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Gut Oxalate Absorption in Calcium Oxalate Stone Disease
University of Alabama at Birmingham
Kidney Stone
Kidney Calculi
Urolithiasis
Urolithiasis, Calcium Oxalate
Nephrolithiasis
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate
kidney stones have an increased absorption of dietary oxalate, which would lead to increased
urinary excretion of oxalate.
The study will recruit adult patients with a history of... expand
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate. The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones. Participants will - ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time - ingest a soluble form of oxalate and sugar preparations to test gut permeability - collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test Type: Interventional Start Date: May 2024 |
O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
University of Alabama at Birmingham
Kidney Stone
Kidney Calculi
Urolithiasis
Urolithiasis, Calcium Oxalate
Nephrolithiasis
The goal of this trial is to test if colonization with the gut bacteria Oxalobacter
formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate
kidney stone disease.
The study will recruit adult participants with a history of calcium oxalate... expand
The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease. The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes. Participants will - ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time - collect urine, blood and stool samples during the fixed diets - ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes Type: Interventional Start Date: May 2024 |
ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)
ProDa BioTech, LLC
Pancreatic Ductal Carcinoma
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the
safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and nab
paclitaxel (G-nP) in previously untreated subjects with metastatic pancreatic ductal
adenocarcinoma... expand
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic pancreatic ductal adenocarcinoma (PDAC) Type: Interventional Start Date: Sep 2023 |
Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation
University of Alabama at Birmingham
Parathyroid Dysfunction
Adenoma
The aim of this study is to determine if fluorescence with or without indocyanine green can
facilitate safe and accurate thyroid and parathyroid surgery.
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The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery. Type: Interventional Start Date: Apr 2024 |
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart...
Bristol-Myers Squibb
Heart Failure
The purpose of this study is to evaluate the safety, tolerability, and exposure-response
(E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved
Ejection Fraction (HFpEF).
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The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF). Type: Interventional Start Date: Nov 2023 |
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung...
Sanofi
Lung Transplant Rejection
This double-blind, randomized, placebo-controlled, multinational, multicenter,
parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil
compared with placebo, both administered on top of azithromycin and standard-of-care regimen
of immunosuppression... expand
This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications. Type: Interventional Start Date: Oct 2023 |
Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)
University of Alabama at Birmingham
Kidney Diseases
Cardiometabolic Risk Factors
We seek to explore the feasibility and acceptability of participation in a decision-support
training program led by lay navigators. ImPart-Multi, an education-telehealth-based, is
designed to empower Black chronic kidney disease patients (CKD) patients and their care
partner... expand
We seek to explore the feasibility and acceptability of participation in a decision-support training program led by lay navigators. ImPart-Multi, an education-telehealth-based, is designed to empower Black chronic kidney disease patients (CKD) patients and their care partner to seek the resources and support needed to be activated allies when making health-related decisions. Participants, based on random assignment, will participate in survey completion at study start and at 12 and 24 weeks of enrollment, and will complete 1, 3, or 4 education sessions via telehealth or audio connection. Participants will also complete an interview to share their thoughts on the program and other factors of interest. Type: Interventional Start Date: Mar 2024 |
The Study of Immunization in People Living With HIV Undergoing an ATI for Elicitation of VRC01-lineage...
National Institute of Allergy and Infectious Diseases (NIAID)
Chronic HIV Infection
This is a multicenter controlled interventional trial. This phase 1 trial is the first study
to assess 426c.Mod.Core-C4b adjuvanted with 3M-052-AF + aluminum hydroxide suspension (Alum)
in people living with HIV (PLWH).
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This is a multicenter controlled interventional trial. This phase 1 trial is the first study to assess 426c.Mod.Core-C4b adjuvanted with 3M-052-AF + aluminum hydroxide suspension (Alum) in people living with HIV (PLWH). Type: Interventional Start Date: Jan 2024 |
Early Parkinson's Disease Monotherapy With CVN424
Cerevance Beta, Inc.
Parkinson's Disease
This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams
(mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in
a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is... expand
This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies. Type: Interventional Start Date: Sep 2023 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis...
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in
subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.
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Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy...
NRG Oncology
Breast Cancer
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer... expand
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). Type: Interventional Start Date: Aug 2023 |
An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
University of Alabama at Birmingham
Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Chronic Illness
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the
purpose of this randomized factorial pilot trial is to identify feasibility, acceptability,
and preliminary efficacy of components of an intervention (UPHOLDS) to improve quality of
life... expand
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial pilot trial is to identify feasibility, acceptability, and preliminary efficacy of components of an intervention (UPHOLDS) to improve quality of life of older adults with advanced heart failure. Using a 2x2x2x2 factorial design, 64 adults with advanced heart failure will be randomized to receive one or more palliative care coach-delivered components, based on Ferrans' Health-Related Quality of Life Model: 1) psychoeducation on palliative care principles (4 vs. 8 sessions); 2) financial coaching (yes vs. no); 3) one-time specialty outpatient palliative care consultation (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks). Type: Interventional Start Date: Apr 2024 |
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete...
