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298 Study Matches

Humanitarian Use Device: Medtronic DBS Therapy for Dystonia (HDE #H020007)

Humanitarian Use device application for DBS therapy for dystonia

Jerrold Vitek
NA
This study is NOT accepting healthy volunteers
NCT00580658
1207M17701
Dystonia
DBS, Dystonia
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SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

This study will test the completion of a fusion and implantation of a neuromodulation device during the same open back procedure.

Michael Park
18 Years and over
Pilot
This study is NOT accepting healthy volunteers
NEUROSURG-2018-27335
STUDY00004880
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Description: This is a 12-month long study of patients between ages 21-79 years old with chronic lower back pain who have been told by a doctor that they should have a single level spinal fusion surgery to address their pain. Despite successful surgery, up to 40% of patients who have had a spinal fusion surgery can experience long-term residual back pain. This study is trying to figure out if this pain can be addressed in a safe and effective way earlier by combining two established treatments into a single procedure. It involves implanting a neuromodulation device during the spinal fusion procedure and starting the neurostimulation during the hospital stay, instead of implanting the device during a separate procedure that typically happens years later.
Chronic Lower Back Pain, DRG, Neurostimulation, Spinal Fusion
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PEPN2111 - A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

A Phase I/II trial of single agent intravenous CBL0137 in pediatric patients (≥ 12 months and ≤ 30 years) with relapsed/refractory solid tumors, including CNS tumors and lymphoma.

Emily Greengard
All
12 Months to 30 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04870944
STUDY00015023
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Inclusion Criteria:

• Parts A and B1: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
• Part B2 (relapsed/refractory osteosarcoma): Patients must be >= 12 months and =< 30 years of age at the time of study enrollment
• Patients must have had histologic verification of malignancy at original diagnosis or relapse, except in patients with diffuse intrinsic brain stem tumors, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
• Part A: Patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases (including untreated or progressive) are eligible
• Part B1: Patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27M-mutant diffuse midline gliomas previously treated with radiation therapy
• Part B2: Patients with relapsed or refractory osteosarcoma
• Part A: Patients must have either measurable or evaluable disease
• Part B1 and B2: Patients must have measurable disease
• Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
• Patients must have a performance status corresponding to Easter Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age. Patients must have a Karnofsky or Lansky score >= 50%
• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive
• Solid tumor patients: >= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid. Patients with CNS tumors receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell Infusions (with or without total body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 30 days
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells, etc.)
• Radiation therapy [XRT]/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, I-131 metaiodobenzylguanidine [131I MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy
• Patients must not have received prior exposure to CBL0137
• For patients with solid tumors without known bone marrow involvement:
• Peripheral absolute neutrophil count (ANC) >= 1000/uL (performed within 7 days prior to enrollment unless otherwise indicated)
• Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
• For patients with solid tumors without known bone marrow involvement:
• Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (performed within 7 days prior to enrollment unless otherwise indicated)
• Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a creatinine based on age/gender as follows (performed within 7 days prior to enrollment unless otherwise indicated):
• Age: Maximum serum creatinine (mg/dL)
• 1 to < 2 years: 0.6 (male); 0.6 (female)
• 2 to < 6 years: 0.8 (male); 0.8 (female)
• 6 to < 10 years: 1 (male); 1 (female)
• 10 to < 13 years: 1.2 (male); 1.2 (female)
• 13 to < 16 years: 1.5 (male); 1.4 (female)
• >= 16 years: 1.7 (male); 1.4 (female)
• Patients with solid tumors:
• Bilirubin (sum of conjugated + unconjugated or total) =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment unless otherwise indicated)
• Patients with solid tumors:
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L (performed within 7 days prior to enrollment unless otherwise indicated)
• Shortening fraction of >= 27% by echocardiogram (performed within 7 days prior to enrollment unless otherwise indicated)
• Ejection fraction of >= 50% by gated radionuclide study (performed within 7 days prior to enrollment unless otherwise indicated)
• Corrected QT (QTC) < 480 msec (performed within 7 days prior to enrollment unless otherwise indicated)
• Patients with seizure disorder may be enrolled if seizures well controlled without the use of enzyme-inducing anti-convulsant agents. Well controlled is defined by no increase in seizure frequency in the prior 7 days
• Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v]5) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible
• Patients have consented to receive a central venous catheter prior to the administration of CBL0137. A central line is required for CBL0137 administration
Exclusion Criteria:

• Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control
• Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Patients who are currently receiving another investigational drug are not eligible
• Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)
• Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
• Patients who are receiving drugs that are strong inducers or inhibitors of CYP3A4, CYP2B6 (e.g., carbamazepine) and CYP1A2 (e.g., ciprofloxacin, enoxacin, fluvoxamine, smoking) are not eligible. These agents are to be avoided for 7 days prior to the start of CBL0137 and for the duration of the protocol therapy. Sensitive substrates of CYP2D6 (e.g., atomoxetine, desipramine, dextromethorphan, eliglustat, nebivolol, nortriptyline, perphenazine, tolterodine, R-venlafaxine) should also be avoided for the duration protocol therapy
• Patients who are receiving drugs that prolong QTc are not eligible. QTc- prolonging drugs are to be avoided for 7 days prior to the start of CBL0137 and for duration of the protocol therapy
• Patients with known peripheral vascular disease are excluded
• Patients with a history of pro-thrombotic disorder are not eligible
• Patients who have an uncontrolled infection are not eligible
• Patients who have received a prior solid organ transplantation are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Drug: FACT Complex-targeting Curaxin CBL0137
Diffuse Midline Glioma, H3 K27M-Mutant, Metastatic Malignant Neoplasm in the Central Nervous System, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Osteosarcoma, Recurrent Primary Malignant Central Nervous System Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Osteosarcoma, Refractory Primary Malignant Central Nervous System Neoplasm
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Aortic, Peripheral & Venous (APV) PRODUCT SURVEILLANCE REGISTRY (PSR) PLATFORM BASE

