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CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Isabella Aspromonte - Isabella.Aspromonte@cchmc.org
ALL
1 year to 85 years old
NA
NCT02397668
Inclusion Criteria:
• Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
• Male or female
• Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent and the pediatric patient (if applicable) provides written assent (if able) prior to procedure
• Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfill all of the expected requirements of this clinical protocol
• Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided valve
Exclusion Criteria:
• Tricuspid annulus too small (\< 10mm) to accommodate the Cor Tricuspid ECM Valve
• Left ventricular ejection fraction (LVEF) \< 25%
• Mean pulmonary pressure \> 50mm Hg or pulmonary vascular resistance greater than 6 Woods Units
• Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery
• Cardiac transplant patient
• Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock
• Patients with a single ventricle where the Cor Tricuspid ECM Valve would be the systemic AV valve
• Documented primary coagulopathy or uncorrected platelet disorder, including thrombocytopenia (absolute platelet count \<30k). Patient can be enrolled regardless of these parameters if in the opinion of the Investigating Surgeon the coagulopathy can be adequately reversed by transfusions. An example would be the reversal of thrombocytopenia by transfusion of platelets
• Documented evidence of intrinsic hepatic disease (defined as liver enzyme values (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin) that are \> 5 times the upper limit of reference range within 30 days of enrollment, except in association with acute/reversible decompensation as determined by the Investigator)
• Documented evidence of significant renal dysfunction (serum creatinine \> 4.0mg/dl or GFR\< 30 on the modified Schwartz formula)
• Stroke within 30 days prior to enrollment
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year
• Known cancer (cancer-free \<1 year; does not include non-metastatic basal cell carcinoma or cervical carcinoma) and/or undergoing treatment including chemotherapy and radiotherapy
• Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs
• Known sensitivity to porcine materials
• Contraindication to anticoagulation/antiplatelet therapy (aspirin (ASA) and/or Plavix)
• Patients who are pregnant (method of assessment Investigator's discretion)
• Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study, without CorMatrix written approval
DEVICE: CorMatrix Cor TRICUSPID ECM Valve
Tricuspid Valve Disease
A Study of Emapalumab for Pediatric Aplastic Anemia
Anthony Sabulski, MD - anthony.sabulski@cchmc.org
ALL
0 years to 25 years old
PHASE2
NCT06430788
Inclusion Criteria:
* Patients undergoing workup for suspected newly diagnosed sAA:
* Patients with severe cytopenias and a hypocellular marrow concerning for sAA
* Patients that meet the definition for suspected sAA (Camitta Criteria) as follows:
Marrow Cellularity: \<25%, or 25-50% with \<30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): \<500 x 10\^9/L Platelets: \<20 x 10\^9/L Absolute Reticulocyte Count: \<60 x 10\^9/L
* Patients that do not have evidence of leukemia or MDS
* Patients \< 25 years of age at time of diagnosis
* Able to tolerate emapalumab and IST (with standard institutional organ function criteria)
Exclusion Criteria:
* Uncontrolled infection at presentation.
* Patients who have undergone previous treatment for sAA.
* Patients with known inherited bone marrow failure
* Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial
* Patients with leukemia or MDS
* Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests. BIOLOGICAL: Emapalumab
Aplastic Anemia, Cytopenia, Hypocellular Marrow
pediatric aplastic anemia, aplastic anemia, cytopenia, hypocellular marrow, Emapalumab, Memorial Sloan Kettering Cancer Center, 23-278
Speech-in-noise Perception in Autism and Fragile X
Elizabeth Smith - elizabeth.smith3@cchmc.org
ALL
15 years to 35 years old
NA
NCT06088589
Inclusion Criteria:
• normal audiograms (PTA ≤ 20 dB HL)
• corrected 20/20 vision (Snellen chart)
• no history of premature birth (prior to 36 weeks gestation)
• no medications known to affect EEG signal
• English as the first language Inclusion for the Autism group requires the following: 1\) diagnosis of Autism Spectrum Disorder either based on previous ADOS administration and developmental history, or confirmed via ADOS and developmental history Inclusion for the Autism + FXS group requires the following:
• Documented PCR/Southern Blot genetic testing confirming full mutation FXS
• Diagnosis of Autism Spectrum Disorder, per Autism group. Inclusion for the Typically Developing group requires the following:
• no siblings or parents with an Autism Spectrum Disorder or Fragile X Syndrome
• no current neurological or psychiatric diagnoses
• IQ over 75
Exclusion Criteria:
* Hearing loss or uncorrected vision loss
* history of premature birth (prior to 36 weeks gestation) BEHAVIORAL: Mismatch negativity
Autism Spectrum Disorder, Fragile X Syndrome
Supraspinal Processing of Sensory Aspects of Pain (SCP)
Catherine Jackson - catherine.jackson@cchmc.org
ALL
10 years to 17 years old
NA
NCT05814497
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
Protocol CAUSE-03 / CHEETAH (CHEETAH)
Molly Brausch-Bradner - Molly.Brausch-bradner@cchmc.org
ALL
6 years to 17 years old
NCT06136091
Inclusion Criteria:
• Participant and/or parent guardian must be able to understand and provide informed consent and assent
• Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE-03 Manual of Operations (MOP) a. Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion
• Either:
• Have had a diagnosis of asthma made \> 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician \<= 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment (asthma group), or
• No report of ever being diagnosed with asthma (non-asthma group)
• Either:
• Require at least Step 2 therapy at the Screening/Enrollment Visit (asthma group), or
• Have not used any asthma medications in the prior year (non-asthma group)
• Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment
• Have documentation of current medical insurance with prescription coverage at the Screening/Enrollment Visit
• Participant and/or parent guardian has a smartphone compatible with the study electronic Patient Reported Outcomes (ePRO) system, Medidata Patient Cloud, and is willing to download one application for study use
Exclusion Criteria:
• Parent or guardian is not able or willing to give written informed consent or comply with study protocol
• Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study
• Are currently receiving immunotherapy
• Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment
• Are currently requiring greater than fluticasone 500 mcg bid plus Long-Acting Beta Agonists (LABA) one puff twice daily or its equivalent plus Long Acting Muscarinic Antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of the Screening/Enrollment Visit
• Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception)
• Have a known, pre-existing clinically important lung condition other than asthma.
• Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment
• Have a known immunodeficiency disease
• Use of investigational drugs within 4 weeks of enrollment
• Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
• If in the asthma group, will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow Protocol CAUSE-03 CHEETAH
• If in the non-asthma group, having bronchodilator reversibility (improvement in Forced expiratory volume in 1 second (FEV1) with albuterol \> = 10%) at the Screening/Enrollment visit
• Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure. Potential participants may be reassessed as outlined in the Protocol CAUSE-03 Manual of Procedures (MOP)
Asthma
Asthma, Observational study, Children
A Study of BLB-201 RSV Vaccine in Infants and Children
Jamie Kidd - jamie.kidd@cchmc.org
ALL
6 months to 5 years old
PHASE1
NCT05655182
Inclusion criteria for sero+ children 18 to 59 months of age enrolled in Groups 1 and 2:
Healthy children at least 18 months but less than 60 months of age whose legally-acceptable representative (LAR) understands and signs the trial informed consent and agrees to vaccine administration following a detailed explanation of the trial.
Determined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.
Sero+ for RSV as defined by serum RSV antibody titer assay
Participant is expected to be available for the duration of the trial.
The LAR confirms that the subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.
Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND has a current height and weight above the 3rd percentile for age.
Inclusion criteria for sero+ or sero- infants and children 8 to 24 months of age enrolled in Groups 3 through 6:
Healthy children at least 8 months but less than 25 months of age whose LAR understands and signs the trial informed consent and agrees to vaccine administration following a detailed explanation of the trial.
Determined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.
Sero- OR sero+ for RSV antibody, defined by serum RSV antibody titer assay not more than 30 days prior to vaccination.
Participant is expected to be available for the duration of the trial.
The LAR confirms that subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.
Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND
If \<1 year of age: has a current height and weight above the 5th percentile for age.
If ≥1 year of age: has a current height and weight above the 3rd percentile for age.
Subject Exclusion Criteria
\<8 months of age and \>60 months of age at the time of planned vaccine inoculation.
Born at less than 34 weeks gestation for subjects ≥ 1 year of age at enrollment
Born at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age.
Maternal history of a positive HIV test before or during pregnancy.
Maternal history of illicit drug abuse or alcohol abuse.
Evidence of chronic disease except for chronic diseases that are mild, stable and not immune compromising or require recent change (\< 60 days) in management (e.g., mild stable eczema, mild allergic rhinitis)
Clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by medical history or physical exam. Abnormal pulse oximetry testing during screening for undetected critical congenital heart disease or concern for such by medical history or physical exam.
Acute or chronic medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.
History of severe infection (e.g., requiring hospitalization).
Known or suspected impairment of immunological functions, bone marrow/solid organ transplant recipients.
Receiving immunosuppressive therapy including systemic corticosteroids.
Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities.
Suspected or documented developmental disorder, delay, or other developmental problem.
Cardiac abnormality requiring treatment. Participants with clinically insignificant cardiac abnormalities (e.g., clinically insignificant patent foramen ovale) requiring no treatment may be enrolled.
Lung disease or reactive airway disease.
History of wheezing episode/s or receipt of bronchodilator therapy
Previous receipt of supplemental oxygen therapy in a home setting.
History of severe RSV infection or severe respiratory virus infection (e.g., requiring hospitalization).
Previous immunization with an investigational RSV vaccine.
Previous or planned administration of any anti-RSV antibody product within 6 months of receipt of study vaccine.
Previous receipt of immunoglobulin or any other antibody products within the past 6 months.
Previous receipt of any blood products within the past 6 months.
Previous anaphylactic reaction.
Previous serious vaccine-associated adverse reaction or one that was Grade 3 or above.
Known hypersensitivity to any study vaccine product component.
Household contact with any of the following groups of individuals for the period up to 28 days after vaccination (including after each dose for cohorts receiving two doses of vaccine):
Member of a household that contains an infant who is less than 6 months of age at the date of inoculation through the 28th day after inoculation. In groups assigned to two doses of vaccine, to include date of inoculation through the 28th day after the second inoculation.
Pregnant woman.
Persons with hospitalization for asthma or other chronic respiratory disease in the past 5 years.
Member of a household that, at the date of inoculation through the 28th day after inoculation (including second dose if scheduled), contains an immunocompromised individual including but not limited to:
A person who is HIV-infected.
A person who has cancer and has received chemotherapy within the 12 months prior to enrollment.
A person with a solid organ or bone marrow transplant.
