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NCT ID: NCT05611034 Recruiting - Colorectal Cancer Clinical Trials

In Vivo Lung Perfusion (IVLP) for Colorectal Cancer Metastatic to Lung

Start date: February 6, 2023
Phase: Phase 1
Study type: Interventional

This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). At the University Health Network, this IVLP technique has been used recently in a Phase I study in patients with sarcoma, and we are now expanding on that experience to include patients with colorectal metastases. The purpose of this study is to test the safety of the IVLP technique and find the dose that seems right in humans. Participants are given oxaliplatin into one lung via IVLP and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more participants are asked to join the study and are given a higher dose of oxaliplatin. Participants joining the study later on will get higher doses of oxaliplatin than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The other lung will not be infused with anything, so that we can limit unforeseen toxicity to a single lung and see if one lung does better than the other.

NCT ID: NCT05610891 Recruiting - High-Grade Glioma Clinical Trials

Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGG

Start date: October 1, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this dose finding study is to evaluate the safety and efficacy of 2 different dose levels of CLR 131 in children, adolescents and young adults with relapsed or refractory high-grade glioma (HGG).

NCT ID: NCT05610319 Recruiting - Clinical trials for Diabetic Macular Edema

Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial

INSITE-DME
Start date: May 1, 2023
Phase: Phase 4
Study type: Interventional

This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.

NCT ID: NCT05610124 Recruiting - Obesity Clinical Trials

Postprandial Glycemia and Satiety of Meals With Potatoes, With and Without Protein

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

The proposed study aims to simulate a meal eaten at home, where meals will provide a fixed amount of protein from beef or vegetarian substitute "meat" balls with ad libitum access to one of mashed potatoes, full-fat fries, or pasta. Postprandial glycemia (PPG), insulin, active ghrelin, satiety, amino acid response and food intake (FI) at the meal and again 3h later (after an ad libitum pizza meal) will be measured. In addition, post-meal PPG and satiety will be measured for one hour after the second meal.

NCT ID: NCT05609968 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

Start date: February 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).

NCT ID: NCT05608681 Recruiting - Clinical trials for Eosinophilic Esophagitis

A Trial to Evaluate EP-104IAR in Adults With Eosinophilic Esophagitis (EoE).

RESOLVE
Start date: March 31, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

An open-label, dose-escalation study to explore the safety, tolerability and pharmacokinetics of EP-104IAR in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104IAR on eosinophilic EoE disease activity. The study will evaluate up to 8 doses of EP-104IAR (4 mg to 40 mg) in cohorts of 3 to 6 participants per cohort. If all planned cohorts are evaluated, or cohorts need to be repeated, up to 24 participants could be enrolled. The study involves 7 site visits spread over approximately 32 weeks. All participants will receive active study drug (EP-104IAR), The study drug will be administered by qualified personnel during an esophagogastroduodenoscopy (EGD) procedure at the Baseline/Dosing visit. Safety will be assessed throughout the study. Blood and urine samples will be collected at site visits for laboratory assessments and to measure plasma levels of EP-104IAR. Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3 EGDs with esophageal biopsies at the Baseline/Dosing Visit, and at 4 and 12 weeks post dose.

NCT ID: NCT05608291 Recruiting - Melanoma Clinical Trials

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

Start date: January 16, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including: - What side effects may happen from receiving the study drugs. - How much study drug is in the blood at different times. - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. - How administering the study drugs might improve quality of life.

NCT ID: NCT05607121 Recruiting - Clinical trials for Body Dysmorphic Disorders

TMS Visual Modulation in Body Dysmorphic Disorder

EMPAC-BDD
Start date: June 30, 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to test the effects of a type of noninvasive brain stimulation called transcranial magnetic stimulation (TMS) on visual processing in adults with body dysmorphic disorder symptoms when combined with modifying visual attention. The main goals are to understand, in people with body dysmorphic disorder and people with subclinical body dysmorphic disorder: - The effects of intermittent and continuous TMS stimulation of parietal brain regions when done right before visual attention modulation on brain functional connections. - The effects of intermittent and continuous TMS stimulation of parietal brain regions when done right before visual attention modulation on global/holistic visual perception. Participants will receive one type of TMS (intermittent or continuous) followed immediately by an fMRI brain scan during which they will view images of their faces. On the second day, they will do the same, but receive either the intermittent or continuous TMS stimulation that they did not receive on the first day.

NCT ID: NCT05606614 Recruiting - Rett Syndrome Clinical Trials

Safety and Efficacy of TSHA-102 in Adult Females With Rett Syndrome (REVEAL Adult Study)

Start date: March 6, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The REVEAL Adult Study is a multi-center, Phase 1/2 open-label, dose-escalation study of TSHA-102, an investigational gene therapy, in adult females with Rett syndrome. The safety, tolerability, and preliminary efficacy of two dose levels will be evaluated. The study duration is estimated to be up to 63 months.

NCT ID: NCT05605899 Recruiting - Clinical trials for High-risk Large B-cell Lymphoma (LBCL)

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

ZUMA-23
Start date: February 10, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.