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NCT ID: NCT05975619 Recruiting - Clinical trials for Head and Neck Cancer

A Prospective Imaging Study of the Integrated TrueBeam-HyperSight CBCT System

Start date: August 29, 2023
Phase: N/A
Study type: Interventional

Cone beam computed tomography (CBCT) images are routinely used in radiation treatment delivery workflows to align patients with the treatment beam. Conventional CBCT image quality is sufficient for this task but not good enough for other radiotherapy-related tasks, such as contouring anatomical structures and calculating radiation dose distributions. HyperSight is a new CBCT imaging system manufactured by Varian Medical Systems. The purpose of this study is to evaluate the integration of the HyperSight imaging system with Varian's TrueBeam radiotherapy system, a linear accelerator with a C-arm gantry that rotates about the patient to delivery radiation to the target malignancy. HyperSight CBCT images will be acquired prospectively from patients who are receiving radiation treatment. The HyperSight/TrueBeam system will be used for imaging only; patients receive their radiation treatment on cleared devices and no aspect of their treatment is affected by participation in the study. HyperSight images collected during the study will be evaluated for quality and utility and compared to conventional CBCT images as well as fan beam CT images used for treatment planning.

NCT ID: NCT05975593 Recruiting - Pancreatic Cancer Clinical Trials

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

METEOR-CRATR
Start date: December 19, 2023
Phase:
Study type: Observational

This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment (imaging, dosimetry, clinical) data before, during, and after treatment with definitive-intent standard of care (SOC) radiotherapy for patients with locally advanced cervical and pancreatic cancer.

NCT ID: NCT05975580 Recruiting - Obesity Clinical Trials

Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery

PROJECT-BARI
Start date: August 29, 2023
Phase: Phase 4
Study type: Interventional

This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.

NCT ID: NCT05975450 Recruiting - Clinical trials for Kidney Transplant Recipient

Subcutaneous Abatacept in Renal Transplant Recipients

RTB-016
Start date: August 2, 2023
Phase: Phase 1
Study type: Interventional

After a kidney transplant, patients take drugs called anti-rejection drugs (immunosuppressives) to prevent their bodies from rejecting the new kidney. At present it is not possible to have a successful transplant without these drugs. These drugs make it possible for a person who receives the transplant to accept the "foreign" kidney. Most patients who get a transplant need to take anti-rejection medications for the rest of their lives, or for as long as the kidney continues to work. Researchers are looking to learn whether abatacept is as good as belatacept in preventing rejection, whether there are other benefits or harms associated with abatacept treatment, and possibly allows greater flexibility on patient's travel and time since abatacept is self-administered at home. This study is being done to answer these questions: Are weekly abatacept injections under the skin a safe and effective substitute for monthly belatacept intravenous (IV) infusions? and How well does the kidney function after switching from belatacept to abatacept?

NCT ID: NCT05975424 Active, not recruiting - Clinical trials for Spinal Cord Injuries

LTFU Study of Subjects With Cervical SCI Who Received AST-OPC1

Start date: June 13, 2018
Phase:
Study type: Observational

This is a LTFU study for cervical SCI subjects that were administered AST-OPC1 cells in the main study AST-OPC1-01.

NCT ID: NCT05975385 Recruiting - Pain, Postoperative Clinical Trials

Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Start date: October 9, 2023
Phase: N/A
Study type: Interventional

The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.

NCT ID: NCT05975372 Not yet recruiting - Tissue Expansion Clinical Trials

Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction

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

The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently available on the market, aims to achieve the same tissue expansion while avoiding frequent injections through the skin by means of an expansion device that slowly and continuously injects a very small amount of saline. Expansion of the device is based on pressure and volume in the expander, allowing for a tailored expansion process for individual patients' physiology. The purpose of this study is to assess the clinical effectiveness of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction/ augmentation compared to standard tissue expansion methods.

NCT ID: NCT05975359 Recruiting - Mastectomy Clinical Trials

Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

Start date: October 5, 2023
Phase: N/A
Study type: Interventional

Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is limited by poor surgical site coverage and low capacity, leading to inconsistent suction and prolonged time that a drain is left in place. The Interi Drain system is a novel, multi-branched manifold with a proprietary suction system that provides consistent suction and addresses many of the shortcoming of JP drains. The purpose of this study is to compare the Interi system to standard JP drains across outcomes including number of surgical drain sites, complication rates, time to drain removal, time to initiate tissue expansion, total fluid volume drained, and patient satisfaction.

NCT ID: NCT05975333 Recruiting - Cancer Patients Clinical Trials

Writing Intervention With Adolescents and Young Adults With Cancer

Start date: August 2, 2023
Phase: N/A
Study type: Interventional

Young people with cancer have difficult experiences and writing exercises may help improve their well-being. However, very few studies have examined how a creative writing activity might be useful for young people with cancer. In this pilot study, researchers at St. Jude Children's Research Hospital hope to explore whether teenagers and young adults with cancer want to participate in a writing exercise and whether they find it to be valuable. Primary Objective To assess the feasibility and acceptability of a writing-based narrative medicine intervention for adolescent and young adult patients with cancer.

NCT ID: NCT05975242 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Acceptability & Impact of a Diabetes Management Smartphone App (mySugr) for Spanish-literate Adults With Type 2 Diabetes

mySugr
Start date: April 4, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare those using a diabetes management smartphone application (mySugr) to those not using the application. This smartphone application is for Spanish-literate adults with poorly controlled, non-intensively treated type 2 diabetes. The main question[s] that it aims to answer are: - What is the impact of the use of mySugr (a smartphone-based application or app) with structured blood glucose monitoring on diabetes self-management among Hispanic/Latino adults with poorly controlled, non-intensively treated T2D? - Will diabetes self-management be more effective for those using mySugr (the Active group) compared to those not using mySugr (the Control group) over a 12-week study period? Participants will be screened and enrolled if they are eligible; they will have the study explained to them in Spanish or English and have time to ask questions and then sign an informed consent form. Clinical measurements (including height, weight, and blood pressure) and hemoglobin A1c will be done. All subjects will be given a blood glucose meter, lancing device, and blood glucose strips for the meter, and they will also receive an electronic scale. Several questionnaires will be answered. If a subject is randomly assigned to the Active group, they will download the mySugr Pro app in Spanish to their smartphone and be trained in its use. They will receive education focused on paired (before and 2 hours after a meal) blood glucose testing, which participants will conduct twice a day for 6 days and once a month for 3 months. Participants will continue structured blood glucose testing with the mySugr PRO app for 12 weeks, and they will have 3 virtual visits in Spanish with mySugr PRO coaches who will review the blood glucose records and advise the subjects. Subjects in the Control group will not receive the mySugr PRO app or coaching. They will continue with their usual diabetes management. All subjects will return after 12 weeks to return the scale and have a close-out visit with clinical measurements and questionnaires. Subjects will also receive a disturbance allowance for their time and participation.