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390 Study Matches

MT2019-01: Adrenoleukodystrophy National Registry Study (ALD) and Biobank

In this protocol, we will enroll pediatric, adolescent and adult patients diagnosed with adrenoleukodystrophy (ALD). These patients will include probands diagnosed by newborn screening and their relatives subsequently diagnosed, as well other patients who are diagnosed with ALD due to other presenting signs and symptoms and subsequently were confirmed to have ALD. We will ask consenting subjects to provide a medical history (with verification via medical records), to participate in a semi-annual health survey and provide consent to collect biospecimens. The overarching goal of this work is to engage with families affected by ALD and to assemble a resource of clinical, medical, and biological data that will allow of to better understand the natural history of ALD, and how this is affected by newborn screening. The initial focus will be on patients within Minnesota, but participation will be open to any family interested in the study, as this will be web-based. This registry and biobank, together with other research conducted in tandem, will possibly provide information describing the natural history of ALD and outcomes with interventions. It is anticipated that the data collected will further our understanding of the natural history of the disease, basic biology of adrenoleukodystrophy, diagnosis and outcomes. Ultimately, this research may lead to new avenues for early diagnosis and development of safer and more effective therapies for ALD.

Ashish Gupta
All
Not specified
NA
This study is NOT accepting healthy volunteers
NCT03789721
STUDY00003605
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Inclusion Criteria
• Age 0 - 100
• ALD patients or family member meeting any of the following criteria:
• Any patient diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation).
• Known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
• Participants living in the United States and territories Exclusion Criteria
• Patients diagnosed with ALD who lack the capacity to consent/assent AND do not have a designated legally authorized representative or guardian.
• Patients who have undergone BMT or other cellular therapy .
• Patients not fluent in English who are unable to consent in-person at the BMT Journey Clinic.
• Patients who are illiterate
• Patient determined by the PI or designee to be unlikely to complete required study components (due to language barriers, compliance issues, etc.)
Other: Medical Record Abstraction, Other: Biospecimen Sample Collection
ALD (Adrenoleukodystrophy), Adrenoleukodystrophy, Cerebral Adrenoleukodystrophy
Registry, VLCFA, ABCD1, X-chromosome
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National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease (NPC-QIC)

This study is a prospective, non-randomized, observational multi-center study, utilizing a quality improvement methodology to facilitate systematic care coordination, interstage cardiovascular monitoring, and nutritional monitoring into every day practice. Utilizes a national registry to document the impact of these changes on various care processes and outcomes. The aim of this Phase II project intends to: 1) develop and support a robust national registry to gather clinical care process, outcome and developmental data on infants with HLHS between diagnosis and the first year of life, 2) engage pediatric cardiology and cardiac surgery programs in using the registry, and 3) use data from the registry to support and monitor the implementation of QI strategies to standardize and improve care for these infants.

Kavisha Shah
All
up to 15 Months old
N/A
This study is NOT accepting healthy volunteers
NCT02852031
STUDY00004329
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Inclusion Criteria:

• Fetuses or newborns diagnosed with HLHS or other univentricular condition
• Intended to undergo Norwood procedure
Exclusion Criteria:

• None
Other: Collaborative Learning Network
Hypoplastic Left Heart Syndrome (HLHS)
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A Registry for Participants With Chronic Hypoparathyroidism (PARADIGHM)

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT01922440
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Inclusion Criteria:

• Participants diagnosed with chronic hypoparathyroidism, ie, hypoparathyroidism with a duration of longer than 6 months, including:
• Adult participants (greater than or equal to [>=] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone.
• Pediatric participants (less than [<] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone.
Exclusion Criteria:

• Participants or legally acceptable representatives unable to provide informed consent.
• Participants using rhPTH(1-34) or used rhPTH(1-34) for more than 2 years and in the last 3 months.
• Participants currently enrolled in an interventional clinical study (whether or not the study is related to hypoparathyroidism). Note that this does not include participants enrolled in other observational registries.
• History of hypoparathyroidism resulting from a known activating mutation in the CaSR gene.
• History of hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism).
Drug: Combination product (Natpara) and drug or supplements [Disease and drug registry]
Chronic Hypoparathyroidism
Chronic Hypoparathyroidism, rhPTH(1-84), Observational study, parathyroid hormone (PTH), Drug registry, rhPTH(1-34)
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Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)

Prospective, long term registry of patients with diagnosis of spinal muscular atrophy to assess the long term outcomes in the context of advances in treatment options.

