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NCT ID: NCT05140902 Active, not recruiting - Glioblastoma Clinical Trials

Accurate DCE-MRI Measurement of Glioblastoma Using Point-of-care Portable Perfusion Phantom

Start date: March 28, 2022
Phase: N/A
Study type: Interventional

The goal of this study is to test whether a new device developed at the University of Alabama at Birmingham (UAB) can decrease the error in calculating blood flow of a brain tumor, leading to better prognosis. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) , or DCE-MRI, over 10 years. This technique has been globally used to calculate blood flow of various tissues including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a brain tumor has typically high blood flow, so the magnitude of blood flow can be used as an indicator to identify the presence and aggressiveness of a brain tumor. In addition, an effective therapy can result in the alteration of the blood flow in a brain tumor. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the blood flow in the brain tumor, and decide whether they need to continue the therapy or try a different one. However, unfortunately, the measurement of blood flow using DCE-MRI is often inaccurate. MRI scanners may use different hardware and software thus the measurement may be different across scanners. The measurement may also be different over time due to hardware instability. Therefore, the investigators propose to use an artificial tissue, named "phantom", together with a patient. The phantom has a constant blood flow thus it can serve as a standard. Errors, if it occurs, will affect the images of both the patient and the phantom. Therefore, the investigators will be able to correct the errors in the patient image using the phantom image. UAB radiological research team invented a new device for this purpose named point-of-care portable perfusion phantom, or shortly P4. The team recently demonstrated the utility of the P4 phantom for accurate measurement of blood flow in pancreatic cancer and prostate cancer. In this study, they will test whether the P4 phantom will improve the measurement accuracy in brain cancer.

NCT ID: NCT05140421 Active, not recruiting - Hiv Clinical Trials

Testing a Novel Data-to-Suppression (D2S) Intervention Strategy in the Ryan White HIV/AIDS Program

D2S
Start date: December 15, 2021
Phase: N/A
Study type: Interventional

The Ryan White HIV/AIDS Program (RWHAP) for low-income people with HIV (PWH) is a key resource for reducing HIV health disparities and scaling up evidence-based interventions. As RWHAP serves >50% of US PWH, RWHAP outcomes are vital to achieving "getting-to-zero"/ Ending the HIV Epidemic (EHE) Plan targets. As a grantee for RWHAP Part A (RWPA) funding distributed to the counties/cities severely affected by HIV, New York City (NYC) conducts regular HIV care continuum monitoring citywide and in its RWPA programs, which offer support services to reduce social and behavioral barriers to care/treatment. Local data consistently show lower viral suppression (VS) among RWPA clients in HIV care than among non-RWPA PWH in HIV care. Relative to NYC HIV cases overall, NYC RWPA clients (~14,000 per year) over-represent Black and Latinx PWH and high-poverty neighborhoods. To address local outcome disparities and to fill gaps left by data-to-care strategies and research focused on medical care (re-)linkage, the investigators propose to implement and rigorously evaluate the effectiveness of a novel 'data-to-suppression' (D2S) intervention among RWPA behavioral health and housing program clients who are in HIV care but unsuppressed. Surveillance-based reports on unsuppressed clients plus D2S capacity-building assistance will guide RWPA providers in targeting and delivering evidence-informed strategies to improve VS.

NCT ID: NCT05139316 Active, not recruiting - Clinical trials for Glycogen Storage Disease Type IA

A Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients With Glycogen Storage Disease Type Ia (GSDIa)

Start date: November 8, 2021
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of DTX401 to reduce or eliminate dependence on exogenous glucose replacement therapy to maintain euglycemia and to maintain or improve the quality of glucose control.

NCT ID: NCT05139225 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of TTI-622 in Combination With Daratumumab Hyaluronidase-fihj in People With Multiple Myeloma

Start date: October 28, 2021
Phase: Phase 1
Study type: Interventional

This study will test the safety of TTI-622 in combination with daratumumab hyaluronidase-fihj in people with relapsed/refractory multiple myeloma. The researchers look for the highest dose TTI-622 that causes few or mild side effects in participants when given in combination with daratumumab hyaluronidase-fihj. Once the researchers find the highest safe dose of each study drug, they will further test the combination TTI-622 + daratumumab hyaluronidase-fihj) in new participants to find out if the combinations are effective in treating relapsed/refractory multiple myeloma. Researchers think that combining TTI-621 or TTI-622 with daratumumab hyaluronidase-fihj, a standard treatment for multiple myeloma, may be an effective treatment approach.

