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Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
University of Kansas Medical Center
NSCLC Stage IV
NSCLC, Recurrent
The purpose of this study is to see if adding pirfenidone to atezolizumab will increase
anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small
cell lung cancer participants. expand
The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung cancer participants. Type: Interventional Start Date: May 2022 |
Amplatzer Amulet LAAO vs. NOAC
Abbott Medical Devices
Atrial Fibrillation
Stroke
Bleeding
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA
occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for
ischemic stroke and who are recommended for long-term NOAC therapy.
The clinical investigation is a prospective, random1 expand
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion. Type: Interventional Start Date: Jul 2020 |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Center for International Blood and Marrow Transplant Research
Hematologic Malignancies
Inherited Disorders of Metabolism
Inherited Abnormalities of Platelets
Histiocytic Disorders
Acute Myelogenous Leukemia (AML or ANLL)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications. expand
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. Type: Observational Start Date: Oct 2011 |
Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers
University of Kansas Medical Center
Obesity
Breast Cancer Risk
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who
are using tirzepatide to achieve weight loss. expand
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss. Type: Observational Start Date: Sep 2024 |
A Study of IBI363 in Subjects with Advanced Solid Malignancies
Innovent Biologics (Suzhou) Co. Ltd.
Melanoma
Non-small Cell Lung Cancer
Colorectal Cancer
Renal Cell Cancer
This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy,
safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory
solid malignancies. expand
This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies. Type: Interventional Start Date: Apr 2024 |
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large1
SWOG Cancer Research Network
Diffuse Large B-Cell Lymphoma
Grade 3b Follicular Lymphoma
Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit
patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by
chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene
ciloleucel, or lisocabtagene maraleucel) for1 expand
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, 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. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them. Type: Interventional Start Date: Jun 2023 |
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy T1
Mercy Health Ohio
Acute Ischemic Stroke
The primary objective is to establish the efficacy of intra-arterial (IA) mechanical
thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus
non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial
vessel occlusion (IVO) in the anterior circul1 expand
The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis). Type: Interventional Start Date: May 2024 |
Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
MedtronicNeuro
Epilepsy
The purpose of this post-approval study is to further evaluate the long-term safety and
effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly
implanted participants through 3 years of follow-up. expand
The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up. Type: Interventional Start Date: Mar 2020 |
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
Spirovant Sciences, Inc.
Cystic Fibrosis
This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational
gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator
therapy. expand
This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy. Type: Interventional Start Date: Sep 2024 |
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
Aptevo Therapeutics
Acute Myeloid Leukemia (AML)
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in
combination with venetoclax and azacitidine (ven/aza) in adult patients with newly
diagnosed, CD123+ AML. expand
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML. Type: Interventional Start Date: Oct 2024 |
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who H1
Kartos Therapeutics, Inc.
Myelofibrosis
Post-PV MF
Post-ET Myelofibrosis
Primary Myelofibrosis
MF
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib
treatment will provide more clinical benefit than ruxolitinib alone for patients with
Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.
Subjects will start by receiving ruxolitinib alone in1 expand
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving. Type: Interventional Start Date: Jun 2024 |
Opioid-Free Pain Treatment in Trauma Patients
University of Kansas Medical Center
Femoral Neck Fractures
Intertrochanteric Fractures
Femoral Shaft Fracture
Distal Femur Fracture
Patella Fracture
Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free
analgesia in post-operative orthopedic patients. expand
Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients. Type: Interventional Start Date: Nov 2023 |
Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Canc1
SWOG Cancer Research Network
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy
without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage
triple negative breast cancer. Paclitaxel is in a class of medications called
anti-microtubule agents. It stops cancer cells f1 expand
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer. Type: Interventional Start Date: Sep 2023 |
Encore PFO Closure Device - The PerFOrm Trial
Encore Medical Inc.