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

Jafar Golzarian
Post Market Monitoring
This study is NOT accepting healthy volunteers
NCT01524276
STUDY00013375
Coronary Artery Disease, Aortic, Peripheral Vascular and Venous Disorders, Cardiac Rhythm Disorders, Cardiovascular Disorders, Diagnostic Techniques and Procedures, Digestive Disorders, Intracranial Aneurysm, Mechanical Circulatory Support, Minimally Invasive Surgical Procedures, Neurological Disorders, Neurovascular, Renal Insufficiency, Respiratory Therapy, Surgical Procedures, Operative, Urological Disorders
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MT2020-33: Study of FT538 in Combination with Daratumumab in Acute Myeloid Leukemia

This study is designed to find the maximum tolerated dose (MTD) of FT538 when given in combination with daratumumab for the treatment of acute myeloid leukemia (AML).

Joseph Maakaron
All
12 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04714372
STUDY00012524
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Disease specific
Inclusion Criteria:
Acute myeloid leukemia relapsed/refractory after 2 lines of therapy; with CD38 expression
• CD38 expression is defined by ≥20% of malignant cells with CD38 expression by flow cytometry on the most recent marrow biopsy (within 30 days of enrollment - archived or fresh).
• Relapsed/refractory is defined as failure to achieve at least a Morphological Leukemia Free State (MLFS) or reverting from MLFS.
• Lines of therapy are defined as (must have had 2 prior therapies):
• One cycle of Intensive induction chemotherapy such as 7+3, 5+2, MEC, FLAG, FLAG-Ida, CLAG ± small molecule inhibitor
• Four weeks of HMA-based induction ± small molecule inhibitor
• Hematopoietic stem cell transplantation (HSCT) if relapse that occurs > 90 days after HSCT
• Gemtuzumab Ozogamicin
• LDAC + glasdegib
• Biomarker-specific targeted agents (FLT3 inhibitors, IDH1/2 inhibitors, others if available)
• Other treatments could be considered after discussion with the PI
Inclusion Criteria:

• Age 12 years or older at the time of consent - Please note, enrollment of minors will be begin until permission to proceed is received from the FDA. At that time, the protocol will be updated to open enrollment to minors.
• Weight ≥ 50 kg due to FT538 fixed cell dosing and FT538 product pre-dose packaging
• Karnofsky performance status of 80-100% for 16 years and older or Lansky Play Score of 80-100 for ≥12 and < 16 years of age
• Evidence of adequate organ function within 14 days of starting study treatment defined as:
• Estimated Glomerular Filtration Rate (estimated creatinine clearance) ≥50 mL/min/1.73m^2
• Total bilirubin ≤ 5 × upper limit normal (ULN), not applicable for patients with Gilbert's syndrome
• AST ≤3 × ULN and ALT ≤ 3 × ULN, not applicable if determined to be directly due to underlying malignancy
• LVEF ≥ 40% by echocardiogram or MUGA
• Contraceptive use by men or women
• Female subjects: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of cyclophosphamide (CY), at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
• Male subjects: Males with a female partner of childbearing potential or a pregnant female partner must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least 4 months after the final dose of CY and at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
• Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.
• Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.
Exclusion Criteria:

• Diagnosis of acute promyelocytic leukemia (APL)
• Pregnant or breastfeeding, Menstruating females of child-bearing potential must have a negative pregnancy test within 14 days of study treatment start
• Known allergy to any of study drugs or their components
• Clinically significant cardiovascular disease including any of the following: myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher or cardiac ejection fraction <40%
• Any known condition that requires systemic immunosuppressive therapy (> 5mg prednisone daily or equivalent) during the FT538 dosing period (3 days before the 1st dose through 14 days after the last dose) excluding pre-medications - inhaled and topical steroids are permitted
• Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the to the first dose of daratumumab. Maintenance hydroxyurea for blast control up to the initiation of lympho-conditioning is permitted
• Known active central nervous system (CNS) involvement or treated CNS disease that has not cleared. If prior disease related CNS involvement must have completed effective treatment of their CNS disease at least 2 months prior to Day 1 with no evidence of disease clinically and at least stable findings on relevant CNS imaging
• Non-malignant CNS disease such as epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
• Clinically significant untreated/uncontrolled infection
• Live vaccine <6 weeks prior to start of lympho-conditioning
• Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR
• Prior solid organ transplant
• Allogeneic HSCT relapse occurring <90 days after HSCT
• Active graft-versus-host-disease (GvHD) requiring systemic immunosuppression within 14 days prior to enrollment
• Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to the participant.
Drug: Daratumumab/rHuPH20, Drug: FT538, Drug: Fludarabine, Drug: Cyclophosphamide
Acute Myeloid Leukemia, Myeloid Leukemia, Monocytic Leukemia
FT538, AML, Daratumumab, CD38, Clinics and Surgery Center (CSC)
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US and Neurodevelopmental Outcomes in the Neonatal Intensive Care Unit (NICU)

All
25 Weeks to 34 Weeks old
This study is NOT accepting healthy volunteers
NCT05071508
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Inclusion Criteria:

• preterm infants born between 25 and 34+6 weeks gestation admitted to University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
• medically stable at time of air displacement measurements
Exclusion Criteria:

• infants that require medical support preventing ADP measurements from being taken
Premature Birth
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MT1999-20 Hematopoietic cell transplantation in children with juvenile myelomonocytic leukemia

To determine the probability of long-term disease-free survival in patients with JMML treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by hematopoietic cell transplantation.

