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MT2019-21 - A Phase II Trial of Tisagenlecleucel in First-Line High-Risk (HR) Pediatric and Young Adult Patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) Who are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy Protocol No: AALL1721, CCTL019G2201J (CASSIOPEIA)
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening phase, enrollment, pre-treatment phase, treatment & follow-up phase, and relapse & survival follow-up phase.
Peter Gordon
1 year to 25 years old
STUDY00009551
Inclusion Criteria:
CD19 expressing B-cell Acute Lymphoblastic Leukemia
De novo NCI HR B-ALL who received first-line treatment and are MRD ≥ 0.01% at EOC. EOC bone marrow MRD will be collected prior to screening and will be assessed by multi-parameter flow cytometry using central laboratory analysis.
Age 1 to 25 years at the time of screening
Lansky (age < 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60%
Adequate organ function during the screening period:
A. Renal function based on age/gender B. ALT ≤ 5 times ULN for age C. AST ≤ 5 times ULN for age D. Total bilirubin < 2 mg/dL (for Gilbert's Syndrome subjects total bilirubin < 4 mg/dL)
E. Adequate pulmonary function defined as:
no or mild dyspnea (≤ Grade 1)
oxygen saturation of > 90% on room air F. Adequate cardiac function defined as LVSF ≥ 28% confirmed by echocardiogram or LVEF ≥ 45% confirmed by echocardiogram or MUGA within 6 weeks of screening
Prior induction and consolidation chemotherapy allowed: 1st line subjects: ≤ 3 blocks of standard chemotherapy for first-line B-ALL, defined as 4-drug induction, Berlin-Frankfurt-Münster (BFM) consolidation or Phase 1b, and interim maintenance with high-dose methotrexate.
Exclusion Criteria:
M3 marrow at the completion of 1st line induction therapy
M2 or M3 marrow or persistent extramedullary disease at the completion of first-line consolidation therapy or evidence of disease progression in the peripheral blood or new extramedullary disease prior to enrollment. Patients with previous CNS disease are eligible if there is no active CNS involvement of leukemia at the time of screening.
Philadelphia chromosome positive ALL
Hypodiploid: less than 44 chromosomes and/or DNA index < 0.81, or other clear evidence of a hypodiploid clone
Prior tyrosine kinase inhibitor therapy
Subjects with concomitant genetic syndromes associated with bone marrow failure states: such as subjects with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Subjects with Down syndrome will not be excluded.
Subjects with Burkitt's lymphoma/leukemia (i.e. subjects with mature B-ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
Has had treatment with any prior anti-CD19 therapy 9. Treatment with any prior gene or engineered T cell therapy
Other protocol-defined inclusion/exclusion may apply.COG AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
This phase II trial studies how well combination chemotherapy works in treating patients (≤ 30 years old) with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).This trial may help doctors find out what effects, good and/or bad, regimen UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT)and regimen ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Emily Greengard
Up to 30 years old
SITE00001038
Inclusion Criteria:
Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN03B2 and have received an initial risk assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a delayed nephrectomy classification showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on AREN03B2 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.
Patients must be =< 30 years old at study enrollment
Patients with the following diagnoses are eligible for this study:
Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:
Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine
High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan
Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations
Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required
Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy
Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery/biopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy
Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment
Patients must have a performance status corresponding to Eastern 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 life expectancy of >= 8 weeks
Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:
Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy
Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the AREN03B2 initial risk assignment results (if available per current version of AREN03B2)
Treatment consisting of vincristine/doxorubicin/cyclophosphamide initiated on an emergent basis and within allowed timing as described
Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible
Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study
Radiation therapy (RT): >= 2 weeks (wks) must have elapsed for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria
Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)
Peripheral absolute neutrophil count (ANC) >= 750/uL (performed within 7 days prior to enrollment)
Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)
Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment)
Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE/Cyclo/Topo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement:
Creatinine clearance or radioisotope GFR >= 60 mL/min/1.73 m^2 (performed within 7 days prior to enrollment)
Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR >= 60 mL/min/1.73 m^2), or an adequate serum creatinine as per the following table:
Age: Maximum Serum Creatinine (mg/dL)
1 month to < 6 months: 0.4 (male and female)
6 months to < 1 year: 0.5 (male and female)
1 to < 2 years: 0.6 (male and female)
2 to < 6 years: 0.8 (male and female)
6 to < 10 years: 1 (male and female)
10 to < 13 years: 1.2 (male and female)
13 to < 16 years: 1.5 (male), 1.4 (female)
>= 16 years: 1.7 (male), 1.4 (female)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age or direct bilirubin =< ULN for patients whose total bilirubin > 1.5 x ULN (performed within 7 days prior to enrollment)
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age or =< 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment)
Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)
Exclusion Criteria:
Patients with a history of bilateral Wilms tumor (synchronous or metachronous)
Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)
Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy
For patients with high-risk or very high-risk relapsed FHWT:
Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate =< 2 mg/dL (or < 0.8 mmol/L) without supplementation
For stages 2-4 DAWT and standard-risk relapsed FHWT patients:
Chronic inflammatory bowel disease and/or bowel obstruction
Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participationCharacterization 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
18 years and over
STUDY00013252
Inclusion Criteria:
• at least 18 years old
Exclusion Criteria:
• individuals who have had a splenectomy
• people with breathing difficulties and/or individuals for whom short breath holds and modification of breathing patterns is difficult or uncomfortable
• unable to maintain five body positions: sitting, sitting with a 45 degree recline, laying on back (supine), laying on right side, and laying face down (prone) comfortably and independently
• unable to speak and read English
Digestive & Liver Health
Imaging, Spleen
A randomized phase II trial of adjuvant Pembrolizumab versus observation following curative resection for stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153
The primary objective is to evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves disease free survival compared with observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size, regardless of PD-L1 TPS score.
