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Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Endometrial Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
The purpose of this study is to find out whether the study drug, LY3537982, is safe and
effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients
must have already received or were not able to tolerate the standard of care, except for
specific groups who have not had c1 expand
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years. Type: Interventional Start Date: Jul 2021 |
A Motion Exergaming Approach for Symptom Management: HNC
University of Alabama at Birmingham
Head and Neck Cancer
This overall objective of the RCT is to test an intervention to overcome the PA barriers
for head and neck cancer (HNC) patients during the first 6 months after their treatment.
PAfitME stands for a personalized Physical Activity intervention with fitness graded
Motion Exergames. PAfitME is deliver1 expand
This overall objective of the RCT is to test an intervention to overcome the PA barriers for head and neck cancer (HNC) patients during the first 6 months after their treatment. PAfitME stands for a personalized Physical Activity intervention with fitness graded Motion Exergames. PAfitME is delivered via a tested mix of FaceTime calls and home visits, uses commercially available exergaming platforms (Nintendo Switch). We propose the following specific aims: (1) When compared to an attention control group, determine the effect of PAfitME on fatigue and musculoskeletal pain at week 6, when controlling for age and sex; (2) when compared to an attention control group, determine the effect of PAfitME on functional status and QOL at week 6, when controlling for age and sex; and (3) explore if PA self-efficacy, PA enjoyment, and exergame minutes mediate the effect of PAfitME on fatigue and musculoskeletal pain. This study will evaluate 150 post-treatment (radiation, chemotherapy, or chemoradiation) HNC patients in an RCT with an attention control. For 6 weeks, the experimental (PAfitME) group will receive the PAfitME intervention, and the attention control group will receive NCI-based survivorship education and exergame equipment. For Aims 1 and 2, using an intention-to-treat framework, we will fit a series of linear mixed effects models with each of the outcome variables. For Aim 3, we will conduct our exploratory analyses in ml_mediation (STATA 15), which will compute direct and indirect effects for multi-level data. Type: Interventional Start Date: Aug 2020 |
Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Pati1
Alliance for Clinical Trials in Oncology
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2 Negative Breast Carcinoma
Hormone Receptor Positive Breast Carcinoma
This phase III trial compares an additional support program (text message reminders
and/or telephone-based counseling) with usual care in making sure breast cancer patients
take their endocrine therapy medication as prescribed (medication adherence). Medication
adherence is how well patients take t1 expand
This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed. Type: Interventional Start Date: Feb 2021 |
Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broad1
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803,
an IL-15 superagonist, with or without combination broadly neutralizing antibodies
(bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI). expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI). Type: Interventional Start Date: May 2021 |
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma1
Sabine Mueller, MD, PhD
Glioblastoma
Malignant Glioma
Recurrent Glioblastoma
Recurrent Malignant Glioma
Recurrent Grade III Glioma
This phase I trial studies the side effects of nivolumab before and after surgery in
treating children and young adults with high grade glioma that has come back (recurrent)
or is increasing in scope or severity (progressive). Immunotherapy with monoclonal
antibodies, such as nivolumab, may help th1 expand
This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: Oct 2020 |
UAB Alzheimer's Disease Center Core Cohort - Imaging Substudy
University of Alabama at Birmingham
Alzheimer Disease
The primary objective of this study is to measure the concentration and the regional
brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in
participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions
between race and vascular risk factors, br1 expand
The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic amyloid deposition using the PET tracer [C-11]PiB in participants in the UAB Alzheimer's Disease Center cohort. Assessment of interactions between race and vascular risk factors, brain amyloid levels measured with [C-11]PiB-PET, and cognitive status will be the primary outcome of this imaging study. Type: Interventional Start Date: Apr 2018 |
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Duke University
Rheumatic Joint Disease
Continuation of the CARRA Registry as described in the protocol will support data
collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will
form the basis for future CARRA studies. In particular, this observational registry will
be used to answer pressing questions abo1 expand
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions. Type: Observational [Patient Registry] Start Date: Jul 2015 |
A Stakeholder-enhanced Intervention to Improve the Decisional Partnership of Chronic Kidney Disease1
University of Alabama at Birmingham
Decision Making, Shared
Family Caregiving
Chronic Kidney Disease
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the
purpose of this study is to pilot test, an optimization trial approach to develop and
refine the decision partnering skills of persons with stage 4 chronic kidney disease and
