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Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
Alliance for Clinical Trials in Oncology
Angioimmunoblastic T-cell Lymphoma
Enteropathy-Associated T-Cell Lymphoma
Follicular T-Cell Lymphoma
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy
consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in
treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of
cancer cells by blocking some of the enzymes... expand
This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, 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. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma. Type: Interventional Start Date: Jul 2021 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive...
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Trastuzumab... expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients
University of Michigan
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
A multicenter, randomized, adaptive allocation clinical trial to determine if increasing
durations of induced hypothermia are associated with an increasing rate of good
neurological outcomes and to identify the optimal duration of induced hypothermia for
neuroprotection in comatose survivors of cardiac... expand
A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest. Type: Interventional Start Date: May 2020 |
A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma...
Hookipa Biotech GmbH
HPV-Related Squamous Cell Carcinoma
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study
of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with
HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose
Expansion. expand
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion. Type: Interventional Start Date: Dec 2019 |
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
ECOG-ACRIN Cancer Research Group
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation
(chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating
patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin,
fluorouracil, and capecitabine, work in different... expand
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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 x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Type: Interventional Start Date: Jan 2020 |
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic...
SWOG Cancer Research Network
Castration Levels of Testosterone
Metastatic Prostatic Adenocarcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
This phase III trial studies how well standard systemic therapy with or without
definitive treatment (prostate removal surgery or radiation therapy) works in treating
participants with prostate cancer that has spread to other places in the body. Addition
of prostate removal surgery or radiation therapy... expand
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Type: Interventional Start Date: Sep 2018 |
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
The purpose of this study is to collect long-term safety, tolerability, effectiveness and
health outcomes data in eligible subjects who have participated in a Novartis ofatumumab
clinical MS study.
Vaccination sub-study The purpose of this research sub-study is to find out the effects
of ofatumumab... expand
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS). Type: Interventional Start Date: Dec 2018 |
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Astellas Pharma Global Development, Inc.
Prostate Cancer
The purpose of this study is to collect long term safety data in subjects who are
continuing to derive clinical benefit from treatment with Enzalutamide from the subjects
participation in an enzalutamide clinical study sponsored by Astellas or Medivation
(i.e., parent study) which has completed, at... expand
The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period. Type: Interventional Start Date: Dec 2016 |
RECOVER-AUTONOMIC Platform Protocol
Kanecia Obie Zimmerman
Long COVID
Long Covid19
Long Covid-19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems and in community settings where it can
be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-arm,... expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel,...
National Cancer Institute (NCI)
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Hormone Receptor-Positive Breast Carcinoma
Localized Breast Carcinoma
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual
chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint
Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer.
Immunotherapy with monoclonal antibodies,... expand
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide 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. There is some evidence from previous clinical trials that people who have a MammaPrint Ultrahigh Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. Type: Interventional Start Date: Nov 2023 |
Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and...
The University of Texas Health Science Center, Houston
Head and Neck Cancer
The PI and the research team developed the New York University (NYU) Electronic Patient
Visit Assessment (ePVA) for head and neck cancer (HNC) as a patient-reported outcome
measure (PRO) for the early detection of uncontrolled symptoms. The ePVA is digital
patient-reported symptom monitoring system,... expand
The PI and the research team developed the New York University (NYU) Electronic Patient Visit Assessment (ePVA) for head and neck cancer (HNC) as a patient-reported outcome measure (PRO) for the early detection of uncontrolled symptoms. The ePVA is digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. The study aims to advance the science of cancer care delivery by testing the effectiveness of the ePVA as a digital patient-reported monitoring system for patients with HNC in real-world settings and identify implementation strategies that optimize the effectiveness of the ePVA in diverse rural and urban settings. The study hypothesis is that participants assigned to the ePVA arm will have better swallowing, taste and smell, and social function than participants assigned to usual care arm at 4 weeks after completing radiation therapy. Type: Interventional Start Date: Jun 2024 |
Trial Readiness and Endpoint Assessment in LGMD R1
Virginia Commonwealth University
Calpain-3 Deficiency Limb Girdle Muscular Dystrophy Type 2A
Limb Girdle Muscular Dystrophy
Limb Girdle Muscular Dystrophy Type R1
LGMD2A
This is a 24-month, observational study of 100 participants with Limb Girdle Muscular
Dystrophy type R1, also known as CAPN3. expand
This is a 24-month, observational study of 100 participants with Limb Girdle Muscular Dystrophy type R1, also known as CAPN3. Type: Observational Start Date: Jan 2024 |
Virtual Care to Improve Heart Failure Outcomes (VITAL-HF)
Duke University
Heart Failure With Reduced Ejection Fraction
The purpose of this study is to evaluate how safe and effective a remote, digital
intervention is that helps clinicians use and optimally adjust heart failure medications,
compared to usual care medication use and adjustment, in participants with heart failure
with reduced ejection fraction expand
The purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction Type: Interventional Start Date: Dec 2022 |
Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other...
