Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial
This phase III trial compares rose geranium in sesame oil nasal spray to isotonic nasal saline in improving symptoms of nasal vestibulitis in cancer patients receiving chemotherapy. Nasal (nose) symptoms (dryness, discomfort, bleeding, scabbing or sores) due to inflammation, termed nasal vestibulitis, is reported as a side effect of cancer-directed therapy. Rose geranium in sesame oil nasal spray may work better than isotonic nasal saline in improving symptoms of nasal vestibulitis.
Sugars, which are present naturally in some tobacco types and are also added to cigarette tobacco filler as additives, are may contribute to the harmful properties of cigarettes in three critical ways: by enhancing smoke palatability and appeal and, as precursors to aldehydes and other constituents in the smoke, by increasing smoke toxicity and carcinogenicity and potentially addictiveness. The overall goal of our research is to provide the U.S. FDA with the scientific basis to determine whether sugars should be added to the list of harmful and potentially harmful constituents (HPHC) list and whether their levels in tobacco products should be regulated. In this particular study, we will investigate the impact of sugar content in cigarette tobacco on cigarette abuse liability and appeal. To achieve this goal, we will conduct a laboratory study in which smokers of cigarettes with medium sugar content will smoke study cigarettes with differing levels of sugars in a laboratory setting. To prepare cigarettes, we will add a mixture of sucrose, glucose, and fructose to cigarettes that have low sugar content to match median and highest levels of sugars found in other commercial brands. Subjective and behavioral measures assessing abuse liability, sensory measures, and smoking topography will be compared across cigarettes with low (original), medium, and high sugar content.
In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribe meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.
• Severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• Age 12 to < 18 years of age at enrollment (screening) and Tanner stage >/= 2 - Female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
• Diabetes (type 1 or 2)
• Current or recent (< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
• Previous metabolic/bariatric surgery
• Current use of a stimulant medication
• History of glaucoma
• Current or recent (<14 days) use of monoamine oxidase inhibitor
• Known hypersensitivity to sympathomimetic amines
• Any history of treatment with growth hormone
• Any history of bulimia nervosa
• Major psychiatric disorder as determined by the local medical monitor
• Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression
• Any history of active suicide attempt
• History of suicidal ideation or self-harm within the previous 30 days
• PHQ-9 score >15
• Current pregnancy or plans to become pregnant during study participation
• Current tobacco use
• ALT or AST >/= 3 times the upper limit of normal
• Bicarbonate <18 mmol/L
• Creatinine > 1.2 mg/dL
• Any history of seizures
• Uncontrolled hypertension as determined by the local medical monitor
• History of structural heart defect or clinically significant arrhythmia
• Diagnosed monogenic obesity
• Any history of cholelithiasis
• Any history of nephrolithiasis
• Clinically diagnosed hyperthyroidism
• Untreated thyroid disorder
• Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
This is a within-subject, multi-session behavioral study that will examine the roles of nicotine concentration and e-liquid flavors on subjective and behavioral measures of electronic cigarette abuse potential for young adult smokers.
We are doing the RARE study to learn more about Cystic Fibrosis (CF). CF is caused by mutations in a gene that produces a protein called the cystic fibrosis transmembrane conductance regulator (CFTR). In people with CF, the CFTR does not function correctly. Medications are being developed to help the CFTR function better, but those medications mostly benefit people with common CFTR mutations. There are more than 1,900 mutations of the CF gene. Some of these mutations are rare and found only in a few people. The goal of this research study is to collect specimens (blood, nasal cells, rectal cells) from people with rare CFTR mutations. Another purpose of this study is to create induced pluripotent stem cells or iPS cells. “Pluripotent” stem cells are cells that can be changed into almost any cell type of the body (such as lung or intestine). They can be kept alive and stored indefinitely. There are different kinds of pluripotent stem cells. Inducted pluripotent stem cells can be created from many different kinds of specimens (such as blood, nasal cells, rectal cells). This is different from embryonic stem cells, which can only be derived from embryos. The specimens collected during this study and iPS cells created from them will be stored for use in future research to learn more about CF and study the effect of new medications. This could identify new medications that may help people with rare CFTR mutations.
• Male or female ≥ 12 years of age at time of consent
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with CF and one or more of the following criteria (1. Sweat chloride ≥ 60 milliequivalents/Liter (mEq/L) by quantitative pilocarpineiontophoresis test (QPIT) OR upon permission of the RARE Investigator- Sponsors, 2. Two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene,
• Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproterenol of lessthan -6.6 mV)
• Confirmed genotype of the current recruitment focus for certain target rare mutations. The initial recruitment focus will be CF patients who are homozygous for pre-mature stop codons. Operations Memos will detail any future current genotype targets.
