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Search Results Within Category "Bones/Joints/Muscles"

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17 Study Matches

Spastic Paraplegia - Centers of Excellence Research Network (SP-CERN)

The Spastic Paraplegia - Centers of Excellence Research Network (SP-CERN) is a collaborative research consortium dedicated to advancing the understanding, diagnosis, and treatment of hereditary spastic paraplegia (HSP) and primary lateral sclerosis (PLS). Aims of the consortium are to a) perform natural history studies of HSP subtypes, b) discover and validate biomarkers and clinician- and patient-reported outcome measures, c) uncover HSP's molecular pathophysiology and develop rational therapeutic targets, and d) perform sufficiently powered clinical trials. The current pilot study is aimed at enrolling 100 individuals with hereditary spastic paraplegia type 4 (SPG4) or hereditary spastic paraplegia type 5A (SPG5A).

Karlee Migneault - Karlee.Migneault@cchmc.org

ALL
This study is NOT accepting healthy volunteers
NCT06553976
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Inclusion Criteria:
* Male or female patients of all ages with a clinical and molecular diagnosis of hereditary spastic paraplegia type 4 (SPG4, SPAST) or hereditary spastic paraplegia type 5A (SPG5A, CYP7B1).
Exclusion Criteria:
* Not having such a diagnosis and/or not being related to such individual.
Hereditary Spastic Paraplegia, Primary Lateral Sclerosis, SPG4, SPG5A, Spastic Paraplegia 4, Spastic Paraplegia 5A, Early Onset Hereditary Spastic Paraplegia, Neuromuscular Diseases, Spastic Paraplegia, Hereditary
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Supraspinal Processing of Sensory Aspects of Pain (SCP)

The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are: * Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain? * What are predictors of recovery from chronic pain? * What brain systems are associated with the spread of pain? For this study participants will undergo: * Functional Magnetic Resonance Imaging (fMRI) * Quantitative Sensory Testing * Psychological Assessments

Catherine Jackson - catherine.jackson@cchmc.org

ALL
10 years to 17 years old
NA
This study is also accepting healthy volunteers
NCT05814497
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Inclusion Criteria:
* Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), diffuse MSK (widespread MSK pain), or CRPS * If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit. * Male or female, age 10 -17 (inclusive) * English speaking, able to complete interviews and questionnaires in English
Exclusion Criteria:
* Weight/size incompatible with MRI scanner * Orthodontic braces, metallic or electronic implants, or other metal objects in the body which obscure or interfere with the MRI, or pose a risk from heating, movement, or malfunction in the MRI environment * Claustrophobia * Youth who are pregnant * Any comorbid rheumatic disease, diagnosis of epilepsy, other neurological diseases, or medical condition (e.g. diabetes, cancer, IBD) * Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study * Skin conditions or past skin damage on the arms or legs in or near sites of sensory testing * Outside the age range (9 years old or younger; 18 years or older) at the time of consent * History of \> 1 month opioid treatment.
OTHER: Multisensory Task, OTHER: Graphesthesia, OTHER: Divided attention
Migraine in Children, Complex Regional Pain Syndromes, Musculoskeletal Pain, Functional Abdominal Pain Syndrome, Fibromyalgia
chronic pain
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Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMIT (DMD-001 SUMMIT)

The goal of this study is to collect additional information on the safety of long-term treatment with AGAMREE® and to explore long-term clinical impact of AGAMREE® on quality of life, as assessed by standardized patient-reported outcome measures (QoL questionnaires) in male patients aged 2 years and older with Duchenne muscular dystrophy (DMD).

Cuixia Tian, MD - Cuixia.Tian@cchmc.org

MALE
2 years and over
This study is NOT accepting healthy volunteers
NCT06564974
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Inclusion Criteria:

• Patient or parent/legal guardian is willing and able to provide written informed consent once the nature of the registry has been explained and prior to the start of any registry-related procedures.
• Patient and/or parent/guardian are willing and able to complete QoL questionnaires.
• Male patients at least 2 years old.
• Confirmed diagnosis of DMD (via genetic testing or muscle biopsy with absent dystrophin staining to anti- dystrophin antibodies 3, 1, or 2, or dystrophin immunohistochemistry or western blot).
• Patient has a current, active prescription for, or is on, AGAMREE®.
Exclusion Criteria:
1\. Any contraindication to AGAMREE® or medical condition, which, in the opinion of the Investigator, would affect registry participation, performance, or interpretation of registry assessments.
DRUG: Vamorolone
Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy, Neuromuscular, AGAMREE®, Vamorolone, DMD, Muscular Dystrophy
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.