A person currently receiving immunosuppressive agents.
Attends a daycare facility that does not separate children by age and contains an infant
\<6 months of age at the date of inoculation through the 28th day after inoculation.
Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
History of postinfectious or postvaccine neurological sequelae.
Autoimmune, inflammatory, vascular, or rheumatic disease.
Household contact of another child enrolled into the trial.
Inadequate venous access for repeated phlebotomy.
Subject's LAR/s who, in the opinion of the site investigator, are not suitable participants for the study, for any reason not previously delineated, including subjects with any condition that would in the opinion of the site investigator place the subject at unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Subjects testing positive for infection with RSV, Influenza, or SARS-CoV-2 in the 3 months prior to enrollment.
Planned receipt of any of the following prior to planned trial vaccine receipt (Day 1 and Day 57 for group receiving 2 doses of vaccine):
Inactivated influenza vaccine within 14 days prior, or
Any other inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
Any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
Another investigational vaccine or investigational drug within 28 days prior.
Salicylate (aspirin) or salicylate-containing products within 28 days prior.
Planned receipt of any of the following after planned trial vaccine receipt (Day 1 and Day 57 for groups receiving 2 doses of vaccine):
Inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
Any live vaccine other than rotavirus in the 28 days after, or
Another investigational vaccine or investigational drug in the 56 days after.
Planned receipt of any of the following medications within 7 days of trial enrollment and 7 days after trial vaccine (Day 1 and also Day 57 for groups receiving 2 doses of vaccine):
Systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or systemic or nasal steroid therapy for acute illness.
Any other intranasal medications, or
Other prescription medications except permitted concomitant medications. Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents.
History of bleeding disorder or significant problem with bleeding
American Indian or Alaska Native Infants/Children (high risk for severe RSV infection) AND eligible to receive nirsevimab
Temporary exclusion criteria for sero+ children, sero- children, and infants:
The following are temporary or self-limiting conditions, and once resolved, the subject may be enrolled, if otherwise eligible. If the period of temporary exclusion is greater than 30 days, sero- children will need to be rescreened for levels of RSV neutralizing antibody.
Any of the following events at the time of enrollment:
Fever (temperature of ≥100.4°F per site standard based on age; e.g., oral for older children, rectal for infants, axillary screening), or
Upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or
Nasal congestion significant enough to interfere with successful vaccination.
Otitis media.
Contact with a person diagnosed with RSV, Influenza, coronavirus disease-2 (COVID- 19) or other viral respiratory illnesses within the preceding 10 days.
BIOLOGICAL: PIV5-vectored RSV Vaccine (BLB-201) Low Dose, BIOLOGICAL: PIV5-vectored RSV Vaccine (BLB-201) High Dose, DRUG: Placebo
Respiratory Syncytial Virus Infections
Human respiratory syncytial virus (RSV), Lower respiratory tract infection (LRTI)
Registry of Asthma Characterization and Recruitment 3 (RACR3) (RACR3)
Kathryn Geil - kathryn.geil@cchmc.org
ALL
NCT05272241
Inclusion Criteria:
• Participant is either:
• At least 18 years old, willing and able to provide informed consent at the time of enrollment
• Under the age of 18, accompanied by a legal guardian who is willing and able to provide informed consent at the time of enrollment
• Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA)
Exclusion Criteria:
• Participant does not speak English or Spanish and/or guardian does not speak English or Spanish
• Participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up
• Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study Participants who are pregnant or lactating will not be excluded or discontinued from the study, but will not undergo any procedures that are prohibited during pregnancy per the Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) Manual of Procedures (MOP)(e.g., allergen skin testing, spirometry) during the pregnancy. Potential participants may be reassessed as outlined in the Protocol CAUSE-02 MOP.
Asthma
Asthma, Allergy, CAUSE, RACR
RASopathy Biorepository
Lindsey Aschbacher-Smith - lindsey.aschbacher-smith@cchmc.org
ALL
NCT04395495
Inclusion Criteria:
* Patients with a suspected or known diagnosis of any of the group of disorders known as RASopathies (e.g., Neurofibromatosis, Costello Syndrome, Noonan Syndrome). Diagnosis may be made clinically and/or confirmed through genetic testing.
* Unaffected relatives of patients with a suspected or known diagnosis of any of the group of disorders known as RASopathies.
Exclusion Criteria:
* Individuals who do not have a suspected or definite diagnosis of a RASopathy.
* Individuals who do not have a relative with a suspected or definite diagnosis of a RASopathy.
* Patients who do not have the ability/capacity to undergo the informed consent process OR whose parent/legal guardian is unable to undergo the informed consent process. RAS Mutation, Neurofibromatosis 1, Noonan Syndrome, Noonan Syndrome With Multiple Lentigines, Noonan Neurofibromatosis Syndrome, Cardiofaciocutaneous Syndrome, Costello Syndrome, Legius Syndrome, Smith-Kingsmore Syndrome, MTOR Gene Mutation, GATOR-1 Gene Mutation, SYNGAP1-Related Intellectual Disability, DLG4, MAPK1 Gene Mutation
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder (AMPAIII)
Karlee Migneault - karlee.migneault@cchmc.org
ALL
8 years to 12 years old
PHASE4
NCT04421248
Inclusion Criteria:
* Either gender, any race, ethnicity or socioeconomic status
* Currently between 8 years 0 months and 12 years, 11 months, 30 days
* Willing to answer questions about ADHD and related diagnoses
* For children with ADHD prescribed stimulant medications, willing to suspend taking medications as specified in the study procedures
* For children with ADHD, willing to participate in the single dose, randomized crossover study to probe acute effects of methylphenidate on biomarkers
* Right hand dominant (predominately right-handed)
* Able to participate in and sign an informed consent
* ADHD inclusion: The diagnosis of ADHD will be based on Diagnostic and Statistical Manual version 5 (DSM-5) criteria using standard rating scales and a structured diagnostic interview. Oppositional Defiant Disorder is permitted; Conduct disorder is excluded.