Amit Kulkarni
18 years and over
STUDY00010745
Inclusion Criteria:
• at least 18 years old
• diagnosis of non-small cell lung cancer (NSCLC)
• tumor size between 1 and 4 cm in size -had complete surgical resection of stage I NSCLC between 4-12 weeks ago
• able to walk and carry out basic activities of living
• women are willing to use highly effective birth control for 120 days after last dose of study drug
• certain laboratory values are required (study staff will review)
Exclusion Criteria:
• chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer
• active additional cancer that is progressing or has required treatment within the past 3 years
• diagnosis of immunodeficiency or receiving chronic steroid therapy
• women who are pregnant or breast feeding
• other active diseases (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Lung Cancer, Lung Cancer, Non-small Cell Lung Cancer (NSCLC)
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study (CHOLINE4)
This is a double-blind randomized placebo-controlled clinical trial examining choline supplementation in 2-5 year old children with Fetal Alcohol Spectrum Disorders. Outcome measures are neurocognitive tests of memory, attention, and behavior.
Jeffrey Wozniak
Up to 18 years old
SITE00000121
Inclusion Criteria:
• ages 2.5 years to 5 years old (<6 years of age)
• prenatal alcohol exposure
Exclusion Criteria:
• history of a neurological condition (epilepsy, traumatic brain injury)
• history of a medical condition known to affect brain function
• other neurodevelopmental disorder (autism, Down syndrome)
• history of very low birthweight (<1500 grams)
Mental Health & Addiction
Fetal Alcohol Spectrum Disorders
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
STUDY00008687
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
MT2021-01: PTCy + Sirolimus/VIC-1911 as GVHD prophylaxis in myeloablative PBSC transplantation
The primary objective of this study is to determine the optimal dose of VIC-1911 when given in combination with standard immunosuppressive therapy in adult patients undergoing myeloablative stem cell transplantation.
Shernan Holtan
18 years and over
STUDY00015049
Inclusion Criteria:
Diagnosis of
acute leukemia in complete remission, or
myelodysplasia with <5% blasts, or
myeloproliferative neoplasm/myelofibrosis with <5% marrow or circulating blasts
chemosensitive Hodgkin or non-Hodgkin lymphoma
Age 18 years or older
Performance status of ≥ 80% Karnofsky
Adequate organ function within 28 days of study registration defined as:
left ventricular ejection fraction ≥ 45%
pulmonary function with FEV1, FVC, and DLCO ≥ 50% predicted
AST and ALT < 2 times upper limit of normal
Total bilirubin <1.5 times the upper limit of normal. If the patient is suspected of having Gilbert syndrome, they require prior approval of the medical monitor
creatinine clearance ≥ 50cc/min
no active/uncontrolled infection
negative HIV, HBV and HCV
ferritin < 2000 ng/ml
Patients able to tolerate oral medication
Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment through 60 days after the last treatment of VIC-1911 or sirolimus
Able to provide written voluntary consent prior to the performance of any research related tests or procedures
Exclusion Criteria:
HCT-CI > 4 or unable to receive myeloablative TBI
Use of planned post-transplant maintenance therapy to begin prior to day +75. Patients may receive standard of care maintenance therapies starting at day
+75 or later
Patients with a history of hypersensitivity to any of the investigational products
Pregnant or breastfeeding as agents used in this study are Pregnancy Category
o C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations, and Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 28 days of study registration.
Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 60 days after the last treatment of VIC-1911 or sirolimus Clinics and Surgery Center (CSC)
A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study (COMPLETE TAVR)
The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes.