Margaret MacMillan, MD
All
up to 18 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT00167219
9911M24961
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Inclusion Criteria:

• Patients must have a diagnosis of JMML and fulfill these minimal criteria (International diagnostic criteria for JMML):
• Leukocytosis (> 13,000) with absolute monocytosis (> 1,000)
• The presence of immature myeloid cells in the peripheral blood
• Less than 30% marrow blasts
• Absence of t(9:22) or BCR-ABL transcript
• Adequate major organ function including:
• Cardiac: ejection fraction > 45%
• Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
• Karnofsky performance status > 70% or Lansky score > 50%
• Creatinine must be < 2 x normal for age
• Written informed consent.
Exclusion Criteria:

• Active uncontrolled infection within one week of HCT.
Biological: Stem Cell Transplant, Drug: Preparative Regimen
Juvenile Myelomonocytic Leukemia
Stem cell transplant, long term survival, retinoic acid
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OPTIMIZING ENDOCRINE THERAPY THROUGH MOTIVATIONAL INTERVIEWING AND TEXT INTERVENTIONS

Nicole Hartung
NA
This study is NOT accepting healthy volunteers
NCT04379570
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Negative Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8
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T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

Nicole Hartung
Phase III
This study is NOT accepting healthy volunteers
NCT04457596
Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma, Multifocal Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Synchronous Bilateral Breast Carcinoma
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Expansion Cohort Study of Disulfiram and Chemotherapy in Pancreas Cancer Patients

Disulfiram is a potential inhibitor of muscle degradation and may reduce tumor induced muscle wasting. Emerging research also suggests it might have anti-cancer effects. This study examines whether targeting muscle loss with Disulfiram will reverse disability and eventually improve survival in patients with incurable pancreatic cancer. It tests the safety, tolerability and potential benefit of disulfiram (Antabuse®) in combination with chemotherapy

Aminah Jatoi
Phase II
This study is NOT accepting healthy volunteers
NCT02671890
15-003194
Stage IV Pancreatic Cancer AJCC v8, Metastatic Pancreatic Adenocarcinoma, Refractory Malignant Solid Neoplasm
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COG APEC1621SC - NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE) SCREENING PROTOCOL

The NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) study, referred to as Pediatric MATCH, will match targeted agents with specific molecular changes identified using genomic sequencing technologies in refractory/recurrent tumors from children and adolescents with cancer. The NCI-COG Pediatric MATCH study (APEC1621) is considered one study under one IND consisting of a Master Version Control protocol, screening protocol component and multiple subprotocol components, with each component being contained in its own separate document. Each “component” consists of the protocol document and its associated informed consent document. The Master Version Control Protocol is the overarching administrative protocol that will keep an up-to-date record of the current version of the screening protocol component and each subprotocol component of Pediatric MATCH. Since each subprotocol component operates independently from the other subprotocol components contained in Pediatric MATCH, each has its own version date. Likewise, the screening protocol component has its own version date since changes in any of the subprotocols may not require changes in the screening protocol.

Emily Greengard
All
12 Months to 21 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03155620
STUDY00001752
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Inclusion Criteria:

• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors, including non-Hodgkin lymphomas, histiocytoses (e.g. langerhans cell histiocytosis [LCH], juvenile xanthogranuloma [JXG], histiocytic sarcoma), and central nervous system (CNS) tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG); in cases where patient enrolls prior to histologic confirmation of recurrent disease, patient is ineligible and should be withdrawn from study if histology fails to confirm recurrence; please note: Patients with Hodgkin lymphoma and plexiform neurofibroma are not eligible
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Tumor Testing Requirement: Tumor sample availability requirement for stage 1 of Pediatric MATCH (patients enrolled from start of study in July 2017 through 12/31/21); Patients must have an formalin-fixed paraffin-embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus
• Please note: Samples that have been decalcified using standardly utilized acid-based decalcification methods are not generally suitable for MATCH study testing; the nucleic acids will have been degraded in the decalcification process
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Tumor molecular profiling report availability requirement for Stage 2 of Pediatric MATCH (patients enrolled starting 2022): In stage 2 of the study, no tumor samples will be submitted for centralized clinical tumor profiling; instead, a tumor molecular profiling report from a College of American Pathologists (CAP)/ Clinical Laboratory Improvements Amendments (CLIA)-approved testing laboratory must be submitted for review by the Molecular Review Committee (MRC)
• This molecular profiling must have been performed on a tumor sample that was obtained at any point after initial tumor recurrence/progression and must be accompanied by a pathology report for the same tumor specimen; a molecular profiling report for a diagnostic (pre-treatment) tumor sample will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus. In the event that molecular profiling reports are available from multiple timepoints, the most recent report should be prioritized for study submission
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age); note: neurologic deficits in patients with central nervous system (CNS) tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have radiographically measurable disease; measurable disease based on imaging obtained less than or equal to 56 days prior to enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
• Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or CSF
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: NOTE: patient does not need to meet all subprotocol criteria at time of enrollment onto the APEC1621SC screening protocol, but will need to meet all criteria prior to enrollment on any assigned treatment subprotocol. Patients must be enrolled onto a subprotocol within 2 weeks (14 days) of treatment assignment
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age); Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of treatment with subprotocol specified therapy, the patients must have radiographically measurable disease; patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard MRI or CT
• Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or CSF
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for RECIST 1.1
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:
• Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anticancer agents known to be myelosuppressive: for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anticancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC]): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell infusions (with or without total-body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 42 days
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer (NK) cells, dendritic cells, etc.)
• X-ray therapy (XRT)/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; note: radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: For patients with solid tumors without known bone marrow involvement:
• Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
• Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
• Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6
• Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8
• Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1
• Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2
• Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4
• Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Serum glutamate pyruvate transaminase (SGPT) (alanine transferase [ALT]) =< 135 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients must be able to swallow intact capsules/tablets, unless otherwise specified in the subprotocol to which they are assigned
• GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Agent specific limitations on prior therapy will be included with specific treatment subprotocols
Exclusion Criteria:

• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, or because there is currently no available information regarding human fetal or teratogenic toxicities; pregnancy tests must be obtained in females who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Concomitant medications
• Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
• Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
• Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible
• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled infection are not eligible
• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have had a prior solid organ transplant are not eligible
• GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will be included with specific treatment subprotocols
Procedure: Biopsy, Procedure: Biospecimen Collection, Drug: Ensartinib, Drug: Erdafitinib, Other: Laboratory Biomarker Analysis, Drug: Larotrectinib Sulfate, Procedure: Mutation Carrier Screening, Drug: Olaparib, Drug: Palbociclib, Other: Pharmacological Study, Drug: Samotolisib, Drug: Selpercatinib, Drug: Selumetinib Sulfate, Drug: Tazemetostat, Drug: Tipifarnib, Drug: Ulixertinib, Drug: Vemurafenib
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Histiocytic Sarcoma, Juvenile Xanthogranuloma, Langerhans Cell Histiocytosis, Malignant Glioma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Glioma, Recurrent Hepatoblastoma, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Primary Central Nervous System Neoplasm, Recurrent Rhabdoid Tumor, Recurrent Soft Tissue Sarcoma, Refractory Ewing Sarcoma, Refractory Glioma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Primary Central Nervous System Neoplasm, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Rhabdoid Tumor, Stage III Osteosarcoma AJCC v7, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Osteosarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7, Wilms Tumor
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Phase II Study of Low-Dose Ibuprofen for Cognitive Impairment in Cancer Patients Receiving Chemotherapy

Phase II
This study is NOT accepting healthy volunteers
NCT03186638
0123456789
Cognitive Impairment, Malignant Neoplasm
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Methodology and Development of Tobacco Related Biomarkers Methodology and Development of Tobacco Related Biomarkers, part of 'Metabolism of Carcinogenic Tobacco-Specific Nitrosamines'

The purpose of this study is to better understand how tobacco and nicotine products affect our bodies. In this observational study smokers, vapers, smokeless tobacco users, nicotine replacement product users, non-users, and ex-users will be asked to provide biological samples. We will look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. Collected samples will be used for the development of biomarkers of toxicant exposure and for assessing exposure between the different groups. The intent is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases. This study will allow us to test currently used biomarkers, and to establish a biorepository (sample bank) to identify and develop new biomarkers associated with tobacco exposure and cessation. The type of samples and amount collected will depend on the specific biomarker(s) being developed or tested. Potential samples include saliva, cheek (buccal) & oral cells, blood, urine, hair, and/or nail clippings.

Stephen Hecht, PhD
18 Years and over
NA
This study is also accepting healthy volunteers
2009NTLS059
0908M70881
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Inclusion Criteria:

• 21 years or older
• Daily user of tobacco or nicotine products
Exclusion Criteria:

• Unstable health condition
• Pregnant or nursing
Cancer, Community Health, Prevention & Wellness
nicotine, nicotine replacement, smokeless tobacco, smoker, smoking, tobacco, vaper, vaping
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Type 1 Diabetes Extension Study (T1DES)

The primary objective of the study will be to further our understanding of the immunologic mechanisms underlying maintenance and loss of beta cell function by evaluating the relationship between longitudinal changes in beta cell function and changes over time in biomarkers known to be associated with a response to immune modulating treatments. This is meant to be a follow up study of the long term effects of participation in selected completed ITN new-onset T1D studies with immunomodulatory agents.

Antoinette Moran
All
8 Years to 35 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02734277
STUDY00001310
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Inclusion Criteria:

• Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
• Ability to sign informed consent/assent (as applicable for children).
Exclusion Criteria:

• Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or
• Inability to comply with the study visit schedule and required assessments.
Type 1 Diabetes Mellitus, T1DM, T1D
Insulin, Glucose Intolerance
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COG ALTE2031 - StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention among Adolescent and Young Adult Childhood Cancer Survivors

The study objectives are to compare the effect of 2 different physical activity programs on physical activity levels in adolescents and young adults who received and completed treatment for cancer and to measure lab tests associated with heart health and information collected from surveys to learn how changes in physical activity levels affect health and quality of life in participants.