Peter Karachunski
All
Not specified
NA
This study is NOT accepting healthy volunteers
NCT04174157
STUDY00008659
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Inclusion Criteria:

• Patients with SMA, genetically confirmed on or after 24 May 2018.
• Appropriate consent/assent has been obtained for participation in the registry
Exclusion Criteria:

• Currently enrolled in an interventional clinical trial involving an investigational medicinal product to treat SMA. Note: Patients that are participating in a Compassionate Use Program (CUP) for AVXS-101 (Zolgensma) such as a Managed Access Program (MAP), an Expanded Access Program (EAP), Single Patient Investigational New Drug (IND) (SPI) or Named Patient Program (NPP) are eligible to enroll in the registry regardless of the date of genetic confirmation of SMA.
Other: Prospective observational registry, Drug: Zolgensma
Spinal Muscular Atrophy (SMA)
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Pediatric Obesity Weight Evaluation Registry (POWER) Study (POWER)

All
up to 18 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02121132
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Inclusion Criteria:

• age 18 years or younger
• overweight or obese patient
• initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.
Exclusion Criteria:

• no exclusion criteria
Overweight, Obesity
Overweight, Obesity
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University of Minnesota Transplant Registry

This registry is open for people of all ages who have either received or donated an organ at the University of Minnesota. This study aims to evaluate organ transplant outcomes among people who have been part of the transplant program.

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT01062581
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Inclusion Criteria:

• Received a transplanted organ at the University of Minnesota
• Living donor who donates an organ at the University of Minnesota
Exclusion Criteria:

• Did not receive a transplant at the University of Minnesota
• Did not donate an organ at the University of Minnesota
Transplant Recipient, Transplant Donation
Recipient, Donor, Organ Transplant, Registry, University of Minnesota
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Colleen Correll
All
up to 21 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02418442
1506M74443
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Inclusion Criteria:

• Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A).
• Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
• Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.
Exclusion Criteria:

• Greater than 21 years of age at the time of enrollment.
Rheumatic Joint Disease
Systemic Arthritis, Oligoarthritis, Polyarthritis (Rheumatoid Factor Negative), Polyarthritis (Rheumatoid Factor Positive), Psoriatic Arthritis, Enthesitis Related Arthritis (ERA), Undifferianted Arthritis, CARRA Consensus Treatment Plans
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The Organ Care System (OCS) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry - OCS Lung TOP PAS Registry (TOP)

To collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™Lung System in lung transplantation.

Stephen Huddleston
All
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT03639025
STUDY00003837
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This is an all-comers registry that will enroll all:
• Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
• Consented patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
• All donor lungs that were perfused on OCS Lung System. Enrolled patients will fall into one of the following three possible analysis categories:
• TOP SCDL PAS Primary Analysis Population: will be comprised of the first 289 eligible/PAS consented recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• TOP DLIDU Primary Analysis Population: Will be comprised of the first 266 eligible/PAS consented recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Device: OCS Lung System
Lung Transplantation
Clinics and Surgery Center (CSC)
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The (IRAD) International Registry for Acute Aortic Dissection

The International Registry of Aortic Dissection (IRAD) was created in 1996 by cardiovascular specialists committed to expanding current knowledge of aortic dissection with the goal of improving patient outcomes. This registry study uses a standardized form to capture data from consecutive patients with aortic dissection at participating hospitals.

Andrew Shaffer
Clinical Outcomes Research
This study is NOT accepting healthy volunteers
NCT01552720
1111M06641
Aortic Dissection
aorta, dissection, feature
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The REPLACE Registry

This is a prospective, observational, non-interventional patient registry designed to document product safety and clinical outcomes for 10 years in patients treated with Cholbam/Kolbam, including those who have been using Cholbam/Kolbam for at least one month (existing users) and those who start Cholbam/Kolbam treatment at enrollment (new users). Patients who have been using Cholbam/Kolbam for less than one month and those who had previously been treated and who restart treatment will also be included but will not be counted in the existing or new users groups.

Boris Sudel
All
Not specified
Post Market Monitoring
This study is NOT accepting healthy volunteers
NCT03115086
STUDY00003757
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Inclusion Criteria:

• Male and female patients, of any age.
• The patient and/or the patient's parent/legal guardian is willing and able to provide signed informed consent, and the patient, if less than 18 years of age, is willing to provide assent as appropriate and in accordance with local regulatory, IRB, and EC requirements.
• The patient has a diagnosis for which Cholbam is indicated.
• The patient is or will be treated with Cholbam at the time of signing the informed consent form (ICF) (enrollment).
Exclusion Criteria:

• Patients who, by judgement of the Investigator, will not be able to comply with the requirements of the protocol will be excluded
Drug: Cholbam
Bile Acid Synthesis Disorders
Bile Acid Synthesis Disorder, Zellweger Spectrum Disorder, Peroxisomal Disorder, Cholic Acid, Cholbam, The REPLACE Registry
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Feasibility of a Yoga Intervention in Sedentary African-American Women

