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NCT ID: NCT04638582 Recruiting - Clinical trials for Lung Cancer, Nonsmall Cell

Pembrolizumab as Neoadjuvant Therapy for Resectable Stage IA3 to IIA Non-Small Cell Lung Cancer (NSCLC)

Start date: August 28, 2022
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized, single-site, open-label Phase II trial of neoadjuvant pembrolizumab (3 cycles) followed by surgery, versus concomitant neoadjuvant pembrolizumab with platinum doublet chemotherapy (3 cycles) followed by surgery for participants with Stage IA3, IB and IIA non-small-cell lung cancer (NSCLC). Participants will be offered pembrolizumab (6 cycles), and standard of care adjuvant chemotherapy (4 cycles) if applicable.

NCT ID: NCT04635891 Recruiting - FSHD Clinical Trials

Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)

MOVE FSHD
Start date: December 15, 2020
Phase:
Study type: Observational

The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD. Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) will have approximately 450 FSHD participants followed for a minimum of 3 years. A subset of MOVE FSHD participants, approximately 200, will participate in the MOVE+ sub-study which includes whole body MRI and muscle biopsy.

NCT ID: NCT04635176 Recruiting - Pain, Postoperative Clinical Trials

Comparing Local Anesthesia With and Without iPACK Block

Start date: October 30, 2022
Phase: Phase 4
Study type: Interventional

Total knee arthroplasty is an effective surgical intervention for patients with chronic osteoarthritis commonly performed worldwide. Postoperative pain management has been a key focus in patient care for this procedure. Poorly controlled pain following total knee arthroplasty is associated with decreased ambulation, increased length of hospital stay, increased complications (particularly related to significant opioid use), and overall suboptimal patient recovery. Appropriate postoperative pain management utilizing motor sparing peripheral nerve blocks and periarticular injections has been shown to provide faster, more optimized patient recovery and reduced hospital length of stay in patients undergoing total knee arthroplasty. Adductor canal block (ACB) is a well-studied peripheral nerve block performed for analgesia following total knee arthroplasty. ACB is an effective component of multimodal analgesia providing improved pain control to the peripatellar and intra-articular aspect of the knee joint while largely preserving the strength of the quadriceps muscles1. In addition, perioperative local infiltration analgesia (LIA) performed by the orthopaedic surgical team is a common practice that has been shown to improve short-term postoperative pain relief and reduce total systemic opioid consumption during hospital stay2 for total knee arthroplasty. The Infiltration between the Popliteal Artery and Capsule of the Knee (iPACK) block is a newly described regional anesthesia technique for postoperative analgesia in total knee arthroplasty, performed under ultrasound guidance. It targets the articular branches of the tibial, common peroneal, and obturator nerves in the popliteal region, and aims to provide analgesia to the posterior aspect of the knee joint without compromising lower extremity motor function following total knee arthroplasty. This study aims to determine whether the IPACK block provides additional analgesia (in combination with ACB + LIA) for total knee arthroplasty surgeries. The study will examine how much additional analgesia IPACK provides in the context of an already-optimized regional anesthesia pathway for total knee arthroplasty, which uses ACB + LIA, both modalities that have reasonable existing evidence.

NCT ID: NCT04634578 Recruiting - Clinical trials for Retinopathy of Prematurity

Bevacizumab Treatment For Type 1 ROP

ROP4
Start date: May 18, 2022
Phase: Phase 2
Study type: Interventional

Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.

NCT ID: NCT04634240 Recruiting - Clinical trials for Coronary Artery Disease

Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement

COMPLETE TAVR
Start date: December 19, 2020
Phase: N/A
Study type: Interventional

Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance. The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure. The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elective transfemoral TAVR and randomized within 96 hours of successful balloon expandable TAVR. Complete Revascularization: Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a ≥70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR. Vs. Medical Therapy Alone: No further revascularization of coronary artery lesions. All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies. The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD.

NCT ID: NCT04633655 Recruiting - Quality of Life Clinical Trials

International CIPN Assessment and Validation Study

ICAVS
Start date: June 8, 2020
Phase:
Study type: Observational

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

NCT ID: NCT04633525 Recruiting - Hip Osteoarthritis Clinical Trials

Defining Optimum Cup Orientation for Hip Replacements Taking Into Account the Individual's Anatomy and Movement Patterns

Start date: November 18, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate and determine the optimal zone for implanting the cup component (the ball that sits in the joint socket) in a total hip replacement. Enrolled participants will have a series of X-rays analyzed before surgery to identify their individual optimal zone or cup orientation. This information will be provided to the operating surgeon, who may use this information to influence the placement of the cup implant. Follow-up X-rays taken after surgery will determine if the cup is within the suggested optimal zone. Questionnaires will be completed before and after surgery, and data on complications or issues with the surgery (including incidents of dislocation) will be collected after surgery.

NCT ID: NCT04632953 Recruiting - Clinical trials for Long-chain Fatty Acid Oxidation Disorders (LC-FAOD)

Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program

Start date: November 30, 2021
Phase:
Study type: Observational

The primary objective of this study is to assess the long-term safety, including pregnancy, infant, and lactation outcomes, of patients with LC-FAOD who are enrolled in the DMP.

NCT ID: NCT04632407 Recruiting - Cardiotoxicity Clinical Trials

Can Flaxseed Prevent Broken Hearts in Women With Breast Cancer Study?

CANFLAX
Start date: October 21, 2020
Phase: N/A
Study type: Interventional

The main goal of the current research program is to examine the use of nutraceuticals, in particular flaxseed (FLX), in the prevention of Doxorubicin and Trastuzumab (DOX+TRZ) mediated cardiotoxicity in the clinical setting. As Manitoba continues to be one of the top FLX producers in the world, there is an increasing public awareness of the importance of the consumption of this whole grain commodity in the prevention of cancer and cardiovascular disease. In North America, approximately 1 in 8 women will develop breast cancer and will receive treatment with DOX+TRZ. Although women with breast cancer are at risk of developing heart failure due to chemotherapy, FLX has the capacity to prevent this outcome. The purpose of the CANFLAX study is to establish FLX "milk" as an effective method in preventing heart failure in women with breast cancer.

NCT ID: NCT04630184 Recruiting - Obesity Clinical Trials

A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity

SPA-VR
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The objectives of the project are to: i) assess the feasibility and acceptability of the protocol and the VR exposure intervention in women with obesity, and ii) obtain an estimate of the effect of VR exposure intervention associated with an exercise training on SPA, compliance, adherence and persistence to the exercise training, as well as persistence in PA practice in the middle term to calculate the sample size for a future larger randomized controlled trial (RCT) in women with obesity. A RCT of feasibility will be carried out. Forty-five women with obesity and a high level of SPA will be randomized into one of the following three groups: 1) Exercice and VR exposure (Ex + expo), 2) Exercise and psychological intervention control (Ex + control) or 3) waiting list (WL). The interventions will have a physical exercise training (identical for all) and a psychology intervention (different according to the condition: VR exposure or control). The feasibility and acceptability of the protocol and the VR exposure intervention will be assessed at the end of the study. SPA, PA practice, anthropometry, internalization of weight bias, body appreciation, perceived pleasure, motivational regulation, self-efficacy, affects as well as perception effort will be evaluated with questionnaires and scales validated before and after the intervention and 6 months after the end of the intervention. Sociodemographic data, depressive symptoms, problematic eating behaviors and propensity to immersion will be assessed during the initial visit only. Adherence, adherence and persistence to the PA program will be calculated at the end of the intervention. Persistence in PA practice will be calculated using data collected immediately after the end of the intervention and 6 months after the intervention.