* Typically Developing (healthy control) inclusion: Free of ADHD or other developmental or psychiatric disorders based on DSM-5 criteria using standard rating scales and a structured diagnostic interview.
Exclusion Criteria:
* Known diagnosis of mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorder.
* Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other Anxiety Disorders, or other developmental psychiatric diagnoses.
* For females, onset of menses, pregnancy.
* Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers.
* Implanted brain stimulator, vagal nerve stimulator, ventriculo-peritoneal shunt, cardiac pacemaker, or implanted medication port.
* Diagnosis of a speech/language disorder or a Reading Disability (RD). DRUG: Methylphenidate, DRUG: Placebo
Attention Deficit Hyperactivity Disorder Combined
Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)
cancer@cchmc.org
ALL
5 years and over
NCT02544022
* SUBJECT INCLUSION CRITERIA:
* Documented NF1 either by NIH clinical criteria or molecularly-proven mutation in the
NF1 gene, PER the Neurofibromatosis Diagnostic Criteria AND \>=1 plexiform neurofibroma in any location that is either symptomatic or asymptomatic, and is defined by the following:
• a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches OR a spinal neurofibroma that involves two or more levels with connection between the levels or extending laterally along the nerve OR a skin thickness neurofibroma;
• measures \>=3 cm on longest diameter by visual exam, palpation or 2D MR imaging OR \>=3 mL by volumetric MR imaging. * For phase 1, Age \>=5 years. (complete) * For phase 2, Age \>= 8 years * Ability of subject or parent or guardian to understand and the willingness to sign a written informed consent document. * Participants must be able to understand, read, and speak the English language. * For phase 1 focus groups only, patients need to report experiencing pNF related pain recently with a minimum pain level of 3 on the current NRS-11 or report taking prescription medication that reduces pain and experiencing pNF related pain recently with a minimum pain level of 1 on the current NRS-11. (complete) * For phase 2 patients with pain, patients need to report recently experiencing at least a minimal amount of pNF-related pain. Specifically, they will be asked if they recently experienced any pain in a target tumor area and will have to respond yes to be eligible. * For phase 2 patients without pain, patients need to report no recent pNF-related pain. Specifically, they will be asked if they recently experienced any pain in a target tumor area and will have to respond no to be eligible. PRIMARY CAREGIVER INCLUSION CRITERIA: * Primary caregiver (i.e. parent,guardian, grandparent) who is \>= 18 years old of participating subject \<= 17 years old * Participants must be able to understand, read, and speak the English language EXCLUSION CRITERIA: * Patients with severe cognitive or behavior impairments who, in the judgment of the investigators, would not be able to cooperate with the study procedures will be excluded. * Patients cannot be newly enrolled on a clinical trial to treat their pNF or cannot have started a new pain treatment regimen (e.g., medication, psychosocial therapy, physical therapy, etc.) at the time of enrollment. Specifically, patients will be ineligible if they were enrolled on a MEK inhibitor trial in the past 12 months or began a new pain medication or treatment within the past 3 months prior to enrollment on this study.
• a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches OR a spinal neurofibroma that involves two or more levels with connection between the levels or extending laterally along the nerve OR a skin thickness neurofibroma;
• measures \>=3 cm on longest diameter by visual exam, palpation or 2D MR imaging OR \>=3 mL by volumetric MR imaging. * For phase 1, Age \>=5 years. (complete) * For phase 2, Age \>= 8 years * Ability of subject or parent or guardian to understand and the willingness to sign a written informed consent document. * Participants must be able to understand, read, and speak the English language. * For phase 1 focus groups only, patients need to report experiencing pNF related pain recently with a minimum pain level of 3 on the current NRS-11 or report taking prescription medication that reduces pain and experiencing pNF related pain recently with a minimum pain level of 1 on the current NRS-11. (complete) * For phase 2 patients with pain, patients need to report recently experiencing at least a minimal amount of pNF-related pain. Specifically, they will be asked if they recently experienced any pain in a target tumor area and will have to respond yes to be eligible. * For phase 2 patients without pain, patients need to report no recent pNF-related pain. Specifically, they will be asked if they recently experienced any pain in a target tumor area and will have to respond no to be eligible. PRIMARY CAREGIVER INCLUSION CRITERIA: * Primary caregiver (i.e. parent,guardian, grandparent) who is \>= 18 years old of participating subject \<= 17 years old * Participants must be able to understand, read, and speak the English language EXCLUSION CRITERIA: * Patients with severe cognitive or behavior impairments who, in the judgment of the investigators, would not be able to cooperate with the study procedures will be excluded. * Patients cannot be newly enrolled on a clinical trial to treat their pNF or cannot have started a new pain treatment regimen (e.g., medication, psychosocial therapy, physical therapy, etc.) at the time of enrollment. Specifically, patients will be ineligible if they were enrolled on a MEK inhibitor trial in the past 12 months or began a new pain medication or treatment within the past 3 months prior to enrollment on this study.