Female
18 Years to 65 Years old
N/A
This study is also accepting healthy volunteers
NCT04710979
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Inclusion Criteria:

• Self-identified as an African-American woman at least 18 years old
• Engaging in less than 30 minutes/week of moderate-to-vigorous physical activity
• If employed, working in a sedentary occupation that requires primarily seated work; • If unemployed, typical day involves sedentary, primarily seated activities
• Able to exercise for 20 minutes continuously
• No pre-existing condition that limits physical activity
• Access to a computer (or mobile device) and internet service
Exclusion Criteria:

• Diagnosed with heart disease, diabetes, cancer, kidney, liver disease, major depression or bipolar disease
• Take more than two daily medications for lipids or blood pressure
• Current smoker
Behavioral: Yoga Intervention
Sedentary Behavior
Yoga, African-American, Feasibility Study
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DegenPRO: A multicenter prospective registry for the management of degenerative spine disorders

This is an observational registry database for adult patients diagnosed with degenerative spine disorders, which aims to add information to the understanding of the disease management of this spine diseases. By creating this registry, a more complete picture of degenerative spine disorders - including treatment practices - will be established, by collecting information about the health status of patients across several hospitals in several countries. Research of this kind will help future patients by providing doctors with information about degenerative spine disorders, and about patients' treatment outcomes. Data from this registry may be used to generate descriptive statistics on demographics, and clinical characteristics, including co-morbidities, treatment patterns and adverse outcomes (resulting from treatment or disease), as well as patients' quality of life measurements. Condition: Patients with a degenerative spine disorder Intervention/procedure investigated: No specific treatment required. Study design: Prospective case series

Christopher Martin
NA
This study is NOT accepting healthy volunteers
NCT02802033
STUDY00000102
Degenerative Diseases, Spinal Cord
Clinics and Surgery Center (CSC), Osteobiologics, Registry, Spinal Fusion, Spine
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An Observational Registry of Abatacept in Patients with Juvenile Idiopathic Arthritis (BMS Protocol IM101240)

The objective of this study is to create an international registry with long-term follow-up to characterize and evaluate the safety of abatacept in juvenile idiopathic arthritis (JIA). The primary objective of the JIA registry is to describe the long-term safety of abatacept treatment for JIA by quantifying the incidence rates of serious infections, autoimmune disorders, and malignancies.

Colleen Correll
All
up to 17 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01357668
1403M48721
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:

• Diagnosis of JIA (any subtype)
• Age < 18 years at the time of enrollment unless currently or previously enrolled in an abatacept clinical trial and received abatacept
• Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial
• Parent or legally acceptable representative willing to participate in the study and sign the informed consent
Exclusion Criteria:

• Pregnant or nursing female at the time of enrollment
• Prior malignancies if the patient has not been malignancy free for at least 5 years.
• Any serious acute or chronic medical condition other than JIA, including chronic infection, which would compromise the patient's ability to participate in the study
• Known poor compliance with clinic visits (based on physician judgment)
Juvenile Idiopathic Arthritis
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Viral Infection and Respiratory illness Universal Study [VIRUS]: COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary)

This is a data-only multi-site registry study looking at current ICU/hospital care patterns during COVID-19.

Ronald Reilkoff
NA
This study is NOT accepting healthy volunteers
NCT04323787
STUDY00009382
Coronavirus
COVID19
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Alport Syndrome Treatments and Outcomes Registry (ASTOR)

The Alport Syndrome Treatments and Outcomes Registry (ASTOR) was founded in 2007 with the goal of facilitating clinical trials of new treatments for the disease. Because Alport syndrome is a rare disorder, rapid recruitment of sufficient participants for meaningful therapeutic trials will be greatly enhanced by pre-existing patient registries.

All
up to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT00481130
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Inclusion Criteria:
History of a diagnosis of Alport syndrome, Family or individuals need to be able to comprehend the consent and HIPAA forms written in the English language.
Exclusion Criteria:
Uncertain diagnosis of Alport syndrome.
Alport Syndrome
Alport Syndrome, x linked, autosomal dominant Alport syndrome, glomerular basement membrane, hereditary nephritis, familial benign haematuria, type IV collagen, hereditary nephritis with neurosensory deafness, vison loss
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SLIP II REGISTRY (SLIP II)

We aim to conduct a randomized control trial comparing patient outcomes and satisfaction with or without expert panel review before making a final decision about surgery for grade I degenerative lumbar spondylolisthesis. A prospective multi-center registry aimed at addressing important issues pertaining to outcomes from treatment for degenerative spondylolisthesis and spinal stenosis will be generated.

