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Carbohydrate Ingestion Prior to Surgery (CIPS)
University of Kansas Medical Center
Urologic Surgical Procedures
Carbohydrate Loading
Preoperative Care
The objective is to determine the impact of taking a specialized form of carbohydrate in
the immediate preoperative period on metabolic markers, surgical outcomes and patient
health. Patients will be randomized to receive a specialized sports drink or a standard
sports drink. Patients will have a... expand
The objective is to determine the impact of taking a specialized form of carbohydrate in the immediate preoperative period on metabolic markers, surgical outcomes and patient health. Patients will be randomized to receive a specialized sports drink or a standard sports drink. Patients will have a continuous glucose monitor (CGM) placed on their upper arm to measure glucose throughout surgery and during the post-operative period. Type: Interventional Start Date: Nov 2023 |
Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Schrödinger, Inc.
Acute Myeloid Leukemia
High-Risk and Very High-Risk Myelodysplastic Syndromes
The purpose of this study is to evaluate safety and tolerability and to determine the
maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921. expand
The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921. 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 |
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal...
Cogent Biosciences, Inc.
Advanced Gastrointestinal Stromal Tumors
Metastatic Cancer
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination
with sunitinib. This is a multi-part study that will enroll approximately 426 patients.
Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of
CGT9486 to be used in subsequent... expand
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. Type: Interventional Start Date: Apr 2022 |
CureDuchenne Link®: A Resource for Research
CureDuchenne
Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
CureDuchenne link is a data hub comprised of integrated biospecimens, clinical data, and
self- and/or caregiver-reported information from participants. Anyone over 4 weeks old
who has been diagnosed with DMD or BMD or who is a carrier of DMD or BMD can join.
Parents or legal guardians can sign up... expand
CureDuchenne link is a data hub comprised of integrated biospecimens, clinical data, and self- and/or caregiver-reported information from participants. Anyone over 4 weeks old who has been diagnosed with DMD or BMD or who is a carrier of DMD or BMD can join. Parents or legal guardians can sign up their child(ren). Type: Observational [Patient Registry] Start Date: Jul 2021 |
Post COVID-19 Biorepository
University of Kansas Medical Center
Coronavirus Infection
Establish a biorepository, clinical data registry, and radiographic image database from
individuals who were COVID positive at one time and are being seen for outpatient
follow-up or a separate study visit. expand
Establish a biorepository, clinical data registry, and radiographic image database from individuals who were COVID positive at one time and are being seen for outpatient follow-up or a separate study visit. Type: Observational [Patient Registry] Start Date: Feb 2021 |
CHIlled Platelet Study "CHIPS"
Philip Spinella
Acute Blood Loss
A phase 3 randomized partial blind storage duration ranging study in patients undergoing
complex cardiac surgery that will compare the transfusion of cold stored platelets to
standard room temperature stored platelets. The primary objective is to establish that
cold stored platelets have a non-inferiority... expand
A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets. Type: Interventional Start Date: Oct 2021 |
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in...
National Cancer Institute (NCI)
Metastatic Bladder Urothelial Carcinoma
Metastatic Renal Pelvis Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma
Metastatic Urethral Urothelial Carcinoma
Metastatic Urothelial Carcinoma
This phase III trial compares the usual chemotherapy treatment to eribulin plus
gemcitabine in treating patients with urothelial cancer that has spread to other places
in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel,
paclitaxel, and sacituzumab govitecan work... expand
This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan 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. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer. Type: Interventional Start Date: Jun 2021 |
Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants &...
Sonya Heltshe
Cystic Fibrosis
This is a two-part, multi-center, prospective longitudinal, exploratory study of highly
effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their
impact on children with cystic fibrosis (CF). expand
This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF). Type: Observational Start Date: Nov 2020 |
The ENCIRCLE Trial
Edwards Lifesciences
Mitral Regurgitation
Mitral Valve Insufficiency
This study will establish the safety and effectiveness of the SAPIEN M3 System in
subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially
available surgical or transcatheter treatment options are deemed unsuitable.
