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AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
University of Alabama at Birmingham
Spinal Cord Injuries
Multiple Sclerosis
Transverse Myelitis
Amyotrophic Lateral Sclerosis
The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive
emotional writing pilot project for adults with paralysis caused by neurological
conditions such as traumatic head or spinal cord injury. expand
The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive emotional writing pilot project for adults with paralysis caused by neurological conditions such as traumatic head or spinal cord injury. Type: Observational Start Date: Sep 2020 |
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
Women and Infants Hospital of Rhode Island
Urgency Urinary Incontinence
The goal of this clinical trial is to compare treatment outcomes between an oral
medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency
urinary incontinence (UUI).
Participants will be randomly selected to receive one of the two treatments. The primary
outcome measure... expand
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity. Type: Interventional Start Date: Jun 2023 |
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
University of Alabama at Birmingham
Stroke
Cognitive Dysfunction
This study will compare two approaches to cognitive rehabilitation in adults with stroke
with persistent, mild to moderate, cognitive impairment. Both approaches will feature a
web-based computer "game" that trains cognitive processing speed, i.e., how quickly
individuals process information that... expand
This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP). Both CICT and BF-HELP will involve 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program. The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis. Participants will be randomly assigned to the interventions. Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Type: Interventional Start Date: Jun 2022 |
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms...
Biogen
Lupus Erythematosus, Systemic
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus
on participants who have active disease and are already taking standard of care
medications. These may include antimalarials, steroids,... expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks. Type: Interventional Start Date: Jul 2021 |
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
University of Florida
Osteoarthritis of Knee
This mechanistic clinical trial proposes to test whether a five-day course of mindfulness
meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory
balance and pain-related brain function, reduce clinical pain, among African Americans
and non-Hispanic whites with knee... expand
This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic whites with knee osteoarthritis (OA). This approach will provide evidence that targeting stress and pain-related brain function will reduce OA-related pain and ethnic group differences therein. Type: Interventional Start Date: Mar 2020 |
Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained...
University of Alabama at Birmingham
Depression
Spinal Cord Injuries
This randomized controlled trial aims to assess effects of videoconferencing acceptance
and commitment therapy (ACT) on mental health outcomes in individuals living with spinal
cord injuries (SCI). A total of 40 individuals living with SCI sustained within 5 years
and experiencing depressive symptoms... expand
This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 40 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in mental health outcomes (e.g., depression) and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT. Type: Interventional Start Date: Mar 2023 |
Low-GI Diet vs High-GI Diet in Individuals With SCI
Ohio State University
Spinal Cord Injuries
Postprandial Hypotension
Glucose Metabolism Disorders
The purpose of this pilot research project is to examine the impact of a low-glycemic
index (GI) diet on postprandial hypotension and glucose control in individuals with
chronic spinal cord injury. The objectives are: 1) To evaluate the effect of the low-GI
diet on the magnitude of postprandial systolic... expand
The purpose of this pilot research project is to examine the impact of a low-glycemic index (GI) diet on postprandial hypotension and glucose control in individuals with chronic spinal cord injury. The objectives are: 1) To evaluate the effect of the low-GI diet on the magnitude of postprandial systolic blood pressure drop compared to a high-GI control diet. 2)To evaluate the effect of a low-GI diet on postprandial glucose and insulin responses compared to a high-GI control diet. Type: Interventional Start Date: May 2022 |
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
University of Alabama at Birmingham
Diabetes Mellitus
Cardiovascular Diseases
Insulin Sensitivity/Resistance
Metabolic Disease
Natriuretic Peptides
Black individuals are more likely to have decreased insulin sensitivity which results in
a high risk for the development of cardiometabolic disease. The reasons for this are
incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart
that play a role in regulating the metabolic... expand
Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril/valsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity & energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population. Type: Interventional Start Date: Aug 2020 |
Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson...
University of Alabama at Birmingham
Parkinson Disease
The purpose of this pilot study is to generate preliminary data on the impact of the
dietary protein pattern on markers of skeletal muscle health and drug efficacy in
Parkinson disease. expand
The purpose of this pilot study is to generate preliminary data on the impact of the dietary protein pattern on markers of skeletal muscle health and drug efficacy in Parkinson disease. Type: Interventional Start Date: Oct 2022 |
American Lung Association (ALA) Lung Health Cohort
Johns Hopkins University
Lung Diseases
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately
4,000 young adults between the ages of 25-35 who do not have severe lung disease. The
overarching objective of the ALA-LHC is to establish a national cohort of young adults
for the purpose of defining lung health... expand
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages. Type: Observational Start Date: Oct 2021 |
Accessible and Inclusive Diabetes Telecoaching Self-Management Program
University of Alabama at Birmingham
Diabete Type 2
Disability Physical
The purpose of this study is to develop and pilot test an accessible and inclusive
Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle
modification intervention (AI4DM) for glycemic control in people with disabilities. expand
The purpose of this study is to develop and pilot test an accessible and inclusive Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4DM) for glycemic control in people with disabilities. Type: Interventional Start Date: Oct 2022 |
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in...
Gilead Sciences
Pre-Exposure Prophylaxis of HIV Infection
The goal of this clinical study is to look at how lenacapavir (LEN) passes through the
body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate
(F/TDF) for prevention of HIV in the cisgender women in the US.