Neurofibromatosis 1, Plexiform Neurofibromas
Pain Scale, QOL, Tool Validation, Cognitive Interviews, Natural History
Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders (ENTRAIN)
Jae Citarella - Jae.Citarella@cchmc.org
ALL
5 years to 10 years old
NA
NCT06227780
Inclusion Criteria:
* FXS Cohort: 1) Aged 5-10 years, inclusive; 2) Patient has full FMR1 mutation confirmed by genetic testing.
* ASD Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator.
* TDC Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator; 6) Patient has met normal developmental milestones; Patient has no family history of heritable neuropsychiatric disorders; 7) Patient has an IQ greater than 85 on the Stanford-Binet; 8) Score ≤8 on an SCQ screen.
Exclusion Criteria:
* All subjects: 1) Patient has auditory or visual impairments that cannot be corrected; 2) History of substance abuse or dependence within the past 6 months OTHER: Alpha Auditory Entrainment, OTHER: Sham
Fragile X Syndrome, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
Neurodevelopmental Disorders, Autistic Disorder, Autism Spectrum Disorder, Fragile X Syndrome, Fragile X, FXS, ASD, Asperger, Autism
Comparison of a Demand Oxygen Delivery (DOSA)
Suzie Hicks - suzie.hicks@cchmc.org
ALL
5 years to 17 years old
NA
NCT06609694
Inclusion Criteria:
• Age 5-17 years with or without Down Syndrome (DS).
• Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).
• Absence of clinically significant hypoxia defined as oxygen saturation \< 88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.
Exclusion Criteria:
• Current CPAP use with documented compliance (\> 4 hrs/ night; \> 70% of nights).
• Oxygen saturation \< 90% at rest during wakefulness
• Chronic daytime or nighttime use of supplemental oxygen.
• Unable to participate in a Polysomnogram (PSG).
• Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
DEVICE: Portable oxygen concentrator Inogen G5 model
Obstructive Apnea
Sleep Apnea, Down Syndrome, Continuous Positive Airway Pressure (CPAP)
Safety of RSV Preventive Monoclonal Antibody
Cathy Boyce - catherine.boyce@cchmc.org
ALL
6 weeks to 30 weeks old
PHASE4
NCT07158814
Inclusion Criteria:
* Infants ≥ 6 weeks to \<30 weeks of age at the time of enrollment
* Infants eligible for RSV monoclonal antibody and at least one routine childhood vaccine in outpatient clinic
* The parent/legal guardian must be willing and capable of providing permission for their infant to participate through the written informed consent process
* Parent/legal guardian must be able to read and comprehend English or Spanish
* The parent/legal guardian must be available for follow-up study contact by telephone from enrollment to completion of the study period
* The parent/legal guardian must agree to sign a medical record release for the infant so that study personnel may obtain medical information about the infant's health (if needed)
* The parent/legal guardian must be willing to delay their child's receipt of RSV monoclonal antibody up to two weeks from the scheduled date and to return for a second visit to receive the deferred RSV monoclonal antibody
Exclusion Criteria:
* Known contraindication or precaution to RSV monoclonal antibody or other routine vaccines being administered
* Received any vaccine within 14 days prior to enrollment and the first immunization day in this study
* Known previous receipt of RSV monoclonal antibody
* Received any experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to immunization in this study or expects to receive an experimental/investigational agent within the follow-up time period (8 days after the second immunization in this study)
* A moderate to severe acute illness and/or a reported temporal temperature greater than or equal to 100.4°F (38.0°C) within 48 hours prior to enrollment or a temporal temperature (measured by temporal artery thermometer) greater than or equal to 100.4°F (38.0°C) at the time of enrollment. (This may result in a temporary delay of immunization)
* Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 48 hours prior to enrollment (This may result in a temporary delay of immunization)
* Planned receipt of a prophylactic antipyretic medication on the day of and/or days following immunization. This exclusion does not apply if the parent/legal guardian indicates they might administer antipyretics after immunization in response to fever or pain
* Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
* Anyone who is a first-degree relative of any research study personnel
* The infant is born to a mother who received a maternal RSV immunization more than 14 days prior to delivery and is not eligible for RSV preventative monoclonal antibody
* Bleeding disorder or condition associated with prolonged bleeding that would present as a safety risk per opinion of the investigator
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the vaccines or RSV monoclonal antibody
* Has an active neoplastic disease, or a history of any hematologic malignancy
* History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of a vaccine administered on the day of study enrollment
* Immunosuppression as a result of an underlying illness or treatment or use of anti-cancer chemotherapy or radiation therapy since birth
* For infants receiving DTaP vaccine (alone or combination vaccine): Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTaP
* Intention to receive non-live or live vaccines during the 4 weeks after Visit 1; vaccines may be administered after enrollment if deemed a personal or public health priority by the health care provider caring for this patient or the study team
* Long term (at least 14 days of prednisone 2 mg/kg/day or equivalent other glucocorticoid) use of any parenteral steroids within the 6 months prior to enrollment (topical, nasal and inhaled steroids are allowed) DRUG: Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
Fever, Adverse Event Following Immunisation
Respiratory Syncytial Virus (RSV), Fever Following Immunization, RSV Monoclonal Antibody
Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science (DHREAMS)
Trish Burns - trish.burns@cchmc.org
ALL
NCT00950118
Inclusion Criteria:
* All individuals affected with a congenital diaphragmatic hernia (CDH), or with a family history of a CDH
Exclusion Criteria:
* Individuals with no personal history of a CDH or family history of a family member affected with congenital diaphragmatic hernia Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia (CDH), Genes, Genetic, Genetic testing, exome sequencing, genome sequencing, RNAseq
Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders
Bliss Magella - bliss.magella@cchmc.org
ALL
NCT00267501
Inclusion Criteria:
* Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older.
* Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy OR family member, or normal control Eosinophilic Gastrointestinal Disease Eosinophilic Inflammatory Disease, Food Allergy
Eosinophilic Disorders
The Congenital Dyserythropoietic Anemia Registry (CDAR)
Theodosia Kalfa - theodosia.kalfa@cchmc.org
ALL
NCT02964494
Inclusion Criteria:
* Diagnosis of Congenital Dyserythropoietic Anemia (CDA), whether a genetic mutation is identified or not
* Evidence of congenital anemia/jaundice or a positive family history
* Evidence of ineffective erythropoiesis
* Typical morphological appearance of bone marrow erythroblasts
* All ages (ages 0-99)
Exclusion Criteria:
* Diagnosis of cancer
* Myelodysplasia
* Secondary dyserythropoiesis: e.g.; vitamin B12 deficiency or drug-related.
Note1: Patients with rare band 3 (SLC4A1) mutations recently described to be associated with dyserythropoiesis will be eligible since the mechanisms appear to involve direct participation of band 3 in the erythroblast mitosis and cytokinesis.
Note2: Siblings, parents, and family members of patients with confirmed CDA diagnosis are encouraged to participate in the study. Congenital Dyserythropoietic Anemia (CDA)
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant
Elizabeth Smith, PhD - elizabeth.smith3@cchmc.org
ALL
6 months to 26 months old
NA
NCT06560242
Inclusion Criteria:
* Diagnoses of Fragile X Syndrome, Typical Development, or History of Premature Birth
* able to sit independently
* English is spoken at home
Exclusion Criteria:
* For all participants: no seizures in the past 6 months
* For typical development group and Fragile X group: not born prior to 32 weeks gestation OTHER: Speech discrimination
Fragile X Syndrome
Food-based Support for Hospitalized Children and Their Families (FRESH)
Kathy Auger - katherine.auger@cchmc.org
ALL
Up to 21 years old
NA
NCT06946355
Inclusion Criteria:
* All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible
Exclusion Criteria:
* Patients admitted for end-of-life care, patients who will be discharged to a location other than home, patients who live independently, and patients in county custody. OTHER: In-hospital food support intervention, OTHER: Post-discharge food support intervention
Food Insecurity
Pediatric, Hospitalization, Food Intake
I-InTERACT Preterm Parenting (I2P-RCT)
Zyah Flagg - zyah.flagg@cchmc.org
ALL
3 years to 8 years old
NA
NCT06767293
Inclusion Criteria:
* Born at \< 32 weeks gestational age.
* Total T score of \> 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of \> 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale.
* English is the primary spoken language in the home.
Exclusion Criteria:
* Is not 18 years or older.
* Participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings).
* English is not the primary language spoken in the home.
* Caregivers with a psychiatric hospitalization in the past year. BEHAVIORAL: I-InTERACT Parenting Intervention (I2P) and coaching sessions, BEHAVIORAL: I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions, OTHER: Internet Resources
Child Behavior Problem, Preterm, Parent-Child Relations, Parenting
telehealth, online learning, microlearning
Health-E You Efficacy Trial for Male Adolescents
Emmanuel Chandler - emmanuel.chandler@cchmc.org
MALE
13 years to 21 years old
NA
NCT06525064
Inclusion Criteria:
* Assigned male sex at birth
* Age 13 to 21 years old
* English and/or Spanish as preferred language to read, listen, and converse
* Self-reported engagement in vaginal and/or anal sex in the past 12 months
* Access to phone or internet for follow-up study activities
Exclusion Criteria:
* Aged 12 or younger or older than 21
* Primary language other than English or Spanish
* Not able to provide informed consent
* Unable to communicate due to cognitive, mental, language, or other difficulties
* Not sexually active, engaged in oral sex only, or more than 12 months have passed since last vaginal and/or anal sex.
* Previous participation in a Health-E You study activity or the app OTHER: Health-E You app
Sexually Transmitted Diseases, Sexual Health, Reproductive Health
male adolescent, condom use, mhealth
Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth
Patrick T Ruck - patrick.ruck@cchmc.org
ALL
2 years to 5 years old
NA
NCT06713330
Inclusion Criteria:
* CCHMC pediatric dental patients between the ages of 2 years to 5 years and 11 months, at the time of recruitment, who present to any CCHMC dental clinic location and then are found to need full mouth dental rehabilitation.
* Patients who speak the most common languages at CCHMC will be able to be recruited for the study.
o English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.
* These patients must qualify for treatment at the CCHMC dental in-office general anesthesia (IOGA) area or the Procedure Center (PC). IOGA and the PC will be selected as a venue of treatment to control behavioral factors. This is not specific to the study and would occur due to their treatment needs.
* Participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch.