Following completion of enrollment, subjects will... expand
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial. Type: Interventional Start Date: Nov 2020 |
A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents...
Celgene
Lymphoma, Non-Hodgkin
The purpose of this study is to evaluate the safety, tolerability, and preliminary
efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants
with relapsed or refractory non-Hodgkin's lymphomas. expand
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas. Type: Interventional Start Date: May 2019 |
Blue Light Cystoscopy With Cysview® Registry
Photocure
Bladder Cancer
Registry study to gather more information on the current use of Blue Light Cystoscopy
with Cysview (BLCC) in urologists' practices. expand
Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices. Type: Observational [Patient Registry] Start Date: Apr 2014 |
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who...
SWOG Cancer Research Network
AL Amyloidosis
This phase III trial compares the effect of adding a stem cell transplant with melphalan
after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and
dexamethasone (Dara-VCD) versus chemotherapy with Dara-VCD alone for treating patients
with newly diagnosed amyloid light chain... expand
This phase III trial compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD) versus chemotherapy with Dara-VCD alone for treating patients with newly diagnosed amyloid light chain (AL) amyloidosis. Melphalan is a chemotherapy given prior to a stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patients to replace the blood forming cells that were destroyed by the chemotherapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs, such as cyclophosphamide and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to lower the body's immune response to help stop the growth of cancer cells. Giving a stem cell transplant with melphalan after Dara-VCD may kill more cancer cells in patients with newly diagnosed AL amyloidosis. Type: Interventional Start Date: Jul 2024 |
Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Unresectable Malignant Solid Neoplasm
This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib
works to shrink tumors in patients with solid tumors that are unlikely to be cured or
controlled with treatment and that may have spread from where it first started to nearby
tissue, lymph nodes, or distant parts... expand
This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Another aim of this study is to find out if, and how, patients' genes influence their response to this specific drug combination. For this part of the study, investigators will run tests using samples of patients' tumor tissue and blood that will be collected during the study. ZEN-3694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Genes are pieces of the DNA code that individuals inherit from their parents. Some genes work to protect against cancer by correcting damage that can occur in the DNA when cells divide. BRCA1 and BRCA2 are two examples of these types of genes, and they are called tumor-suppressor genes. For example, if a person has a mutation in a BRCA1/2 gene they have a greatly increased risk of developing breast and ovarian cancer because their cells may no longer be able to completely repair damaged DNA. It is the accumulation of DNA damage which causes a cell to change into a cancerous cell. Other genes are also involved in this process, and these are called DNA damage repair genes. The KRAS mutation is a change in a protein in normal cells. Normally KRAS serves as an information hub for signals in the cell that lead to cell growth, but when there is a mutation in KRAS it signals too much and cells grow without being told to, which causes cancer. Combination therapy with ZEN-3694 and talazoparib may be effective at slowing or stopping tumor growth in patients with advanced cancer. Type: Interventional Start Date: Nov 2022 |
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Ono Pharmaceutical Co. Ltd
Refractory Primary Central Nervous System Lymphoma
Primary CNS Lymphoma
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib
monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in
combination with one of two different high dose methotrexate based regimens
(methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/
vincristine)... expand
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B) Type: Interventional Start Date: Dec 2021 |
Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy...