Greg Helmer
18 years and over
STUDY00012707
Inclusion Criteria:
• at least 18 years old
• diagnosis of severe symptomatic aortic valve stenosis and coronary artery disease
• successful transfemoral transcatheter aortic valve replacement (TAVR) defined as the implantation of a single transcatheter aortic valve within the past 96 hours
Exclusion Criteria:
• percutaneous coronary intervention (PCI) already completed less than 90 days before TAVR
• planned PCI or cardiac surgery
• additional significant heart or medical diagnosis (study team will review)
Heart & Vascular
Clinics and Surgery Center (CSC), Aortic Stenosis, Coronary Artery Disease, TAVR, transfemoral transcatheter aortic valve replacement
MT2020-28: Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study
The purpose of this study is to learn whether the use of Pregnyl with the drug ruxolitinib is able to reduce the need for high dose steroids to treat severe acute Graft versus Host Disease (GVHD).
Shernan Holtan
12 years and over
STUDY00014365
Inclusion Criteria:
HCT recipients over 12 years of age within the first 7 days of initial treatment of high-risk aGVHD, defined as:
Newly diagnosed Minnesota high-risk aGVHD -OR-
Newly diagnosed Minnesota standard risk aGVHD with plasma amphiregulin ≥ 33 pg/ml tested at the UMN Cytokine Reference Lab. For amphiregulin lab ordering information, see Fairview Lab Guide: http://labguide.fairview.org/showtest.asp?testid=6766&format=long -OR-
Newly diagnosed Minnesota standard risk aGVHD Ann Arbor 3 biomarkers tested by Viracor. For ordering information, see: https://www.viracor-eurofins.com/test-menu/403572p-agvhd-symptomatic- onset-algorithm/
Renal: Serum creatinine ≤2.5x upper limit of normal (ULN)
Cardiac: Left ventricular ejection fraction (LVEF) ≥ 35%
Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17-year-olds).
Exclusion Criteria:
Progressive malignancy
Uncontrolled bacterial, fungal, parasitic, or viral infection at initiation of protocol treatment
Unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations)
Unwilling or unable to stop GnRH antagonists, aromatase inhibitors, or anti-androgens
History of a hormone responsive malignancy
Current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible
Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
Pregnancy
Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment Clinics and Surgery Center (CSC)
Investigation of Persistent HIV Immune Stimulation in Lymphoid Tissues During Therapy as a Cause of Sustained Immune Activation
Even when HIV levels are suppressed in the blood, HIV infection continues to cause immune system activation that can lead to other health problems in people living with HIV. In this study, we want to recruit people living with HIV but also HIV-negative participants. We want to see if there is a relationship between the levels of HIV medications within cells, how many cells in the body are still producing HIV, and how the immune system continues to be activated. We need HIV-negative participants so we can compare tissues and understand the findings. The study involves two to three visits. The first visit is consent and screening which requires a blood sample. The second visit (and potentially third if the procedures are split up in different days) involves the procedures which are: a blood draw, a stool sample, a lymph node biopsy, and a colonoscopy with biopsy. There is compensation for participating.
Timothy Schacker
18 years and over
STUDY00009216
Inclusion Criteria:
• At least 18 years of age
• HIV infection
• Receiving an ART regimen
• Able to provide written voluntary consent before performance of any study related procedure.
Exclusion Criteria:
• BMI greater or equal to 30
• Currently taking anticoagulant blood thinners such as warfarin, enoxaparin, heparin
• Pregnant or breastfeeding
• Adults lacking capacity to consent and/or adults with diminished capacity to consent, including, but not limited to, those with acute medical conditions, psychiatric disorders, neurologic disorders, developmental disorders, and behavioral disorders.
• More than 3 pervious lymph node biopsies for the main study. No more than 2 lymph nodes for the sub-study.
Infectious Diseases
HIV, immune activation, immune response
Plasticity of motor systems in early stage Parkinson's disease
The purpose of this project is to provide new knowledge of the relationship between structural and functional changes in cortico-basal ganglia pathways and the severity of motor and non-motor deficits in humans with PD.
Colum MacKinnon
18 years and over
STUDY00008043
Inclusion Criteria:
Inclusion Criteria For PD Group:
• Diagnosis of Parkinson's disease
• Not taking medication to treat Parkinson's
• Age: 21-75 years
• Able to walk independently Inclusion Criteria For Control Subject Group: Age and sex matched to participants with PD and able to walk independently
Exclusion Criteria:
Exclusion criteria for PD group:
• Dementia diagnosis
• History of musculoskeletal disorders
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
• Other significant neurological disorders that may affect participation or performance in the study
• Implanted DBS or other neurosurgeries to treat PD
• Pregnant women
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment Exclusion Criteria for Control subject Group: same as exclusion criteria of PD group
Brain & Nervous System
Parkinson
ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation (ZEUS)
We are doing this study to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for 2.5 to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Daniel Duprez
18 years and over
SITE00001298
Inclusion Criteria:
• diagnosis of chronic kidney disease (there are specific lab values required)
• evidence of atherosclerotic cardiovascular disease (ASCVD) i.e. coronary heart disease, cerebrovascular disease, or symptomatic peripheral artery disease (PAD)
Exclusion Criteria:
• clinical evidence active infection
• myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within past 60 days
• planned coronary, carotid or peripheral artery revascularisation
• major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days
Heart & Vascular, Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Cardiovascular Risk, Chronic Kidney Disease, Heart Disease, Inflammation
PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.