David Polly
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03570801
STUDY00003517
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Inclusion Criteria:

• Symptomatic lumbar spinal stenosis: defined as radicular and/or back pain either induced or aggravated by activity and relieved by rest.
• Single-level grade I degenerative spondylolisthesis (3-14mm)
Exclusion Criteria:

• Serious medical illness (ASA Class IV or higher)
• Spondylolysis
• Multilevel spondylolisthesis or high grade spondylolisthesis (grade II or greater than 14mm)
Other: Expert Panel Review
Bone, Joint & Muscle, Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis, Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis, Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
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Connect? MDS/AML Disease Registry

This is a prospective, longitudinal, multi-center observational cohort study of patients with newly diagnosed MDS, ICUS or AML within 60 days prior to the date of ICF signature. Each enrolled patient will be followed for 8 years, or until early study termination, patient withdrawal or death, whichever occurs first. This study is observational and all decisions regarding patient care will be made by the treating physician. Objectives of this study is to describe the current and evolving patterns for diagnosis, prognosis, treatment, clinical monitoring and outcome measures in patients with LR or HR MDS, ICUS and AML, to compare routine clinical practice patterns with existing management guidelines, to describe treatment patterns and outcomes in patients with or without additional cytogenetic abnormalities, and to summarize patient-reported HRQoL outcomes and economic outcomes and their associations with patient characteristics, treatment regimens and clinical outcomes.

Birendra Kumar
NA
This study is NOT accepting healthy volunteers
NCT01688011
1503M66501
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Primary Myelofibrosis
AML, Acute myeloid leukemia, Connect®, ICUS, Idiopathic Cytopenias of Undetermined Significance, MDS, MDS/MPN overlap syndromes, MF, Myelodysplastic syndromes, Myelodysplastic/Myeloproliferative overlap syndromes, Myelofibrosis, Registry
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Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO)

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT02061436
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Inclusion Criteria:

• Patients undergoing CTO PCI at each of the participating centers.
Exclusion Criteria:

• None
Coronary Artery Disease
chronic total occlusion, percutaneous coronary intervention
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Electronic patient reporting of symptoms during outpatient cancer treatment: A U.S. national randomized controlled trial (the ?PRO-TECT? trial)

Early Feasibility
This study is also accepting healthy volunteers
NCT03249090
201800231
Metastatic Cancer
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Pulmonary Hypertension Association Registry (PHAR) (PHAR)

The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. The goals of the PHAR include 1) measuring and improving quality of care (including assessing differences in adherence to evidence-based guidelines and establishing benchmarks for health outcomes), 2) determining the clinical effectiveness, comparative effectiveness, and cost effectiveness of treatment approaches, 3) understanding risk factors for outcomes and regional/center differences, and 4) facilitating funded clinical trials of new therapies and collaboration with the PAH community at large, including providers, patients, and their caregivers.

Thenappan Thenappan
All
Not specified
Clinical Outcomes Research
This study is NOT accepting healthy volunteers
NCT04071327
1702M07281
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Inclusion Criteria:

• All age groups
• Written informed consent
• Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), or pediatric PH due to developmental lung disease
• Within 6 months of first outpatient visit at a PH Care Center
Exclusion Criteria:

• Diagnosis of WSPH Group 2 pulmonary hypertension
• Diagnosis of WSPH Group 3 pulmonary hypertension, except PH due to developmental lung disease
• Diagnosis of WSPH Group 5 pulmonary hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension
Clinics and Surgery Center (CSC)
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Corrona Inflammatory Bowel Disease (IBD) Registry

This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.

Byron Vaughn
NA
This study is NOT accepting healthy volunteers
NCT03162549
STUDY00007736
Inflammatory Bowel Diseases
Clinics and Surgery Center (CSC)
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Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry (IPF/ILD-PRO)

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) established at the enrolling centers. In addition, blood samples will be collected and banked for future research projects.

Hyun Kim
All
30 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT01915511
1408M52921
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Inclusion Criteria:

• Willing and able to provide informed consent
• Established a new diagnosis of IPF by the enrolling subspecialty center (as defined by ATS/ERS/JRS/ALAT criteria)
• Age 30 years or older, or
• Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype
Exclusion Criteria:

• Malignancy, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years
• Currently listed for lung transplantation at the time of enrollment
• Currently enrolled in a clinical trial at the time of enrollment in this registry
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Idiopathic pulmonary fibrosis, Pulmonary fibrosis, IPF, Registry, 1199.174, Interstitial Lung Disease, ILD, Interstitial Lung Disease with Progressive Phenotype, Clinics and Surgery Center (CSC)
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ALX-HPP-501: An Observational,Longitudinal Prospective, Long-term Registry of Patients with Hypophosphatasia

This multinational, multicenter, observational, prospective, long-term registry is designed to collect data on epidemiology, HPP history, clinical course, symptoms (including multi-systemic aspects of disease), and burden of disease from patients of all ages who have a diagnosis of HPP. In addition, the Registry will collect data on asfotase alfa dosing, effectiveness of treatment, SAEs, immunogenicity, pregnancy and neonatal outcome data (for patients treated with asfotasealfa only), and targeted EOI.