The primary objectives of this study are: 1) to characterize... expand
The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US. The primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women. Type: Interventional Start Date: Nov 2023 |
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
Joseph Broderick, MD
Intracerebral Hemorrhage
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time
(FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral
hemorrhage (ICH) within a time window and subgroup of patients that is most likely to
benefit. The central hypothesis is that... expand
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. Type: Interventional Start Date: Dec 2021 |
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
Duke University
Cognitive Impairment, Mild
Dementia
Cardiovascular Diseases
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority
study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large
study conducted in community-dwelling older adults without cardiovascular disease (CVD)
or dementia will demonstrate the... expand
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events. Type: Interventional Start Date: Sep 2020 |
PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis
University of Alabama at Birmingham
Obesity
Cardiovascular Diseases
Hypertension
Nocturnal Blood Pressure
Natriuretic Peptides
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping
blood pressure (BP). These conditions are associated with an increased risk of
cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by
the heart which directly regulate BP by causing... expand
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System [RAAS]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals. Type: Interventional Start Date: Feb 2022 |
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension
Mannkind Corporation
MAC Lung Disease
Treatment Refractory MAC Lung Disease
Mycobacterium Infections, Nontuberculous
This clinical trial is designed to compare the efficacy and safety of Clofazimine
Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) expand
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) Type: Interventional Start Date: Sep 2024 |
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment...
Biosense Webster, Inc.
Drug Refractory Paroxysmal Atrial Fibrillation
The purpose of this study is to demonstrate safety and effectiveness of the Biosense
Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and
TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in
treatment of participants with paroxysmal atrial... expand
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow. Type: Interventional Start Date: Dec 2023 |
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+...
National Cancer Institute (NCI)
Malignant Female Reproductive System Neoplasm
Malignant Solid Neoplasm
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Malignant Solid Neoplasm
This phase II ComboMATCH treatment trial compares the effect of neratinib to the
combination of neratinib and palbociclib in treating patients with HER2 positive solid
tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors.
They work by blocking the action of an abnormal... expand
This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2. Type: Interventional Start Date: May 2024 |
Pulsed Field Ablation (PFA) Vs Anti-Arrhythmic Drug (AAD) Therapy As a First Line Treatment for Persistent...
Boston Scientific Corporation
Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field
ablation as a first-line ablation treatment for subjects with persistent atrial
fibrillation as compared to subjects who received an initial treatment with
anti-arrhythmic drugs. expand
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs. Type: Interventional Start Date: Dec 2023 |
Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Jaeb Center for Health Research
Intermittent Exotropia
Determine whether full-time patching is more effective than observation for improving
distance control of IXT after 3 months of treatment (on-treatment outcome). expand
Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome). Type: Interventional Start Date: Nov 2022 |
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft...
Equillium
Graft Versus Host Disease
GVHD
Acute-graft-versus-host Disease
Acute GVHD
aGVHD
This is a multi-center study to compare the efficacy and safety of itolizumab versus
placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI
involvement, in combination with corticosteroids expand
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids Type: Interventional Start Date: Apr 2022 |
Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive...
National Cancer Institute (NCI)
Endometrial Serous Adenocarcinoma
Uterine Corpus Carcinosarcoma
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk
(Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the
usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with
HER2 positive endometrial serous carcinoma... expand
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Type: Interventional Start Date: Nov 2022 |
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive...
Janssen Research & Development, LLC
Urinary Bladder Neoplasms
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination
with intravenous (IV) cetrelimab and IV cetrelimab alone. expand
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone. Type: Interventional Start Date: Jul 2022 |
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
Genmab
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma
The purpose of this trial is to measure the safety and effectiveness of epcoritamab
(EPKINLY™), either by itself or together with other therapies, when treating subjects
with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to
identify the most appropriate dose of epcoritamab,... expand
The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating subjects with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied. Trial details include: - The total trial duration will be up to 6 years. - The treatment duration for each participant depends upon which arm of treatment they are assigned to receive, but will be no more than 3 years. - The visit frequency for each participant depends upon which arm of treatment they are assigned to receive, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks. - All participants will receive active drug; no one will be given placebo. Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned. Participants who receive standard treatments will have IV infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned. Arm 9 (follicular lymphoma (FL)) is still open for enrolment of new patients, while the other arms have closed their recruitment. Type: Interventional Start Date: Nov 2020 |
Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic...
University of Alabama at Birmingham
Pancreatic Cancer
The goal of this study is to investigate whether the therapeutic response of pancreatic
tumors can be accurately assessed using quantitative DCE-MRI, when the
inter/intra-scanner variability is reduced using the Point-of-care Portable Perfusion
Phantom, P4. The intra-scanner variability over time... expand
The goal of this study is to investigate whether the therapeutic response of pancreatic tumors can be accurately assessed using quantitative DCE-MRI, when the inter/intra-scanner variability is reduced using the Point-of-care Portable Perfusion Phantom, P4. The intra-scanner variability over time leads to errors in therapy monitoring, while the inter-scanner variability impedes the comparison of data among institutes. The P4 is small enough to be imaged concurrently in the bore of a standard MRI scanner with a patient for real-time quality assurance. The P4 is safe, inexpensive and easily operable, thus it has great potential for widespread and routine clinical use for accurate diagnosis, prognosis and therapy monitoring. This study has identified two arms, one arm is healthy individuals that will undergo DCE MRI at three different MRI locations to establish baseline results. The healthy volunteers will undergo these MRIs prior to the second arm, which contains patients with pancreatic cancer. The pancreatic cancer patients will only have DCE MRI done at one location. Type: Interventional Start Date: Oct 2020 |