Patent Foramen Ovale
Cryptogenic Stroke
The objective of this study is to establish reasonable assurance of safety,
effectiveness, and noninferiority of the Encore PFO closure device when compared to any
investigator chosen FDA-approved PFO closure device. expand
The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device. Type: Interventional Start Date: Jul 2023 |
Fitness After Stroke Trial
University of Kansas Medical Center
Stroke
Stroke, Ischemic
Stroke Hemorrhagic
People living with stroke have very low aerobic fitness, which can negatively impact
brain health. Identifying the best exercise which includes exercise stimulus type
(interval, continuous) or intensity, how hard to exercise (moderate, high) that benefit
aerobic fitness, vascular health, and the br1 expand
People living with stroke have very low aerobic fitness, which can negatively impact brain health. Identifying the best exercise which includes exercise stimulus type (interval, continuous) or intensity, how hard to exercise (moderate, high) that benefit aerobic fitness, vascular health, and the brain's main blood vessels after stroke are unknown. This study is designed to determine the preliminary efficacy of high-volume HIIT to moderate intensity exercise using a seated stepper exercise device that allows the arms and legs to move back and forth. Type: Interventional Start Date: Jul 2023 |
PCOM2 - The Physician Communication Intervention, Version 2.0
University of Colorado, Denver
HPV Infection
Preventive Health Services
Poor quality of primary care providers' vaccine recommendations lead to low adolescent
human papillomavirus vaccination rates and hundreds of thousands of adolescents
unnecessarily at risk for HPV-associated cancers and diseases. Though a previous provider
communication intervention, called PCOM, w1 expand
Poor quality of primary care providers' vaccine recommendations lead to low adolescent human papillomavirus vaccination rates and hundreds of thousands of adolescents unnecessarily at risk for HPV-associated cancers and diseases. Though a previous provider communication intervention, called PCOM, was found to be effective for increasing adolescent HPV vaccination in primary care, its dissemination is limited by the need for significant research team involvement to teach providers how to use the intervention's components. To address this, investigators propose to develop and test a virtual version of PCOM, use mixed methods to assess contextual factors affecting its use compared to the original PCOM intervention, and develop an optimized version of PCOM for broad dissemination to increase adolescent HPV vaccination nationally. Type: Interventional Start Date: Nov 2023 |
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangio1
TransThera Sciences (Nanjing), Inc.
Cholangiocarcinoma
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate
the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with
Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR
Inhibitor-Refractory/Relapsed Cholangiocarcinoma expand
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma Type: Interventional Start Date: Dec 2023 |
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Abbott Medical Devices
Movement Disorders
Parkinson Disease
Essential Tremor
Tremor
Dystonia
The purpose of this international study is to evaluate long-term safety and effectiveness
of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's
disease, essential tremor or other disabling tremor and dystonia. expand
The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia. Type: Observational Start Date: Nov 2019 |
Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease
University of Colorado, Denver
Rheumatoid Arthritis
Interstitial Lung Disease
A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung
Disease (RA-ILD) that are at the highest risk for progression.
The goal of the investigators is to recruit a group of patients with RA-ILD and collect
information to help us understand more about disease progress1 expand
A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression. The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features. Type: Observational [Patient Registry] Start Date: Jan 2024 |
Complex Adult Deformity Surgery (CADS)
International Spine Study Group Foundation
Adult Spinal Deformity
Scoliosis
Kyphosis
Sagittal Imbalance
Evaluate surgical treatment outcomes and identify best practice guidelines for complex
adult spinal deformity (ASD) patients, including radiographic and clinical outcomes,
surgical and postoperative complications, risk factors for and revision surgery rates,
and the role of standard work to improve1 expand
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications. Type: Observational [Patient Registry] Start Date: Jul 2018 |
Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA
Geisinger Clinic
Obstructive Sleep Apnea
This study seeks to enhance long-term positive airway pressure (PAP) adherence among
Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will
assess the feasibility of a linguistically and culturally adapted tele-management
intervention (Automated Management, AM) for1 expand
This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will assess the feasibility of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with OSA. Type: Interventional Start Date: Oct 2023 |
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
Jun Zhang, MD, PhD
Lung Cancer
NSCLC
NSCLC Stage IV
To test whether it is feasible to perform the 3D-EX functional predictive response
bioassay in the context of patients with advanced/metastatic NSCLC receiving immune
checkpoint inhibitors in the standard of care clinical setting. expand
To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting. Type: Observational Start Date: Jul 2022 |
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
CHDI Foundation, Inc.
Huntington's Disease
Enroll-HD is a longitudinal, observational, multinational study that integrates two
former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North
America and Australasia-while also expanding to include sites in Latin America. More than
30,000 participants have now enrolled int1 expand
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more. Type: Observational [Patient Registry] Start Date: Jul 2012 |
Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT A1
University of Kansas Medical Center
Non Small Cell Lung Cancer Stage
The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions
(2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance
durvalumab will improve locoregional control at 18 months by 10% compared to
standard-fractionated chemo-IMRT/durvalumab. A mo1 expand
The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance durvalumab will improve locoregional control at 18 months by 10% compared to standard-fractionated chemo-IMRT/durvalumab. A modest improvement in locoregional control (LRC) was selected as a target which could merit further study of this hypofractionated IMRT regimen in a Phase III trial Type: Interventional Start Date: Feb 2022 |
Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determi1
Celyad Oncology SA
Acute Myeloid Leukemia
Myelodysplastic Syndrome
An open-label, phase I, multi-center study to determine in relapsed/refractory (r/r)
acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended
dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a
potential CYAD-02 consolidation cycle for1 expand
An open-label, phase I, multi-center study to determine in relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive patient. A maximum of 27 r/r AML/MDS patients will be evaluated in this study in case of no dose limiting toxicity (DLT) and no replacement of patients. Type: Interventional Start Date: Nov 2019 |
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