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability to comply with the requirements of the study.
• Willing to travel (if needed) to a regional study site for cell collection.
• Presence of a medical condition, abnormality, or laboratory value(s) that in the opinion of the onsite principal investigator and/or collaborating gastroenterologist may compromise the quality of the data or place the subject at significant risk by undergoing the research related biopsy, including: Significantly diseased distal rectal/GI tissue that could place the participant at risk by participating in the study (as judged by the collaborating gastroenterologist, such as significant hemorrhoids, vascular abnormalities, colonic infection, radiation injury or history of radiation therapy to the rectum, prostate and/or pelvic area) Any of the following abnormal lab values at the study visit: i. Platelets < 50 x 103/µL ii. Hemoglobin < 10 gm/dL iii. Hematocrit < 30% iv. WBC > 20 x 103/µL v. Neutropenia (ANC < 1.5 x 103/µL) vi. Lymphopenia (absolute lymphocyte count < 1.5 x 103/µL) vii. PT/INR > 1.5 viii. Other bleeding diathesis
• Positive pregnancy test (for female of childbearing potential) at the study visit.
• Breastfeeding (if patient opts to use sedation).
• Current use of drugs with significant risks of compromising immunity (e.g. oral steroid use >20 mg/day) for >14 days prior to the rectal biopsy.
• History of organ transplant.
• Use of oral anticoagulant medications (e.g., chronic anticoagulant therapy such as warfarin or platelet inactivators such as aspirin) within seven days prior to rectal biopsy.
• Unable or unwilling to withhold use of oral anticoagulant medications (e.g., chronic anticoagulant therapy such as warfarin or platelet inactivators such as aspirin) within 7 days after rectal biopsy.
Understand the extent of proprioceptive impairments in the upper and lower limbs in individuals with stroke by evaluating ankle and wrist joint proprioceptive acuity using the ankle and wrist robotic devices
This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.
Subject-Collected Dried Blood Spot CMV Testing to Optimize Preemptive Therapy Late After Allogeneic HCT
• Must be >/= 15 years of age at the time of enrollment
• Must be able to provide written consent and complete the informed consent
• Must have received allogeneic hematopoietic cell transplantation within 60-180 days prior to randomization
• Cytomegalovirus (CMV) seropositive or had a donor who was CMV positive
• One or both of the following:
• CMV event* within the first 100 days post-transplant requiring anti-viral treatment
• Receipt of CMV prophylaxis**(for at least 30 days) prior to randomization. Continuation of letermovir prophylaxis after day 100 per institutional standard of care is permitted * CMV event defined as deoxyribonucleic acid (DNA) detection or disease ** Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, or letermovir
• Direct availability to the internet either by a computer in the residence or a smart phone
• Had at least one or more of these conditions:
• HLA mismatch*
• umbilical cord blood source**
• Graft versus host disease (GVHD)***
• T-cell depletion**** * Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1
• Use of umbilical cord blood as stem cell source ***Acute or chronic GVHD requiring topical steroid for gastrointestinal (GI) GVHD and/or systemic steroid treatment (>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment
• Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab Observation Cohort:
• Must be >/= 15 years of age at the time of enrollment
• Must have one of the following:
• Consented for retrospective studies at their transplant center, or
• Be included under the auspices of the site's IRB approved waiver of additional consent for retrospective studies
• Must have received allogeneic hematopoietic cell transplantation within 360 days prior to enrollment
• CMV seropositive or had a donor who was CMV positive
• One or both of the following:
• CMV event* within the first 100 days post-transplant requiring anti-viral treatment
• Receipt of CMV prophylaxis**(for at least 30 days) prior to registration. Continuation of letermovir prophylaxis after day 100 per institutional standard of care is permitted * CMV event defined as DNA detection or disease ** Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, or letermovir
• Meet at least one or more of criteria of the following:
• HLA mismatch*
• umbilical cord blood source**
• T-cell depletion****
• Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1 **Use of umbilical cord blood as stem cell source ***Acute or chronic GVHD requiring topical steroid for GI GVHD and/or systemic steroid treatment (>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment ****Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab
• Inability to fully comprehend the study website and study procedures
• Any other condition, which in the opinion of the investigator would interfere with successful completion of this clinical trial
• Morphological relapse (bone marrow or peripheral blood blast) prior to registration Observational Cohort:
• Did not meet all inclusion criteria
• Morphological relapse (bone marrow or peripheral blood blast) prior to registration