Megan Quinlan-Waters - megan.quinlan-waters@cchmc.org

ALL
Up to 21 years old
This study is NOT accepting healthy volunteers
NCT02418442
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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:
1\. 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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JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction

The goal of this observational study is to learn about the outcomes of medial patellofemoral ligament (MPFL) reconstruction for the treatment of recurrent patellar instability. The main questions it aims to answer are: * What are the risk factors for recurrent patellar instability after MPFL reconstruction? * What functional outcomes do patients report after MPFL reconstruction? Participants undergoing MPFL reconstruction will answer survey questions about their knee and activity level 1 year and 2 years after surgery.

Matthew Veerkamp - Matthew.Veerkamp@cchmc.org

ALL
10 years to 35 years old
This study is NOT accepting healthy volunteers
NCT06883396
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Inclusion Criteria:
* 10-35 years old * Recurrent patellar instability with at least one episode defined as either (1) a dislocated patella requiring reduction in the emergency department or (2) a convincing history for dislocation, associated with full giving way, and the following physical findings: (a) hemarthrosis or effusion, (b) tenderness along the medial retinaculum, and (c) apprehension when laterally directed force was applied to the patella or (3) MRI-documented dislocation with associated bone bruises
Exclusion Criteria:
* Previous ipsilateral knee surgery * Obligatory/fixed/habitual patella dislocation or subluxation * Unloadable inferior or lateral chondral damage on the patella that would require a tibial tubercle transfer for unloading purposes * Pathologic tibiofemoral instability
PROCEDURE: Medial Patellofemoral Ligament (MPFL) Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation, Patellar Instability, Patellofemoral Dislocation, Patellofemoral Joint Dislocation, Patellofemoral Disorder
Patella, Patella Dislocation, Patellar Instability, Recurrent Patellar Instability, MPFL, Medial Patellofemoral Ligament, Medial Patellofemoral Ligament Reconstruction, Patellofemoral Instability
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Simple Bone Cysts in Kids (SBoCK)

Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today.

Krista Carpenter - krista.carpenter@cchmc.org

ALL
2 years to 21 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT02193841
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Inclusion Criteria:
* Patients with a confirmed simple bone cyst in a long bone (ie. arm or leg) within last 3 months * At least 3 weeks must have elapsed since last fracture * At least 3 months must have elapsed since last cyst treatment * Patients and/or their legal representatives willing to provide written informed consent (and assent, when appropriate) * Patients with stabilizing implants in the bone where the cyst is located
Exclusion Criteria:
* Patients with bone disease (ie. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease) * Pregnant or breastfeeding female * Patients with cysts crossing the growth plate (area where bone grows)
PROCEDURE: Curettage with puncture (C & P), DEVICE: Curette, DEVICE: Vitoss morsels
Bone Cyst
Simple bone cyst, Unicameral bone cyst
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A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma (FAST)

Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and to limit abdominal CT evaluation to solely those at non-negligible risk. The focused assessment sonography for trauma (FAST) examination can help focus patient evaluation in just this manner by potentially safely decreasing abdominal CT use in low risk children. This research study is a multicenter, randomized, controlled trial to determine whether use of the FAST examination, a bedside abdominal ultrasound, impacts care in 3,194 hemodynamically stable children with blunt abdominal trauma. The overall objectives of this proposal are 1) to determine the efficacy of using the FAST examination during the initial evaluation of children with blunt abdominal trauma, and 2) to identify factors associated with abdominal CT use in children considered very low risk for IAI after a negative FAST examination. The long-term objective of the research is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality.