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
Early Stage Triple-Negative Breast Carcinoma
The phase III trial compares the effect of pembrolizumab to observation for the treatment of
patients with early-stage triple-negative breast cancer who achieved a pathologic complete
response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy... expand
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab. Type: Interventional Start Date: May 2023 |
Nutrition for Precision Health, Powered by the All of Us
RTI International
Nutrition
Health
Dietary Habits
The goal of this investigational study is to develop algorithms that predict human response
to foods. The main question it aims to answer are:
- How does varying foods and eating patterns impact one's biological and physiological
responses?
- In what... expand
The goal of this investigational study is to develop algorithms that predict human response to foods. The main question it aims to answer are: - How does varying foods and eating patterns impact one's biological and physiological responses? - In what ways can novel dietary assessment measures be used to improve dietary assessments and to prescribe assessments to people in future research with increased precision? - Can artificial intelligence and machine learning techniques be combined to prescribe foods and eating patterns to individuals for optimization of their health? There are 3 Modules participants may take part in: - Module 1- A participant's dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, as well as physiological responses to a liquid mixed meal tolerance test will be measured. - Module 2- Participants will undergo three controlled dietary interventions provided for 14-days each and separated by washout periods of at least 14 days. Physiological responses following a diet-specific meal test will be measured. - Module 3- Participants will undergo the same three dietary interventions during the same 14 day periods as Module 2 while being studied in-residence. Physiological responses following a liquid mixed meal tolerance test and a diet-specific meal test will be measured. Type: Interventional Start Date: Apr 2023 |
Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma
Alliance for Clinical Trials in Oncology
Advanced Dedifferentiated Liposarcoma
Locally Advanced Dedifferentiated Liposarcoma
Metastatic Dedifferentiated Liposarcoma
Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
This phase II trial compares the effect of treatment with palbociclib alone to treatment with
palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may
have spread from where it first started to nearby tissue, lymph nodes, or distant parts of... expand
This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cemiplimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The combination of these two drugs may be more effective in shrinking or stabilizing advanced dedifferentiated liposarcoma compared to palbociclib alone. Type: Interventional Start Date: May 2023 |
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Olatec Therapeutics LLC
Acute Gout Flare
Gout Attack
Gout Flare
Gouty Arthritis
Gout
The purpose of this trial is to investigate the efficacy and safety of dapansutrile
(OLT1177®) tablets in subjects with an acute gout flare.
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The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare. Type: Interventional Start Date: Jan 2023 |
Stepping Into Lifestyle Changes
University of Alabama at Birmingham
Overweight and Obesity
Pre-Diabetes
High Blood Pressure
The purpose of this study is to promote healthy weight loss among African American women, age
30 or older, who are pre-diabetic and/or have high blood pressure and who live, work, or
worship in select rural communities throughout Alabama and Mississippi. The goal of the study... expand
The purpose of this study is to promote healthy weight loss among African American women, age 30 or older, who are pre-diabetic and/or have high blood pressure and who live, work, or worship in select rural communities throughout Alabama and Mississippi. The goal of the study is to help reduce the burden of obesity, diabetes, and high blood pressure for these women and to collect information on the reach, effectiveness, adoption, implementation, maintenance, and cost effectiveness of our two evidence-base weight loss programs. Type: Interventional Start Date: Mar 2023 |
Alzheimer's Disease Neuroimaging Initiative 4
University of Southern California
Mild Cognitive Impairment
Alzheimer Disease
Dementia
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical
trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that
have... expand
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD. Type: Observational Start Date: Jun 2023 |
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX)...
Alliance for Clinical Trials in Oncology
Locally Advanced Rectal Carcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course
chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs,
such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX
(leucovorin,... expand
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. Type: Interventional Start Date: Dec 2022 |
Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial
National Cancer Institute (NCI)
Malignant Solid Neoplasm
Ovarian Low Grade Serous Adenocarcinoma
Pancreatic Carcinoma
Stage IV Ovarian Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
This phase II ComboMATCH treatment trial evaluates the effectiveness of palbociclib and
binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are
both in a class of medications called kinase inhibitors. They work by blocking the action of
abnormal... expand
This phase II ComboMATCH treatment trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA. Type: Interventional Start Date: Dec 2023 |
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
BeiGene
Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma (MCL)
Relapsed Mantle Cell Lymphoma
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417
(sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of
BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates
efficacy... expand
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1. Type: Interventional Start Date: Sep 2022 |
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Janssen-Cilag Ltd.
Fistulizing Crohns Disease
Perianal Crohns Disease
The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing,
perianal Crohn's disease and to assess the overall safety of guselkumab.
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The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab. Type: Interventional Start Date: Sep 2022 |
EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
Amgen
Cardiovascular Disease
Myocardial Infarction
Stroke
Coronary Revascularization
The primary objective of this study is to evaluate the effectiveness of early treatment with
evolocumab plus routine lipid management vs routine lipid management alone when administered
in the acute setting to reduce myocardial infarction, ischemic stroke, arterial
revascularization,... expand
The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]). Type: Interventional Start Date: Oct 2022 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients...
Hoffmann-La Roche
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
The main objective of the study is to evaluate the efficacy of satralizumab compared with
placebo based on time from randomization to the first occurrence of an adjudicated MOGAD
relapse in the double-blind (DB) treatment period
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The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period Type: Interventional Start Date: Aug 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
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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 |
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