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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 in male or... 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 |
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 ways can novel dietary assessment... 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 |
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. expand
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 |
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Locally Advanced Malignant Solid Neoplasm
Malignant Female Reproductive System Neoplasm
This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical
trials to study cancer treatment directed by genetic testing. Patients with solid tumors
that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to
other places in the body (advanced)... expand
This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors. Type: Interventional Start Date: Apr 2023 |
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female...
Sanofi
Fabry Disease
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3
study, in which participants will be randomized to venglustat versus standard of care
therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of
venglustat on left ventricular mass index (LVMI)... expand
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3 study, in which participants will be randomized to venglustat versus standard of care therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of venglustat on left ventricular mass index (LVMI) in adult participants with Fabry disease and left ventricular hypertrophy. - Study visits will take place approximately every 3 to 6 months - Participants who complete the randomized period may continue to the long-term extension (LTE) to receive venglustat for up to additional 34 months with the total study duration up to 4.4 years maximum. Type: Interventional Start Date: May 2022 |
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic...
Hoffmann-La Roche
Metastatic Colorectal Cancer
This open-label, exploratory study is designed to evaluate the safety and efficacy of
targeted therapies or immunotherapy as single agents or combinations, in participants
with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per
treatment arm-specific definition. Eligible... expand
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results. Type: Interventional Start Date: Oct 2021 |
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled...
Incyte Corporation
B-Cell Malignancies
This is a Phase 2, multicenter, open-label study to provide continued supply of
parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or
ibrutinib to participants from Incyte-sponsored studies of parsaclisib. expand
This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib. Type: Interventional Start Date: Aug 2020 |
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk...
NRG Oncology
Ovarian Carcinoma
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy
and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salpingo-oophorectomy... expand
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations. Type: Interventional Start Date: Sep 2020 |
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment...
National Cancer Institute (NCI)
Bladder Urothelial Carcinoma In Situ
Invasive Bladder Mixed Carcinoma
Stage 0a Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating
patients with non-muscle invasive bladder cancer whose cancer does not respond to
Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work
in different ways to stop the growth of... expand
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone. Type: Interventional Start Date: Mar 2020 |
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Human Papillomavirus Type 16
Cervical Intraepithelial Neoplasia Grade II
Cervical Intraepithelial Neoplasia, Grade III
The primary goal of this phase I open label study is to determine the safety and
tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM)
injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19
years), with biopsy confirmed cervical intraepithelial... expand
The primary goal of this phase I open label study is to determine the safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM) injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19 years), with biopsy confirmed cervical intraepithelial (CIN) II or III that is human papillomavirus (HPV) 16+. Type: Interventional Start Date: Sep 2020 |
Study of Treatment for HPV16+ ASC-US or LSIL
University of Alabama at Birmingham
ASC-US
LSIL
Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein
vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine expand
Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine Type: Interventional Start Date: Jul 2023 |
Personalized Theratyping Trial
University of Alabama at Birmingham
Cystic Fibrosis
The purpose of this study is to explore the use of off-label CFTR modulators that may
affect CFTR function in patients with CFTR mutations that are not currently approved for
these drugs. expand
The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs. Type: Interventional Start Date: Aug 2019 |
Human IPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
University of Alabama at Birmingham
Diabetes Complications
Diabetic Retinopathy
This study proposes to carefully examine the hypothesis that human inducible pluripotent
stem cells (iPSCs) can be effectively employed as a future therapeutic option for
individuals with diabetic retinopathy and macular ischemia. iPSCs will be generated from
the peripheral blood cells of subjects... expand
This study proposes to carefully examine the hypothesis that human inducible pluripotent stem cells (iPSCs) can be effectively employed as a future therapeutic option for individuals with diabetic retinopathy and macular ischemia. iPSCs will be generated from the peripheral blood cells of subjects with diabetes and age matched controls. The human iPSC cells will be used to generate mesoderm cells for injection into the vitreous cavity of diabetic rodents and primate eyes. The ability of mesoderm cells to generate endothelial cells and pericytes in areas of degenerated capillaries will be examined. The human iPSCs will also be used to generate hematopoietic CD34+CD45+ cells. The combination of CD34+CD45+ cells derived from iPSCs and iPSC derived mesoderm will be examined in combination for their potentially beneficial effect to enhance the vessel formation. Type: Observational Start Date: Jan 2018 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
Platform Clinical Study for Conquering Scleroderma
Scleroderma Research Foundation, Inc.
