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Набира участници Фаза 3

A Study of Migalastat in Pediatric Subjects (2 to

Fabry Disease

An open-label study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of migalastat treatment in pediatric subjects 2 to \< 12 years of age with Fabry disease and with amenable GLA variants.

Начало: 08.01.2026 Край: 01.12.2028 Възраст: 2–11 г.

Belgium, Germany, Spain +2 Amicus Therapeutics NCT06904261

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PVI vs ESP Block for Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery.

Surgical Blood Loss Postoperative Pain Lumbar Spinal Fusion Surgery

This randomized controlled trial compares periarticular vasoconstrictor infiltration (PVI) versus erector spinae plane block (ESP) to reduce bleeding and postoperative pain in adults undergoing lumbar fusion surgery (up to 3 levels). Patients are randomly assigned 1:1 to receive ultrasound-guided ropivacaine 0.2% + epinephrine 1:200,000: PVI (150-200mL bilateral in retrolaminar, thoracolumbar fascia, supraspinous ligament, subcutaneous planes) or ESP (20mL/side at transverse processes). Both groups receive standardized general anesthesia (TIVA), multimodal analgesia (dexamethasone, paracetamol, dexketoprofen/metamizole, ketamine, magnesium), and tranexamic acid. Multicenter study: Hospital de la Santa Creu i Sant Pau (Barcelona, 32 patients) and Hospital Quirón Salud Murcia (30 patients). Primary outcome: intraoperative blood loss (surgical aspirate minus irrigation + gravimetric gauze weight). Secondary outcomes: Fromme surgical field scale, pain (NRS at REA discharge/24h/48h), opioid consumption (morphine equivalents), PONV/antiemetic use, drain output, hospital stay, patient satisfaction. N=62 patients (31/arm). Blinded outcome assessment.

Начало: 08.01.2026 Край: 01.03.2028 Възраст: от 18 г.

Spain Fundació Institut de Recerca de l'Hospital de la Santa NCT07550114

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Colorectal Cancer Prevention Research Study: Eat Right, Screen Right

Colorectal Cancer Prevention

The Eat Right, Screen Right Extension program aims to help adult learners manage nutrition risks and screening options for colorectal cancer prevention. Participants navigate through 6 tailored lessons covering user-identified, evidence-based information relevant to reducing colorectal cancer risk. First, participants receive an overview of colorectal cancer screening guidelines (e.g., age, modalities), personalized nutrition risk factors (e.g., how their intake of red meat, processed meat, and alcohol aligns with nutrition guidelines for colorectal cancer prevention), and additional optional colorectal cancer prevention topics via a branched conversational pathway selected by the participant. Subsequently, participants also have the opportunity to access five additional modules, providing more in-depth information. Self-reported outcomes include changes in cancer information overload, dietary intentions, and cancer screening intentions. This is an extension of previously funded pilot study and aims to enhance reach by leveraging the UF/IFAS Extension infrastructure allowing participants to achieve the following goals: (1) demonstrate accurate understanding of the modifiable dietary behavior that decrease colorectal cancer risk, (2) demonstrate understanding of screening guidelines and several ways to screen for colorectal cancer (e.g., home stool tests, colonoscopy, others), (3) develop confidence to obtain colorectal cancer screening and stay up to date with screening based on guidelines, (4) apply behavior change strategies to support cancer prevention behaviors.

Начало: 07.01.2026 Край: 01.02.2028 Възраст: от 18 г.

United States University of Florida NCT07393906

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Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis

Myelodysplastic Syndrome Myelofibrosis

In transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. Standard oral iron chelation therapies can be intolerable for some patients due to adverse effects. The MEX-CD1 device (class III) could potentially offer an alternative for these patients by reducing serum iron levels through a novel, extracorporeal approach. MEXIRON clinical investigation focuses on the use of MEX-CD1, a medical device designed for extracorporeal chelation therapy to reduce iron overload in patients suffering from transfusion-dependent myelodysplastic syndromes (MDS) and myelofibrosis. MEXIRON aims to evaluate the device's use feasibility, safety, and effectiveness in reducing iron levels. Transfusions needs, patient experience and quality of life are also assessed. Each enrolled patients will undergo three low-volume continuous veno-venous haemodialysis cycles within one week. Following the three- haemodialysis cycles, patients will be monitored through on-site follow-up visits at 7 days, 28 days, and 90 days post-treatment to assess long-term effects.

Начало: 06.01.2026 Край: 06.05.2027 Възраст: от 18 г.

