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NCT ID: NCT05076357 Recruiting - Weight Loss Clinical Trials

Cold, Appetite and Weight Loss in Individuals With Obesity

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

This study is an 8 week weight loss intervention with 3 randomly assigned groups: DIET, cold exposure (CE), and DIET+CE. The study will be a total of 13 weeks. All participants will undergo a screening session, two experimental sessions at baseline and two experimental sessions after the intervention. There will be a control (ambient) experimental session and a cold exposure experimental session These will be done in a randomized order both before and after the intervention. Therefore, a total of 5 lab visits will be required for all participants regardless of group outside of their assigned group intervention. Participants in the CE and DIET+CE groups will report to the laboratory every 2nd day for the 8 week intervention to undergo cold exposure as outlined below. The DIET and DIET+CE groups will have a weekly nutritional consultation at the lab as well as a weekly check-in with the nutritionist via text, phone, or email. Participants will be randomly assigned a group after completing the screening session and prior to the experimental session.

NCT ID: NCT05076175 Recruiting - Colitis, Ulcerative Clinical Trials

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Start date: May 30, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

NCT ID: NCT05075590 Recruiting - Clinical trials for Transcatheter Aortic Valve Replacement

Coronary Access After Supra-Annular THV Implantation

CAN-ACCESS
Start date: October 27, 2021
Phase: N/A
Study type: Interventional

To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.

NCT ID: NCT05075577 Recruiting - Prostate Cancer Clinical Trials

EPI-7386 in Combination With Enzalutamide Compared With Enzalutamide Alone in Subjects With mCRPC

Start date: December 21, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2 study of EPI-7386 orally administered in combination with enzalutamide in subjects with mCRPC. Phase 1 of the study will be a single-arm dose escalation study of EPI-7386 in combination with a fixed dose of enzalutamide. This portion of the study will primarily evaluate the safety and tolerability of the drug combination and establish the RP2CDs for EPI-7386 and enzalutamide when dosed in combination. In addition, blood sampling will be conducted for PK evaluation to assess the potential DDI between the two drugs. Once the RP2CD for each drug has been established, Phase 2 of the study will commence. Phase 2 is a two-arm, randomized (2:1), open-label study. Approximately 120 subjects will be randomized 2:1 to: - Group 1: EPI-7386 at the RP2CD + enzalutamide(depending on the results of the Phase 1) (n=80) - Group 2: Enzalutamide single agent (n=40) The planned dose of enzalutamide and EPI-7386 for the combination arm will be those determined in the Phase 1 of this study based on safety and exposure data. Subjects may remain on study treatment as long as they are tolerating treatment without disease progression based on RECIST v1.1 and/or PCWG3.

NCT ID: NCT05075317 Recruiting - Clinical trials for Coronary Artery Disease

Time Restricted Eating and Cardiac Rehabilitation

TREat-CR
Start date: July 11, 2022
Phase: N/A
Study type: Interventional

This study will use a form of intermittent fasting called time-restricted eating (TRE) where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE could be an effective addition to cardiac rehabilitation as it has demonstrated cardiovascular health benefits and potential for synergy when combined with exercise training. This study will determine if TRE is a feasible and safe nutrition intervention during cardiac rehabilitation and if TRE improves the health benefits of cardiac rehabilitation compared to cardiac rehabilitation alone.

NCT ID: NCT05075226 Recruiting - Clinical trials for Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Visual Outcomes of Vivity in Patients With Well Controlled Glaucoma