Allison Ackermann - allison.ackermann@cchmc.org

ALL
Up to 17 years old
NA
This study is NOT accepting healthy volunteers
NCT05910567
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Children younger than 18 years of age (0 to 17.9999 years) with blunt abdominal trauma presenting to the participating EDs within 24 hours of the traumatic event will be eligible if the do not meet any exclusion criteria and meet any one of the following inclusion criteria.
Inclusion Criteria:

• Blunt torso trauma resulting from a significant mechanism of injury: * Motor vehicle collision: greater than 60 mph, ejection, or rollover * Automobile versus pedestrian/bicycle: automobile speed \> 25 mph * Falls greater than 20 feet in height * Crush injury to the torso * Physical assault involving the abdomen
• Decreased level of consciousness (Glasgow Coma Scale (GCS) score 9-14 or below age-appropriate behavior) in association with blunt torso trauma
• Blunt traumatic event with any of the following (regardless of the mechanism): * Extremity paralysis * Multiple long bone fractures (e.g., tibia and humerus fracture)
• History and physical examination suggestive of blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)
Exclusion Criteria:
The following patients will be excluded from the study:
• Age-adjusted low blood pressure (Hemodynamic instability) * Patients will be excluded for prehospital or initial age-adjusted ED low blood pressure. This is because the standard evaluation of these patients involves immediate FAST based on prior work by our group. Low blood pressure is determined based upon the patient's age, and will be defined as a systolic blood pressure less than 70 mm Hg for patients younger than 1 month, less than 80 mm Hg for ages 1 month to 5 years, and less than 90 mm Hg for ages over 5 years.
• Penetrating trauma: Patients who are victims of stab or gunshot wounds
• Traumatic injury occurring \> 24 hours prior to the time of presentation to the ED
• Transfer of the patient to the ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
• Transferred with FAST exam already performed at outside hospital
• Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts
• Initial GCS score ≤ 8 as it is standard for children with GCS scores ≤ 8 to undergo abdominal CT if blunt abdominal trauma is suspected
• Known pregnancy
• Known prisoner
• Known intra-abdominal injury diagnosed within 30 days prior of this ED visit
DIAGNOSTIC_TEST: Focused Assessment with Sonography for Trauma (FAST) Examination, OTHER: No Intervention: Standard of Care - Without the FAST Examination
Blunt Trauma to Abdomen, Wounds and Injuries, Abdomen Injury, Abdominal Injury, Abdomen, Acute
Child, Wounds and Injuries, Blunt Trauma to Abdomen, Abdomen Injury, Blunt Abdominal Trauma
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A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering

Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device

Nichole Leitsinger - nichole.leitsinger@cchmc.org

ALL
Up to 18 years old
NA
This study is NOT accepting healthy volunteers
NCT04914507
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Inclusion Criteria:
Skeletally immature patients that receive AVBT surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. Specifically: * Diagnosis of idiopathic scoliosis * Planned recipient of AVBT surgical treatment * Skeletally immature * Major Cobb angle ≥30° and ≤65° * Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging * Failed or intolerant to bracing
Exclusion Criteria:
* Presence of any systemic infection, local infection, or skin compromise at the anticipated surgical site * Prior spinal surgery at the level(s) to be treated * Evidence of documented poor bone quality * Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions as determined by the treating physician * Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent * Unwillingness to sign Informed Consent Form and participate in study procedures
DEVICE: Anterior Vertebral Body Tethering
Scoliosis Idiopathic
anterior vertebral body tethering
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Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With Achondroplasia (ASPEN)

This is a multicenter, multinational, randomized, active-controlled, operationally seamless Phase 2/3 study of BMN 333 in treatment-naïve pediatric participants with achondroplasia (ACH). The study consists of a Phase 2 part and a Phase 3 part.