Lucie Turcotte
All
15 Years to 20 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04089358
STUDY00013015
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Inclusion Criteria:

• First diagnosis of malignant neoplasm (International Classification of Diseases for Oncology [ICD-O] behavior code of "3") in first and continuous remission at the time of enrollment
• Curative cancer treatment must have included chemotherapy (including cellular therapy) and/or radiation (including radioactive iodine)
• Note: Childrens Oncology Group (COG) therapeutic trial participation is not required
• All cancer treatment must have been completed within 3-36 calendar months prior to enrollment
• Patients must have a life expectancy of > 1 year
• Self-report of < 420 minutes of moderate-to-vigorous physical activity per week as assessed via the study-specific Physical Activity Worksheet
• Note: See COG Study Web Page for the Godin-Shephard Leisure Time Physical Activity Questionnaire or link to online calculator
• Ambulatory and no known medical contraindications to increasing physical activity
• Note: Patients with amputation, rotationplasty, or other prothesis are not automatically excluded as long as they are ambulatory and have no known medical contraindications to increasing physical activity and all other eligibility criteria are satisfied
• No known significant physical or cognitive impairment that would prevent use of the electronic devices used for the protocol intervention (e.g. Fitbit, smartphone, tablet, or computer)
• Able to read and write English
• Note: For patients < 18 years, consenting parent/legal guardian does not have to be able to read and write English
• All patients and/or their parents or legal guardians must sign a written informed consent
• Note: Informed consent may be obtained electronically/online if allowed by local site policy and Institutional Review Board (IRB)/Research Ethics Board (REB) of record
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded
• Note: Pregnancy status can be established by clinical history with patient. Post-menarchal female patients are eligible as long as they agree to use an effective contraceptive method (including abstinence) during study participation
• Patients with previous hematopoietic stem cell transplant (HSCT) are excluded
• Note: Patients with previous autologous HSCT, chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate as long as all other eligibility criteria are satisfied
Other: Educational Intervention, Device: FitBit, Other: Goal Setting, Other: Health Promotion and Education, Other: Media Intervention, Behavioral: Telephone-Based Intervention
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
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Stress Response and Opioid Dysfunction in Nicotine Dependence

This study includes healthy adults between 18-70 years old who are either non-smokers or cigarette smokers interested in quitting. The purpose of this study is to learn more about how people respond to stress and to taking one dose of a widely and safely used drug called naltrexone as well as to learn about how these responses relate to whether or not someone smokes, smoking cessation, and smoking relapse.

Mustafa al'Absi
18 Years and over
NA
This study is NOT accepting healthy volunteers
DMED-2019-28512
STUDY00008687
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Inclusion Criteria:

• Live in Minnesota.
• Between 18-70 years old.
• Generally healthy.
• Want to quit using tobacco and nicotine.
• Are willing to attend up to 11 online (videoconference) study visits over a period of approximately 4 months (though you may be asked to complete the last visits over a period of up to 1 year).
Exclusion Criteria:

• Do not live in Minnesota.
• Not between 18-70 years old.
• Not willing to attend to up to 11 online (videoconference) study visits over a period of approximately 4 months.
Heart & Vascular, Mental Health & Addiction, Prevention & Wellness
cigarette, nicotine, quit smoking, smoker, smoking, smoking cessation, stress, tobacco
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Corrona Inflammatory Bowel Disease (IBD) Registry

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

Byron Vaughn
NA
This study is NOT accepting healthy volunteers
NCT03162549
STUDY00007736
Inflammatory Bowel Diseases
Clinics and Surgery Center (CSC)
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PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial

More than 65% of people with lower extremity peripheral artery disease (PAD) are overweight or obese. Overweight or obese people with PAD have greater functional impairment and faster functional decline than normal weight people with PAD. Walking exercise is first line therapy to improve walking performance in PAD. However, our NHLBI-funded observational longitudinal study of functional decline in PAD showed that overweight and obese PAD participants who combined weight loss with walking exercise had significantly less functional decline than those who walked for exercise but did not lose weight. Therefore, we hypothesize that among people with PAD who are overweight or obese, a weight loss intervention combined with exercise will improve walking ability more than exercise alone. However, the effects of intentional weight loss in overweight or obese people with PAD are unknown and may not be beneficial if weight loss exacerbates PAD-related sarcopenia. Behavior change that achieves sustained weight loss is particularly challenging in older obese people with chronic disease. Therefore, among people with PAD and BMI>28 kg/m2, we will conduct a randomized clinical trial to test the hypothesis that a weight loss intervention combined with walking exercise achieves greater improvement in functional performance than exercise alone at 12-month follow-up.

Diane Treat-Jacobson
NA
This study is NOT accepting healthy volunteers
NCT04228978
STUDY00006194
Overweight or Obesity, Peripheral Artery Disease
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ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP)

This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.

Gregory Vercellotti
Post Approval
This study is NOT accepting healthy volunteers
NCT04883905
STUDY00012826
Acute Hepatic Porphyria
AHP, Acute hepatic porphyria, Clinics and Surgery Center (CSC), Givosiran
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Study of Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant (Prevent)

All
1 Year and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT05305040
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Key
Inclusion Criteria:

• ≥1 year of age at the day of screening visit.
• No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
• Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
• Meet one or more of the following criteria at the time of randomization:
• Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
• Haploidentical donor
• Matched or Mismatched unrelated donor
• Use of umbilical cord blood as stem cell source
• Ex vivo graft manipulation resulting in T cell depletion
• Received anti-thymocyte globulin or alemtuzumab (Campath-1H) Key
Exclusion Criteria:

• History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
• Evidence of active Grade >2 acute GVHD
• Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
• Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day) within 24 hours prior to dosing
• Relapse of primary malignancy other than minimal residual disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Biological: Posoleucel (ALVR105), Biological: Placebo
Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection, JC Virus Infection
Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel, Viralym-M
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Does Social Buffering Continue to be Effective Over the Peripubertal Period When Friends Share the Stressor Experience?