Kyriakie Sarafoglou
NA
This study is NOT accepting healthy volunteers
NCT02306720
STUDY00004936
Hypophosphatasia (HPP)
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Pulmonary Fibrosis Foundation Patient Registry (PFFR) (PFFR)

The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients at approximately 40 clinical sites in the US. The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients at approximately 40 clinical sites in the US. Participants will be asked to complete patient reported outcome (PRO) surveys related to ILD symptoms and quality of life at the time of enrollment and during clinical follow-up visits (Appendix A – PRO Questionnaires). Each patient will donate approximately 30 mL of blood to the Biorepository, which will be separated into plasma, serum, RNA, and DNA.

Hyun Kim
All
18 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02758808
1605M87921
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Inclusion Criteria:

• 18 years old or older
• Understand and sign the informed consent document
• ILD Diagnosis must be made / confirmed at a participating Registry center.
• The diagnostic evaluation must include, at a minimum, a medical history, physical examination, pulmonary function testing and a computerized tomography (CT) scan of the chest.
• If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD.
• Anticipated additional follow up at the Registry center within one year.
Exclusion Criteria:

• Diagnosed with:
• Sarcoid
• Lymphangioleiomyomatosis (LAM)
• Pulmonary alveolar proteinosis (PAP)
• Cystic fibrosis (CF)
• Amyloidosis
Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF)
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MT2010-09 Primary Immune Deficiency Treatment Consortium (PIDTC). PROJECT 1: A Prospective Natural History Study of Diagnosis, Treatment and Outcomes of Children with SCID Disorders (RDCRN PIDTC #6901)

Christen Ebens
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT01186913
1011M93312
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Inclusion Criteria:
Stratum A: Typical SCID (formerly referred to as Classic SCID)- -Subjects who meet the following inclusion criteria and the intention is to treat with allogeneic hematopoietic cell transplant (HCT) are eligible for enrollment into Stratum A (Typical SCID) of the study:
• Absence or very low number of T cells (CD3 T cells <300/microliter) AND
• No or very low T cell function (<10% of lower limit of normal) as measured by response to phytohemagglutinin (PHA) OR
• T cells of maternal origin present. Stratum B: Leaky SCID, Omenn Syndrome, Reticular Dysgenesis- -Subjects who meet the following criteria and the intention is to treat with HCT are eligible for enrollment into Stratum B: Leaky SCID:
• Maternal lymphocytes tested for and not detected AND
• Either one or both of the following (a,b) :
• a.) <50% of lower limit of normal T cell function as measured by response to PHA, OR response to anti-CD3/CD28 antibody
• b.) Absent or <30% of lower limit of normal proliferative responses to candida and tetanus toxoid antigens
• AND at least two of the following (a through e):
• a.) Reduced number of CD3 T cells
• age ≤2 years: <1500/microliter
• age >2 years and ≤4 years: <800/microliter
• age >4 years: <600/microliter
• b.) ≥80% of CD3+ or CD4+ T cells that are CD45RO+
• AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative
• AND/OR >50% of CD3+ or CD4+T cells express HLA-DR (at <4 years of age)
• AND/OR are oligoclonal T cells
• c.) Hypomorphic mutation in IL2RG in a male, or homozygous hypomorphic mutation or compound heterozygosity with ≥1 hypomorphic mutation in an autosomal SCID-causing gene
• d.) Low T Cell Receptor Excision Circles (TRECs) and/or the percentage of CD4+/45RA+/CD31+ or CD4+/45RA+/CD62L+ cells is below the lower limit of normal.
• e.) Functional testing in vitro supporting impaired, but not absent, activity of the mutant protein, AND
• Does not meet criteria for Omenn Syndrome. Omenn Syndrome:
• Generalized skin rash
• Maternal lymphocytes tested for and not detected; --Note: If maternal engraftment was not assessed and ruled out, the subject is not eligible as Omenn Syndrome.
• ≥80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR
• 80% of CD3+ or CD4+T cells are CD62L negative AND/OR
• 50% of CD3+ or CD4+ T cells express HLA-DR (at <2 years of age);
• Absent or low (< 30% lower limit of normal) T cell proliferation response to antigens (Candida, tetanus) to which the subject has been exposed NOTE: If proliferation to antigen was not performed, but at least 4 of the following 9 supportive criteria, at least one of which must be among those marked with an asterisk (*) below are present, the subject is eligible as Omenn Syndrome:
• Hepatomegaly
• Splenomegaly
• Lymphadenopathy
• Elevated IgE
• Elevated absolute eosinophil count
• *Oligoclonal T cells measured by CDR3 length or flow cytometry
• *Proliferation to PHA is reduced <50% of lower limit of normal or SI <30
• *Hypomorphic mutation in a SCID causing gene
• Low TRECS and/or the percentage of CD4+/45RA+/CD31+ or CD4+/45RA+/CD62L+ cells is below the lower limit of normal. Reticular Dysgenesis:
• Absence or very low number of T cells (CD3 <300/µL
• No or very low (<10% lower limit of normal) T cell response to PHA
• Severe neutropenia (absolute neutrophil count < 200 /µL) AND
• ≥2 of the following (a,b,c):
• a.) Sensori-neural deafness
• b.) Deficiency of marrow granulopoiesis on bone marrow examination
• c.) A pathogenic mutation in the adenylate kinase 2 (AK2) gene identified. Stratum C: Subjects who meet the following criteria and the intention is to treat with therapy other than allogeneic HCT, primarily PEG-ADA ERT or gene therapy with autologous modified (gene transduced) cells, are eligible for enrollment into Stratum C:
• ADA Deficient SCID with intention to treat with PEG-ADA ERT
• ADA Deficient SCID with intention to treat with gene therapy
• X-linked SCID with intention to treat with gene therapy
• Any SCID patient previously treated with a thymus transplant (includes intention to treat with HCT, as well as PEG-ADA ERT or gene therapy)
• Any SCID patient who received therapy for SCID deemed "non-standard" or "investigational", including in utero procedures.
Exclusion Criteria:
-Subjects who meet any of the following exclusion criteria are disqualified from enrollment in Strata A, B, or C of the study:
• Presence of an Human Immunodeficiency Virus (HIV) infection (by PCR) or other cause of secondary immunodeficiency
• Presence of DiGeorge syndrome
• MHC Class I and MHC Class II antigen deficiency, and
• Metabolic conditions that imitate SCID or related disorders such as folate transporter deficiency, severe zinc deficiency or transcobalamin deficiency.
Severe Combined Immunodeficiency (SCID), Leaky SCID, Omenn Syndrome, Reticular Dysgenesis, ADA SCID, XSCID
Severe Combined Immunodeficiency (SCID), natural history study, SCID treatment
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FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) (FLASH)

