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Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma
Duke University
Metastatic Renal Cell Carcinoma
ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer
management and health-related quality of life in patients with mRCC in routine real-world
clinical practice in the United States, including both community and academic treatment
settings. expand
ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings. Type: Observational Start Date: Apr 2022 |
DALY II USA/ MB-CART2019.1 for DLBCL
Miltenyi Biomedicine GmbH
Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Relapsed Diffuse Large B Cell Lymphoma
High Grade B-cell Lymphoma (HGBCL)
Primary Mediastinal B-cell Lymphoma (PMBCL)
Transformed Lymphoma
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy,
safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients
with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at
least two lines of therapy. expand
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Type: Interventional Start Date: May 2021 |
Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study...
International Spine Study Group Foundation
Cervical Deformity
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically
treated patients with adult cervical spinal deformity. expand
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity. Type: Observational Start Date: Aug 2019 |
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness...
LivaNova
Treatment Resistant Depression
Objectives of this study are to determine whether active VNS Therapy treatment is
superior to a no stimulation control in producing a reduction in baseline depressive
symptom severity, based on multiple depression scale assessment tools at 12 months from
randomization. expand
Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization. Type: Interventional Start Date: Sep 2019 |
Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment...
University of Kansas Medical Center
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Melanoma
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Unresectable Melanoma
This phase II trial tests how well lifileucel, with reduce dose fludarabine and
cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with
melanoma that cannot be removed by surgery (unresectable) or that has spread from where
it first started (primary site) to other places... expand
This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma. Type: Interventional Start Date: Dec 2023 |
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment...
NRG Oncology
Prostate Adenocarcinoma
This phase III trial uses the Decipher risk score to guide intensification (for higher
Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to
better match therapies to an individual patient's cancer aggressiveness. The Decipher
risk score evaluates a prostate cancer... expand
This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Type: Interventional Start Date: Nov 2021 |
The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective...
University of Kansas Medical Center
Advanced Biliary Tract Cancer
The purpose of this study is to measure how effective combining Durvalumab and
Regorafenib will be for participants with advance stage biliary track carcinoma who have
received one line of prior treatment expand
The purpose of this study is to measure how effective combining Durvalumab and Regorafenib will be for participants with advance stage biliary track carcinoma who have received one line of prior treatment Type: Interventional Start Date: Mar 2022 |
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After...
NRG Oncology
Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
This phase III trial studies whether adding apalutamide to the usual treatment improves
outcome in patients with lymph node positive prostate cancer after surgery. Radiation
therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male
sex hormones, can cause the growth... expand
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach. Type: Interventional Start Date: Mar 2020 |
Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide...
NRG Oncology
Glioblastoma
Gliosarcoma
This phase III trial compares the effect of adding lomustine to temozolomide and
radiation therapy versus temozolomide and radiation therapy alone in shrinking or
stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as
lomustine and temozolomide, work in different ways... expand
This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, 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. Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma. Type: Interventional Start Date: Nov 2021 |
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
University of Kansas Medical Center
Risk Reduction
Breast Cancer
Women at risk for development of breast cancer and experiencing vasomotor menopausal
symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens
(CE) for 6 months versus a wait list control. Two risk factors for development of breast
cancer will be studied pre-study and... expand
Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and after 6 months: fibroglandular volume (FGV) on mammogram as assessed by Volpara software and proliferation by Ki-67 immunocytochemistry in benign breast tissue acquired by random periareolar fine needle aspiration (RPFNA). Change in biomarkers will be compared between groups. Type: Interventional Start Date: Dec 2021 |
The Acute Burn ResUscitation Multicenter Prospective Trial
American Burn Association
Burn Injury
This is a prospective randomized multi-center study which will compare acute fluid
resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR
alone), in adults with an acute burn involving at least 25% of their total body surface
area. expand
This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area. Type: Interventional Start Date: Apr 2021 |
Study of CYR-064 Versus Placebo in Patients.
Cyrano Therapeutics, Inc.
Hyposmia
Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy
of CYR-064. expand
Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064. Type: Interventional Start Date: Sep 2023 |
A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic...