The purpose of this experiment is to determine whether social buffering of stress physiology by friends remains effective later in puberty when the friend shares the load versus when they provide support but are not undergoing the stressor with the target child. There are four conditions: (1) Friend and Target both undergo the stressor, (2) Friend provides support but does not undergo the stressor, (3) Unfamiliar Peer and Target undergo the stressor, and (4) Alone (no partner).

All
11 Years to 14 Years old
N/A
This study is also accepting healthy volunteers
NCT04311996
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Inclusion Criteria:

• sufficient vision, hearing, and language skills to provide verbal and written assent
• ability to see and read stimuli presented on the computer screen
• ability to hear verbal instructions provided by the experimenter and judges
Exclusion Criteria:

• premature birth (less than 37 weeks)
• congenital and/or chromosomal disorders (e.g. cerebral palsy, FAS, mental retardation, Turner Syndrome, Down Syndrome, Fragile X)
• Autism Spectrum Disorders
• history of serious medical illness (e.g., cancer, organ transplant)
• serious psychiatric illness
• systemic glucocorticoids or beta-adrenergic medication use
Other: Questionnaires, Other: TSST
Adolescent Behavior, Social Stress
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EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature driven Analysis

Phase III
This study is NOT accepting healthy volunteers
NCT03793179
0123456789
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
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State Representation in Early Psychosis (STEP)

Our Center will focus on the unifying hypothesis that processes underlying state representation dysfunction are relevant to psychosis, providing a window into pathophysiologic heterogeneity and precision treatment. Our Center will study three species (nonhuman primates, mice, and humans) using eight methodologies (genetic manipulations, slice physiology, ensemble recordings, LFP, behavior, EEG, fMRI, cognitive training). We will use a central computational perspective to translate and integrate across species and methodologies: Changes in neural information processing that affect parameters underlying attractor dynamics and influence state representation processes. Such changes create observable effects in behavior and neurophysiology, which we will study through the lens of attractor network models to inform our understanding of pathophysiologic heterogeneity, clinical trajectories, and precision treatment.

All
15 Years to 40 Years old
N/A
This study is also accepting healthy volunteers
NCT05273164
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Inclusion Criteria:

• English proficiency, as determined by staff observation and participant self-report
• Estimated IQ at or above 70, as estimated by the cognitive assessments Additional Inclusion Criteria for Early Psychosis Participants:
• Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis, with onset of psychotic symptoms within the previous 5 years
• Achieved clinical stability, defined as outpatient status for at least one month prior to study participation plus clinically stable doses of psychiatry medications for at least one month prior to study participation
Exclusion Criteria:

• Unable or unwilling to provide informed consent
• The participant is unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
• Participant is pregnant
• Participant is illiterate
• Cannot pass the CMRR Subject Safety Screen due to MRI contraindications
• Presence of a major neurological disorder
• Previous clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-Is
• Meets criteria for substance or alcohol dependence within 3 months of enrollment
• The presence of any major medical condition that, in the opinion of the PI/Co-Is, would impede participation in the study or would put the participant at additional risk by participating Additional Exclusion Criteria for Early Psychosis Participants:
• Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is
• Meets criteria for clinical risk of suicidal behavior, as defined by:
• Clinician judgement
• A suicide attempt within 6 months of enrollment
• Active suicidal ideation at screening or baseline, as indicated by the C-SSRS
• Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment, as indicated by the C-SSRS Additional Exclusion Criteria for Control Participants:
• Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorder
• Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder
Device: Computerized Cognitive Training
Psychosis, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Schizoaffective Disorder
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Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

All
up to 17 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT04851717
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Inclusion Criteria:

• Signed informed consent form and/or assent and willingness of patient and parent(s) to participate in the trial.
• In US sites: Paediatric male or female patients, aged ≥3 and <18 years scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial.
• In European sites: Paediatric male or female patients, aged full term birth to <18 years scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial.
• Maximum planned duration of procedure: 2 hours
• ASA Physical Status I-III
• Planned spontaneous breathing during sedation
• A female who is of child bearing potential (i.e. after menarche) and sexually active must use a highly effective method of birth control during the trial period (from the time of consent until all specified observations are completed)
• Negative pregnancy test at screening and on treatment day -
Exclusion Criteria:

• Emergency procedures
• Condition/procedure that requires planned airway control via endotracheal tube or LMA/IGEL insertion
• Cranio-facial malformation, which would severely limit the possibilities for emergency airway rescue
• Other abnormalities relating to the airway (including large tonsils and anatomical abnormalities of upper airway or lower airway) which may compromise emergency airway rescue
• Known hypersensitivity to benzodiazepines, flumazenil, dextran or any of the ingredients of the drug product
• Known paradoxical reactions to benzodiazepines
• History of sleep apnoea
• Active respiratory failure
• Active neuromuscular disease
• Active cardiac failure
• Active hepatic failure
• Breast feeding females
• Prohibited medication
• Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the trial for any other reason
Drug: Remimazolam
Pediatric ALL
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Maternal Metabolism, Breastmilk Composition, and Transmission to Infants

This is a pilot prospective cohort study of the differences between women with and without diabetes during pregnancy in their breast milk composition (microbiome and hormone composition), and test for group differences in the relationship of breast milk composition to infant gut microbiome characteristics, weight gain, and body composition. Women with diabetes during pregnancy (N=50) will be recruited de novo in this study, while women without diabetes (N=100) already have been enrolled and have provided consent for all necessary data involved in the comparison with the diabetic women, except that the non-diabetic women have not provided consent for the meta-genomic sequencing analysis and so will provide that consent under this protocol.