Emily Greengard
12 months to 30 years old
SITE00001347
Inclusion Criteria:
PART A: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
PART B: Patients must be >= 12 months and =< 30 years of age at the time of study enrollment
Patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse
PART A: Patients with relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors
PART B: Patients with recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations. For the Wnt pathway aberrations cohort we will include the most common CTNNB1 mutations (S37F, S45F, T41A, S45P, S33C, S37C, D32Y, S33F, T41I, G34R, G34V, D32N, S33P, G34E, D32G) as well as any loss of function mutations in the APC, Axin2FBXW7, TCF7L2, and RNF43 genes or any gain-of-function mutations in the GSK3B, LRP6, and LGR5 genes. For patients without prior sequencing, immunohistochemistry (IHC), is required. IHC showing strong nuclear beta-catenin staining will be accepted for the following tumor types: colorectal carcinoma, melanoma, endometrial cancer, ovarian cancer, neuroblastoma, non-Hodgkin lymphoma, pancreatic ductal adenocarcinoma, and solid pseudopapillary tumor of the pancreas
PART A: Patients must have either measurable or evaluable disease. For desmoid tumors, the patient must have disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk/benefit to the patient to participate in the trial
PART B: Patients must have measurable disease. For desmoid tumors, the patient must have measurable disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk/benefit to the patient to participate in the trial
Patients must have a performance status corresponding to Eastern 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 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)
Non-Hodgkin lymphoma patients
A waiting period prior to enrollment is not required for patients receiving standard maintenance chemotherapy (i.e., corticosteroid, vincristine, thioguanine [6MP], and/or methotrexate)
>= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy
NOTE: Cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy
Anti-cancer 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
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., 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: >= 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.).
External beam 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, iobenguane I-131 [131I MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy
Patients must not have received prior exposure to tegavivint
PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to enrollment)
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) (within 7 days prior to enrollment)
PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions) (within 7 days prior to enrollment)
Patients with known bone marrow metastatic disease will be eligible for study provided they meet 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 on Part A 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 (within 7 days prior to enrollment):
Age; maximum serum creatinine
Age 1 to < 2 years; 0.6 mg/dL (male); 0.6 mg/dL (female)
Age 2 to < 6 years; 0.8 mg/dL (male); 0.8 mg/dL (female)
Age 6 to < 10 years; 1 mg/dL (male); 1 mg/dL (female)
Age 10 to < 13 years; 1.2 mg/dL (male); 1.2 mg/dL (female)
Age 13 to < 16 years; 1.5 mg/dL (male); 1.4 mg/dL (female)
Age >= 16 years; 1.7 mg/dL (male); 1.4 mg/dL (female)
PATIENTS WITH SOLID TUMORS: Bilirubin (sum of conjugated + unconjugated or total) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
PATIENTS WITH SOLID TUMORS: Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L (within 7 days prior to enrollment)
PATIENTS WITH SOLID TUMORS: Albumin >= 2 g/dL (within 7 days prior to enrollment)
Exclusion Criteria:
Pregnant or breast-feeding women will not be entered on this study 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
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 currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to the 1st dose of tegavivint to the end of the study
Patients who have received bisphosphonates within 4 weeks prior to study enrollment will be excluded
Patients who have received denosumab within 180 days prior to study enrollment will be excluded
Patients with primary brain tumors are ineligible
Patients with known central nervous system (CNS) metastasis, except for craniopharyngeal tumors, will be excluded
Patients with a known metabolic bone disease (ex: hyperparathyroidism, Paget's disease, osteomalacia) are not eligible
Patients with a disorder associated with abnormal bone metabolism will be excluded
Patients with grade >= 2 hypocalcemia that is not corrected with oral calcium supplementation will be excluded
Patients with vitamin D < 20 ng/mL will require supplementation, or will otherwise be excluded. Patients must agree to take vitamin D +/- calcium supplements (if necessary) according to institutional or published guidelines. Additional calcium supplementation is not required if adequate dietary intake can be ascertained
Patients with pre-existing grade 3 osteoporosis are excluded
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 eligibleA Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults with Spinal Cord Injury
Almost 300,000 Americans with a spinal cord injury or disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function, which can compromise functional independence and quality of life. The purpose of this study is to find better treatment options for improving sensation and movement after SCI/D.
Ann Van de Winckel
18 years and over
STUDY00014710
Inclusion Criteria:
• 18 to 75 years old
• incomplete or complete SCI/D of more than 3months
• medically stable.