FLASH is a post-market, prospective data collection registry. The intention of this registry is to evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice. The study involves no intervention and all medical procedures are standard of care and not research. The device is FDA approved and being used according to the instructions for use and the physician's discretion.

Michael Rosenberg
All
18 Years and over
Phase IV
This study is NOT accepting healthy volunteers
NCT03761173
STUDY00008046
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Inclusion Criteria:

• Clinical signs and symptoms consistent with acute PE
• Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
• Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion*
• US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.
Exclusion Criteria:

• Unable to be anticoagulated with heparin or alternative
• Diagnosis with a minor PE with a less than 0.9 RV/LV ratio
• Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated*
• Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention*
• Life expectancy < 30 days, as determined by Investigator
• Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
• US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria
Device: FlowTriever System, Drug: Anticoagulation Agents
PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, Anticoagulation Medication
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Aortic, Peripheral & Venous (APV) PRODUCT SURVEILLANCE REGISTRY (PSR) PLATFORM BASE

Patient-centric, active post-market registry with an extensible design allowing products to be added following market release. Patients are enrolled and followed in accordance with the routine care practices of their care provider.

Jafar Golzarian
Post Market Monitoring
This study is NOT accepting healthy volunteers
NCT01524276
STUDY00013375
Coronary Artery Disease, Aortic, Peripheral Vascular and Venous Disorders, Cardiac Rhythm Disorders, Cardiovascular Disorders, Diagnostic Techniques and Procedures, Digestive Disorders, Intracranial Aneurysm, Mechanical Circulatory Support, Minimally Invasive Surgical Procedures, Neurological Disorders, Neurovascular, Renal Insufficiency, Respiratory Therapy, Surgical Procedures, Operative, Urological Disorders
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Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts (CAG-00324R2) (ECP)

The primary aims of this revised study are to determine the efficacy and tolerability of ECP for the treatment of either refractory (i.e., in an expanded series of patients within the original prospective cohort Registry) or new (i.e., in a new prospective randomized con-trolled trial sub-study) BOS after lung transplantation in a large patient series.

