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Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
https://clinicaltrials.gov/ct2/show/NCT02669251

Jul 1st, 2022 - Background: Chronic graft-versus-host disease (cGVHD) is the leading cause of non-relapse morbidity and mortality in persons after allogeneic hematopoietic stem cell transplantation (SCT). Bronchiolitis obliterans syndrome (BOS) is a complication of cGVHD associated with a high morbidity and mortality, and treatment options are limited. Neutrophil elastase (NE) is a protease released by neutrop...

Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health
https://clinicaltrials.gov/ct2/show/NCT02669212

Jul 1st, 2022 - Objective: The primary objective is to explore the clinical and biological phenotypes of post-infectious myalgic encephalomyelitis/chronic fatigue syndrome (PI-ME/CFS). The secondary objective is to explore the pathophysiology of fatigue and post-exertional malaise (PEM). Study population: Up to 206 persons will be enrolled as part of this protocol. Up to 150 persons aged 18-60 will be part of ...

Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People
https://clinicaltrials.gov/ct2/show/NCT02669225

Jul 1st, 2022 - Objective: To assess if there are differences in [18F]florbetaben uptake following the first 120 minutes of its injection (reflecting amyloid-beta or Ab load and/or docked Ab) in subjects during rested wakefulness (RW) after normal sleep compared to wakefulness after 24 hrs of sleep deprivation (SD). Specifically, we hypothesize that during RW after a normal night s sleep there will be less [18...

Molecular Basis of Human Phagocyte Interactions With Bacterial Pathogens
https://clinicaltrials.gov/ct2/show/NCT00339287

Jul 1st, 2022 - Human phagocytic cells such as polymorphonuclear leukocytes (neutrophils or PMNs) are readily mobilized to sites of infection and ingest microorganisms by a process known as phagocytosis. The combined effects of reactive oxygen species (ROS) and antimicrobial peptides released into forming bacterial phagosomes kill most ingested bacteria. However, many bacterial pathogens have devised means to ...

Genome Expression in Lymphoma, Leukemia and Multiple Myeloma
https://clinicaltrials.gov/ct2/show/NCT00339963

Jul 1st, 2022 - Current diagnosis of the lymphoid malignancies relies upon the morphological appearance of the cancer cells supplemented by a few molecular markers. Within a diagnostic category, the clinical courses and responses of patients to therapy are variable, suggesting that the existing diagnostic categories may harbor more than one disease entity. Recent genomic technologies allow a comprehensive mole...

Establishment of a Perinatal Database and a Bank of Biological Materials
https://clinicaltrials.gov/ct2/show/NCT00339235

Jul 1st, 2022 - The aim of this project is to establish a clinical database and a bank of biological materials which will be used to improve the pathophysiologic understanding of the mechanisms underlying various pregnancy diseases. The US-Mexico Reproductive Health Research Development Workshop, sponsored by the NIH, recommended that the setting up of "tissue, blood, and placental banks from human and relevan...

Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
https://clinicaltrials.gov/ct2/show/NCT00339911

Jul 1st, 2022 - Background -NCI-Frederick scientists performing in vitro studies involving human specimens have a need for a reliable and consistent source of samples which protects the donor from research risks. Objective -The purpose of this protocol is to establish a centralized repository for the collection and distribution of samples (either blood, buccal mucosal cells, semen, urine, or nail clippings) fr...

Prospective Studies of the Natural History of Diabetes Mellitus and Its Complications in the Gila River Indian Community
https://clinicaltrials.gov/ct2/show/NCT00339482

Jul 1st, 2022 - This project is a continuation of an extensive longitudinal population-based epidemiological investigation of the etiology and determinants of type 2 diabetes (and its complications) and formerly arthritis. The original baseline observations were made on the residents of the Gila Indian Reservation, predominantly Pima Indians, in 1965. We attempt to reexamine the population at two-yearly interv...

Physicians' Understanding of Human Genetic Variation
https://clinicaltrials.gov/ct2/show/NCT00339924

Jul 1st, 2022 - In recognition of the emerging social and scientific research related to assessing the complex relationships between self-identified race, ancestral origin and the genetic components of diseases, it is important to study physicians and other health professionals knowledge of human genetic variation and how they interpret and apply race, ethnicity and human genetic variation in their clinical de...

Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial
https://clinicaltrials.gov/ct2/show/NCT00339495

Jul 1st, 2022 - The Division of Cancer Preventionl (DCP, formerly DCPC), under extramural contracts to 10 U.S. clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal and ovarian cancer (The PLCO Trial). In 1996 the NCI Executive Committee approved the expansion of the PLCO Trial to collect additional materials and to conduct additional studies. About, 74,000 men and 74,00...

