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Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis
University of Alabama at Birmingham
Amyotrophic Lateral Sclerosis
Myasthenia Gravis
The aim of this study is to understand how well a 6-week virtual yogic breathing exercise
program (YBEP) will improve breathing, speech, and emotional well-being in people with
amyotrophic lateral sclerosis (ALS). expand
The aim of this study is to understand how well a 6-week virtual yogic breathing exercise program (YBEP) will improve breathing, speech, and emotional well-being in people with amyotrophic lateral sclerosis (ALS). Type: Interventional Start Date: Nov 2023 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis...
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women with Obesity
University of Alabama at Birmingham
Obesity
The goal of this clinical trial is to investigate if a 4-hour acceptance and commitment
therapy workshop can help the adoption and maintenance of healthy lifestyle behaviors in
women with obesity. The objectives are as follows:
1. To assess changes in ACT-related constructs before and after the... expand
The goal of this clinical trial is to investigate if a 4-hour acceptance and commitment therapy workshop can help the adoption and maintenance of healthy lifestyle behaviors in women with obesity. The objectives are as follows: 1. To assess changes in ACT-related constructs before and after the workshop 2. To assess changes in other psychological constructs that have been shown to hinder successful weight management before and after the workshop 3. To assess changes in dietary and physical activity behaviors before and after the workshop. Participants will complete baseline questionnaires and anthropometric measures at three time points: baseline, 1 week after the workshop, and 1 month after the workshop. Researchers will compare an active intervention group to a waitlist control group to investigate the efficacy of the workshop. Type: Interventional Start Date: Aug 2023 |
An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure
University of Alabama at Birmingham
Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Chronic Illness
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the
purpose of this randomized factorial pilot trial is to identify feasibility,
acceptability, and preliminary efficacy of components of an intervention (UPHOLDS) to
improve quality of life of older adults with advanced... expand
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial pilot trial is to identify feasibility, acceptability, and preliminary efficacy of components of an intervention (UPHOLDS) to improve quality of life of older adults with advanced heart failure. Using a 2x2x2x2 factorial design, 64 adults with advanced heart failure will be randomized to receive one or more palliative care coach-delivered components, based on Ferrans' Health-Related Quality of Life Model: 1) psychoeducation on palliative care principles (4 vs. 8 sessions); 2) financial coaching (yes vs. no); 3) one-time specialty outpatient palliative care consultation (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks). Type: Interventional Start Date: Aug 2024 |
A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer
Bristol-Myers Squibb
Esophageal Carcinoma
Gastroesophageal Junction Carcinoma
The purpose of this study is to describe the effectiveness and use of nivolumab after
surgery in participants with early stage (Stage II/III) Esophageal
Cancer/Gastroesophageal Junction Cancer (EC/GEJC). expand
The purpose of this study is to describe the effectiveness and use of nivolumab after surgery in participants with early stage (Stage II/III) Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC). Type: Observational Start Date: Aug 2023 |
Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma
Alliance for Clinical Trials in Oncology
Advanced Dedifferentiated Liposarcoma
Locally Advanced Dedifferentiated Liposarcoma
Metastatic Dedifferentiated Liposarcoma
Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
This phase II trial compares the effect of treatment with palbociclib alone to treatment
with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma
that may have spread from where it first started to nearby tissue, lymph nodes, or
distant parts of the body (advanced).... expand
This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cemiplimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The combination of these two drugs may be more effective in shrinking or stabilizing advanced dedifferentiated liposarcoma compared to palbociclib alone. Type: Interventional Start Date: May 2023 |
Alzheimer's Disease Neuroimaging Initiative 4
University of Southern California
Mild Cognitive Impairment
Alzheimer Disease
Dementia
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD)
clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3
studies that have combined public/private... expand
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD. Type: Observational Start Date: Jun 2023 |
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX)...
Alliance for Clinical Trials in Oncology
Locally Advanced Rectal Carcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
This phase II trial compares the effect of irinotecan versus oxaliplatin after
long-course chemoradiation in patients with stage II-III rectal cancer. Combination
chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and
oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin,... expand
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. Type: Interventional Start Date: Dec 2022 |
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active...
Pfizer
Stable Nonsegmental Vitiligo
Active Nonsegmental Vitiligo
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental
Vitiligo (Active and Stable) Tranquillo expand
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo Type: Interventional Start Date: Dec 2022 |
Regulation of Inflammatory Genes in Hidradenitis Suppurativa
University of Alabama at Birmingham
Hidradenitis Suppurativa
The purpose of this protocol is to examine the cytokine profi le of pati ents with
hidradeniti s suppurati va (HS) and idemechanisms responsible for post-transcripti onal
regulati on of these genes. The primary objecti ve is to determinfollowing cytokines
linked to hidradeniti s suppurati va are diff... expand
The purpose of this protocol is to examine the cytokine profi le of pati ents with hidradeniti s suppurati va (HS) and idemechanisms responsible for post-transcripti onal regulati on of these genes. The primary objecti ve is to determinfollowing cytokines linked to hidradeniti s suppurati va are diff erenti ally expressed in hidradeniti s pati ents versus controlalso doing a sub-study to determine the eff ect of childhood trauma on HS. The parti cipati on in the sub-study is opti onal Type: Observational Start Date: Oct 2022 |
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
BeiGene
Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma (MCL)
Relapsed Mantle Cell Lymphoma
The study consists of two parts. Part 1 determines the safety and tolerability of
BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended
Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma.