Yuka Furuya
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02181257
STUDY00002299
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INCLUSION Criteria for REFRACTORY BOS
• Age (18 years old or older).
• Medicare-eligible status
• Lung transplant recipient (combined organ transplant recipients, e.g. heart-lung or liver-lung or lung re- transplantation recipients are eligible).
• Patients with a diagnosis of BOS using at least two laboratory based FEV1 values obtained at least three weeks apart that are both at least 20% lower than baseline FEV1 using the International Society for Heart and Lung Transplantation (ISHLT) definition (The average of the two highest FEV1 measurements obtained at least 3 weeks apart after transplantation). The date of Diagnosis of New BOS is the first date of the two FEV1s that were used for the BOS diagnosis.
• Refractory BOS defined as ongoing decline in FEV1 despite at least one of the following treatments: azithromycin, high-dose steroid, anti-thymocyte globulin, total lymphoid irradiation, sirolimus, or everolimus.
• At minimum five recorded FEV1 measurements obtained at intervals of at least two weeks apart, over the 9 months preceding study enrollment, of which one FEV1 must be within two weeks prior to enrollment.
• History of frequent spirometry monitoring defined as having had regular FEV1 measurements within the context of either of the following two options: (1) During the preceding four months prior to enrollment with no time interval between FEV1 measurements that exceeds 8 weeks. (2) During the preceding six months prior to enrollment with no time interval between FEV1 measurements that exceeds 12 weeks.
• A documented clinical assessment including a physical assessment and Complete Blood Count (CBC) with White Blood Cell Count (WBC) within two weeks prior to enrollment. INCLUSION criteria for NEWLY Diagnosed BOS
• Age (18 years old or older)
• Medicare-eligible status.
• Lung transplant recipient (combined organ transplant recipients, e.g. heart-lung or liver-lung, lung re-transplantation recipients, are eligible).
• History of close FEV1 monitoring prior to diagnosis of new BOS defined as having had either of the two monitoring approaches: (1) Frequent laboratory based spirometry defined as having had regular FEV1 measurements within the context of either of the following two options: A. During the preceding six months prior to diagnosis of new BOS with no time interval between FEV1 measurements that exceeds 8 weeks. (Participants must be at least 6 months post transplant) B. During the preceding nine months prior to diagnosis of new BOS with no time interval between FEV1 measurements that exceeds 12 weeks (Participants must be at least 9 months post- transplant) (2) Frequent Home Spirometry through the separate IRB approved Standardized Home Spirometry Method sub-protocol.
• Diagnosis of new BOS (i.e., "new BOS" is defined as within nine weeks of enrollment) based on laboratory-based spirometric FEV1 measurements obtained on at least two separate occasions (i.e., at least 3 weeks apart) that have declined by more than 20% from post-transplant baseline values (i.e., using ISHLT definition). The date of Diagnosis of New BOS is the first date of the two FEV1s that were used for the BOS diagnosis. Inherent to the diagnosis of new BOS is the exclusion of other potential causes of allograft dysfunction such as acute rejection, respiratory tract infection, and airway anastomotic complications. Thus, sites are encouraged to conduct appropriate evaluation for declining allograft function including bronchoscopy with bronchoalveolar lavage (BAL) and lung biopsies if clinically appropriate to exclude other potential causes of allograft dysfunction.
• Achievement of a statistically significant rate of decline in lung function (FEV1) at the diagnosis of new BOS per the criteria in Section 3.6 as assessed by the following criteria:
• For patients who are monitored with laboratory based spirometry, at least five recorded FEV1 measurements obtained at intervals of at least two weeks apart, over either the 6 or 9 (i.e., depending on the frequency of spirometry testing) months preceding study enrollment accompanied by a statistically significant (p<0.05) rate of decline of FEV1 that exceeds 30 mL/month; or
• For patients who are monitored with home Spirometry, 4-6 recorded home spirometry FEV1 measurements obtained one week apart, over the 4-6 weeks prior to a confirmed FEV1 variance (i.e., the date of the second of two consecutive FEV1 values below the patient's normal range) along with 4-6 recorded weekly FEV1 measurements obtained after a confirmed variance accompanied by a statistically significant (p<0.05) rate of de-cline of FEV1 that exceeds 30 mL/month 7. Documented clinical assessment including a physical assessment and a CBC with WBC within two weeks prior to enrollment. EXCLUSION Criteria (Subjects meeting any one of these criteria will be excluded)
• Current participation in another clinical treatment trial with an investigational agent used to manage BOS before or after enrollment.
• Any condition that may interfere with the subject's ability to perform pulmonary function testing.
• Known allergy or hypersensitivity to pharmacologic agents used during ECP
• Any condition that would significantly affect the participant's ability to adhere to the protocol, affect interpretation of the study results, or put the participant at unacceptable risk for study-related complications as judged by the referring clinician. This may include a) patients with a specific acute contraindication to receiving ECP due to any acute condition such as new or evolving myocardial infarction or central nervous system disorder, hemodynamic instability or hypovolemia, acute bleeding, respiratory distress.
• Patients with lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, albinism, or other dermatologic or ocular condition that contraindicates the use of methoxsalen or markedly enhances photosensitivity in the investigator's judgment.
• Aphakia or absence of ocular lenses
• Pregnancy (positive pregnancy test - a urine or blood pregnancy test must be obtained within 2 weeks prior to enrollment in women of childbearing potential)
• Inability to provide informed consent or to comply with study treatments or assessments (e.g. due to cognitive impairment or geographic distance)
• Recent (i.e., within 2 weeks prior to enrollment) leukopenia (white blood cell count < 30K/cumm or 3,000/mm3/ or 3.0 109 /L)
• Patients whose decline in lung function (FEV1) is related to either Restrictive Chronic Lung Allograft Dysfunction (CLAD) or other causes that do not represent BOS such as pneumonia, heart failure, etc. For patients under review for eligibility for ECP for refractory BOS:
• Patients with a post-transplant baseline FEV1 > 3 liters and most recent FEV1 < 900 mL
• Patients with a post-transplant FEV1< 3 liters and the most recent FEV1 < 30% of post-transplant baseline
• Rate of FEV1 decline within the last 6 or 9 months > 300 mL/month.
• History of receiving ECP therapy within 6 months prior to enrollment. For patients under review for eligibility for RCT:
• Patients post-transplant treated with any agent that depletes T lymphocytes for In-duction, acute cellular rejection or for any other reason can only be enrolled 12 months after the last dose of these agents assuming they meet enrollment inclusion criteria. T Lymphocyte depleting therapies include (but not limited to):
• monoclonal antibodies such as Alemtuzumab (Campath) that target CD52 T cell receptors
• polyclonal antibodies such as anti-thymocyte globulin (ATG) via immunization of rabbits (rATG) to either human thymocytes or Jurkat cells or via immunization of horses (hATG) to human thymocytes
• Radiation. Anti-B cell agents that do not deplete T lymphocytes such as Rituximab can be used and will not affect eligibility.
• Any patient who at least 6 months after transplant is treated with an escalated dose of steroids (i.e., prednisone greater than 30 mg/day or that exceeds 900 mg in a 30 day period or equipotent doses of other steroids like Solumedrol ) for more than one month for an acute decline in lung function that is suspected to be secondary to acute cellular rejection.
Combination Product: Extracorporeal Photopheresis (ECP)
Bronchiolitis Obliterans Syndrome (BOS)
Clinics and Surgery Center (CSC), Bronchiolitis Obliterans Syndrome, Lung Transplantation, Extracorporeal Photopheresis, Methoxsalen
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APOL1 Long-term Kidney Transplantation Outcomes Network