Interstitial Lung Disease Due to Systemic Disease
Scleroderma
The goal of this clinical trial is to test efficacy of different investigational products
(IPs) compared with placebo on the change from baseline to the end of the treatment
period at Week 52 in lung capacity in participants with Interstitial Lung Disease
Secondary to Systemic Sclerosis. expand
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis. Type: Interventional Start Date: Apr 2024 |
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer
Lantheus Medical Imaging
Prostate Cancer
The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can
safely and accurately detect the presence or absence of prostate cancer growing beyond
the prostate gland in men with favorable intermediate risk prostate cancer.
Participants will receive a single dose of PYLARIFY... expand
The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer. Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan. Type: Interventional Start Date: Feb 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 to measure effect on... 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 |
Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis
University of Alabama at Birmingham
Amyotrophic Lateral Sclerosis
Myasthenia Gravis
The aim of this study is to understand how well a 6-week virtual yogic breathing exercise
program (YBEP) will improve breathing, speech, and emotional well-being in people with
amyotrophic lateral sclerosis (ALS). expand
The aim of this study is to understand how well a 6-week virtual yogic breathing exercise program (YBEP) will improve breathing, speech, and emotional well-being in people with amyotrophic lateral sclerosis (ALS). Type: Interventional Start Date: Nov 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. expand
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 |
ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women with Obesity
University of Alabama at Birmingham
Obesity
The goal of this clinical trial is to investigate if a 4-hour acceptance and commitment
therapy workshop can help the adoption and maintenance of healthy lifestyle behaviors in
women with obesity. The objectives are as follows:
1. To assess changes in ACT-related constructs before and after the... expand
The goal of this clinical trial is to investigate if a 4-hour acceptance and commitment therapy workshop can help the adoption and maintenance of healthy lifestyle behaviors in women with obesity. The objectives are as follows: 1. To assess changes in ACT-related constructs before and after the workshop 2. To assess changes in other psychological constructs that have been shown to hinder successful weight management before and after the workshop 3. To assess changes in dietary and physical activity behaviors before and after the workshop. Participants will complete baseline questionnaires and anthropometric measures at three time points: baseline, 1 week after the workshop, and 1 month after the workshop. Researchers will compare an active intervention group to a waitlist control group to investigate the efficacy of the workshop. Type: Interventional Start Date: Aug 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 the body (advanced).... 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 |
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 combined public/private... 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, fluorouracil, oxaliplatin,... 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 |
Regulation of Inflammatory Genes in Hidradenitis Suppurativa
University of Alabama at Birmingham
Hidradenitis Suppurativa
The purpose of this protocol is to examine the cytokine profi le of pati ents with
hidradeniti s suppurati va (HS) and idemechanisms responsible for post-transcripti onal
regulati on of these genes. The primary objecti ve is to determinfollowing cytokines
linked to hidradeniti s suppurati va are diff... expand
The purpose of this protocol is to examine the cytokine profi le of pati ents with hidradeniti s suppurati va (HS) and idemechanisms responsible for post-transcripti onal regulati on of these genes. The primary objecti ve is to determinfollowing cytokines linked to hidradeniti s suppurati va are diff erenti ally expressed in hidradeniti s pati ents versus controlalso doing a sub-study to determine the eff ect of childhood trauma on HS. The parti cipati on in the sub-study is opti onal Type: Observational Start Date: Oct 2022 |
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 of BGB-11417 monotherapy... 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 |
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