Racheal Powers - Racheal.Powers@cchmc.org

ALL
2 years to 17 years old
PHASE2
This study is NOT accepting healthy volunteers
NCT07441876
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Inclusion Criteria:

• Participants must be aged ≥ 2 to \< 11 years (Phase 2) or ≥ 2 to \< 18 years (Phase 3), at the time of signing the informed consent
• Participants must have ACH (confirmed by documented genetic testing) and open epiphyses
• Are Tanner Stage I (Phase 2) or any Tanner stage (Phase 3)
• Are ambulatory and able to stand without assistance
Exclusion Criteria:

• Have any short stature condition other than ACH (eg, hypochondroplasia, trisomy 21, pseudoachondroplasia, GH deficiency)
• Have any of the following disorders: Hypothyroidism or hyperthyroidism, unless treated with evidence of normalized thyroid-stimulating hormone (TSH) levels, diabetes mellitus, unless considered well-controlled, autoimmune inflammatory disease, inflammatory bowel disease, autonomic neuropathy, anemia defined as hemoglobin \< 10 g/dL, vitamin D deficiency, significant hip pathology.
• Have history of any renal insufficiency or cardiac/ cardiovascular disease that places the participant at increased risk of an adverse cardiac outcome in the setting of hypotension.
• Have had bone fractures of the long bones or spine within 6 months prior to screening.
• Have used vosoritide, any other approved product (except GH, as detailed below), investigational product, or investigational medical device for the treatment of ACH or short stature at any time
• Have been treated with GH, insulin-like growth factor 1, or anabolic steroids in the 6 months prior to treatment start
DRUG: BMN 333, DRUG: Vosoritide Injection [Voxzogo]
Achondroplasia
Achondroplasia, ACH, Bone Diseases, Developmental Dwarfism, Bone Diseases, Genetic Diseases, Inborn, Musculoskeletal Diseases, Natriuretic Peptide, C-type, Osteochondrodysplasias, Physiological Effects of Drugs, Skeletal Dysplasias
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Natural History of Cerebral Palsy Prospective Study

The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.

Karen L Harpster, PhD, OTR/L - karen.harpster@cchmc.org

ALL
3 months to 24 months old
NCT05576948
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Inclusion Criteria:
* Infants will be included if they have a diagnosis of CP or "at high risk of CP" and under the age of 12 months. * Infants at high risk of CP as defined by any two (any combination) of the following:
• Neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, Basal Ganglia, Posterior Limb of the Internal Capsule, pyramids.
• Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age
• Hammersmith Infant Neurological Exam (HINE) scores \<57 @ 3months or \<60 @ 6months or \<63 @9 months Infants will also be included if they meet BOTH of the following criteria (even if infants have a HINE score greater than the cut off scores stated above: i. Unilateral brain injury on neuroimaging (magnetic resonance imaging (MRI) or cranial ultrasound (CUS)) predictive of CP ii. Clinical signs of asymmetry
Exclusion Criteria:
* Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP * Infants with other disability diagnoses e.g. Down Syndrome
Cerebral Palsy
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The BRIDGE Pain Study (BRIDGE)

The purpose of the study is to discover at least two distinct Musculoskeletal pain subtypes. These types are caused by different brain-and-immune system signals that affect how the body feels pain, and they are also shaped by a person's biology, psychology, and social environment. Aim 1. We want to sort adolescents and young adults with long lasting muscle and bone pain into two different groups. To do this, we will look at participants' childhood medical histories, past treatments, when their pain started, the sex they were assigned at birth, what their pain feels like now, tests of how their body senses pain, and immune system markers found in their blood. We think we will find at least two different types of chronic pain groups, plus one group of patients who had a higher risk for pain (because of a rheumatic disease or past surgery) but never developed long term pain. Aim 2. We want to find out if certain patterns of inflammation in the body change how nerve cells react to pain. Aim 3: We want to understand how different biological, psychological, and social factors are connected to the chronic pain groups we identified. We think we will find certain mental, behavioral, and social risks-as well as protective factors-that help explain why some people develop long-lasting pain and others do not. We expect these factors to play different roles in each pain group, including the group that does not develop chronic pain.