Regeneron Pharmaceuticals
Eosinophilic Gastritis
Eosinophilic Duodenitis
Eosinophilic Gastrointestinal Disease
The study is researching an experimental drug called dupilumab. The study is focused on
participants with active eosinophilic gastritis (EoG) with or without eosinophilic
duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD
are uncommon, persistent, allergic/immune... expand
The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Type: Interventional Start Date: May 2023 |
Stroke Thrombectomy and Aneurysm Registry
Medical University of South Carolina
Stroke
Thromboses, Intracranial
Aneurysm, Brain
This international multi-center registry is used to collect existing information and
outcomes for patients undergoing an operation for treatment of injuries to the brain
including the blockage of blood flow to an area of the brain, an abnormal ballooning of
an artery, abnormal tangling of blood vessels,... expand
This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes. Type: Observational [Patient Registry] Start Date: Sep 2019 |
Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy
Jun Zhang, MD, PhD
NSCLC Stage IV
NSCLC Stage IIIB
For metastatic/advanced NSCLC patients who do not have targetable mutations, either
immunotherapy targeting the programmed death-1 and its ligand (PD-1/L1) pathway alone or
in combination with platinum doublet chemotherapy is now a standard of care. However,
still about half of the patients do not... expand
For metastatic/advanced NSCLC patients who do not have targetable mutations, either immunotherapy targeting the programmed death-1 and its ligand (PD-1/L1) pathway alone or in combination with platinum doublet chemotherapy is now a standard of care. However, still about half of the patients do not benefit due to treatment resistance. It is therefore critically important to find novel therapies and combinations to benefit patients who have failed or are intolerant to 1st line immunotherapy. This study hypothesizes that ipatasertib in combination with taxane (e.g. docetaxel) can be an effective strategy. Ipatasertib is a novel adenosine triphosphate (ATP)-competitive inhibitor that has demonstrated robust and selective targeting of protein kinase B (PKB, also known as AKT) in cancer patients. Importantly, evidence from preclinical studies has demonstrated that AKT inhibitors (e.g. ipatasertib) can enhance the therapeutic effect of chemotherapy as well as immunotherapy via modulating Phosphatidylinositol 3-kinase (PI3'K)-AKT activity. Type: Interventional Start Date: Sep 2021 |
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
University of Kansas Medical Center
Hypertension
Cardiovascular Diseases
The main purpose of research is to examine and understanding the development of
hypertension in obese adults with insulin resistance. Findings from our studies will
identify unique mechanisms that can be targeted to limit increases in vascular
dysfunction and reduce the excessively high prevalence... expand
The main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. Findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (CVD). This study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. The extent to which ascorbic acid (Vitamin C) improves the function of the blood vessels will be determined. The primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid. Type: Interventional Start Date: Jun 2021 |
Citadel Embolization Device Study
Stryker Neurovascular
Unruptured Wide-neck Aneurysms
The purpose of this study is to gather safety and effectiveness data on Stryker
Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the
Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of
wide-neck intracranial aneurysms. expand
The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms. Type: Interventional Start Date: Jul 2019 |
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
Bioventus LLC
Lumbar Spine Disease
Lumbar Spondylolisthesis
Lumbar Spine Instability
Lumbar Spondylosis
Degenerative Disc Disease
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone
Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in
skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an
intra-patient control model. expand
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model. Type: Interventional Start Date: May 2022 |
Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC)
University of Kansas Medical Center
Pancreatic Ductal Adenocarcinoma
Pancreas Adenocarcinoma
Pancreas Cancer
A Phase II Open-Label Study of Enfortumab Vedotin in Patients with Previously Treated
Locally Advanced, Recurrent, or Metastatic Pancreatic Adenocarcinoma (EPIC) expand
A Phase II Open-Label Study of Enfortumab Vedotin in Patients with Previously Treated Locally Advanced, Recurrent, or Metastatic Pancreatic Adenocarcinoma (EPIC) Type: Interventional Start Date: Jun 2023 |
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19):...
Ansun Biopharma, Inc.
Lower Respiratory Tract Infection
Parainfluenza
Immunocompromised
COVID-19
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza
infection.
It also contains a sub-study to enroll patients with severe COVID-19. expand
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19. Type: Interventional Start Date: May 2019 |
Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer
University of Kansas Medical Center
Breast Cancer
This study evaluates the safety and efficacy of sacituzumab govitecan plus alpelisib for
treatment of metastatic or locally recurrent HER2-negative breast cancer. expand
This study evaluates the safety and efficacy of sacituzumab govitecan plus alpelisib for treatment of metastatic or locally recurrent HER2-negative breast cancer. Type: Interventional Start Date: Mar 2022 |
Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry
University of Kansas Medical Center
Breast Cancer
Hereditary Breast and Ovarian Cancer
PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients
who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2
genes). expand
PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes). Type: Observational [Patient Registry] Start Date: Mar 2011 |
Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and...
University of Kansas Medical Center
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndromes
Gamma delta T-cells are part of the innate immune system with the ability to recognize
malignant cells and kill them. This study uses gamma delta T-cells to maximize the
anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and
myelodysplastic patients who have had a partially... expand
Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients who have had a partially mismatched bone marrow transplant (haploidentical). Type: Interventional Start Date: Jan 2020 |
CEND-1 in Combination With Neoadjuvant FOLFIRINOX With or Without Panitumumab
Anup Kasi
Colon Cancer
Pancreas Cancer
Digestive Cancer
This is a phase IB/IIA trial to ensure the safety of CEND-1 in combination with with
Folfirinox with or without Panitumumab for treatment of pancreatic, colon and appendiceal
cancers expand
This is a phase IB/IIA trial to ensure the safety of CEND-1 in combination with with Folfirinox with or without Panitumumab for treatment of pancreatic, colon and appendiceal cancers Type: Interventional Start Date: Oct 2021 |
Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis
University of Kansas Medical Center
ALS
The purpose of this research study is to evaluate the safety and effectiveness of
Ranolazine, and how well it is tolerated in patients with Amyotrophic Lateral Sclerosis
(ALS). Ranolazine is an FDA approved drug that is used for decreasing chest pain. expand
The purpose of this research study is to evaluate the safety and effectiveness of Ranolazine, and how well it is tolerated in patients with Amyotrophic Lateral Sclerosis (ALS). Ranolazine is an FDA approved drug that is used for decreasing chest pain. Type: Interventional Start Date: Jun 2018 |
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