France Hospices Civils de Lyon NCT06781099

Набира участници Фаза 3

Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Advanced Non-Small Cell Lung Cancer Non-Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Carcinoma, Non-Small-Cell Lung (NSCLC) +2

This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC. * Is not a candidate for complete surgical resection or curative chemoradiotherapy. * Do not have known actionable genomic alterations * Be treatment naïve for advanced or metastatic disease Participants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion: * Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor. * Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor. Participants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects. The study will include regular visits for: * Treatment and health checks: while participant continues receiving treatment. * Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.

Начало: 06.01.2026 Край: 26.08.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +11 Pfizer NCT07222566

Набира участници Фаза 2/3

Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease

Huntington Disease

The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.

Начало: 06.01.2026 Край: 01.08.2029 Възраст: от 25 г.

Argentina, Brazil, Georgia Skyhawk Therapeutics, Inc. NCT07378644

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A Methodological Study to Learn More About Kidney Function in Healthy People and in People With Reduced Kidney Function

Acute Kidney Injury, Renal Insufficiency

The main purpose of this study is to investigate how reliable a test assessing the renal functional reserve (RFR) and the maximum glomerular filtration rate (maxGFR) are. MaxGFR and RFR assessments are repeated twice at 1-month intervals. If precise, this test may improve the measure of kidney function and be useful in future studies for people with chronic kidney problems. To do this, the researchers will collect and analyze information about kidney function from up to 50 adults, including healthy people and people with stable kidney problems. Each person will come to the study center for a screening visit and then three study days, each about a month apart. On each study day, participants will have blood and urine samples taken before and after drinking a protein shake. The tests will measure things like creatinine, cystatin C, and other markers in the blood and urine to see how the kidneys are working. The study will also record basic health information, weight, blood pressure, and any medicines being taken. The study will last about 2 to 2.5 months for each participant.

Начало: 06.01.2026 Край: 19.02.2027 Възраст: 18–75 г.

Germany Bayer NCT07368712

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Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression

Treatment-resistant Depression (TRD) Major Depression Disorder

The primary objective of this study is to evaluate the clinical efficacy of moderate-dose transcranial photobiomodulation (t-PBM) at different frequencies (10 Hz and 40 Hz) in patients with treatment-resistant depression (TRD). It further aims to explore the differential efficacy across various symptom subtypes, with a particular focus on the somatic symptom-dominant subtype. Additionally, this study will collect paired-pulse neurophysiological parameters (e.g., the ratio of cortical inhibition to excitation) to preliminarily explore the neural mechanisms underlying the modulation of cortical excitability by t-PBM intervention, and to analyze their correlation with the magnitude of clinical symptom improvement. The specific aims of this study are as follows: To evaluate the differential efficacy of t-PBM at varying frequencies (10 Hz vs. 40 Hz) in improving clinical depressive symptoms (as measured by scales such as HAM-D and MADRS). To investigate the therapeutic response to t-PBM in patients with the somatic symptom-dominant depression subtype, analyzing its potential suitability for targeting specific symptoms. To explore the changes in paired-pulse TMS parameters (e.g., SICI, ICF, and LICI) before and after t-PBM treatment, gaining preliminary insights into the potential association between its cortical modulatory effects and clinical outcomes.

Начало: 06.01.2026 Край: 31.03.2027 Възраст: 18–65 г.

Taiwan Taipei Veterans General Hospital, Taiwan NCT07543328

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The EFFECT of VİRTUAL REALİTY HEADSETS on ANXİETY, FEAR and PHYSİOLOGICAL PARAMETERS in CHİLDREN With CANCER UNDERGOİNG INTRATHECAL CHEMOTHERAPY

Pediatric Cancer

This study was planned to determine the effect of virtual reality glasses on anxiety, fear, and physiological parameters in cancer patients aged 4-10 years undergoing intrathecal chemotherapy. The main questions that the study aimed to answer are as follows: * Could virtual reality glasses affect the fear experienced by children undergoing intrathecal chemotherapy? * Could virtual reality glasses affect the anxiety experienced by children undergoing intrathecal chemotherapy? * Does virtual reality goggles have an effect on the physiological parameters of children undergoing intrathecal chemotherapy? Researchers will compare the effects of virtual reality glasses on fear, anxiety, and physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation) in children with cancer undergoing intrathecal chemotherapy to a control group that will not receive any intervention. Cancer patients participating in the study will be given virtual reality glasses before intrathecal chemotherapy treatment.

Начало: 05.01.2026 Край: 01.06.2026 Възраст: 4–10 г.

Turkey (Türkiye) TC Erciyes University NCT07537062

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Feasibility and Acceptability of Primary Palliative Care Intervention in Patients Undergoing Hematopoietic Stem Cell Transplantation

Hematopoietic Cell Transplant Hematologic Malignancy

Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. This study will assess Sentinel's feasibility and acceptability.