* For example, tooth A \& J, B \& I, S \& L, or T \& K
* For each participant, a minimum of one SSC or one PRC will be randomly assigned via a split mouth design to be placed as part of the study.
* Need for Full coverage and high caries risk will be defined by AAPD Best Practice Guidelines 2,16
o Teeth With
• Extensive caries
• Cervical decalcification
• Developmental defects (e.g., hypoplasia, hypocalcification)
• When failure of other available restorative materials is likely (e.g., interproximal caries extending beyond line angles, patients with bruxism)
• Following pulpotomy or pulpectomy
• For definitive restorative treatment for high caries-risk children as defined by the AAPD
• For patients who exhibit high caries risk and whose treatment is performed under sedation or general anesthesia. This would be normal and not specific to the study. * Participants who consent to the study, and who can be available for follow-up recall appointments. * All participants will be ASA I or ASA II as defined by the American Society of Anesthesiologists.15
Exclusion Criteria:
* Participants who do not meet inclusion criteria will be excluded.
* Participants whose teeth do not meet the inclusion criteria.
* Participants who do not wish to participate in the study.
* Patients who do not wish to or cannot reliably return for follow-up visits.
* Red dye allergy as patient will not be able to be plaque disclosed during follow-up visits.
* Participants who do not speak English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French. DEVICE: BioFLX crown, DEVICE: 3M Stainless Steel Crown
Dental Caries
Pediatric dentistry
Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study (SAVI)
Dean Beebe - BEEBD0@cchmc.org
ALL
11 years to 12 years old
NCT07636525
Inclusion Criteria:
* Healthy 11-12 years olds who have neither had initial meningococcal vaccination nor known exposure to meningococcal illness.
Exclusion Criteria:
* Condition or treatment resulting in immunosuppression
* Prior severe vaccine reaction
* Symptoms of clinical insomnia or organic sleep disorder
* Known neurologic condition or intellectual/developmental disability
* Use of a medication that impacts sleep
* Average nightly sleep of 8-8.99 hours (between the two groups)
* Daily intake of \>1 coffee or "energy drink" or \>2 caffeinated sodas. Vaccination
Sleep
Overlapping Pain Trajectory Study (COPC)
Catherine Jackson - catherine.jackson@cchmc.org
ALL
10 years to 19 years old
NCT05752396
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
Neonatal Platelet Transfusion Threshold Trial (NeoPlaTT)
Traci Beiersdorfer - traci.beiersdorfer@cchmc.org
ALL
1 hour to 48 hours old
NA
NCT06676904
Inclusion Criteria:
* Gestational age of 23 0/7 to 26 6/7 weeks
* Postnatal age of \< 48 hours
Exclusion Criteria:
* Comfort care or withdrawal of care planned
* Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder
* Receipt of platelet transfusion
* No receipt of Vitamin K
* Parents/guardian decline consent PROCEDURE: Higher Platelet Transfusion Threshold, PROCEDURE: Lower Platelet Transfusion Threshold
Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Thrombosis
platelet transfusion, neonatal, thrombosis
Chicago Parent Program for Foster and Kinship Caregivers
Laura Fossett - laura.fossett@cchmc.org
ALL
2 years and over
NA
NCT06170047
Inclusion Criteria:
* Must be a licensed foster caregiver or kinship caregiver to a foster child between the ages of 2 and less than 9 years of age
* Must be a licensed foster caregiver or kinship caregiver to a foster child in Ohio and in the custody of Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services
* Must be in good standing with the foster care agency
* Must be English-speaking
Exclusion Criteria:
* Not having a foster child between the ages of 2 and less than 9 years
* The foster child not being in the custody of Ohio counties: Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services
* The foster child was placed in the home more than 45 days prior to enrollment
* The foster child being moved out of the placement prior to the start of the intervention
* The foster child having been previously enrolled with another caregiver
* The caregiver having been previously enrolled with another child
* The caregiver unable to commit to completing all study activities
* The foster child is not enrolled in the study BEHAVIORAL: Chicago Parent Program for Foster Care, OTHER: Usual Care
Behavior Problem, Parenting
Foster care, Child behavior, Parenting skills, Behavioral health, Prevention, Parenting confidence, Parenting stress
A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
Benjamin Kercsmar - Benjamin.Kercsmar@cchmc.org
ALL
Not specified
PHASE3
NCT06866405
Pregnant Participants-Cohort 1 and Cohort 2 Key Inclusion Criteria
* Women aged 18 to 49 who are pregnant, between 24 and 36 weeks along, and expecting one baby without known risks for complications can participate.
* Had the RSVpreF or Abrysvo vaccine during a previous pregnancy.
* Had an ultrasound scan at 18 weeks or later during their current pregnancy, with no major fetal problems detected.
* Based on their medical history, physical check-up, and the doctor's judgment, they are found suitable to join the study.
* Agrees to let their baby take part in the study and gives their permission.
* Able to sign a consent form, agreeing to follow the rules and conditions of the study.
Key Exclusion Criteria
* Received any approved or experimental RSV vaccine since their previous pregnancy.
* Has a pre-pregnancy body mass index (BMI) over 40 kg/m2.
* History of a severe bad reaction to a vaccine or a serious allergic reaction (like anaphylaxis) to any ingredient in the study vaccine or a similar vaccine.
* Current pregnancy problems or issues at the time of giving consent.
* Previous pregnancy issues or problems at the time of giving consent.