National Cancer Institute (NCI)
Diffuse Astrocytoma, IDH-Wildtype
Recurrent Glioblastoma
This phase II trial studies the best dose and effect of tocilizumab in combination with
atezolizumab and stereotactic radiation therapy in treating glioblastoma patients whose
tumor has come back after initial treatment (recurrent). Tocilizumab is a monoclonal
antibody that binds to receptors for... expand
This phase II trial studies the best dose and effect of tocilizumab in combination with atezolizumab and stereotactic radiation therapy in treating glioblastoma patients whose tumor has come back after initial treatment (recurrent). Tocilizumab is a monoclonal antibody that binds to receptors for a protein called interleukin-6 (IL-6), which is made by white blood cells and other cells in the body as well as certain types of cancer. This may help lower the body's immune response and reduce inflammation. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Fractionated stereotactic radiation therapy uses special equipment to precisely deliver multiple, smaller doses of radiation spread over several treatment sessions to the tumor. The goal of this study is to change a tumor that is unresponsive to cancer therapy into a more responsive one. Therapy with fractionated stereotactic radiotherapy in combination with tocilizumab may suppress the inhibitory effect of immune cells surrounding the tumor and consequently allow an immunotherapy treatment by atezolizumab to activate the immune response against the tumor. Combination therapy with tocilizumab, atezolizumab and fractionated stereotactic radiation therapy may shrink or stabilize the cancer better than radiation therapy alone in patients with recurrent glioblastoma. Type: Interventional Start Date: Mar 2022 |
ProACT Post-Approval Study
Uromedica
Stress Urinary Incontinence
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study
designed to evaluate the long-term incidence of urethral stricture and device erosion
after ProACT implantation. In addition, the study will evaluate whether treatment with
ProACT affects clinical outcomes after... expand
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies. Type: Interventional Start Date: Feb 2019 |
Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory...
National Cancer Institute (NCI)
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Recurrent B Acute Lymphoblastic Leukemia
Refractory B Acute Lymphoblastic Leukemia
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in
treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly
diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal
antibodies, such as inotuzumab ozogamicin... expand
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: May 2019 |
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
Leland Metheny
Acute Lymphocytic Leukemia
This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of
this research study is to see what doses post-transplant inotuzumab ozogamicin can safely
be given to subjects without having too many side effects.
The Phase II portion of this study is to see what side effects... expand
This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects. The Phase II portion of this study is to see what side effects are seen with medication after transplant. Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed/refractory acute lymphocytic leukemia (ALL). Inotuzumab ozogamicin is considered experimental in this study. Type: Interventional Start Date: Jul 2017 |
MEASuRE: Metreleptin Effectiveness And Safety Registry
Aegerion Pharmaceuticals, Inc.
Generalised Lipodystrophy
Partial Lipodystrophy
The study is a post-authorization, prospective, voluntary registry of patients treated
with commercial metreleptin including, but not limited to, patients in the US and EEA. expand
The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA. Type: Observational [Patient Registry] Start Date: Oct 2016 |
Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer...
ECOG-ACRIN Cancer Research Group
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
This study examines the impact of social and genetic factors on outcomes in adolescent
and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to
both older adult and childhood cancer patients, AYAs with cancer experience different
diagnoses and specific biological, clinical,... expand
This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to both older adult and childhood cancer patients, AYAs with cancer experience different diagnoses and specific biological, clinical, psychological and social factors that affect their risks for post-treatment morbidity and premature death. Collecting samples of blood samples and health and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma may help doctors identify conditions that increase the likelihood of AYAs getting sick and dying after treatment of cancer and better understand how to address the needs of adolescent and young adult cancer survivors. Type: Observational Start Date: Oct 2023 |
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
National Cancer Institute (NCI)
Recurrent Ovarian High Grade Serous Adenocarcinoma
Recurrent Platinum-Resistant Ovarian Carcinoma
This phase I/Ib trial identifies the side effects and best dose of abemaciclib when given
together with olaparib in treating patients with ovarian cancer that responds at first to
treatment with drugs that contain the metal platinum but then comes back within a certain
period (recurrent platinum-resistant).... expand
This phase I/Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer. Type: Interventional Start Date: Jul 2021 |
Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small...
SWOG Cancer Research Network
Lung Adenocarcinoma
Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating
non-squamous non-small cell lung cancer that is stage IV or has come back (recurrent) and
has a specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may
cause the cancer to grow. AMG 510, a targeted... expand
This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous non-small cell lung cancer that is stage IV or has come back (recurrent) and has a specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation, may help stop the growth of tumor cells. Type: Interventional Start Date: Apr 2021 |
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Mario Castro, MD, MPH
Asthma
COPD
Interstitial Lung Disease
Cystic Fibrosis
Pulmonary Hypertension
The purpose of this study is to develop and evaluate the usefulness of hyperpolarized
(HP) 129Xe gas MRI for regional assessment of pulmonary function. expand
The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function. Type: Interventional Start Date: Nov 2020 |
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