Начало: 05.01.2026 Край: 30.03.2027 Възраст: от 18 г.

United States Massachusetts General Hospital NCT06676852

Набира участници Фаза 2

A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation

Microvascular Inflammation

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time. In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI. The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is: • How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab? Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study. Adverse events are health problems that may or may not be caused by the study drug. The study will be done in 2 parts as follows: * Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo. * Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this. * All treatments will be given by intravenous (IV) infusion at the study site. * Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation. * Participants will stay in the study for about 1 year.

Начало: 05.01.2026 Край: 10.02.2028 Възраст: 18–74 г.

Austria, Brazil, Czechia +4 Biogen NCT07219043

Набира участници Фаза 3

A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Relapsed and/or Refractory Multiple Myeloma (RRMM)

This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies. The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Начало: 02.01.2026 Край: 17.09.2034 Възраст: от 18 г. Лечение

Australia, South Korea, United Kingdom +1 Regeneron Pharmaceuticals NCT07222761

Набира участници Фаза 1

Imetelstat Combinations in Relapsed AML

Relapsed Acute Myeloid Leukemia

IMAGINE is a two-part trial to evaluate the safety and preliminary efficacy of imetelstat in combination with azacitidine with or without venetoclax in patients with relapsed or refractory AML. The trial will consist of a safety run-in phase (Part A) employing a 3+3 design to monitor dose-limiting toxicities of imetelstat when administered in combination with a fixed dose of azacitidine. Part B will consist of a phase 1b trial employing a BOIN12 design to determine the optimal biological dose of imetelstat, starting at a lower dose level, in combination with azacitidine and venetoclax. Total of up to 36 participants will be accrued over 54 months at Mount Sinai Hospital. Estimated duration of trial is 114 months including recruitment, screening, treatment, and follow-up.

Начало: 02.01.2026 Край: 15.06.2035 Възраст: от 18 г.

United States Douglas Tremblay NCT07320235

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Comparing Traditional Risk Scores and an AI-Based Multimodal Model for Predicting Cardiovascular Events After Gastrointestinal Surgery

Postoperative Complications Cardiovascular Diseases Digestive System Surgical Procedures

The goal of this observational study is to develop and evaluate an artificial intelligence (AI)-based multimodal model for predicting major cardiovascular events within 30 days after gastrointestinal surgery in adults at Bach Mai Hospital. The study will also compare the predictive performance of this AI-based model with commonly used traditional risk scores. The main questions it aims to answer are: Can an AI-based multimodal model predict major cardiovascular events within 30 days after gastrointestinal surgery? Does the AI-based model show better predictive performance than the Revised Cardiac Risk Index (RCRI), the American College of Surgeons National Surgical Quality Improvement Program Myocardial Infarction or Cardiac Arrest calculator (ACS NSQIP MICA), and the ACS NSQIP Surgical Risk Calculator (ACS NSQIP SRC)? Researchers will compare the AI-based multimodal model with traditional risk scores using measures of predictive performance, including discrimination, calibration, net reclassification improvement, and integrated discrimination improvement. Participants will be adults undergoing gastrointestinal surgery. Researchers will review medical record data from patients treated in 2025 and will also collect the same types of clinical data prospectively in 2026. The clinical outcome being predicted is the occurrence of major cardiovascular events within 30 days after surgery. The study will not change routine clinical care.

Начало: 01.01.2026 Край: 31.07.2026 Възраст: от 16 г.

Vietnam Bach Mai Hospital NCT07539532

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Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS) Fibromyalgia (FM)

Dietary modifications are often recommended as first-line treatment for irritable bowel syndrome, with the FODMAP diet being the most effective intervention to improve global gastrointestinal symptoms. Due to the heterogeneity of symptoms, patients often seek complementary or alternative therapies. This randomized clinical trial aims to determine whether osteopathic care provides additional improvement in gastrointestinal symptoms compared to sham osteopathic care, when both are combined with a flexible FODMAP diet. The trial will also assess the safety and tolerability of osteopathic care. The main questions it aims to answer are: Does osteopathic care reduce IBS symptom severity more than sham osteopathic care? Does osteopathic care improve pain, quality of life, anxiety, fatigue, work productivity, and gut microbiota compared to sham osteopathic care? Do participants adhere to the flexible FODMAP diet and osteopathic care, and are the effects of osteopathic care maintained at 3- and 6-months post-intervention? Can pretreatment factors, such as sociodemographic characteristics, IBS severity, predominant symptoms, psychological state, or gut microbiota composition, predict response to osteopathic care? What adverse effects occur with osteopathic care compared to sham care? Participants will: Visit the osteopathy clinic to receive four sessions of real or sham osteopathic care Complete online assessments before and after the intervention, and at 3- and 6-months post-intervention Provide stool samples before and after the four osteopathic or sham sessions Keep a three-day food diary and a ten-day stool diary before and after the intervention, and at 3- and 6-months post-intervention

Начало: 01.01.2026 Край: 01.06.2027 Възраст: от 18 г.