Ellen Demerath
All
Not specified
Pilot
This study is also accepting healthy volunteers
NCT03522597
STUDY00002127
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Inclusion Criteria:
(For new enrollment of 50 pregnant women with gestational diabetes and their infants. Enrollment of normal weight and obese cohort comparators already accomplished under ClinicalTrial NCT03301753):
• Pregnant women
• age 21-45 at time of delivery
• report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior), and if parity >1, that they successfully breastfed after a previous pregnancy for at least 3 months
• singleton pregnancy
• known gestational diabetes Definition of Gestational Diabetes: 1) an elevated glucose challenge test >200 mg/dL or 2) two abnormal values on the glucose tolerance test according to Carpenter-Coustan criteria.
Exclusion Criteria:

• alcohol consumption >1 drink per week during pregnancy/lactation
• tobacco consumption during pregnancy/lactation,
• inability to speak/understand English
• known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding
• planned delivery at a site other than the University of Minnesota Medical Center- West Bank campus.
• preexisting diabetes
Obesity, Diabetes, Gestational
Obesity, Gestational Diabetes, Breast Milk, Microbiome, Infant Growth
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Characterization of spleen motion and anatomy using imaging and sensors

This research is being performed to examine how the spleen moves during breathing in various body positions and breathing conditions. Physical measurements of the participant's body will be recorded (weight, height, and body dimensions) and then noninvasive recordings of the spleen and breathing patterns will be recorded. The spleen motion will be measured using standard abdominal ultrasound imaging, and breathing will be measured with accelerometers (small devices about the size of a quarter that measure the movement of the chest during breathing).

Hubert Lim
NA
ENT-2021-29988
STUDY00013252
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MT2015-17 :Transplantation of Umbilical Cord Blood from Unrelated Donors in Patients With Hematological Diseases Using a Non-Myeloablative Preparative Regimen

The primary objective is to estimate the probability of grade II-IV acute GVHD at Day 100 after unrelated donor umbilical cord blood transplantation using a non-myeloablative preparative regimen along with Sirolimus/MMF for GVHD prophylaxis in persons with hematologic malignancies.

Margaret MacMillan, MD
All
up to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02722668
1603M84843
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Inclusion Criteria:

• Age, Performance Status, and Graft Criteria
• <70 years of age with no matched 5/6 or 6/6 sibling donor - patients ≥ 70 and ≤ 75 years of age may be eligible if they have a Co-Morbidity score ≤ 2 (http://www.qxmd.com/calculate-online/hematology/hct-ci)
• Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (< 16 years)
• UCB graft selected according to current University of Minnesota umbilical cord blood graft selection algorithm
• Eligible Diseases All diseases listed below are advanced hematologic malignancies not curable by conventional chemotherapy. Responses to conventional treatment range from zero to 30% but are typically short lived.
• Acute Leukemias: Must be in remission by morphology (<5% blasts). Note cytogenetic relapse or persistent disease without morphologic relapse is acceptable. Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.
• Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients > 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk. Favorable risk AML is defined as having one of the following:
• t(8,21) without cKIT mutation
• inv(16) or t(16;16) without cKIT mutation
• Normal karyotype with mutated NPM1 and wild type FLT-ITD
• Normal karyotype with double mutated CEBPA
• Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation
• Acute lymphoblastic leukemia (ALL)/lymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL. High risk ALL is defined as having one of the following:
• Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1
• 30 years of age or older at diagnosis
• White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis
• CNS leukemia involvement during the course of disease
• Slow cytologic response (>10% lymphoblasts in bone marrow on Day 14 of induction therapy)
• Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy
• Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR
• Chronic myelogenous leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (<5% blasts): Chronic phase patients must have failed at least two tyrosine kinase inhibitors, been intolerant to all available TKIs, or have T315I mutation.
• Myelodysplastic syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC < 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be < 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to <5% blasts prior to transplantation.
• MRD positive leukemia (AML, ALL or accelerated/blast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.
• Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.
• Burkitt's lymphoma in CR2 or subsequent CR
• Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR/PR that has failed or ineligible for an autologous transplant.
• Natural killer cell malignancies
• Large-cell lymphoma, Hodgkin lymphoma and multiple myeloma with chemotherapy sensitive disease who are ineligible for an autologous transplant.
• Relapsed Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for debulking chemotherapy before transplant. Patients with refractory disease are eligible, unless bulky disease and an estimated tumor doubling time of less than one month.
• Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy if chemotherapy sensitive.
• Relapsed Multiple Myeloma that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.
• Plasma Cell Leukemia after initial therapy if achieved at least in partial remission; or relapsed and achieved subsequent remission (CR/PR)
• Acquired Bone marrow failure syndromes, except for Fanconi anemia
• Myeloproliferative Neoplasms/Myelofibrosis
• Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.
• Additional Criteria for Bulky Disease (lymphomas)
• If stable disease is best response, the largest residual nodal mass must < 5 cm (approximately)
• If response to previous therapy, the largest residual mass must represent a 50% reduction and be < 7.5 cm (approximately)
• Organ Function Criteria Adequate organ function is defined as:
• Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.
• 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.
• Liver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg/dL except for patients with Gilbert's syndrome or hemolysis
• Renal: Creatinine ≤ 2.0 mg/dl (adults) and creatinine clearance ≥ 40 mL/min (pediatrics). Adults with a creatinine > 1.2 mg/dl or a history of renal dysfunction must have estimated creatinine clearance ≥ 40 ml/min/1.73m^2. Adequate performance status is defined as Karnofsky score ≥ 70% (≥ 16 years of age) or Lansky score ≥ 50 (pediatrics)
• Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment.
• Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
Exclusion Criteria:

• Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
• Untreated active infection
• Active HIV infection or known HIV positive serology
• Less than 3 months since prior myeloablative transplant
• Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.
• CML in blast crisis
• Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.
• Active central nervous system malignancy
Drug: Fludarabine, Drug: Cyclophosphamide, Drug: MMF, Drug: Sirolimus, Radiation: TBI, Biological: Umbilical cord blood cell infusion, Biological: ATG
Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia/Lymphoma, Burkitt's Lymphoma, Natural Killer Cell Malignancies, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Large-cell Lymphoma, Hodgkin Lymphoma, Multiple Myeloma, Relapsed Chronic Lymphocytic Leukemia, Relapsed Small Lymphocytic Lymphoma, Marginal Zone B-cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-cell Lymphoma, Prolymphocytic Leukemia, Bone Marrow Failure Syndromes, Myeloproliferative Neoplasms/Myelofibrosis, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, MRD Positive Leukemia, Leukemia or MDS in Aplasia, Relapsed T-Cell Lymphoma, Relapsed Multiple Myeloma, Plasma Cell Leukemia
Clinics and Surgery Center (CSC), AML, ALL, CML, CLL, SLL
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Assistive Technology and Functional Outcomes Following Spinal Cord Injury

The purpose of this study is to begin to build empirical evidence needed to support adequate funding of assistive technology (AT) for both veterans and civilians with SCI. Information gathered from this mixed-methods investigation will be used as a foundation to develop population-specific tailored information and interventions to improve access to and utilization of AT.

Kimberley Monden
18 Years and over
NA
This study is NOT accepting healthy volunteers
PMR-2021-29956
STUDY00011544
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Inclusion Criteria:

• You are between 18 and 65 years of age
• You are living with tetraplegia (C7 or higher) and have limited hand function
• You are greater than 1-year post-spinal cord injury
• You are fluent in English
Exclusion Criteria:

• Spinal cord disorder (e.g., ALS, MS, transverse myelitis, Guillain-Barre)
• SCI without neurologic impairment (i.e., ASIA Impairment Scale E ? normal motor and sensory function)
• Severe cognitive impairment
• Active military personnel
Community Health, Prevention & Wellness
assistive technology, quadriplegia, spinal cord injury, tetraplegia
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EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis

The purpose of this research study is because Cystic Fibrosis Related Diabetes (CFRD) has been identified by the cystic fibrosis (CF) community as one of the top ten priorities for CF research. We know that high blood sugars caused by not enough insulin lead to worse lung function in CF even before diabetes develops. However, we do not know which people with abnormal blood sugars will have long term problems.

Amir Moheet
All
6 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03650712
STUDY00004854
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Inclusion Criteria:

• Age >/= 6 years
• Diagnosis of cystic fibrosis
• CF patients regularly attending the CF centers
• Clinically stable in previous 3wks:
• absence of major clinical events including pulmonary exacerbations,
• no change in their habitual treatment regimen including introduction of antibiotics or steroids in the past 3 weeks
Exclusion Criteria:

• Diagnosis of type 1 diabetes, type 2 diabetes, or MODY
• Organ transplantation
• new diagnosis of CFRD in the past 6 months
• antidiabetic treatment in past 6 mos (insulin or oral hypoglycemic agents) -patients with previous CFRD diagnosis, but not currently taking insulin/glucose-lowering medications for at least 6 months should be included
• pulmonary exacerbation associated with systemic steroid requirement in the last 6 months
• on CFTR corrector less than 6 months prior to enrollment
Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Continuous glucose monitoring, Diagnostic Test: Dexa scan
Cystic Fibrosis-related Diabetes
cystic fibrosis, insulin, glucose, children, abnormal glucose tolerance, impaired glucose tolerance, indeterminate glycemia, diabetes
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Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure

Smokeless tobacco users who are unable or unwilling to quit tobacco use may be exposed to the potent oral and esophageal carcinogen NNN not only from tobacco itself, but also via its endogenous synthesis from nornicotine. The proposed study will lead to an understanding of the endogenous formation of NNN from nornicotine in humans, and will also investigate the effect of the reduction of nornicotine content in smokeless tobacco on the extent of endogenous NNN formation. The knowledge gained in this study will lead to the development of recommendations for the regulation, or potentially elimination, of nornicotine in smokeless tobacco products in order to minimize exposure to NNN in the users of these products.

Irina Stepanov
NA
This study is also accepting healthy volunteers
NCT03998735
STUDY00002464
Smokeless Tobacco
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