Exclusion Criteria:
• MRI contra-indications (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder
• cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevents following directions or learning
• ventilator dependent
• other major medical complications
• pregnant women
Brain & Nervous System
movement, sensation, spinal cord injury, SCI
Site for ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
We are continuing to study the SARS-CoV-2 coronavirus and the evolving new variants. We are looking at drugs that have Food and Drug Administration (FDA) approval for other uses. The goal is to determine if these drugs can make participants who get the coronavirus feel better faster and reduce death and hospitalizations.
Carolyn Bramante
30 years and over
SITE00001271
Inclusion Criteria:
• at least 30 years old
• confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days before starting study
• two or more current symptoms of acute infection for no more than 7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
Exclusion Criteria:
• current or recent (within 10 days of starting study) hospitalization for COVID-19 infection
• current or planned participation in another interventional trial to treat COVID-19 (study physician will review)
• current or recent use (within the last 14 days) of study drug or study drug/device combination
COVID-19, Infectious Diseases
Primary Care, COVID, COVID-19
Biologic Abatement and Capturing Kids Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK OFF JSpA) (BACK-OFF JSpA)
This study is enrolling participants who have been diagnosed with juvenile spondyloarthritis, are taking a tumor necrosis factor inhibitor (TNFi) and have reached a clinically inactive disease state for a minimum of six months. Researchers want to know if children who have maintained inactive disease for at least 6 months can maintain quiet disease without taking their medication as frequently or stop the TNFi therapy. Quiet disease means that disease related symptoms are not active or being experienced in the patient. Researchers also want to know the safest method to bring patients off medication. If a flare does occur during therapy reduction, researchers want to find out whether they can predict when a flare is most likely to happen, and how quickly an inactive disease state can be recaptured.
Colleen Correll
Not specified
SITE00001260
Inclusion Criteria:
• age 8 to 21 years
• juvenile SpA diagnosis symptom with symptoms starting before their 16th birthday
• currently taking one of the following therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab) at standard doses
• have reached a clinically inactive state for at least 6 months
• English speaking or Spanish speaking
• willing to taper off medications
Exclusion Criteria:
• History of inflammatory bowel disease or history of uveitis
• psoriasis that started before TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
Arthritis & Rheumatic Diseases, Children's Health, Rare Diseases
arthritis, Juvenile Spondyloarthritis
Understanding the long term impact of COVID-19 on the brain by advanced MR imaging and spectroscopy
In this study, we want to learn more about what kinds of structural and chemical changes are happening in the nervous systems of people recovering from COVID-19 compared to people who have not been exposed to COVID-19.
Gulin Oz
18 years and over
STUDY00012571
Inclusion Criteria:
• Participants must be 18 years or older
• Participants must fall into one of the following groups: a) no known COVID-19 exposure (for controls), or b) laboratory confirmed COVID-19 who present with neurological symptoms in the months after infection and were either 1) non-hospitalized, or 2) hospitalized, but never underwent invasive (tube in throat) ventilation
• Participants must be English or Spanish speaking
• Participants must be able to provide written informed consent
Exclusion Criteria:
• Medical conditions likely to interfere with the study, including chronic neurologic conditions (such as Alzheimer disease, Parkinson's disease, ALS, HIV-Associated Neurocognitive Disorder, brain infections, or brain tumors), traumatic brain injury with loss of consciousness, end-stage kidney disease, end-stage liver disease, restless leg syndrome, chronic lung disease unrelated to COVID-19 needing oxygen, history of stroke unrelated to COVID-19, history of bipolar disorder or psychotic illness (such as schizophrenia or schizoaffective disorder)
• Individuals who had COVID-19 and required mechanical invasive ventilation
• Pregnant women
• Inability to undergo MRI scanning, including but not limited to claustrophobia, unable to remain still in an MRI scanner for more than 30 minutes, presence of metallic foreign bodies or pacemakers in body, weight over 350 lbs. *Study not registered on Clinicaltrials.gov
Brain & Nervous System, COVID-19
CMRR, COVID-19, Coronavirus, MRI, MRS, SARS-CoV-2, long COVID, long-term, neurological
Safety and efficacy of a self-administered treatment for MDD using an external combined occipital and trigeminal nerve stimulator (Relivion?DP). (MDD)
Ziad Nahas
18 years and over
SITE00001344
Inclusion Criteria:
• 18 to 70 years of age
• diagnosis of major depressive disorder
• have not had a good response to multiple treatments (study staff will review)
• currently on at least one antidepressant and be willing to stay on that dose for the time of the study
Exclusion Criteria:
• history of brain surgery
• have an implanted device
• history of a traumatic brain injury
• other current medical or psychiatric illness (study staff will review)
Mental Health & Addiction
Depression, MDD
Telehealth study assessing the removal of filter ventilation on smoking behavior and biomarkers
Dorothy Hatsukami
18 years and over
STUDY00012328
Inclusion Criteria:
• 21 years old or greater
• Current smoker
• Generally in good health
• Access to smartphone or tablet -Device capable of Telehealth visit
Mental Health & Addiction
Filter, Nicotine, Policy, Regulatory, Smoking, Tobacco, Ventilation
The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT) (SURPASS-CVOT)
Les Forgosh
18 years and over
STUDY00009070
Inclusion Criteria:
• diagnosis of type 2 diabetes
• confirmed atherosclerotic cardiovascular disease
• HbA1c between 7.0% and 10.5%
• body mass index (BMI) at least 25 kilograms per meter squared (kg/m?)