RANDOMIZED NON-INFERIORITY TRIAL COMPARING OVERALL SURVIVAL OF PATIENTS MONITORED WITH SERUM TUMOR MARKER DIRECTED DISEASE MONITORING (STMDDM) VERSUS USUAL CARE IN PATIENTS WITH METASTATIC HORMONE RECEPTOR POSITIVE HER-2 NEGATIVE BREAST CANCER
• Enrolled in EPI-MINN: Measurement Based Care protocol, STUDY00009334
• Good general health (i.e. not acutely ill or experiencing a severe/chronic illness that would impede their ability to complete study activities. This determination shall be, if necessary, made at the discretion of the PIs)
• Estimated IQ at or above 70, as estimated by the Penn CNP Matrix Reasoning Test
• Achieved clinical stability, defined as outpatient status for at least one month prior to study participation and clinically stable doses of psychiatric medication (by PI discretion) for at least one month prior to study participation (including no medication)
• Has access to a smartphone or other mobile device to use the PRIME app
• Under legal commitment to treatment or is under medical guardianship, and there is no provision in the guardianship order or a court order to allow the guardian to consent to participation in research
• Participated in significant cognitive training programs within the last three years
• Diagnosed with a neurological disorder (Autism Spectrum Disorder is allowed)
• Clinically significant substance abuse that is impeding the participant's abulity to participate fully during recruitment, enrollment, assessment, or training, (is unable to remain sober for assessments and training)
• Risk of suicidal behavior, as indicated by the clinicall obtained C-SSRS or clinician judgement. Risk of suicidal behavior is defined as:
• Active suicidal ideation at screening or baseline, or
• Previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study (CHOLINE4)
• Ages 2.5 years to 5 years old (<6 years of age) at enrollment
• Prenatal alcohol exposure
• Available parent or legal guardian capable of giving informed consent for participation.
• History of a neurological condition (ex. epilepsy, traumatic brain injury)
• History of a medical condition known to affect brain function
• Other neurodevelopmental disorder (ex. autism, Down syndrome)
• History of very low birthweight (<1500 grams)
This study pursues the question of whether deep engagement in creative activities may benefit adolescents with depression symptoms by introducing a more flexible way of thinking, helping adolescents recognize and foster their own creative talents, and (ultimately) developing more positive views of themselves and their futures.
This study will measure the relationship between voice-related quality of life and psychosocial distress in transgender and gender diverse patients with a voice concern. Participants participate in an semi-structured interview to characterize their voice-related experiences and the role of voice-related perceived control related to their voice concerns.
We have started this program from other existing projects focused on families. The main difference is that we would like to deliver a program that helps refugee families that have come to the United States. We know that transition can be difficult for parents and teenage children. Our goal is to help families develop tools and skills to work through family problems. Based on your feedback we will make small changes to the program sot that it meets the needs of refugee families. Once we have done this, we will deliver the program to larger numbers of refugee families living in Minnesota. Please note the changed title to match the K23 submission title. I updated the funding with the K23 SPA CON number as well as a CTSI pilot grant that started in March and is supporting project activities.
• Adult inclusion criteria:
• Above the age of 18
• Karen refugees resettled to the United States greater than one year prior to enrollment
• Caregiving responsibility for at least one child between the ages of 11 and 18
• Reported primary or secondary torture or war trauma exposure, based on assessments conducted during UMN IRB STUDY00000729
• Participation in UMN IRB STUDY00000729 and having agreed to be contacted for future research
• Youth inclusion criteria:
• Ages 11 to 18
• Living in the home with the primary caregivers
• Considered a dependent of the primary caregivers (still in high school or transitioning from school to workforce, not married and/or raising their own children - will take individual youth circumstances into consideration individually to make a determination of dependence)
• Self-reported or study team observed severe or unstable mental or physical illness such as acute psychosis, presence or risk of safety concerns, and/or a physical disability or illness, which prevents the potential participant from engaging in the study activities. Youth will be excluded if screening is positive for PTSD. Caregivers will not be excluded if mental health screening is positive for PTSD/severe depression.
• Nonbiological caregiving relationships with child
• If one member of the family declines to participate in the initial enrollment, the family will be excluded. If the randomly selected index youth declines to participate, we will open enrollment to other youth in the family that meet the inclusion criteria.
Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
MT2017-17: T cell receptor Alpha/Beta T Cell Depleted Hematopoietic Cell Transplantation in Patients with Fanconi Anemia (FA)
The primary objective is to determine the incidence of grade II-IV acute graft versus host disease (GVHD) by Day 100 using an alpha/beta T cell depleted peripheral blood stem cells (PBSC) and without routine GVHD prophylaxis.
• Diagnosis of Fanconi anemia
• Less than 65 years of age
• Karnofsky performance status of ≥ 70% or, for children < 16 years of age, Lansky Play Score ≥ 50
• Presence of at least one of the following risk factors:
• Severe aplastic anemia (SAA) defined as: Aplastic anemia is defined as having at least one of the following when not receiving growth factors or transfusions:
• platelet count <20 x 109/L
• absolute neutrophil count of <5 x 108/L
• hemoglobin <8 g/dL
• Myelodysplastic syndrome (MDS) or acute leukemia
• High risk genotype
• Adequate organ function defined as:
• Bilirubin, AST or ALT, ALP <5 x normal, Cardiac: left ventricle ejection fraction (LEFV) ≥45% by ECHO
• Pulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.
• Identification of a suitable donor for peripheral blood cells per match criteria found in Section 5.
• Females of childbearing potential and males with partners of child-bearing potential must agree to use of contraception for the duration of treatment and 4 months after the transplant
• Able to provide written voluntary consent prior to the performance of any research related tests or procedures with parental/guardian consent for minor (and assent as appropriate)
• Pregnant or breastfeeding as the treatment used in this study are Pregnancy Category D. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration
• Active, uncontrolled infection within 1 week prior to starting study therapy
• Malignant solid tumor cancer within previous 2 years Donor Selection (Inclusion Criteria): meets one of the following match criteria:
• an HLA-A, B, DRB1 matched sibling donor (matched sibling)
• an HLA-A, B, DRB1 matched related donor (other than sibling)
• a related donor mismatched at 1 HLA-A, B, C and DRB1 antigen
• 7-8/8 HLA-A,B,C,DRB1 allele matched unrelated donor per current institutional guidelines Patients and donors are typed for HLA-A and B using serological or molecular techniques and for DRB1 using high resolution molecular typing. If a donor has been selected on the basis of HLA-A, B, C and DRB1 typing as above, preference will be made for donors matched at the HLA-C locus.
• Body weight of at least 40 kilograms and at least 12 years of age
• Willing and able to undergo mobilized peripheral blood apheresis
• In general good health as determined by the medical provider
• Adequate organ function defined as:
• Hematologic: hemoglobin, WBC, platelet within 10% of upper and lower limit of normal range of test (gender based for hemoglobin)
• Hepatic: ALT < 2 x upper limit of normal
• Renal: serum creatinine < 1.8 mg/dl
• Performance of a donor infectious disease screen panel including CMV Antibody, Hepatitis B Surface Antigen, Hepatitis B Core Antibody, Hepatitis C Antibody, HIV 1/2 Antibody, HTLVA 1/2 Antibody, Treponema, and Trypanosoma Cruzi (T. Cruzi) plus HBV, HCV, WNV, HIV by nucleic acid testing (NAT); and screening for evidence of and risks factors for infection with Zika virus, or per current standard institutional donor screen - must be negative for HIV and active hepatitis B
• Not pregnant - females of childbearing potential must have a negative pregnancy test within 7 days of mobilization start
• Voluntary written consent (parent/guardian and minor assent, if < 18 years) prior to the performance of any research related procedure
• No evidence of significant cognitive delay;
• Evidence of language impairment;
• Evidence of deficits on expressive grammatical forms: score below 30% accuracy on at least two of the following forms: third person singular -s, regular past tense -ed, auxiliary is/are in statements, auxiliary do/does in questions;
• Typical hearing and vision, with correction if necessary;
• Native English speaker with English spoken in the home by at least one primary caregiver since birth;
• Speaker of Mainstream American English;
• Be able to articulate final-position phonemes /s/, /z/, /t/, and /d/; and
• Majority of utterances (> 50%) include subject and verb in obligated contexts based on a 20-min conversational language sample to ensure appropriateness of study intervention.