The National Institutes of Health (NIH)-sponsored collaborative APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) is charged with prospectively assessing the effects of renal-risk variants (RRVs) in the apolipoprotein L1 gene (APOL1) on outcomes for kidneys from donors with recent African ancestry and the recipients of their kidneys, after deceased- and living-donor renal transplantation. For the purposes of APOLLO, recent African ancestry is defined as individuals with similar genetic make-up to those currently residing in Africa. APOLLO will also study the impact of APOL1 RRVs on the health of living kidney donors with recent African ancestry.

Samy Riad
NA
This study is NOT accepting healthy volunteers
NCT03615235
STUDY00007354
Kidney Disease, Chronic, Kidney Diseases, Kidney Failure
Apolopoprotein L1 gene (APOL1), Association of Organ Procurement Organizations (AOPO), Kidney Donor, Kidney Transplantation, Kidney Transplantation Outcomes Network, United Network for Organ Sharing (UNOS)
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COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Emily Greengard
All
up to 25 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02402244
1603M85344
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Inclusion Criteria:

• Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
• Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
• Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
• All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant)
• All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
• The following other benign/borderline conditions:
• Mesoblastic nephroma
• Teratomas (mature and immature types)
• Myeloproliferative diseases including transient myeloproliferative disease
• Langerhans cell histiocytosis
• Lymphoproliferative diseases
• Desmoid tumors
• Gonadal stromal cell tumors
• Subjects must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
• If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1
Other: Cytology Specimen Collection Procedure, Other: Medical Chart Review
Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid-Type Fibromatosis, Lymphoproliferative Disorder, Malignant Solid Neoplasm, Myeloproliferative Neoplasm, Stromal Neoplasm
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