National Cancer Institute (NCI)
Chronic Myelomonocytic Leukemia
Myelodysplastic Syndrome
Myelodysplastic Syndrome With Excess Blasts
Myeloproliferative Neoplasm
This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination
with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow
cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic
syndrome/myeloproliferative neoplasm (MDS/MPN)... expand
This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts. Blasts are immature blood cells. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The combination of ASTX727 and venetoclax may be more effective in reducing the cancer signs and symptoms in patients with CMML, or MDS/MPN with excess blasts. Type: Interventional Start Date: Jun 2023 |
Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases
SWOG Cancer Research Network
Anatomic Stage IV Breast Cancer AJCC v8
Invasive Breast Carcinoma
Metastatic HER2 Negative Breast Carcinoma
Metastatic Malignant Neoplasm in the Brain
Prognostic Stage IV Breast Cancer AJCC v8
This phase II trial studies the effect of sacituzumab govitecan in treating patients with
HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab
govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug,
called govitecan. Sacituzumab is... expand
This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse. Type: Interventional Start Date: Jun 2021 |
CAR-T Long Term Follow Up (LTFU) Study
Novartis Pharmaceuticals
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Per Health Authorities guidelines for gene therapy medicinal products that utilize
integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of
treated patients is required. The purpose of this study is to monitor all patients
exposed to CAR-T therapied for 15 years following... expand
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence. Type: Interventional Start Date: Jan 2016 |
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Celldex Therapeutics
Eosinophilic Esophagitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult
Eosinophilic Esophagitis patients. expand
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients. Type: Interventional Start Date: Jun 2023 |
Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions
University of Kansas Medical Center
Obesity
Obesity, Morbid
The purpose of this study is to compare two methods for managing obesity in rural primary
care patients. The first method includes quarterly 1:1 meetings with the participant and
their primary care provider and the second includes a group lifestyle intervention over
Zoom paired with quarterly team... expand
The purpose of this study is to compare two methods for managing obesity in rural primary care patients. The first method includes quarterly 1:1 meetings with the participant and their primary care provider and the second includes a group lifestyle intervention over Zoom paired with quarterly team meetings with the participant, their primary care provider and their lifestyle coach, the coach joining via Zoom. Investigators will evaluate which method is best at helping participants lose weight over 18 months. Type: Interventional Start Date: Mar 2023 |
Obeticholic Acid for Prevention in Barrett's Esophagus
National Cancer Institute (NCI)
Barrett Esophagus
This phase II trial studies the effect of obeticholic acid in treating patients with
Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to
neoplastic progression in Barrett's esophagus. Obeticholic acid has shown
anti-cholestatic, anti-inflammatory and anti-fibrotic... expand
This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression. Type: Interventional Start Date: Jan 2024 |
Brain Responses to Contextual Influences on Drinking Decisions
University of Kansas Medical Center
Alcohol Drinking
This study is using functional magnetic resonance imaging (fMRI) to examine brain
activity associated with making decisions about drinking alcohol in everyday situations,
some of which may involve important activities happening the next day. The secondary aims
are to determine whether severity of... expand
This study is using functional magnetic resonance imaging (fMRI) to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks. Type: Interventional Start Date: Feb 2023 |
STEM-Parkinson's Disease
Scion NeuroStim
Parkinson Disease
Parkinson's Disease and Parkinsonism
This is a double-blinded, controlled, randomized clinical trial (RCT) to establish the
safety and efficacy of a non-invasive neuromodulation device for treating symptoms
associated with Parkinson's disease. expand
This is a double-blinded, controlled, randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease. Type: Interventional Start Date: May 2022 |
Changing Talk Online Training (CHATO) National Trial
University of Kansas Medical Center
Dementia
Alzheimer Disease
Communication
The National Plan to Address Alzheimer's disease has identified education of dementia
care providers as a top priority to address the need for quality care for the population
of persons with dementia that will triple in the next 30 years. This study will test new
online interactive training for nursing... expand
The National Plan to Address Alzheimer's disease has identified education of dementia care providers as a top priority to address the need for quality care for the population of persons with dementia that will triple in the next 30 years. This study will test new online interactive training for nursing home staff that improves staff communication and also reduces behavioral symptoms of persons with dementia that they care for. Innovative approaches to reach care providers are essential to achieve implementation of evidence-based practices to improve care. Type: Interventional Start Date: Apr 2021 |
Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication...
National Cancer Institute (NCI)
Castration-Resistant Prostate Carcinoma
Metastatic Malignant Neoplasm in the Lymph Nodes
Metastatic Prostate Carcinoma
Stage IV Prostate Cancer AJCC v8
This phase I/II trial studies the best dose of M3814 when given together with radium-223
dichloride or with radium-223 dichloride and avelumab and to see how well they work in
treating patients with castrate-resistant prostate cancer that had spread to other places
in the body (metastatic). M3814... expand
This phase I/II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy. Type: Interventional Start Date: Oct 2020 |
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Mirati Therapeutics Inc.
Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease
This study will evaluate the safety, tolerability, drug levels, molecular effects, and
clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have
a KRAS G12C mutation. expand
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation. Type: Interventional Start Date: Dec 2018 |
A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic...
Beam Therapeutics Inc.
Lymphoblastic Lymphoma
T-Cell Lymphoblastic Leukemia/Lymphoma
Lymphoblastic Leukemia
This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of
BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase
1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort
(will enroll patients ages 1... expand
This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to < 12 years), and a Phase 2 cohort. Type: Interventional Start Date: May 2023 |
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