Megan Kirschman - bridgestudy@cchmc.org

ALL
14 years to 26 years old
This study is NOT accepting healthy volunteers
NCT07602595
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Inclusion Criteria:
* Diagnosis of rheumatic/autoimmune disease/pain condition or surgery prior to age 18; Current age 14 to 26 years; Participant (and parent/legal guardian of participants \< 18 yo) can read and write in English; At least 1 year from diagnosis of pain or rheumatic disease; For individuals with MSK surgical history, at least 1 year after initial surgical intervention; For individuals with rheumatic disease, their disease must be considered inactive
Exclusion Criteria:
* They have active disease, or Other major medical comorbidities have developed after surgery following MSK surgical intervention.
OTHER: Not applicable- observational study
Juvenile Idiopathic Arthritis (JIA), Fibromyalgia, Lupus, Scoliosis, Pectus Excavatum, Chronic Pain, Musculoskeletal Pain
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Overlapping Pain Trajectory Study (COPC)

The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: 1. If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls. 2. If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth. Participation includes: * quantitative sensory testing * blood draw * sleep assessment * questionnaires

Catherine Jackson - catherine.jackson@cchmc.org

ALL
10 years to 19 years old
This study is also accepting healthy volunteers
NCT05752396
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Inclusion Criteria:

• General Criteria * Access to the internet either by laptop, tablet, or phone (for REDCap Surveys) * English-speaking * Parent or guardian willing to comply with protocol, complete study assessments, and provide written informed consent
• Control Specific Criteria * No history/active chronic pain
• Patient Specific Criteria * Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), or diffuse MSK (widespread MSK pain) * If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit.
Exclusion Criteria:

• General Criteria * Skin conditions (e.g., eczema) or past skin damage on the arms and legs in or near sites of sensory testing * Any comorbid rheumatic disease (e.g., arthritis, lupus), neurological (e.g., epilepsy, traumatic brain injury) or medical condition (e.g., cancer, diabetes)
• Control Specific Criteria * Taking medications that can alter pain sensitivity (e.g., NSAIDs, opioids, stimulants, anticonvulsants; psychiatric)
• Patient Specific Criteria * Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
OTHER: Conditioned Pain Modulation, OTHER: Offset Analgesia, OTHER: Spatial Summation, OTHER: Temporal Summation
Migraine, Musculoskeletal Pain, Functional Abdominal Pain Disorders, Chronic Pain, Widespread Chronic Pain, Low Back Pain, Healthy Volunteers
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Project: Every Child for Younger Patients With Cancer

This study gathers health information for 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.

- cancer@cchmc.org

ALL
Up to 25 years old
This study is NOT accepting healthy volunteers
NCT02402244
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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 one "1" (borderline), 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 * All neoplastic lesions of the kidney 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 * Neuroendocrine tumors including pheochromocytoma * Melanocytic tumors, except clearly benign nevi * Ganglioneuromas * 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
Adrenal Gland Pheochromocytoma, Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Kidney Neoplasm, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Ganglioneuroma, Lymphoproliferative Disorder, Malignant Neoplasm, Malignant Solid Neoplasm, Melanocytic Neoplasm, Myeloproliferative Neoplasm, Neoplasm of Uncertain Malignant Potential, Neuroendocrine Neoplasm, Stromal Neoplasm
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Markers of Trajectory in Pediatric CRPS

Complex Regional Pain Syndrome (CRPS) is a severe and complex chronic pain condition in children. Many psychosocial factors impact its development and recovery. CRPS has a strong central component, which is reflected by structural and functional changes in the brain. However, the interaction between these cerebral changes and trajectory of recovery has been seldom investigated to date. Furthermore, interactions between cerebral changes and psychosocial factors, which might affect trajectory of recovery, are unknown. The aim of this study is to identify the psychosocial factors and cerebral changes that predict the trajectory of recovery from CRPS. Children between the ages of 10 and 17 years will be enrolled with one of their parents or legal guardians for this study. Three populations will be recruited: patients with CRPS undergoing treatment at the Functional Independence Restoration Program (FIRST), patients with CRPS undergoing treatment at the Pain Management Center and matching healthy controls. Participants will undergo three sessions: the first session will be scheduled immediately before or as soon as possible at the beginning of the patients' treatment; the second session will take place at the end of the patients' treatment; the last session will be scheduled six months post-treatment. The timing of the sessions of the healthy participants will follow a schedule similar to the FIRST patients. Each session will last approximately three hours and include acquisition of psychosocial, psychophysical, and brain imaging data in the child participants, as well as acquisition of psychosocial data in the parent participants.