their caregivers. Using a 2x2x2 full1 expand
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one or more lay coach-delivered decision partnering training components, based on Pearlin's Stress-Health Model of Family Caregiving and Rini's Social Support Effectiveness theory. The components include: 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no). Type: Interventional Start Date: Sep 2024 |
Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)
National Alliance for Sickle Cell Centers
Sickle Cell Trait
The main purpose of this study is to create a longitudinal cohort of those with Sickle
Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS,
assess for differences in those with varying quantities of HbS and assess for potential
clinical complications of SCT. expand
The main purpose of this study is to create a longitudinal cohort of those with Sickle Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS, assess for differences in those with varying quantities of HbS and assess for potential clinical complications of SCT. Type: Observational Start Date: Apr 2023 |
Investigating the Use of TaVNS to Treat Insomnia in Individuals with Breast Cancer (taVNS-insomnia-1
University of Alabama at Birmingham
Breast Cancer
Insomnia
In the present study, the investigators aim to investigate feasibility of utilizing
noninvasive neuromodulation, specifically taVNS, as a nonpharmacologic approach to
address insomnia in patients with stage I-IV breast cancer. expand
In the present study, the investigators aim to investigate feasibility of utilizing noninvasive neuromodulation, specifically taVNS, as a nonpharmacologic approach to address insomnia in patients with stage I-IV breast cancer. Type: Interventional Start Date: Sep 2023 |
Study of Tazemetostat in Lymphoid Malignancies
University of Alabama at Birmingham
T-cell Lymphoma
Tazemetostat is an oral EZH2 inhibitor which has been FDA approved for adult patients
with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for
an EZH2 mutation as detected by an FDA-approved test and who have received at least 2
prior systemic therapies, and for adul1 expand
Tazemetostat is an oral EZH2 inhibitor which has been FDA approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment option. We propose a study to evaluate the safety of tazemetostat in relapsed / refractory peripheral T-cell lymphoma. Type: Interventional Start Date: Sep 2024 |
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
Tenax Therapeutics, Inc.
Pulmonary Hypertension
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with
placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6
MWD; Day 1 to Week 12). expand
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12). Type: Interventional Start Date: Jan 2024 |
Lupus Landmark Study: A Prospective Registry and Biorepository
Lupus Research Alliance
Systemic Lupus Erythematosus (SLE)
Lupus Nephritis
Neuropsychiatric Systemic Lupus Erythematosus
The purpose of the registry and biorepository is to provide a mechanism to store clinical
data, linked biospecimens and molecular data to support the conduct of future research on
Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN). expand
The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN). Type: Observational [Patient Registry] Start Date: Jun 2023 |
Stimulation-Induced Changes in Fronto-Limbic Network
University of Alabama at Birmingham
Epilepsy
Mental Disorders
The purpose of this research is to better understand how emotion processing unfolds in
the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This
study will use standard behavioral emotion processing tasks combined with neural
recording and direct brain stimulation to as1 expand
The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future. Type: Interventional Start Date: Mar 2023 |
Selinexor in Maintenance Therapy After Systemic Therapy for Participants with P53 Wild-Type, Advanc1
Karyopharm Therapeutics Inc
Endometrial Cancer
The purpose of this study is to evaluate the efficacy and safety of selinexor as a
maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have
achieved a partial response (PR) or complete response (CR) (per Response Evaluation
Criteria in Solid Tumors version 1.1 [RECIST v 1.1 expand
The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo. Type: Interventional Start Date: Apr 2023 |
Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A Comb1
National Cancer Institute (NCI)
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Unresectable Malignant Solid Neoplasm
This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy
(paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be
removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally
advanced) or from where it first started (1 expand
This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy (paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced) or from where it first started (primary site) to other places in the body (metastatic), and has PTEN and AKT genetic changes. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy, such as Ipatasertib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of ipatasertib to paclitaxel in solid tumors with PTEN and AKT genetic changes could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression). Researchers hope to learn if paclitaxel plus ipatasertib will shrink this type of cancer or stop its growth. Type: Interventional Start Date: Sep 2023 |
Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity
University of Alabama at Birmingham
Type 2 Diabetes
It has been shown that individuals with type 2 diabetes have higher blood sugar
throughout the night than individuals without type 2 diabetes. However, it is still
unknown if this rise in blood sugar can be controlled using medications.