* Women who are breastfeeding at the time of enrollment
Infant Participants
* Proof that the parent(s) or legal guardian(s) has signed and dated a consent form.
* Parent(s) or legal guardian(s) must agree to attend scheduled visits and follow the study plan, including laboratory tests and other procedures.
Nonpregnant Participants-Cohort 3 Key Inclusion Criteria
* Have already received one dose of the RSVpreF vaccine during their previous pregnancy as part of the Pfizer clinical trial, and the results from that time can be used for this study.
* Able to sign a consent form, agreeing to follow the rules and requirements of the study.
Key Exclusion Criteria
* Received any approved or experimental RSV vaccine after participating in the Pfizer clinical trial.
* Taking part in other studies with new drugs within 28 days before giving consent or during the study period.
BIOLOGICAL: RSVpreF, BIOLOGICAL: Placebo
RSV Infection
Pregnancy, RSV vaccine, RSV, Maternal immunization
BSGM to Evaluate Patients With GI Symptoms
Khalil El-Chammas, MD - Khalil.El-Chammas@cchmc.org
ALL
8 years to 25 years old
NCT05880199
Inclusion Criteria for Cases
• Males or females age 8 to 25 years.
• Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
• Confirmed diagnosis of a Functional Gastrointestinal and/or Motility Disorder OR undergoing one of the following procedures as part of their clinical care at one of the participating centers:
• HRVB
• PENFS
• ADM
• Colonic Manometry
• Pyloric Botox
• Pyloric Dilation
• Gastric Scintigraphy
• GES
• gammaCore
• Those with a body mass index of \< 35.
• Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Cases
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. (Please note, majority of feeding tubes can be accommodated by the array placement.)
• Pregnant women.
• Those with any condition, where fasting is not recommended by a physician.
• Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
• Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
• Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
• Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Inclusion Criteria for Controls
• Males or females age 8 to 25 years.
• Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
• Do not have an active Functional Gastrointestinal disorder (FGID) diagnosis and will not be undergoing any procedures outlined in the recruitment plan in the near future.
• Those with a body mass index of \< 35.
• Individuals may include siblings of those with FGIDs.
• Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Controls
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.
• Pregnant women.
• Those with any condition, where fasting is not recommended by a physician.
• Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal.
• Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.
• Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
• Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
• Males or females age 8 to 25 years.
• Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
• Confirmed diagnosis of a Functional Gastrointestinal and/or Motility Disorder OR undergoing one of the following procedures as part of their clinical care at one of the participating centers:
• HRVB
• PENFS
• ADM
• Colonic Manometry
• Pyloric Botox
• Pyloric Dilation
• Gastric Scintigraphy
• GES
• gammaCore
• Those with a body mass index of \< 35.
• Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Cases
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. (Please note, majority of feeding tubes can be accommodated by the array placement.)
• Pregnant women.
• Those with any condition, where fasting is not recommended by a physician.
• Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
• Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
• Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
• Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Inclusion Criteria for Controls
• Males or females age 8 to 25 years.
• Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
• Do not have an active Functional Gastrointestinal disorder (FGID) diagnosis and will not be undergoing any procedures outlined in the recruitment plan in the near future.
• Those with a body mass index of \< 35.
• Individuals may include siblings of those with FGIDs.
• Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Controls
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.
• Pregnant women.
• Those with any condition, where fasting is not recommended by a physician.
• Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal.
• Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.
• Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
• Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
DEVICE: Body surface gastric mapping device
Gastrointestinal Motility Disorders in Children, Functional Gastrointestinal Disorders, Gastroparesis, Dyspepsia and Other Specified Disorders of Function of Stomach
GI motility, gastroparesis, functional dyspepsia
Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults (HPXeMR)
Carrie Stevens - Carrie.Stevens@cchmc.org
ALL
6 years and over
PHASE1
NCT02272049
Inclusion Criteria:
* Ages 6 and up
* Participant must be able to hold breath for up to 16 seconds
Exclusion Criteria:
* History of heart defect
* Pregnancy or positive pregnancy test
* History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month
* Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week
* Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula
* Participant is claustrophobic and unable to tolerate the imaging.
* Standard MRI exclusions (metal, implants) DRUG: Hyperpolarized 129 Xenon
Respiratory Disorders
Respiratory
Suicide Treatment Alternatives for Teens (START)
Katelyn Armstrong - katelyn.armstrong@cchmc.org
ALL
12 years to 18 years old
NA
NCT04089254
Inclusion Criteria:
• Adolescents that are 12 through 17 years old (including 17 year olds who will turn 18 years old during the course of the study).
• Are brought to the Emergency Department (ED) due to suicidal thoughts or behaviors
• Require a higher level of care (OCIC or Inpatient) indicated by clinician determination and a CHRT-SR score of 15 to 52.
• The presence of a legal guardian
• Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
• Adolescents with suicidal thoughts that place themselves at a serious imminent risk of suicide based on clinical judgment.
• Adolescents who require 24 hour/day supervision but no adult can provide 24 hour/day supervision outside of the hospital
• Adolescents without the ability to read and answer survey questions
• Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.
BEHAVIORAL: Inpatient Psychiatry, BEHAVIORAL: Outpatient Crisis Intervention Clinic
Suicidal Ideation
Suicide, Suicidal, Adolescent
Markers of Trajectory in Pediatric CRPS
Geraldine Schulze - geraldine.schulze@cchmc.org
ALL
10 years to 17 years old
NCT03838107
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