patients with an acute ischemic stroke showed an overall LAA thrombus detection of 6.6% and 15% in patients with AF by extending the CTA 6 cm below the carina. This is an extraordinarily high prevalence of LAA compared to 0.5% to 4.8% of intracardiac thrombi identified on TEE in most previous studies. The major limitation of previous CTA and TEE studies is their observational design, so the differing prevalence of LAA thrombi could be explained by dissimilar population characteristics or selection bias. Based on the methodological limitation of prior studies and the promising role of extended CTAs (eCTA), a randomized controlled trial comparing eCTA + standard of care stroke workup vs. sCTA + standard of care stroke workup is needed.

NCT ID: NCT05521711 Recruiting - Food Allergy Clinical Trials

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

TRADE
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Tree nut immunotherapy Route Assessment and DEvelopment (TRADE) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.

NCT ID: NCT05521360 Recruiting - Clinical trials for Stress, Psychological

Autonomic Modulation Training for Police Exposed to Post-Traumatic Stress Injuries

AMT
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

Police officers are exposed to hazardous, disturbing events that impose stress and long-term trauma. Upwards of 15-26% of public safety personnel (PSP) report one or more mental health symptoms. Accumulated stress and posttraumatic stress injuries (PTSI) result in chronic physical and mental health disorders including anxiety, depression, substance abuse, and cardiovascular disease. PTSI are related to reduced occupational performance, absenteeism, and risky behaviour, with implications for both police and public safety. Recent empirical evidence and government reports highlight a mental health and suicide crisis among various PSP sectors in Canada. Prior research forms an urgent call for evidence-based programs that build resilience and wellness capacity to prevent PTSI symptoms before they manifest as severe, chronic, diagnosable disorders. The current study addresses the limited effectiveness issues associated with existing interventions for PTSI among PSP and also considers sex and gender as central determinants of health. Advances in physiology and neuroscience demonstrate that resilience is maintained by the healthy functioning of psychophysiological systems within the body. Objective biological measures have shown that chronic stress and trauma disrupt both psychological and physiological functioning, eroding resilience and reducing wellness capacity. Traditional interventions to build resilience among PSP have not adequately addressed the physiological underpinnings that lead to mental and physical health conditions, as well as burnout and fatigue following trauma. Together with previous empirical research lead by the NPA, the current proposal addresses this gap in PSP intervention research by employing Autonomic Modulation Training (AMT), a biological approach to building resilience and wellness capacity among PSP exposed to PTSI. Prior research shows that core AMT techniques effectively reduce psychophysiological stress and mental health symptoms in clinical and non-clinical populations. Further, research has shown that AMT techniques improve police health and occupational performance when completed during scenario-based, in-person training. The aim of the proposed study is to test if a web-based delivery of AMT for police officers can build resilience and wellness capacity, and reduce symptoms of PTSI with similar effectiveness as in-person training. An additional novel scientific contribution of the current proposal includes an examination of sex and gender in baseline biological presentation of PTSI among police, and in response to a resilience building intervention.

NCT ID: NCT05520710 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Symptom-Targeted Rehabilitation for Concussion

STAR-C2
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The investigators are comparing two methods for helping improve everyday cognitive functioning in Canadian Armed Forces (CAF) veterans who have sustained a mild traumatic brain injury (mTBI). The two methods are 1) providing educational materials (Education Group) and 2) individual cognitive rehabilitation delivered by a trained Occupational Therapist or Speech-Language Pathologist (Therapy Group). The study is a pilot randomized controlled clinical trial (RCT), and will serve as pilot data for a future RCT.

NCT ID: NCT05520255 Recruiting - Prostate Cancer Clinical Trials

18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028

Start date: July 25, 2023
Phase: Phase 3
Study type: Interventional

A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: 1. Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L 2. Adult patients with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months 3. Adult patients with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c 4. Adult patients who do not meet criteria 1-3 but in whom a 18F-PDAM-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta) The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways: 1. The participant will be screened for adverse effects immediately post-injection 2. The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection) 3. The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection) The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows: 1. All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax > 2.5 but no corresponding lesion on CT) will be recorded 2. The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant) 3. Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021) 4. Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy

NCT ID: NCT05519566 Recruiting - Urethral Stricture Clinical Trials

The Accuracy of Pulsed Fluoroscopy Retrograde Urethrogram Vs the Traditional Retrograde Urethrogram In Diagnosing Urethral Stricture

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study is designed as a prospective comparative randomized clinical study to determine the diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of pulsed fluoroscopy retrograde urethrogram for urethral stricture disease. The target population includes patients scheduled for retrograde urethrogram either new referral or follow up at Thunder Bay Regional Health Sciences Centre (TBRHSC) for treatment of urethral stricture who meet the specific eligibility criteria. The overall number of participants targeted will be 46. Upon presentation to the urology clinic or ambulatory care unit, the treating urologist/investigator will notify the patient of an opportunity to participate in the study. If the patient is interested, a research team member who is not directly involved in the patient care will be invited to discuss the study to the potential participant. The study team member will obtain a full-informed consent form the potential participant. Following informed consent, participants will be screened to ensure they meet the specific eligibility requirements of this study, through consultation with their medical records and the treating urologist. Randomization will be conducted in a 1:1 allocation ratio to either treatment arm: (1) the Pulsed fluoroscopy retrograde urethrogram, or (2) the Traditional retrograde urethrogram. Using an Excel sheet, the RAND function will give a random code. The random code is a figure ranging from 0.00000000 to 0.9999999999. A 0.5 cut-off code will be used, below which we will use the small blocks of 4 cells (4 rows of excel) and above which we will use the large blocks of 8 cells (8 rows of excel). Participants will undergo procedures according to the order of randomization Participants will undergo either Pulsed fluoroscopy retrograde urethrogram or Traditional retrograde urethrogram, depending on the treatment arm they are randomized to. Clinical data such as stricture location, stricture length and possible adverse effects will be recorded. According to the urologist decision based on data obtained during RUG, participant will be scheduled for urethroplasty or cystoscopy. All participants will undergo these procedures according to standard care procedures at TBRHSC. Data collection at baseline will include demographics, and relevant medical history. All retrograde urethrogram data including the type of urethrogram, the urethrogram date, fluoroscopy time, cumulative radiation dose, stricture location, stricture length and intraprocedural complications. Furthermore, we will record intraoperative data such as operative date, stricture location and stricture length. De-identified research files will be maintained in a secure office of a research team member during the conduct of the study. De-identified research data will be input into an electronic database that is password protected and maintained on research team member's computers or encrypted USB devices. An enrolment log, linking Participant ID to identifiable information will be maintained in hard copy in a locked office, or electronically as a password-protected document on the TBRHSC network. Only delegated research team members and the Principal Investigator will have access to research and patient data. Upon study closure, research records will be kept in secure storage in a research team member's office for a period of 5 years. Following this, the files will be securely shredded, and any electronic documents permanently deleted. Data will be analyzed using the commercially available SPSS software version 26 (SPSS Inc., Chicago, IL, USA). For both techniques, data obtained during baseline and postoperative urethrograms will be compared in terms of stricture location, stricture length, fluoroscopy time, cumulative radiation dose and the occurrence of intraprocedural complications. Categorical data will be compared using Chi-squared or Fisher test. Continuous data will be analyzed using the T test or Mann-Whitney U test Data obtained during urethroplasty will set as a standard of comparison to determine sensitivity, specificity, positive predictive value and negative predictive value of pulsed fluoroscopy and traditional urethrograms. For each comparison, 2 × 2 contingency tables were used to present the results and calculate the diagnostic accuracy estimates with 95% confidence intervals Data analysis will be done blindly regarding the type of performed procedure. One procedure will be coded as "1" and the other will "2". Categorical variables will be presented using number and percentage, and continuous variables will be presented using median and ranges. Two-tailed p-values of less than 0.05 will be set for statistical significance.

NCT ID: NCT05519085 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

SUCCESSOR-1
Start date: September 20, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

NCT ID: NCT05518227 Recruiting - Cataract Clinical Trials

Patient Satisfaction and Visual Outcomes After Bilateral PanOptix Implantation in Patients With Previous Multifocal Contact Lens

Start date: January 19, 2023
Phase:
Study type: Observational

To evaluate spectacle independence and patient satisfaction and visual outcomes after bilateral PanOptix implantation in patients with previous multifocal contact lens experience.