Exclusion Criteria:
• major cardiovascular event within the last 60 days
• type 1 diabetes
• history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
• planning treatment for diabetic retinopathy and/or macular edema
• planning a coronary, carotid, or peripheral artery revascularization procedure
• history of pancreatitis
• history of ketoacidosis or hyperosmolar state/coma
• undergone or currently planning gastric bypass (bariatric) surgery or restrictive bariatric surgery
• history of an active or untreated cancer or are in remission from cancer for less than 5 years
• blood transfusion or severe blood loss within last 90 days or have known hematological conditions that may interfere with HbA1c measurement
Diabetes & Endocrine, Heart & Vascular
Heart Disease, Type 2 Diabetes
Lifestyle Counseling and Medication for Adolescent Weight Management (QUEST)
This study will compare the effectiveness and durability of intensive behavioral counseling vs. medical management plus low-intensity behavioral counseling on BMI, body fat, cardiometabolic risk factors, and quality of life in adolescents with severe obesity. We hypothesize that Wegovy (semaglutide) plus low-intensity behavioral counseling will elicit superior reductions in BMI (primary efficacy endpoint) and body fat and greater improvement in cardiometabolic factors and quality of life compared to intensive behavioral counseling at 56 weeks.
Aaron Kelly
Up to 18 years old
STUDY00012932
Inclusion Criteria:
• ages 12-17
• BMI 35 kg/m2 or more or Body Mass Index 120% or more for 95th percentile for age and sex
Exclusion Criteria:
• Type 1 or Type 2 diabetes
• use of medications for obesity in the past 6 months
• any treatment with growth hormone
• bariatric surgery -major mental health diagnosis (study staff will review)
• pregnant or plan to become pregnant
• significant medical diagnosis (study staff will review)
Diabetes & Endocrine, Children's Health
Obesity, Overweight, weight loss
Bone as Regulator of Energy Balance and Male Fertility after SCI: A Pilot Study (Osteocalcin Protocol)
This study will evaluate if there is a relationship between bone health, fertility, and metabolism to help develop future treatments for SCI. Both men with and without SCI will be participating in this trial to better understand how bone health, fertility, and metabolism are impacted by an injury to the spinal cord.
Leslie Morse
18 years and over
STUDY00011054
Inclusion Criteria:
• Male age 18-50
• diagnosis of motor complete spinal cord injury (SCI)
• completed inpatient rehabilitation and living in the community
• use a wheelchair as primary mobility mode -English and non-English speakers
• For healthy volunteers: male age 18-50, able to walk independently, English and non-English speakers
Exclusion Criteria:
• presence of other neurological condition
• use of chronic ventilator support
• metabolic bone disease
• thyroid disorder
• current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year)
• study team will review additional exclusion criteria
• for Healthy Volunteers: presence of neurological condition, metabolic bone disease, thyroid disorder, current use of medications that potentially affect bone healthy, osteoporosis, diabetes, infertility, or other medical conditions (study staff will review)
Brain & Nervous System
Spinal Cord Injury
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.
Boris Winterhoff
18 years and over
STUDY00014893
Inclusion Criteria:
• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
Exclusion Criteria:
• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Advanced Solid Tumor, Endometrial Cancer, NSCLC, Ovarian Cancer
STRIKE-PE: A Prospective, Multicenter Study of the IndigoTM Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
The purpose of this study is to collect information on how patients with PE recover after treatment with the Indigo Aspiration System. The Indigo Aspiration System is a medical device that has been cleared by the U.S. Food and Drug Administration (FDA) for removing blood clots from the blood vessels throughout the body, excluding the head. The device is commercially available globally. Participants will be in this research study for about one year. Participants will be asked to complete a screening and baseline visit, device procedure in-patient visit as part of routine treatment for their PE, one post-procedure visit in the hospital and two follow-up visits. The study team will collect information on tests and procedures done during these visits from their medical records. They will also be asked to complete a quality of life questionnaire.