Part 2 evaluates efficacy of BGB-11417 monotherapy... expand
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1. Type: Interventional Start Date: Sep 2022 |
Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
University of Alabama at Birmingham
Cutaneous T Cell Lymphoma
Mycosis Fungoides
This is an open label, single center, non-randomized dose de-escalation phase I study of
combination of BV and Mogamulizumab.
The primary objective of the study is to assess the safety and tolerability of the
combination. The primary objective is also to explore safe dose of combination for future
expansion. expand
This is an open label, single center, non-randomized dose de-escalation phase I study of combination of BV and Mogamulizumab. The primary objective of the study is to assess the safety and tolerability of the combination. The primary objective is also to explore safe dose of combination for future expansion. Type: Interventional Start Date: May 2023 |
PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
Artivion Inc.
Acute Aortic Dissection
Prospective, non-randomized, multicenter clinical investigation to assess the safety and
effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection,
with evidence of malperfusion, through open surgical repair. expand
Prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection, with evidence of malperfusion, through open surgical repair. Type: Interventional Start Date: May 2022 |
AlloSure Lung Assessment and Metagenomics Outcomes Study
CareDx
Lung Transplant Infection
Lung Transplant; Complications
Lung Transplant Failure and Rejection
ALAMO is a prospective, multi-center, perspective, registry of patients receiving
LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant.
This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung
(dd-cfDNA) to detect a spectrum of rejection... expand
ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic). Type: Observational [Patient Registry] Start Date: Oct 2021 |
Nonalcoholic Fatty Liver Disease in HIV Database
Johns Hopkins University
NAFLD
NASH - Nonalcoholic Steatohepatitis
Hiv
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated
with fat accumulation that ranges from benign, non-progressive liver fat accumulation to
severe liver injury, cirrhosis, and liver failure. The spectrum of NAFLD encompasses
simple nonalcoholic steatosis (nonalcoholic... expand
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. The spectrum of NAFLD encompasses simple nonalcoholic steatosis (nonalcoholic fatty liver [NAFL]) and nonalcoholic steatohepatitis (NASH) in which there is evidence of hepatocellular injury and/or fibrosis. NAFLD is the most common liver disease in adults and the second leading cause for liver transplantation in the U.S. The natural history of NAFLD in the general population has been well described. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002 to further the understanding of the diagnosis, mechanisms, progression and therapies of NASH. This effort has resulted in numerous seminal studies in the field. However, NASH CRN studies have systematically excluded persons living with HIV (PLWH) , as NAFLD in PLWH was thought to be different from that in the general population due to HIV infection, antiretroviral therapy (ART), concomitant medications and co-infections. This resulted in major knowledge gaps regarding NAFLD in the setting of HIV infection. Thus, the natural history of NAFLD in PLWH is largely unknown. The goal of this ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), is to conduct a prospective, observational, multicenter study of NAFLD in PLWH (HIV-associated NAFLD). Type: Observational Start Date: May 2022 |
Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury
Texas A&M University
Spinal Cord Injuries
Neuropathic Pain
The purpose of this study is to determine if playing a virtual reality walking game can
help improve neuropathic pain in adults with chronic spinal cord injury. expand
The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic spinal cord injury. Type: Interventional Start Date: Nov 2021 |
Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures
University of Alabama at Birmingham
Pulmonary Hypertension
The objective of this proposal is to study circulating and echocardiographic markers of
pulmonary vascular and right ventricular remodeling in patients with a WHO-2 diagnosis of
pulmonary hypertension after mitral valve procedures. The investigators are proposing the
study will be impactful for the... expand
The objective of this proposal is to study circulating and echocardiographic markers of pulmonary vascular and right ventricular remodeling in patients with a WHO-2 diagnosis of pulmonary hypertension after mitral valve procedures. The investigators are proposing the study will be impactful for the early detection and prediction and of residual pulmonary hypertension (PH) that would otherwise be undetected and fatal with no curative treatment. Type: Observational Start Date: Dec 2021 |
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
United Therapeutics
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against
placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. expand
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. Type: Interventional Start Date: Jun 2021 |
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab...
SWOG Cancer Research Network
Acral Lentiginous Melanoma
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Cutaneous Melanoma
Metastatic Malignant Neoplasm in the Brain
Metastatic Melanoma
This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus
ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has
spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth
of tumor cells by blocking some of... expand
This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma. Type: Interventional Start Date: Jan 2021 |
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled...
Incyte Corporation
B-Cell Malignancies
This is a Phase 2, multicenter, open-label study to provide continued supply of
parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or
ibrutinib to participants from Incyte-sponsored studies of parsaclisib. expand
This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib. Type: Interventional Start Date: Aug 2020 |
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, randomized,... 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 |
Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease
UniQure Biopharma B.V.
