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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 |
Advancing Transplantation Outcomes in Children
National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant
This is a pediatric kidney transplant study comparing the safety and efficacy of an
immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate
Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups
within 24 hours following the transplant procedure.... expand
This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months. Type: Interventional Start Date: May 2024 |
Investigating the Use of TaVNS to Treat Insomnia in Individuals with Breast Cancer (taVNS-insomnia-BC)
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 adult... 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 |
A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor...
Taiho Oncology, Inc.
Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
The purpose of this study is to evaluate the safety and efficacy of zipalertinib in
patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and
other mutations. expand
The purpose of this study is to evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other mutations. Type: Interventional Start Date: Jul 2023 |
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 assess... 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 |
Prehabilitation Feasibility Among Older Adults Undergoing Transplantation
Smith Giri
Multiple Myeloma
This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo
Autologous Stem Cell transplantation at UAB. Participants will be randomized into either
a prehabilitation program or an attention control group before their transplant. The
primary outcomes will be feasibility and secondary... expand
This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomized into either a prehabilitation program or an attention control group before their transplant. The primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up. Type: Interventional Start Date: Jul 2023 |
Selinexor in Maintenance Therapy After Systemic Therapy for Participants with P53 Wild-Type, Advanced...
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 ComboMATCH...
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... 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 diabetes... 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 |
Harmony TPV Post-Approval Study
Medtronic Cardiovascular
Congenital Heart Disease
Tetrology of Fallot
RVOT Anomaly
Pulmonary Regurgitation
The purpose of this study is to characterize the functionality of transcatheter
implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by
real-world implanters. expand
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters. Type: Interventional Start Date: Oct 2021 |
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 cardiovascular... 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 |
Clinical Trial of Multi-Periscopic Prism Glasses for Hemianopia
Massachusetts Eye and Ear Infirmary
Homonymous Hemianopia
This clinical trial will evaluate the efficacy of two types of high-power prism glasses
that provide field of view expansion for patients with homonymous hemianopia (the
complete loss of half the field of vision on the same side in both eyes). expand
This clinical trial will evaluate the efficacy of two types of high-power prism glasses that provide field of view expansion for patients with homonymous hemianopia (the complete loss of half the field of vision on the same side in both eyes). Type: Interventional Start Date: Oct 2022 |
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... 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 and... 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 Newly...
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... 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... 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 goal... 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 |
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants...
Iovance Biotherapeutics, Inc.
Metastatic Melanoma
Unresectable Melanoma
Melanoma
This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study
to assess the efficacy and safety of lifileucel in combination with pembrolizumab
compared with pembrolizumab alone in participants with untreated, unresectable or
metastatic melanoma. Participants randomized to... expand
This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period. Type: Interventional Start Date: Mar 2023 |
Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral...
SWOG Cancer Research Network
Malignant Solid Neoplasm
This phase III trial compares the effect of 3 study approaches in preventing
chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous
compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel
or docetaxel, can cause a nerve disorder called peripheral... expand
This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called peripheral neuropathy, which can cause numbness, tingling, or pain in the arms and legs. The 3 study approaches will use a device, called the Paxman Limb Cryocompression System, made of wraps that cool and/or compress the arms and legs. This study may help researchers determine if any of the study approaches are able to prevent taxane chemotherapy from causing peripheral neuropathy. Type: Interventional Start Date: Jun 2023 |
A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic...
Boston Children's Hospital
Severe Aplastic Anemia
Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough
new blood cells. SAA can be cured with immune suppressive therapy or a bone marrow
transplant. Regular treatment for patients with aplastic anemia who have a matched
sibling (brother or sister), or family donor... expand
Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough new blood cells. SAA can be cured with immune suppressive therapy or a bone marrow transplant. Regular treatment for patients with aplastic anemia who have a matched sibling (brother or sister), or family donor is a bone marrow transplant. Patients without a matched family donor normally are treated with immune suppressive therapy (IST). Match unrelated donor (URD) bone marrow transplant (BMT) is used as a secondary treatment in patients who did not get better with IST, had their disease come back, or a new worse disease replaced it (like leukemia). This trial will compare time from randomization to failure of treatment or death from any cause of IST versus URD BMT when used as initial therapy to treat SAA. The trial will also assess whether health-related quality of life and early markers of fertility differ between those randomized to URD BMT or IST, as well as assess the presence of marrow failure-related genes and presence of gene mutations associated with MDS or leukemia and the change in gene signatures after treatment in both study arms. This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for treatment of SAA. Type: Interventional Start Date: Jan 2023 |
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