Christopher Jones
18 years and over
STUDY00013412
Inclusion Criteria:
• at least 18 years old
• diagnosis of acute PE within past 14 days or less
Exclusion Criteria:
• unable to take heparin
• Stage III/IV cancer or cancer which requires active chemotherapy
• women who are pregnant
• other exclusions apply, contact study staff for more information
Heart & Vascular, Respiratory System
PE, Pulmonary Embolism
MAYFLOWERS-0B-20: A Prospective Study Evaluating Maternal and FetaL Outcomes in the ERa of ModulatorS (MAYFLOWERS) (MAYFLOWERS)
This is a prospective, multi-center, observational study in pregnant women with cystic fibrosis (CF) to characterize forced expiratory volume in 1 second (FEV1) changes based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The key factors contributing to the change in lung function during pregnancy and for 2 years post-delivery will be evaluated along with assessment of fetal and maternal outcomes.
Joanne Billings
16 years and over
SITE00001209
Inclusion Criteria:
• at least 16 years old
• pregnant, intending to continue pregnancy
• enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
Exclusion Criteria:
• none
Rare Diseases, Respiratory System
Clinics and Surgery Center (CSC), Cystic Fibrosis, Pregnancy
MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases
This study is intended to determine the clinical benefit of tabelecleucel (EBV-specific cytotoxic T-lymphocytes) in subjects with EBV-associated diseases.
Joseph Maakaron
STUDY00013494
Inclusion Criteria:
Diagnosis of EBV+ disorder
Eastern Cooperative Oncology Group performance status <= 3 for participants aged >= 16 years; Lansky score >= 20 for participants from >=1 year to < 16 years
Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator
Cohort-specific Inclusion Criteria:
For participants with PID LPD:
R/R or newly diagnosed PID LPD for whom the standard first-line therapy is inappropriate, as determined by investigator. The LPD is confirmed by at least biopsy-proven EBV+ LPD or positive cerebrospinal fluid (CSF) cytology with or without radiographically measurable intracranial disease with EBV detected in CSF.
Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification (Cheson BD, et al. J Clin Oncol. 2014;27:3059) during or after treatment or failure to achieve a CR or partial response (PR) (defined by Lugano radiographic criteria) after standard first-line therapy
Participant may have systemic disease only, systemic and CNS disease, or CNS disease only
For participants with AID LPD:
R/R or newly diagnosed AID LPD for whom the standard first line therapy is inappropriate, as determined by the investigator. The LPD is confirmed by at least biopsy-proven EBV+ LPD or positive CSF cytology, with or without radiographically measurable intracranial disease, with EBV detected in CSF.
Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification during or after treatment or failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy
Participant may have systemic disease only, systemic and CNS disease, or CNS disease only
For participants with AID etiology or AID attributable to immunosenescence, objective laboratory evidence of immunodeficiency
For participants with CNS PTLD:
R/R or newly diagnosed EBV+ CNS PTLD for whom the standard first-line therapy is inappropriate, as determined by the investigator. The CNS PTLD is histologically confirmed by at least biopsy-proven EBV+ CNS PTLD or positive CSF cytology with or without radiographically measurable intracranial disease with EBV detected in CSF.
Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification during or after treatment or failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy
Participant may have systemic and CNS disease or CNS disease only
For participants with EBV+ PTLD, including CD20-negative disease:
Biopsy-proven EBV+ PTLD for whom standard first-line therapy (rituximab and/or chemotherapy) is inappropriate, as determined by the investigator
Participants must have systemic disease measurable per Lugano Classification criteria, except when contraindicated or mandated by local practice, then MRI may be used
For participants with sarcoma, including LMS, or smooth muscle tumors:
EBV+ sarcoma or smooth muscle tumor with rapidly progressive disease defined as progressive disease per RECIST 1.1 criteria as documented radiographically within a 6-month interval prior to enrollment
Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line therapy is inappropriate, as determined by the investigator
Biopsy-proven EBV+ sarcoma meeting one of the criteria's of pathologically confirmed EBV+ Leiomyosarcoma or EBV+ sarcoma or smooth muscle tumor
Measurable disease using diagnostic CT and/or MRI following RECIST 1.1 criteria (Eisenhauer et al. 2009. Eur J Cancer 45[2]:228-247)
Exclusion Criteria:
Currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment, or known history of human immunodeficiency virus (HIV) infection
Suspected or confirmed Grade >= 2 acute graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system or extensive chronic GvHD per National Institutes of Health (NIH) consensus criteria at the time of the enrollment
Need for vasopressor or ventilatory support at the time of enrollment
Prior therapy (in order of increasing washout period) prior to enrollment as follows:
Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational product and/ or any chemotherapy (systemic or intrathecal), targeted small molecule therapy, or antibody/biologic therapy. Note: prior anti-CD20 antibody use is permitted within the washout period if a subsequent disease response assessment indicates disease progression
Within 8 weeks: prior tabelecleucel (>8 weeks prior to enrollment) is permitted if response was obtained or if usual protocol-directed therapeutic options were not exhausted, for cellular therapies (chimeric antigen receptor therapies directed at T-cells or T-cell subsets, donor lymphocyte infusion, other CTLs or virus-specific T-cells); and/or therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab)
Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above
Women who are breastfeeding or pregnant
Unwilling to comply with protocol specified contraceptive/reproductive restrictions from enrollment through 90 days after the last treatment
Ongoing need for daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis (for participants with CNS disease, protocol-specified dexamethasone is permitted and concludes by the time of enrollment)
Any conditions that may put the study outcomes at undue risk (life expectancy < 60 days or any life-threatening illness, medical condition, or organ system dysfunction)
For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid organ transplant
For participants with EBV+ PTLD: prior systemic therapy for PTLD Clinics and Surgery Center (CSC)
Real-Time Feedback (RTFB) to Improve Colonoscopy
To test whether real-time feedback during the withdrawal phase of colonoscopy improves quality of colonoscopy and the adenoma detection rate.