Belgium Universitair Ziekenhuis Brussel NCT07176078

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The Effect of EEG and BIS-guided Anaesthesia on the Incidence of Emergent Delirium in Children

Emergence Delirium, Anesthesia

The aim of the study is to compare two modalities of measuring the depth of general anaesthesia on the incidence of emergent delirium in children.

Начало: 01.01.2026 Край: 01.12.2028 Възраст: 1–6 г.

Czechia University Hospital Ostrava NCT07534215

Набира участници Фаза 2

A Pilot Study Evaluating β-hydroxybutyrate Supplementation Concomitant to Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer

Rectal Cancer Radiotherapy Immunotherapy Chemotherapy

This study is a prospective phase II clinical trial aimed at exploring the potential benefits of supplementing β-hydroxybutyrate with existing short course radiotherapy sequential immunotherapy and CAPEOX therapy.

Начало: 01.01.2026 Край: 01.06.2027 Възраст: 18–75 г.

China Tao Zhang NCT07239466

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The ISAR InflEx Trial (Inflammation and Exercise)

Inflammation Obesity (Disorder)

A sedentary lifestyle and obesity are associated with chronic low-grade inflammation and an elevated risk of cardiovascular disease (CVD). This study aims to systematically characterize and compare the effects of three distinct exercise modalities - moderate-intensity, vigorous-intensity, and short-duration maximal exercise - each differing in duration and intensity, on systemic inflammation and immune function. The study investigates the potential of exercise as an effective anti-inflammatory intervention for the prevention of CVD.

Начало: 01.01.2026 Край: 01.06.2027 Възраст: 18–45 г.

Germany Department of Cardiology German Heart Center Munich TUM NCT07543666

Набира участници

Efficacy of Combining Ultrasound-Guided Needle Release of Transverse Carpal Ligament and Median Nerve Dextrose Water Hydrodissection for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Dextrose Carpal Tunnel Release Ultrasound +1

Carpal tunnel syndrome (CTS) is a common musculoskeletal disorder, which is caused by compression of the median nerve as it travels through the wrist. There are several treatments for CTS, including conservative and surgical options. Though local corticosteroid injection has been considered more effective than physical therapy for treatment of CTS and has significant short-term benefits, long term benefits are not evidenced. Several studies in recent years reported significantly superior longer-term benefit of D5W and PRP compared with corticosteroid injections and other conservative managements. In addition, percutaneous release of the transverse carpal ligament (TCL) was developed to treat CTS in recent years. Because the effectiveness of the recently developed techniques in treating CTS has not been well established, the investigators aim to investigate whether combining US-guided partial release of the transverse carpal ligament with a needle plus D5W hydrodissection is more beneficial for CTS comparing to either treatment alone.

Начало: 01.01.2026 Край: 31.12.2030 Възраст: 20–80 г.

Taiwan Shin Kong Wu Ho-Su Memorial Hospital NCT07324005

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Effect of Non-Surgical Periodontal Therapy on Salivary Biomarkers in Smokers and Non-Smokers With Periodontitis

Periodontitis Smoking ( Cigarette)

This study evaluates the effect of non-surgical periodontal therapy on salivary biomarkers (Dkk-1, Sclerostin, and PLAP-1) and clinical periodontal parameters in patients with periodontitis. Periodontitis is a chronic inflammatory disease that destroys tooth-supporting tissues. Smoking is a significant risk factor that worsens periodontal destruction and reduces the effectiveness of standard therapies. * The trial is a non-randomized comparative clinical study. * It includes 44 adult patients diagnosed with Stage II and III periodontitis. * The participants are divided into two equal groups: 22 current smokers and 22 non-smokers. * Participants will undergo a baseline examination, followed by standardized non-surgical periodontal therapy consisting of scaling and root planing. * A follow-up visit will be conducted six weeks post-therapy to repeat clinical measurements and saliva collection. * The primary objective is to evaluate changes in salivary biomarker levels and clinical parameters (Plaque Index, Gingival Index, bleeding on probing, Probing Pocket Depth, Clinical Attachment Level) after treatment.

Начало: 01.01.2026 Край: 01.10.2026 Възраст: от 18 г.

Iraq Al-Mustansiriyah University NCT07547202

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