NCT ID: NCT05139121 Active, not recruiting - Contraception Clinical Trials

Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles

Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles

NCT ID: NCT05139043 Active, not recruiting - Clinical trials for Metastatic Malignant Neoplasm in the Brain

Low Dose Versus Standard Dose Dexamethasone for Reduction of Swelling in Patients With Primary or Metastatic Brain Tumors

Start date: April 9, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery in patients with primary brain tumors or cancer that has spread from other places in the body to the brain (metastatic). Surgery is an important part of the treatment of brain tumors; however, it results in injury to surrounding brain tissue, leading to brain swelling. Dexamethasone is effective for controlling the swelling of the brain; however, dexamethasone can cause many unwanted side effects. To minimize the side effects of dexamethasone, the lowest dose needed to control swelling of the brain should be used. This research study is assessing the safety of using a lower than standard dose of dexamethasone after the surgery to control brain swelling.

NCT ID: NCT05138900 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

A Pilot Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) in Central Non-Small Cell Lung Cancer

Start date: December 16, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a single treatment of targeted radiation (called SBRT or Stereotactic Body Radiation Therapy) can be as safe and effective as multiple doses of radiation in patients with central non-small cell lung cancer

NCT ID: NCT05138328 Active, not recruiting - Clinical trials for Carcinoma, Basal Cell

Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

Start date: June 3, 2021
Phase: N/A
Study type: Interventional

This pilot study will examine the treatment of basal cell carcinoma (BCC) with laser technology under the guidance of imaging modalities to assist with surgical excision, including optical coherence tomography imaging (OCT) and reflectance confocal microscopy (RCM). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a nonablative laser already shown to effectively treat BCC. The addition of OCT and RCM has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. OCT is being used to enhance the effectiveness of Mohs Micrographic Surgery of these cancers by elucidating more definitive tumor margins. RCM has been shown to detect changes in the composition of cells consistent with BCC. We propose to use these imaging devices to guide the laser treatment to achieve optimal efficacy with minimized side-effects. Primary outcome measured include complete clearance of the BCC lesion, which will be determined through clinical examination, dermoscopy, imaging (OCT and/or RCM), and saucerization biopsy. Secondary outcome variables include the significance of lesion depth (by OCT and/or RCM), lateral extent (by OCT and/or RCM), BCC type, and anatomical region on rate of clearance and recurrence.

NCT ID: NCT05138198 Active, not recruiting - Metabolic Syndrome Clinical Trials

Lifestyle Intervention to Reduce Body Weight and Systemic Inflammation Among World Trade Center Responders

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The goal of this randomized control trial (RCT) is to test the feasibility and acceptability of a lifestyle intervention with a focus on implementing a high dose Mediterranean Diet protocol with physical activity to reduce systemic inflammation and body weight among WTC first responders having overweight/obesity and PTSD. The findings of this study will demonstrate the suitability of the proposed approach to reduce comorbidities among similar populations exposed to traumatic events; the findings will also inform the World Trade Center Health Program's extensive research and clinical efforts with the potential to provide a preventive care model to reduce systemic inflammation and related chronic disease among WTC responders with PTSD.

NCT ID: NCT05138068 Active, not recruiting - Clinical trials for Social Anxiety Disorder

Social Anxiety MDMA-Assisted Therapy Investigation

SAMATI
Start date: April 13, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label delayed treatment study to assess the safety and effect of MDMA-assisted therapy in treating 20 participants diagnosed with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype. This study will obtain an estimate of effect size for two experimental sessions of MDMA-assisted therapy for the treatment of social anxiety disorder on measures of safety, social anxiety, functional outcomes, psychiatric symptoms, and putative mechanisms of action. The primary outcome for this study will be the Liebowitz Social Anxiety Scale (LSAS) administered by a blinded Independent Rater (IR). Other assessments, including physiological, self-report, and behavioral tasks will be used to assess other exploratory variables. An additional aim of the trial will be the development of a treatment manual for MDMA-AT for SAD for future research.