Piet de Groen
18 years and over
STUDY00007271
Inclusion Criteria:
• Any endoscopist willing to parcipate and performing routine colonscopy
Exclusion Criteria:
• No exclusion criteria
Digestive & Liver Health
Clinics and Surgery Center (CSC)
Mechanisms of a Dynamic Stability Approach
If you have been referred to occupational therapy for thumb carpometacarpal osteoarthritis and you are 18 years or older, you are eligible for this study. Arthritis is the leading cause of disability in the United States, with an estimated 25.6 million Americans affected by osteoarthritis (OA) of the hand. Thumb carpometacarpal osteoarthritis (thumb carpometacarpal (CMC) joint osteoarthritis) is the most common and limiting form of hand osteoarthritis, causing chronic pain, weakness, reduced joint movement, and difficulty carrying out common daily tasks. The purpose of this research study is to find out if an 8-week dynamic stability program can help people with a range of CMC OA severity and symptoms. Dynamic stability (DS) is a new occupational therapy program that uses a series of exercises to strengthen specific muscles around the thumb CMC joint. By strengthening these muscles, the DS approach aims to reduce joint pain, delay further damage, and improve function and participation in daily activities. If you enroll, we expect that you will be in this research study for 9 weeks, for a total of about 15 hours of participation. During the study, you will participate in: 4 occupational therapy (OT) study visits (about 60 minutes each), a home exercise program (15-20 minutes/day) for 8 weeks and, 2 assessment visits (Baseline, and week 9) where we will using Computerized Tomography, a type of X-ray, and ultrasound to take measures of your affected joint and have you complete questionnaires related to pain and disability.
Corey McGee, PhD, MS, OTR/L, CHT
18 years and over
STUDY00015249
Inclusion Criteria:
• Thumb Carpometacarpal (CMC) Osteoarthritis confirmed by xray
• Referred to occupational therapy for treatment of thumb CMC osteoarthritis
Exclusion Criteria:
• Cortisone treatments to the affected thumb within the prior three months
• Hand rehabilitation within the past six months
• thumb CMC joint replacement
• Diagnosis of inflammatory arthritis
Arthritis & Rheumatic Diseases, Bone, Joint & Muscle
Arthritis, Hand Arthritis, Occupational Therapy, Carpometacarpal, Osteoarthritis, Thumb joint, Clinics and Surgery Center (CSC)
Fecal Microbiota Transplant for Postoperative Crohn's Disease
People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery. This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery. Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.
Byron Vaughn
18 years and over
STUDY00014833
Inclusion Criteria:
• 18 years or older
• able to speak English
• have Crohn's Disease (CD) for at least 6 months
• have had an ileocecal resection for CD
• medications stable for at least six months
Exclusion Criteria:
• on antibiotics or probiotics in the last 15 days
• adenomatous polyps that have not been removed
• had subtotal or total colectomy
• current ostomy (ileostomy or colonoscopy)
• anticipate need for surgery or antibiotics during study time frame
• pregnancy
• severe food allergy
• diagnosis of end stage liver disease or cirrhosis
Digestive & Liver Health
Clinics and Surgery Center (CSC), Crohn's Disease, Fecal microbiota, Gut bacteria
Vasomotor symptoms of menopause and cardiovascular disease: What is the link?
Study to examine the physiological responses that occur during a hot flush in postmenopausal women
Manda Keller-Ross
18 years and over
STUDY00013742
Inclusion Criteria:
Participants must have completed menopause and experience either no menopausal hot flashes or experience three menopausal hot flashes a day.
Exclusion Criteria:
• Reported nicotine/tobacco use within the last six months
• Diabetic or asthmatic
• Diagnosed significant carotid stenosis
• History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
• Existing metabolic or endocrine abnormalities
• Use of heart/blood pressure medications that are determined to interfere with study outcomes
• Use of oral contraceptives (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or hormone therapy
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two and three.
• Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
• Unwilling or unable to fast in the eight hours before visit two or three
• Body mass index ? 35 kg/m2
Blood Disorders, Brain & Nervous System, Women's Health
autonomic nervous system, Blood pressure, hot flashes, hypertension, menopause, night sweats