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NCT ID: NCT06203977 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)

Start date: May 1, 2024
Phase: Phase 1
Study type: Interventional

Phase 1 basket trial including 2 open-label single-arm cohorts: REPAIR CKD cohort and REPAIR Dialysis cohort. Open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.

NCT ID: NCT06203210 Not yet recruiting - Clinical trials for Small Cell Lung Cancer

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

IDeate-Lung02
Start date: June 10, 2024
Phase: Phase 3
Study type: Interventional

This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).

NCT ID: NCT06202989 Not yet recruiting - Postsurgical Pain Clinical Trials

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

Start date: January 2024
Phase: Phase 3
Study type: Interventional

Total knee arthroplasty is a surgical treatment which involves replacing the damaged articular cartilage of the knee joint with an artificial prosthetic in end-stage knee osteoarthritis. Although total knee arthroplasties are mostly successful, approximately 1 in 5 patients are unsatisfied with their outcomes with 16-33% of patients of patients experiencing lasting pain following total knee arthroplasty. Multiprofen-CC™ is a compounded topical analgesic currently available to healthcare professionals for prescription in patients experiencing localized musculoskeletal pain. To date there has been no evidence-based guidance generated to evaluate the efficacy of Multiprofen-CC™ in osteoarthritis patients. This study will test, in patients with end-stage knee osteoarthritis undergoing total knee arthroplasty, if the use of topical Multiprofen-CC™ in addition to standard of care pain management is more effective in controlling knee pain and reducing opioid use compared to placebo plus standard care alone.

NCT ID: NCT06193122 Not yet recruiting - Breast Cancer Clinical Trials

Three-Dimensional Ultrasound and Spectroscopy as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment

Start date: April 2024
Phase:
Study type: Observational

The purpose of the study is to test the hypothesis that ultrasound imaging and spectroscopy may be used as a predictive marker of advanced tumour response to neoadjuvant treatment consisting of chemotherapy or concurrent chemotherapy-radiotherapy. The main goal is to select the best ultrasound spectroscopy parameter and vascular-distribution index to use as an early predictor of pathological complete or partial response as a primary endpoint and tumour size decrease as a secondary endpoint.

NCT ID: NCT06191159 Not yet recruiting - Clinical trials for Postoperative Complications

Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions

SCPPB
Start date: May 2024
Phase: N/A
Study type: Interventional

This study will compare the cosmetic scar result from the use of scalpel, electrocautery, and pulsed electron avalanche knife (PEAK) PlasmaBlade (PPB) for the initial skin incision for total mastectomy procedures without immediate breast reconstruction. It is hypothesized that there will be no significant difference in mastectomy scar cosmesis. The purpose and objectives of this study are: 1. To evaluate and compare the cosmetic scar result from the use of scalpel, standard electrocautery, or PEAK PlasmaBlade for initial incision for total mastectomy procedures without immediate breast reconstruction. 2. To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.

NCT ID: NCT06189872 Not yet recruiting - Clinical trials for Osteo Arthritis Knee

Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement

Start date: March 2024
Phase: N/A
Study type: Interventional

This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.

NCT ID: NCT06185972 Not yet recruiting - Breast Cancer Clinical Trials

Novel Magnetic Resonance Imaging-Guided Ultrasound-Stimulated Microbubble Radiation Treatment for Patients With Chest-Wall and Locally Advanced Breast Cancer-Phase II

Start date: February 1, 2024
Phase: Phase 2
Study type: Interventional

The objective of this study is to demonstrate the efficacy and response of novel Magnetic Resonance Imaging (MRI)-guided ultrasound stimulated microbubble treatment to enhance radiation effects in humans receiving external beam radiotherapy delivered using a LINAC (linear accelerator) radiation therapy device.

NCT ID: NCT06182449 Not yet recruiting - Anxiety Clinical Trials

Virtual Reality Distraction for Maternal Milk Expression (PILOT)