Geraldine Schulze - geraldine.schulze@cchmc.org

ALL
10 years to 17 years old
This study is also accepting healthy volunteers
NCT03838107
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Inclusion Criteria:
All Children: * Age between 10 and 17 years old * Fluent in English Inpatients: * Diagnosis of CRPS * Former unsuccessful treatment for CRPS * Scheduled for or beginning the usual inpatient treatment for CRPS at the FIRST clinic at CCHMC. Outpatients: * Diagnosis of CRPS * Scheduled for or beginning the usual outpatient treatment for CRPS at the pain management clinic Healthy children: \- No diagnosis of chronic pain. Parents: * Fluent in English * Child participating in the study
Exclusion Criteria:
All child participants: * Weight/size incompatible with MRI scanner * Identification of brain, neurologic, or severe psychiatric abnormalities beyond those normally associated with chronic pain. * Documented developmental delays or impairment * Any MRI contra-indication, including * Braces, stents, clips, pace-maker or other metal implants affecting the safety of the participants in the scanner and/or the quality of the images * pregnancy * claustrophobia
BEHAVIORAL: observation and measure of trajectory of recovery in CRPS
Complex Regional Pain Syndromes
pediatric complex regional pain syndrome, fMRI, psychosocial, quantitative sensory testing, markers
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The Baby Duchenne Study: Characterizing Developmental and Clinical Outcomes in the First Three Years in Children With Duchenne Muscular Dystrophy (BABY DUCHENNE)

The aim of the BABY DUCHENNE study is to evaluate the natural history and characterize the early clinical outcomes in very young children (0-3 years) with Duchenne muscular dystrophy (DMD) identified by newborn screening programs.

Angela Edmondson - angela.edmondson@cchmc.org

MALE
0 days to 3 years old
This study is NOT accepting healthy volunteers
NCT07092540
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Inclusion Criteria:
* Male child between birth and 3.0 years of age at time of enrollment. * A confirmed and documented pathogenic or likely pathogenic variant in the DMD gene. * Ability of parent/guardian to understand and provide written informed consent (signing Parental Permission and Consent Form). * Willingness of parent/guardian to comply with the protocol Schedule of Activities, including all study site visits.
Exclusion Criteria:
* Female * Presence of any confirmed genetic disease, other than DMD, that could impact early development, which, in the opinion of the PI, may confound interpretation of developmental progress. * Presence of any significant medical condition (i.e., extreme prematurity, hypoxic ischemic encephalopathy) which, in the opinion of the PI, may confound interpretation of the clinical course of DMD. * Inability/unwillingness of parent/guardian to provide written permission (sign PPF) or to comply with the protocol Schedule of Activities.
Duchenne Muscular Dystrophy (DMD)
New born screening
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Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE)

The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after posterior spine fusion (PSF) in children.

Geisler - Kristie.Geisler@cchmc.org

ALL
10 years to 18 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT06626503
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Inclusion Criteria:

• Age 10 - \< 18 years
• American Society of Anesthesiologists (ASA) Physical Status 1 or 2
• Undergoing PSF for idiopathic scoliosis
• Participant or legal guardian can speak and read English or Spanish
Exclusion Criteria:

• Pregnant patients
• Methadone allergy
• Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
• Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine)
• Preoperative opioid use within 30 days before surgery
• History of severe sleep apnea, defined as a prior sleep study demonstrating an apnea-hypopnea index (AHI) greater than 10.
• Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator
DRUG: Methadone based ERAS, DRUG: Non-methadone based group
Idiopathic Scoliosis
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Motor Training for Infants With Cerebral Palsy

The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.

Karen L Harpster, PhD, OTR/L - karen.harpster@cchmc.org

ALL
3 months to 8 months old
NA
This study is NOT accepting healthy volunteers
NCT04886895
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Inclusion Criteria:
* Age at enrollment: between 3-8 months corrected age * Caregivers fluent in English * Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR * High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either: * "Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR * A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)
Exclusion Criteria:
* Medical conditions that restrict active participation such as oxygen dependence * Infants with significant visual deficits defined by the inability to track an object horizontally * Living in a remote location prohibiting drives to the hospital every other week.
OTHER: Let's Move Motor Intervention
Cerebral Palsy
motor skills, occupational therapy, physical therapy
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