Huntington's Disease
This is the first study of AMT-130 in patients with early manifest HD and is designed to
establish safety and proof-of-concept (PoC). CT-AMT-130-01 is a Phase I/II, randomized,
multicenter, multiple dose, double-blind, imitation surgery, first-in-human (FIH) study.
Cohort 3 participants will receive... expand
This is the first study of AMT-130 in patients with early manifest HD and is designed to establish safety and proof-of-concept (PoC). CT-AMT-130-01 is a Phase I/II, randomized, multicenter, multiple dose, double-blind, imitation surgery, first-in-human (FIH) study. Cohort 3 participants will receive either high or low dose (1:1 randomization). Participants enrolled in Cohort 3 will also receive an immunosuppression regimen consisting of dexamethasone, sirolimus, and rituximab. Type: Interventional Start Date: Sep 2019 |
Study of Treatment for HPV16+ ASC-US or LSIL
University of Alabama at Birmingham
ASC-US
LSIL
Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein
vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine expand
Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine Type: Interventional Start Date: Jul 2023 |
Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM...
Florida State University
HIV/AIDS
The overall goal of this 5-year Mentored Research Scientist Development K01-Award is to
support Henna Budhwani, PhD, MPH to become an independent implementation science
investigator in the field of HIV prevention. The proposed project seeks to address the
HIV crisis in Alabama, where rates of undiagnosed... expand
The overall goal of this 5-year Mentored Research Scientist Development K01-Award is to support Henna Budhwani, PhD, MPH to become an independent implementation science investigator in the field of HIV prevention. The proposed project seeks to address the HIV crisis in Alabama, where rates of undiagnosed HIV in black young men who have sex with men (YMSM, 18-29 years) exceed 20%. This project will adapt and test a behavioral intervention to promote HIV rapid testing in the community, deliver culturally appropriate prevention education, offer sociostructural support, and refer eligible participants for pre-exposure prophylaxis (PrEP). Four training objectives are proposed that are in lockstep with three specific aims. Type: Interventional Start Date: Feb 2020 |
The DETECT Study: Discovery and Evaluation of Testing for Endometrial and Ovarian Cancer in Tampons
University of Alabama at Birmingham
Endometrial Cancer
Endometrial Cancer Precursors
Ovarian Cancer
Complex Atypical Endometrial Hyperplasia
BACKGROUND:
Endometrial cancer is a common and deadly cancer for women. It is getting more common and
deadly because risk factors like age and obesity are increasing. Also, this cancer is
becoming more common and deadly for black women than white women. Researchers want to
find better ways to take... expand
BACKGROUND: Endometrial cancer is a common and deadly cancer for women. It is getting more common and deadly because risk factors like age and obesity are increasing. Also, this cancer is becoming more common and deadly for black women than white women. Researchers want to find better ways to take samples and test them for this cancer. They want to study this for a racially diverse population. One way to take samples might be from a tampon. If identified early, endometrial cancer can be highly curable; however, the earliest stages may be asymptomatic, and clinical symptoms are often missed. Combining sensitive molecular testing approaches with non-invasive sampling techniques may to lead to the development of novel endometrial cancer early detection approaches with the potential to overcome disparities in access to care and time to diagnosis and treatment. In contrast to endometrial cancer, ovarian cancer is typically detected at advanced stages with poor survival since symptoms manifest only late in the disease process and are very unspecific. Racial disparities in ovarian cancer incidence and mortality are also much less pronounced. Racial disparities can manifest particularly when screening, symptom appraisal and early detection, and effective treatment interventions have important roles in determining outcomes of cancers. OBJECTIVES: The purpose of this study is to see if it is possible and acceptable for individuals to have an endometrial or ovarian sample collected by using a tampon placed in the vagina. The investigators will look at DNA in these samples. DNA is the genetic information participants inherited from their parents. The investigators want to see whether the investigators can find changes in DNA and proteins related to endometrial or ovarian cancer from tampon samples. Tests on the samples from tampons will help to understand endometrial and ovarian cancer. The samples collected during this study will be used for research related to both endometrial and ovarian cancer and non-cancer conditions. ELIGIBILITY: Women at least ≥18 years undergoing clinically-indicated hysterectomy and/or bilateral salpingo-oophorectomy for endometrial or ovarian cancer, cancer precursors, or benign conditions. DESIGN: 1. Participants will put a tampon in their vagina at least 30 minutes before their surgery. 2. Participants will take a short survey. 3. The tampon will be collected during the surgery. 4. A small piece of tissue will be collected from the uterus +/- ovary that is removed in surgery. 5. Participants will give a blood sample. 6. Before or after surgery, participants will answer questions. These will be about their medical history and basic data such as age and race. 7. Researchers will follow participants medical records for up to 5 years after the study. Additional blood may be taken from patient if patient agrees. 8. Researchers will study the samples and tampons. They will compare how well cancer and other markers are detected between the samples. Type: Observational Start Date: Jul 2019 |
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