Biospecimen Procurement for Genitourinary Malignancies Branch Immunotherapy Protocols
https://clinicaltrials.gov/ct2/show/NCT02682667

Jul 1st, 2022 - Background: -Immunotherapy is a promising approach to the treatment of cancer. GMB investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes. Objectives: To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with cancer o...

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
https://clinicaltrials.gov/ct2/show/NCT02682511

Jul 1st, 2022 - This study is a randomized, placebo-controlled, double-blind phase 2 trial of patients with dcSSc or SSc-PAH. Twenty participants with SSc-PAH and 14 participants with dcSSc will be randomized to receive either oral ifetroban daily or matching placebo. Study participants will be treated for 12 months, followed by a 30-day follow-up period. The study will test whether ifetroban is safe and stati...

Retrospective Case Series of Trans-scleral Cryotherapy for Retinal Hemangioblastoma
https://clinicaltrials.gov/ct2/show/NCT04458935

Jul 1st, 2022 - Study Description: This study is a retrospective review of medical records in the NIH eye clinic. To our knowledge, there has been no report in the current era dedicated to a description of trans-scleral cryotherapy for retinal hemangioblastomas despite its routine use in this setting. This study aims to explore features and outcomes of these cases to better inform best practices. Objectives: T...

Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death
https://clinicaltrials.gov/ct2/show/NCT00246857

Jul 1st, 2022 - This protocol is designed to screen patients with suspected or identified genetic diseases of immune cell homeostasis, reflecting abnormalities in programmed cell death, survival, development, activation, and/or proliferation. Patients determined by clinical history and initial outside evaluation by their referring physician to be of interest will be consented and enrolled into this study. Bloo...

Study of Skin Cells That Stop Replicating (Senescent) During Wound Healing
https://clinicaltrials.gov/ct2/show/NCT02755584

Jul 1st, 2022 - Objectives and Specific Aims: The objective of this proof-of-concept study is to understand the physiological role of senescent cells in humans during the aging process using a model of wound healing. Cellular senescence is the phenomenon by which normal cells cease to divide in response to a stress. We aim to determine if in healthy humans: (1) senescent cells appear around wound sites a few d...

Evaluation of Children With Endocrine and Metabolic-Related Conditions
https://clinicaltrials.gov/ct2/show/NCT02769975

Jul 1st, 2022 - Study Description: This protocol is designed to allow endocrine-related evaluations of children with known or suspected endocrine or metabolic disorders. Children with endocrine or metabolic-related condition(s) who may or may not be eligible for a specific NICHD research protocol, may be evaluated under the auspices of this protocol. Standard clinically indicated laboratory or radiological stu...

Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer
https://clinicaltrials.gov/ct2/show/NCT02769962

Jul 1st, 2022 - Background: Small cell lung cancer (SCLC) is an aggressive cancer with a poor prognosis. Although highly responsive to chemotherapy initially, SCLC relapses quickly and becomes refractory to treatment within a few months. Urothelial Carcinoma (UC) of the Bladder is the fourth most common malignancy in men and the ninth most common in women. Prostate cancer is the most common cancer among men in...

Pediatric Patients With Metabolic or Other Genetic Disorders
https://clinicaltrials.gov/ct2/show/NCT02769949

Jul 1st, 2022 - The aim of this protocol is to allow genetic-related evaluations for patients with a variety of known or suspected genetic disorders, supplement and offer an additional opportunity for training in clinical genetics, dysmorphology and metabolic genetics in the National Institute of Child Health and Human Development (NICHD) and other Institutes of the National Institutes of Health (NIH). If not ...

Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients (RECOVER-19)
https://clinicaltrials.gov/ct2/show/NCT04466800

Jul 1st, 2022 - In France, more than 150 000 patients have been infected by the SARS-CoV-2 virus and COVID has been responsible for more than 100 000 hospitalizations. Following the acute phase of this disease, some patients may have sequelae, such as breathing difficulties or malnutrition. However, the prevalence and intensity of those sequelae still remain unknown. Thus, a functional and respiratory rehabili...

A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma
https://clinicaltrials.gov/ct2/show/NCT04467281

Jul 1st, 2022 - The purpose of this study is to see if using the radioactive tracer 89Zr-DFO-daratumumab with PET/CT scans is a practical and effective way to view and monitor multiple myeloma in participants before and during their treatment with daratumumab. We also want to see if 89Zr-DFO-daratumumab PET/CT scans can predict a participant's response to therapy, and if they can better locate any leftover dis...