Start date: July 29, 2021
Phase:
Study type: Observational

Glaucoma is a progressive optic neuropathy that results in a loss of contrast sensitivity and visual field if not detected and treated. When glaucoma patients undergo cataract surgery, they are often not ideal candidates for many existing presbyopia correcting IOLs as they reduce contrast sensitivity because of the splitting of light and are more likely to have visual disturbances secondary to diffractive steps in the IOL design. This is largely because of a higher rate of ocular surface disease and meibomian gland dysfunction in this patient population due to the chronic utilization of topical drops. As a result of this, patients with glaucoma currently receive aspheric monofocal IOLs during cataract surgery, which are lenses with minimal loss of contrast sensitivity but only one point of focus (typically targeted for distance). This necessitates the use of glasses for near and intermediate vision and has an impact on quality of life for these patients. The Vivity Extended Depth of Focus (EDOF) IOL is a new technology that maintains uncompromised distance vision and provides improved intermediate vision correction, reducing the need for glasses. This lens uses a new optical system with no diffractive steps in the IOL; trials in non-glaucomatous patients have shown the rate of visual aberrations to be comparable to an aspheric monofocal IOL which are currently the standard of care in patients with glaucoma. There is no published data on outcomes of this IOL in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT). Studies are required to evaluate the clinical success of this new lens technology in glaucomatous patients. This will be the first study in Canada to report clinical outcomes of the Vivity IOL in this patient cohort.

NCT ID: NCT05074355 Recruiting - Clinical trials for Myeloproliferative Neoplasm

Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms

Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to look at how safe and useful a drug called azacitidine in combination with a drug called venetoclax, is in people with accelerated or blast phase BRC-ABL negative myeloproliferative neoplasms.

NCT ID: NCT05073302 Recruiting - Type 1 Diabetes Clinical Trials

Device-Less Technique in Islet Transplantation

Start date: March 22, 2022
Phase: Phase 1
Study type: Interventional

Islet transplantation is an effective modality for treating type 1 diabetes. Despite marked progress in clinical islet transplantation with the achievement and maintenance of insulin independence in over half of recipients up to 5 years, transplant approaches are limited to those that struggle to control their diabetes. Furthermore, this approach remains restricted due to the scarcity of human pancreas donors. While transplanting insulin-producing cells into the liver has been demonstrated as an efficacious means of restoring glycemic control to patients with T1D, the procedure often results in cell loss, and carries risks. Moreover, transplant in to the liver does not permit imaging or retrieval of donor islets. The ability to retrieve the cells is also important for safety reasons. In theory, the space under the skin is an attractive alternate site for transplanting insulin producing cell, due to ready access, and potential for monitoring cellular transplant function through novel imaging techniques. However, transplantation of insulin producing cells into an unmodified site under the skin universally fails to reverse diabetes in research animal models, or in human studies. Other techniques using devices with different type of technologies and biomaterials have been explored with variable success. Unfortunately, the foreign body and inflammatory reaction persist in the implant. Shapiro Lab, has developed a novel technique called 'device-less' (DL) transplant modality. This approach was designed to harness an innate foreign body response in a favorable and controlled manner, to induce growth of new blood vessels to allow the survival of the insulin producing cells without the natural body response to foreign body. Briefly, this site transforms the inhospitable under the skin site into a viable location through the temporary implantation of a small tube called angiocatheter. For this study, 5 patients will received transplant in to the modified site under the skin using the DL transplant technique.

NCT ID: NCT05073081 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Feasibility of Prehab for Lumbar Spinal Stenosis

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

The literature has shown evidence of the effectiveness of prehabilitation programs on post-operative recovery for musculoskeletal conditions; however, evidence for prehabilitation for lumbar spinal stenosis (LSS) is limited. Investigators have found that there is very low to low quality evidence for the effect of prehabilitation interventions for improving outcomes following lumbar spine surgery. Therefore, the purpose of this study will be to determine the feasibility of a prehabilitation program for patients undergoing LSS surgery, and pilot test the protocol to provide the foundation for future design of a larger, multicenter randomized controlled trial.

NCT ID: NCT05072743 Recruiting - Sleep Disorder Clinical Trials

Improvement in Sleep Symptomatology and Neurocognitive Function Using Photobiomodulation in Post-Concussion Patients

Start date: October 20, 2021
Phase: N/A
Study type: Interventional

The emphasis on this study is to review the use of PBMT as a potential treatment modality to improve both sleep symptoms and consequent neuropsychological functions affected by sleep disturbances in a cohort of post-mTBI patients with sleep issues not secondary to sleep apnea.