• Evidence of significant cognitive delay;
• No evidence of deficits on expressive grammatical forms: score below 30% accuracy on at least two of the following forms: third person singular -s, regular past tense -ed, auxiliary is/are in statements, auxiliary do/does in questions;
• Atypical hearing and vision, with correction if necessary;
• Non-native English speaker;
• Speaker of Non-mainstream American English;
• Unable to articulate final-position phonemes /s/, /z/, /t/, and /d/; and
• Non-majority of utterances (< 50%) include subject and verb in obligated contexts based on a 20-min conversational language sample to ensure appropriateness of study intervention.
Among people with peripheral artery disease (PAD) age 55 and older, we will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. We will randomize 190 participants (32 in Minnesota) with PAD age 55 and older to one of two groups for six months: cocoa flavanols vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are six-month change in maximal treadmill walking distance, Actigraph-measured physical activity, whole body oxygen consumption, measures of nitric oxide (brachial artery flow-mediated dilation (FMD)), calf muscle endothelial nitric oxide synthase (eNOS) and phosphorylated eNOS, calf muscle perfusion (measured by magnetic resonance imaging (MRI)) and calf muscle characteristics (measured by calf muscle biopsy). To achieve our specific aims, we will randomize 190 participants age 55 and older with PAD to one of two groups: cocoa flavanols vs placebo. Participants will be followed for seven months.
• Age 55 and older
• Presence of peripheral artery disease (PAD). PAD will be defined as either an ABI <= 0.90 at baseline or vascular lab evidence of PAD or angiographic evidence of PAD.
• Unable to tolerate study pills
• Inability to walk or requiring walker to ambulate
This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglio-neuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
• All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study
• There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype
• Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:
• Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
• It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy
• In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:
• For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted
• For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment
• Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
• Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
• Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol
• Patients must have been diagnosed with Fabry disease
• Patients must be between the ages of 1 day-90 years
• Fabry disease patients who have had a renal transplant
• Fabry disease patients who are, or have been, subjects in any investigational drug study
Stability 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs Quad Tendon (Protocol # PRO19020231) (STABILITY 2)
STABILITY 2 is a 21-site multicenter, international, randomized clinical trial that will randomly assign 1236 individuals with an anterior cruciate ligament (ACL) deficient knee who are at high risk of re-injury to anatomic anterior cruciate ligament reconstruction (ACLR) using bone patellar tendon bone (BPTB) or quadriceps tendon (QT) autograft with or without a lateral extra-articular tenodesis (LET).
• Age 14-25,
• An ACL-deficient knee,
• Skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs),
• At least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity (Beighton score of ≥4) and/or genu recurvatum >10 degrees.
• Previous ACLR on either knee,
• Partial ACL injury (defined as one bundle ACL tear requiring reconstruction/augmentation of the torn bundle with no surgery required for the intact bundle),
• Multiple ligament injury (two or more ligaments requiring surgery),
• Symptomatic articular cartilage defect requiring treatment other than debridement,
• >3 degrees of asymmetric varus,
• Inflammatory arthropathy,
• Inability to provide consent,
• Pregnancy at baseline.
• age 18 years or younger
• overweight or obese patient
• initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.
• no exclusion criteria
3.1 Primary Endpoint/Event/Outcome: To determine if stimulated T cell production of IFN-γ and stimulated monocyte production of TNFα as quantitated by ELISpot, better predicts important clinical metrics of impaired immunity in patients with sepsis than commonly used protein and nucleic acid measures of immune endotype.
• All adults (age ?18)
• Ability to obtain Informed Consent prior to blood collection.
• Current, chronic steroid use
• Current or recent (within 7 days) use of antibiotics.
• Currently being cared for in the University of Minnesota Masonic Children's Hospital Intensive Care Unit (ICU)
• Already have an arterial line in place
• ICU staff state that it would be a good time to approach possible participants
• If members of the research team are unable to access and measure with the Photovault the area that was measured via pulse oximetry by the care team
• Patients who do not have SpO2 or SaO2 measurements
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients undergoing Sevoflurane Anesthesia
Study is to investigate the relationship between Bispectral Index (BIS) values including EEG profile and anesthetic agents in the pediatric population.
• Taking any medications that may have an impact on the Central Nervous System
• 16 years or older
• Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
• Stable fixation (+/- 1 deg) using their PRL.
• No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
• Satisfactory calibration achievable using eye tracker
• Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
• Poor fixation (worse than+/- 1 deg) using their PRL.
• Cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
• Satisfactory calibration not achievable using eye tracker
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
• Males or females ages birth to 21 years.
• Patients diagnosed with congenital heart disease
• Patients undergoing a noncardiac procedure (surgical or nonsurgical)
• Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
• Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study