This study will examine the effects of three different diabet1 expand
It has been shown that individuals with type 2 diabetes have higher blood sugar throughout the night than individuals without type 2 diabetes. However, it is still unknown if this rise in blood sugar can be controlled using medications. This study will examine the effects of three different diabetes treatments to determine if they improve night time blood sugars. Participants will be randomly assigned for 8 weeks to one of the following three groups: GROUP 1: Insulin. Participants will be instructed on self-injecting insulin glargine once-daily in the morning. The dose will be increased by the study team to avoid episodes of low blood sugar and to maintain fasting blood sugar concentrations between 70 to 180 mg/dl. GROUP 2: Metformin. Participants will start the drug (500 mg twice daily) with meals. After 72 hours and in the absence of side effects, they will increase the dose to 500 mg with breakfast and 1,000 mg with supper. After a further 72 hours and in the absence of side effects, they will increase the dose to 1,000 mg twice daily with meals and continue until the end of the trial. The dose will be adjusted by the study team to maintain fasting blood sugar concentrations between 70 to 180 mg/dl. GROUP 3: Dorzagliatin. This medication dose will be 75 mg twice daily. The investigators anticipate fasting glucose concentrations will be between 70 to 180 mg/dl since the dose of this medication cannot be titrated. Type: Interventional Start Date: Mar 2022 |
Improving Age-Related Cognitive Decline with Exercise in Hypertensive Older Adults
University of Alabama at Birmingham
Hypertension
The investigator aims to assess the extent to which a brief exercise intervention
improves systemic growth factor concentrations, reverses loss of systemic vascular
networks and hypertension, and by extension, improves neurocognition. To test the
investigator's hypothesis that increased cardiovascu1 expand
The investigator aims to assess the extent to which a brief exercise intervention improves systemic growth factor concentrations, reverses loss of systemic vascular networks and hypertension, and by extension, improves neurocognition. To test the investigator's hypothesis that increased cardiovascular fitness will correlate with improved vascular density, the investigator proposes the innovative use of retinal density scans. Type: Interventional Start Date: Oct 2021 |
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Jason Sperry
Hemorrhagic Shock
Traumatic Injury
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma
centers designed to determine the efficacy and safety of low titer whole blood
resuscitation as compared to standard of care resuscitation in patients at risk of
hemorrhagic shock and to appropriately characterize t1 expand
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age. Type: Interventional Start Date: Apr 2022 |
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
Forma Therapeutics, Inc.
Sickle Cell Disease
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of
etavopivat and test how well etavopivat works compared to placebo to improve the amount
of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when
the blood vessels become blocked an1 expand
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain). Type: Interventional Start Date: Mar 2021 |
Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
University of Alabama at Birmingham
Maternal Cytomegalovirus Infections
Cytomegalovirus Congenital
This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV)
risk-reduction behavioral intervention will prevent maternal CMV infections during
pregnancy in women. expand
This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women. Type: Interventional Start Date: Jan 2021 |
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Ne1
National Cancer Institute (NCI)
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
This phase III trial compares the effect of usual treatment of chemotherapy and steroids
and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab.
Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability
of cancer cells to grow and spread. The i1 expand
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care. Type: Interventional Start Date: Jan 2021 |
MitraClip REPAIR MR Study
Abbott Medical Devices
Mitral Valve Regurgitation
The objective of this randomized controlled trial (RCT) is to compare the clinical
outcome of MitraClip™ device versus surgical repair in patients with severe primary MR
who are at moderate surgical risk and whose mitral valve has been determined to be
suitable for correction by MV repair surgery b1 expand
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. Type: Interventional Start Date: Jul 2020 |
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
University of Alabama at Birmingham
Pregnancy Complications
Maternal Distress
Adverse Birth Outcomes
Infant Conditions
The PᵌOPPY study is designed to support the American Heart Association's mission to
improve maternal/infant health outcomes and address inequities in maternal/infant health
care. The P3OPPY Project is one of five projects within the American Heart Association P3
EQUATE Network. The overarching goal1 expand
The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes. Type: Interventional Start Date: Aug 2024 |
BPL-003 Efficacy and Safety in Treatment Resistant Depression
Beckley Psytech Limited
Treatment Resistant Depression
This is a Phase 2 study randomized, quadruple masked, multi-center study designed to
investigate the efficacy and safety of a single dose of BPL-003 combined with
psychological support in patients with treatment resistant depression (TRD). expand
This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD). Type: Interventional Start Date: Sep 2023 |
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