VR-MOM
Start date: January 6, 2024
Phase: N/A
Study type: Interventional

Background In neonatal intensive care units (NICUs), mothers are encouraged to express their milk using an electric breast pump. This practice is promoted by nurses and neonatologists due to its beneficial outcomes for newborns. Compared to newborns exclusively fed commercial infant formula, preterm newborns fed breast milk (BM) are less likely to suffer from necrotizing enterocolitis and late-onset sepsis. However, the discomfort associated with using an electrical pump may discourage its use, and almost all mothers start expressing their BM after a premature birth but many stop after a few weeks due to fatigue and stress. Therefore, virtual reality (VR), an immersive experience, seems to be an interesting option as it would provide a relaxing environment and distract mothers of newborns in NICU from the stress and discomfort experienced in order to promote breast milk expression. Aim The aim of this within-subject, pilot clinical trial is to assess the feasibility, acceptability, and preliminary effects of VR on stress, discomfort, and volume of expressed milk in mothers of preterm newborns. Methods Design: Within-subject, randomized pilot clinical trial in which participants are their own control. Setting and sample: Level 3 neonatal intensive care unit (NICU) at a Montreal pediatric teaching university center. Newborns under 29 weeks of age were chose to ensure that newborns would be admitted and remain in the NICU. The objective is to recruit 20 mothers of premature newborns. This will correspond to a total sample of 40 participants as they will be their own control. There will be 50% more mothers recruited (10) to compensate for the usually high attrition or rejection rate for this population, thus a total sample of 30 mothers. Healthcare professionals (nurses and doctors) providing care to participating mothers will be asked to fill a questionnaire on the feasibility of the VR intervention. Randomization and exposure to the interventions: The sequence of exposure to VR will be randomized, not the participants: sequence of 2 days with VR and 2 days without VR. The study will take place over the course of one week. Participating mothers will either be exposed to VR for a minimum of 2 sessions of 30 minutes/day for two days and the following two days to the control intervention or the opposite.

NCT ID: NCT06182436 Not yet recruiting - Pain Clinical Trials

Virtual Reality for Pain Management During Dupilumab Injection

VR-DERMA
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The aim of this within-subject randomized study is to examine the efficacy of a VR immersive game for pain and anxiety management of children during the subcutaneous injection of dupilumab for moderate to severe atopic dermatitis. We will recruit children from 6 to 17 years. The main research question is: 1. Does VR immersive game will generate less anxiety and pain than standard procedures, for children receiving dupilumab injection for moderate to severe atopic dermatitis? 2. Does the occurence of side effects is similar between both study groups? Participants will be randomized according to either sequences: VR-Standard care or Standard care-VR. During the VR sequence, participants will be playing the VR immersive game during the injection. During the Standard care sequence participants will not benefit from any pain management but passive distraction tools will be offered (and documented) to children. The investigators will take measures of pain and anxiety, using validated scales, before and after the procedures at each sequence.

NCT ID: NCT06179134 Not yet recruiting - Multiple Sclerosis Clinical Trials

Cognitive Rehabilitation for People With Multiple Sclerosis

Start date: June 3, 2024
Phase: N/A
Study type: Interventional

Cognitive rehabilitation is designed to enhance a person's capacity to process and interpret information and improve their ability to function in all aspects daily, family and community life. Given the clear and consistent documentation of cognitive deficits in persons with MS, the most notable deficit being information processing speed, learning and memory and executive function, there is an obvious need for effective cognitive rehabilitation. The proposed study will be a randomized controlled single-blinded trial with treatment and wait-list control group. The treatment group will be administered the Goal Management Training (GMT) program; the wait-list control group will be given usual care by their neurologist. Intervention details: The treatment group will receive in-person computerized cognitive rehabilitation (using the GMT program) (virtual training is optional) for 5 weeks (40-min sessions, twice per week), session will be tailored according to patient cognitive concerns at index assessment, and level of ability. The wait list control group, will not receive treatment Our primary outcome is information processing speed, secondary aims include learning and memory, and executive function. The minimal assessment of cognitive function in MS (MACFIMS) will be utilized to assess cognitive function. Additionally, tertiary aims include the following patient reported outcomes (PROs) will be collected: the hospital anxiety and depression scale (HADS), the modified fatigue impact scale (MFIS), the multiple sclerosis impact scale (MSIS-29), and the European quality of life (EQ-5D-5L) scale, to capture level of depression and anxiety, fatigue, impact of MS and quality of life. Cognitive performance of all patients in both groups will be assessed at baseline, immediate post-5-week assessment, and at post 6-month follow-up assessment. We hypothesized that, compared to persons in the wait-list group, the participants receiving the GMT intervention will demonstrate significant improvements across all cognitive measures. The wait-list control group will be given the option to receive the GMT intervention after the 6 months follow-up is complete. The individuals in the treatment group, wishing to continue with the GMT program, will be given a referral by Dr. Feinstein to a GMT certified therapist.